Kathleen M. Shay concentrates her practice in the areas of business law and finance, securities regulation, venture capital financings, mergers and acquisitions, corporations, partnerships and limited liability companies.
Ms. Shay serves as outside counsel to a significant number of emerging growth companies in the life science and technology fields and represents venture capital investors in their investments in these emerging companies. Ms. Shay's representation ranges from structuring and organizing start-up companies through structuring and negotiating venture capital and other financings, licensing transactions and strategic alliances, and representing companies in mergers and acquisitions and public offerings.
Ms. Shay works proactively and collaboratively with clients' managements and boards of directors to coordinate and oversee clients' legal needs and their integration with operations and business initiatives.
Ms. Shay serves on the Boards of Directors of University City Science Center and Life Sciences PA (formerly Pennsylvania Biotechnology Association) and the Board of Consultors of Villanova Law School, and she is a Director Emeritus of the Philadelphia Alliance for Capital and Technologies (PACT) and a Trustee Emeritus of the Academy of Notre Dame de Namur. Ms. Shay previously served as a director of the Philadelphia Chapter of the Association for Corporate Growth and as the Chair of the Executive Committee of the Business Law Section of the Philadelphia Bar Association, and she is a past-Chair of the Securities Regulation Committee. Ms. Shay is an Advisory Board member and former director of the Alliance of Women Entrepreneurs (AWE) and has served as AWE’s counsel since its inception.
A frequent lecturer, she is a 1977 graduate of Villanova University School of Law and a graduate of Villanova University.
Areas of Practice
- Mergers and Acquisitions
- Venture Capital
- Licensing/Strategic Alliances
- Limited Liability Companies
- Business Law and Finance
- Securities Regulation
Represented Early Medical Inc., and Night Owl Medical, Inc., medical device companies that provide solutions for women’s health, in their Series A Preferred Stock financing.
Represented Runway Healthcare—an accelerator that funds and manages the product development of emerging medical device companies and seeks to exit those companies before commercialization with at least 50% ownership—in acquiring control of Waypoint Orthopedics, which focuses on surgical solutions for the treatment of spinal disorders, and Toetal Solutions, which is developing the Ziptoe™ Hammertoe System.
Represented 5Metis, Inc., an agrichemical discovery company, in its Series A Preferred Stock financing from private investors led by Ospraie Ag Sciences, and in its multi-year grant from the Bill & Melinda Gates Foundation.
Represented Gilknik Inc., a privately owned biotech company, in its Series C Preferred Stock financing; the proceeds are being used primarily to progress the growing pipeline of Gliknik products.
Represented Venatorx Pharmaceuticals, Inc., a clinical-stage pharmaceutical company providing treatments for multidrug-resistant bacterial infections and hard-to-treat viral infections, in its Series C Preferred Stock financing.
Represented Integral Molecular, a biotechnology company specializing in discovering therapeutic antibodies–and the industry leader in membrane protein solutions–in its research collaboration and licensing agreement with Context Therapeutics, a clinical-stage women’s oncology company, to advance a potential gynecological cancer therapy involving an anti-claudin 6 (CLDN6) bispecific monoclonal antibody.
Represented NephroDI, a pharmaceutical company focusing on concentration disorders of the kidney, in its initial corporate structuring and capitalization and in an exclusive patent and technology license from Emory University.
Represented Waypoint Orthopedic, an innovative company focused on making vertebral fixation safer and more efficient, in an exclusive license agreement for orthopedic applications to a proprietary needle guidance system to assist surgeons with needle placement during orthopedic surgical procedures.
- Represented SIRPant Immunotherapeutics, a biotechnology company focused on the development of novel autologous cell therapy for solid tumors, in an exclusive license from Georgia State University and a $25 million Series A Preferred Stock financing, with BIOS Equity Partners III, LP as the lead investor.
Represented AgriMetis, LLC, a company working to fulfill the emerging need for sustainable crop protection products by applying cutting-edge technology and novel business models, in connection with the sale of its lead asset and related product development program to BASF, the German multinational chemical company.
