O’H , D & C October 15, 2020 ANLON EMERATH€¦ · • Evolve initially plans to launch two...

O’HANLON, DEMERATH & CASTILLOATTORNEYS AND COUNSELORS AT LAW

808 WEST AVENUE AUSTIN, TEXAS 78701

TELEPHONE: (512) 494-9949 FACSIMILE: (512) 494-9919

October 15, 2020

Local Government Assistance & Economic Analysis Texas Comptroller of Public Accounts P.O. Box 13528 Austin, Texas 78711-3528

RE: Supplement001 to the Bryan Independent School District from Evolve Biologics (USA) Inc.

To the Local Government Assistance & Economic Analysis Division:

Enclosed. Please find Supplement001 to the Bryan ISD from Evolve Biologics (USA) Inc. The following changes have been made:

1. Tab 2 – Added the outgoing wire transfer2. Tab 4 – Company added the following information to the first paragraph of tab 4:

• Evolve initially plans to launch two plasma protein therapeutics with its 1,000,000-liter commercial facility, IVIG and HSA. Evolve has completed a Phase III clinical trial for its IVIG product in the US and Canada and does not require a clinical trial for its HSA product. Therefore, Evolve plans to acquire regulatory approval for commercial license in the US and Canada for these two products with its planned 1,000,000-liter facility. IVIG and HAS are two of the largest market segments sizes for plasma protein.

3. Company has updated tab 5 with the following information:• Evolve’s headquarters and majority of its staff is currently located in Mississauga,

Ontario, Canada. Ontario is a potential site for Evolve’s 1st commercial facility and Evolve has also applied for Canadian federal funding support through Strategic Innovations Fund, with a prospective commercial facility based in Ontario. Evolve is also investigating Greenville, NC.

4. Section 10 Question 5: Has been added to Tab 65. Tab 7 – Company explained the equipment investment6. Tab 8 – Company explained the equipment investment and explained the shell, site and

interior works of the new facility.7. Company added the following additional maps:

• Vicinity and ISD map• Vicinity and County map• Proposed location of project• Proposed reinvestment zone• Possible Evolve Site

A copy of the application will be submitted to the Brazos County Appraisal District.

1526-Bryan-Evolve-Supplement001 October 15, 2020

Sincerely,

Kevin O’Hanlon School District Consultant

Cc: Brazos CAD Evolve Biologics (USA) Inc.


Proof of payment of filing fee received by the Comptroller of Public Accounts per TAC Rule §9.1054 (b)(5)

(Page Inserted by Office of Texas Comptroller of Public Accounts)

420 Ambassador Drive Mississauga Ontario Canada L5T 2J3

P +1 (905) 286-6200 F +1 (905) 286-6300

evolvebiologics.com

Tab 4

Detailed description of the project

Project Summary Evolve Biologics® is in the process of selecting a site to construct and operationalize a 1,000,000-liter throughput manufacturing facility, in order to successfully commercialize its novel proprietary PlasmaCap EBA® technology and manufacturing of Intravenous Immunoglobulin (IVIG) and human serum albumin (HSA) for the US and Canadian markets. Evolve initially plans to launch two plasma protein therapeutics with its 1,000,000-liter commercial facility, IVIG and HSA. Evolve has completed a Phase III clinical trial for its IVIG product in the US and Canada and does not require a clinical trial for its HSA product. Therefore, Evolve plans to acquire regulatory approval for commercial license in the US and Canada for these two products with its planned 1,000,000-liter facility. IVIG and HSA are two of the largest market segments sizes for plasma proteins. Human plasma will be the principal raw material for Evolve’s innovative manufacturing process. Plasma from human donors, acquired from collection centers across the US, will be transported via trucks to a central storage facility, which will be then in turn transported via trucks to the main manufacturing facility. Once manufactured, the final IVIG and HSA finished products will then be shipped via trucks to buyers and healthcare providers across the US and Canada. Evolve plans to finalize a location for its new manufacturing facility and break ground early 2021, with an estimated two to three years construction period. A New Kind of Biologics Company Evolve Biologics (“Evolve”, or the “Company”) is focused on the development, manufacturing and commercialization of lifesaving, plasma-derived therapeutics using PlasmaCap EBA® technology. PlasmaCap EBA® can deliver high-quality therapeutics at improved levels of efficiency, yield and reliability compared to existing technologies. Significant regulatory milestones were achieved by completing Phase III Adult intravenous immunoglobulin (IVIG) Clinical Trial in Primary Immune Deficiency Disease (PIDD), based on written FDA guidance. Evolve’s planned products initially target the fast-growing product segments of the underserved $12 billion US plasma products market: Immunoglobulin (IG): $8.1B market growing at >13% CAGR and Albumin (HSA): $0.5B market growing



