U.S. Departm·ent of Agriculture 

Food Safety and Inspection Service; 

U.S. Department of Health and Human Services 

U.S. Food and Drug Administration 

MATERIAL TRANSFER AGREEMENT 

PARTIES: 

U.S. Department ofAgriculture (USDA) 

Food Safety and Inspection Service (FSIS) 

Office ofPublic Health Science 

Room 341-E, Whitten Bldg. 

·1400 Independence Ave, SW 

Washington, DC 20250 

Phone: (202) 720-2644 

Fax: (202) 690-2980 

FDA: U.S. Depaiiment ofHealth and Human Services (DHHS) 

U.S. Food and Drug Administration (FDA) 

10903 New Hampshire A venue 

Silver Spring, MD 20993 

PURPOSE: 

This document details the procedure for the interagency exchange of biological materials, pathogens, 

toxins, genetic elements, chemicals and associated knowledge, hereinafter collectively referred to as 

the "MATERIAL" between U.S. Department of Agriculture, Food Safety and Inspection Service 

(FSIS) and the U.S. Department of Health and Human Services, Food and Drug Administration 

(FDA). Patented material and human materials may not be exchanged under this Material Transfer 

Agreement (MT A). 

DEFINITIONS: 

PROVIDER: Paiiy providing the MATERIAL. The name and address of this party will be included 

in Template 1. 

PROVIDER Contact Official: The name and addl'ess of the PROVIDER contact official will be 

included in template 1. 

RECIPIENT: Party receiving the MATERIAL. The name and address of this party will be specified 

in Template 1. 

RECIPIENT Scientist: The name and address of the RECIPIENT scientist who will receive the 

MATERIAL will be included in Template 1. 

FSIS-FDA Materials Transfer Agreement Page 1 of5 
RECIPIENT Supervisor: The name and address of the RECIPIENT scientist's supe1visor will be 

specified in Template 1. , · 

THIRD PARTY: Organization (typically a university or state public health agency) receiving the 

MATERIAL from the RECIPIENT with approval from the PROVIDER. 

MATERIAL: Biological materials, pathogens, toxins, genetic elements, chemicals and associated 

knowledge to be shared between Parties. The description of and anticipated use for the material to be 

transferred will be specified in Template 1. 

GENERAL PROVISIONS: 

The PROVIDER will release the MATERIAL to RECIPIENT under the following conditions: 

1. The MATERIAL shall be used only by RECIPIENT scientists supervised by the RECIPIENT 

supervisory scientist identified in Materials Transfer Agreement Template 1. Subsequent 

distribution may be authorized as specified below. 

2. RECIPIENT scientist will send requests for MATERIAL to the PROVIDER contact official 

using Material Transfer Agreement Template 1: Request for Materials and Data Reporting 

Requirements. 

3. PROVIDER and RECIPIENT shall specify data reporting expectations in Materials Transfer 

Agreement Template 1, Section B: Data Reporting Requirements in accordance with FSISFDA Materials Transfer Agreement (MTA). 

4. PROVIDER will transfer the MATERIAL to RECIPIENT after the appropriate Material 

Transfer Agreement Template 1 is received and the PROVIDER internal documents are 

completed and approved. 

a. Copies of the approved Template 1 shall be forwarded via email or fax to the 

originating RECIPIENT scientist and the RECIPIENT supervisor (as specified on 

Template 1). 

b. The PROVIDER Contact Official has the prerogative, after consulting the appropriate 

scientific and/or administrative staff, to deny, delay, or alter the request as appropriate. 

c. If the MATERIAL is not received within 14 days ofrequest, the PROVIDER Contact 

Official will explain via electronic-mail to the RECIPIENT scientist and RECIPIENT 

supervisor why the MATERIAL cannot be shipped at this time. 

d. One submitted and approved Materials Transfer Agreement Template 1 will suffice for 

ongoing requests for the same Material, not to exceed two years from approval date. 

