Bulk API Microbial Manufacturing Facility Vacaville, CA

OFFERING MEMORANDUM :: LIFE SCIENCES GROUP April 2015

www.cbremarketplace.com/vacavillebiopharma

AVAILABLE FOR PURCHASE

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VACAVILLE API PLANT TABLE OF CONTENTS

CBRE has been retained as the exclusive sales and marketing agent for the sale of the Vacaville, CA Bulk API microbial manufacturing facility.

The Opportunity ..........................................................1

Communication All communications, inquiries, and property tour requests should be directed to the CBRE team as representatives of the Seller. Management and staff at the property must not be contacted.

Executive Summary .....................................................2 Location & Labor Force.................................................3 Aerial .........................................................................4 Site Overview..............................................................5 Production Facilities ....................................................7 Laboratory Overview . ..................................................8

PRIMARY CONTACTS: Thomas Sullivan CBRE, Senior Vice President +1 732 509 8920 [email protected]

Jeff Luebker CBRE, Managing Director +1 317 269 1100 [email protected]

Michael Lyons CBRE, Senior Vice President +1 916 446 8290 [email protected]

Floor Plans

Manufacturing Facility, First Floor ............................9



Manufacturing Facility, Second Floor .....................10



Purification Unit ...................................................11



Maintenance Building ..........................................12



QC Labs ............................................................13

Utilities .............................................................15 - 16 Regulatory Inspection History .....................................17 Business Park Plan & Zoning Map ..............................18 Disclaimers ............................................................19­­

Property Tours Arranged by appointment. Property and detailed information is available in the Document Center of the property website: www.cbremarketplace.com/vacavillebiopharma 101 West Washington Street | Suite 1000 East | Indianapolis, IN 46204

THE OPPORTUNITY CBRE offers the rare opportunity to acquire a Bulk API microbial manufacturing facility located on a 52 Acre Campus in Vacaville, CA. This world-class facility is a modern fully integrated bioprocessing fermentation plant. The property is strategically located in northern California midway between San Francisco and Sacramento. This opportunity includes: • The ±74,577 square foot facility consists of a Bulk API manufacturing facility for recombinant microbial-based Biopharmaceuticals in the US • Flexible - multi-purpose facility for production of enzymes, peptides, and proteins, using microbial and lower eukaryote systems • Equipment capabilities include enzymatic and chemical reactions • EU & US licensed facility with over a dozen successful international health authority inspections since 2006 • Outstanding track record of 9 successful tech transfers since commissioning in 1993 • Facility can handle a wide range of processes covering a broad variety of hosts, expression systems, technology and products • The infrastructure is well maintained, unique features include an EX-proof purification suite • 1 MW Solar array on site for energy expense reduction • Economy of scale makes site highly competitive from a cost perspective for medium-high volume products

Jeff Luebker CBRE, Managing Director +1 317 269 1100 [email protected]

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Thomas Sullivan CBRE, Senior Vice President +1 732 509 8920 [email protected]

Michael Lyons CBRE, Senior Vice President +1 916 446 8290 [email protected]

EXECUTIVE SUMMARY

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Property Address

2010 Cessna Drive, Vacaville, CA 95688

Site Area

52 Acres

Square Footage

±74,577

Description Location

Bulk API manufacturing facility for recombinant microbial-based Biopharmaceuticals in the US. The property is located in the Vacaville - Golden Hills Business Park and lies directly adjacent to I-505 and Vaca Valley Parkway.

Zoning

The property is located 54 miles from San Francisco and 34 miles from Sacramento. Industrial Park Airport Zoning E: Adjacent to runway, most nonresidential uses

Vacaville

LOCATION & LABOR FORCE Location • ±74,577 SF on a 52 Acre Campus, with 28 adjacent acres available for future expansion • The property is located in Area III of the Vacaville Business Plan Park north of Interstate 80 and west of Interstate 505 near the Vaca Valley Parkway/505 interchange. • Surrounding development consists of warehouse/distribution, office and R&D with a major Kaiser Health Care facility and Genentech facility nearby. To the west is residential and the city center and to the south along Interstate 80 is significant retail and other vital service centers. • The property and Vacaville area benefit from a close proximity to the San Francisco Bay Area, Napa Valley, state capitol of Sacramento and the greater Lake Tahoe area. • The Interstate freeway system, Amtrak passenger train system and proximity to Sacramento, San Francisco and Oakland International Airports provide a variety of transportation options. • The local zoning allows for a wide variety of manufacturing and distribution uses. • The City Fire Station is located on the north border of the property. Extensive Biomedical Employment Labor Force • High concentration of biomedical workforce is located in the region • 70,476 biomedical related employees were located in the combined Sacramento and Bay Area as of 2013 which represents 26% of California’s biomedical workforce.

