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Insurance for life sciences:
Everything you need from a specialist broker

"I didn't become a scientist, but I want to use my experience as a risk and insurance expert to support the companies that are making real breakthroughs in science. We take care of the protection of your risks with tailor-made life sciences insurance, so that you can take care of advances in research and development. In this way, we as business economists and lawyers can also indirectly make a small contribution to science."

We support companies in the life sciences sector (e.g. biotechnology, pharmaceutical, medical technology (MedTech) and HealthTech companies) in identifying and insuring their various liability risks. We offer comprehensive insurance solutions for laboratory facilities as well as for complex liability risks, including those arising from the German Medicines Act (AMG) or patents (intellectual property).

Protecting your private assets and those of your employees is at least as important as protecting the company's assets. The same applies to tailor-made insurance cover for service providers in the life sciences sector. Read our brief summary of the most important life sciences insurance policies to get an initial overview. We would be happy to discuss your questions or critical points in more detail in a personal meeting or in our specialist articles. Please visit our blog on a regular basis, where we regularly discuss current topics from the world of life sciences insurance. 

Among others known from:

D&O insurance for life sciences

Insurance fordirectors and officers (D&O insurance) protects managers from all sectors against the financial consequences of a professional mistake. Our D&O concept offers comprehensive cover through a combination of financial loss liability insurance and legal protection. This provides you as a decision-maker with comprehensive cover in the event of financial losses in legal disputes or (criminal) legal investigations by (supervisory) authorities and regulators:

  • Managing directors and board members bear a great deal of responsibility and are increasingly personally liable for errors arising from their activities as board members - in some cases with their private assets to an unlimited extent.
  • D&O insurance protects, for example, members of the management, executive board and supervisory board against claims from their own company (internal liability) and from third parties (external liability) due to financial loss.
  • We offer special extensions to the group of insured persons for life sciences companies. For example, our Life Sciences D&O concept also covers Chief Medical Officers, Chief Research Officers, Health & Safety Officers and other safety officers, Quality Officers, the Qualified Person (QP) within the meaning of Section 14 of the German Medicinal Products Act (AMG) or the Responsible Persons (PRRC) pursuant to Section 15 of the Medical Device Regulation (MDR), as well as special industry representatives, also in accordance with foreign legal standards.
  • Worldwide industrial criminal legal protection insurance (as required as partial cover for management or as stand-alone insurance for all employees).

Manager liability - How to cover your ass! 

Our Managing Director Florian was a guest on the Recruiting DNA podcast by the life science specialists from Pates and gives valuable tips on the topic of "manager liability".

  • Public liability insurance does not cover the risk associated with clinical trials or liability towards trial subjects. For such cases, separate insurance is required, which is prescribed by the ethics committees as mandatory for the approval of a study or ethics application.
  • In each country in which clinical trials are conducted, specific legal standards and insurance cover requirements apply.
  • We have the necessary know-how and a broad network to offer suitable protection for foreign probationer insurance policies. We can offer worldwide insurance cover in the local language.
  • We are happy to provide accident insurance for the test subjects - we can also help with this and are familiar with these concepts from numerous clinical trial projects.

Together with our subsidiary "Atrialis GmbH - experts in clinical trial insurances", we are one of the leading and most experienced market players in the DACH region for clinical trials and support you worldwide with your trial project.

Get our guide to becoming a Life Sciences Expert!

Intellectual Property Insurance - Patent insurance for IP disputes

Not only the risk of IP in the context of an information security breach, but also the number of lawsuits relating to intellectual property (IP) rights has increased significantly in recent years. In addition, the number of registered patents and trademarks is also growing, but unfortunately so is the amount of IP litigation that is being conducted to protect the associated economic benefits.

Our Intellectual Property Insurance for intellectual property is designed to protect companies against the significant financial risks associated with intellectual property disputes. Insurance cover is generally available worldwide, but can also be taken out for selected regions only if desired.

What does IP insurance cover?

