Archive for February, 2020

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Q&A on FDA’s Requirements Related to Financial Disclosure by Clinical Investigators

What financial arrangements between clinical trial sponsors and clinical investigators must be disclosed in a drug, biologic or device marketing application? In a marketing application, FDA requires that four types of financial arrangements be disclosed: (1) any financial arrangement between the sponsor and the investigator whereby the value of the…

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What has contributed to the rising cost of Directors and Officers (D&O) Liability Insurance for new public companies?

Over the past year, the cost of obtaining D&O insurance for new public companies has increased substantially. Rates have increased from $50-60,000 per million dollars of coverage to over $150,000 per million dollars of coverage. Along with increased premiums, retention amounts have increased substantially (from $5 million to $10 million for…

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When does my patent expire?

To determine when your (or your competitor’s) patent expires, first identify the correct filing date of the patent application. A U.S. utility patent (filed on or after June 8, 1995) expires 20 years from the earliest filing date of the patent. If the patent claims priority to an earlier patent…

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I want to engage a consultant to provide services on behalf of the company, but that consultant is a professor at an academic institution. Can I still do so?

Yes. Many life sciences and biotech clients work with consultants that are associated with academic or research institutions. However, in considering whether to engage such a consultant, life sciences companies should be aware that the consultant will be subject to the intellectual property and conflict of interest policies of the…

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I want to license technology out of an academic or research institution. What kind of compensation will the institution typically look to receive?

Academic or research institutions are at the core of early-stage innovation in the life sciences and biopharmaceutical industries. In order to gain access to the intellectual property generated or owned by those institutions, institutions typically offer to grant a license to its owned intellectual property to companies. In exchange for…

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