The following represents Azarith Sofia’s experience prior to joining Low & Partners:
HEALTHCARE, LIFE SCIENCES & CLINICAL RESEARCH
Pharmaceutical and Biotechnology Projects
- Advised Duopharma (Malaysia) Sendirian Berhad in respect of its collaboration with foreign entities in the United States and Singapore involving the development, manufacturing, supply, commercialisation and technology transfer of a vaccine, including conducting legal due diligence and drafting the relevant commercial agreements.
2. Advised the National Institute of Biotechnology Malaysia in respect of the CanSinoBIO messenger ribonucleic acid (mRNA) vaccine projects, including drafting and negotiating the term sheet, Memorandum of Agreement and subsequent addenda.
Healthcare, Clinical Trials and Medical Research
3. Advised KPJ Healthcare Berhad in respect of National Specialist Register (NSR) compliance and the training obligations of medical specialists, including drafting the Employment Bond Agreement.
4. Advised Universiti Putra Malaysia (UPM) and Hospital Pengajar Universiti Putra Malaysia (HPUPM) in respect of the following matters:
- Reviewing and negotiating the Clinical Trial Agreement for a clinical research study sponsored by Johnson & Johnson Sdn Bhd involving a study drug for major depressive disorder, executed between the sponsor, Universiti Putra Malaysia and the principal investigator.
- Reviewing and negotiating the Clinical Study Agreement for a clinical research study sponsored by Novartis Corporation (Malaysia) Sdn Bhd involving a study drug for chronic migraine patients, executed between the sponsor, Universiti Putra Malaysia and the principal investigator.
- Preparing and finalising the template Clinical Research Agreement for Hospital Pengajar Universiti Putra Malaysia to be used in multiple clinical studies undertaken with industry sponsors and principal investigators.
- Drafting and negotiating the Services Agreement for the procurement, installation, commissioning and training of clinical simulators and medical manikins for Universiti Putra Malaysia’s Clinical Skills and Simulation Centre.