  • Legal defense and liability for damages in the event of allegations and actual patent infringements in accordance with statutory and contractual liability
  • First-order financial losses, such as business interruption in the event of injunctions by IP rights holders
  • Optional additions: ACTIVE, own enforcement of rights (injunction and prosecution) from patents, utility models and designs, etc.
  • Our products also cover additional costs such as legal representation, experts, translations, product return fees and loss mitigation.

Find out more about patent liability insurance and patent legal protection insurance in our wiki article "IP insurance".

Public and product liability for life sciences

To protect your company against liability claims arising from the manufacture of medical technology products or drugs or active pharmaceutical ingredients and from research and development in general, you need an insurance broker with a keen understanding of the multi-layered liability framework in which you operate.

Talk to us about your research and development goals as well as planned products and services for life sciences companies for a detailed risk analysis. We will then tailor our concepts to your individual needs:

What is covered by business and product liability insurance?

  • Laboratory site risks or genetic engineering site risks in accordance with the official approval notices. Reference to the possible safety levels (usually S 1 or S 2 laboratory) and genetic engineering product liability insurance
  • Participation in trade fairs, congresses, conferences, business trips worldwide
  • Rented buildings and premises for administrative and laboratory areas
  • Damage to third-party laboratory equipment and technical facilities provided for use, including loss of keys to university and hospital laboratory facilities and rented rooms. - This is particularly important for young companies that are sometimes dependent on the use of third-party equipment for economic reasons!
  • Damage to third-party materials provided for analysis, examination, processing, e.g. samples, active substances, reagents
  • Co-insurance of environmentally relevant substances in the company (solvents, cleaning agents, reagents, chemicals) - if necessary, special radiation liability insurance when using X-ray equipment
  • Co-insurance of product risk for own products, but also when importing products from non-EU countries into the European market
  • Special compulsory insurance for products within the meaning of the German Medicinal Products Act (AMG cover) or in accordance with the Medical Device Regulation (MDR) for medical technology

Cyber insurance for life sciences

The increasing cyber threats to life sciences companies are due to several key factors and risks:

  • The intellectual property (IP) of life sciences companies is often one of their most important assets. IP can take the form of a formulation for drugs, cures or plans for medical devices based on years of research and clinical trials. This valuable know-how can make a lot of money for companies if marketed and used correctly with patients, which is why this information and IP is also of great interest to hackers.
  • Targeted attacks by cyber criminals that are used for corporate espionage or are financially motivated can not only paralyze and corrupt the IT infrastructure of life sciences companies, but also lead to valuable data being stolen or encrypted.
  • However, the necessary exchange of confidential information and data with a large number of partners and service providers across national and liability regime borders in order to conduct research and development more efficiently and quickly unfortunately also increases the risk of intellectual property and protected health information falling into the wrong hands or violating national laws.
  • Supply chains are usually global and consist of many different international suppliers, which can further increase a company's cyber vulnerability. Even a single supplier without effective security controls represents a vulnerability that could allow cybercriminals to infiltrate companies along the chain. Companies can also face threats if suppliers have access to their networks. Furthermore, problems with business continuity can arise if a supplier falls victim to a cyber attack. This has already happened to a number of well-known companies in the life sciences sector in Germany.(see report on Evotec SE

  • Wireless, sensor-based medical devices such as insulin pumps are changing patient care. However, they pose security risks as potential vulnerabilities can be exploited, which could lead to tampering with these devices. As a result, patients could be harmed and confidential patient data could be compromised. See also the TÜV warning.

  • The proliferation of consumer health and wellness technologies (HealthTech), including wearable devices such as smartwatches, can be an attractive target for hackers. Infiltrated HealthTech software and app providers are at risk of privacy lawsuits and reputational damage if hacked data is compromised.
  • Continuously increasing legislative requirements for companies and their managers. In particular, the new possibilities of utilization.
  • To keep subjects engaged in studies with a longer-term horizon, we see increased use of technology by sponsor/CRO with corresponding additional personal data and points of attack.  

