A version of this article appeared in The Journal of Biolaw and Business, Vol. 6, No. 4, 2003
This article addresses contractual and intellectual property considerations that frequently arise in the drafting and negotiation of sponsored research agreements (“SRAs”), license agreements with universities (and other non-profit organizations) and the federal government, and clinical trial agreements. Each of these subjects is addressed separately, but most of the article and much of this portion of the program will be devoted to sponsored research, which is the driver for much of the innovation in the medical and life sciences industries. Article I below discusses SRAs in some detail; Article II focuses on a few key provisions of license agreements with universities and non-profits; and Article III is a very brief overview of clinical trial agreements, the terms of which are frequently dictated by the hospital (especially if it is a prominent teaching hospital) employing the clinical investigator. Included in the Appendix are a few model agreements and sample actual agreements (redacted, of course) and other relevant materials. A disclaimer: My background in this practice area is representing the pharmaceutical company. As a result, this article is biased towards that perspective.
I. Sponsored Research Agreements
II. University and Government License Agreements
III. Clinical Trial Agreements
A. Publication of Results
B. Who Owns What
C. Indemnification; Insurance
To read the full article, Special Contractual and Intellectual Property Rights Considerations, please download the PDF.
Or for more information, please contact the author Jeffrey P. Somers.
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