Spruce Law’s Life Sciences Practice: Our Value Proposition
Legal Services Optimized. Spruce Law provides “big-firm” quality, highly-responsive representation, delivered with individualized service and unmatched value. Our attorneys have practiced in some of the largest and most respected global firms, and corporate life sciences legal departments. We are a team of seasoned legal professionals with deep-seated industry expertise, and we provide superior quality legal and transactional support for life sciences companies. Spruce Law’s model ensures that you will never pay for on-the-job lawyer training. Our pedigrees are equal to those found at traditional large firms, and our highly innovative law firm structure enables us to serve your needs with maximum efficiency. We are committed to delivering top-quality legal service with more predictable, value-driven billing arrangements.
Simply put …we get it!
Today’s Life Sciences Industry. We recognize that today’s life sciences companies are focused even more on the need to achieve results in an increasingly competitive, highly regulated environment, in which a strong focus on details and the bottom line can mean the difference between success and failure. Whether you are an established pharmaceutical or medical device industry leader, a specialty life sciences company, an early-stage start-up, or a research university or medical center, you need responsive and experienced legal representation on which you can rely to provide the right advice, or to complete the critical transaction. We provide the creativity, ingenuity, attention to detail, and tireless drive required to minimize your risks and to get your deals across the finish line.
Common Sense, Results-Driven Approach. The achievement of your business goals and objectives are of paramount importance. SLG’s service and support are designed with this deliverable in mind. Our substantial experience in the life sciences field enables us to work efficiently and effectively to get the job done. We anticipate the challenges along the way based on our past experience, look to minimize risk, wherever possible, and apply practical, effective, and streamlined solutions. We also take the time to learn what is most important to you, so that each representation is tailored to your precise business needs and objectives.
We Always Deliver Innovative and Efficient Service. We take great pride in working with our clients by utilizing our wealth of experience, innovation, and knowledge. Working from these strengths, we efficiently deliver precisely what you need. This is how we work at Spruce Law, whether supporting a strategic transaction, or providing legal insight and strategy on a difficult commercial, regulatory, licensing, or intellectual property matter. We lessen the burden on clients by guiding them through the complexities of the transaction process, and by helping them overcome the regulatory and legal hurdles.
Cross-Disciplinary Skills and Experience. Spruce Law’s veteran life science and transactional attorneys have practiced in some of the largest and most respected corporate legal departments of global life sciences companies, global law firms, and university research centers. We have successfully closed thousands of large, complex life sciences deals, and advised on numerous matters involving thorny regulatory, commercial, and intellectual property issues. Our life sciences team was strategically built for the multi-faceted nature of today’s life sciences and pharmaceutical industry. We bring commercial, corporate, intellectual property, licensing, tax, and transactional life sciences knowledge and know-how to the table to get your deals closed and to provide crucial advice with maximum efficiency.
Life Sciences Transaction Capabilities
Our life sciences transactional experience encompasses all phases of drug, device, vaccine, and biological product research, development, and commercialization. Representative transactions include:
- Technology transfer and research collaboration agreements
- Research consortia agreements
- Intellectual property in-licensing, out-licensing, and cross-licensing agreements
- Drug, device, vaccine, and biological product research and development agreements
- Life sciences mergers and acquisitions
- Early stage drug, device, vaccine, and biological product development agreements
- Co-promotion and co-marketing agreements
- Manufacturing and supply agreements
- Distribution agreements
- Grant agreements
- Pre-clinical research agreements
- Government contracts
- CRO services agreements
- Clinical trial agreements
- General transactional support
Life Sciences Advisory Capabilities
Our life sciences advisory experience encompasses all phases of drug, device, vaccine, and biological product research, development, and commercialization. Representative matters include counseling and advice for the following:
- Under the Food, Drug & Cosmetic Act (FD&C Act) with respect to applicable advertising, promotion, labeling, sales, marketing, approvals, clearances, and registrations of prescription drugs, vaccines, biological products, therapeutic biological products, and medical/dental devices.
- Commercial operations matters related to the manufacturing, distribution and supply of prescription drugs, vaccines, biological products, therapeutic biological products, and medical/dental devices.
- Compliance matters, including the development and implementation of compliance programs to comply with relevant Federal and state laws and regulations, including the False Claims Act (FCA), the Stark Law, the Anti-Kickback Statute, and the Foreign Corrupt Practices Act (FCPA).
- Compliance with Corporate Integrity Agreements and other government-imposed mandates.
- General corporate governance matters.
- Internal and government investigations.
- Intellectual property matters, including patent infringement, non-infringement, validity, invalidity, clearance, freedom-to-operate, state-of-the-art, landscape, novelty, and patentability studies and opinions; assistance with the preparation and filing of patent applications in the US and globally; preparation and filing of trademark applications with the US Patent and Trademark Office (USPTO); preparation and filing of applications for copyright registrations in the US Copyright Office; and management of global intellectual property portfolios.
Representative Life Sciences Transactions and Advisory Matters
- Provided legal advice to numerous life science companies, clinical investigators, research universities, and medical research centers in connection with applicable Food and Drug Administration (FDA) approvals, exemptions, and clearances related to drugs, biologics, and devices, including exemptions and approvals related to investigational new drugs – via Investigational New Drug Applications (IND’s); product registrations of new drugs – via New Drug Applications (NDA’s) under Section 505 (b) (1) and Section 505 (b) (2) of the Federal Food Drug & Cosmetic Act (FD&C Act); supplemental New Drug Applications (sNDA’s); and Abbreviated New Drug Applications (ANDA’s) under Section 505 (j) of the FD&C Act; approvals of vaccines, biological products, and therapeutic biological products – via Biologic License Applications (BLA’s) under the FD&C Act and the Public Health Service Act; and clearances/ approvals of medical/dental devices – via remarket Notifications (PMN’s) under Section 510 (k) of the FD&C Act; Premarket Approval Applications (PMA’s) under Section 515 of the FD&C Act and under the Medical Device Amendments of 1976 to the FD&C Act; and PMA supplements under the FDA Modernization Act of 1997.