With our cyber insurance policies, we offer you a flexible, innovative and individual insurance solution for cyber risks for life sciences companies of all sizes. Our special concept generally protects against cyber risks and a wide range of losses - for example:

  • A hacker attack, manipulation by your own employees or, for example, the failure of your IT service providers: additional costs or lost profits and ongoing costs resulting from a business interruption are covered by our cyber insurance.
  • Expert and consultancy costs are included, e.g. arising from industrial espionage or breaches of data protection laws.
  • The insurance covers the costs of restoring your data and programs to their previous, operational state. The same applies to the removal of malware or the recovery/restoration of master and transaction data. And also the costs of replacing hardware if recovery is not possible.
  • In reputation and crisis management, e.g. in the event of a hacker attack or denial-of-service attack, the costs of preventing or mitigating reputational damage are covered - including by external crisis/communications consultancy.
  • Cyber liability claims are covered, e.g. due to the deletion, loss, modification or unavailability of data or programs of a third party or due to the violation of data protection laws. The expenses for the legally required information and notification of authorities, patients, service providers/partners and potentially affected persons are also covered.
  • Costs incurred as a result of blackmail (ransomware), e.g. due to encryption of data and programs, disruption of the IT system or Internet-based services of the website, can be optionally covered.
  • In the event of Internet fraud caused, for example, by manipulation of the website or connected databases and programs, direct financial losses (e.g. fraud) caused by a deliberate and unlawful hacker attack are also insured.

In addition, depending on the technology set-up, we also examine so-called E&O / IT liability concepts with a view to digital (liability) risks.

In the event of a #cyberattack, the company affected initially bears the main responsibility. However, managers can still be held liable if they do not take sufficient steps to ensure #cybersecurity.

Webinar agenda :

  • What is the basis of liability for managing directors?
  • What are the main personal liability traps for directors and officers?
  • In focus: We show you how managers can avoid liability traps in the event of cyber incidents
    Q&A: Space and time for your questions to us

Our Managing Director Florian and Reiner Wetzel (Account Manager at Control Risks) discuss this in #29 Minutes. 

Play video

Electronics insurance for laboratory and office equipment

The expensive technical equipment in scientific laboratories and production areas requires comprehensive risk protection for these assets. Electronics insurance offers an all-risk solution here. Operating errors in particular are often the cause of damage in the field of laboratory technology, e.g. due to improperly fitted centrifuges, improperly closed centrifuge lids or torn hose connections in autoclaves with causal water leakage. In many cases, complex technical building installations, such as extraction, compressed air and air conditioning technology, are taken over by the landlord at his own risk; these items must also be included in the all-risk insurance.

By choosing a reasonable deductible for small claims in the event of an insured event, the amount of the insurance premium can sometimes be significantly more economical. We have attractive framework contract conditions.

Initial situation:

  • Because a broken freezer was beeping "annoyingly", a man pulled the plug in a New York laboratory at Rensselaer Polytechnic Institute. The samples it contained from years of research were destroyed as a result. The result was millions in damage.
  • Further information can be found here
 

Insurability assessment

  • In addition to insuring laboratory technology, life sciences companies should also consider insuring existing cell cultures, cell / bacterial strains and their own active ingredient bases and research results in their insurance concepts. The Risk Partners cover concepts assume the full reconstruction costs in the event of damage and, in the event of failure or interruption of refrigeration facilities, the resulting spoilage of stored materials, cell cultures, sample material and active pharmaceutical ingredients.
  • In addition to the asset values, our business insurance also covers the costs of restoring valuable original documents, business records, e.g. also study documents - laboratory diaries etc., e.g. as a result of a fire in the laboratory.
  • Regardless of its own cover, in this case the research institute can possibly also hope that the service provider will be liable for damages. For the man who worked in the laboratory as a service provider for a third-party company and has since been sued by the research institute for millions of euros for his misconduct, one can only hope that his employer has good public liability insurance to cover the damage. To this end, we strongly recommend that you make appropriate contractual agreements with service providers and obtain confirmation of the insurance cover and premium payment.

Laboratory/office contents insurance

In addition to the aforementioned items, it is also important to protect existing cell cultures, cell / bacterial strains and your own active ingredient bases and research results. Our cover concepts assume the full reconstruction costs in the event of damage.

