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What is a “Biological Material Transfer Agreement” and When to Use It

A biological transfer agreement is a written contract between a provider of biological material to another, generally an entity engaged in biomedical research. The agreement is designed to govern the rights and obligations of the parties in connection with biologic materials such as cells, reagents, and plasmids, although these types of agreements sometimes govern other materials such as chemical compounds. They are typically used by educational institutions and others engaged in research for medical purposes.

Most biological material transfer agreements restrict the user of the materials transferred to use those materials for specific purposes and by specific individuals. They also generally require that the materials transferred be utilized for academic and scientific purposes as opposed to commercial uses. While the materials transferred under the agreement cannot be sold for profit, some agreements permit the derivatives of the materials transferred to be sold or transferred for commercial purposes.

Any time biological materials are transferred from their owner to a recipient, it is extremely important to ensure the transfer is the subject of an agreement. To highlight how important the need for an agreement is, consider the California Supreme Court opinion in Moore v. Regents. University of California, 51 Cal.3d 120, 793 P.2d 479 (1990). In the Moore case, a physician employed by the University of California, Los Angeles, treated Mr. Moore for hairy-cell leukemia. During the course of that treatment, the physician removed Mr. Moore’s spleen after informing him that it was necessary to slow the progress of his disease. Mr. Moore signed a consent for the splenectomy but was not told that the physician and another researcher of the Regents of the University of California (“Regents”) intended to utilize portions of the spleen for research purposes.

Several other samples of Mr. Moore’s tissue was taken by the physician and used for research purposes, and the Regents assisted with the physician in negotiating agreements for the commercial development of a “cell line and products derived from it” to produce lymphokines with The Genetics Institute, Inc. Mr. Moore sued UCLA, the Regents, the physician and the researcher, and The Genetics Institute, Inc. for thirteen causes of action, including breach of fiduciary duty, lack of informed consent, and conversion of the spleen for profit and sought damages.

In the Moore case, Mr. Moore essentially claimed that there was no agreement with him by any of the defendants for the transfer or use of his organ and tissue and claimed that he had the right to recover his property (his spleen) as well as any profits (which were expected to be sizeable) derived from those tissues. This case presents a classic case which could have been completely avoided had the doctors, as well as the Regents, simply disclosed their intentions to Mr. Moore and gained his agreement for the use of his tissue.

If you are engaged in any aspect of biomedical research in California, before you agree to any use of human tissue for commercial or academic purposes, you must obtain the services of a qualified and experienced attorney. With a background in biology, chemistry and mathematics, Michael Leonard, Esq. of San Diego Corporate Law is just such an attorney. To schedule a consultation with Mr. Leonard to discuss any business-related matter, you can visit San Diego Corporate Law or call (858) 483-9200.

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