What do we mean by R&D materials?
R&D materials are all property and materials deployed in and resulting from research & development operations. This includes cell lines and cultures, clinical trial samples models, moulds and prototypes. It may also include written, printed or inscribed documents, lab books, plans, records, formulas or processes.
Why is specialist insurance required?
The business model of many biotechnology firms often places great importance upon R&D operations – and R&D materials resulting from those operations are often stored in controlled environments such as freezers, refrigerators or Dewars. Deterioration of R&D materials – through accident, malfunction, loss of refrigerant or interruption to the power supply – could have a disastrous effect on the business. Standard commercial insurance policies don’t adequately address this exposure, so specialist insurance is vital.
How does the insurance coverage work?
Specialist insurance will pay for the reinstatement, reproduction or recreation of R&D materials following their loss or deterioration.
How do I value my R&D materials?
The insurance pays for recreation of R&D materials. The insured value of these materials must therefore take account of the cost of both the raw materials involved in their commissioning and the accumulated investment in processes, labour and other costs involved in their production.
Consider the following when valuing your R&D materials:
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The cost of pre-R&D raw materials
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Personnel expenditure (work out the hourly rates for your technical & senior staff)
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The cost of consumables
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Regulatory & other compliance costs
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If your R&D activities led you down a path that, with the benefit of hindsight, you now understand you would not need to replicate you can deduct such costs from the overall total
And remember…
You may need to increase your R&D insurance values around critical development ‘bottlenecks’, like R&D milestones or in the run-up to product or clinical trials when the stocks of R&D materials are often significantly higher than normal. You may also need to insure R&D materials being held at the premises of your partners, like outsourced manufacturers or CROs.