In addition to the asset values, the business insurance covers the costs of restoring valuable original documents, business records, e.g. also study documents - laboratory diaries, etc.

Insurance cover is also of particular importance in the event of failure or interruption of refrigeration facilities and the resulting spoilage of stored materials, cell cultures, sample material and active pharmaceutical ingredients.

Transport insurance

Transport insurance for active substance and sample material transports, refrigerated goods transports, special cover for active substance transports in clinical trials including storage of test subject material:

As the liability of the shipping company / parcel service is only given in the case of fault and is also always limited in terms of amount, independent transport insurance is recommended - especially for high value concentrations of medical devices, reagents, active ingredients and sample material.

Our cover concept offers worldwide all-risks cover for all transports - full insurance protection, in particular also in the event of spoilage of goods due to failure/interruption of refrigeration measures, including direct consequential financial losses.

Liability of the Quality Officer and other responsible persons:

Personal liability is not only an issue at top management level. Senior executives and employees who are entrusted with special functions in life sciences companies can also incur personal liability with their private assets. Persons with special duties of care or even guarantor duties towards third parties are, for example, a quality officer, safety officer, the Qualified Person (QP) in accordance with Section 14 of the German Medicinal Products Act (AMG ) or the Responsible Person (PRRC) in accordance with Section 15 of the Medical Device Regulation (MDR).

If you would like to find out more about liability and insurance solutions for these groups of people, you are welcome to ask for our free guide without obligation.

IPO or further capital raising planned (in the medium term)? Prepare in good time!

Are you planning to raise further capital for your projects? Would you like to finance clinical studies or promote and market your product pipeline to international investors? Regardless of whether Frankfurt, Amsterdam or NASDAQ is your stock exchange of choice, we are also your partner for international projects with our renowned co-broker network.

Find out more about how you can properly cover the liability risks from IPOs and capital market liability on the "Road to IPO". We will help you to make the necessary adjustments to your D&O insurance in advance. We also offer a free IPO readiness workshop on your D&O exposure and hedging solutions in the context of prospectus liability, while strictly maintaining project confidentiality.

Keyman Insurance

If there is a key person in your company, such as a "super brain" of science or a particular leader who is critical to the success of your business, without whom the company would suffer greatly both financially and in terms of its reputation, keyperson insurance should be considered. This insurance is essentially life insurance or pays out in the event of a prolonged mental or medical absence of the key person in your business. Although the insurance benefit cannot prevent the loss of the key person, it can cover the costs of recruiting via headhunters, attractive signing bonuses or higher salaries for highly qualified replacements. An experienced partner for the recruitment of highly qualified personnel in the life sciences sector is pates AG. Please contact our partner, Max Kraft, for a non-binding discussion.

Business interruption insurance

Business interruption insurance provides cover for ongoing costs and loss of profit in the event of consequential damage to property. This applies during the period of business interruption until operations are fully resumed. This cover concept is also extremely important for biotech companies that are not yet generating sales or profits. This ensures that the "cash burn" of the invested capital remains as low as possible during the period of business interruption.

Compensation is provided for all ongoing fixed operating costs, including in particular wages/salaries, leasing and financing costs, license fees, fixed fees and any rental expenses - as well as income from research contracts, milestone payments and collaborations.

This so-called fixed cost cover is only offered by a few insurers and must be expressly agreed separately in each case. A 'normal business interruption insurance' is not sufficient here.

Actively managing personnel risks and skills shortages

We see ourselves not just as an insurance broker, but as a holistic partner for your risks. We also help with risks that are not insurable. For example, when it comes to personnel risks, such as the challenging search for well-trained specialists, we work together with pates' team of experts with experience in the industry. With the help of pates, life sciences companies can find qualified candidates for their company despite a shortage of skilled workers . Please contact our team for an intro or visit the pates website directly: pates-experts.com

Our services

A holistic approach to risk management

We place identified and insurable risks for you in the best possible way on the global insurance markets with customized life sciences insurance policies. We know that this does not always solve all your challenges. Strong growth can lead to bottlenecks in the insurance department and/or a professionalization of risk management may be necessary. We can help.

