King & Spalding has worked with hundreds of early-stage and emerging pharmaceutical, biotechnology and medical device companies to address their intellectual property, corporate/licensing, FDA/regulatory, litigation and other legal needs. As a result, we understand their size, culture and competitive landscape, allowing us to deliver high-quality, timely and cost-effective solutions.
For many clients, King & Spalding works in client service teams to ensure our clients are able to navigate the road to prosperity. Our multidisciplinary professionals work across practice groups to better anticipate and respond to all our clients’ needs. We also recognize the unique financial constraints of many small life sciences companies. In addition to leveraging extensive work for early-stage and emerging companies, to provide a variety of sophisticated services in a cost-effective manner, we have successfully structured non-traditional
- Fixed-fee arrangements for projects with well defined parameters and deliverables
- Blended hourly rate structures, which encourage efficient staffing models
- Shared-risk arrangements coupling success fees with discounts for “busted” deals
- Volume-based hourly discounts
- Other arrangements that help to align our interests with those of our clients
From start-up through public financing and product launch to patent expiry, our clients rely on King & Spalding’s substantive expertise, bench strength and collaborative approach to client service.
King & Spalding specializes in assisting early-stage companies in the following areas:
Corporate
- Advise on the appropriate corporate structure
- Assist in preparation of shareholders’ agreements, option plans, right of first refusal agreements and other documentation
- Assist in positioning to secure financing
- Advise in negotiating and structuring strategic alliances and partner relationships
- Negotiate major transactions such as mergers and acquisitions or sales or exclusive licenses of assets
- Advise on labor and employment practices and executive compensation matters
- Advise on board composition and corporate governance matters
Intellectual Property
- Manage and advise on global patent portfolio strategies, including drafting and prosecuting domestic and international patent applications, and preparing long-term budgets for such filings
- Conduct patent due diligence for transactions: in-licenses, venture financings, mergers and public offerings
- Prepare patentability and freedom to operate opinions to help inform clients and potential investors on the relative strength and risks for target patent positions
- Prepare non-disclosure, confidentiality and employee/consulting agreements to help protect proprietary trade secrets and other technology
- Negotiate and draft license, joint venture, material transfer, supply university sponsored research and technology transfer agreements
- Develop programs and train employees on invention disclosure and other IP record-keeping procedures
- Assist with the selection, procurement, clearance and protection of trademark and tradenames
- Develop licensing compliance programs for software development activities using “open source” licensed software programs and proprietary programs
FDA / Regulatory
- Perform audits of suppliers of components, raw materials, services providers (contract laboratories), chemistry, microbiology laboratories, etc.; audit for GMP, QSR, and GLP (good manufacturing practices, quality system regulations and good laboratory practices, respectively)
- Design internal audit programs to conduct audits of manufacturing, laboratory and quality operations; and conduct their own supplier audit programs
- Train technical staff and management on responsibility as it relates to FDA compliance matters
- Host and manage FDA inspections
- Generate project plans for implementing quality systems; write validation master plans
- Conduct mock FDA inspections or pre-approval inspections to exercise site to host and manage FDA
- Investigate non-conformances related to complex issues such as sterility assurance issues, possible chemical or microbial routes of contamination of products, possible insufficient validation of manufacturing processes or process validation of products
Healthcare / Regulatory
- Assist in the design of clinical trials with respect to FDA and CMS requirements and advise on structuring of agreements with investigative sites and principal investigators, as well as discuss possible payer reimbursement for certain clinical trial costs
- Arrange meetings early in the product development process with key policymakers concerning possible coding, coverage and payment issues
- Work with physician and patient groups, as well as other manufacturers possibly, to generate support on coding, coverage and payment issues
- Assist in obtaining CPT codes through the AMA and temporary or permanent HCPCS codes through CMS
- Work to institute or revise national coverage decisions and local medical review policies for cutting-edge procedures, drugs, biologics or medical devices
- Review and advise on written agreements/relationships with physicians and other providers
- Review and advise on material on Website or provided to customers and/or sales force regarding coding and reimbursement issues, and train employees on compliance issues
- Provide strategic planning advice regarding all payers, including Medicare, Medicaid and commercial payers
Government Relations
- Represent and counsel clients on policy and legal reform issues relating to government programs, pharmaceutical research, drug pricing and rebates, insurance reimbursement, marketing practices and other healthcare issues
- Provide expert counsel on compliance with federal and state campaign and ethics laws and regulations
- Assist in working in coalition with physician and patient groups on advocacy issues
- Assist in developing written material to provide to key policymakers regarding certain diseases and/or therapies
- Build awareness on Capitol Hill about certain diseases or treatments and/or about certain companies through meetings with key Members and staff and through special events
- Secure legislative or report language to obtain Medicare coverage and reimbursement of new therapies
- Advocate before Congress and federal agencies on needed policy changes to influence coverage, coding, and payment decisions that might impact emerging companies
- Counsel and represent clients in government investigations relating to clinical trials, product performance data, pricing, and marketing issues