P +1 (905) 286-6200 F +1 (905) 286-6300

evolvebiologics.com

at >9% CAGR. To commercialize its PlasmaCap Platform, Evolve has significantly reduced execution risk by securing innovative partnerships that share in successful commercial execution across its business model. Proven Disruptive Technology Through Successful Clinical Campaign Evolve’s novel approach to extract plasma proteins has significant benefits over traditional cold-ethanol method, with IVIG product seeing potentially up to 69% process yield, which is up to a 40% increase compared to current published industry norm. These successes provide a strong foundation for the company to develop additional products as part of our corporate strategy. Evolve has successfully demonstrated the capabilities of PlasmaCap EBA™ technology by supplying a successful pivotal Phase III clinical trial in Canada and the US. The trial uses approximately 6,000 vials of drug product produced at a Mississauga contract manufacturing facility. With a larger scale 1,000,000-liter facility, Evolve expects a higher net yield of products and more cost-effective manufacturing. Evolve will establish its PlasmaCap platform with its first commercial facility to generate revenue for further development of the PlasmaCap EBA technology and expand our product pipeline to include other critical plasma-derived therapeutics, to meet growing market demands from patients with rare diseases. Scope of Project Evolve is planning to select a green-field site to construct a new plasma protein manufacturing facility capable of processing 1,000,000 liter plasma throughput annually. In partnership of Texas-based developer William Cole, the facility would be constructed for the purpose of commercial manufacturing of two or more plasma protein products. The project will include facility design, build management, site works, shell construction, support works, utilities and ancillary systems, interior with integrated mechanical and electrical work, proprietary process equipment, fill and finish equipment, process integration and validation. Final Site Selection The Appraised Value Limitation from Bryan ISD is a significant factor in determining whether to allocate the limited amount of capital to this specific project and location. The Appraised Value Limitation would remove a significant financial disadvantage when internally competing for capital versus a project in a competing location, as Texas has a significantly higher property tax rate than other locations under consideration.



P +1 (905) 286-6200 F +1 (905) 286-6300

evolvebiologics.com

Tab 5

Documentation to assist in determining if limitation is a determining factor

The Appraised Value Limitation from Bryan ISD is a significant factor in determining whether to allocate the limited amount of capital to this specific project and location. The Appraised Value Limitation would remove a significant financial disadvantage when internally competing for capital versus a project in a competing location, as Texas has a significantly higher property tax rate than other locations under consideration. Other than Texas, Evolve is currently looking into North Carolina and Ontario, Canada as alternative sites for its commercial facility. Evolve has filed or plans to file for local incentives and government funding at these alternative sites as Evolve finalizes its site decision. Evolve’s headquarters and majority of its staff is currently located in Mississauga, Ontario, Canada. Ontario is a potential site for Evolve’s 1st commercial facility and Evolve has also applied for Canadian federal funding support through Strategic Innovations Fund, with a prospective commercial facility based in Ontario. Evolve is also investigating Greenville, NC.



