Pre-revenue, pre-approval, and already carrying product exposure.

Clinical trial liability

Injury to trial subjects, required before an ethics committee will approve a protocol.

Without it — The study cannot start and the sites will not sign.

Products liability

Harm from a compound, device or diagnostic once it reaches patients.

Without it — The exposure that follows an approval and outlives the company that got it.

Directors and officers

Claims against the board, which venture investors require as a condition of funding.

Without it — No serious investor joins a board without it, so this is a financing gate.

Property and equipment breakdown

Laboratory equipment, freezers and controlled environments, plus the samples inside.

Without it — A freezer failure destroys irreplaceable material that has no market value and enormous cost.

Cargo and cold chain

Product and samples in transit, at temperature.

Without it — A shipment excursion is a total loss of the shipment and the study data with it.

Intellectual property and contractual

The indemnities in licensing, CRO and manufacturing agreements you have already signed.

Without it — Partnership agreements routinely require cover the company has not bought.

We are pre-revenue. What do we actually need?

Less than a commercial-stage company and more than nothing, and the trigger is usually an event rather than a stage. Directors and officers comes first because investors require it at the financing. Clinical trial liability comes before ethics submission, not before dosing. Property and equipment cover follows the first lab. Products liability matters from the point anything reaches a human. A pre-revenue company with a trial running has real exposure and no revenue to absorb it, which is exactly why the sequencing matters.

What a trial policy has to do

Why do investors care about D&O so much?

Because they are joining your board and their personal assets follow them there. Claims against life science boards cluster around disclosure — what was said about trial results, safety signals, regulatory timelines and runway — and those are decisions, not accidents, so no property or liability policy answers them. Expect the requirement in the term sheet, and expect the limit to be specified. Getting quotes before the round closes avoids it becoming the item holding up a signature.

Our partner’s agreement demands specific cover. Is that normal?

Entirely, and it is the most common reason a life sciences company calls us. CRO agreements, license deals, manufacturing contracts and university collaborations all carry insurance schedules with named limits, additional insured requirements and sometimes local admitted policies. They are usually negotiable before signature and never after, so send the draft schedule while it is still a draft — companies routinely sign obligations they then cannot buy on the terms specified.

What is the freezer exposure everyone mentions?

Loss of biological material when temperature control fails, and it is the loss that hurts most because the material has no replacement cost in any ordinary sense. A minus-eighty failure over a weekend can destroy years of samples, cell lines and study material. It needs equipment breakdown for the plant, a specific extension for the contents at temperature, and it prices better with monitoring and alarms that call somebody — insurers ask whether the alert goes to a person or to an empty building.