UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

____________________

 

FORM 10-K

(Mark One)

 

  S Annual Report Pursuant To Section 13 or 15(d) Of The Securities Exchange Act of 1934

For The Fiscal Year Ended December 31, 2011

 

or

 

  £ Transition Report Pursuant To Section 13 or 15(d) Of The Securities Exchange Act of 1934 For The Transition Period From _______________ to _______________ .

  

Commission file number 1-08789

____________________

 

American Shared Hospital Services

(Exact name of registrant as specified in its charter)

 

  California 94-2918118
  (State or other jurisdiction of (IRS Employer
  incorporation or organization) Identification No.)

 

  Four Embarcadero Center, Suite 3700, San Francisco, California   94111-4107
  (Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (415) 788-5300

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Name of each exchange on which registered
Common Stock No Par Value   NYSE Amex

 

Securities registered pursuant to Section 12(g) of the Act: None

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes £ No S  

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes £ No S

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes S No £

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. £

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes S No £

 

Indicate by check mark if the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of “large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act (check one):

 

Large accelerated filer £ Accelerated Filer £ Non-accelerated Filer £ Smaller reporting company S

 

Indicate by check mark if the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes £ No S

 

As of June 30, 2011, the aggregate market value of the common stock held by non-affiliates of the registrant was approximately $10,821,000.

 

Number of shares of common stock of the registrant outstanding as of March 1, 2012: 4,611,060.

 

DOCUMENTS INCORPORATED BY REFERENCE

 

Portions of the registrant’s definitive Proxy Statement for the 2012 Annual Meeting of Shareholders are incorporated by reference into Part III of this report.

 

 
 

 

TABLE OF CONTENTS

 

  Page
     
PART I:     
     
Item 1 Business 3
     
Item 1A Risk Factors 12
     
Item 1B Unresolved Staff Comments 14
     
Item 2 Properties 14
     
Item 3 Legal Proceedings 14
     
Item 4 Mine Safety Disclosures 14
     
PART II:    
     
Item 5 Market for the Registrant’s Common Equity, Related Stockholder  
  Matters and Issuer Purchases of Equity Securities 15
     
Item 6 Selected Financial Data 17
     
Item 7 Management’s Discussion and Analysis of Financial Condition  
  and Results of Operations 18
     
Item 7A Quantitative and Qualitative Disclosure about Market Risk 28
     
Item 8 Financial Statements and Supplementary Data 29
     
Item 9 Changes in and Disagreements with Accountants on Accounting  
  and Financial Disclosure 29
     
Item 9A Controls and Procedures 29
     
Item 9B Other Information 30
     
PART III:    
     
Item 10 Directors, Executive Officers and Corporate Governance 30
     
Item 11 Executive Compensation 30
     
Item 12 Security Ownership of Certain Beneficial Owners and Management  
  and Related Stockholder Matters 30
     
Item 13 Certain Relationships and Related Transactions, and Director Independence 31
     
Item 14 Principal Accountant Fees and Services 31
     
PART IV:    
     
Item 15 Exhibits and Financial Statement Schedules 31

 

2
 

 

PART I

 

ITEM 1.

 

BUSINESS

 

GENERAL

 

American Shared Hospital Services (“ASHS” and, together with its subsidiaries, the “Company”) provides Gamma Knife stereotactic radiosurgery equipment and radiation therapy and related equipment to nineteen (19) medical centers in sixteen (16) states in the United States and Turkey, as of March 1, 2012. The Company provides Gamma Knife services through its 81% indirect interest in GK Financing, LLC, a California limited liability company (“GKF”). The remaining 19% of GKF is owned by GKV Investments, Inc., a wholly owned U.S. subsidiary of Elekta AG, a Swedish company (“Elekta”). Elekta is the manufacturer of the Leksell Gamma Knife â (the “Gamma Knife”). GKF is a non-exclusive provider of alternative financing services for Elekta Gamma Knife units.

 

GKF has established the wholly-owned subsidiaries, GK Financing U.K., Limited (“GKUK”) and Instituto de Gamma Knife del Pacifico S.A.C. (“GKPeru”), and the 70% majority owned subsidiary EWRS, LLC (“EWRS”) for the purpose of providing similar Gamma Knife services in England, Peru and Turkey, respectively. The remaining 30% of EWRS is owned by EMKA, Ltd, a wholly owned U.S. subsidiary of Ozyurek, A.S., a Turkish company which is a distributor of Gamma Knife and other equipment in Turkey. EWRS owns 100% of EWRS Tibbi Cihazlar Ticaret Ltd Sti (“EWRS Turkey”). GKF also owns a 51% interest in Albuquerque GK Equipment, LLC (“AGKE”) and Jacksonville GK Equipment, LLC (“JGKE”). The remaining 49% in each of these companies is owned by various physician groups.

 

Gamma Knife revenue accounted for 95% of the Company’s revenue in 2011. The Company also provides Image Guided Radiation Therapy (“IGRT”) and related equipment to two medical centers located in Massachusetts and Turkey which accounted for 5% of the Company’s revenue in 2011.

 

In April 2006, the Company invested $2,000,000 for a minority equity interest in Mevion Medical Systems, Inc. (formerly Still River Systems, Inc.) (“Mevion”), a development-stage company based in Littleton, Massachusetts which, in collaboration with scientists from MIT’s Plasma Science and Fusion Center, is developing a medical device for the treatment of cancer patients using proton beam radiation therapy (“PBRT”). In September 2007 and December 2011 the Company invested approximately $617,000 and $70,000, respectively, for additional equity interests in Mevion. The Company has deposited an additional $2,500,000 towards the purchase of three Mevion S250 (“Mevion S250”) PBRT systems from Mevion for anticipated delivery beginning in 2013. Mevion has received Conformite Europeene Mark (“CE Mark”) certification for the Mevion S250 PBRT system, which allows Mevion to market, sell and install the system in the European Union and in any country recognizing CE Mark approval. Mevion has filed a 510(k) application for marketing clearance with the U.S. Food and Drug Administration (“ FDA”).

 

The Company is also seeking to expand its financing model to the supply of multi-room PBRT systems to major medical centers in the United States and abroad. This effort remains in the development stage and no significant revenues are expected in the next two years.

 

The Company continues to develop its design and business model for “The Operating Room for the 21 st Century” â (“OR21” â ). OR21 is not expected to generate significant revenue within the next twelve months.

 

The Company was incorporated in the State of California in 1983 and its predecessor, Ernest A. Bates, M.D., Ltd. (d/b/a American Shared Hospital Services), a California limited partnership, was formed in June 1980.

 

3
 

 

OPERATIONS

 

Gamma Knife Operations

 

Gamma Knife stereotactic radiosurgery, a non-invasive procedure, is an alternative to conventional brain surgery or can be an adjunct to conventional brain surgery. Compared to conventional surgery, Gamma Knife radiosurgery usually involves shorter patient hospitalization, lower risk of complications and can be provided at a lower cost. Typically, Gamma Knife patients resume their pre-surgical activities one or two days after treatment. The Gamma Knife treats patients with 201 single doses of gamma rays that are focused with great precision on small and medium size, well circumscribed and critically located structures in the brain. During 2006 Elekta introduced a new Gamma Knife model, the Perfexion™ unit (“Perfexion”), which treats patients with 192 single doses of gamma rays and will also provide the ability to perform procedures on areas of the upper cervical spine. The Gamma Knife delivers a concentrated dose of gamma rays from Cobalt-60 sources housed in the Gamma Knife. The Cobalt-60 sources converge at the target area and deliver a dose that is high enough to destroy the diseased tissue without damaging surrounding healthy tissue.

 

The Gamma Knife treats selected malignant and benign brain tumors, arteriovenous malformations, and functional disorders including trigeminal neuralgia (facial pain). Research is being conducted to determine whether the Gamma Knife can be effective in the treatment of epilepsy and other functional disorders.

 

As of December 31, 2011, there were approximately 126 Gamma Knife sites in the United States and more than 320 units in operation worldwide. Based on the most recent available data, an estimated percentage breakdown of Gamma Knife procedures performed in the U.S. by indications treated is as follows: malignant (44%) and benign (35%) brain tumors, vascular disorders (13%), and functional disorders (8%).

 

The Company, as of March 1, 2012, has nineteen (19) Gamma Knife units located at eighteen (18) sites in the United States and one site in Turkey. The Company’s first Gamma Knife commenced operation in September 1991. The Company’s Gamma Knife units performed approximately 2,000 procedures in 2011 for a cumulative total of approximately 26,400 procedures through December 31, 2011.

 

Revenue from Gamma Knife services for the Company during each of the last five (5) years ended December 31, and the percentage of total revenue of the Company represented by the Gamma Knife for each of the last five years, are set forth below:

 

Year Ended     Total Gamma Knife     Gamma Knife % of  
December 31,     Revenue (in thousands)     Total Revenue  
  2011     $ 21,077 (1)     94.9 %
  2010     $ 15,600       93.6 %
  2009     $ 15,505       92.5 %
  2008     $ 17,713       92.7 %
  2007     $ 22,056 (1)     97.5 %

 

(1) includes $4,984,000 in 2011 and $3,200,000 in 2007 of equipment sales revenue from the sale of Gamma Knife systems to existing Gamma Knife customers at the end of the contract term.

