Common use of CureVac Clause in Contracts

CureVac. Overview: Founded in 2000 35, CureVac is a NASDAQ- listed36 biopharmaceutical company headquartered in Germany37. Its revenue in the same nine-month period increased by 304% from €10.6 million in 2019 to €42.8 million during the first nine months of 202038. 25 European Pharmaceutical Review, “AstraZeneca”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/organisations/astrazeneca/ 26 AstraZeneca, “Contact Information”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/investor-relations/annual-reports/annual-report-2016/contact-information.html 27 AstraZeneca, “FAQs”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/investor-relations/faqs.html 28 AstraZeneca, “What science can do - AstraZeneca Annual Report and Form 20-F Information 2020”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/content/dam/az/Investor_Relations/annual-report-2020/pdf/AstraZeneca_AR_2020.pdf 29 ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, “AstraZeneca COVID-19 Vaccine (AZD1222)”, January 27, 2021, ▇▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/vaccines/acip/meetings/downloads/slides-2021-01/02-COVID-▇▇▇▇▇▇▇▇▇.pdf 30 European Medicines Agency, “Vaxzevria (previously COVID-19 Vaccine AstraZeneca)”, 31 Reuters, “AstraZeneca agrees to supply Europe with 400 million doses of COVID-19 vaccine”, June 13, 2020, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇.▇▇▇/article/us-health-coronavirus-vaccines-idUSKBN23K0HW 32 ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, “The Serum Institute of India”, December 8, 2020, Fierce Pharma, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/special-report/top-10-manufacturers-fight-against-covid-19-serum-institute-india 33 ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, “AstraZeneca hopes warmer storage needs for COVID-19 vaccine will be an advantage against mRNA competitors”, November 23, 2020, Fierce Pharma, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/manufacturing/astrazeneca-hopes-warmer-storage-needs-for-covid-19-vaccine-will-be-advantage-against 34 ▇▇▇▇▇▇ ▇▇▇▇▇, et al. Who funded the research behind the Oxford-AstraZeneca COVID-19 vaccine? Approximating the funding to the University of Oxford for the research and development of the ChAdOx vaccine technology. medRxIV, 10 April 2021. Available online: ▇▇▇▇▇://▇▇▇.▇▇▇/10.1101/2021.04.08.21255103 35 CureVac, “History, How it all began”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇.▇▇▇/en/about-us/historie-rework/ 36 ▇▇▇▇▇▇ ▇▇▇▇▇▇, “▇▇▇▇▇▇▇ says well on track to request vaccine approval as planned”, May 5, 2021, Reuters, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇.▇▇▇/business/healthcare-pharmaceuticals/curevac-says-well-track-request-vaccine-approval-planned-2021-05-05/ 37 CureVac, “CVnCoV, CureVac’s mRNA-based vaccine candidate against COVID-19”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇.▇▇▇/en/covid-19/#timeline 38 BioSpace, “CureVac Announces Financial Results and Business Updates for the Third Quarter and First Nine Months of 2020”, November 30, 2020, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇.▇▇▇/article/curevac-announces-financial-results-and-business-updates-for-the-third-quarter-and-first-nine-months-of-2020/ therapies, and rare disease treatment)39. Notably, ▇▇▇▇▇▇▇ claimed to be the first to be granted a patent for the manufacturing process of in vitro transcribed RNA40. Covid-19 relevant product: CureVac’s ‘CVnCoV’ is an mRNA COVID-19 ▇▇▇▇▇▇▇▇▇. The European Medicines Agency (EMA) started a rolling review of CVnCoV in February 202142, and ▇▇▇▇▇▇▇’s chief executive said in May 2021 that it is on track to file for European approval43. Novartis, GlaxoSmithKline, Bayer, and several other companies have also joined CureVac’s European vaccine manufacturing network to help it produce CVnCoV44. CureVac claims that its use of non-modified mRNA in the vaccine closely mimics the natural immune response to COVID-19 45. Another advantage is that unlike the Pfizer/BioNTech vaccine (also an mRNA vaccine), the CureVac vaccine does not require ultra-cold refrigeration for storage46 . The European Commission signed a contract to purchase up to 405 million doses of CVnCoV47. Public investment in the vaccine development: CureVac has received the following financial support for the development and production of its Covid-19 vaccine: 300 million Euro from the German Federal government48, 75 million Euro loan from the European Investment bank supported by Horizon 202049, the EC’s R&D fund, and earlier $13.5 million from the Coalition for Epidemic Preparedness Innovations, for phase I research50. In addition to these financial contributions, according to the APA, the company will benefit from additional undisclosed amounts of money in pre-purchase payments that it is not obliged to refund if the product is not approved by the EMA and the money has already been spent (see section 3.10).

