From changes to patent systems and licensing to new data exclusivity rules and PTE frameworks, landmark developments across Latin America and APAC are reshaping the global IP and regulatory landscape. This roundtable will examine key jurisdictional updates across these strategically important regions, and explore what key changes mean for your cross-border IP and regulatory strategy.

Deal obligations, such as Commercially Reasonable Effort (CRE), Commercially Diligent Effort (CDE) and “best effort” clauses, play a central role in allocating developmental and commercialisation risk in life science transactions. This discussion will examine how these obligations are defined, managed and enforced, and how teams can mitigate risk exposure under these obligations across collaboration and licensing agreements.

In sensitive, high-value life science transactions, clean rooms require more than technical safeguards; they demand clear governance structures and documented accountability. This discussion will explore how legal teams can design oversight frameworks, define escalation protocols and maintain irreproachable audit trails that withstand third-party scrutiny and post-transaction challenge.

This session examines the legal and structural complexities facing small-to-medium-sized life science companies when pursuing licensing, collaboration, joint venture and M&A agreements with larger, more established players in the market. Participants will examine how life science SMEs can structure transactions strategically to optimise valuation, protect foreground and background IP and retain sufficient governance control to support secondary patent filings and pipeline expansions.

This session examines the legal and governance challenges that arise when life sciences companies engage in joint advocacy through trade associations, industry coalitions and collective policy initiatives. Participants will examine how companies can structure regulatory engagement and industry collaboration to support effective advocacy while implementing appropriate safeguards to prevent anti-competitive coordination.

The growth of online pharmacy platforms and sustained parallel trade across the EU has intensified pressure on pharmaceutical trademark rights, particularly where medicines are repackaged and relabelled for distribution across borders. This roundtable will explore the practical strategies companies are deploying to monitor digital marketplaces, challenge unlawful repackaging and coordinate cross-border enforcement while remaining aligned with EU principles on exhaustion and competition law.

This session will examine evolving Environmental, Social and Governance (ESG) obligations affecting the life sciences sector, including the revised Urban Waste Water Treatment Directive and its potential cost-allocation consequences for pharmaceutical manufacturers. Participants will explore the new European ESG legislation and discuss how environmental liability exposure, supply chain transparency requirements and new reporting standards are reshaping risk management frameworks and long-term operational planning across the industry. 

Ongoing amendments and transitional extensions are continuing to reshape the practical implementation of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) across the EU. This session will outline the latest updates to these legislations and explore the persisting uncertainties and challenges for legal teams managing medical device and IVD portfolios.

Managing IP ownership transfers following cross-border M&A transactions remains an underestimated challenge for many organisations, with ownership errors creating significant hidden risk across global IP portfolios. This roundtable will explore how to manage multi-jurisdictional portfolio transitions efficiently, covering best practices for reducing risk and ensuring compliance during IP ownership changes. Attendees will discuss the operational and strategic challenges in post-acquisition IP integration, and leave with a clearer picture of how to improve visibility, coordination and efficiency in global IP portfolio transitions. 

U.S. product liability continues to represent a material litigation risk for life sciences companies, with multidistrict litigation and escalating jury awards intensifying exposure. This roundtable will examine how pharmaceutical and medical device manufacturers are structuring their defence strategy in this space and mitigating against financial reputational damage.