 

The Company conducts its Gamma Knife business through its 81% indirect interest in GKF. The remaining 19% interest is indirectly owned by Elekta. GKF, formed in October 1995, is managed by its policy committee. The policy committee is composed of one representative from the Company, Ernest A. Bates, M.D., ASHS’s Chairman and CEO, and one representative from Elekta. The policy committee sets the operating policy for GKF. The policy committee may act only with the unanimous approval of both of its members. The policy committee selects a manager to handle GKF’s daily operations. Craig K. Tagawa, Chief Executive Officer of GKF and Chief Operating and Financial Officer of ASHS, serves as GKF’s manager.

 

GKF’s profits and/or losses and any cash distributions are allocated based on membership interests. GKF’s operating agreement requires that it have a cash reserve of at least $50,000 before cash distributions are made to its members. From inception to December 31, 2011, GKF has distributed $36,450,000 to the Company and $8,550,000 to the non-controlling member.

 

4
 

 

Image Guided Radiation Therapy Operations

 

The Company’s radiation therapy business currently consists of one IGRT system that began operation in September 2007, and another that began operation in December 2011, both at existing Gamma Knife customer sites. Revenue generated under IGRT services accounted for approximately 5% of the Company’s total revenue in 2011.

 

IGRT technology integrates imaging and detection components into a state-of-the-art linear accelerator, allowing clinicians to plan treatment, verify positioning, and deliver treatment with a single device, providing faster, more effective radiation therapy with less damage to healthy tissue.  IGRT captures cone beam imaging, fluoroscopic and/or x-ray images on a daily basis, creating three-dimensional images that pinpoint the exact size, location and coordinates of tumors. Once tumors are pinpointed, the system delivers ultra-precise doses of radiation which ultimately leads to improved patient outcomes.

 

Based on the most recently available information, there are approximately 4,000 linear accelerator based radiation therapy units installed in the United States, and it is estimated that a majority of these units provide IMRT, IGRT or a combination of this advanced radiation therapy capability. Radiation therapy services are provided through approximately 2,200 hospital based and free-standing oncology centers.

 

Additional information on our operations can be found in Item 6–“Selected Financial Data”, Item 7–“Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Note 1 of our consolidated financial statements beginning on page A-8 of this report.

 

CUSTOMERS

 

The Company’s current business is the outsourcing of stereotactic radiosurgery services and radiation therapy services. The Company typically provides the equipment, as well as planning, installation, reimbursement and marketing support services. The majority of the Company’s customers pay the Company on a fee per use basis. The market for these services primarily consists of major urban medical centers. The business is capital intensive; the total cost of a Gamma Knife or IGRT facility usually ranges from $3 million to $5.5 million, including equipment, site construction and installation. The Company pays for the equipment and the medical center generally pays for site and installation costs. The following is a listing of the Company’s sites as of March 1, 2012:

 

Customers (Gamma Knife except as noted)   Original Term of Contract   Year Contract Began   Basis of Payment
             
Southwest Texas Methodist Hospital   10 years   1998   Fee per use
San Antonio, Texas            
Yale New Haven Hospital   10 years   1998   Fee per use
New Haven, Connecticut            
Kettering Medical Center   10 years   1999   Revenue sharing
Kettering, Ohio            
Tufts Medical Center   10 years   1999   Fee per use
Boston, Massachusetts            
University of Arkansas for Medical Sciences   15 years   1999   Revenue sharing
Little Rock, Arkansas            
Froedtert Memorial Lutheran Hospital   10 years   1999   Fee per use
Milwaukee, Wisconsin            
JFK Medical Center   10 years   2000   Fee per use
Edison, New Jersey            
Sunrise Hospital and Medical Center   10 years   2001   Fee per use
Las Vegas, Nevada            
Central Mississippi Medical Center   10 years   2001   Fee per use
Jackson, Mississippi            

 

5
 

 

OSF Saint Francis Medical Center   10 years   2001   Fee per use
Peoria, Illinois            
Bayfront Medical Center   10 years   2002   Fee per use
St. Petersburg, Florida            
Mercy Medical Center   10 years   2002   Fee per use
Rockville Centre, New York            
Albuquerque Regional Medical Center   10 years   2003   Fee per use
Albuquerque, New Mexico            
Northern Westchester Hospital   10 years   2005   Fee per use
Mt. Kisco, New York            
Mercy Health Center   10 years   2005   Revenue Sharing
Oklahoma City, Oklahoma            
Tufts Medical Center  (IGRT)   10 years   2007   Revenue Sharing
Boston, Massachusetts            
USC University Hospital   10 years   2008   Fee per use
Los Angeles, California            
Ft. Sanders Regional Medical Center   10 years   2011   Revenue Sharing
Knoxville, Tennessee            
St. Vincent’s Medical Center   10 years   2011   Revenue Sharing
Jacksonville, Florida            
Baskent University Application and Research Center (Gamma Knife and IGRT)   5 years   2011   Revenue Sharing
Adana, Turkey            

 

The Company’s fee per use agreement is typically for a ten year term. The fixed fee per use reimbursement amount that the Company receives from the customer is based on the Company’s cost to provide the service and the anticipated volume of the customer. The Gamma Knife contracts signed by the Company typically call for a fee ranging from $7,500 to $9,500 per procedure. There are no minimum volume guarantees required of the customer. Typically, GKF is responsible for providing the Gamma Knife and related ongoing Gamma Knife equipment expenses (i.e., personal property taxes, insurance, and equipment maintenance) and also helps fund the customer’s Gamma Knife marketing. The customer generally is obligated to pay site and installation costs and the costs of operating the Gamma Knife. The customer can either renew the agreement or terminate the agreement at the end of the contractual term. If the customer chooses to terminate the agreement, then GKF removes the equipment from the medical center for possible placement at another site.

 

The Company’s revenue sharing agreements (“retail”) are for a period of ten to fifteen years. Instead of receiving a fixed fee, the Company receives all or a percentage of the reimbursement (exclusive of physician fees) received by the customer. The Company is at risk for any reimbursement rate changes for radiosurgery or radiation therapy services by the government or other third party payors. Other than one site, there are no minimum volume guarantees required of the customer.

 

In 2011, one customer accounted for approximately 25% of the Company’s total revenue. Included in total revenue was $4,984,000 in equipment sales revenue to this customer whose contract ended. Excluding this transaction, there were two customers who accounted for approximately 13% and 11% of revenue. In 2010, one customer accounted for approximately 13% of the Company’s total revenue. In 2009, two customers accounted for approximately 14% and 10% each of the Company’s total revenue.

 

6
 

 

MARKETING

 

The Company markets its services through its preferred provider status with Elekta and a direct sales effort led by its Vice President of Sales and Business Development and its Chief Operating Officer. The major advantages to a health care provider in contracting with the Company for Gamma Knife services include:

 

§ The medical center avoids the high cost of owning the equipment. By not acquiring the Gamma Knife unit or other medical equipment, the medical center is able to allocate the funds otherwise required to purchase and/or finance the Gamma Knife to other projects.

 

§ The medical center avoids the risk of equipment under-utilization. The Company does not have minimum volume requirements. The medical center pays the Company only for each procedure performed on a patient.

 

§ The medical center transfers the risk of technological obsolescence to the Company. The medical center and its physicians are not under any obligation to utilize technologically obsolete equipment.

 

§ The Company provides planning, installation, operating and marketing assistance and support to its customers.

 

FINANCING

 

The Company’s U.S. IGRT site is owned by ASHS and is financed at approximately 100% of the total project cost, under a loan that fully amortizes over an 84-month period and is fully collateralized by the equipment, the customer contract and accounts receivable.

 

The Company’s Gamma Knife business is operated through GKF. GKF generally finances its U.S. Gamma Knife units, upgrades and additions with loans or capital leases from various finance companies for 100% of the cost of each Gamma Knife, plus any sales tax, customs and duties. GKF’s international operations are financed at approximately 85% of the cost of the equipment. The financing is predominantly fully amortized over an 84-month period and is collateralized by the equipment, customer contracts and accounts receivable, and is generally without recourse to the Company and Elekta.

 

COMPETITION

 

Conventional neurosurgery and radiation therapy are the primary competitors of Gamma Knife radiosurgery. Gamma Knife radiosurgery has gained acceptance as an alternative and/or adjunct to conventional surgery due to its more favorable morbidity outcomes for certain procedures as well as its non-invasiveness. Utilization of the Company’s Gamma Knife units is contingent on the acceptance of Gamma Knife radiosurgery by the customer’s neurosurgeons, radiation oncologists and referring physicians. In addition, the utilization of the Company’s Gamma Knife units is impacted by the proximity of competing Gamma Knife centers and providers using other radiosurgery devices.

 

The Company’s ability to secure additional customers for Gamma Knife services and other radiosurgery and radiation therapy services is dependent on its ability to effectively compete against (i) Elekta, the manufacturer of the Gamma Knife, (ii) manufacturers of other radiosurgery and radiation therapy devices, and (iii) other companies that outsource these services. The Company does not have an exclusive relationship with Elekta or other manufacturers and has previously lost sales to customers that chose to purchase equipment directly from manufacturers. The Company may continue to lose future sales to such customers and may also lose sales to the Company’s competitors.

 

GOVERNMENT PROGRAMS

 

The Medicare program is administered by the Centers for Medicare and Medicaid Services (“CMS”) of the U.S. Department of Health and Human Services (“DHHS”). Medicare is a health insurance program primarily for individuals 65 years of age and older, certain younger people with disabilities, and people with end-stage renal disease, and is provided without regard to income or assets.

