Material Transfer Agreements (and a little about Data Sharing Agreements)

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Material Transfer Agreements(and a little about
Data Sharing Agreements)

• Some Basics
• USC Stevens Center for Innovation
• Judy Genovese, Sr. Transactions Officer
• Sue Kim, Transactions Assistant

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Agenda

• What is an MTA?
• Why is an MTA important?
• Who are the Parties?
• Some critical terms in an MTA

• What is being transferred?
• USCs process
• Our Forms
• Data Use Agreements
• Questions

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What is an MTA?

• A Material Transfer Agreement (MTA) is a contract
  between the USC and a third party.
• An MTA outlines the rights and responsibilities
  of the parties that arise due to the transfer and
  use of the materials.
• Provider
  Recipient

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What is an MTA? Contd

• An MTA is used for the transfer of material that
  will be used for basic research purposes only
  normally no clinical uses are permitted
• An MTA should not have a transfer of funds.

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Why is the MTA important?

• The MTA can affect ownership of the PIs research
  results and his/her ability to publish
• MTAs can protect proprietary material.
• Informs Recipient when Material being transferred
  may be infectious or hazardous.
• Can resolves issues liability, academic credit,
  loss of control of the material, disagreements.

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Why is the MTA important? Contd

• Without an MTA, the recipient of the material has
  free rein over use and further distribution of
  the materials. The provider is giving away the
  materials if an MTA is not in place.
• For transfer of human samples, an MTA is required
  to ensure compliance with law.

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Who are the Parties?

• University of Southern California
• University policy dictates that research
  agreements must be signed by an authorized
  university representative
• Researchers/faculty are not parties
• Third Party-
• Industry
• Government or other Non-profit
• Academic
• Two USC Faculty

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Types

• University to University
• Uniform Biological Material Transfer Agreement
  (UBMTA) can be used.
• University to Industry
• Industry to University
• Non-Profit/Government to University
• University to Non-Profit/Government
• Intra-University

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Some Critical Terms in MTAs

• Definitions
• Scope of research work
• Research purposes only (non-commercial)
• No in-vivo testing
• Compliance with Federal rules and regulations
• Confidentiality
• Re-distribution of material
• Disclaimers warranties

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Some Critical Terms contd

• No grant of license
• Acknowledgment in publications, possible
  co-authorship
• Ownership of Results
• Results
• Encompasses a fairly broad range of items
• IP, discoveries, public disclosures, data

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What is being transferred?

• Biological materials
• E.g. cell lines, mice, tissue samples, DNA, etc.
• Note Generally, Material includes Progeny and
  Unmodified Derivatives, but does not include
  Modifications
• Chemical materials
• E.g. Salts, analogs, formulations, compounds,
  etc.
• Prototypes
• ???Software???

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Inbound vs. Outbound

• Inbound Material

• Outbound Material

• A USC PI is receiving material from another
  party.
• Other party provides their MTA template for our
  review.
• Our PI is restricted to the terms of the MTA in
  order to protect other partys interests.
• PI must have applicable approvals in place before
  using material (IRB, IBC, IACUC)

• A USC PI is providing material to another party.
• We provide our MTA template for the other partys
  review.
• We want to protect potentially proprietary and
  valuable IP.
• We want to protect university and PI interests.
• We must be sure we have the right to provide the
  material.
• PI must have applicable approvals in place before
  sending material (IRB, IBC, IACUC, shipping
  training)

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Example (inbound material)

• Dr. Cardinal, A USC Principal Investigator (PI),
  is studying effects of alcohol on the liver.

• He reads in a publication that Dr. Blue, his
  colleague at UCLA has created a unique mouse
  strain that could aid in his research.

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Example, contd

• Dr. Cardinal emails Dr. Blue and asks for a
  breeding pair of these new unique mice.
• Dr. Blue, wanting to protect his new invention,
  responds, Why certainly! Please sign this MTA
  first.

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Example, contd

• Dr. Cardinal, knowing the drill on MTAs, forwards
  the agreement to us at USC Stevens Center for
  Innovation so we can review and sign the MTA on
  behalf of the USC.
• We will notify the PI if there are non-standard
  terms in the MTA.