P +1 (905) 286-6200 F +1 (905) 286-6300

evolvebiologics.com

Tab 6

Description of how project is located in more than one district, including list of percentage in each district and, if determined to be a single unified project, documentation from the Office of the Governor (if applicable)

Not applicable. Additional Info to Section 10 Question 5:

County Incentive of 5 year Property Tax Rebate (30% rebate) Start Year: 2023 End Year: 2027 City Incentive of 10 year Property Tax Rebate (step down from 90-10%) Start Year: 2023 End Year: 2032 10 year tax rebate with schedule that steps down annually. Schedule is 90%, 80%, 70%, 70%, 50%, 50%, 30%, 30%, 20%, 10%.



P +1 (905) 286-6200 F +1 (905) 286-6300

evolvebiologics.com

Tab 7

Description of Qualified Investment

Evolve plans to invest estimated $60 million in process equipment for its manufacturing facility and enter into a capitalized lease of a new construction of estimated $80 million manufacturing facility for a total estimated investment of $140 million. The facility will be used for production of IVIG and HSA. Facility Investment include:

• shell, site, and interior works of a new construction of a plasma-derived therapeutics manufacturing facility estimated 120,000 square feet in a greenfield location in the bio-corridor in Bryan ISD in Brazos County.

Equipment Investment include:

• proprietary expanded bed adsorption chromatograph columns which selectively purifies plasma proteins of interest and remove impurities

• buffer exchange systems which facilitate different buffer conditions throughout the manufacturing process

• filtration systems which removes impurities from the process and prevent impurities from flowing downstream in the process

• fill/finish equipment which fills finished products into glass vials of various sizes

• buffer prepare systems to prepare buffer solutions that will be used for different conditions throughout the manufacturing process that is critical for control of the process and quality of products

• ancillary equipment necessary for manufacturing activity and facility operation such as heating, cooling, water supply, electrical

• Installation, qualification and validation testing equipment to operationalize equipment and facility for production



P +1 (905) 286-6200 F +1 (905) 286-6300

evolvebiologics.com

Tab 8

Description of Qualified Property

Facility: • shell, site, and interior works of a new construction of a plasma protein

manufacturing facility estimated 120,000 square feet in a greenfield location in the bio-corridor in Bryan ISD in Brazos County.

Equipment:

• proprietary expanded bed adsorption chromatograph columns which selectively purifies plasma proteins of interest and remove impurities

• buffer exchange systems which facilitate different buffer conditions throughout the manufacturing process

• filtration systems which removes impurities from the process and prevent impurities from flowing downstream in the process

• fill/finish equipment which fills finished products into glass vials of various sizes

• buffer prepare systems to prepare buffer solutions that will be used for different conditions throughout the manufacturing process that is critical for control of the process and quality of products

• ancillary equipment necessary for manufacturing activity and facility operation such as heating, cooling, water supply, electrical

• Installation, qualification and validation testing equipment to operationalize equipment and facility for production



P +1 (905) 286-6200 F +1 (905) 286-6300

evolvebiologics.com

Tab 11

Map

Evolve is working with Texas-based builder William Cole to select the new site in the Brazos County Bio-Corridor. Currently there is no finalized decisions or paperwork for a specific site. Potential site and information attached.


MAPS

VICINITY AND ISD MAP

PROPOSED SITE

PROPOSED SITE

St t St t STATE-LEVEL VICINITY MAP PROPOSED SITE CLOSE-UP


MAPS

VICINITY AND COUNTY MAP

PROPOSED SITE

BRAZOS COUNTY

St t STATE-LEVEL VICINITY MAP

EVOLVE Project/RZ Site

St t PROPOSED SITE CLOSE-UP


MAPS

PROPOSED LOCATION OF PROJECT

Evolve Project

SITE

Evolve Project Boundary/Evolve Reinvestment Zone Boundary


mhanley

Highlight

mhanley

Highlight

MAPS

PROPOSED REINVESTMENT ZONE

Evolve

REINVESTMENT

ZONE


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