Contractual design

Our areas of focus are extremely diverse due to the high intensity of regulation in the health sector, the same applies to the multiple contractual relationships between the different players. The trend towards outsourcing is unmistakable – especially on the part of small and medium-sized businesses. Even group companies tend to work sharing thus dividing individual work steps further defined in Service Level Agreements among the individual affiliates, not unlike the general practice of mid-sized companies which employ external consultants and service providers. We advise our clients in the field of research and development contracts as well as service agreements, serving as a basis on which the regulatory experts guide the results of research and development market maturity.

Our core competencies include the contract design related to clinical studies. Also associated with this topic is the contract design related to co-operation with hospitals, physicians and pharmacists. Following market authorization (pharmaceutical drugs) and certification (medical devices) we support our clients in negotiating manufacturing agreements and/or distribution agreements, which regulate not only issues of commercial and technical origin and in particular issues related to warranty and liability but also the demarcation of responsibility which is legally required for pharmaceutical drugs.

During procedures for mergers & acquisitions we assist international law firms by providing our expertise regarding due diligence and the legal assessment of pitfalls deriving from regulatory procedures, contractual relations and competition conflicts between target parties.

Areas of focus

  • Agency agreements
  • Service agreements
  • Research and development contracts
  • Distribution agreements
  • License agreements
  • Manufacturing agreements
  • Co-distribution agreements
  • Discount agreements
  • Service-Level-Agreements
  • Contracts for clinical studies and non-interventional trials
  • Contracts for the co-operation with hospitals, physicians and pharmacists
  • Contracts for demarcation of responsibility regarding the production of pharmaceutical drugs and wholesale trade
  • Contracts with external representatives responsible for gathering information and executing studies, QPPV and specialists (QP)
  • Agreements for the purchase of licenses