Life sciences clauses

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This subtopic includes a selection of definitions and standard commercial clauses for use in agreements in the life sciences sector.

For boilerplate commercial clauses and standard definitions which may be used in life sciences agreements, see: Boilerplate clauses—overview and Definitions—overview.

For a summary of the law, guidance and practice in relation to the execution of documents, along with standard execution clauses, see: Execution—overview.

Life sciences definitions

For examples of definitions which are frequently used in life sciences agreements, see Precedents:

  1. •

    Applicable Laws and Medical Product Law definitions—life sciences

  2. •

    Clinical trial laws definition—life sciences

  3. •

    Derivatives definition—life sciences

  4. •

    EU Notified Body and UK Approved Body definition—life sciences

  5. •

    Exploit definition—life sciences

  6. •

    Good Clinical Practice (GCP) definition—life sciences

  7. •

    Good Laboratory Practice (GLP) definition—life sciences

  8. •

    Governmental Entity definition—life sciences

  9. •

    Industry Practice definition—life sciences

  10. •

    Material definition—life sciences

  11. •

    Principal investigator (PI) definition—life sciences

  12. •

    Product definition—life sciences

  13. •

    Progeny definition—life sciences

  14. •

    Regulatory Documentation definition—life sciences

  15. •

    Regulatory Approvals definition—life sciences

  16. •

    Regulatory Authority definition—life sciences

Intellectual property

Intellectual

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Latest Life Sciences News

EU countries question proposed approach for delaying AI Act’s key duties

MLex: A planned delay for key EU AI Act duties has come under question from Member States, which warn that the European Commission’s proposed approach lacks clear criteria, predictability and sufficient involvement of national authorities. Even supporters of a pause raised concerns, while others asked what happens if the relevant compliance tools aren’t ready even with the new timeline or if the amendments don’t pass before the August 2026 deadline.

MedTech Europe welcomes Commission’s proposed European Competitiveness Fund

MedTech Europe has published a position paper welcoming the European Commission’s proposal for a European Competitiveness Fund (ECF). It states that the ECF represents a key opportunity for the medical technology and digital health sectors to bridge the gap between research and large-scale deployment, maintain Europe’s leadership in health innovation, and support sustainable and resilient healthcare systems. However, MedTech Europe stresses that the ECF must include clear, predictable, and operational mechanisms to safeguard long-term investment in health research, development, and innovation; ensure the effective deployment and scale-up of health innovations; reinforce health data, cybersecurity, and sustainability infrastructures; and embed health-resilience objectives in national and regional investment planning.

Life Sciences weekly highlights—4 December 2025

This week's edition of Life Sciences weekly highlights includes analysis by Bird & Bird of new MDCG guidance on the interplay between the Medical Devices Regulation (MDR) and the EU AI Act for AI-enabled medical devices, providing both EU and UK perspectives, and analysis by Mishcon de Reya of recent ASA decisions on misleading claims in the beauty industry. Also included is news that the Commission announced that the first four European Database on Medical Devices (EUDAMED) modules will become mandatory from 28 May 2026, and has published results of its second survey on EU medical device market availability, as well as news that the government has announced a UK-US pharmaceuticals deal, establishing a preferential tariff framework for medicinal products, NICE announced that cost-effectiveness thresholds for new medicines will rise from April 2026, the EU Member State Coordination Group on Health Technology Assessment (HTACG) adopted its 2026 Health Technology Assessment Work Programme. Further news includes the Council of the EU’s agreed position on the Critical Medicines Act and EFPIA’s response and news that International Council for Harmonisation (ICH) has adopted three final pharmaceutical guidelines and endorsed three draft guidelines, the ABPI published its annual clinical trials report showing a 25% decline in UK commercial clinical trial recruitment, the Science, Innovation and Technology Committee launched an inquiry into the potential harms associated with hair and beauty products, and the EU has launched new health crisis preparedness and response plan, among other stories.

MHRA publishes guidance on regulatory advice meetings for medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on applying for regulatory advice meetings regarding medical devices and in vitro diagnostic devices. The guidance establishes a fee of £987 per meeting, with payment required at least three weeks before the scheduled meeting date. The MHRA will propose meeting dates within 15 days of receiving requests. Each meeting is limited to one hour and requires applicants to deliver a 10-15 minute presentation. Following the meeting, attendees must submit meeting notes within 15 working days, which the MHRA will review for accuracy and return within 30 days.

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