Represented Annovis Bio, Inc. (NYSEAMERICAN: ANVS ), a manufacturer of pharmaceuticals for the treatment of neurodegenerative diseases, in connection with its initial public offering.
- Represented Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, in its $25 million Series C Preferred Stock extension financing, with Vensana Capital as the lead investor. Vensana was joined by existing investors, including New Enterprise Associates, H.I.G. Bioventures, and Quaker Partners.
- Represented Complexa Inc., a clinical stage biopharmaceutical company focused on transforming the treatment of fibrosis and inflammation-associated orphan diseases, in connection with a $28 million Series C-1 Preferred Stock financing, of which approximately $12 million was sold at the initial closing. The financing was led by New Enterprise Associates and Pfizer Venture Investments, LLC. Participation in the financing also included BioDiscovery 5 represented by Andera Partners, HBM Healthcare Investments Ltd. and JAFCO Investment Ltd. The financing was a follow-on investment to the Company's sale of $40.261 million of Series C Preferred Stock in July 2016 to the same lead investors.
- Represented Vesper Medical, Inc., a private medical device company developing innovative venous stent solutions for peripheral vascular disease, in its $37 million Series B Preferred Stock financing. Lead investors Vensana Capital and Gilde Healthcare were joined by existing investors New Enterprise Associates and Quaker Partners.
- Represented Tangen Biosciences, Inc., a molecular diagnostic company, in its $9 million Series A Preferred Stock financing. The financing was led by Connecticut Innovations, with participation by existing and new investors, including VC23, Axiom, and Leading Edge Ventures.
- Represented VenatoRx Pharmaceuticals, Inc., a biopharmaceutical company developing next-generation antibiotics, in connection with the sale of $42 million of Series B Preferred Stock to various investors, including Abingworth, Foresite Capital and lead investor Versant Ventures, with an additional $5 million follow-on investment of Series B Preferred Stock by Everest Medicines II Limited.
- Represented a pharmaceutical company developing injectable products to treat allergic reactions in its acquisition by a developer of specialty pharmaceutical products; the transaction included significant upfront cash consideration, additional milestone payments, and contingent consideration based on product sales.
- Represented Psyadon Pharmaceuticals, Inc. in its acquisition by a subsidiary of Paragon Biosciences, bringing with it rights to develop, register and market ecopipam, a new chemical entity with orphan drug designation for the treatment of pediatric Tourette Syndrome.
- Represented AgriMetis, LLC, a private company innovating agricultural crop protection products, in its $23.5 million Series B financing, in which new investors and company's co-founders participated; handled ongoing negotiations with collaborative and strategic alliances.
- Represented Strata Skin Sciences, Inc. (SSKN: Nasdaq), a dermatology and plastic surgery company, in a $17 million common stock financing led by Accelmed Growth Partners, an investment firm focused on medical technologies, which resulted in the appointment of a new CEO and a restructuring of the Board of Directors.
- Represented CD Diagnostics, Inc., a Delaware-based diagnostics company focused on developing immunoassays and biomarker testing to inform treatment decisions that improve patient outcomes, in its sale to Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare.
- Represented Celator Pharmaceuticals, Inc. (NASDAQ:CPXX) in a follow-on underwritten public offering of four million shares of common stock at a price of $9.50 per share, with expected gross proceeds of $38 million.
- Represented Inovio Pharmaceuticals, Inc. in entering into an agreement to gain all of Bioject Medical Technologies' assets for $4.5 million in stock and $1 million in cash. Inovio plans to launch a device combining its needleless, skin-surface electroporation technology with Bioject's jet injection technology.
- Represented MELA Sciences, Inc. (NASDAQ:MELA) in its purchase of the XTRAC and VTRAC Dermatology business from PhotoMedex, Inc. for $42.5 million in cash and the assumption of certain business-related liabilities and the related financing with institutional investors consisting of a private placement of $42.5 million aggregate principal amount of senior secured notes and convertible debentures and warrants to purchase 3.0 million shares of common stock.
- Represented Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, in its $38.9 million Series B Preferred Stock financing to accelerate the development and FDA approval of the company's endovascular dissection repair technology.
- Represented Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) in its public offering of 10.925 million shares of its common stock for total gross proceeds of $87.4 million.
