Common use of BACKGROUND AND RATIONALE Clause in Contracts

BACKGROUND AND RATIONALE. Neuroimmunological diseases (“NIDs”) including multiple sclerosis (“MS”), neuromyelitis optica (“NMO”) and myasthenia gravis (“MG”) are chronic inflammatory diseases of the nervous system and are common causes of neurological disability in adults. The effects of NIDs are characterised by attacks of neurological symptoms and signs with variable recovery. MS patients can additionally develop a progressive clinical course. The clinical course of NIDs is highly variable. People with NIDs often receive immunosuppressive or immunomodulatory treatments, sequentially or in combination. There is a global requirement for patients, doctors, regulators and the pharmaceutical industry to understand the risk factors, course and outcomes of these diseases including: • Short and long-term outcomes of NIDs as assessed by standard clinical rating scales and outcome measures • Clinical and paraclinical outcome predictors including imaging results, blood tests and self-monitoring devices and applications • Medication exposure patterns and their short and long-term efficacy • Individualised prediction of treatment response • Safety of medications in the real-world setting, in particular long-term safety • Pregnancy and infant risks and outcomes in women exposed to medications during conception, in pregnancy and during breastfeeding The challenges for multi-centre investigator-initiated clinical research of this nature include harmonisation of protocols and minimum datasets, a suitably flexible data collection platform, retention of data ownership, the identification of collaborators, ongoing communication between study sites, data quality assurance, legal data storage, data management platforms and study governance. The MSBase Foundation provides Investigators with the best possible logistic solutions to meet these challenges at no cost.

BACKGROUND AND RATIONALE. Neuroimmunological Neuro-immunological diseases (“NIDs”) including multiple sclerosis (“MS”), neuromyelitis optica (“NMO”) and myasthenia gravis (“MG”) are chronic inflammatory diseases of the nervous system and are common causes of neurological disability in adults. The effects of NIDs are characterised by attacks of neurological symptoms and signs with variable recovery. MS patients can additionally develop a progressive clinical course. The clinical course of NIDs is highly variable. People with NIDs often receive immunosuppressive or immunomodulatory treatments, sequentially or in combination. There is a global requirement for patients, doctors, regulators and the pharmaceutical industry to understand the risk factors, course and outcomes of these diseases including: • Short and long-term outcomes of NIDs as assessed by standard clinical rating scales and outcome measures • Clinical and paraclinical outcome predictors including imaging results, blood tests and self-monitoring devices and applications • Medication exposure patterns and their short and long-term efficacy • Individualised prediction of treatment response • Safety of medications in the real-world setting, in particular long-term safety • Pregnancy and infant risks and outcomes in women exposed to medications during conception, in pregnancy and during breastfeeding The challenges for multi-centre investigator-initiated clinical research of this nature include harmonisation of protocols and minimum datasets, a suitably suitable flexible data collection platform, retention of data ownership, the identification of collaborators, ongoing communication between study sites, data quality assurance, legal data storage, data management platforms and study governance. The MSBase Foundation provides Investigators with the best possible logistic solutions to meet these challenges at no cost.

BACKGROUND AND RATIONALE. Neuroimmunological Neuro-immunological diseases (“NIDs”) including multiple sclerosis (“MS”), neuromyelitis optica (“NMO”) and myasthenia gravis (“MG”) are chronic inflammatory diseases of the nervous system and are common causes of neurological disability in adults. The effects of NIDs are characterised by attacks of neurological symptoms and signs with variable recovery. MS patients can additionally develop a progressive clinical course. The clinical course of NIDs is highly variable. People with NIDs often receive immunosuppressive or immunomodulatory treatments, sequentially or in combination. There is a global requirement for patients, doctors, regulators and the pharmaceutical industry to understand the risk factors, course and outcomes of these diseases including: • Short and long-term outcomes of NIDs as assessed by standard clinical rating scales and outcome measures • Clinical and paraclinical outcome predictors including imaging results, blood tests and self-monitoring devices and applications • Medication exposure patterns and their short and long-term efficacy • Individualised prediction of treatment response • Safety of medications in the real-world setting, in particular long-term safety • Pregnancy and infant risks and outcomes in women exposed to medications during conception, in pregnancy and during breastfeeding The challenges for multi-centre investigator-initiated clinical research of this nature include harmonisation of protocols and minimum datasets, a suitably suitable flexible data collection platform, retention of data ownership, the identification of collaborators, ongoing communication between study sites, data quality assurance, legal data storage, data management platforms and study governance. The MSBase Foundation provides Investigators with the best possible logistic solutions to meet these challenges at no cost.