Biotech & Pharmaceutical Transaction Attorneys 

Protecting Research, Innovation, and Commercial Success 

In the fast-moving biotech and pharmaceutical industries, contracts aren't just paperwork. They're the foundation of success. Whether you're securing funding, partnering on research, or licensing intellectual property, every agreement carries risks that can impact your business, your innovations, and even patient safety. 

Companies in this space must navigate complex legal frameworks while ensuring compliance with global regulations. The most common challenges include: 

• Protecting intellectual property in collaborative research settings. 
• Managing licensing agreements without sacrificing control. 
• Avoiding regulatory fines and compliance issues that can delay commercialization. 

At Horn Wright, LLP, our transaction attorneys understand the high stakes of the biotech and pharmaceutical industries. Our team specializes in structuring, negotiating, and enforcing contracts that protect your intellectual property, ensure regulatory compliance, and maximize your market potential.  

Whether you're securing R&D partnerships, navigating complex clinical trial agreements, or licensing groundbreaking innovations, you deserve one of the best law firms in America on your side. 

Research & Development Agreements—Avoiding Costly Legal Pitfalls 

Collaborations drive biotech advancements, but R&D agreements need careful structuring to protect all parties involved. Without clear terms, disputes over ownership rights and funding responsibilities can arise, jeopardizing progress. 

Key considerations in research agreements include: 

• IP Ownership & Control: Establishing who owns the discoveries and how they can be used. 
• University & Private Sector Partnerships: Clarifying rights when institutions and private companies collaborate. 
• Funding & Milestones: Structuring agreements that align incentives and ensure continued support. 

Failing to address these legal concerns upfront can lead to costly disputes, lost patents, and stalled innovation. A well-drafted agreement sets clear expectations and ensures a fair distribution of benefits from breakthrough discoveries. 

Clinical Trials & Regulatory Compliance—Managing Risk Before It’s Too Late 

Clinical trials are critical to bringing new therapies to market, but they come with immense regulatory scrutiny. From patient consent forms to liability clauses, every aspect must be legally airtight to avoid compliance violations and lawsuits. 

Essential elements of clinical trial agreements include: 

• Regulatory Compliance: Ensuring alignment with FDA, EMA, and other regulatory bodies. 
• Data Privacy & Security: Protecting patient data under HIPAA, GDPR, and global privacy laws. 
• Liability for Adverse Events: Clarifying responsibilities if participants suffer harm. 

Neglecting these aspects can result in trials being halted, heavy fines, or reputational damage. Strong contracts protect research institutions, pharmaceutical companies, and trial participants alike. 

Licensing & Commercialization—Monetizing Innovation Without Losing Control 

A successful biotech venture depends on getting licensing agreements right. Whether you’re licensing a breakthrough drug or commercializing a novel therapy, the terms of the agreement dictate financial success and market reach. There are some main aspects of licensing contracts you’ll want to focus on heavily during the process: 

• Patent Protection & Enforcement: Defining ownership rights and enforcement strategies. 
• Royalty & Milestone Payments: Structuring agreements to maximize profitability. 
• Global Licensing Challenges: Addressing jurisdictional risks and IP transfer laws. 

Poorly negotiated licensing deals can lead to revenue losses, unwanted competition, or even the loss of proprietary technology. A strong legal foundation ensures biotech companies retain control while maximizing financial returns. 

Manufacturing & Supply Chain—Securing Your Path to Market 

Once a drug or biotech product is ready for production, manufacturing and supply chain agreements must ensure reliability, quality, and regulatory adherence. Weak contracts in this stage can lead to shortages, recalls, and legal liabilities. 

While contracts typically cover a wide-range of topics, the structure of the contract needs to be based on solid terms and conditions for a few key areas: 

• Good Manufacturing Practices Compliance: Ensuring adherence to strict quality standards. 
• Supply Chain Security: Defining responsibilities across production and distribution. 
• Product Liability & Recalls: Clarifying obligations in case of defects or safety concerns. 

Manufacturing agreements must anticipate potential disruptions and include safeguards that protect businesses from financial and legal exposure. The right contract strategy prevents production issues from derailing market success. 

Risk & Compliance—The Legal Landmines That Can Destroy a Business 

The biotech and pharmaceutical industries operate under some of the most stringent regulatory frameworks in the world. From data privacy concerns to compliance with international laws, every contract must be structured to minimize risk. 

Key risk management strategies include: 

• Data Privacy Compliance: Ensuring compliance with HIPAA, GDPR, and other global regulations. 
• Regulatory Fines & Penalties: Structuring contracts to mitigate exposure to violations. 
• International Compliance Challenges: Navigating differences in global pharmaceutical regulations. 

Failure to address these compliance risks can lead to regulatory shutdowns, financial penalties, and loss of market trust. Our transaction lawyers are ready to issue check any agreements to keep you and your business out of the civil litigation system. 

The Legal Partner That Keeps Biotech & Pharma Companies Ahead 

Contracts are the foundation of success in biotech and pharmaceuticals. Without legally sound agreements, companies risk losing control of their innovations, facing regulatory penalties, or encountering costly disputes that stall progress. 

At Horn Wright, LLP, we specialize in drafting, negotiating, and enforcing contracts that protect biotech and pharmaceutical businesses. From licensing deals to regulatory compliance, we ensure that your agreements safeguard your innovations and keep your business moving forward.  

Contact us today to secure your legal foundation and drive success in the competitive biotech landscape.