EXPERTISE IN IP-DRIVEN UNDERTAKINGS AND COMPLIANCE
Legal Services
Drafting, Negotiating, Advising, Implementing
When relying on third-party technologies and know-how in research, development and commercialization of your assets, controlling intellectual property rights and maintaining freedom to operate is key. Interactions with qualifying third parties and materials deserve attention.
Development and commercial manufacturing of API and drug product, packaging including quality compliance, warehousing, transportation and other supply chain related activities.
Commercial collaborations, outsourcing of commercial and medical activities, research collaborations.
Commercial out- and in-licensing of products.
Services, procurement for e.g. lab equipment, IT, commercial and research data, distribution, cooperations.
Governance of bodies and committees, corporate housekeeping, general corporate law, start-up advice, shareholder agreements.
Employment agreements, labor lease, recruitment agreements, general advice, employment policies.
Research collaborations, publication agreement, research IT/AI/data agreements, MTAs, license agreements for modified organisms, cell cultures, human materials.
For tax, notary services, transactional work, patents, trademarks, copyrights and privacy law matters I rely on and collaborate with my network of expert individuals and boutique law firms.
Compliance Services
Build-Out, Build-Up, Implement, Train
A solid corporate compliance program fosters your culture and controls risk. A strong healthcare compliance program at core ensures patients are first.
Drafting and amending of the corporate compliance program and shaping processes and policies, e.g. code of business conduct, anti-bribery & anti-corruption, conflict of interest & handling of non-compliance, speak-up, etc. and holistic training of the work force.
Donations, sponsoring, publications, commercial interactions, medical interactions, advertising, patient support programs. Drafting and amending of the healthcare compliance program, e.g. healthcare compliance framework, HCP/HCO/PO interaction, patient and patient organization interactions, grants/donations/sponsoring, implementations of committees.
Investigations in corporate compliance, healthcare compliance matters and white-collar crime.
Trainings on corporate and healthcare compliance matters, e.g. general compliance trainings to work force, disease awareness trainings.