EFFECTIVE RESULTS

Life Sciences Transactions

LEADERSHIP: Rachael M. Bushey

Representative engagements include the following:

Capital Raising

  • Amicus Therapeutics, Inc. in its $225 million public offering
  • Interpace Diagnostics Group, Inc. in its $14.7 million public offering and a series of public offerings aggregating $14.1 million
  • Interpace Diagnostics Group, Inc. in its $9.3 million debt/equity exchange
  • Zynerba Pharmaceuticals in its $48 million initial public offering and its $57.5 million follow-on
  • Recro Pharma, Inc. in its $16 million and $55 million public offerings
  • Zynerba Pharmaceuticals in its $30 million and $50 million at-the-market offerings
  • Collegium Pharmaceutical, Inc. in its $55 million public offering
  • Applied DNA Sciences, Inc. in its $8.8 million public offering
  • Interpace Diagnostics Group, Inc. in its $5 million equity line of credit
  • Medgenics, Inc. in its $40 million public offering
  • TetraLogic Pharmaceuticals Corporation in its $17 million equity line of credit
  • Zynerba Pharmaceuticals, Inc. in its $48 million initial public offering
  • Fibrocell Science, Inc. in its $15 million public offering
  • Amicus Therapeutics, Inc. in its $259 million public offering
  • Collegium Pharmaceutical, Inc. in its $80 million initial public offering
  • TetraLogic Pharmaceuticals Corporation in its $25 million public offering
  • TetraLogic Pharmaceuticals Corporation in its $25 million at-the-market public offering
  • Unilife Corporation in the $60 million private placement of venture debt
  • investors in Spark Therapeutics’ $75 million Series B private placement
  • TetraLogic Pharmaceuticals Corporation in connection with an offering of $47 million aggregate principal amount of TetraLogic’s 8% Convertible Senior Notes due 2019 in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933
  • a private equity syndicate in connection with a $45 million growth equity investment in a pharmaceutical industry company
  • a venture capital syndicate in connection with a $24 million investment in a specialty pharmaceutical company
  • a national venture capital fund’s $17 million investment in a pharmaceutical services technology company
  • a private equity fund’s $8 million sub-debt investment in a medical products company
  • a pharmaceutical staffing company in connection with its $10 million private equity and sub-debt financing
  • a privately held specialty pharmaceutical company in its $35 million acquisition by a publicly held Canadian pharmaceutical company.

Licensing, Collaboration and Partnering Arrangements

  • a global pharmaceutical company in the out-licensing of a pharmaceutical compound candidate directed to the treatment of heart disease and related intellectual property to a venture-backed pharmaceutical company
  • a publicly traded biotechnology and diagnostics company in the global commercialization of a patented technology platform for various diagnostic applications, including structuring and negotiating research, development and supply agreements for instrumentation; assays and related supplies; and the cross-licensing of technologies
  • a specialty pharmaceutical company in all aspects of its commercialization activities, including out-licensing, in-licensing of a drug candidate and various vendor contracts, including supply and quality agreements
  • several major universities in the structuring and negotiation of sponsored research agreements, materials transfer and evaluation agreements, license agreements and equity-based technology transfers

Intellectual Property

  • preparing, filing and securing patent applications and patents throughout the world for innovations in pharmaceuticals, nutraceuticals, tissue engineering, orthopedics, neurosurgery, molecular imaging, biochemistry, genetics, plastic surgery and many other life sciences fields
  • on behalf of a biopharmaceutical company in the molecular imaging field, navigated through the IP due diligence process that led to an acquisition of the company by a global pharmaceutical company for up to $800 million
  • conducting internal IP due diligence reviews and audits on behalf of pharmaceutical, biopharmaceutical and medical device companies in preparation for partnering, financing and public offerings conducting internal IP due diligence reviews and audits on behalf of pharmaceutical, biopharmaceutical and medical device companies in preparation for partnering, financing and public offerings
  • counseling drug companies on unique patent issues relating to drug development, including Orange Book listing, label claims, patent term restoration and extension, and subtle issues of written description, enablement, genus and species issues, and anticipation and obviousness in the “unpredictable arts”
  • managing diverse patent portfolios and invention disclosure programs to document and protect life sciences inventions through patent, trade secret and copyright laws

Product Acquisition and Disposition

  • the acquisition of an off-the-market pharmaceutical product line, including all related assets
  • negotiation of a 363 purchase of a development-stage compound, including a related license agreement
  • a publicly traded pharmaceutical company in a product development transaction, international licensing arrangements and strategic alliances

Regulatory Counseling

  • advice to pharmaceutical and medical device companies, biotech firms, clinical investigators, IRBs and CROs on regulatory compliance concerning all aspects of clinical trial development, including review of clinical trial documentation, clinical data packages, and the full range of related SOPs, together with the identification and analysis of litigation risk in clinical trial programs
  • evaluation and review of regulatory submissions, promotional materials and communications, including all product labeling, REMS materials and risk management plans, FDA Advisory Committee meeting materials, clinical trial registries, websites, medical letters, manuscripts for medical meetings and journals, sales training materials, press releases, stand-by statements, labeling changes for a marketed product during litigation and external communications during litigation
  • advice to pharmaceutical and medical device companies responding to safety inquiries from the FDA, 483s, NOVs and warning letters, product recalls, FDA investigations and document preservation issues
  • counsel to providers on billing, reimbursement and claims issues; documentation audits by federal, state and private payors; managed care contracting; anti-kickback and physician self-referral regulations; False Claims Act investigations and network formation; and issues under Medicare Parts A, B & D, Medicaid and commercial payor requirements
  • evaluation of fraud and abuse compliance of pharmaceutical manufacturers, medical device companies, physician practice groups, hospitals and other providers and suppliers in connection with marketing programs; discount, rebate and other pricing arrangements; and corporate integrity agreements
  • advice to GPOs regarding safe harbor regulations and regulatory issues impacting relationships with manufacturers, suppliers and pharmacies
  • evaluation of marketing and promotional practices for potential Unfair Trade Practice, Lanham Act and common law claims brought by private plaintiffs or state payors threatening consumer protection or related claims
  • advice on compliance issues presented by off label/unapproved use of drugs and devices or drugs and devices subject to the humanitarian exception to the approval process
  • regulatory due diligence and counseling for mergers and acquisitions, in-licensing, co-development, co-licensing or CRO arrangements