Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
CONFIDENTIAL IDT INFORMATION

c. Aspects of exploitation after marketing authorisation

Based on a collaboration contract that is under negotiation IDT Biologika GmbH will hold the
relevant commercial licenses to background and foreground IP generated under this funding
and be responsible for the product licensure strategy. If commercially reasonable the
applicant and marketing authorization holder for the submission of the Product will be IDT
Biologika GmbH. Alternatively the Product may be licensed to third parties taking into
consideration of manufacturing capacities, national presence and an equitable access
approach. This could be a partner of IDT amongst the world’s leading Top Vaccine
Companies (Big Pharma) or other competent pharmaceutical partners in BRIC or developing
countries. In this case it should be assured that all information will be provided and the
licensure of the Product will be obtained. WHO Prequalification is targeted. Further a
cooperation with the relevant NGO’s as CEPI/ GAVI will be evaluated to ensure an equitable
access to the vaccine in the context of urgency and outbreaks.

At this stage no final definition for licensure of the vaccine can be provided since success
and proven indications are not known yet. Approval of the vaccine in the European Economic
Area (EEA) atthe EMA and the consecutive approval of the vaccine in COVID-19 affected
countries outside the EEA is the most likely approach. The development does not currently
take into account specific requirements for submission of a BLA to the US FDA.

For application of a European Marketing Authorization the clinical Phase Ill study should be
completed. Atthis stage we consider the possibility to apply an MAA for conditional licensing
at EMA. Our CMC and clinical development program is aimed at completion of essential
validation and qualification studies for filing an MAA.

The approval of the authorization strategy requires Scientific EMA Advice.

We are committed to provide the vaccine as early as possible to the German and European
population. Due to the unknown dose regimen final pricing of the product cannot be
calculated yet.

As soon as possible and commercially reasonable we would like to enter into supply
negotiation with German authorities for supply of guaranteed vaccines doses with defined
tiered pricing and Germany’s supply strategy (as Germany already ordered quantities of
AstraZeneca’s potential COVID-19 adenovirus-based vaccine candidate.

Our price per dose should be calculated based on typically used in Public Sector Agency
purchases considering all direct and indirect Cost of Goods for manufacturing for such
vaccine provided that all costs for supportive activities and a commercial reasonable margin
are included.
Pricing of the vaccine outside of Germany/ Europe will basically be calculated based on
market prices considering a broad and equitable global access to the epidemic vaccine.

39

Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
CONFIDENTIAL IDT INFORMATION

6. Division of labour/cooperation with third parties

We envisage a broad collaboration with several partners inside of DZIF, clinical trial centers
in Gabon and Vietnam. Furthermore additional laboratories will be contracted. Such
collaboration will be contracted by IDT, DZIF, or individual partners. We implemented a
Framework Contract model to enable efficient and quality controlled collaboration. As
required GMP, GCP or GLP regulations may apply. The current collaboration model provides
an overview on the planned structure and responsibilities. Please note that we are still in the
design phase and detailed regulations will be implemented in the next weeks.

Table 16 MVA-SARS-2-S Consortium - Delineation of core responsibilities

 
 

Project coordination and
management
Generation and characterization of
the vaccine vector
Preparation Phase for CTM
Manufacturing and generation of
material for preclinical toxicity
studies

Preclinical studies: Toxicology and
Efficacy stud

Development and Qualification of
Analytical methods

IMPD Preparation / Synopsis

 
    
  

  
 
    
   
   
 
 
   
  
    

 

  
  

Clinical Trial Phase Ib and Ila/b

Process scale up for CTM-2 and
commercial manufacturing
Investigation of humoral and
cellular immunological responses

Filing of the Marketing Approval
File for conditional licensing

 

 

    

40

Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
CONFIDENTIAL IDT INFORMATION

The legally binding budget plans are part of the formal application (AZK).

We calculated the effort reflected in the work packages and outline in the attached Project
GANTT (Annex 2)

Our cost calculation performed according to the requested principles identified following cost
structure.

Table 17 Part 1 - Budget for manufacturing of 15 single MVA-SARS-2 S batches

 

41

Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
CONFIDENTIAL IDT INFORMATION

Table 18 Part 2 - Budget for Expansion of the Drug Substance manufacturing facility

 

42

Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
CONFIDENTIAL IDT INFORMATION

Table 19 Part 3- Expansion of the Drug Product manufacturing capacities / Line@Formulation and
Filling

 

43

Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
CONFIDENTIAL IDT INFORMATION

Table 20 Part 4 — Estimated Budget for clinical trials and Market Approval Application

IDT GmbH - Project MVA-SARS-CoV-2-S BMBF Application Summary

 

44

Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
CONFIDENTIAL IDT INFORMATION

Table 21 Summary Budget

 

The respective payment schedule will be provided as an attachment to this proposal.

45

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Sonderprogramm zur Beschleunigung von Forschung und Entwicklung dringend benötigter Impfstoffe gegen SARS-CoV-2
CONFIDENTIAL IDT INFORMATION

Annex Il - Synopsis for Clinical Investigations

Il.1. Synopsis of MVA-SARS-2-S Phase la clinical trial

 

Title of Study: An open, single-center Phase la trial to assess the safety,
tolerability and immunogenicity of two ascending doses of the
candidate vaccine MM —

Principal EEE — | |

ee he ER center:

 

 

 

 

re, No. UKE-DZIF-SARS-COV-2
EudraCT-No. u — 2020-002998-10
Study Period Study Timelines:

Total study duration (FSFV to LSLV) approx. 7 months
Planned screening Start SEPT 2020

 

 

 

FSFV OKT 2020
LSFV NOV 2020
LSLV MAY 2021
Phase of development: | Phase la, first-in-human
Objectives: « To evaluate safety, tolerability and reactogenicity of two
, Eat intramuscular dose administrations and two ascending dose
Primary Objective levels of the candidate MVA-SARS- 2-5 in healthy adults
Secondary Objectives ® To evaluate SARS-CoV-2-S-specific antibody responses in
healthy adults induced by two dosage levels and after two
administrations of MVA-SARS-2-S
Exploratory Objectives e To evaluate SARS-CoV-2-specific cellular immune

    
  
   
 
   
    

responses after administration of MVA-SARS-2-S

» To evaluate SARS-CoV-2-induced B and T cell memory
responses

e To evaluate innate cell subset phenotypes and function
induced by MVA-SARS-2-S

« To evaluate early innate immunity gene expression
signatures induced by MVA-SARS-2-S

e To investigate vaccine-induced humoral immune responses
and antibody functions, including vector-immunity and
neutralizing and non-neutralizing antibody functions

« To evaluate pre-existing humoral and cellular immunity to
coronaviruses

» To identify potential biomarkers and gene signatures of
innate immune responses to MVA-SARS-2-S and their

correlation to dose, reactogenicity, immune response and

 

 

 

48