Risk Mitigation

We fit the contract’s risk mitigation language to your circumstances. Using our knowledge of the law and industry norms, we navigate the complicated and often messy job of mitigating risk. We help you understand and weigh the risks so that you can make informed business decisions.

We Cut to the Chase…in Plain English

Clients turn to us for easy-to-digest explanations of complex terms. We help you understand and weigh the risks so that you can make informed business decisions. 

risk mitigation steps

We believe in balance and fairness:  reasonably protecting our clients’ interests while enabling the parties to move forward. These four steps outline our approach.
1

Know the Risks

Risk comes in many forms:  indemnification, subject injury, limitation of liability, insurance, cybersecurity, fraud and abuse, regulatory compliance and more. The first step for mitigating risk is to identify the risks and to understand your pain points and your company policies. There is a lot at stake. We help clients do this every day.

2

Decide Your Tolerance

We guide you through the various interrelated risk mitigation provisions in your contracts. We explain difficult concepts in plain English to help you figure out what matters. Then we build your decisions into your documents.

3

Properly Allocate Risk

We believe in balance and fairness. Well-crafted contracts appropriately allocate risk between the parties. We use our deep legal and industry knowledge to help our clients mitigate risk.

4

Negotiate Compromise

We have been negotiating contracts (and other things…ask our families) for years. We understand each side’s motivations. For revisions that we expect to be more contentious, we explain our rationale while seeking to accommodate the other side. 

risky business

All business involves risk. From protecting study subjects to complying with regulations to protecting business assets, we can help you mitigate your risk so that you can get down to business. Common risks that our clients face include:

Study Subject
Risk

Clinical studies involve research using human volunteers. Risks to study subjects include subject injury and data breaches.

Regulatory & Compliance Risk

Life sciences entities operate in a highly regulated industry. Regulatory risk includes complying with:

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FDA regulations:

  • Federal and state privacy and security laws relating to data and specimens; international data protection laws
  • Federal and state fraud and abuse laws
  • Financial disclosure, transparency, and conflict of interest  laws and best practices
Business Assets & Contract Risks

Life sciences contracting involves a complex web of interrelated concerns. Business threat risk includes:

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• Data rights
• Cybersecurity concerns
• Intellectual property rights
• Confidentiality obligations
• Publication rights
• Payment obligations
• Indemnification obligations
• Liability caps
• Subject injury coverage
• Insurance requirements
• Contractual warranties
• Reputation

Let us help you get down to business!

All business involves risk. We can give you best practices or simply review for dealbreakers. Taking our cue from you, we advise at the level you need.

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