- Represented Current Analysis, Inc., an IT and telecom market-research firm, in the sale of the company to Progressive Digital Media Group through a merger transaction for a purchase price of $19.6 million.
- Represented Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) in an underwritten public offering, the gross proceeds of which were approximately $64 million.
- Represented Gliknik Inc., a privately held biopharmaceutical company, in negotiating an exclusive worldwide license agreement with Pfizer Inc. for Gliknik's recombinant stradomer™ GL-2045, a drug candidate designed to replace and improve on pooled human intravenous immunoglobulin (IVIG). Gliknik received an upfront payment of $25 million and is eligible to receive development, regulatory and commercial milestone payments and tiered, double-digit royalties on net sales of any products commercialized under the license agreement.
- Represented Inovio Pharmaceuticals, Inc. with regard to a collaboration agreement with Roche to research, develop and commercialize Inovio's highly-optimized, multi-antigen DNA immunotherapies targeting prostate cancer (INO-5150) and hepatitis B (INO-1800) as well as use of Inovio's CELLECTRA® electroporation technology for delivery of the vaccines. The deal called for Inovio to receive an up-front payment of $10 million, as well as milestone payments of up to $412.5 million.
- Counsel to Celator Pharmaceuticals, Inc. (NASDAQ – CPXX), which is developing oncology drugs, in transitioning from a venture-financed company to a public company and raising more than $125 million in several rounds of financing from venture capital and other accredited investors since 2005. Celator evolved from technology developed at the British Columbia Cancer Agency and maintains a subsidiary in Vancouver, British Columbia. The Series B round included a completed cross-border restructuring. After subsequent venture financings, we represented Celator in attaining status as a public company through a Form 10 filing, followed by a $39.3 million private placement led by Valence Life Sciences.
- Represented Marinus Pharmaceuticals, Inc., a neuroactive steroid developer, in its $21 million Series C financing from U.S. venture capital firm Domain Associates, LLC, Russian state-owned investment fund RusnanoMedInvest, and co-investors Canaan Partners, Sofinnova Ventures and Foundation Medical Partners.
- Counsel to Novira Therapeutics, Inc., an antiviral drug discovery company developing first-in-class antiviral therapeutics for the treatment of chronic HBV and HIV infections, in a $25 million Series A Preferred Stock financing, which was invested in two tranches in August 2012 and February 2013, respectively.
- Represented CD Diagnostics, Inc., a diagnostics company, in its Series A preferred stock financing and a strategic partnership with Zimmer Inc.
- Represented Bioconnect Systems, Inc., a medical device firm, in raising $9.1 million in a private stock sale.
- Represented Agile Therapeutics, Inc., a transdermal contraceptive patch developer, in more than $100 million preferred stock financing and numerous strategic relationships and other business transactions.
- Counsel to Inovio Pharmaceuticals Inc., a publicly traded biotechnology company focused on the development of DNA vaccines. Inovio was formed in 2008 upon the merger of equals of Inovio Biomedical Corporation and VGX Pharmaceuticals, Inc. Served as counsel to VGX Pharmaceuticals in the merger and as outside corporate counsel to VGX Pharmaceuticals for several years prior thereto.
- Represented Protez Pharmaceuticals, Inc. in two rounds of Preferred Stock financing from venture capital investors and its acquisition by Novartis Pharmaceuticals Corporation, a structured acquisition with a $100 million up-front payment. Counsel to Protez Pharmaceuticals in venture capital financings and business initiatives for several years prior to its sale.
- Represented Prinston Pharmaceutical, a generic drug company subsidiary of China-based Zhejiang Huahai Pharmaceutical Ltd., in the acquisition from Par Pharmaceutical of a drug manufacturing plant in Charlotte, N.C. and the right to produce and market 18 generic medicines.
- Represented Psyadon Pharmaceuticals in an in-license of a drug compound from Schering Corporation (now Merck).
- Counsel to a start-up pharmaceutical company in its licensing agreement from the University of Chicago. Also represent the client in an ongoing search for its seed round of venture capital financing to enable it to commercialize preventative treatments for necrotizing enterocolitis and inflammatory bowel disease.
