Team size: Two

What are the most significant cases or transactions that your legal team has recently been involved in?

There are a few projects are that are worth mentioning. The first would be the ‘Sandoz Turkey and Sandoz Grup (STO) Spin-off Project.’ We successfully completed the spin-off of Sandoz Turkey and Sandoz Grup (STO-Manufacturing entity) from Novartis Group Companies before October 4th, 2023. To achieve this, we executed share transfer agreements from Novartis Pharma to Sandoz and completed the transfers in March 2023, earlier than many other Sandoz countries. Additionally, we separated all agreements, including STO agreements, before the due date. We also signed MSA, LLTSA, and LSA contracts for the services being received from Novartis Turkey, changed the Board of Directors of both companies, conducted General Assembly Meetings, and changed signature circulars in accordance with the new management before October 4th of last year.

During the spin-off, especially the STO separation, was difficult and complex. This is because all management of the STO was part of Novartis TechOps organisation from the beginning. It was also not easy to harmonise them into the Sandoz organisation. Despite STO Turkey being the sixth biggest manufacturing site of Sandoz globally, we are pleased to merge with the Sandoz organisation without facing any problems and did not work with any external counsel.

After the spin-off, I started to lead Sandoz Group Turkey’s legal function and manage all legal work with my team.

A second transaction I would like to focus on is our ‘Mycamine Product Acquisition from Astellas Turkey’. Mycamine is one of the biggest and most important anti-fungal products globally. We signed a very detailed Asset Purchase and Manufacturing Agreement with Astellas, wherein we regulated the terms and conditions of the asset sale. Subsequently, we applied to the Turkish Competition Authority and received approval in a record time, within 45 days, in February of last year. Despite it being a busy season for the Competition Authority, we managed to receive approval earlier than our expected timeline due to our thorough preparation and the submission of a well-prepared application with the help of external counsel.
Third, we provided significant support on an OTC Project. Sandoz Turkey has decided to establish an OTC team to directly promote OTC products to pharmacists. However, as Turkeys lacks specific details in OTC regulations, companies are unable to offer certain incentives or enter direct contracts for certain services. We worked with the project team from the outset, thoroughly analysed all pharmaceutical regulations, and generated a legal solution: signing lease agreements as well as special sales agreements with the pharmacists. This solution has been highly appreciated by management as we have pioneered the first and unique contract framework for the project.

Finally, we have assisted on a non-Interventional clinical study for diabetes patients in Turkey. Our medical department wanted to initiate a clinical study for diabetes patients across 30 hospitals involving more than 1500 patients throughout Turkey. To realise this, we met with the CRO firm and prepared a clinical study service agreement with the CRO for this purpose. Thereafter, in accordance with clinical study regulations, we prepared draft clinical study agreements to be signed with the 30 hospitals where the patients will participate. This is one of the biggest clinical study agreements, in terms of participants, in Turkey.