5. RECIPIENT will provide the PROVIDER Contact Official with a copy of any communication 

(e.g. manuscript, abstract and/or document) intended for release outside ofthe RECIPIENT or 

PROVIDER organizations that describes the work with the MATERIAL prior to submission 

for publication. RECIPIENT will acknowledge PROVIDER contribution to the work 

FSIS-FDA Materials Transfer Agreement Page2 of5 
(includ,ing acknowledgement of PROVID~R as the source of the MATERIAJ;.,). On joint 

FSIS-FDA projects, collaborative authorship is expected. · 

a. Prior to the RECIPIENT'S submission of a paper and/or abstract for publication or any 

other fonn of public disclosure about data or results generated from the use of the 

MATERIAL, the PROVIDER will have thirty (30) days to review the proposed 

manuscript(s), abstract(s), etc. 

b. If at the end ofthe review period, there is no comment from the PROVIDER, then the 

RECIPIENT will be free to publish or otherwise publicly disclose. 

c. Umesolved disagreements between the PROVIDER's edits/requests and RECIPIENT's 

paper/abstract author will be resolved by an adhoc committee consisting of FDA 

Center-Level Leadership and appropriate PSIS Assistant Administrator(s). 

6. RECIPIENT shall not transfer the MATERIAL, in whole or in pa.it, to a THIRD PARTY 

without written consent from PROVIDER. RECIPIENT will use the Material Transfer 

Agreement Template 2: Request to Transfer Material to Third Party to request such approval° 

from PROVIDER Contact Official. 

a. Copies of the approved Template 2 shall be forwarded via email or fax to the 

originating RECIPIENT scientist and the RECIPIENT supervisor ( as specified on 

Template 1 ). 

b. The PROVIDER Contact Official has the prerogative, after consulting the appropriate 

scientific and/or administrative staff, to deny, delay, or alter the request as appropriate. 

c. If the request (Template 2) is not approved within 14 days of being received by 

PROVIDER, the PROVIDER Contact Official will explain via electronic-mail to the 

RECIPIENT scientist and RECIPIENT supervisor why the request cannot be approved 

at this time. 

d. One submitted and approved Materials Transfer Agreement Template 2 will suffice for 

ongoing requests for the same Material, not to exceed two years from approval date. 

7. When transferring the MATERIAL to a THIRD PARTY, RECIPIENT shall indicate that: 1) 

the source of the MATERIAL is the PROVIDER, 2) the MATERIAL shall remain the 

property of PROVIDER and 3) the MATERIAL shall not be used for commercial purposes 

without appropriate license(s) and/or agreement(s) from PROVIDER. Any THIRD PARTY 

Recipient of the MATERIAL shall use the same degree of care to protect Confidential or 

Proprietary Information received under this Agreement as it uses to protect its own 

information of a similar nature, but in any event not less than reasonable care under the 

circumstances. 

8. If FSIS and FDA decide to engage in additional activities using the MATERIAL, these 

Agencies will develop a formal lnteragency Agreement, Memorandum of Understanding, or 

other research agreement. Negotiation, execution, and administration of each such agreement 

must comply with all applicable statutes and regulations. 

9. Upon completion ofRECIPIENT's activities using the MATERIAL, RECIPIENT and THIRD 

PARTY shall return, destroy, or otherwise dispose of the MATERIAL as instructed by the 

PROVIDER. 

FSIS-FDA Materials Transfer Agreement Page3 ofS 
10. FDA an~ FSIS representative(s) shall meet to determine inventorship if an invention should 

arise during RECIPIENrs work with the MATERIAL. . 

11. FDA and FSIS shall exclude MATERIAL from the confidentiality requirements of this 

Agreement if: (1) RECIPIENT had possession of the MATERIAL prior to the PROVIDER 

providing the MATERIAL; (2) the MATERIAL is generally available to the public at the time 

of the PROVIDER provides the MATERIAL; (3) the MATERIAL becomes generally 

available to the public through no fault of RECIPIENT after PROVIDER provides the 

MATERIAL; or ( 4) after PROVIDER provides the MATERIAL, the RECIPIENT receives the 

MATERIAL from a third party having the right to the MATERIAL and who does not impose 

a confidentiality obligation upon the RECIPIENT. 