- Counsel to emerging businesses in structuring, negotiating and drafting venture capital and other private equity financing arrangements and related corporate governance, executive compensation, securities law compliance and due diligence issues.
- Counsel to both buyers and sellers in public and private acquisition and divestiture transactions, including assistance with structuring the transaction from business and tax perspectives, undertaking due diligence, negotiating and drafting the documentation, and closing and post-closing representation.
- Counsel to public companies in connection with securities regulation reporting and financing activities.
- Counsel to biotechnology and other life science companies in the structure, negotiation and drafting of various types of technology transfer, licensing and collaboration agreements relating to novel technologies.
- Counsel to private equity funds, including structuring and formation advice, assisting with the preparation of offering materials and securities law compliance in raising capital, and representing the funds in structuring and making investments in portfolio companies and real estate transactions.
- Supreme Court of Pennsylvania
- U.S. Court of Appeals for the Third Circuit
- U.S. District Court for the Eastern District of Pennsylvania
- Villanova University Charles Widger School of Law, J.D., 1977
Villanova Law Review, Editor-in-Chief, 1976-1977
- Association for Corporate Growth
- Pennsylvania Biotechnology Association; BIOTECH 2006, 2004, 2003 and 2002 Symposium Committees
- Greater Philadelphia Alliance for Capital and Technologies (PACT)
- Founding member of the Board of Directors and Executive Committee, 2010, 2011
- Alliance of Women Entrepreneurs, legal counsel and former director
- American Bar Association
- Business Law Section
- Pennsylvania Bar Association
- Corporation, Banking and Business Law Section
- Philadelphia Bar Association
- Business Law Section
-- Executive Committee, member since 2001
--- Chair, 2005
--- Vice Chair, 2004
--- Treasurer, 2003
--- Secretary, 2002
- Steering Committee on Securities Regulation
--- Chair, 2001
--- Vice Chair, 2000
--- Secretary, 1999
- Order of the Coif
Honors and Awards
Listed in The Best Lawyers in America, 2006-2023
Recognized in Chambers USA: America's Leading Business Lawyers, 2004-2022
LIsted in Pennsylvania Super Lawyers
- Philadelphia Business Journal Best of the Bar: Top Lawyer 2017
- Listed in Best Lawyers Greater Philadelphia, 2016
- Listed in Smart CEO's Leading Lawyers, 2011
- Recipient of The Philadelphia Business Journal's Life Science Award for Best Consultant (Early Stage), 2010
- Named a 2008 Woman of Distinction by the Philadelphia Business Journal
- Recipient of the WIN Iris Newman Award in 2006. The award is given each year to a woman business leader who has demonstrated a strong commitment to helping advance women entrepreneurs.
- Recipient of the Gerald Abraham Alumni Association Award for service to the Villanova University School of Law, 2006. The award is presented annually to someone who has demonstrated outstanding leadership and made significant contributions to the law school's mission.
- AV Preeminent® Peer Review Rated by Martindale-Hubbell®
- Board of Directors, University City Science Center, 2015-present
Board of Directors, Life Sciences Pennsylvania (Pennsylvania Biotechnology Association), 2013-present
- Board of Directors, Greater Philadelphia Alliance for Capital and Technologies, 2010-2014
- Board of Consultors, Villanova University School of Law, 1992-present
- Chair, 2004-2008
- Vice Chair, 2001-2004
- Board of Trustees, Academy of Notre Dame de Namur, 2004-present, 1995-2001
- Board of Directors, Philadelphia Chapter of the Association of Corporate Growth, 2004-2009
- Advisory Board, Alliance of Women Entrepreneurs (AWE); Board of Directors, 2000-2006
- Board of Directors, The Delaware Valley Venture Group, 1995-1997
Civic and Charitable Activities
- Treasurer, Llanfair Condominium Association, Ardmore, PA
Quoted, "What's the Deal with M&A?" Philadelphia Business Journal, March 1, 2018
- Moderator, Buyer Perspectives roundtable discussion featured in Mergers & Acquisitions Supplement to Philadelphia Business Journal, May 11, 2007
- Ms. Shay appeared on the cover of the April 2007 issue of Technology Times and was featured in the article "Five Well-Placed Women and How They Got There."
