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YOU’RE PASSIONATE ABOUT YOUR IDEAS. SO ARE WE
CROWLEYLAWLLC.COM
JUNE 2025
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The Changing Tides of Regulatory Reform Nothing can stop the moving target of history. I’m writing this article at a time of significant change for our country. We’re seeing headline Although I don’t have a crystal ball to help guide anyone through these uncertain times, I’d nonetheless like to share what I suspect Shake-Ups and Strategic Shifts
DON’T LET OTHERS TAKE ADVANTAGE OF YOU! Scan the QR code to read our book – AVOID STARTUP FAILURE!
Learn the Top Ten Causes of Failure for Technology Startups and How to Turn Them to Your Advantage.
may be the pros and cons of our current state of affairs and what the future may hold. Ultimately, if the FDA streamlines its procedures for early-stage research, we may see an acceleration of phase 1 and 2 clinical trials that could result in lower costs. More comprehensive standards may also be established concerning the proof required in phase 3 trials. Conversely, the exit of experienced and senior personnel could prevent thoughtful and helpful regulation of health care products. Whether policies and procedures will be created to compensate for the fact that certain senior people have left government agencies remains to be seen. Change opens the door to new thinking. Depending on how you perceive the changes occurring almost daily, this is either a threat or a critical driver of innovation. Only time will tell whether the scale of evolution we’re currently witnessing will maintain, elevate or reduce government efficiencies and perhaps uncover positive opportunities within existing bureaucracies that have been ignored for decades. Whether it’s DOGE or another entity doing the heavy lifting, they mustn’t throw out the baby with the bathwater. With clarity being such a rare commodity these days, I urge our readers to keep tabs on industry-specific groups tuned in to what’s
after headline about the efforts made by the Department of Government Efficiency (“DOGE”) to slim down non-essential parts of our government. Clearly, these endeavors have uncovered billions of dollars dedicated to things that, to be most kind, had an unclear benefit to American citizens. Unsurprisingly, this disruption to the status quo has had a ripple effect on areas of interest to us here at Crowley Law LLC, principal among them being the Food and Drug Administration (“FDA”) — especially the high-profile resignation of Dr. Peter Marx as director of the FDA’s Center for Biologics Evaluation and Research — and the Department of Health and Human Services. Discussions on these matters can be polarizing. Even though different points of view exist, the goal is ultimately the same: the health and welfare of the American population. Although the best way to meet this objective is a matter of public debate, it’s always better to avoid polarization and focus simply on the facts. Of course, this is easier said than done when not all the facts are immediately evident and outside perspectives on these matters are largely speculative. One has to hope that if the proponents of change are correct and can change the focus and efficiency of government agencies, we’ll be able to have activities more focused on providing our citizens with needed benefits at a lower cost without wasting assets.
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occurring and serve as trusted sources of information. Examples include PhRMA, medical device trade associations and the Biotechnology Innovation Organization. Overall, I’m optimistic about the potential improvements in governmental processes that may become evident over the next 2–5 years. Just as in the startup world, where you need to wait a bit to see which changes have an impact, I don’t anticipate that we’ll see the concrete effects of current activities tomorrow or at all in 2025. The regulatory state’s overreach has occurred over decades, so you can’t expect everything to be suddenly new in one or six months. However, I know one thing to be true in the here and now: The ability to pivot is one of our clients’ greatest strengths, and making quick decisions when necessary isn’t foreign to them. I have no doubt the same spirit of ingenuity that guides your businesses will propel you through uncertain waters and enable you to make the right strategic decisions — and Crowley Law LLC will be Continued on Page 3 ...
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A New Book Tackles Startup Killers Crowley’s Code
Pursuing a career as a life science or tech entrepreneur can be a fascinating and rewarding journey — but only if you don’t defeat your ambitions at the starting gate. Far too often, new business owners in these industries make legal and strategic mistakes that could have lasting and sometimes irreparable consequences, especially to their finances. Unfortunately,
to Patient, Garage to Market,” a regular video podcast featuring leaders in life sciences, technology, startups and related fields. Philip P. Crowley Esq. is the founder and managing partner at Crowley Law LLC, a boutique corporate law firm focused on helping emerging tech and life sciences startups launch and reach their full potential. Phil’s firm guides clients in forming and structuring new business entities, and in helping them negotiate the legal landscape that follows. As a trusted advisor, he guides entrepreneurs in strategic
plenty of opportunistic vendors and investors can’t wait to take advantage of innovators who lack the experience to identify and avoid common pitfalls. Thankfully, a practical, real-world guide to maneuvering past common and avoidable mistakes has finally arrived. “AVOID STARTUP FAILURE!: Learn The Top Ten Causes Of Failure For Technology Startups And How To Turn Them To Your Advantage,” the debut book by Philip Crowley of Crowley Law LLC, reveals the insider secrets and strategic tools that have protected many startups by avoiding “game ending” missteps. Told through the tale of an intrepid innovator, Crowley’s words provide invaluable insights and practical strategies drawn from experience as a research physicist- turned-corporate lawyer. Readers will learn how to better protect their ideas, navigate challenges and bring their innovations to market while adhering to the book’s mantra: Don’t
business initiatives, including contract review and negotiation, licensing, IP planning and protection, and founders and key employee arrangements. His primary objectives are to help startup businesses proactively avoid costly mistakes while laying a solid foundation for business growth and success. In addition to providing an analysis of and planning strategy for protection against liabilities, he offers ongoing proactive counseling services for clients without in-house counsel. Before launching the firm, he served as a corporate counsel for Johnson & Johnson. In this role, he was a valuable partner for the company’s diversified businesses and provided strategic legal guidance in mergers and acquisitions, finance and
commercial law, FDA regulations and environmental compliance.
let others take advantage of you! This book is essential reading for anyone new to the world of life sciences or tech entrepreneurship. Look for more details about the book in upcoming editions of this newsletter. Go to http://bit.ly/4396BxS to order your copy today! Visit the Crowley Law LLC website at CrowleyLawLLC.com to access the firm’s library of free resources — including “From Lab
Phil is a Trustee of Stevens Institute of Technology and member of the Board of Directors of Ben Franklin Technology Partners of Northeastern Pennsylvania. As a Mentor to life sciences incubators at Weill Cornell Medical College, in New York City, he is uniquely qualified to help emerging life sciences companies at every stage in their life cycles.