 

7
 

 

The Medicare program is subject to statutory and regulatory changes, administrative rulings, interpretations and determinations, requirements for utilization review, and federal and state funding restrictions, all of which could materially increase or decrease payments from these government programs in the future, as well as affect the cost of providing services to patients and the timing of payments to our client hospitals.

 

The Company’s Gamma Knife and radiation therapy customers receive payments for patient care from federal government and private insurer reimbursement programs. Currently in the United States, Gamma Knife services are performed primarily on an out-patient basis. Gamma Knife patients with Medicare as their primary insurer, treated on either an in-patient or out-patient basis, comprise an estimated 30-40% of the total Gamma Knife patients treated nationwide. Radiation therapy patients with Medicare as their primary insurer are treated primarily on an out-patient basis, and comprise an estimated 45% to 50% of the total radiation therapy patients treated. The Company estimates that its percentage of patients with Medicare as their primary insurer approximates these national averages.

 

A Prospective Payment System ("PPS") is utilized to reimburse hospitals for care given to hospital in-patients covered by federally funded reimbursement programs. Patients are classified into a Diagnosis Related Group ("DRG") in accordance with the patient's diagnosis, necessary medical procedures and other factors. Patient reimbursement is limited to a predetermined amount for each DRG. The reimbursement payment may not necessarily cover the cost of all medical services actually provided because the payment is predetermined. Effective October 1, 1997, Gamma Knife services for Medicare hospital in-patients are reimbursed under various DRG codes.

 

In 1986 and again in 1990, Congress enacted legislation requiring the DHHS to develop proposals for a PPS for Medicare out-patient services. DHHS proposed a new payment system, Ambulatory Payment Classifications (“APC”), which affects all out-patient services performed in a hospital based facility. APC implementation took place in the third quarter of 2000.

 

The APC consists of 346 clinically homogenous classifications or groupings of codes that are typically used in out-patient billing. Out-patient services are bundled with fixed rates of payment determined according to specific regional and national factors, similar to that of the in-patient PPS.

 

The Gamma Knife APC rate is modified periodically but the total reimbursement amount has historically remained fairly constant. Effective January 1, 2012, total Gamma Knife reimbursement based on all commonly used billing codes will have a decrease of approximately 2% (to approximately $9,308) compared to 2011. This follows a 4% increase in 2011, a 3% decrease in 2010 and a 5% decrease in 2009 compared to the prior years, respectively. The Company has five Gamma Knife contracts from which its revenue is directly affected by changes in payment rates under the APC system.

 

IGRT is a relatively new service to radiation oncology. The 2005 through 2007 APC payment rates averaged approximately $80 for each of five procedure codes. In 2008 DHHS determined that these services were to be packaged into other services. As a result, there are currently no specific outpatient payment rates for IGRT, and reimbursement is made through various packaged codes. However, standard radiation therapy services are reimbursed by CMS and other third party payors.

 

We are unable to predict the effect of future government health care funding policy changes on operations. If the rates paid by governmental payers are reduced, if the scope of services covered by governmental payers is limited, or if one or more of our hospital clients are excluded from participation in the Medicare program or any other government health care program, there could be a material adverse effect on our business.

 

Affordable Care Act

In March 2010, President Obama signed the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, (“Affordable Care Act”) into law, which will result in significant changes to the health care industry. The primary goal of the legislation is to extend health care coverage to approximately 32 million uninsured legal U.S. residents through both an expansion of public programs and reforms to private sector health insurance. The expansion of insurance coverage is expected to be funded in part by measures designed to promote quality and cost efficiency in health care delivery and by budgetary savings in the Medicare and Medicaid programs. Because the Company is not a health care provider, we are not directly affected by the law, but we could be indirectly affected principally as follows:

· An increase in the number of insured residents could potentially increase the number of patients seeking Gamma Knife or radiation therapy treatment.
     
8
 

 

· The Company’s retail contracts are subject to reimbursement rate changes for radiosurgery or radiation therapy services by the government or other third party payors. Any changes to Medicare or Medicaid reimbursement through the implementation of the Affordable Care Act could affect revenue generated from these sites.

 

We are unable to predict with certainty the full impact of the Affordable Care Act on our future revenues and operations at this time due to the law’s complexity, the limited amount of guidance available, pending court challenges and possible amendments.

 

GOVERNMENT REGULATION

 

The payment of remuneration to induce the referral of health care business has been a subject of increasing governmental and regulatory focus in recent years. Section 1128B(b) of the Social Security Act (sometimes referred to as the "federal anti-kickback statute") provides criminal penalties for individuals or entities that offer, pay, solicit or receive remuneration in order to induce referrals for items or services for which payment may be made under the Medicare and Medicaid programs and certain other government funded programs. The Affordable Care Act amended the anti-kickback statute to eliminate the requirement of actual knowledge, or specific intent to commit a violation, of the anti-kickback statute. The Social Security Act provides authority to the Office of Inspector General through civil proceedings to exclude an individual or entity from participation in the Medicare and state health programs if it is determined any such party has violated Section 1128B(b) of the Social Security Act. The Company believes that it is in compliance with the federal anti-kickback statute. Additionally, the Omnibus Budget Reconciliation Act of 1993, often referred to as "Stark II", bans physician self-referrals to providers of designated health services with which the physician has a financial relationship. On September 5, 2007, the third and final phase of the Stark regulations (Phase III) was published. The term "designated health services" includes, among others, radiation therapy services and in-patient and out-patient hospital services. On January 1, 1995, the Physician Ownership and Referral Act of 1993 became effective in California. This legislation prohibits physician self-referrals for covered goods and services, including radiation oncology, if the physician (or the physician's immediate family) concurrently has a financial interest in the entity receiving the referral. The Company believes that it is in compliance with these rules and regulations.

 

On August 19, 2008, the CMS published a final rule relating to inpatient hospital services paid under the Inpatient Prospective Payment System for discharges in the Fiscal Year 2009 (the “Final Rule”). Among other things, the Final Rule prohibits “per-click payments” to certain physician lessors for services rendered to patients who were referred by the physician lessor. This prohibition on per-click payments for leased equipment used in the treatment of a patient referred to a hospital lessee by a physician lessor applies regardless of whether the physician himself or herself is the lessor or whether the lessor is an entity in which the referring physician has an ownership or investment interest. The effective date of this prohibition was October 1, 2009. However, referrals made by a radiation oncologist for radiation therapy or ancillary services necessary for, and integral to, the provision of radiation therapy (such as Gamma Knife services) are not subject to this prohibition so long as certain conditions are met. GK Financing’s majority owned subsidiaries, Albuquerque GK Equipment, LLC (“AGKE”) and Jacksonville GK Equipment, LLC (“JGKE”) have minority ownership interests that are held solely by radiation oncologists, who are otherwise exempt from the referral prohibition under the Final Rule. The Company believes it is in compliance with the Final Rule.

 

A range of federal civil and criminal laws target false claims and fraudulent billing activities. One of the most significant is the Federal False Claims Act, which prohibits the submission of a false claim or the making of a false record or statement in order to secure a reimbursement from a government-sponsored program. In recent years, the federal government has launched several initiatives aimed at uncovering practices which violate false claims or fraudulent billing laws. Claims under these laws may be brought either by the government or by private individuals on behalf of the government, through a "whistleblower" or "qui tam" action. The Company believes that it is in compliance with the Federal False Claims Act; however, because such actions are filed under seal and may remain secret for years, there can be no assurance that the Company or one of its affiliates is not named in a material qui tam action.

 

9
 

 

Legislation in various jurisdictions requires that health facilities obtain a Certificate of Need ("CON") prior to making expenditures for medical technology in excess of specified amounts. Four of the Company’s existing customers were required to obtain a CON or its equivalent. The CON procedure can be expensive and time consuming and may impact the length of time before Gamma Knife services commence. CON requirements vary from state to state in their application to the operations of both the Company and its customers. In some jurisdictions the Company is required to comply with CON procedures to provide its services and in other jurisdictions customers must comply with CON procedures before using the Company's services. The Company is unable to predict if any jurisdiction will eliminate or alter its CON requirements in a manner that will increase competition and, thereby, affect the Company's competitive position.

 

The Company's Gamma Knife units contain Cobalt 60 radioactive sources. The medical centers that house the Company's Gamma Knife units are responsible for obtaining possession and user's licenses for the Cobalt 60 source from the Nuclear Regulatory Commission.

 

Standard linear accelerator equipment utilized to treat patients is regulated by the FDA. The licensing is obtained by the individual medical center operating the equipment.

 

The Company believes it is in substantial compliance with the various rules and regulations that affect its businesses.

 

INSURANCE AND INDEMNIFICATION

 

The Company's contracts with equipment vendors generally do not contain indemnification provisions. The Company maintains a comprehensive insurance program covering the value of its property and equipment, subject to deductibles, which the Company believes are reasonable.

 

The Company's customer contracts generally contain mutual indemnification provisions. The Company maintains general and professional liability insurance. The Company is not involved in the practice of medicine and therefore believes its present insurance coverage and indemnification agreements are adequate for its business.

 

PROTON BEAM RADIATION THERAPY BUSINESS

 

PBRT is an alternative to traditional external beam, photon based radiation delivered by linear accelerators. PBRT, first clinically introduced in the 1950s, has physics advantages compared to photon based systems which allow PBRT to deliver higher radiation doses to the tumor with less radiation to healthy tissue. PBRT currently treats prostate, eye, cranial-spinal, head and neck, lung, liver and breast tumors. In excess of 80,000 patients have been treated with protons worldwide.

