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Life sciences companies often turn to geographical licensing to realise the maximum value from their assets, and to ensure their products reach markets worldwide, particularly where they do not have a global footprint. In the context of a collaboration agreement, the owner of certain intellectual property rights may collaborate with…
Flexibility provides the greatest value in laboratory space design for both owners and users of life sciences real estate. Science and technology are evolving at such a rapid pace that it is difficult to predict future needs. Bespoke spaces can become obsolete before they are even occupied. Spaces that can…
In this post, we discuss FDA’s conduct of inspections of manufacturing facilities for new drugs and biologics during the COVID-19 pandemic. These inspections, known as pre-approval and pre-licensure inspections (PAIs/PLIs, respectively), are performed to give FDA assurance that a manufacturing site named in a new drug or biologics license application…
When submitting a new drug application (“NDA”) with the FDA, an applicant (or branded company) is required to file a list of patents that cover the drug product. These patents will be listed in the FDA’s Orange Book upon approval of the drug for commercial sale. Patents that are eligible…
The process of underwriting tenants can be complex at the best of times, even more so when you add the particular requirements of early stage and/or fast growing life sciences companies and a global pandemic into the equation. With that in mind, we have summarized a few of the key…
Life sciences real estate clusters Record investment in the life sciences sector has created geographic concentrations of interconnected life sciences companies and institutions, or “clusters,” forming in key global locations, including the U.S. and the UK. The forming of clusters has been driven by a variety of factors, including a…
