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    Agreements (Material Transfer)

 

  • A material transfer agreement (MTA) is a type of legal document popularized in the 1980s, intended to both facilitate the exchange of research data and to define the conditions under which the party providing such research data will allow the party receiving such research data to use such research data.

 

  • In legal terms, an MTA is deemed to create a bailment, in which only the actual possession (whether permanently, or for a specified period of time) of the specified materials but not the title thereto (which is retained by the provider of the materials) is transferred from the providing party to the recipient party (which then holds such transferred materials in trust, for the benefit of the provider of such transferred materials).

 

  • MTAs are prevalent in both academia and in many industries, but are generally more-prevalent in academia, where the unimpeded exchange of information is more collegial, and is treated as being essential to furthering general intellectual progression and to achieving collaborative solutions to critical problems (generally in the field of human health), as opposed to industry, which is both secretive by nature and profit-driven by necessity.

 

  • Material transfers between private and public sector institutions are typically much more complex than transfers between two academic institutions and may be more prone to failure, particularly when the transfer is from a company to an academic institution, because of the different mindsets of such entities (companies are profit-driven, whereas academic institutions are results-driven).

 

  • The National Institutes of Health (NIH) have published a Uniform Biological Material Transfer Agreement (UBMTA) and a Simple Letter Agreement for the Transfer of Non-proprietary Biological Material (Sample Letter) that are widely used by numerous institutions in academic circles , under which, if both parties have previously-approved the use of the UBMTA master agreement, any transfer or materials under such UBMTA terms requires only an Implementing Letter between the parties.

 

  • Any academic institution that receives any funding from the Federal government must ensure that all their MTAs comply with all NIH guidelines and policies, such as the Principles and Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.

 

  • There is no approved industry-standard MTA form of agreement, so the parties are free to negotiate whatever terms and conditions they wish to apply to any particular materials transfer situation.

 

  • MTAs may be used by technology transfer offices (TTO) in academic institutions or by legal departments in corporations to memorialize any materials transfer transaction between parties for particular specified uses, of perhaps actual physical assets, or raw research data, or sophisticated proprietary intellectual property (IP) rights.

 

  • In general, a well-drafted MTA must, at a minimum: delineate the duties and responsibilities of the providers and recipients of materials; describe in detail the materials to be transferred; the consideration (whether money or other tangible benefit in terms of collaboration, shared research, or the like) to be exchanged in return; any terms and conditions placed on the use of the transferred materials by the provider of such materials; any exclusivity limitations (meaning the number of third-parties, if any, with whom the receiver of the transferred materials may share them); the identification of the parties; contact information for the parties; term of the agreement; data privacy; data security; indemnification; insurance; limitation of liability; disclaimer of damages (such as consequential, incidental, lost profits, special or the like); compliance with all applicable domestic and international laws; confidentiality; non-compete; non-disclosure; non-solicitation; change in ownership; consequences of ;governing law; governing language; dispute resolution protocol; dispute resolution venue; independent contractor status statement; no assignment without prior consent; order of precedence for attachments and exhibits; full contact information for notices; UCC title considerations, if any; representations and warranties; termination (whether for cause or without cause, and outlining all the predicate events of breach and default); a detailed description of IP ownership and rights between the parties; all the relevant definitions for important terms used in the agreement (in particular, for any IP technical terms that may be necessary to understand the use of the license being granted to the licensee); and the like.

 

  • MTAs may be either incoming (for recipients of transferred materials) or outgoing (for providers of outgoing materials).

 

  • All MTAs, whether incoming or outgoing, should undergo an internal review board (IRB) compliance review before being sent, to check (depending upon the subject matter of the materials to be transferred) issues such as: the care and use of animals; the handling of human matter, pursuant to the Federal Policy for the Protection of Human Subjects (also known as the "Common Rule"), Code of Federal Regulations (CFR) 45 CFR 46 Subpart A; compliance with all applicable Federal and state data privacy and security laws; compliance with all applicable Federal and state hazardous materials ("hazmat") laws; any potential conflicts of interest; and, any requirements for licenses from the Bureau of Industry and Security (BIS) or the Department of Commerce for any export-controlled material to be transferred.

 

    Last updated 201020_1340

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