 

Introduction of PBRT in the United States, until recently, has been limited due to lack of adequate reimbursement and the high capital costs of these projects. The Company believes that the current development of one and two treatment room PBRT systems at lower capital costs, and the recent implementation of reimbursement rates for PBRT from the CMS will help make this technology available to a larger segment of the market.

 

There are several competing manufacturers of proton beam systems, including Mevion, IBA Particle Therapy Inc., Hitachi Ltd., Optivus Proton Therapy Inc., Varian Medical Systems, Inc. (Accel), Sumitomo Heavy Industries and Mitsubishi Electric. The Company has invested in Mevion and has made deposits towards the purchase of three of the Mevion S250 systems. The Mevion system potentially provides cancer centers the opportunity to introduce single treatment room PBRT services with cost in the range of approximately $20 to $25 million rather than four and five PBRT treatment room programs costing in excess of $120 million. The Mevion system is not yet FDA approved and there can be no assurance that it will be approved.

 

The Company believes the business model it has developed for use in its Gamma Knife and radiation therapy businesses can be tailored for the PBRT market segment. The Company is targeting large, hospital based cancer programs. The Company’s ability to develop a successful PBRT financing entity depends on the decision of cancer centers to self fund or to fund the PBRT through conventional financing vehicles, the Company’s ability to capture market share from competing alternative PBRT financing entities, and the Company’s ability to raise capital to fund PBRT projects.

 

10
 

 

EMPLOYEES

 

At December 31, 2011, the Company employed nine (9) people on a full-time basis. None of these employees is subject to a collective bargaining agreement and there is no union representation within the Company. The Company maintains various employee benefit plans and believes that its employee relations are good.

 

EXECUTIVE OFFICERS OF THE COMPANY

 

The following table provides current information concerning those persons who serve as executive officers of the Company. The executive officers were appointed by the Board of Directors and serve at the discretion of the Board of Directors.

 

Name:   Age:   Position:
Ernest A. Bates, M.D.   75   Chairman of the Board of Directors and Chief Executive Officer
         
Craig K. Tagawa   58   Senior Vice President - Chief Operating and Financial Officer
         
Ernest R. Bates   45   Vice President of Sales and Business Development

 

Ernest A. Bates, M.D., founder of the Company, has served in the positions listed above since the incorporation of the Company.  A board-certified neurosurgeon, Dr. Bates is Emeritus Vice Chairman of the Board of Trustees of the Johns Hopkins University and serves on the Board of Visitors of the Johns Hopkins Medical Center and the Johns Hopkins Neurosurgery Advisory Board.  He serves on the boards of the University of Rochester and FasterCures.  Dr. Bates was appointed to the California Commission for Jobs and Economic Growth and the Magistrate Judge Merit Selection Panel. From 1981-1987 he was a member of the Board of Governors of the California Community Colleges, and he served on the California High Speed Rail Authority from 1997 to 2003.  Dr. Bates is a member of the Board of Overseers at the University of California, San Francisco, School of Nursing.  Dr. Bates is a Partner in Black Coyote Chateau Wines, LLC.  He is a graduate of the School of Arts and Sciences of the Johns Hopkins University, and he earned his medical degree at the University of Rochester School of Medicine and Dentistry.

 

Craig K. Tagawa has served as Chief Operating Officer since February 1999 in addition to serving as Chief Financial Officer since May 1996. Mr. Tagawa also served as Chief Financial Officer from January 1992 through October 1995. Previously a Vice President in such capacity, Mr. Tagawa became a Senior Vice President on February 28, 1993. He is also the Chief Executive Officer of GKF. From September 1988 through January 1992, Mr. Tagawa served in various positions with the Company. He is a former Chair of the Industrial Policy Advisory Committee of the Engineering Research Center for Computer-Integrated Surgical Systems and Technology at The Johns Hopkins University. He received his undergraduate degree from the University of California at Berkeley and his M.B.A. from Cornell University.

 

Ernest R. Bates joined the Company in January 2007 as Vice President of Sales and Business Development. He was on the Board of Directors of the Company from 2004 through February 2007. Prior to joining the Company, he had been Managing Director, Institutional Fixed Income Sales of HSBC Securities (USA), Inc. since 2003. Mr. Bates has also served as Managing Director, Head of Asian Product for HSBC Securities (USA) Inc. from 1999 to 2003. From 1993 through 1999, Mr. Bates held various positions with Merrill Lynch, last serving as Vice President, European Syndicate for Merrill Lynch International. He received his undergraduate degree from Brown University and a M.B.A. degree from The Wharton Business School. Ernest R. Bates is the son of Chairman of the Board and Chief Executive Officer Dr. Ernest A. Bates.

 

AVAILABLE INFORMATION

 

Our Internet address is www.ashs.com . We make available free of charge, through our Internet website under the “Investor Center” tab in the “Corporate” section, our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (“Exchange Act”) as soon as reasonably practicable after such material is electronically filed with or furnished to the SEC. The information contained on our Internet website is not part of this document.

 

11
 

 

ITEM 1A.

 

RISK FACTORS

 

In addition to the other information in this report, the following factors could affect our future business, results of operations, cash flows or financial position, and could cause future results to differ materially from those expressed in any of the forward-looking statements contained in this report.

 

The Company’s Capital Investment at Each Site is Substantial

Each radiosurgical or radiation therapy device requires a substantial capital investment. In some cases, we contribute additional funds for capital costs and/or annual operating and equipment related costs such as marketing, maintenance, insurance and property taxes. Due to the structure of our contracts with medical centers, there can be no assurance that these costs will be fully recovered or that we will earn a satisfactory return on our investment.

 

The Market for the Gamma Knife is Limited

There is a limited market for the Gamma Knife, and the market in the United States may be mature. The Company has begun operation at only six new Gamma Knife sites in the United States since 2004. Due to the substantial costs of acquiring a Gamma Knife unit, we must identify medical centers that possess neurosurgery and radiation oncology departments capable of performing a large number of Gamma Knife procedures. As of December 31, 2011, there were approximately 126 operating Gamma Knife units in the United States, of which 18 units were owned by us. There are more than 320 units in operation worldwide, and the Company owned one operational international unit as of December 31, 2011. There can be no assurance that we will be successful in placing additional units at any sites in the future. The Company’s existing contracts with its customers are fixed in length and there can be no assurance that the customers will wish to extend the contract beyond the end of the term.

 

The Company Has a High Level of Debt

The Company’s business is capital intensive. The Company finances an IGRT system through ASHS and its Gamma Knife units and another IGRT system through its GKF subsidiary. The amounts financed through GKF have been generally non-recourse to ASHS. The Company’s combined long term debt and present value of capital leases totals $35,751,000 as of December 31, 2011 and is collateralized by the Gamma Knife and IGRT equipment and other assets, including accounts receivable and future proceeds from any contract between the Company and any end user of the financed equipment. This high level of debt may adversely affect the Company’s ability to secure additional credit in the future, and as a result may affect operations and profitability. If default on debt occurs in the future, the Company’s creditors would have the ability to accelerate the defaulted loan, to seize the Gamma Knife unit or other equipment with respect to which default has occurred, and to apply any collateral they may have at the time to cure the default. The Company also has a line of credit with a bank, against which it has drawn $7,850,000 as of December 31, 2011.

 

A Small Number of Customers Account for a Major Portion of our Revenues

A limited number of customers have historically accounted for a substantial portion of the Company’s total revenue, and the Company expects such customer concentration to continue for the foreseeable future. For example, in 2011, one customer accounted for approximately 25% of the Company’s total revenue because of an equipment sale to the customer upon the end of the contract. However, excluding this transaction, the Company had two customers who each accounted for more than 10% of the Company’s revenue, and six customers who accounted for more than 50% of the Company’s revenue during 2011. The loss of a significant customer or a significant decline in the business from the Company’s largest customers could have a material adverse effect on the Company’s business and results of operations.

 

The Market for the Company’s Services is Competitive

The Company estimates that there are three other companies that actively provide alternative, non-conventional Gamma Knife financing to potential customers. We believe there are no competitor companies that currently have more than six Gamma Knife units in operation. The Company’s relationship with Elekta, the manufacturer of the Leksell Gamma Knife unit, is non-exclusive, and in the past the Company has lost sales to customers that chose to purchase a Gamma Knife unit directly from Elekta. In addition, the Company may continue to lose future sales to such customers and may also lose future sales to its competitors. There can be no assurance that the Company will be able to successfully compete against others in placing future units.

 

12
 

 

There are Alternatives to the Gamma Knife

Other radiosurgery devices and conventional neurosurgery compete against the Gamma Knife. Each of the medical centers targeted by the Company could decide to acquire another radiosurgery device instead of a Gamma Knife. In addition, neurosurgeons who are primarily responsible for referring patients for Gamma Knife surgery may not be willing to make such referrals for various reasons, instead opting for invasive surgery. There can be no assurance that the Company will be able to secure a sufficient number of future sites or Gamma Knife procedures to sustain its profitability and growth.