- Author, "Buyer Beware: Well Drafted Legal Agreements May Not Be Enough," featured in Mergers & Acquisitions Supplement to Philadelphia Business Journal, May 2004
- Co-moderator of a corporate counsel roundtable discussion titled "What Do Business Leaders Want From Their Lawyers?" that appeared in the Fall 2005 issue of The Philadelphia Lawyer
- Co-author, "Effective Investor Presentations: What the VCs Want to Know," Venture Guide 2003
- "Organizing Your Start-Up as a Legal Entity," Entrepreneurs' Newsletter, published by Success Start, Inc., Spring 1998
- "Private Placement of Securities," The Delaware Valley Financing Manual, published by the Pennsylvania Innovation Network in August 1995
- Note 21 VILL. L.REV. 535 (1975-1976); Note 21 VILL. L.REV. 537 (1975-1976)
Selected Speaking Engagements
- Moderator, "Building a Powerful & Purposeful Brand," Women In Bio-Philadelphia Metro: Journey Series, March 15, 2023
- Faculty Member, "Off to a Good Start (Up): Representing the Start-Up from Formation to Financing," Pennsylvania Bar Institute and Pennsylvania Bar Education Center Course, Philadelphia, PA, December 3, 2012
- Faculty Member, "Mergers and Acquisitions: Practice, Process. . .and Forms!" Pennsylvania Bar Institute and Pennsylvania Bar Education Center Course, Philadelphia, PA, August 27, 2007; April 26, 2007
- Speaker, "The Art of the Deal, Preferences and Contracts," Biotechnology Entrepreneurship Symposium sponsored by The Wharton Small Business Development Center and LSU Health Sciences Center, Frazer, Pennsylvania, April 23-24, 2007
- Presenter, "Private Placement Essentials: What You Need to Know Now, The Nuts & Bolts of Private Placements," audio conference for CLE credits sponsored by the National Constitution Center, March 22, 2007
- Faculty Member, "Mergers and Acquisitions," Pennsylvania Bar Institute and Pennsylvania Bar Education Center Course, Philadelphia, PA, July 20, 2005; July 24, 2001; June 24, 1999
- Moderator, "Opportunities in the Nation's Pharmaceutical Center," Biotech 2004 Symposium, Philadelphia, PA, October 4-5, 2004
- Panelist, "Ready, Aim, Raise - The Essentials of Raising Venture Financing," a venture capital education program sponsored by the Greater Philadelphia Venture Group, Philadelphia, PA, April 2, 2004
- Moderator, "New Compensation and Staffing Strategies: Meeting Today's Challenges," Biotech 2003 Symposium, Jersey City, New Jersey, September 30, 2003
- Facilitator, "The Venture Capitalist vs. The Entrepreneur, The Good, the Bad, and the Equity," Venture Institute VII, a venture capital educational program sponsored by the Greater Philadelphia Venture Group, Philadelphia, PA, April 25, 2003
- Guest Lecturer, "Stakeholder Agreements," The Wharton School of the University of Pennsylvania, MBA course on Entrepreneurial Studies, Philadelphia, PA, February 2003; January 28, 2002; March 29, 2000; February 17, 1999; November 16, 1998; March 25, 1998; October 22, 1997
- Course Planner and Panelist, "Private Placement of Securities," three-credit CLE course sponsored by the Pennsylvania Bar Institute, Philadelphia, Pennsylvania, October 11, 2002; October 5, 2001; October 6, 2000; October 8, 1999; October 2, 1998; September 26, 1997
- Presenter, "Practical Advice on Negotiating an Employment Agreement," ExecuNet Presentation at American College, Bryn Mawr, PA, August 15, 2002
- Presenter, "Structuring and Negotiating the Deal," an educational program for venture capitalists sponsored by the Women's Investment Network, Philadelphia, PA, July 17, 2002
- Presenter, "The Board of Directors," an educational program for women CEOs sponsored by the Women's Investment Network, Philadelphia, PA, June 5, 2002
- Facilitator and Panelist on "Legal Nuances of Venture Capital Transactions," Venture Institute VI, a venture capital educational program sponsored by the Greater Philadelphia Venture Group, Philadelphia, PA, April 4, 2002
