Failing to contractually address well-known "hot-button" issues, and hoping (essentially holding your breath) that contractual
disputes will not arise and litigation will be unnecessary is a recipe for disaster. Suppliers and purchasers are well advised
to negotiate commercial-supply agreements in advance of problems, spelling out the parties respective rights and obligations.
Because of the substantial financial and legal risks, purchase-order contracting in pharmaceutical transactions should generally
Stephen D. Sayre is a member of Dykema's corporate finance department and Todd Grant Gattoni* is a member of Dykema with his
practice concentrated on products liability, business, and chemical exposure toxic-tort litigation, including pharmaceutical
and medical device manufacturers in mass tort and class-action lawsuits involving commercial-supply agreements, 400 Renaissance
Center, Detroit, MI 48243, tel. 313.568.5318, fax 313.568.6893, firstname.lastname@example.org
* To whom correspondence should be directed.
1. FDA, The Center for Drug Evaluation and Research's Report to the Nation: 2005 (FDA, Rockville, MD, 2005), http://
http://www.fda.gov/cder/reports/rtn/2005/rtn2005.PDF, accessed Aug. 27, 2007.