Phil brings decades of big company executive experience combined with an entrepreneurial ability to think outside the box.
– Tom Scholl, Entrepreneur, Technology Innovator and Investor, Professional Venture Capitalist
These challenges can include meeting strict regulatory standards, protecting intellectual property (“IP”) and complying with employment and tax laws. Effectively managing these issues is essential for sustained growth and success. Crowley Law LLC offers practical strategies to help address these concerns, providing focused support to safeguard your business and promote growth.
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A legal risk refers to the possibility of an organization suffering the negative consequences of regulatory action, prosecution, litigation or disadvantageous provisions in agreements with third parties. Such risks often originate from a business’ failure to comprehend or properly comply with the legal and statutory requirements related to its operations.
Failure to adhere to these obligations will inevitably attract legal risks that could compromise business operations or eventually result in business closure.
Identifying legal risks and mitigating them where possible is essential for life sciences and other technology companies. It helps them to maintain stability and avoid unnecessary costs. These challenges depend on the business type, structure and operational factors.
These arise from misunderstandings or errors in agreements with suppliers, partners or employees, as well as agreeing to terms that have the potential to damage the business. For instance, unclear terms or unfavorable indemnities in a supplier contract might expose the company to unexpected costs or disputes.
You could face a lawsuit for infringing another entity’s intellectual property (“IP”), including patents, trademarks, copyright materials and trade secrets. Failing to secure IP rights from employees and owners, for instance, can lead to litigation or a failure to attract investors.
Employment laws, such as the applicable State Wage and Hour Laws, are designed to protect workers’ rights. Serious legal risks may arise if these laws are violated or if workplace practices fail to ensure compliance. Further, there are Federal, State and local laws, ordinances and regulations that require specific actions on the part of employers. Many of these requirements subject the employer to fines and other liabilities for failure to comply.
Product liability manifests when products or services offered to the public cause harm or endanger customers. For example, a new drug by a life sciences company could cause adverse, unintended health effects.
Companies are being subjected to increasing requirements with respect to protecting the privacy of personal data they acquire. Companies that fail to ensure data security and protect users’ privacy can subject themselves to litigation, fines and expensive remediation requirements.
Companies must be aware of and comply with applicable State and Federal environmental laws and related regulations. Breaking such laws and regulations can result in heavy fines and reputational damage.
Tax compliance is a critical issue for all companies, given the complexities of State and Federal tax regulations. Businesses often struggle to identify all applicable tax obligations. Failure to comply can result in costly penalties or legal action.
Managing legal risks means identifying and reducing potential issues that could disrupt business operations or result in unanticipated costs. By establishing a structured approach, companies can regularly assess their practices, stay compliant and adapt to regulatory changes for smoother operations.
In addition, legal risk management plays a vital role in enterprise risk management, offering a comprehensive framework to address risks that may hinder a company’s key objectives. Furthermore, effective legal risk management can help avert several pitfalls, including:
The strategies for mitigating legal risks will vary depending on the specific legal risk. Here are some of the notable strategies you should consider for your company:
It is essential to sign contracts only after fully understanding their terms, which may require consulting legal professionals. Proactive measures can help prevent unintended contract breaches. These steps include:
Monitor all business finances and accurately file tax returns based on applicable Federal and State guidelines. Engage an experienced tax advisor to help ensure compliance and, importantly, identify opportunities to reduce or defer taxes legitimately.
Developing a comprehensive management plan is crucial for adhering to State, Federal and foreign regulations. This approach helps prevent environmental lawsuits and costly fines.
Stay up to date with new or updated State and Federal laws and regulations. This is particularly critical in States where legal authorities are actively developing new laws, especially regarding environmental and social responsibility.
Draft and elaborate code of conduct and make it available to all employees to encourage compliant business practices. For example, you should have a comprehensive employee handbook explaining your company’s rules and policies. This can help mitigate potential risks related to harassment, discrimination and other employment issues.
Having a legal team to guide your business activities is arguably the most effective approach to mitigate legal risks. Attorneys with experience working with life sciences and other technology companies can help you flag potential legal risks before they occur and meet all current legal requirements.
At Crowley Law LLC, we understand that mitigating business and legal risks is a critical component of strategic planning for life sciences and other technology companies, given the dynamic and highly regulated nature of these industries. That is why we provide comprehensive support to help our clients navigate and minimize these risks effectively. Here are some of our pertinent services:
We guide our clients in performing risk assessments, helping them identify potential business and legal vulnerabilities. By doing so, we help clients better understand the areas where they are most exposed to risk and develop targeted strategies to address these issues.
Life sciences and other technology companies often face stringent and evolving regulatory requirements. Thus, we help startups and established companies stay compliant by monitoring changes in laws and regulations, such as FDA guidelines for life sciences or data privacy laws that apply to all companies.
IP is usually a core asset for life sciences and other technology companies. While Crowley Law LLC does not directly handle the filing of patent or trademark applications, we are experienced in identifying contractual and operational strategies to protect IP as it is produced. We also have and can access a network of experienced attorneys who specialize in securing patents, trademarks and other forms of IP.
We review, draft and negotiate contracts that protect the client’s interests, including employment agreements, vendor contracts, partnership agreements and terms of service. By doing so, we help prevent disputes, reduce litigation risk and ensure that obligations and liabilities are clearly defined and manageable.
We offer advice on employment law matters, ensuring clients comply with local, State and Federal regulations. This includes helping draft employment contracts and nondisclosure agreements. We also counsel clients on best practices for handling workplace disputes.
We help clients choose the right legal structure (limited liability company, corporation or partnership) to minimize tax liabilities, protect personal assets and facilitate future fundraising or exit strategies. We also advise on corporate governance practices to ensure compliance with laws and regulations, reducing the risk of internal disputes and legal challenges.
Phil brings decades of big company executive experience combined with an entrepreneurial ability to think outside the box.
– Tom Scholl, Entrepreneur, Technology Innovator and Investor, Professional Venture Capitalist
Phil responded to me quickly, identifying a variety of risk scenarios to consider and he turned over his recommended red-lined contract in a matter of hours. Ever since then, I rely on him as a consummate legal resource and trusted advisor.
– Leigh Ann Soltysiak, Silverleaf Consulting, Commercialization Strategy Consultant, Consumer Tech & Health Wellness
“Phil has been of tremendous legal help to the progress of our early-stage biotech start-up. He is very experienced and conducts his work in a time and cost efficient manner. Great counsel!”
– Joanna Stanicka
Phil Crowley has been extremely helpful in providing quick and thoughtful counsel regarding our business needs. Highly recommend his services.
– Tor Alden, Principal, high technology design engineering firm
Phil has been a trusted advisor to our company as we have expanded into the US market. His extensive legal and business experience has proven invaluable to the company. A great sounding board for practical, strategic advice, Phil is always one of the first people we turn to.
– Alex Kelly, President and Co-Founder of Ireland-based software-as-a-service company
Phil has been a great partner in my consulting business. He is responsive and practical and he focuses on the key areas that need attention… I recommend him highly.
– Clinical and FDA regulatory Affairs Expert
Understanding and managing legal risks is crucial for the sustainability and growth of your business. By actively assessing and mitigating potential legal pitfalls, you can:
Effective legal risk management is vital for life sciences and other technology companies and can provide a range of benefits that promote stability, enable innovation and safeguard assets. As it is said, “An ounce of prevention is worth a pound of cure!” Given the costs of litigation and the size of penalties for noncompliance, this is more true now than ever before. Some notable benefits of this approach include:
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