TOWN OF JUPITER DATE: December 14, 2012 TO: Honorable Mayor and Members of Town Council FROM: Andrew D. Lukasik, Town Manager SUBJECT: Approval of a loan guarantee in the amount of $115,000 to CHS Pharma, Inc. and granting authorization to the Town Manager and Town Attorney to develop the necessary agreements to implement the terms for approval by the Mayor. EXECUTIVE SUMMARY: Town staff recommends approval of a $115,000 loan guarantee to CHS Pharma, Inc. for the acquisition of technology that is currently licensed from the Florida Atlantic Research Corporation and granting authorization to the Town Manager and Town Attorney to develop the necessary agreements to implement the terms for approval by the Mayor. Company Background: CHS Pharma, Inc is a biotechnology product development company focusing on a pharmaceutical treatment for Actinic Keratosis (AK). AK is a very common dermatologic problem. It is a precancerous skin growth generally caused by sun exposure which is usually characterized by rough, red, scaly crusted areas that appear on the outer layer of skin. While not life threatening, if untreated, it can progress to carcinomas that can become fatal. CHS’s application and technologies are unique in that preliminary studies have indicated that Sulindac, an existing product, when combined, with an oxidizing agent, such as hydrogen peroxide or dichloroacetic acid, not only helps to eradicate the AK, but preferentially targets it, leaving the normal cells unharmed. While the precise mechanism of action is being investigated, CHS believes that its technologies offer significant promise in the growing AK and skin cancer markets. CHS was formed as a Florida limited liability company in February, 2005 and in October, 2005 licensed its technology, which was developed by Dr. Herb Weissbach of Florida Atlantic University, from FAU Research Corporation, an affiliate of Florida Atlantic University. To date, CHS has raised in excess of $500,000 from its members and a State of Florida Commercialization Research Grant, which has been used for various preliminary studies regarding a treatment for AK. Previous Loan Guarantee Details: In April, 2010, the Town Council approved a loan guarantee to provide for a $275,000 loan to CHS Pharma (fka CHS Resources, Inc.) as recommended by the Town’s Economic Development Advisory Board. The original loan guarantee provisions included that the Town would guarantee $233,750 (85%) of a $275,000 loan and that the Town would be granted stock options in CHS equal to 2.5% of the company’s total equity for providing the loan guarantee. The exercise price of the stock options was to be equal to the price of equity in CHS’ next round of fund raising. The proceeds from the funding were to be used to prepare and file an IND with the FDA with respect to the application of the CHS’ product for the treatment of AK and operational costs related to the relocation of the Company. CHS has relocated its offices to Jupiter, however, the commercialization effort was not pursued and, instead, the technology was improved to reduce the time a consumer would have to use the product by expediting the aging process of cancer cells (i.e. application time reduced from 21 to 3 days). As a result of this effort, CHS Pharma was unable to maintain its licensing payments to FAU and was on the verge of falling behind on its loan payments to First United Bank (Town staff has worked with the bank to keep CHS’ loan from defaulting even though the payments have fallen behind schedule). To keep CHS from defaulting, the Town has advanced $9,487.50 from accumulated interest on the CHS CD (which is the CD the Town maintains at Seacoast Bank) to keep the loan current. FAU was on the verge of repealing the licensing agreement with CHS, but the Town and others who see the technology’s potential advocated on its behalf and, consequently, CHS has negotiated a pathway to secure the technology from FAU and commercialize the technology. Current Financing Request and Use of Proceeds: As mentioned above, CHS Pharma has embarked on a new strategy to commercialize its technology: The company will be purchasing the technology from FAU and will be filing an IND for an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for a topical treatment for AK and other skin cancers with the assistance of Sancillio & Company, Inc (SCI). SCI is a local R&D/biomanufacturing company, which also has received a loan guarantee from the Town, and has a history of successful commercialization of technology. SCI will take the technology through the FDA phase I process. SCI recently completed a due diligence analysis of the technology and has agreed to take the technology through the phase I process (which costs approximately $1.5 million) at no up-front cost to CHS but for significant ownership of the company. Its willingness to take the product through phase I at no cost is an indication of its confidence in the technology’s ability to be commercialized. To facilitate this new pathway to commercialization, Town staff is recommending that the Town provide an additional loan guarantee of $105,000 to allow CHS to acquire the licensed technology from FAU and pay for