 

International Operations

The Company has made an effort to expand its operations internationally and has active or projected operations in Turkey, Peru and Brazil. International operations can be subject to exchange rate volatility which could have an adverse effect on our financial results and cash flows. In addition, international operations can be subject to legal and regulatory uncertainty and political and economic instability, which could result in problems asserting property or contractual rights, potential tariffs, increased compliance costs, increased regulatory scrutiny, potential adverse tax consequences, the inability to repatriate funds to the United States, and the Company’s inability to operate in those locations.

 

The Company’s Revenue Could Decline if Federal Reimbursement Rates are Lowered

The amount reimbursed to medical centers for each Gamma Knife or radiation therapy treatment may decline in the future. The reimbursement decrease may come from federally mandated programs (i.e., Medicare and Medicaid) or other third party payor groups. Thirteen of the Company’s nineteen existing contracts in the United States are reimbursed by the medical center to the Company on a fee per use basis. The primary risk under this type of contract is that the actual volume of procedures could be less than projected. However, a significant reimbursement rate reduction may result in the Company restructuring certain of its existing contracts. There are also six contracts in the United States where the Company receives revenue based directly on the amount of reimbursement received for procedures performed. Revenue under those contracts and any future contracts with revenue based directly on reimbursement amounts will be impacted by any reimbursement rate change. Some of the Company’s future contracts for Gamma Knife services may have revenue based on such reimbursement rates instead of a fee per use basis. There can be no assurance that future changes in healthcare regulations and reimbursement rates will not directly or indirectly adversely affect the Company’s Gamma Knife revenue.

 

New Technology and Products Could Result in Equipment Obsolescence

There is constant change and innovation in the market for highly sophisticated medical equipment. New and improved medical equipment can be introduced that could make the Gamma Knife technology obsolete and that would make it uneconomical to operate. During 2000, Elekta introduced an upgraded Gamma Knife which cost approximately $3.6 million plus applicable tax and duties. This upgrade includes an Automatic Positioning System™ (“APS”), and therefore involves less health care provider intervention. In early 2005, Elekta introduced a new upgrade, the Gamma Knife Model 4C (“Model 4C”). The cost to upgrade existing units to the Model 4C with APS is estimated to be approximately $200,000 to $1,000,000, depending on the current Gamma Knife configuration. In 2006 Elekta introduced a new model of the Gamma Knife, the Perfexion, which costs approximately $4.5 million plus applicable taxes and duties. The Perfexion can perform procedures faster than previous Gamma Knife models and it provides the additional ability to perform procedures on areas of the cervical spine. Existing models of the Gamma Knife are not upgradeable to the Perfexion model. As of March 1, 2012, ten of the Company’s Gamma Knife units are Perfexion models; of the Company’s remaining Gamma Knife units, five are Model 4C with APS and four are upgradeable to more advanced Model 4C units. The failure to acquire or use new technology and products could have a material adverse effect on our business and results of operations.

 

In addition, there are constant advances made in radiation therapy equipment. The Company purchased IGRT and CT Simulator systems in 2006 with a list price of approximately $8,300,000. As in the Gamma Knife business, new and improved IGRT equipment can be introduced that could make the existing technology obsolete and that would make it uneconomical to operate.

 

13
 

 

The Company Has Invested in a Proton Beam Business that is Developmental and Unproven

We have committed a substantial amount of our financial resources to next-generation proton beam technology. The PBRT system being developed by Mevion is not commercially proven and cannot be reimbursed by most major insurors prior to FDA approval, which may not be obtained. Prior to that time, we must make progress payments of $6,500,000 for three Mevion S250 systems (the Company has already made deposits of $2,500,000 towards this commitment). There can be no assurance that we will recover this investment or future investments, or our $2,656,000 minority investment in Mevion. Our current belief is that we will begin to receive revenue for PBRT systems placed and financed by us in 2014, assuming FDA approval is obtained.

 

The Trading Volume of Our Common Stock is Low

Although our common stock is listed on the NYSE Amex Exchange, our common stock has experienced low trading volume, both historically and recently. Reported average daily trading volume in our common stock for the three-month period ended December 31, 2011 was approximately 4,500 shares. There is no reason to think that a more active trading market in our common stock will develop in the future. Limited trading volume subjects our common stock to greater price volatility and may make it difficult for you to sell your shares in a quantity or at a price that is attractive to you.

 

ITEM 1B.

 

UNRESOLVED STAFF COMMENTS

 

None.

 

ITEM 2.

 

PROPERTIES

 

The Company's corporate offices are located at Four Embarcadero Center, Suite 3700, San Francisco, California, where it leases approximately 4,600 square feet for $24,355 per month with a lease expiration date in May 2016.

 

For the year ended December 31, 2011 the Company's aggregate net rental expenses for all properties and equipment were approximately $423,000.

 

ITEM 3.

 

LEGAL PROCEEDINGS

 

There are no material pending legal proceedings involving the Company or any of its property. The Company knows of no legal or administrative proceedings against the Company contemplated by governmental authorities.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

14
 

 

PART II

 

ITEM 5.

 

MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Market Information and Dividend Policy

 

The Company's common shares, no par value (the "Common Shares"), are currently traded on the NYSE Amex Exchange. At December 31, 2011, the Company had 4,611,060 issued and outstanding common shares, 577,680 common shares reserved for options, 3,500 restricted stock units issued and 25,851 restricted stock units reserved for issuance.

 

The following table sets forth the high and low closing sale prices of the Common Shares of the Company on the NYSE Amex Exchange for each full quarter for the last two fiscal years.

 

    Prices for Common Shares   
Quarter Ending   High     Low  
March 31, 2010   $ 3.04     $ 2.53  
June 30, 2010   $ 3.10     $ 2.55  
September 30, 2010   $ 3.37     $ 2.70  
December 31, 2010   $ 3.10     $ 2.75  
March 31, 2011   $ 3.69     $ 2.82  
June 30, 2011   $ 3.58     $ 3.05  
September 30, 2011   $ 3.26     $ 2.68  
December 31, 2011   $ 2.98     $ 2.44  

 

The Company estimates that there were approximately 2,200 beneficial holders of its Common Shares at December 31, 2011.

 

There were no dividends declared or paid during 2011 or 2010. Dividends had been paid by the Company from 2001 to 2007, but during 2007 the Board of Directors suspended dividends for the purpose of preserving cash for the development of its PBRT business. The Company did not pay cash dividends prior to 2001.

 

Stock Repurchase Program

 

In 1999 and 2001, the Board of Directors approved resolutions authorizing the Company to repurchase up to a total of 1,000,000 shares of its own stock on the open market from time to time at prevailing prices, and in 2008 the Board reaffirmed these authorizations. There were no shares repurchased during 2011 or 2010. In 2009 and 2008, the Company repurchased approximately 119,000 and 316,000 shares of its stock, respectively. Prior to 2008, there were no shares repurchased on the open market since the year ended December 31, 2001. A total of approximately 919,000 shares have been repurchased in the open market pursuant to these authorizations at a cost of approximately $1,927,000. As of December 31, 2011 there are approximately 81,000 shares remaining under the repurchase authorizations.

 

15
 

  

Shareholder Rights Plan

 

On March 22, 1999, the Company adopted a Shareholder Rights Plan (“Plan”). Under the Plan, the Company made a dividend distribution of one Right for each outstanding share of the Company’s common stock as of the close of business on April 1, 1999. The Rights become exercisable only if any person or group, with certain exceptions, becomes an “acquiring person” (acquires 15 percent or more of the Company’s outstanding common stock) or announces a tender or exchange offer to acquire 15 percent or more of the Company’s outstanding common stock, which may prevent a person from acquiring 15% or more of the Company’s common stock without the approval of the Board of Directors. The Company’s Board of Directors adopted the Plan to protect shareholders against a coercive or inadequate takeover offer. On March 12, 2009, the Board of Directors of the Company approved the First Amendment to its existing shareholder rights plan which, among other things, extends the final date on which the Rights are exercisable until the close of business on April 1, 2019.

 

Equity Compensation Plans

 

During 2011 no holders of options to acquire the Company’s common stock exercised their respective rights pursuant to such securities; however, 3,500 new shares of common stock were issued to the Company’s Board of Directors and Corporate Secretary from stock grants that vested in 2011. Additional information regarding our equity compensation plans is incorporated herein by reference from the 2012 Proxy Statement. Also, see Note 9-Shareholders’ Equity to the Consolidated Financial Statements.

 

16
 

 

 

 

ITEM 6.

