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.
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 – which is split fairly evenly between arbitration and mediation -- are the following. This list is not all-inclusive, and note that Ms. Weiner’s counseling/legal experience (discussed below) is significantly broader than the issues covered to date by her ADR practice:
Representative Life Sciences matters (pharmaceutical, device, diagnostics, vaccines), such as research, development, commercialization, manufacturing and intellectual property:
- Neutral party-appointed arbitrator for tripartite panel in international arbitration regarding dispute over long-term supply and distribution agreements regarding blood plasma products between two pharmaceutical companies
- Neutral party-appointed arbitrator for tripartite panel in international arbitration regarding dispute over earnout provisions of an acquisition agreement between two pharmaceutical companies requiring use of commercially reasonable efforts to achieve milestones targeted to increases in sales of a basket of acquired products
- Sole arbitrator in connection with university hospital – pharmaceutical company dispute over scope of permissible scope of patents sublicensing rights and appropriate royalty rate
- Sole arbitrator in connection with biological materials storage agreement dispute
- Sole arbitrator in dispute over valuation of private shares in biotechnology company
- International mediation regarding disputes between global diagnostics company and privately held diagnostics development company related to diagnostics research, development and commercialization agreement, including allegations of failure to use commercially reasonable efforts to both develop and commercialize diagnostics products in context of significant long-term collaboration
- International, multiple-party mediation of dispute amongst inventors, start-up company and research institution relating to inventorship, patent and commercialization rights and responsibilities with respect to psychiatric pharmaceutical product
- Mediation of research university and pharmaceutical company licensee dispute regarding university’s entitlement to sublicensing income from pharmaceutical company sublicense to large pharmaceutical company
- Mediation of university-based vaccines supplier dispute with pharmaceutical company over effects of termination of long term supply agreement in connection with flu vaccines
- Mediation of patient/subject injury claims in context of clinical trial; disputes over informed consent, foreseeability of claimed injury, causation, damages
- International mediation of dispute over sale of products to pharmaceutical company and failures to achieve sales and revenue targets
- Mediation involving university clinical trial compliance and data issues
- Mediation regarding gene therapy research foundation contribution to academic medical center research which resulted in down-stream licensing deal
- Mediation involving distribution and sales agency rights and obligations in connection with diagnostics products
Representative Health Care Matters (such as managed care, payor-provider, physician practice 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:
- Sole arbitrator of significant dispute between health plan and its pharmacy benefit manager regarding appropriate basis for determining rebate payments due health plan after adjustments for modified AWP calculations.
- Sole arbitrator in connection with payor-provider dispute centering around appropriate reimbursement of bundled incidental charges
- Neutral party-appointed arbitrator in connection with payor-provider dispute over reimbursement of thousands of out-of-network claims
- Emergency arbitrator appointed to assess applications for emergency relief in connection with termination of health providers from health plan
- Neutral party-appointed arbitrator for tripartite panel in hospital/physician compensation dispute (complicated by potential Stark Law issues)
- Chair of tripartite panel in physician partnership dispute involving allegations of failure adequately to compensate departing/retiring disabled partner
- Sole arbitrator payor-provider coverage dispute regarding appropriate level of reimbursement for inpatient and outpatient mental health treatment of potential suicide risk patient
- Sole arbitrator in connection with ambulance services and managed care provider reimbursement dispute
- Mediator in connection with termination of medical supplies agreement by hospital chain in connection with acquisition by chain of community hospitals
- Mediation of university-based vaccines supplier dispute with pharmaceutical company over effects of termination of long term supply agreement
- Mediation of pharmaceutical company false advertising/trade defamation federal litigation involving cross claims with respect to accuracy of respective ad campaigns
- Mediation of complex dispute between health system and therapeutic hardware/software supplier in connection with long term collaboration on cancer radiology therapy and associated software
Representative Employment matters
- Sole arbitrator in hostile work environment and retaliation matter involving employee allegations of widespread harassing and male-dominated culture at company resulting in discrimination and a conspiracy among management employees to retaliate against female employees; assessment of extent of permissible me-too discovery in connection with same.
- Neutral party-appointed arbitrator for tripartite panel in dispute over denial of severance benefits under an ERISA plan in connection with change of control
- Sole arbitrator in connection with FLSA, discrimination and retaliation claims brought by terminated employee
- Neutral party-appointed arbitrator for tripartite panel in connection with breach of partnership agreement and fiduciary duty by law firm partner
- Sole arbitrator in connection with age discrimination claims in connection with reduction in force at community hospital associated with acquisition of community hospital by national hospital organization
- Charges of defamation on social media and other platforms
International and Domestic Franchise Arbitrations
Ms. Weiner has extensive international and U.S. experience as a sole arbitrator in franchise termination arbitrations, having arbitrated over 50 cases involving a number of different franchisors, including food service and hair salons
Ms. Weiner has arbitrated a number of disputes between attorneys and their clients, including fee and malpractice disputes, including as chair of tribunals.
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