After beginning her career as a civil litigator at Paul, Weiss, Rifkind, Wharton & Garrison in New York counseling both plaintiffs and defendants, Conna Weiner moved on to inside counsel leadership positions with multinational corporations in the U.S. and abroad., where she amassed experience in virtually every area of law that crosses a generalist’s desk (including as a General Counsel). She has special expertise, however, in the full range of unique legal issues facing innovation companies in healthcare and the life sciences, including every phase of product research, development and commercialization. She has worked for branded and generic, human and animal pharmaceutical, vaccine and device manufacturers, and collaborated extensively with their business partners, including providers (such as hospitals, health plans, managed care entities, academic medical centers/universities and physicians), contract manufacturers and suppliers, clinical research organizations and state and federal governmental entities.
Conna has a broad and sophisticated understanding of the issues facing participants in the life sciences and healthcare industries and more generally of the challenges facing companies and individuals involved in highly regulated, technical and innovative fields.
As a result of her diverse experience with outside counsel and in-house in the U.S. and abroad, Conna has expertise in:
- Negotiation and drafting of complex commercial transactions, such as licensing technology (in and out), asset purchases and divestures (including voluntary and government agency-driven acquisitions and divestitures), mergers and acquisitions and global research, development and commercialization collaboration agreements;
- Hands-on management of complex litigations, investigations and arbitrations, including cases involving alleged securities law violations, disputes over purchase price adjustments, trademarks/Lanham Act, loan guarantees, crude oil transshipment, biotechnology supply, antitrust (including In Re Brand Name Prescription Drug Litigation, a multi-district litigation involving Robinson-Patman and Sherman Act claims in the pharmaceutical industry), the exercise of a material adverse event clause in the context of an government agency-driven product divestiture, federal agency lawsuits (including suits under the Administrative Procedure Act against regulatory agencies), government contractor pricing audits, product liability matters, cross-border jurisdictional and discovery issues;
- Regulatory, including product research (such as research subject protection) and development, product approval, labeling and launch requirements in pharmaceuticals and devices, federal and state law government affairs issues involving drugs and devices, pharmaceutical and device sales and marketing practices including advertising, promotional and anti-kickback/anti-bribery counseling (including FCPA), false claims, OIG compliance guidances, advisory opinions and company policies, Sunshine Act, securities law disclosures regarding business operations, privacy, government pricing and reimbursement, legislation drafting and analysis;
- Research and development-related counseling and contracting, including clinical trials, clinical research organization agreements, sponsored research, material transfer agreements and related agreements;
- Intellectual property, including licensing and acquisition issues, patent/Hatch Waxman litigation and patent department management, copyright and trademarks, and trade secrets;
- Antitrust and trade association counseling, including Sherman Act, Clayton Act and Robinson-Patman Act (and state analogues);
- Customer pricing and product contracting with hospitals, group purchasing organizations, managed care and health plans, retailers, wholesalers, governmental entities and related government reimbursement issues;
- Supply chain issues, such as procurement practices, global supply and manufacturing agreements, product shortages, quality issues, recalls, GMP’s;
- Numerous therapeutic areas and technologies including transplantation and immunology, drug-coated stents, epilepsy, oncology, vaccines, ophthalmics, companion and farm animal diseases and pest control, orphan drugs (such as lysosomal storage disease therapies) radiology, vascular interventional, small molecules, biotechnology, generics and devices; and
- Compliance policies, procedures, investigations.
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