For startups, scaleups & life sciences companies

Risk management as a service

It is particularly important for start-ups and pre-IPO companies to develop simple and less complex (risk management) concepts. These must identify, assess and transfer the key risks in order to avoid the insolvency of the business model in the worst-case scenario.
⮕ See the Watchmaster case, for example.

From a risk management perspective, it is essential to create a common risk awareness in the first step, which is largely supported by the risk strategy. Convince your investors in the due diligence process of your next financing round with a risk report and a deep understanding of your risks, thereby safeguarding against risks that could threaten your company's existence.

On the basis of sound risk and insurance management, we develop a decision-making basis for your company. You decide what to insure and what not to insure. Because not every risk is worth insuring. Here is our basic approach:

  • Risk identification in joint risk workshops, coupled with our experience in industry-typical risks for life sciences, FinTech, tech companies and venture capital firms
  • Risk analysis and assessment (software supported on request)
  • Development of a joint risk management strategy (Which risks can be accepted, avoided, reduced or transferred?)
  • Determination of your company's risk-bearing capacity and risk acceptance and impact analysis on KPIs in your balance sheet (how much risk can you afford or do you want to take?)
  • Creation of an insurance strategy (what risk should be borne by the company, what should be insured? Goal: Minimization of risk premiums)
  • Implementation and placement of risk and insurance strategies on the insurance market

 

Your added value through active risk and insurance management:

  • Sustainably increase the security level for your company
  • Value-oriented risk management will boost your valuation in the next financing round
  • Significantly reduce your insurance costs
  • Manage and process claims more efficiently
  • CONSCIOUSLY take risks and promote growth!

 

The importance of this for young growth companies was demonstrated not least by the Silicon Valley Bank case, which was identified as part of a risk management process and - if necessary - would have led to an adjustment of the banking/treasury strategy.

From a risk management perspective, it is essential to create a common risk awareness in the first step, which is largely supported by the risk strategy. Convince your investors in the due diligence process of your next financing round with a risk report and a deep understanding of your risks, thereby safeguarding against risks that could threaten your company's existence.

On the basis of sound risk and insurance management, we develop a decision-making basis for your company. You decide what to insure and what not to insure. Because not every risk is worth insuring. Here is our basic approach:

  • Risk identification in joint risk workshops, coupled with our experience in industry-typical risks for life sciences, FinTech, tech companies and venture capital firms
  • Risk analysis and assessment (software supported on request)
  • Development of a joint risk management strategy (Which risks can be accepted, avoided, reduced or transferred?)
  • Determination of your company's risk-bearing capacity and risk acceptance and impact analysis on KPIs in your balance sheet (how much risk can you afford or do you want to take?)
  • Creation of an insurance strategy (what risk should be borne by the company, what should be insured? Goal: Minimization of risk premiums)
  • Implementation and placement of risk and insurance strategies on the insurance market
  • Documentation of the risk workshops including follow-up and preparation of an initial (investor) risk report
 

Your added value through active risk and insurance management:

  • Sustainably increase the security level for your company
  • Value-oriented risk management will boost your valuation in the next financing round
  • Significantly reduce your insurance costs
  • Manage and process claims more efficiently
  • CONSCIOUSLY take risks and promote growth!

The importance of this for young growth companies was demonstrated not least by the Silicon Valley Bank case, which was identified as part of a risk management process and - if necessary - would have led to an adjustment of the banking/treasury strategy.

For listed corporations and SMEs

Rent-an-Insurance-Manager

We place identified and insurable risks on the global insurance markets for you in the best possible way. We know that this does not always solve all your challenges. Strong growth can lead to bottlenecks in the insurance department and/or a professionalization of risk management may be necessary. We can help you with this.

On the other hand, many companies do not (yet) have an insurance department with their own staff or cannot find suitable personnel. Above a certain size, your industrial risk and insurance issues require professional support to ensure that your investments and strategies are adequately protected. This is where we provide you with support tailored to your needs.

Building up your own staff to deal with your internal insurance issues is time-consuming and cost-intensive. This work is often carried out by the head of finance or legal, for example, but not by professionally trained insurance staff.

