Transnational licensing, research, development, manufacturing, and commercialization agreements among life sciences businesses, institutions, and governments are essential to the life sciences industry. Demanding timelines for research, development, regulatory approval, supply, manufacturing, distribution, marketing, and sales of new biopharmaceuticals and medical devices to save and improve lives—and the enormous investments involved—make keeping these projects on course vitally important.

Opportunities for disputes exist all along these timelines. If—and when—disputes occur, they must be handled efficiently, economically, cooperatively, and confidentially.

Plan for Protection

Select the Right Dispute Resolution Provider

The not-for-profit American Arbitration Association^® (AAA^®)-International Centre for Dispute Resolution^® (ICDR^®) is the largest private global provider of alternative dispute resolution (ADR) services in the world.

The AAA-ICDR’s goal—and its expertise—is to get opposing parties back to business. Its rules and expert panelists aim to lessen the cost and time spent in dispute.

In fact, in 2020, 68% of cases settled prior to an award.

AAA-ICDR is a prepared and flexible provider, as demonstrated most recently during the pandemic, when services pivoted overnight to provide parties with virtual proceedings. Virtual proceedings were not new to the AAA-ICDR, which had made this cost-effective option available to parties for years.

Select the Appropriate Rules of Arbitration

Life sciences ventures typically involve parties or performance across international jurisdictions, so it may be particularly important to provide for international arbitration in the contract.

The standard-bearers for a fair and successful dispute resolution are

• The ICDR International Dispute Resolution Procedures (including Mediation and Arbitration Rules)—updated 2021
• The availability of dispositive motions; emergency arbitration and the ability to enforce it; and limitations on discovery are particular advantages.
• The AAA Commercial Arbitration Rules and Mediation Procedures (including Procedures for Large, Complex Commercial Disputes)

Prepare the Clause

A well-written dispute resolution clause is the foundation of an effective dispute resolution process.

In-house attorneys responsible for the contract’s dispute-resolution clause can use AAA ClauseBuilder^® to that end. It is a self-guided, online process to safeguard their companies’ needs in clear, effective arbitration and mediation agreements. All elements of the clause are addressed, including expedited procedures; number, selection, and qualification of arbitrators; place and language of arbitration, and more.

AAA Expertise

The AAA-ICDR Life Sciences Panel

The specialized life sciences panel includes international and domestic arbitrators and mediators with significant and relevant industry experience. These are attorneys admitted to the bar in one or more jurisdictions, as well as retired practitioners and industry professionals, whose practice for a minimum of 10 years has been significantly (typically 50% or more) devoted to Life Sciences (Pharmaceuticals, Biotechnology, Biomedical Technologies, or Medical Devices) and comprising, in particular, one or more or some combination of the following:

• Transactions including mergers, acquisitions, joint ventures, partnerships, collaborations, new venture formation and investments, licensing, research and development (including regulatory, pre-clinical, and clinical development) intellectual property rights, and due diligence
• Business development and other commercial transactions supporting manufacturing (including sourcing and supply-chain development), marketing, distribution, and sales
• Research and development, including basic research, pre-clinical and clinical development, clinical trials, regulatory submission, and regulatory science and compliance
• Manufacturing, sourcing, supply, and distribution
• Pricing, marketing, and sales
• Financial evaluation and analysis, finance, accounting, IT (including, for example, privacy and cybersecurity), and other life sciences support services
• Government regulation, governance, stewardship, and compliance

Most panel members bring hands-on experience working as litigators or transactional lawyers, either in house or as outside counsel representing businesses and institutions in the biopharmaceuticals, medical device, and related industries.

The Life Sciences Caseload

Top Caseload categories include:

• Pharmaceuticals
• Medical Devices

Types of Disputes include:

• Intellectual Property
• Joint Ventures
• License Agreements
• Manufacturing, Supply, and Distribution Agreements

Selected AAA-ICDR Life Sciences cases include:

• Multi-million dollar dispute arising out of a license, supply, and distribution agreement
• Dispute arising out of a marketing and distribution of pharmaceutical products agreement involving an undisclosed claim and counter claim exceeding $10 million
• $3 million-dollar claim arising out of a pharmaceutical development and supply agreement
• Over $600,000 payment dispute involving the manufacture and testing of a pharmaceutical ingredient
• Dispute over exclusive licensing of intellectual property for therapeutics involving non-monetary and undisclosed claims

For more information on handling life sciences disputes:

For domestic life sciences inquiries: Please contact Michelle Skipper, VP, by telephone at 704.643.8605 or by email at [email protected] or fill out the form to the right.

For international life sciences inquiries: Please contact Luis M. Martinez, Esq., VP, by telephone at 212.716.5823 or by email at [email protected]. or fill out the form to the right.