c. Risk assessment, mitigation and avoidance Overall Risk Management Strategy Figure 9: CureVac's risk management process For further details, refer to CureVac’s Risk Management Policy (Annex 3). 37

CVnCoV Risk Assessment For the development of CVnCoV a broad risk analysis was performed covering all relevant areas to identify risk and appropriate mitigation strategies. The following table provides a summary on key risks, their impact and likelihood as well as specific mitigation measures. 38

Table 6: Summary on key risks, their impact and likelihood of CVnCoV development

Risk Category Risk description ade) er 1 e11 1133 Impact Mitigation Plan

40

Key mitigation strategies: Based on the risk analysis described above key mitigation strategies that are already executed and addressing major milestones are described below.  41

 42

5. Exploitation and Dissemination Plan a. Brief overview The SARS-CoV-2 pandemic is one of the greatest challenges of the present day, and concerted action by all political and economic entities is required to successfully navigate this crisis. Consensus among the global scientific community suggests that achieving "herd 43

immunity" of 60%-70% of total population is required to successfully contain and combat the pandemic. Due to health and economic risk, and, more importantly, ethical considerations, this immunity cannot be achieved by natural infection of the population. The availability of a safe and effective COVID-19 vaccine is the most effective and efficient method to confer immunity, to address the pandemic, and to minimize global human suffering. While the need for a vaccine is clear, development of such an agent is typically a lengthy and cost-intensive undertaking. Extensive preclinical and clinical trials involving tens of thousands of patients, multiple hospitals sites across the global community, and hundreds of healthcare professionals are required to successfully prove a vaccine’s safety and efficacy. In addition, scale-up of manufacturing capabilities must occur to ensure supply is available; this process typically involves challenges, both known and unforeseen, which must be addressed. Curevac plans to distribute and commercialize a vaccine to prevent COVID-19 developed under this Grant globally with focus on Germany, the EU and rest of the world (ROW). As soon as possible during clinical development of the vaccine we plan to make the vaccine available to the public. Therefore, we anticipate to successively including further population segments in the clinical development program to address all age groups and risk populations. Fast-track Phase IIb trials are planned to establish a comprehensive safety database and, if possible preliminary efficacy, to pursue conditional approval in early 2021. Supplementary indications will be sought from the EMA for use in persons above 61 years of age, in pediatric populations and in special populations (e.g. immunocompromised, HIV, pregnant women). Other global approvals will be sought after full EMA authorization; approval staging will depend on disease epidemiology, number of doses available, and availability of other vaccines in a particular region. In advance of EMA conditional approval, we intent to co-operate with international agencies to ensure global distribution of the vaccine. We plan to cooperate with the scientific community and share information about success and failure via journals and scientific meeting according scientific standards and make funded infrastructure available to third parties for manufacture alternative candidates in the case of an own total failure in development and in line with national and European law, even though, we included plans for an alternative candidate to catch up in case of an early failure. . While many variables still need to be fixed and demonstrated in the clinic, CureVac expects to offer the vaccine in Europe at a reasonable price, pricing in the developing countries needs to be sustainable. b. Aspects of economic, scientific and technical exploitation prior to marketing authorisation CureVac intents to use the grant funding to finance Phase II and III clinical studies (see section 4a) until approval, to accelerate development timelines (see section 4b(i)), and to rapidly 44

expand manufacturing capacity (see section 4b.(iii)) up to 127.5 million doses in a multi-dose format per quarter until 2021). As described in the respective sections Curevac ensures the supply of required doses and scientific sound development of the candidate until approval. Even though, clinical development bears a couple of uncertainties and final success can’t be guaranteed. CureVac will cooperate with the Federal Republic of Germany and, in the event of failure of the vaccine candidate, the company will make the funded infrastructure available to produce other promising candidates including from German third parties. Further investment and reimbursement of expenses necessary for such a scenario are not part of this application and require additional financing. For avoidance of doubt, pre-existing company infrastructure, not funded under this grant, couldn´t be used for other candidates without written permission by CureVac and appropriate additional funding, if required. Operational costs and efforts to enable such third party usage will need to be reimbursed adequately. As an own risk mitigation and in a case of an early failure of the current vaccine candidate, Curevac established a back-up candidate able to catch up with clinical development. The overall objectives of the clinical development program are to determine a dose level that is safe and immunogenic in different age-categories and to establish efficacy of the vaccine candidate CVnCoV to support global registration in 2021. Regulatory authorities will be consulted to agree on a pediatric investigational plan and studies in children, including dose finding or confirmation, will be implemented in an age-de-escalating sequence. When sufficient safety and efficacy data are available from Phase IIb/III (to be agreed on with the EMA) an application will be submitted for EMA Conditional Approval for vaccine use in persons older than 18 years of age. In advance of EMA and conditional approval, the WHO will be consulted regarding rapid vaccine availability to the developing world, e.g. Emergency Use Listing (similar timing as EMA Conditional Approval) followed WHO Pre-Qualification (similar timing to EMA full market authorization) or filing directly for WHO PQ. To overcome the current crises it is necessary to accelerate research in the field of COVID-19 via exchange of scientific knowledge. Curevac respect the need to make results transparent for the scientific community and plans to publish the results in accordance to scientific standards in peer reviewed journals and present data at upcoming scientific meetings. Preferred journals to publish the data are the Lancet or Lancet ID, New England Journal of Medicine. Besides that, the data will be presented at international conferences targeting an audience interested in infectious diseases, such as ID week, ECCMID, ESPID (pediatric data), as well as at conferences specifically focusing on new technologies or biotechnologies (such as the yearly RNA conference). CureVac will make original data of the publications available to the scientific community in accordance with the FAIR principles (findable, accessible, interoperable and reusable principles) and in compliance with the rights of third parties, in particular data protection and copyright. As good practice we also have already registered our ongoing Phase I and intend to register all future clinical trials on accredited platforms like e.g. clinicaltrials.gov; and will do so equally with the upcoming clinical studies. CureVac acknowledges that BMBF will share relevant application and project data with international funding agencies. The data to be published will be agreed upon with the funding recipients. 45

c. Aspects of exploitation after marketing authorisation 6. Division of labour/cooperation with third parties CureVac has established collaborations with experienced partners and subcontractors that support the development and manufacture of the CVnCoV product. The organizations are listed in Table 7 below, including their respective role on the project, CureVac’s previous experience with each organization and their specific qualification. 46