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USCs Process

• The completed MTA form and any questions can be
  sent to mta_at_stevens.usc.edu

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Data Sharing Agreements

• A Data Sharing Agreement (DA) handled by USC
  Stevens Center is a contract covering the
  transfer of non-public or restricted data to or
  from a nonprofit, government or private industry
  for research use.
• Data Agreements often have other names,
  including Data Use Agreements, Letters or
  Memoranda of Understanding, Data Consortium
  Agreements, etc.

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Data Sharing Agreements

• For researchers at USC the same process is
  followed for DAs as MTAs
• Exception when information subject to HIPAA or
  privacy laws is involved.
• Review by USCs Office of Compliance in addition
  to the other MTA steps.
• USC Stevens handles obtaining Compliance review

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Data Sharing Agreements

• Identifiable Health Information
  questions/categories are listed in the MTA Intake
  forms (See Appendix, 24 on incoming form and 19
  on outgoing form)
• USC Stevens Center is working with compliance to
  expand the list to be sure it includes all
  Identifiable Health Information and non-health
  privacy related information
• NOTE Identifiable Health Information can
  sometimes be provided (intentionally or not) with
  material transferred under an MTA. Care and
  attention should be used to identify and deal
  with any such information as in any other
  circumstance.

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The Limited Data Set from the HIPAA Privacy
Rule

• Not to be confused with Data Agreements as
  negotiated by USC Stevens Center /Compliance
  Office
• Covered entities may use or disclose health
  information that is de-identified without
  restriction under the Privacy Rule. Covered
  entities seeking to release this health
  information must determine that the information
  has been de-identified using either statistical
  verification of de-identification or by removing
  certain pieces of information from each record as
  specified in the Rule.

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The Limited Data Set from the HIPAA Privacy
Rule

• A covered entity may de-identify data by removing
  all 18 elements that could be used to identify
  the individual or the individual's relatives,
  employers, or household members these elements
  are enumerated in the Privacy Rule.
• The covered entity also must have no actual
  knowledge that the remaining information could be
  used alone or in combination with other
  information to identify the individual who is the
  subject of the information.

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The Limited Data Set from the HIPAA Privacy
Rule

• Under the de-identification method, the
  identifiers that must be removed are the
  following
• Names.
• All geographic subdivisions smaller than a state,
  including street address, city, county, precinct,
  ZIP Code, and their equivalent geographical
  codes, except for the initial three digits of a
  ZIP Code if, according to the current publicly
  available data from the Bureau of the Census
• The geographic unit formed by combining all ZIP
  Codes with the same three initial digits contains
  more than 20,000 people.
• The initial three digits of a ZIP Code for all
  such geographic units containing 20,000 or fewer
  people are changed to 000.
• All elements of dates (except year) for dates
  directly related to an individual, including
  birth date, admission date, discharge date, date
  of death and all ages over 89 and all elements
  of dates (including year) indicative of such age,
  except that such ages and elements may be
  aggregated into a single category of age 90 or
  older.

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The Limited Data Set from the HIPAA Privacy
Rule

• Telephone numbers.
• Facsimile numbers.
• Electronic mail addresses.
• Social security numbers.
• Medical record numbers.
• Health plan beneficiary numbers.
• Account numbers.
• Certificate/license numbers.
• Vehicle identifiers and serial numbers, including
  license plate numbers.
• Device identifiers and serial numbers.
• Web universal resource locators (URLs).

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The Limited Data Set from the HIPAA Privacy
Rule

• Internet protocol (IP) address numbers.
• Biometric identifiers, including fingerprints and
  voiceprints.
• Full-face photographic images and any comparable
  images.
• Any other unique identifying number,
  characteristic, or code, unless otherwise
  permitted by the Privacy Rule for
  re-identification.

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Questions?

• Judy Genovese
• jgenoves_at_stevens.usc.edu
• Sue Kim
• suekkim_at_stevens.usc.edu
• MTA email address
• mta_at_stevens.usc.edu
• MTA website
• http//stevens.usc.edu/mta.php

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Appendix
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Appendix contd
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Appendix contd

• UBMTA
• http//www.autm.net/AM/Template.cfm?SectionTechno
  logy_Transfer_ResourcesTemplate/CM/ContentDispla
  y.cfmContentID2810
• UBMTA Signatories
• http//www.autm.net/AM/Template.cfm?SectionTechno
  logy_Transfer_ResourcesTemplate/CM/ContentDispla
  y.cfmContentID8374