- Panelist, "Venture Capital 101," Greater Philadelphia Venture Group's "Venture Institute VI", Philadelphia, Pennsylvania, April 4, 2002
- Panelist, "Venture Capital Financing Course," Pennsylvania Bar Institute's Commercial Document Series, Philadelphia, PA, March 21, 2002; and Mechanicsburg, PA, March 26, 2002
- Course Planner and Speaker, "Private Placement of Securities," Pennsylvania Bar Institute and the Pennsylvania Bar Education Center, Philadelphia, PA, October 5, 2001; October 6, 2001; October 8, 1999; October 2, 1998; September 26, 1997
- Panelist, "Auditor Independence, Audit Committees and the SEC's New Proxy Rules," SEC Issues Update 2001, co-sponsored by Glasser Legal Works and Bowne, Philadelphia, PA June 20, 2001
- Facilitator, Venture Institute V, a venture capital educational program sponsored by the Greater Philadelphia Venture Group, Philadelphia, PA, April 26, 2001
- Panelist, "Use of Electronic Media Under the Federal Securities Laws," "Auditor Independence," and "The SEC's New Audit Rules and Audit Committees," SEC Issues Update 2000, co-sponsored by Glasser LegalWorks and Bowne, Philadelphia, PA, June 1, 2000
- Panelist, "How to Help Your Client Avoid the Pitfalls of the Securities Laws - What Every Business Law Attorney Needs to Know," Securities Regulation Committee of the Business Law Section of the Philadelphia Bar Association, Philadelphia, PA, February 22, 1999
- Guest Lecturer, St. Joseph's University, Philadelphia, PA, February 4, 1999; June 1, 1998
- "Going Public: A Primer for the Entrepreneur," four-part seminar series co-sponsored by Packard Press and The Wharton Small Business Development Center, Philadelphia, PA, November 20, 1998
- Faculty Member, "Limited Liability Company Operating Agreements," Pennsylvania Bar Institute's Continuing Legal Education Commercial Document Series, Philadelphia, PA, August 1996 and November 1995; Course Planner, August 1998
- Panelist and Moderator, "Creative Compensation Strategies," Women's Investment Network, Bala Cynwyd, PA, July 21, 1998
- Faculty Member, "Deal Structure--How Both Sides Win," Growing Your Business Through Alliances--Theory and Reality, co-sponsored by the Women's Investment Network, the Snider Entrepreneurial Center of The Wharton School of the University of Pennsylvania and the Ben Franklin Technology, Philadelphia, PA, June 23, 1997
- Commencement Speaker, Academy of Notre Dame de Namur, Villanova, PA, June 8, 1997
- Moderator, "Starting a New Business with Venture Capital," co-sponsored by the Greater Philadelphia Venture Group and the Philadelphia Bar Education Center, Philadelphia, PA, May 1997
- Panelist, "Private Placements of Securities," Philadelphia Bar Education Center Continuing Legal Education Course, Philadelphia, PA, October 1996
- Panelist, "Restructurings and Recapitalizations," Financial Executives Institute and Howard, Lawson & Company panel discussion, Philadelphia, PA, June 1996
- Moderator, "Case Studies: Technology Transfer Today," Delaware Valley Venture Group panel discussion, West Conshohocken, PA, April 1996
- Panelist, "Joint Ventures and Strategic Alliances," The New Jersey Capital Conference '96, sponsored by the New Jersey Technology Council and Business News New Jersey, Princeton, NJ, January 1996
- Panelist, "The Greater Philadelphia Financing Manual: The Region's Road Map for Entrepreneurial Financing and Growth Strategies," Philadelphia Innovation Network and Delaware Valley Venture Group panel discussion and entrepreneurial reception, Philadelphia, PA, October 1995
- Panelist, "Benelux: Your Biotech Gateway to Europe," 1993 Pennsylvania Biotechnology Association Annual Meeting and Symposium, Philadelphia, PA, April 1993