- Provided legal advice to numerous life sciences companies, clinical investigators, research universities, medical research centers, and Institutional Review Boards (IRB’s) related to clinical trials, data management, privacy, Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliance, human subjects protections, conflicts of interest, risk management, indemnification, liability, and adverse event reporting.
- Provided legal advice to numerous life science companies in connection with the marketing, labeling, and promotion of drugs and devices (e.g., on versus off-label uses and comparative advertising).
- Provided legal advice to numerous life science companies related to Medicaid and Medicare reimbursement issues.
- Formed and led a crisis management team for major medical device company responding to major newspaper front page article linking its device to severe adverse events in children. Issues involved FDA regulatory, congressional interaction, legal risk mitigation and media and communication management.
- Successfully represented global company’s dental division in connection with criminal investigations involving alleged bribery and corruption in Russia and in the EU.
- Established Corporate Integrity Agreement (CIA) and Independent Review Organization (IRO) processes for global pharmaceutical company in connection with Department of Justice (DOJ) settlements involving off-label promotion and falsification of cGMP data.
- Negotiated a settlement with a state Attorney General in connection with consumer fraud relating to data falsification. As part of this settlement, was responsible for submitting all quarterly reports under the Consent Decree as well as interacting with the IRO appointed to oversee this matter.
- Formed and led the major pharmaceutical company crisis management team, which managed all aspects of responding to a vaccine crisis, including negotiations with non-governmental organizations (NGOs), government agencies, legal risk mitigation, licensing and development. As part of this process negotiated an indemnity from the U.S. government against product liability exposure as a result of the emergency approval of the pandemic vaccine based upon in vitro data.
- Led major pharmaceutical company’s cost reduction and efficiency project that resulted in substantial improvements in the delivery of global legal services, as well as a rationalization of external counsel management and utilization, which yielded over $60 million in savings over 3 years.
- Responsible for coordinating the antitrust approvals in connection with the merger of two global pharmaceutical companies, including the Federal Trade Commission (FTC) and European Commission (EC) approvals. Led the settlement negotiations with the FTC and the EC which resulted in the FTC Consent Decree and the EC Mandate. As part of this process, was responsible for working with the FTC Monitor Trustee with respect to post-merger obligations. Also led the team that divested the various products mandated by the FTC and the EC to be sold as a pre-condition to approving the merger, most notable of which were the $1.1 billion global sale of a drug to a competitor and the $1.68 billion global divestiture of another drug to a key competitor.
- Presided over medical research center scientific misconduct hearing involving cardiovascular research.
Acquisitions and Divestitures:
- Managed $2.3 billion acquisition of pharmaceutical services company from large health care company.
- Oversaw $1.45 billion divestiture of major pharmaceutical company’s animal health business.
- Represented major pharmaceutical company in $2.2 billion acquisition of health care division from global company and related $1 billion spin-off of North American part of the business to a major competitor.
- Represented global pharmaceutical company in connection with the $124 billion merger with another global pharmaceutical company.
- Managed publicly-traded CRO’s $17.4 million acquisition of 30% of common stock of leading specialist CRO.
- Oversaw global CRO’s $45.8 million acquisition of leading US provider of bioanalytical and immunoassay services
- Represented global CRO in $10.9 million acquisition of Phase I clinical trial management services company.
- Drafted and negotiated a joint venture between major health care company and key division of global pharmaceutical company for the creation of a new company to dispense prescription pharmaceuticals by mail.
- Formed UK joint venture company between global pharmaceutical company and European manufacturer for the global production of certain antibiotic bulk products.
- Represented Belgium-based pharmaceutical division in formation of U.S. joint venture company with, and related equity investment in, contract manufacturer for the worldwide development and commercialization of vaccine products.
- Represented major pharmaceutical company division in connection with restructuring of $2 billion North American partnership.
Marketing Alliances and Commercial Transactions:
- Completed a series of worldwide country-specific marketing arrangements between global pharmaceutical company and German-based company for the global commercialization and marketing of a cardiovascular drug.
- Completed numerous U.S. Co-Promotion Agreements for numerous medical device and pharmaceutical companies.
- Drafted and negotiated numerous marketing alliances for major medical device company involving a variety of medical device products throughout the world.
- Drafted and negotiated numerous commercial agreements for medical device and pharmaceutical companies, including manufacturing, supply and distribution agreements. Representative Life Sciences Transactions and Advisory Matters
Licensing and Research Deals:
- Completed numerous in-licensing and out-licensing and collaborative R&D ventures in the biotechnology, medical device, and pharmaceutical industries, including many deals between global companies and major research universities.
- Completed numerous clinical trial agreements between major research university and global medical device and pharmaceutical companies.
- Completed numerous sponsored research agreements between major research universities and biotechnology, medical device, and pharmaceutical companies.
- Completed numerous grant agreements from federal agencies and departments involving millions of dollars of research by major medical research center.
Credit Lines and Loan Facilities Agreements:
- Represented and completed deal for European CRO to obtain $50 million 3-year committed credit facility from major European bank.
- Represented and completed deal for global CRO to obtain $25 million 4-year committed credit facility from major European bank.
- Represented global CRO in completion of deal for $10 million 364-day committed credit facility from major global bank.