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AERIAL Now Available for Purchase - One of the largest bulk API microbial facilities for Biopharmaceuticals in the US.

Solar Array

Cessna Drive

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Manufacturing Campus (VMF)

SITE OVERVIEW Facility

Maintenance Bldg. (VMT) Complete mechanical workshop for equipment maintenance and calibration.

Hazardous Materials Waste Storage Units

Tank Farm

Fermentation & Primary Separation, Vacaville Manufacturing Facility (VMF)

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VMF - 1st floor

±36,473

VMF - 2nd floor

±11,642

VPU

±17,905

VMA

±5,875

QC Labs

±2,682

Purification Unit (VPU)

QC Labs

Solar Carport

Square Feet

PRODUCTION FACILITIES Production Facilities • US and EU licensed Multi-Host/Multi-Product bulk API microbial facility • 2 prior commercial products produced on site: »» r-human SuperOxide Dismutase (SOD) »» r-human Platelet-Derived Growth Factor (PDGF) • 24,000L total fermenter capacity, three purification suites located in a segregated building (VPU) • Stand alone facility with: »» 6 independent Quality Control laboratories • Fully integrated facility, with capacity to cover the whole supply chain from raw materials supplier qualification to bulk filling and shipping, including raw material, as well as final product testing and release • Recently built, state-of-the art, downstream processing building, capable of handling complex purification steps, including Explosion-proof facility for solvent-involving steps (i.e. RPC, conjugation) • Modern analytical laboratories for raw materials, environmental monitoring and release testing, as well as stability studies • Six existing labs with mechanical and support infrastructure Additional Features • Complete mechanical workshop for equipment maintenance and calibration • Solar Carport for employee parking • Site was operating 24/7 (2 x 12 hours shift, 4 shifts)

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LABORATORY OVERVIEW Capabilities • The site’s manufacturing history featured strong collaboration between Manufacturing Technology and QC. • Fully ready to use laboratories for processes such as: »» HPLC (Peptide Mapping, Reverse Phase, Size Exclusion Chromatography)

»» Cell based Bioassays

»» Gas Chromatography

»» Endotoxin, Microbial Testing

»» Capillary Zone Electrophoresis

»» Wet Chemistry tests

»» SDS Page (Qualitative and Quantitative)

»» Rapid Micro Technology

»» Plasmid Mapping

»» Manage Full Stability Program on Site

»» DNA Threshold

»» Full Range of Stability chambers to support even accelerated

»» Various ELISA Methods

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»» UV Spectrophotometry

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studies

VMF FLOOR PLANS Vacaville Manufacturing Facility (VMF) First Floor

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VMF FLOOR PLANS Vacaville Manufacturing Facility (VMF) Second Floor

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VPU FLOOR PLANS Vacaville Purification Unit (VPU)

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VMT FLOOR PLANS

Vacaville Maintenance Building (VMT)

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QC LABS FLOOR PLANS QC Labs

Note: 2 QC labs are located in existing modular buildings and 4 QC labs are located in the VMF building.

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UTILITIES Electricity, Water and Sewer • Electric service provided to the Site by Pacific Gas and Electric Company (PG&E), 12 KV existing service • The on-site transformers are owned and maintained by owner • Potable Water and Sanitary Sewer Services are provided by the City of Vacaville Utilities: GMP • Clean Steam (VMF): 6 bar, 1730 kg/hr

• The site has the capability to handle a full range of process chemicals.

• Clean Steam (VPU): 2 bar, 750 kg/hr

• Two Plant Steam Boilers: 7 bar, 10,200 kg/hr (total)

• Nitrogen & Oxygen - infrastructure in place

• VMF Glycol Chillers: minus 5 deg C, 2.8 bar, 267 tons

• Two Purified Water generation systems (generation, storage):

• VPU Glycol Chillers: minus 5 deg C, 3.5 bar, 150 tons • VMF Chilled Water: 4 deg C, 3 bar, 270 tons

135 LPM, 60 KL (total) »» Purified Water (VMF dist): 9 bar, 750 LPM, 30 POU

• VPU Chilled Water: 4 deg C, 3 bar, 293 tons

»» Purified Water (VPU WFI makeup): 75 psig, 105 LPM

• VMF Cooling Tower (two cells): 4.5 bar, 6000 lpm,

• VPU WFI #1: vapor compression (gen/store): 38 lpm, 4250 L »» VPU WFI #1(dist): ambient – 6 bar, 140 LPM

• VPU Cooling Tower (one cell): 4.5 bar, 4050 lpm, 446 tons



• Emergency Generators supports the VMF building, 2Mw Unit

80 deg C – 6 bar, 280 LPM

• VPU WFI #2: multi effect (gen/store): 46 lpm, 20 KL »» VPU WFI #2(dist): 80 deg C – 6 bar, 300 LPM • Process Air: 7 bar, 2200 scfm • Instrument Air: 7 bar, 300 scfm (non-GMP) • Building Management System: Siemens Apogee – Utilities, HVAC, qualified chambers

