References

International Pharmaceutical Companies

• Patent applications and invention disclosures
• R&D contracts, contracts for clinical trials (international)
• Evaluation of IP situations
• Advice with regard to Supplementary Protection Certificate (SPC)
• Advice on importation via Named Patient Use/Single Importation and Compassionate Use.

• Reimbursement of drugs in the statutory health system
• M&A, drafting of contract manufacturing agreements, GMP, quality and pharmacovigilance agreements, IP agreements, supply agreements, advice on drug approvals
• Drafting compliance manuals and corporate guidelines
• Advice on drug approvals
• Advice on import of tissue engineered products and regulatory matters

International Biotechnology Companies

• Contracts for clinical trials, R&D contracts
• Patent/trademark applications, expert opinions Patent evaluations, patent infringement proceedings
• Drafting and negotiating license agreements
• Compliance/anti-corruption, unfair competition

Universities/University Hospitals

• Drafting and negotiation of license agreements, R&D contracts, M&A
• Evaluation of patent situation, patent infringements
• Advice for start-ups,
• ATMPs (cell and gene therapies), manufacturing agreements for ATMPs, cooperations, regulatory affairs and GMP für ATMPs

Innovative Biotechnology Companies

• Compliance/unfair competition
• License agreements
• Off-Label Use

Innovative Pharmaceutical Company

• Advice on ATMP regulatory matters, patents, unfair competition, reimbursement, contracts, pharmacovigilance.

German Biotechnology Company

• Advice on GMP
• M&A Covid-19 drug
• License agreements

German Pharmaceutical Company

• Drafting and prosecuting patent applications, invention disclosures, evaluation of patent situations Regulatory affairs

Innovative Biopharmaceutical Company

• Consulting Patent and Legal Department