 

SELECTED FINANCIAL DATA

 

Summary of Operations   Year Ended December 31,  
    (Amounts in thousands except per share data)  
    2011     2010     2009     2008     2007  
Revenue   $ 22,221     $ 16,675     $ 16,768     $ 19,099     $ 22,622  
Costs of revenue     14,224       9,466       9,781       10,877       13,354  
Selling and administrative expense     4,041       4,240       3,928       4,323       4,646  
Transaction costs     -       -       342       -       -  
Interest expense     2,367       2,104       2,064       2,437       1,946  
Total expenses     20,632       15,810       16,115       17,637       19,946  
Income from operations     1,589       865       653       1,462       2,676  
Interest and other income     108       107       60       404       328  
Income before income taxes     1,697       972       713       1,866       3,004  
Income tax expense     208       166       247       534       919  
Net income   $ 1,489     $ 806     $ 466     $ 1,332     $ 2,085  
Less net income attributable to non-controlling interest     (983 )     (749 )     (654 )     (855 )     (1,134 )
Net (loss) income attributable to ASHS   $ 506     $ 57     $ (188 )   $ 477     $ 951  
                                         
Net (loss) income per common share attributable to ASHS:                                        
Basic   $ 0.11     $ 0.01     $ (0.04 )   $ 0.10     $ 0.19  
Assuming dilution   $ 0.11     $ 0.01     $ (0.04 )   $ 0.10     $ 0.19  
Cash dividend declared per common share   $ 0.0000     $ 0.0000     $ 0.0000     $ 0.0000     $ 0.0950  
Dividend payout ratio (paid and declared)     -       -       -       -       0.50  

See accompanying note (1)

 

Balance Sheet Data   As of December 31,  
    (Amounts in thousands)  
    2011     2010     2009     2008     2007  
Cash and cash equivalents   $ 2,580     $ 1,438     $ 833     $ 10,286     $ 6,340  
Certificate of deposit and securities- current     9,000       9,000       9,000       -       2,605  
Restricted cash     50       50       50       50       50  
Working capital (deficit)     7,671       7,631       6,497       (205 )     747  
Securities- long-term     -       -       -       -       1,065  
Total assets     74,535       65,340       60,621       62,196       63,044  
Advances on line of credit     7,850       8,500       7,900       6,500       4,100  
Current portion of long-term debt/capital leases     7,616       6,073       6,705       7,633       8,272  
Long-term debt/capital leases, less current portion     28,135       23,170       19,069       21,053       24,004  
Shareholders' equity   $ 25,171     $ 23,044     $ 22,755     $ 22,938     $ 22,693  

See accompanying note (1)

 

(1) In 1995, the Company entered into an operating agreement granting to American Shared Radiosurgery Services (a California corporation and a wholly-owned subsidiary of the Company) an 81% ownership interest in GKF. During 2010 and 2011, GKF established new wholly-owned subsidiaries, GKUK and GKPeru and majority owned subsidiaries, EWRS, EWRS Turkey, AGKE, and JGKE. ASHS incorporated a new wholly-owned subsidiary, OR21, Inc. in 1999, and a new wholly-owned subsidiary, MedLeader.com, Inc. (“MedLeader”) in 2000. Accordingly, the financial data for the Company presented above include the results of GKF and its subsidiaries, OR21 and MedLeader for 2007 through 2011.

 

17
 

 

This financial data as of December 31, 2011, 2010 and 2009 and for the years ended December 31, 2011, 2010 and 2009 should be read in conjunction with our consolidated financial statements and the notes thereto beginning on page A-1 of this report and with Item 7–“Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

 

ITEM 7.

 

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

APPLICATION OF CRITICAL ACCOUNTING POLICIES

 

The Company’s consolidated financial statements are prepared in accordance with generally accepted accounting principles and follow general practices within the industry in which it operates. Application of these principles requires management to make estimates, assumptions and judgments that affect the amounts reported in the financial statements and accompanying notes. These estimates, assumptions and judgments are based on information available as of the date of the financial statements; accordingly, as this information changes, the financial statements could reflect different estimates, assumptions and judgments. Certain policies inherently have a greater reliance on the use of estimates, assumptions and judgments and as such have a greater possibility of producing results that could be materially different than originally reported.

 

The most significant accounting policies followed by the Company are presented in Note 2 to the consolidated financial statements. These policies along with the disclosures presented in the other financial statement notes and in this discussion and analysis, provide information on how significant assets and liabilities are valued in the financial statements and how those values are determined. Based on the valuation techniques used and the sensitivity of financial statement amounts, and the methods, assumptions and estimates underlying those amounts, management has identified the determination of the allowance for doubtful accounts, revenue recognition and the carrying value of its Mevion investment to be three areas that required the most subjective or complex judgments, and as such could be most subject to revision as new information becomes available. The following are our critical accounting policies in which management’s estimates, assumptions and judgments most directly and materially affect the financial statements:

 

Revenue Recognition

The Company has one revenue-generating activity, which consists of equipment leasing to hospitals, and includes the operation of Gamma Knife units by GKF and the operation of IGRT sites by ASHS and GKF.

 

Revenue is recognized when services have been rendered and collectability is reasonably assured, on either a fee per use or revenue sharing basis. The Company has contracts with thirteen hospitals for fee per use services and seven hospitals for retail services. Under both of these types of agreements, the hospital is responsible for billing patients and collection of fees for services performed. Revenue associated with installation of the Gamma Knife and IGRT units, if any, is a part of the negotiated lease amount and not a distinctly identifiable amount. The costs, if any, associated with installation of the units are amortized over the period of the related lease to match revenue recognition of these costs.

 

For fee per use agreements, revenue is not estimated because these contracts provide for a fixed fee per procedure, and are typically for a ten year term. Revenue is recognized at the time the procedures are performed, based on each hospital’s contracted rate. There is no guaranteed minimum payment. Costs related to operating the units are charged to costs of operations as incurred, which approximates the recognition of the related revenue. Revenue under fee per use agreements is recorded on a gross basis.

 

18
 

 

ASHS has one agreement and GKF has six agreements that are based on revenue sharing. These can be further classified as either “turn-key” arrangements or “revenue sharing” arrangements. For GKF’s four turn-key sites, GKF is solely responsible for the costs to acquire and install the Gamma Knife. In return, GKF receives payment from the hospital in the amount of its reimbursement from third party payors. Revenue is recognized by the Company during the period in which the procedure is performed, and is estimated based on what can be reasonably expected to be paid by the third party payor to the hospital. The estimate is primarily determined from historical experience and hospital contracts with third party payors. These estimates are reviewed on a regular basis and adjusted as necessary to more accurately reflect the expected payment amount. The Company also records an estimate of operating costs associated with each procedure during the period in which the procedure is performed. Costs are determined primarily based on historical treatment protocols and cost schedules with the hospital. The Company’s estimated operating costs are reviewed on a regular basis and adjusted as necessary to more accurately reflect the actual operating costs. Revenue for turn-key sites is recorded on a gross basis, and the operating expenses the Company reimburses to the hospital are recorded in other operating costs.

 

Under revenue sharing arrangements the hospital shares in the responsibility and risk with the Company for the capital investment to acquire and install the equipment. Unlike our turn-key arrangement, the lease payment under a revenue sharing arrangement is a percentage of revenue. Payments are made by the hospital, generally on a monthly basis, to the Company based on an agreed upon percentage allocation of cash collected. Revenue is recognized during the period in which procedures are performed, and is estimated based on the reimbursement amount that the Company expects to receive from the hospital for those procedures. This estimate is reviewed on a regular basis and adjusted as necessary to more accurately reflect the expected payment amount. Revenue from revenue sharing sites is recorded on a gross basis.

 

Revenue from retail arrangements amounted to approximately 28%, 35% and 35% of total revenue for the years ended December 31, 2011, 2010 and 2009, respectively. Because the revenue estimates are reviewed on a quarterly basis, any adjustments required for past revenue estimates would result in an increase or reduction in revenue during the current quarterly period.

 

Allowance for Doubtful Accounts

The allowance for doubtful accounts is estimated based on possible losses relating to the Company’s revenue sharing customers. The Company receives reimbursement from the customer based on the customer’s collections from individuals and third-party payors such as insurance companies and Medicare. Receivables are charged against the allowance in the period that they are deemed uncollectible.

 

If the Company’s net accounts receivable estimates for revenue sharing customers as of December 31, 2011 changed by as much as 10% based on actual collection information, it would have the effect of increasing or decreasing revenue by approximately $233,000.

 

Carrying Value of Mevion Investment

The Company carries its investment in Mevion at cost ($2,656,000) and reviews it for impairment on a quarterly basis, or as events or circumstances might indicate that the carrying value of the investment may not be recoverable. In assessing whether the impairment is other than temporary, we evaluate the length of time and extent to which market value has been below cost, the financial condition and near term prospects of Mevion and our ability and intent to retain our investment for a period sufficient to allow for an anticipated recovery in the market value. Mevion completed and submitted on March 1, 2012 its final application to the FDA for 510(k) clearance for the world’s first superconducting synchrocyclotron, and Mevion announced on March 14, 2012 that it had received CE Mark certification for its Mevion S250 Proton Therapy System, which allows Mevion to market, sell and install the system throughout the European Union and any country recognizing the CE Mark approval. The investment is not without certain risk, and the completion of the first unit is taking longer than originally anticipated. However, the Company believes that the current market value, which we believe to be less than cost, is a temporary situation brought on solely due to the continuing downturn of the economy, and is not a reflection on the progress or viability of Mevion or its PBRT design, and believes that our investment in Mevion is only temporarily impaired. If the Company’s view changes, it could be required to write off some or all of its investment, which would have a material negative impact on earnings in the period. For additional information, see “Impairment Analysis of Investment in Preferred Stock.”

 

GENERAL

 

For the year ended December 31, 2011, 95% of the Company’s revenue was derived from its Gamma Knife business, and 5% from its IGRT business. For the year ended December 31, 2010, 94% of the Company’s revenue was derived from its Gamma Knife business, and the remaining 6% from its IGRT business.

