This document outlines partnerships that would be beneficial for a startup developing a manufacturing platform for producing therapeutics like alpha-1 antitrypsin (AAT) in tobacco. Potential partners include UC Davis, tobacco growers, the Alpha-1 Foundation, tobacco companies, biotech companies, contract manufacturing organizations, clinical research organizations, and wholesalers. Each partnership would provide various benefits, resources, and costs to developing and commercializing the therapeutic product.

1. “insero” = to plant
”gen” = gene
Manufacturing platform for Lucas Arzola (EL)
rapid, cost-effective, and scalable Karen McDonald (PI)
production of therapeutics in tobacco Vasilis Voudouris (Mentor)

2. The Business Model Canvas Target Product –alpha-1 antitrypsin (AAT)
UC Davis R&D Cost-Effectiveness Publications Wholesalers
Tobacco Growers Manufacturing Robustness Conferences AAT deficient
Gene Synthesis Regulatory Approval Scalability Long-Term patients
Companies Licensing Safety Contracts with
CMO Marketing U.S. Supply Wholesalers
Clinical CROs Product uniformity
Alpha 1 Foundation
Tobacco Companies
IP – Patents, Trade
Secret
Manufacturing Facility
Distribution through
Wholesalers
Capital Investments Grants
Manufacturing Costs Upfront/Milestone Payments w/Partners
Licensing Costs Licensing (Royalties)
Marketing Virtual Biotech Company (Sales)
Fully Integrated Manufacturing (Sales) (LONG TERM)

3. Partners
Why do we need them?
 Technology license agreement
 Startup incubator space
Why will they partner with us?
 Campus becoming more entrepreneurial – new Chancellor is revamping the
technology transfer process, success story for UC Davis and Sacramento area
What’s the cost of the partnership?
 Licensing costs – upfront payment, assume patent costs
 Incubator space lease agreement

4. Partners
Why do we need them?
 For the clinical trials – the foundation manages the alpha-1 research registry, a
confidential database of diagnosed alpha-1 deficient individuals and alpha-1
carriers willing to participate in research, from filling a research questionnaire
to enlisting in clinical trials
 For research funding - they have provided $42M in funding for alpha-1
research and programs to date
Why will they partner with us?
 Because of their mission – dedicated to providing leadership and resources
that will result in increased research, improved health, worldwide detection,
and a cure for the disease. Using our manufacturing platform to make AAT
more affordable, safer and reliably available would be an incentive for them to
partner with us.
What’s the cost of the partnership?
 No direct costs, although personnel time for relationship building, grant
writing, etc.

6. Partners
Tobacco Farmers
Why do we need them?
 Raw Material Supply and Expertise – they have the infrastructure and know
how to grow tobacco
Why will they partner with us?
 New Market – they are looking for new, high value markets for their crops in a
declining smoking tobacco market
What’s the cost of the partnership?
 Research and Development – agricultural practices and germplasm may need
to be modified for new application
 Long-term contracts – payments for harvested tobacco crops
 Relationship building, monitoring and development

7. Partners
Tobacco Companies
Why do we need them?
 Funding – we are repurposing tobacco for the production of therapeutics
Why will they partner with us?
 Positive PR – they are looking for new and better uses for tobacco (using
tobacco to provide a treatment for hereditary-based emphysema).
What’s the cost of the partnership?
 Public perception? – associating our company with them might transfer strong
feelings from the public towards us

8. Partners
Large Biotech Companies
Why do we need them?
 For product co-development – provide funds and resources for research,
product/process development, clinical trials and regulatory approval
Why will they partner with us?
 Large pharma companies are constantly seeking new technologies and
products for their pipeline
What’s the cost of the partnership?
 Exclusive rights to the product – joint venture for product co-development,
startup is acquired if product is successful

9. Partners
Contract Manufacturing Organizations
Why do we need them?
 To complete our manufacturing – use our core technology to make AAT,
outsource our purification, fill and finish, we can focus on our core competency
without increasing overhead costs, infrastructure and number of staff
Why will they partner with us?
 Because it’s their business – CMOs act as single source providers, offer
specialized and comprehensive manufacturing services
What’s the cost of the partnership?
 Service fee – a manufacturing contract is negotiated that specifies process
development work, crude extract to process, amount of product to be purified,
quality specifications, formulation, price, and timeline

10. Partners
Clinical Research Organizations
Why do we need them?
 Preclinical and human clinical trial expertise and process manufacturing
support for Chemistry, Manufacturing and Control (CMC)
Why will they partner with us?
 Because it is their business – CROs assist partners in drug discovery and
development by providing them with customized high-quality research models
and preclinical and clinical support services.
What’s the cost of the partnership?
 Consulting and Service Agreements – Preclinical, Phase I, Phase II, and Phase III,
process manufacturing support
 QC, QA & Regulatory compliance costs of manufacturing facility – we need
qualified staff for internal regulatory oversight

11. Partners
Wholesalers
Why do we need them?
 Distribution – get our product to AAT deficient patients
Why will they partner with us?
 Because it’s their business – wholesalers mark up the product price when it
goes through their channels to the retailers
What’s the cost of the partnership?
 Long term contracts – assure pricing and steady supply of product