associated legal expenses. In exchange for this additional funding, the Town will receive an increase in the Town’s share of stock options from 2.5% to 10% of the company with a strike price set at $0.01 as opposed to the value at the next round of financing. Simply put, this means that the Town, in one transaction, will purchase and sell CHS stocks. While the Town will “purchase” the stocks for $0.01 per share, it will not actually have an outlay of cash. When the transaction is made, the Town will receive the difference between the $0.01 per share purchase price and the per share value of the company when the Town calls in its stock options. This return, then, can be reinvested in the Economic Development Fund for future use. Additional terms of the loan guarantee include the following: Prior to the Town’s deposit of $115,000 with First United bank to guarantee the loan, an amount of $30,000 of private funding be deposited with the bank to service the loan expenses, and The Town will be reimbursed the $9,487.50 of interest revenue from the original loan guarantee Certificate of Deposit that was used to service the debt on behalf of CHS at the time of the closing. The $145,000 being deposited with First United Bank will also be used by CHS to apply for a Florida Commercialization Fund grant to pay other, ongoing operating costs. All terms are being included in agreements being drafted by the Town Attorney. RECOMMENDATION: Approval of a loan guarantee to provide for a $115,000 loan guarantee to CHS Pharma, Inc and granting authorization to the Town Manager and Town Attorney to develop the necessary agreements to implement the terms for approval by the Mayor. Strategic Priority: Strong Local Economy Attachments: Resolution Economic Development Fund Update Term Sheet Presentation Funding Source: x Approved in Budget $ Additional Funding Required $ $115,000 Sources: Sources: Economic Development Fund TERM SHEET OFFERING OF FINANCIAL SUPPORT For CHS Pharma, LLC (CHS) From Town of Jupiter (TOJ) December 2012 * * * THIS TERM SHEET SUMMARIZES THE PRINCIPAL TERMS OF THE OFFER OF FINANCIAL SUPPORT FROM THE TOWN OF JUPITER. THE TRANSACTIONS CONTEMPLATED BY THIS TERM SHEET ARE SUBJECT TO THE SATISFACTORY COMPLETION OF DUE DILIGENCE BY THE TOWN OF JUPITER. THIS TERM SHEET DOES NOT CONSTITUTE EITHER AN OFFER TO SELL OR AN OFFER TO PURCHASE SECURITIES. THIS DOCUMENT IS INTENDED TO SET FORTH THE INTENT OF THE PARTIES AND IS NOT INTENDED TO BE BINDING UPON ANY PARTY OR PERSON. This term sheet summarizes the principal terms and conditions of an offer of financial support from the Town of Jupiter (the “Offer”). The Offer Form of Offer: Loan Guarantee Amount / Term: $115,000 loan for a maximum period of 60 months. Guarantee In addition to any financial covenants required by the lender of CHS, the TOJ will provide a Amount: cash guarantee of $115,000 and CHS will provide $30,000 as cash or cash equivalents. Prior to the Town’s deposit of $115,000 to guarantee the loan, the amount of $30,000 of private funding is to be deposited with the bank with the use restricted solely to service of the loan expenses. Repayment The Loan will be repaid monthly. The loan will be paid in full at the end of the 60 month term. Terms of repayment may include interest only payments for the first 36 months of the term and interest/principle payments for the remaining 24 months at an interest rate to be determined by the lender of CHS’ choice. Use of Funds: The investment will be used to fund the development of pharmaceutical treatments for Actinic Keratosis. Stipulations The Loan will be secured by all the assets of CHS. The company will execute a UCC-1 confirming the lender’s title ownership to the equipment until such time that the loan is repaid in full. CHS shall execute a personal guarantee agreement that shall be a continuing, unconditional, and irrevocable guarantee to repay and indemnify TOJ in the amount equal to the cash guarantee provided. The personal guarantee will not require a minimum net asset threshold to be valid. 1 CHS shall be subject to any provisions or stipulations required by the lender. CHS must continue to be located within the boundaries of any of the cities or unincorporated Palm Beach County that constitute "North County" (Jupiter, Palm Beach Gardens, Riviera Beach, Mangonia Park, Lake Park and unincorporated Palm Beach County) during the term of the loan. Failure to meet this obligation will require the Loan to become immediately due and repaid in full. CHS shall deliver a lease or purchase agreement or any documentation found to be adequate by the TOJ to indicate that CHS has secured a physical location in North County in which to operate. The Town will be reimbursed the $9,487.50 of interest revenue from the original loan guarantee Certificate of Deposit that was used to service the debt on behalf of CHS at the time of the closing on the loan. Management: The company will maintain the existing members of the Board of Directors. TOJ will be notified of any change in the management of CHS during the term of the loan. CHS is an LLC with Stephen Chakoff and Saeid Rezvankhah as its Managing Members, CHS will maintain Stephen Chakoff