Practices Overview

Securities   |   Corporate    |

Our representation of companies focuses on the all encompassing model:

 

Corporate Formation & Structure

We counsel and advise clients from company inception. We find it most practical to assess at the outset which corporate structure best fits a company based on its overall objectives, with tax, jurisdictional, and state law considerations always in mind. 

 

Debt & Equity Finance

The firm assists and secures financing for our emerging business clients and our small to mid cap companies. We help connect the dots between our clients and private equity firms, venture capital groups, and angel investors to ensure that our clients receive the resources they need to meet their company objectives and satisfy their shareholders. We have extensive experience in navigating clients through the regulatory landscape of state and federal securities law and regularly advise clients on best practices and compliance with those laws. 

 

Intellectual Property & Brand Protection

By developing an intellectual property portfolio for our clients, we are able to strategically place our clients ahead of competitors, both domestically and internationally. Intellectual property and brand protection play a significant role from the early stages of business planning to beyond the exit strategy. Intellectual property is one of the most attractive business tools when gaining market share from competitors. We stay bullish on our clients intellectual property.

 

Corporate Counsel

We counsel issuers, underwriters, institutional investors, broker-dealers, investment advisers and other clients in connection with regulatory developments across the spectrum. We serve side by side with our clients executive management teams and board of directors as their de facto general counsel. 

 

Commercialization Strategies

As part of our legal strategy, we regularly draft and advise on a series of commercial agreements and provide clients with best commercialization strategies when bringing products to market while ensuring all compliance and regulatory practices are followed.

Regulatory & Compliance

We advise clients on healthcare regulatory and compliance matters to ensure they are in compliance with state and federal laws and receive the necessary regulatory approvals to operate. We continuously monitor and are regularly involved with providing comments to state and federal agencies regarding proposed rule making. For more information, please see our Regulatory/Compliance and FDA Practices below.

Minimizing Risk

The significance of having legal counsel from the onset is to avoid as much exposure to legal risk without handicapping business opportunities. Depending on the client, this ranges from compliance with state and federal laws to careful drafting of corporate agreements between the company and shareholders, strategic partners, vendors, investors, directors and employees. 

 

The Exit Strategy

Whether the strategy is a merger, acquisition, leveraged buyout or initial public offering, we regularly counsel and guide clients through the complex deal landscape. We assess based on factors that are consistent with the company’s capabilities and various market conditions. We assist in identifying strategic partners to execute the most profitable exit.    ​​​

 

Securities

Our firm handles a wide array of complex securities matters for our clients. Our primary areas of practice include:

  • Regulation D Offerings

  • Regulation CF Offerings

  • Regulation A/A+ Offerings

  • Regulation S/Offshore Offerings

  • At-the-Market Offerings

  • Registration Statements (Form S-1 & S-3)

  • Prospectus Preparation

  • ​​Securities Reporting (10-K, 10-Q & 8-K)

  • Confidential Treatment Requests

  • Going Private Transactions

  • Section 13 & 16 Reporting

  • Tender Offers

  • Sarbanes-Oxley Compliance 

  • Blue Sky Compliance

  • Proxy Preparation

 

Corporate

  • Licensing

  • Manufacturing, Supply & Distribution

  • Sponsored Research & Collaborations

  • IP Assignment & Data Sharing

  • Shareholder Agreements 

  • Executive Employment

  • Pharmacy Program Applications

  • Mergers, Acquisitions & Buyouts

  • Debt & Equity Agreements

  • Investor & Joint Ventures

  • Divestitures

  • Cross Border Transactions

  • Technology Transactions

  • Bylaws, Minutes & Resolutions

  • Asset Purchase/Sale Agreements

  • Stock Options & Warrants 

Our firm regularly drafts, negotiates and advises on a broad series of corporate transactions and regulatory matters. Our primary areas of practice include:

 

State Licensing Practice

We represent and advise drug manufacturers, wholesale distributors, virtual manufacturers, third party logistic companies, and pharmacies in ensuring compliance with required professional state licensing. We manage the entire complex process allowing our clients to focus on what matters most - development, commercialization, and distribution of products. With a strong emphasis on cost, our model follow is project based rather than based on hourly rates.

License Research. State government agencies frequently change requirements and update their forms making it challenging to identify which licenses are required in various jurisdictions.  We assess clients licensing needs associated with every state government agency as well as provide the proper license/permit application forms, filing instructions, list of required supporting documents, and fees. 

 

License Filing. We manage the filing process for clients by obtaining and completing application forms and ensure all required supporting documentation is included. We will do this on an ongoing basis.  

 

License Verification. We conduct research for all clients required licenses in all relevant jurisdictions, obtain confirmation of license status and renewal dates as well as produce a comprehensive report containing state-by-state license information. 

 

We provide licensing services as required by each state for clients which includes:​

  • Submitting all required data and documentation.

  • Providing a summary of registration fees.

  • Liaising between clients and state regulatory agencies.

  • Managing the closing process.

  • DSCSA reporting, where required by jurisdiction.

  • Reviewing revisions to state filing requirements.

  • Continuous assessment and monitoring to ensure compliance.

Regulatory & Compliance

 

Our FDA practice include:

  • Recall, correction, removal, and supply chain issues.

  • Export and import matters.

  • Investigational device submissions.

  • 510(k) and premarket approval applications.

  • Product modifications.

  • Medical device reporting.

  • Medicare and Medicaid coverage and reimbursement.

  • Sunshine, state distribution, and related device-compliance matters.

  • 483 observations and warning letters.

  • US Food and Drug Administration (FDA) Compliance matters.

  • Pathway strategies.

  • PDUFA refund & waiver requests.

  • Investigational new drug, new drug, and biologics license applications.

  • Reimbursement strategies.

  • Available market exclusivity assessments.

  • Promotional, reimbursement, marketing, distribution, and pricing strategies.

  • Labeling and advertising matters.

  • Manufacturing processes.

FDA Practice

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