Conna A. Weiner, Esq. brings to her U.S. and international mediation and arbitration practice a unique combination of litigation, transactional and in-house experience after roles with internationally known outside counsel and multinational life sciences (pharmaceuticals, medical device, diagnostics, vaccines) and health care companies. She has extensive experience mediating and arbitrating complex general commercial cases in the U.S. and internationally, as well as franchise and employment matters, and has served as a sole arbitrator, neutral party-appointed arbitrator on three member panels and as the chair of arbitration tribunals.
Although she has decades of experience in general commercial and employment matters representing both plaintiffs and defendants and is noted for her ability to help parties assess their positions before and after litigations or arbitrations are filed, Ms. Weiner’s extensive transactional and deal work over the years help her rapidly appreciate the core issues involved in business arbitrations and mediations and creatively assist parties in structuring an appropriate arbitration process or working out negotiated business solutions that help preserve relationships. Her inside counsel experience helps her understand and communicate with clients and maintain an objective perspective in connection with a wide variety of matters.
Ms. Weiner has special expertise in the full range of unique, complex legal issues and contractual arrangements prevalent in life sciences (such as intellectual property, licensing and acquisitions, supply agreements and the research, development and commercialization of pharmaceuticals, medical devices and diagnostics), health care (both payors and providers) and other technology arenas. She is a Fellow in the Chartered Institute of Arbitrators and holds a number of leadership positions in legal and dispute resolution organizations.
Details of her experience are set forth below.
ADR Experience and Qualifications
Ms. Weiner began her career as a general commercial litigator at Paul, Weiss, Rifkind, Wharton & Garrison. She then moved on to leadership roles in-house with multinational firms such as Novartis, where, in addition to all of the work required of an in-house corporate generalist, she gained hands-on experience in the full range of unique legal issues facing life sciences and healthcare companies, including every phase of discovery, research, development and commercialization. She has worked for branded and generic, human and animal pharmaceutical, vaccine and device manufacturers and has collaborated extensively with their business partners, including providers (such as hospitals, physicians, academic medical centers and universities), payors (such as health plans/insurers and managed care entities), contract manufacturers and suppliers, software companies, clinical research organizations and state and federal governmental entities.
Her transactional, counseling and litigation experience includes:
- 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), False Claims Act, the exercise of a material adverse event clause in the context of a 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 Act counseling and corporate integrity agreements, 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
- Customer purchase and distribution contracting (including with retailers, wholesalers, hospitals and hospital buying groups, specialty pharmacy, managed care organizations), including pricing and reimbursement questions (e.g., federal government contracting, Medicare and Medicaid, requiring an understanding of regulatory and operational issues of diverse customer base such as government programs, hospitals, physician groups and managed care organizations) and AWP litigation
- 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)
- Supply chain issues, such as procurement practices, global supply and manufacturing agreements, product shortages, quality issues, recalls and GMPs
- 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
- Compliance policies, procedures and investigations
- As an advocate in an ad hoc arbitration concerning a complex international commercial dispute involving crude oil long-term supply and transshipment agreement
- Involvement as an advocate in significant ICC arbitrations
- Latin-American compliance/legal investigations
- Switzerland-based, global experience as a general counsel and litigation manager, including oversight of a global patent, trademark and copyright function as part of responsibilities as General Counsel and Global Compliance Officer for Novartis Animal Health; training and experience as required by issues arising in practice with local country laws outside the U.S. and European Union laws/directives (such as competition law, privacy); and direct global compliance officer experience and Ex-Americas global litigation and alternative dispute resolution management experience, including Sarbanes–Oxley–related issues
Ms. Weiner has applied her years of substantive, hands-on experience to help parties in connection with a wide range of ADR matters. Representative of her active ADR practice are the following:
- International mediation between diagnostics development and commercialization partners regarding allegations of failure to use commercially reasonable efforts to develop and commercialize diagnostics products in context of significant long-term collaboration
- International, multiple party mediation amongst inventors, start-up company and research institution relating to patent and commercialization rights and responsibilities with respect to psychiatric pharmaceutical product
- Charges of defamation on social media and other platforms
- University-based vaccines supplier dispute with pharmaceutical company over effects of termination of long term supply agreement
- Research university and pharmaceutical company licensee dispute
- Health system and therapeutic hardware/software supplier dispute
- Diagnostics sales agency and distribution agreements dispute
- False advertising (significant federal case involving pharma companies under Lanham Act)
- General commercial contracts
- Personal injury