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From Lab to Patient, Patient to Garage Maximize and Manage Your Company’s Worth
“I’ve been working with Phil for a very long time; it’s been a great experience working with him. He restructured the company altogether from the get-go. He’s astounding. He comes at law from a very detailed perspective and a very business-oriented perspective I hadn’t encountered before. [A] focus on taxes and exit strategies is an obvious thing for a startup company to think through, but it was not obvious to me that we would be thinking about these things this early on. He’s just a really good attorney.” What Businesses Say About Crowley Law, LLC Real Voices, Real Results available to help guide you toward the best conclusion for your operations as these new chapters in your industry unfold. Whether modern times give you cause for alarm or have inspired a newfound positive outlook, the fact remains that nothing in business stays static. New issues and struggles will always arise, but how we approach and address them will determine whether they serve as opportunities or obstacles. Although it would be wonderful to have solid and immediate answers to our concerns, it doesn’t appear we’ll enjoy that luxury anytime soon. All we can do is our best to remain proactive instead of reactive when a question mark clouds so much of the future. Patience — not panic — is the ultimate virtue in times like these. Note: The foregoing may constitute attorney advertising under applicable bar rules. ... continued from Cover –Philip Crowley
The product(s) you bring to market may be invaluable to consumers, but the value of the business behind them often isn’t always clear — which is why it’s essential to check out Episode 18 of Philip Crowley’s “From Lab to Patient, Garage to Market” podcast. To assist entrepreneurs in better understanding their companies’ worth, Philip welcomes Andrew Mackson, managing partner and co-founder of InteleK Business Valuations & Advisory, for an in-depth yet easily digestible discussion on the ins and outs of valuation. Here are just a few of the many topics explored: • The key differences between investment value and fair market value (and common causes of considerable gaps between the two figures) • The standard (or basis) of value for a business • Effective communication of valuation to employees • A valuation’s intended user and audience • Tax benefits and considerations • Valuations for compliance purposes • Tips on choosing the right valuation expert for your business Throughout the discussion, Mackson unpacks several critical ways companies can ensure the highest value possible. While simply going to market and listening to feedback on the positive or negative factors influencing your business’s value is perhaps the best way to accomplish this goal, he cautions that this approach may not work for everyone. “If you do that, you’ll be showing information externally, and there are several risks. Your confidential data may ‘leak’ – intentionally or by mistake – into the marketplace. This can educate your competitors about your company and damage your position in the marketplace. There’s a better way to estimate value.” You can arrange a ‘test run’ with an independent party who is contractually obligated to keep your information confidential. That’s essentially what we’ve had the valuation process described as. When we value a business, we ask all these questions — financial and non-financial — that a sophisticated buyer most probably will ask. So, you receive the benefits of an independent review without the inherent risks of disclosure.” Hosted by Crowley Law LLC Founder and Managing Partner Philip Crowley, the “From Lab to Patient, Garage to Market” podcast explores the critical issues and concerns impacting the biotech, life sciences and startup markets by offering fresh perspectives from industry leaders and experts. It is available on YouTube, LinkedIn, Facebook, Apple Podcasts, Spotify, all the major podcast channels and at CrowleyLawLLC.com .
–Chris Marshall CEO/founder/president, Calder Biosciences, Inc.
“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
For information on how our services and expertise can help your business thrive and succeed, please visit CrowleyLawLLC.com .
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In This Issue
1. New Oversight, New Opportunities
2. Mistake-Proof Your Mission
3. Podcast Preview
Client Testimonials
4. Steps Toward Building a Strong Business Credit Score
Build Your Business Muscles Protect Your Company’s Credit Score
Building a business can require long hours growing sales, putting out fires, and driving ideas to fruition. Checking your business credit score might not be the first thing that comes to mind, but it can make a difference in your ability to achieve those other goals. A low credit score will inflate your borrowing costs and make attracting strong business partners and vendors harder. To establish business credit, register for a Dun & Bradstreet Data University Numbering System or D-U-N-S number. Your payment history, the age of your business credit accounts, the size of your debt and trade credit extended by suppliers all affect your score. To put your best foot forward, check your score frequently with Dun & Bradstreet, Equifax and Experian. Ensure your
business and financial information, revenue figures and industry classification are accurate. Mixups happen more easily with business credit scores than personal ones because identifying information is indexed only to your business name and address. If your DBA is similar to another company’s, your business might be confused with theirs. Also, pay your bills on time or, preferably, before they are due. The clock runs faster on business credit than on personal loans. While consumer debt typically isn’t treated as late until 30 days after invoicing, business debt payments are considered “late” if only one day overdue. Your payment history determines Dun & Bradstreet’s Paydex score and is vendors’ primary information source. If you pay your bills on their due date, you will earn a
Paydex score of 80 on a scale of 100. To get closer to 100, you must pay before the due date! Also, segregate your business and personal borrowing as much as possible. When starting a business, maxing out a personal credit card is a common but ill- advised strategy. Businesses typically use far more credit than consumers and can access far more credit. Following these basic rules can help you demonstrate your trustworthiness to prospective business partners and lenders, increasing your financial flexibility and opening up new opportunities!
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