By: Michelle Skipper, Vice President, AAA® Commercial Division and Luis M. Martinez, Vice President, ICDR®
Businesses in the pharmaceutical, biotechnology, biomedical technology, and medical devices space all have demanding timelines for research, development, regulatory approval, manufacturing, marketing, sales, supply, and distribution of new products. That and the enormous investments involved require keeping these projects on course.
Opportunities for disputes exist all along these timelines, most in the areas of intellectual property, joint ventures, licensing agreements, and manufacturing, supply, and distribution agreements.
If—and when—disputes occur, it is urgent that they are handled efficiently, economically, cooperatively, and confidentially. Alternative dispute resolution (ADR) is the best choice to achieve this result.
Plan for Protection
Select a dispute resolution provider. Ascertain that its goal matches the company’s goal—to get the opposing parties back to business in order to lessen the cost and time spent in dispute.
Select the appropriate rules of arbitration. If the life sciences project involve parties or performance across international jurisdictions, it may be particularly important to provide for international arbitration in the contract.
Prepare the clause. As always, a well-written dispute resolution clause is the foundation of an effective dispute resolution process.
Select the right arbitrator or mediator
Look for a provider that offers a specialized life sciences panel of international and domestic arbitrators and mediators with significant, relevant industry experience, for example:
- 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
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
The content of this webpage is not offered as legal advice or legal opinion and it should not be relied upon for any specific situation. This webpage is for informational purposes only. While the AAA-ICDR endeavors to keep the information updated and correct, AAA-ICDR makes no representations or warranties of any kind, express or implied, about the completeness, accuracy, or reliability of the information contained on this webpage. AAA-ICDR is not responsible for any inaccuracies, errors or omissions, or for the results obtained from the use of this webpage or the content herein.