Our solution for your company: Rent-an-Insurance-Manager

  • Rent your "own" insurance department for a certain period of the year
  • Simply outsource the management and administration of insurance contracts
  • Reduce costs - increase security

Our "Rent-an-Insurance-Manager" concept allows you to hire core competencies in the field of insurance for a limited period of time and tailored to your needs, as if you had your own staff in place.

As an outsourced insurance department, Risk Partners manages and handles your company's insurance work, e.g. as an in-house contact for insurance issues, an interface to your insurance broker or to your insurers.

Your added value through Rent-an-Insurance-Manager:

  • Efficient use of personnel and costs. Existing processes are optimized while at the same time freeing up your internal resources in their specialist areas (legal/finance)
  • "Bookable on a temporary basis", for example if you have staff shortages during peak periods such as renewals or annual financial statements and need support at short notice
  • Saves time: freed-up capacity can be used in other core areas of your company
  • "Professional sparring" relieves and supports your existing team with a second opinion
  • Professional support for your insurance issues through the use of qualified insurance expertise
  • By increasing the quality of work, you also reduce risks for your management's liability

On the other hand, many companies do not (yet) have an insurance department with their own staff or cannot find suitable personnel. Above a certain size, your industrial risk and insurance issues require professional support to ensure that your investments and strategies are adequately protected. This is where we provide you with support tailored to your needs.

Building up your own staff to deal with your internal insurance issues is time-consuming and cost-intensive. This work is often carried out by the head of finance or legal, for example, but not by professionally trained insurance staff.

Our solution for your company: Rent-an-Insurance-Manager

  • Rent your "own" insurance department for a certain period of the year
  • Simply outsource the management and administration of insurance contracts
  • Reduce costs - increase security

Our "Rent-an-Insurance-Manager" concept allows you to hire core competencies in the field of insurance for a limited period of time and tailored to your needs, as if you had your own staff in place.

As an outsourced insurance department, Risk Partners manages and handles your company's insurance work, e.g. as an in-house contact for insurance issues, an interface to your insurance broker or to your insurers.

Your added value through Rent-an-Insurance-Manager:

  • Efficient use of personnel and costs. Existing processes are optimized while at the same time freeing up your internal resources in their specialist areas (legal/finance)
  • "Bookable on a temporary basis", for example if you have staff shortages during peak periods such as renewals or annual financial statements and need support at short notice
  • Saves time: freed-up capacity can be used in other core areas of your company
  • "Professional sparring" relieves and supports your existing team with a second opinion
  • Professional support for your insurance issues through the use of qualified insurance expertise
  • By increasing the quality of work, you also reduce risks for your management's liability

Blog / News

Finance Day 2024

Growth capital for biotechnology and life sciences - Finance Day 2024 A few days ago, Jutta and Florian from our team attended Finance Day 2024 at the analytica trade fair in Munich. The event once again offered exciting expert panels on current financing and capital market issues for life sciences companies. As the panels focused on three of our key consulting areas, namely life sciences, venture capital and IPOs, a visit was of course a must for us as a specialist insurance broker. Our team has

Read more "

Digital and effective prevention of directors' and officers' liability by Risk Partners & Fides Technology

Innovation by Risk Partners & Fides Technology Now on Vimeo and Soundcloud: get practical tips from experts with high relevance for avoiding liability for business managers. Question unanswered? Content: Personal liability is a constant sword of Damocles hovering over managing directors in everyday life. The standard of care is strict and directors bear the burden of proof. In cooperation with the distinguished corporate lawyer Eva Homborg (Esche Schümann Commichau) and the governance expert Philippa Peters (Fides Technology GmbH)

Read more "

"I believe in a strong IPO comeback in 2024" - Interview Platform Life Sciences

Risk Partners in the trade press. Florian was approached by the journalists from Plattform Life Sciences for an interview on our view of 2024 and the development of Risk Partners over the past year. In addition to challenging claims, product innovations (e.g. all about POSI insurance) from Risk Partners, Florian also discusses our reasons for "teaming up" with our fantastic colleagues from Atrialis GmbH - experts in clinical trials.

Read more "
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