NP’s Fertility, Reproductive Medicine, Sexual Health & Wellness Services team takes a comprehensive approach to this dynamic industry. We use our extensive knowledge of the reproductive medicine space to guide clients including:
- Digital health startups
- Investors and private equity firms
- Pharmaceutical companies
- Physician practices
- Technology companies
We understand your needs, and your position in the reproductive space, are unique. We offer deep experience with industry-specific regulatory matters (including permit, certification, and licensure regulation), corporate structuring advice, mergers and acquisitions, capital raising, payment and reimbursement, litigation and government investigations (including investigations led by the DEA, FDA and law enforcement), intellectual property, privacy, and tax and finance issues.
We also work with clients offering innovative products and services, such as direct-to-consumer diagnostic testing for men’s health, cryobanking/tissue banking services related to sperm and ova preservation, a variety of cutting-edge assisted reproductive technology (ART) services for fertility treatments, and manufacturers and distributors of medical devices and software solutions.
Our client base spans the country, with a heavy focus in California, New York, and the Midwest, where we concentrate on a wide range of fertility, reproductive medicine, and sexual health needs, including:
- Acting as general counsel to fertility clinics and physician practices on issues including:
- forming a network of fertility practices
- advising on dispensing of pharmaceuticals and negotiating cryobank agreements for egg storage
- following state and federal guidance on seeking patient authorization, HIPAA, Information Blocking
- securing licensing and certifications
- addressing privacy breaches, drug diversion, and government investigations including the DEA and FDA
- arranging for the disposition of stored tissue and the dissolution of the IVF practice
- Representing investors and private equity firms in capital investments in fertility and women’s health practices
- Representing a pharmaceutical company in its investments in research and development of labs that develop infertility treatments, and developing its affiliations with existing IVF and alternative therapies (acupuncture, cupping therapy)
- Working with startup entities and emerging companies focused on men’s health, cryobanking, and Y-combinators, online prescriptions and products for birth control, and assisting organizations in compliance, transactions, trade secrets, IP, employment, GDPR, and HIPAA matters
- Collaborating with pharmaceutical companies, manufacturers, and clinical laboratories on a variety of matters such as prescription litigation, negligence claims with respect to paternity and drug testing, product liability matters involving fertility drugs, patent prosecution, and counseling for pharmaceutical products to improve sexual health, and non-compete agreements relating to high-tech personalized care
- Working with universities, including research and technology transfer offices, regarding drafting, prosecuting, and protecting patents focused on microscopy techniques for selecting metabolically healthy eggs, sperm, and embryos, along with mitochondrial disease in the context of IVF and ART.