and Saeid Rezvankhah as the Managing Members during the term of the loan and keep the Scientific Advisory Board intact. CHS will cooperate fully with the efforts of Sancilio & Company, Inc (SCI), which has been engaged by CHS to complete the FDA development and approval process. Change in In the event of a change in control, the Loan may, in the sole discretion of the TOJ become Control: immediately due and repaid in full. Information CHS will provide all required documents for due diligence and regular loan covenant review Rights: to the lender. Expenses: The TOJ will pay for its own legal and related fees for creation of the final agreement and the issuance loan guarantee. CHS will pay for all legal and accounting fees that it incurs for advice related to this Offer. Lender: CHS may negotiate the terms of the loan with a lender of its choosing. Final Agreement: The TOJ will request a law firm of its own choosing to draft a Final Agreement which incorporate the terms outlined herein as well as all other terms and indemnifications required by the TOJ. Equity The TOJ will be granted stock options in CHS equal to 10% of the equity in CHS at the Participation: time of consummation of the loan but subsequent to the Sancillio & Company, Inc (SCI) investment (55%) for providing the loan guarantee. Value of the stock options will be $0.01. Financial CHS shall furnish to the TOJ the following financial information, in each instance prepared Reporting: in accordance with generally accepted accounting principles consistently applied and otherwise in form and substance satisfactory to the TOJ: 1) Annual Financial Statements: CHS shall deliver to the TOJ, within 120 days after the close of each fiscal year, financial statements that reflect its operations during such fiscal year, including, without limitation, a balance sheet, profit and loss statement and statement 2 of cash flows, with supporting schedules. 2) Budget/Projections: CHS shall deliver to the TOJ current budget and projection statements as soon as available and in any event within 30 days after the close of each fiscal quarter; all in reasonable detail. Project CHS shall provide semi-annual reports advising the TOJ of the status of the project for Reporting: which funding has been requested. Closing CHS will be obligated to: (i) provide financial information as requested by the TOJ or the Conditions: Lender, (ii) obtain all required consents and approvals from its shareholders, partners, or directors, (iii) affirm that their business is in compliance with all federal and state laws that are applicable to the CHS’s business, (iv) attest to being authorized to execute the final agreement, and (v) execute the final agreement. 3 Town of Jupiter Economic Development Advisory Board Fund Funding Update Initial Fund Deposit May, 2012 3,000,000 Completed Transactions: Transdermal Technologies 350,000 * Direct loan Leinco Technologies 350,000 * Direct Loan WPB Int pyts Nov 2010. Int only til Nov 2013 Palm Beach Community College 72,500 Educational Grant PBG Grant only Ocean Ridge BioSceince Phase I 50,000 Loan Guarantee PBG Maturity Sept 2013 Sancilio & Company 350,000 Loan Guarantee PBG Maturity June 2012 Biotools 191,250 Loan Guarantee PBC Maturity Sept 2013 CURNA 350,000 * Loan Guarantee TOJ Maturity Sept 2013 Cytonics 297,500 * Loan Guarantee TOJ Maturity Janury 2014 GLG Pharma 212,500 Loan Guarantee TOJ Maturity June 2014 CHS Pharma 233,750 Loan Guarantee TOJ Maturity July 2015 Endeavour Capital 300,000 Loan Guarantee TOJ Maturity October 2016 GLG Pharma - Phase II 137,500 Loan Guarantee TOJ Maturity March 2016 Akron Biotech 350,000 Loan Guarantee TOJ Maturity February 2017 Grant - State required match TOJ Project Cube 30,000 Total funded projects 3,275,000 Plus : Repayments to Town 1,347,500 * Balance after funded projects and reimbursments 1,072,500 CHS Pharma Town of Jupiter Economic Development Fund Request for Funding December 18, 2012 CHS Pharma Request for Funding • Working to commercialize technology developed by Florida Atlantic University that treats Actinic Keratosis (AK), a precancerous skin condition • Require a $105,000 loan guarantee from the Town of Jupiter Economic Development Fund to acquire from FAU, their IP Portfolio related to the technology developed by Dr. Weissbach, to pursue commercialization in collaboration with Sancilio & Company. CHS Pharma Company Background • • • • • Established in 2005 Early-Stage Product Development Relocated to Jupiter in 2010 Completed formulation and POC studies Have a platform technology – Actinic Keratosis (AK) – Dry Macular Degeneration (Dry AMD) • Seasoned Management/Consultants/BOD Technology Development 1. Sulindac was one of the first antiinflammatory drugs similar to Ibuprofen or Aleve. 2. Our research discovered that sulindac enhances the killing of cancer cells exposed to harmful agents that cause oxidative damage. Normal cells are protected against these agents. Normal Cells React Differently To Sulindac Than Cancer Cells Cancer Cells Normal Cells Sulindac + oxidative stress Protection Enhanced Killing Potential Uses Cardiac Ischemia Stroke Retinal diseases Lung diseases UVB skin damage Actinic keratosis Skin and other cancers CHS Pharma – Treatment for Actinic Keratoses (AK)* 1. Based on research performed at FAU, CHS Pharma has developed a dual drug treatment for AK. The drug combination is sulindac + hydrogen peroxide. 