Biotechnology & Life Sciences Companies

Biotechnology and life sciences companies can face a host of regulatory requirements, from FDA, FTC, and other three-letter agencies and require a realistic appraisal of the regulatory barriers and what they can do to overcome.

Agreements for Biotechnology & Life Sciences Clients

Our biotechnology and life sciences lawyers understand FDA, FTC, and relevant state laws that apply to your business. We provide regulatory compliance advice and corporate legal services, and can help you with:

  • Acquisition Agreements
  • Clinical Research Agreements
  • Collaboration Agreements
  • Dietary Supplement Structure/Function Claims
  • Distribution and Manufacturing Agreements
  • Drafting FDA-Compliant Product Labels
  • Financing Agreements
  • Intellectual Property and Technology Transfer
  • Joint Venture Agreements
  • Legal Review of Marketing Materials for FDA and FTC Compliance
  • Licensing Agreements
  • Manufacturing Agreements
  • Medical Device 510(k) Review
  • Private Label Agreements
  • Regulatory Advice on Food Supplements
  • Sales Representative Agreements

In the biotech and life sciences industry, corporate agreements are not the run-of-the-mill, standard templates that other businesses sometimes try to grab off the Internet.

Rather, the deals require customized care and attention, including:

  • Protecting the intellectual property (IP) of the life sciences or biotechnology venture;
  • Managing key business points such as pricing, payment terms, and setting other legal boundaries;
  • Capturing the value of the product or service and then protecting the company through strong indemnification, confidentiality, and other essential terms.

At every phase of company development, our biotechnology and life sciences lawyers work with our clients to maximize company value.

Bioetechnology and Regulatory Issues

Our biotechnology and life sciences lawyers are familiar with the regulatory framework that underpins the transactions.  We can thus draft and negotiate agreements with an understanding of the legal constraints—and opportunities.

Specific examples of our regulatory counseling and corporate legal advice include:

  • Advice to medical device companies concerning FDA regulatory requirements to bring their product to market, including substantial equivalence review.
  • Counsel to a client with respect to an FDA investigation and seizure of imported products, and FDA-766 application to re-label.
  • Counseling providers on billing, reimbursement and claims issues; anti-kickback, and physician self-referral (Stark) regulations; as well as Medicare issues.
  • Drafting licensing and technology transfer agreements for a medical device start-up.
  • Evaluation of fraud and abuse issues and advice concerning business structure for a company involved in preventative, diagnostic screenings and imaging.
  • Legal guidance to a cosmetics start-up with respect to marketing claims and over-the-counter (OTC) drug regulations.
  • Review of marketing practices for a telemedicine company promoting off-label drug use.

On the FDA side, we handle:

  • Administrative support software
  • Adulteration and misbranding
  • Clinical decision-making (CDS) software
  • Combination products
  • Cosmetics labeling
  • CURES Act issues
  • Direct-to-consumer Genetic Health Risk (GHR) tests
  • Dietary supplement labeling
  • FDA Warning Letters and FDA Form 483s
  • General wellness products
  • Genetic variant detection and health risk assessment systems
  • Health claims
  • In vitro diagnostics
  • Medical image communications devices
  • Medical device data systems (MDDS)
  • Medical image storage devices
  • Mobile medical apps
  • Personal Use Importation
  • Pharmacy compounding issues
  • Regulatory classification of medical devices
  • Structure/function claims
  • Other FDA issues

Our life sciences clients include companies at all stages of development, including:

  • Companies pioneering genomics and DNA-based diagnostics and therapeutics
  • Cosmetics, dietary supplement, and nutraceutical companies
  • Diagnostics companies
  • eHealth, mHealth and telemedicine companies
  • Medical device companies
  • Mobile medical app manufacturers
  • Personalized healthcare (P4) companies
  • R&D companies
  • Stem cell and regenerative medicine enterprises
  • Wearable health technology companies

And we handle many other types of life sciences ventures.

Our life sciences and biotechnology lawyers cross-collaborate to ensure coverage of regulatory issues as well as corporate law issues, IP protection, real estate issues, corporate governance, and nitty-gritty business deal points of agreements the life sciences company may make with ventures, strategic partners and affiliates, and others.

Resources

California stem cell regulations guide the emerging stem cell research effort and industry

California stem cell laws boost the stem cell industry by funding stem cell research, but the product side of industry is largely in the hands of the FDA.

Court upholds FDA’s legal authority to regulate stem cell therapies

FDA survived a legal challenge to its authority to regulate stem cells as drugs, in a landmark decision by the U.S. District Court of Appeals for the DC Circuit. FDA had cited Regenerative […]

FDA Attorney Michael H. Cohen Speaking on FDA Legal Issues at the Ventura BioScience Incubator

FDA Attorney Michael H. Cohen speaks on FDA Legal Issues at the Ventura BioScience Incubator on October 17, 2013.The talk will focus on FDA regulation of cosmetics, dietary supplements, and […]

Health Care Reform – Legal – Part 3: Longevity & Anti-Aging Medicine, Genomics, Robotics, Nanotechnology, and The New Healthcare Legal Landscape

Healthcare reform—aka “Obamacare”—changes much of the financial, tax, and insurance landscape for healthcare. However, it leaves huge swathes of healthcare law untouched.

FDA Attorney Michael H. Cohen Speaking on FDA Legal Issues at the Ventura BioScience Incubator

FDA Attorney Michael H. Cohen speaks on FDA Legal Issues at the Ventura BioScience Incubator on October 17, 2013.The talk will focus on FDA regulation of cosmetics, dietary supplements, and […]

Marketing “wearable caffeine” can get you in trouble with FTC, the regulatory watchdog over advertising

The Federal Trade Commission (FTC) has proposed to settle charges with two marketing companies promoting “shapewear garments” with “slimming claims for caffeine-infused products.” FTC vigorously […]

Off-label drug promotion and marketing yields significant penalties: Part 1 (Amgen settlement)

Off-label drug use is not illegal, but off-label drug promotion and marketing can result in significant legal penalties.

P4 Healthcare Means Medical Devices Increasingly Important in Healthcare Regulation

P4 medicine takes healthcare to a whole level, requiring deeper understanding of how healthcare & FDA law shape the path to market for your healthcare service or product.

Physician stem cell therapies legally ambiguous, while regenerative clinics prosper

Recent press calls into question widespread “regenerative” and anti-aging medicine, and physician practices that use stem cell therapies.

Court upholds FDA’s legal authority to regulate stem cell therapies

FDA survived a legal challenge to its authority to regulate stem cells as drugs, in a landmark decision by the U.S. District Court of Appeals for the DC Circuit. FDA had cited Regenerative […]

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