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III. Agreements to Transfer Materials

D. Other Specialized Material Transfer Agreements

1. Materials In Repositories

The point of a repository is to enable researchers to access samples of research materials, typically biological materials, from a centralized source. Some of the Institutes at the NIH maintain repositories of biological materials, including transgenic animals, cDNA clones, and viruses. The NCI maintains a special repository of natural products collected from around the world. Private entities, such as American Type Culture Collection and the Jackson Laboratories, maintain repositories for public access.

Use of repositories raises one common issue relating to MTAs, specifically, relating to "background rights." When the creator of the materials places a supply in the custody of a repository, the creator may have filed patent applications on the materials, and may demand that the repository put restrictions on the further distribution of the materials. Normally, these restrictions are similar to those that would appear in a standard MTA (i.e., don’t do anything stupid or unethical with the materials). Occasionally, the creator demands that the repository extract "reach-through" rights from any recipient for the benefit of the creator. Those who would access a private repository should be vigilant for such terms.

The NCI natural-products repository has a unique twist, which is serving as a model for transnational research in other arenas. NCI’s authority under the law to control what happens to materials it sends out of a repository is severely limited. Because most of the materials were collected from developing countries, the NCI negotiated agreements with these countries, trying to find ways within U.S. law to ensure that a significant portion of any economic benefits derived from materials collected would flow back to the country of origin. Ultimately, the NCI established a Memorandum of Understanding with each source country, which has resulted in the favorable cooperation of -- and even collaboration with -- the local scientists and universities in these countries.

2. Software Transfer Agreements

Suppose a scientist at NIH wants to work on software now under development. If the software was written by a potential collaborator, can a Material Transfer Agreement be used to allow the collaborator to transfer the software? Alternatively, what about transferring the software out? The answer to both is a qualified "yes."

On a superficial level, the use of an MTA should be legally sufficient to permit the transfer of the physical floppy disk or CD containing the code. On a deeper, more theoretical level, the issue is somewhat more complicated. Specifically, it is not clear whether the NIH’s authority to transfer biological materials 37

42 U.S.C. § 282(c) ("substances and living organisms").

includes the intangible essence of software code (separated from the physical media on which it is written).

Regardless, an agreement to transfer software must always conform to all laws and NIH policies, such as that the software is not commercially available, and that the provider does not demand reach-through to NIH inventions. The NIH Office of the General Counsel has approved use of a software transfer agreement by some of the Institutes; hopefully the PHS Technology Transfer Policy Board soon will adopt a version as the PHS Model Software Transfer Agreement.

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Page Last Updated: 12-02-2008