2. A proof of concept clinical trial sponsored by CHS Pharma indicated that this treatment has similar efficacy as other drug treatments (e.g. efudex, zyclara, solaraze, picato). 3. The major advantage of the CHS Pharma drug treatment is the lack of inflammation and damage to surrounding normal tissues, seen with the other drugs. *Actinic Keratoses is precancerous skin lesion with a market of >$700 million. Patient - Day 30 Using Efudex Source: http://www.sannerud.com/people/efudex/ Patient – Day 44 with Efudex Source: http://www.sannerud.com/people/efudex/ Effect of sulindac and hydrogen peroxide on actinic keratoses NO AFTER AFTER TREATMENT 3 WEEKS 6 WEEKS Technology Summary 1- 2- 3- Research at FAU has led to the development of a treatment for actinic keratoses using a drug combination containing sulindac. Sulindac can protect normal cells against oxidative damage that could lead to new therapies for several age related diseases. The intellectual property for both the sulindac effect on cancer killing and protection of normal cells has been licensed to CHS Pharma and patents have been issued.* * Weissbach, H., Brot, N. Catalytic antioxidants and methods of use. Florida Atlantic University October 2006: US Patent 7,129,374. * Weissbach, H., Resnick, L., Binninger, D. Treatment or prevention of cancer and precancerous disorders. Florida Atlantic University September 2012: US Patent: 8,258,181. Commercialization Pathway • Acquisition of IP portfolio from FAU – Loan from Jupiter will be used to purchase the technology • Partnership with SCI – SCI to conduct Pre-Clinical leading to IND – SCI to have ownership interest in company Loan Parameters • $115,000 loan guarantee – Acquire technology from FAU and pay associated legal expenses – This is in addition to the existing $275,000 loan guarantee (guaranteed 85% Town/15% private funding) – Requires initial deposit of $30,000 of private monies • Repayment of Town Interest Revenue – $9,487.50 to be repaid to Town at the time of the closing on the loan. – These were funds the Town expended to temporarily maintain CHS’ existing loan. Loan Parameters • Increase the Town’s warrant position – Increased from 2.5% to 10% – Strike price (meaning the initial value of the warrant/stock options at $0.01 instead of being based upon the company valuation at the next round of funding • Avoids the problem the Town experienced when a company sold before a strike price was established. • The Town nets the difference between the strike price and the value of the shares when the Town calls the warrants/stock options • This occurs in one transaction; the Town will NOT expend funds to purchase the stocks. RESOLUTION NO. 99-12 A RESOLUTION OF THE TOWN COUNCIL OF THE TOWN OF JUPITER FLORIDA APPROVING A LOAN GUARANTEE IN AN AMOUNT NOT TO EXCEED $115,000 FOR A LOAN AMOUNT NOT TO EXCEED $115,000 FOR CHS PHARMA, LLC; AND PROVIDING FOR AN EFFECTIVE DATE. WHEREAS, The Florida Constitution, applicable laws of the State of Florida and the Charter of the Town of Jupiter, Florida (the Charter), authorize and grant the Town Council broad home rule authority to act in the best interests of its citizens; and WHEREAS, CHS Pharma, LLC (CHS) is applying for a business purpose bank loan to acquire and commercialize technology currently being licensed by CHS from Florida Atlantic University and the Town has agreed to support this application by making funds available to be used as cash collateral for the CHS loan; and WHEREAS, as part of its commitment to Palm Beach County to be the location of Scripps Florida, the Town created an Economic Development Advisory Board whose purpose it was to assist businesses in the biotechnology sector to relocate or expand their businesses in Palm Beach County and the Town; and WHEREAS, the Town’s Economic Development Advisory Board had previously recommended, and the Town Council approved that the Town provide a loan guarantee in an amount not to exceed $233,750 for CHS loan amount not to exceed $275,000; and WHEREAS, the Town Council has determined that it is in the best interest of the Town to accept Town staff’s recommendation to provide additional funding to CHS; and 1 WHEREAS, funds for the loan guarantee would be set aside from the $3 million contribution the Town Council has previously committed to Palm Beach County in order for the selection of the Town as the location for the Scripps Florida headquarters. NOW, THEREFORE, BE IT RESOLVED BY THE TOWN COUNCIL OF THE TOWN OF JUPITER, FLORIDA, AS FOLLOWS: Section 1. The foregoing recitals are true, correct and incorporated into this Resolution. Section 2. The Town Council hereby agrees to provide a loan guarantee in the amount of $115,000 for a loan amount not to exceed $115,000 with a local bank for CHS Pharma, LLC in accordance with the attached term sheet developed by Town staff. Section 3. This Resolution shall take effect immediately upon adoption. 2
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