12. This research MATERIAL is provided as a service to the research community. It is being 

supplied to the RECIPIENT with no warranties, expressed or implied, including any warranty 

of merchantability or fitness for a particular purpose. The PROVIDER makes no 

representation that the use of the research MATERIAL will not infringe any patent or 

proprietary rights ofthird parties. 

13. FDA and FSIS acknowledge and agree to comply with all applicable laws, permits, and 

regulations including those ofthe USDA Animal and Plant Health Inspection Service, and the 

Centers for Disease Control and Prevention pertaining to possession, handling, shipment or 

transfer of technical information, biological materials, pathogens, toxins, genetic elements, 

genetically engineered microorganisms, vaccines, and similar agents. THE MATERIAL MAY 

NOT BE USED IN HUMAN SUBJECTS. 

14. Nothing in this Material Transfer Agreement shall obligate either FDA or }?SIS to obligate or 

transfer any funds. 

15. This Material Transfer Agreement shall be construed in accordance with United States of 

America Federal Law as interpreted by the Federal Courts in the District ofColumbia. 

16. This Material Transfer Agreement shall become effective upon the date of the final signature 

and shall continue in effect for a period offive years. Either FDA or FSIS may terminate this 

Material Transfer Agreement with a 60wday written notice; however, its terms will remain in 

effect for any MATERIAL that has already been transferred for two years from the date ofthe 

transfer. 

FSISwFDA Materials Transfer Agreement Page4of5 
AI Alman 

Administrator, FSIS 

/' 

i 

ETY AND INSPECTION SERVICE 

///j 3(1 2..-

Date 

1400 Independence Ave., SW 

Washington, DC 20250-3700 

202-720-7025 (o) 

Davia ~)~ Goldman, MPH 

Assistant Administrator, Office ofPublic Health Science, FSIS 

Room 341-E, Whitten Bldg. 1400 Independence Ave, SW 

Washington, DC 20250 

202-720-2644 ( o ); 202-720-2644(m) 

David.Goldman@fsis.usda.gov 

Date 

Dav· . White, PhD 

Chief Scientist (Acting) 

Office ofFoods and Veterinary Medicine 

MOD2 Gl0l,HFV-500 

8401 Muirkirk Road 

Laurel, MD 20708 

301-21 '.'_ 187 ); 240-475-3597 (m) 

Senior cience Advisor 

Center for Food Safety and Applied Nutrition 

CPKl RM4A004, HFS-006 

5100 Paint Branch Parkway 

College Park, MD 20740 

240-402-16~.{o); 240-216-1456 (m) 

Dona~d,', 

- M 

~ 

. z rrM . 

William B. Martin, Phi) 

Senior Advisor for Science (Acting) 

Office ofRegulatory Affairs I 

W031 Rm3542, HFC-1, 10903 New Hampshire Ave, I 

I 

Silver Spring, MD 20993 

301-796-8802 (o); 2400216-1456 (m) 

William.Martin@fda.hhs.gov 

FSIS-FDA Materials Transfer Agreement Page 5 ofS 
FSIS-FDA Materials Transfer Agreement (MTA) Template 1: 

Request for Materials and Data Reporting Requirements 

Request Date: 

PROVIDER: Organization providing MATERIAL 

Organization: 

RECIPIENT: Organization receiving MATERIAL 

Organization: 

Section A: Request for Materials 

Description of MATERIAL (type, quantity, frequency): 

Description of project: 

Purpose/Potential l_mpact: 

Analyses to be performed: 

Section B: Data Reporting Requirements 

PROVIDER will provide RECIPIENT with the following: 

Data Description: 

Frequency of Data Transfer: 

Data Format: 

Transfer Procedures: 

RECIPIENT will provide PROVIDER with the following: 

Data Description: 

Frequency of Data Transfer: 

Data Format: 

Transfer Procedures: 

Page 1 of 3 
----

----

FSIS-FDA Materials Transfer Agreement (MTA) Template 1: 

Request for Materials and Data Reporting Requirements 

Section C: Contact Information and Signatures 

PROVIDER scientist Information: 

From: (Name of PROVIDER scientist) 

(Lab Name) 

(Address) 

{Telephone: Number) 

(Fax: Number) 

(Email) 

Through: (Name of PROVIDER supervisor*) 