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800 tons (total)

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• 1 MW solar array provides 20% of site’s electricity

UTILITIES Utilities: Waste Systems • Biowaste Inactivation: 57 lpm at 80 deg C

• Design capacity of site sewer system to city

• Cell Kill: 121 deg C, 7 KL tank; batch process

»» Original 6” line: 520 lpm / 136 GPM

• Waste Neutralization discharge (5 min. average, max)

»» New 10” line: 1585 lpm / 417 GPM

»» Permitted for 635 lpm; 167 GPM • Permitted Waste Discharge to City »» Daily maximum: 562 K liters; 148 K gal »» Monthly average (of daily discharge): 456 K liters; 120 K gal

• Cell Waste: Three tanks totaling 75.6 KL • Solvent Waste: 30 KL storage • VMF Rm. 182 – Current solvent waste pumping capacity: 15 liters / 4 GPM @ 69 FT TDH • VPU Rm. 107 – Current solvent waste pumping capacity: 105 liters / 28 GPM @ 55 FT TDH

Solar Array • 1 Megawatt (MW) Solar Array on 5 acres • Includes 4,100 photovoltaic panels • Vacaville is an ideal location for solar power generation with 25% more sunny days than the average American city.1 • The Array generates enough electricity that can offset utility costs for a future owner of approximately $200K/year. The solar panel array is expected to have a useful life for an additional 15-20 years.

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Note: Re-permitting will be required for the systems for the restart of manufacturing.

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SOLAR ARRAY

REGULATORY INSPECTION HISTORY The site features an excellent regulatory inspection history.

Health Authority Inspection History Year

Inspection History • Over a dozen successful FDA and EMA inspections since 2006 • 0 observations during FDA inspection in July 2011 (CDER general GMP) • No major environmental incident in the history of the site

FDA-QSIT

2006

FDA - Team Biologics 4 Observations (VAI) Biennial EMA Periodic Inspection 0 Observations

2006 2008

• • • • •

P-15-94(t1) P-58-93(t1) P-33-10(t) P-67-04(t1) P-76-02(1)

Fermentor FR2240 Boiler: Natural Gas, Dormant Boiler: Water Heating, Dormant IPA Usage Generator

Licenses • State Operating License

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2008 2009 2009

Air Permits

Outcome

2006

Discharge Permits • Discharge permit (No. CA-05-1014) from City of Vacaville POTW, origiinally issued October 31, 2009, was last revised on February 6, 2013, and expired 4th Quarter, 2014.

Topic

State of CA, Dept. of Health Services, Food and Drug Branch FDA - Biennial Inspection Extavia PAI

0 Observations (NAI)

0 Obervations

13 Observations (VAI) 0 Observations Recommended Approval 0 Observations

2009

State of CA, Dept. of Health Services, Food and Drug Branch FDA - CSO (Biologics)

2010

FDA - General GMP

2010

EMA Periodic Inspection 11 Observations (Classified as “Other”) (GMP Certificate Issued) FDA - CBER - General 8 Observations (VAI) GMP (SOD Focus) FDA CDER - Genral 0 Observations (NAI)­­­ GMP (PDGF Focus)

2011 2011

0 Observations (NAI) 0 Observations (NAI)

BUSINESS PARK PLAN & ZONING MAP Objectives of the Zone • To provide a wide range of industrial and warehouse land uses. • To encourage employment opportunities. • To minimize any adverse effect of industry on other land uses. • To support and protect industrial land for industrial uses. • To facilitate a range of non-industrial land uses that serve the needs of workers and visitors.

Property Address

2010 Cessna Drive, Vacaville, CA 95688

Council

City of Vacaville

Zoning

Area III, IP Industrial

Governing Planning Document

Vacaville - Golden Hills Business Park Policy Plan

Permitted Uses • Manufacturing establishments, including, but not limited to, clay and pottery products, electrical equipment and instruments, pharmaceuticals, non-odorous food products, small scale miscellaneous products and stone and cut stone products; • Research and development facilities; • General warehousing and large wholesaling and distribution; • Public utility and public service buildings and structures; • Commercial and services uses for employees and businesses Permitted with conditional use permit • Any facility which stores or uses sufficient quantities of hazardous materials on site such that a state or federal hazardous materials use or storage permit is required; • Warehouse facilities with wholesale and retail sales, of large items including furniture, floor and wall coverings and appliances, provided that such uses are conducted completely within an enclosed building Prohibited • Uses such as saw mills, petroleum refineries, cement manufacturing or other uses constituting a public or private muisance because of emissions are prohibited.