 

19
 

 

TOTAL REVENUE

 

(in thousands)   2011     Increase
(Decrease)
    2010     Increase
(Decrease)
    2009  
                               
Total revenue   $ 22,221       33.3 %   $ 16,675       (0.6 )%   $ 16,768  

 

Total revenue increased 33.3% in 2011 compared to 2010, primarily due to $4,984,000 of equipment sales revenue generated by the sale of a new Perfexion unit to an existing Gamma Knife customer in the third quarter of 2011 in connection with the early termination of the lease with the customer. This increase was also due to an increase of 3.2% and 6.4% in Gamma Knife and IGRT medical services revenue, respectively. Total revenue decreased in 2010 compared to 2009, primarily due to a 14.9% decrease in IGRT revenue, partially offset by a 0.6% increase in Gamma Knife medical services revenue.

 

Gamma Knife Revenue

Total Gamma Knife revenue for 2011 increased by 35.1% to $21,077,000 compared to $15,600,000 in 2010. Total Gamma Knife revenue for 2010 increased 0.6% to $15,600,000 compared to $15,505,000 in 2009. The revenue for 2011 includes $4,984,000 of equipment sales revenue, which was generated by the sale of a new Perfexion unit to an existing Gamma Knife customer in the third quarter in conjunction with the early termination of the customer lease. Revenue from this equipment sale is not considered medical services revenue, and is not included in the table below.

 

    2011     Increase
(Decrease)
    2010     Increase
(Decrease)
    2009  
                                         
Medical services revenue from Gamma Knife (in thousands)   $ 16,093       3.2 %   $ 15,600       0.6 %   $ 15,505  
                                         
Number of Gamma Knife procedures     1,954       4.8 %     1,864       4.4 %     1,785  
                                         
Average revenue per procedure   $ 8,236       (1.6 )%   $ 8,369       (3.6 )%   $ 8,686  

 

The increase in Medical services revenue in 2011 compared to 2010 was primarily due to a 4.8% increase in Gamma Knife procedures performed. The Company also replaced existing Gamma Knife units with two new Perfexion units at new sites and one Perfexion unit at an existing site, and added a new 4C Gamma Knife unit at another new site, all of which contributed to the increase in revenue. The Company also sold a Perfexion unit to an existing customer in connection with the early termination of the customer lease. The loss of medical services revenue from this site partially offset the revenue increase in 2011. The increase in 2010 compared to 2009 was primarily due to a 4.4% increase in procedure volume, particularly at sites where Perfexion units have been placed. The Company added Perfexion units to three of its current customer sites to the Perfexion unit during 2011, bringing the total number of Company sites with Perfexion units to ten at December 31, 2011. The Company had nineteen Gamma Knife units in operation at December 31, 2011, 2010 and 2009.

 

The number of Gamma Knife procedures in 2011 increased by 90 compared to 2010 primarily due a new site that began operation in the second quarter 2011 and increases in the number of procedures performed at sites where Perfexion model Gamma Knife units are installed, partially offset by the loss of procedures from one site where the Gamma Knife unit was sold to the customer. The number of Gamma Knife procedures performed in 2010 increased by 79 compared to 2009, primarily due to an increase in the number of procedures performed at sites where Perfexion model units have been installed.

 

Revenue per procedure decreased by $133 in 2011 and by $317 in 2010 compared to the prior years, respectively. For both 2011 and 2010, this is primarily due to normal variations in procedure mix between sites. For 2011 it is also partially due to lower than average contracted revenue per procedure at one of the Company’s new customer sites. The Company’s contracts generally have different procedure rates because their investment basis varies, so revenue per procedure can vary year to year depending primarily on the mix of procedures performed at certain locations.

 

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IGRT Revenue

(In thousands)   2011     Increase
(Decrease)
    2010     Increase
(Decrease)
    2009  
                               
Medical services revenue from IGRT   $ 1,144       6.4 %   $ 1,075       (14.9 )%   $ 1,263  

 

Medical services revenue from the Company’s IGRT services increased by $69,000 in 2011 compared to 2010 and decreased by $188,000 in 2010 compared to 2009. The increase in 2011 was due to increased revenue generated from the Company’s existing IGRT site, and additional revenue generated from the Company’s new site in late fourth quarter 2011. The decrease in 2010 was due to generally lower volume at the Company’s IGRT site.

 

COSTS OF REVENUE

 

(In thousands)   2011     Increase
(Decrease)
    2010     Increase
(Decrease)
    2009  
                               
Total costs of revenue   $ 14,224       50.3 %   $ 9,466       (3.2 )%   $ 9,781  
                                         
Percentage of total revenue     64.0 %             56.8 %             58.3 %

 

The Company's costs of revenue, consisting of cost of equipment sales, maintenance and supplies, depreciation and amortization, and other operating expenses (such as insurance, property taxes, sales taxes, marketing costs and operating costs from the Company’s retail sites) increased by $4,758,000 in 2011 compared to 2010 and decreased $315,000 in 2010 compared to 2009.

 

Costs of operations in 2011 included $4,146,000 in cost of equipment sales, compared to no cost of equipment sales in 2010 and 2009. Cost of equipment sales is specific to equipment sales revenue, and represents approximately 19% of total revenue in 2011.

 

The Company's maintenance and supplies costs were 7% of total revenue in 2011 and 9% of total revenue in each of the years 2010 and 2009. Maintenance and supplies costs decreased by $82,000 in 2011 compared to 2010 and increased $137,000 in 2010 compared to 2009. The decrease in 2011 compared to 2010 was due to lower costs on both the Company’s maintenance contracts and maintenance costs not covered by maintenance contracts. Several of the Company’s sites that had been upgraded to Perfexion units in 2010 and 2011 were still under warranty for periods of time in 2011 before the maintenance contracts started. The increase in 2010 compared to 2009 is primarily due to a maintenance contract that started at the Company’s IGRT site, and an increase in costs of maintenance that weren’t covered by maintenance contracts.

 

Depreciation and amortization costs as a percentage of total revenue were 28%, 35%, and 38% in 2011, 2010 and 2009, respectively. Depreciation and amortization costs increased $239,000 in 2011 compared to 2010 and decreased $490,000 in 2010 compared to 2009. The increase in 2011 was primarily due to the addition of four new Gamma Knife units and one IGRT unit that were installed during 2011. Three of the new Gamma Knife units were Perfexion units which replaced older Gamma Knife units that had been depreciated to their salvage value. The decrease in 2010 compared to 2009 is primarily because depreciation ended on three Gamma Knife units where the remaining value of the equipment had reached salvage value. In addition, the asset life of one Gamma Knife unit was changed because the contract with the customer was extended.

 

Other direct operating costs as a percentage of total revenue were 11%, 12% and 12% in 2011, 2010 and 2009, respectively. Other direct operating costs increased $455,000 in 2011 compared to 2010 and $38,000 in 2010 compared to 2009. The increase in 2011 was primarily due to increased costs from the Company’s turn-key sites and increased property taxes, partially offset by lower marketing costs. Costs from the turn-key sites increased primarily because of increased volume at the turn-key sites. Property taxes are higher because of the higher property tax valuation on the new Perfexion units installed during 2010 and 2011. The increase of $38,000 in 2010 is primarily due to higher property and other taxes, partially offset by lower insurance costs.

 

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SELLING AND ADMINISTRATIVE EXPENSE

 

(In thousands)   2011     Increase
(Decrease)
    2010     Increase
(Decrease)
    2009  
                               
Selling and administrative costs   $ 4,041       (4.7 )%   $ 4,240       7.9 %   $ 3,928  
                                         
Percentage of total revenue     18.2 %             25.4 %             23.4 %
                                         
Transaction costs   $ -       n/a     $ -       n/a     $ 342  
                                         
Percentage of total revenue     n/a               n/a               2.0 %

 

The Company's selling and administrative costs decreased by $199,000 in 2011 compared to 2010 and increased $312,000 in 2010 compared to 2009. The decrease in 2011 was primarily due to lower legal fees of $285,000, investor relations costs of $58,000, and building rent of $20,000. These cost reductions were partially offset by increased travel and business development costs of $37,000, insurance of $62,000 and accounting and audit fees of $36,000. The increase in 2010 compared to 2009 was primarily due to increased travel and other business development costs of $55,000, legal fees, most of which were for the development of new business, of approximately $278,000 and investor relations costs of approximately $65,000. These increases were partially offset by lower insurance costs of $46,000 and lower accounting and tax fees and various other costs.

 

There were no transaction costs in 2011 and 2010 compared to $342,000 in 2009. In 2009 the Company had engaged in discussions with two parties concerning the possible sale of its 81% interest in GKF, with one of the parties providing indicative pricing for the interest that would be attractive to the Company if it were to sell its interest in GKF. Accordingly, the Company permitted the prospective acquirer to conduct a due diligence review of GKF and the parties engaged in preliminary negotiations of the terms of a transaction.  In May 2009, the Company announced that the parties failed to reach an agreement and that the negotiations had terminated. Under applicable accounting rules, the Company is required to expense the legal, accounting, investment banking and other costs incurred for these activities.

 

INTEREST EXPENSE

 

(In thousands)   2011     Increase
(Decrease)
    2010     Increase
(Decrease)
    2009  
                               
Interest expense   $ 2,367       12.5 %   $ 2,104       1.9 %   $ 2,064  
                                         
Percentage of total revenue     10.7 %             12.6 %             12.3 %

 

The Company's interest expense increased $263,000 in 2011 compared to 2010, and increased $40,000 in 2010 compared to 2009. The increase in 2011 was primarily due to interest expense from new financing on two new Perfexion units and one new Gamma Knife 4C model placed in 2011, and a full year of interest expense on three new Gamma Knife units financed in 2010. The increase in 2010 compared to 2009 was primarily due to new financing on two Perfexion units and a 4C upgrade during 2010. This was partially offset by lower interest expense on the financing for the Company’s more mature Gamma Knife units. Interest expense on financing decreases over time as payments reduce the principal amount outstanding.

