Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Practice Tip: Keys to Successful Negotiation of Clinical Trial Agreements
Clinical (human) trials are essential to pharmaceutical companies that develop and market new drugs. They are required by the United States Food & Drug Administration (“FDA”) both prior to approval of the drug for marketing, and during post-approval marketing, as a means of evaluating the drug's safety and efficacy. Without clinical trials, a drug will not reach the market. Clinical trial agreement (“CTA”) negotiation has become the most common cause of delay in studies. Because the cost of bringing a new drug to market is astronomical, pharmaceutical companies typically lose millions of dollars per week as a result of any delay in the process.
In order to conduct a clinical trial, a pharmaceutical company (the “Sponsor” of the trial) typically contracts with hospitals and universities (the clinical trial “Sites” or “Institutions”) and at times physicians (“Investigators”) to conduct research. The resulting clinical trial agreement can cover many topics, including, but not limited to, each party's duties, payment terms, payment amounts, confidentiality, ownership of intellectual property, publication rights and financial responsibility for any injuries caused. As is true with many contracts, huge financial gains and losses can result based on the wording.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.