CureVac. Overview: Founded in 2000 35, CureVac is a NASDAQ- listed36 biopharmaceutical company headquartered in Germany37. Its revenue in the same nine-month period increased by 304% from €10.6 million in 2019 to €42.8 million during the first nine months of 202038. 25 European Pharmaceutical Review, “AstraZeneca”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/organisations/astrazeneca/ 26 AstraZeneca, “Contact Information”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/investor-relations/annual-reports/annual-report-2016/contact-information.html 27 AstraZeneca, “FAQs”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/investor-relations/faqs.html 28 AstraZeneca, “What science can do - AstraZeneca Annual Report and Form 20-F Information 2020”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/content/dam/az/Investor_Relations/annual-report-2020/pdf/AstraZeneca_AR_2020.pdf 29 ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, “AstraZeneca COVID-19 Vaccine (AZD1222)”, January 27, 2021, ▇▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/vaccines/acip/meetings/downloads/slides-2021-01/02-COVID-▇▇▇▇▇▇▇▇▇.pdf 30 European Medicines Agency, “Vaxzevria (previously COVID-19 Vaccine AstraZeneca)”, 31 Reuters, “AstraZeneca agrees to supply Europe with 400 million doses of COVID-19 vaccine”, June 13, 2020, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇.▇▇▇/article/us-health-coronavirus-vaccines-idUSKBN23K0HW 32 ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, “The Serum Institute of India”, December 8, 2020, Fierce Pharma, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/special-report/top-10-manufacturers-fight-against-covid-19-serum-institute-india 33 ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, “AstraZeneca hopes warmer storage needs for COVID-19 vaccine will be an advantage against mRNA competitors”, November 23, 2020, Fierce Pharma, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇/manufacturing/astrazeneca-hopes-warmer-storage-needs-for-covid-19-vaccine-will-be-advantage-against 34 ▇▇▇▇▇▇ ▇▇▇▇▇, et al. Who funded the research behind the Oxford-AstraZeneca COVID-19 vaccine? Approximating the funding to the University of Oxford for the research and development of the ChAdOx vaccine technology. medRxIV, 10 April 2021. Available online: ▇▇▇▇▇://▇▇▇.▇▇▇/10.1101/2021.04.08.21255103 35 CureVac, “History, How it all began”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇.▇▇▇/en/about-us/historie-rework/ 36 ▇▇▇▇▇▇ ▇▇▇▇▇▇, “▇▇▇▇▇▇▇ says well on track to request vaccine approval as planned”, May 5, 2021, Reuters, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇.▇▇▇/business/healthcare-pharmaceuticals/curevac-says-well-track-request-vaccine-approval-planned-2021-05-05/ 37 CureVac, “CVnCoV, CureVac’s mRNA-based vaccine candidate against COVID-19”, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇.▇▇▇/en/covid-19/#timeline 38 BioSpace, “CureVac Announces Financial Results and Business Updates for the Third Quarter and First Nine Months of 2020”, November 30, 2020, ▇▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇.▇▇▇/article/curevac-announces-financial-results-and-business-updates-for-the-third-quarter-and-first-nine-months-of-2020/ therapies, and rare disease treatment)39. Notably, ▇▇▇▇▇▇▇ CureVac claimed to be the first to be granted a patent for the manufacturing process of in vitro transcribed RNA40. Covid-19 relevant product: CureVac’s ‘CVnCoV’ is an mRNA COVID-19 ▇▇▇▇▇▇▇▇▇. The European Medicines Agency (EMA) started a rolling review of CVnCoV in February 202142, and ▇▇▇▇▇▇▇CureVac’s chief executive said in May 2021 that it is on track to file for European approval43. Novartis, GlaxoSmithKline, Bayer, and several other companies have also joined CureVac’s European vaccine manufacturing network to help it produce CVnCoV44. CureVac claims that its use of non-modified mRNA in the vaccine closely mimics the natural immune response to COVID-19 45. Another advantage is that unlike the Pfizer/BioNTech vaccine (also an mRNA vaccine), the CureVac vaccine does not require ultra-cold refrigeration for storage46 . The European Commission signed a contract to purchase up to 405 million doses of CVnCoV47. Public investment in the vaccine development: CureVac has received the following financial support for the development and production of its Covid-19 vaccine: 300 million Euro from the German Federal government48, 75 million Euro loan from the European Investment bank supported by Horizon 202049, the EC’s R&D fund, and earlier $13.5 million from the Coalition for Epidemic Preparedness Innovations, for phase I research50. In addition to these financial contributions, according to the APA, the company will benefit from additional undisclosed amounts of money in pre-purchase payments that it is not obliged to refund if the product is not approved by the EMA and the money has already been spent (see section 3.10).