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Affiliated Business Disclosure CBRE, Inc. operates within a global family of companies with many subsidiaries and/or related entities (each an “Affiliate”) engaging in a broad range of commercial real estate businesses including, but not limited to, brokerage services, property and facilities management, valuation, investment fund management and development. At times different Affiliates may represent various clients with competing interests in the same transaction. For example, this Memorandum may be received by our Affiliates, including CBRE Investors, Inc. or Trammell Crow Company. Those, or other, Affiliates may express an interest in the property described in this Memorandum (the “Property”) may submit an offer to purchase the Property and may be the successful bidder for the Property. You hereby acknowledge that possibility and agree that neither CBRE, Inc. nor any involved Affiliate will have any obligation to disclose to you the involvement of any Affiliate in the sale or purchase of the Property. In all instances, however, CBRE, Inc. will act in the best interest of the client(s) it represents in the transaction described in this Memorandum and will not act in concert with or otherwise conduct its business in a way that benefits any Affiliate to the detriment of any other offeror or prospective offeror, but rather will conduct its business in a manner consistent with the law and any fiduciary duties owed to the client(s) it represents in the transaction described in this Memorandum.

Confidentiality Agreement This is a confidential Memorandum intended solely for your limited use and benefit in determining whether you desire to express further interest in the acquisition of the Property. This Memorandum contains selected information pertaining to the Property and does not purport to be a representation of the state of affairs of the Property or the owner of the Property (the “Owner”), to be all-inclusive or to contain all or part of the information which prospective investors may require to evaluate a purchase of 19

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VACAVILLE API PLANT

The Owner expressly reserved the right, at its sole discretion, to reject any or all expressions of interest or offers to purchase the Property, and/or to terminate discussions with any entity at any time with or without notice which may arise as a result of review of this Memorandum. The Owner shall have no legal commitment or obligation to any entity reviewing this Memorandum or making an offer to purchase the Property unless and until written agreement(s) for the purchase of the Property have been fully executed, delivered and approved by the Owner and any conditions to the Owner’s obligations therein have been satisfied or waived.

real property. All financial projections and information are provided for general reference purposes only and are based on assumptions relating to the general economy, market conditions, competition and other factors beyond the control of the Owner and CBRE, Inc. Therefore, all projections, assumptions and other information provided and made herein are subject to material variation. All references to acreages, square footages, and other measurements are approximations. Additional information and an opportunity to inspect the Property will be made available to interested and qualified prospective purchasers. In this Memorandum, certain documents, including leases and other materials, are described in summary form. These summaries do not purport to be complete nor necessarily accurate descriptions of the full agreements referenced. Interested parties are expected to review all such summaries and other documents of whatever nature independently and not rely on the contents of this Memorandum in any manner. Neither the Owner or CBRE, Inc, nor any of their respective directors, officers, Affiliates or representatives make any representation or warranty, expressed or implied, as to the accuracy or completeness of this Memorandum or any of its contents, and no legal commitment or obligation shall arise by reason of your receipt of this Memorandum or use of its contents; and you are to rely solely on your investigations and inspections of the Property in evaluating a possible purchase of the real property.

By receipt of this Memorandum, you agree that this Memorandum and its contents are of a confidential nature, that you will hold and treat it in the strictest confidence and that you will not disclose this Memorandum or any of its contents to any other entity without the prior written authorization of the Owner or CBRE, Inc. You also agree that you will not use this Memorandum or any of its contents in any manner detrimental to the interest of the Owner or CBRE, Inc. If after reviewing this Memorandum, you have no further interest in purchasing the Property, kindly return this Memorandum to CBRE, Inc.

Exclusive Offering Website www.cbremarketplace.com/vacavillebiopharma

Thomas Sullivan Senior Vice President CBRE, Inc. Two Tower Center Boulevard 20th Floor East Brunswick, NJ 08816 +1 732 509 8920 [email protected]

Jeff Luebker Managing Director CBRE, Inc. 101 West Washington Street Suite 1000 East Indianapolis, IN 46204 +1 317 269 1100 [email protected]

Michael Lyons Senior Vice President CBRE, Inc. 500 Capitol Mall 24th Floor Sacramento, CA 95814 +1 916 446 8290 [email protected] R.E. License No. 00839339

© 2015 CBRE, Inc. The information contained in this document has been obtained from sources believed reliable. While CBRE, Inc. does not doubt its accuracy, CBRE, Inc. has not verified it and makes no guarantee, warranty or representation about it. It is your responsibility to independently confirm its accuracy and completeness. Any projections, opinions, assumptions or estimates used are for example only and do not represent the current or future performance of the property. The value of this transaction to you depends on tax and other factors which should be evaluated by your tax, financial and legal advisors. You and your advisors should conduct a careful, independent investigation of the property to determine to your satisfaction the suitability of the property for your needs.

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