(Agency/Lab Unit) 

(Lab Location) 

Signature:___________ Date: 

RECIPIENT Scientist Information: 

From: (Name of RECIPIENT scientist) 

(Lab Name) 

(Address) 

(Telephone: Number) 

(Fax: Number) 

(Email} 

Through: (Name of RECIPIENT supervisor*) 

(Agency/Lab Unit) 

(Lab Location) 

Signature:___________ Date: 

*Supervisor= Branch Chief (FSIS) or Division Director (FDA) 

Page 2 of 3 
------

FSIS-FDA Materials Transfer Agreement (MTA) Template 1: 

Request for Materials and Data Reporting Requirements 

Email scanned copy to appropriate Agency Coordinators: 

FDA: 

Contact Official 

Center for Food Safety and Applied Nutrition 

5100 Paint Branch Parkway 

College Park, MD 207 40 

Contact Official 

Center for Veterinary Medicine 

8401 Muirkirk Road 

Laurel, MD 20708 

Contact official 

Office of Regulatory Affairs 

10903 New Hampshire Ave, 

Silver Spring, MD 20993 

FDA Internal Contract ID: ______ 

FDA Laboratory(ies) involved: ______ 

FSIS: 

FSIS LQAD Branch Chief/Contact Official 

Laboratory Quality Assurance Division 

USDA FSIS OPHS 

950 College Station Rd. 

Athens, GA 30605 

Internal References: 

FSIS Internal Contract ID: R 

FSIS Laboratory(ies) involved: ______ 

Page 3 of 3 
----

FSIS-FDA Materials Transfer Agreement (MTA) Template 2: 

Request to Transfer Materials To Third Party Laboratory 

Request Date: 

PROVIDER: Organization providing MATERIAL 

Organization: 

RECIPIENT: Organization receiving MATERIAL 

Organization: 

OTHER LABORATORY: Organization receiving MATERIAL from RECIPIENT 

Organization: 

PROVIDER Information: 

(Name of PROVIDER supervisor*) 

(Agency/Lab Unit) 

(Lab Location) 

(Address) 

(Telephone: Number) 

(Fax: Number) 

(Email) 

Signature:___________ Date: 

RECIPIENT Scientist Information: 

(Name of RECIPIENT supervisor*) 

(Agency/Lab Unit) 

(Lab Location) 

(Address) 

(Telephone: Number) 

(Fax: Number) 

(Email) 

Signature:___________ Date:----

Page 1 of 3 
FSIS-FDA Materials Transfer Agreement (MTA) Template 2: 

Request to Transfer Materials To Third Party Laboratory 

Intended OTHER LABORATORY Recipient: 

(Name of OTHER LABORATORY supervisor*) 

(Agency/Lab Unit) 

(Lab Location) 

(Address) 

(Telephone: Number) 

(Fax: Number) 

(Email) 

Description of Materials: 

Description of Other Laboratory project: 

Other Laboratory Purpose: 

Analyses to be performed by Other Laboratory: 

* Supervisor= Branch Chief (FSIS), Division Director (FDA) or equivalent (Other Laboratory) 

Page 2 of 3 
FSIS-FDA Materials Transfer Agreement (MTA) Template 2: 

Request to Transfer Materials To Third Party Laboratory 

Email scanned copy to appropriate Agency Coordinators: 

FDA: 

Contact Official 

Center for Food Safety and Applied Nutrition 

5100 Paint Branch Parkway 

College Park, MD 207 40 

Contact Official 

Center for Veterinary Medicine 

8401 Muirkirk Road 

Laurel, MD 20708 

Contact official 

Office of Regulatory Affairs 

10903 New Hampshire Ave, 

Silver Spring, MD 20993 

FDA Internal Contract ID: ------

FDA Laboratory(ies) involved: ______ 

FSIS: 

FSIS LOAD Branch Chief/Contact Official 

Laboratory Quality Assurance Division 

USDA FSIS OPHS 

950 College Station Rd. 

Athens, GA 30605 

Internal References: 

FSJS Internal Contract ID: R-~----

FSIS Laboratory(ies) involved: ______ 

Page 3 of 3