 

INTEREST AND OTHER INCOME

 

(In thousands)   2011     Increase
(Decrease)
    2010     Increase
(Decrease)
    2009  
                               
Interest and other income   $ 108       0.9 %   $ 107       78.3 %   $ 60  
                                         
Percentage of total revenue     0.5 %             0.6 %             0.4 %

 

22
 

 

Other income increased by $1,000 in 2011 compared to 2010 and increased by $47,000 in 2010 compared to 2009. The increase in 2011 was primarily due to a gain on the sale of assets of $72,000, offset by a loss on exchange rates of $27,000 and a reduction in interest income of approximately $50,000. The increase in 2010 was primarily from higher interest income due to interest received on state and federal income tax refunds. The interest income was offset by a cost of approximately $9,000 on the early extinguishment of debt, compared to a $20,000 cost in 2009.

 

INCOME TAX EXPENSE

 

(In thousands)   2011     Increase
(Decrease)
    2010     Increase
(Decrease)
    2009  
                               
Income tax expense   $ 208       25.3 %   $ 166       (32.8 )%   $ 247  
                                         
Percentage of total revenue     0.9 %             1.0 %             1.5 %
                                         
Percentage of income before income taxes     12.3 %             17.1 %             34.6 %

 

Income tax expense increased $42,000 in 2011 compared to 2010, and decreased $81,000 in 2010 compared to 2009. The increase in 2011 is due mostly to higher income before income taxes compared to 2010, partially offset by an apportionment method change specific to California that resulted in lower state income taxes. The decrease in 2010 is due mostly to lower state income taxes, primarily from a reduction in a state income tax valuation allowance, which offset higher federal income taxes on higher income before income taxes compared to 2009. Generally the Company has higher state income taxes because they are calculated at the Company’s profitable operating subsidiary level, where in many states, separate state income tax returns are required and net operating loss carryforwards cannot be applied.

 

The Company anticipates that it will continue to record income tax expense if it operates profitably in the future. Currently there are state income tax payments required for most states in which the Company operates. However there are minimal current federal income tax payments required due to net operating loss carryforwards and other deferred tax assets available for tax purposes.

 

The Company had a net operating loss carryforward for federal income tax return purposes at December 31, 2011 of approximately $8,989,000.

 

NET INCOME ATTRIBUTABLE TO NON-CONTROLLING INTERESTS

 

(In thousands)   2011     Increase
(Decrease)
    2010     Increase
(Decrease)
    2009  
                               
Net income attributable to non-controlling interests   $ 983       31.2 %   $ 749       14.5 %   $ 654  
                                         
Percentage of total revenue     4.4 %             4.5 %             3.9 %

 

Net income attributable to non-controlling interests increased $234,000 in 2011 compared to 2010 and increased $95,000 in 2010 compared to 2009. Net income attributable to non-controlling interests represents the pre-tax income earned by the 19% non-controlling interest in GKF, and the pre-tax income or losses of the non-controlling interests in various subsidiaries controlled by GKF. The decrease or increase in net income attributable to non-controlling interests reflects the relative profitability of GKF.

 

NET INCOME (LOSS) ATTRIBUTABLE TO AMERICAN SHARED HOSPITAL SERVICES

 

(In thousands,
except per share amounts)
  2011     Increase
(Decrease)
    2010     Increase
(Decrease)
    2009  
                               
Net income (loss) attributable to ASHS   $ 506       787.7 %   $ 57       130.3 %   $ (188 )
                                         
Net  income (loss) per share attributable to ASHS, diluted   $ 0.11       1,000.0 %   $ 0.01       125.0 %   $ (0.04 )

 

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Net income attributable to American Shared Hospital Services was $506,000 in 2011, compared to net income of $57,000 in 2010 and a net loss of $188,000 in 2009. The increase in 2011 of $499,000 was primarily due to Equipment sales revenue of $4,984,000 in 2011, an increase in Medical services revenue of $562,000 and a reduction in Selling and administrative expense of $199,000, offset by an increase in Costs of revenue of $4,758,000, of which $4,146,000 was from Cost of equipment sales, and Interest expense of $263,000. The increase in net income was also partially due to a reduction in the percentage of income tax expense to income before income taxes to 12.3% from 17.1% in 2010. The $245,000 increase in 2010 compared to 2009 was primarily due to increased revenue from the Company’s Gamma Knife sites, lower depreciation expense, no transaction costs, and lower income tax expense. This was partially offset by lower revenue from the Company’s IGRT site and an increase in selling and administrative expense and maintenance and supply costs.

 

IMPAIRMENT ANALYSIS OF INVESTMENT IN PREFERRED STOCK

 

The Company evaluated its investment in Mevion for impairment at December 31, 2011 in light of both current market conditions and the ongoing needs of Mevion to raise cash to continue its development of the first compact, single room PBRT system, including the following specific events.

 

Since October 2008 Mevion has continued to offer a sequence of Series D rounds of funding to raise cash for its next phase of development and continued manufacture of the prototype model of the proton beam unit. Due to the troubled economy and scarcity of funds available during this time, these rounds were offered at a price less than the Company’s investment. Mevion has received approximately $65 million from these Series D rounds from new and existing investors.

 

In July, 2011, Mevion and MIT reached a long-term Patent License Agreement, which included a settlement and release agreement regarding two lawsuits that were filed by MIT against Mevion in late December 2010.

 

In January 2012, Mevion announced that it had closed a $45 million round of Series E financing which will be used to accelerate the manufacturing and worldwide deployment of the Mevion S250. A new investor was the largest investor in this round, which also included existing investors. This round of financing was offered at a price higher than the effective price of the last round of Series D financing, and initially funded at 55%, with the remaining 45% due upon Mevion’s receipt of final FDA 510(k) clearance. The Company committed to invest an additional $70,000 in this round.

 

The lower price per share of the Series D and Series E offerings compared to the Company’s original investment could be viewed as a reasonable estimate of the fair value of our cost-method investment, indicating that our investment is impaired. The Company estimates that there is currently an unrealized loss (impairment) of approximately $1.3 million based on the issuance of the Series E funding compared to the Company’s cost of its investment.

 

In assessing whether the impairment is other than temporary, we evaluated the length of time and extent to which market value has been below cost, the financial condition and near term prospects of Mevion and our ability and intent to retain our investment for a period sufficient to allow for an anticipated recovery in the market value. Although the investment is not without risk, and the manufacture of the first unit has taken longer than originally anticipated, the Company believes that the current market value is a temporary situation brought on solely due to the continuing downturn of the economy, and is not a reflection on the progress or viability of Mevion or its PBRT design, and believes that our investment in Mevion is only temporarily impaired.

 

24
 

 

This is based primarily on the following:

· Mevion completed and submitted on March 1, 2012 its final application to the FDA for 510(k) clearance for the world's first superconducting synchrocyclotron. Phase 2 of its 510(k) submission was filed in June 2011, with Phase 1 having been submitted in February 2011. Mevion has already received comments from the FDA regarding the earlier submissions which should mitigate risks of delays for final FDA approval. The minimum expected review period after final submission is 3 months, and Mevion is planning for a 6 month review period. However, it is not possible to predict the actual review period and outcome, and it is uncertain as to whether the FDA will require an inspection of the unit prior to deeming Mevion’s application complete.
· On March 14, 2012, Mevion announced that it had received CE Marking Certification for its Mevion S250 Proton Therapy System which enables Mevion to market, sell and install these systems throughout the European Union and any country that recognizes the CE Mark.
· Phase 3 of the the installation of Mevion’s first proton beam unit at Barnes Jewish is complete, and the Gantry has been commissioned. Beam extraction was achieved in early March and further testing of the equipment and the software is continuing. Commissioning of the system is expected during 2012.
· Mevion is continuing installation at two other sites. The second phase of installation is complete at Robert Wood Johnson Medical Center in Houston (“RWJ”), and the cyclotron is being readied in the factory for delivery to RWJ, where the accelerator installation, or phase 3, is expected to begin in mid-2012. The second phase of installation has also been completed at Oklahoma University and is scheduled for accelerator installation in the Fall of 2012. The fourth projected site at M.D. Anderson Orlando, which is the Company’s first site, has completed construction documents and we are in the process of negotiating a delivery date with M.D. Anderson and Mevion.
· In spite of the uncertain economic climate and a limited number of potential investors, with the initial Series D offering Mevion was still able to raise the cash required to continue its operations, was able to add two new major investors, and continued to be able to raise additional cash with Series D extensions and the new Series E offering. It also added an additional major investor in the Series E offering with ProQuest Investments. Due to the high level of interest in more compact and lower cost proton beam radiation therapy devices, Mevion has been able to attract funding from financially significant and highly sophisticated investors, such as Caxton Health and Life Sciences, Venrock Associates and CHL Medical Partners, who have continued to invest in the various rounds of financing, and the new investor, ProQuest Investments.
· Based on ongoing discussions with Mevion management and regular review of their financial statements and cash flow projections, the Company believes that Mevion will have adequate cash flow to continue installation of the system at current sites under construction, and begin construction on new sites in the pipeline. Mevion states that their burn rate of cash is approximately $1.2 million per month, and expects that the additional funding from the Series E offering will be sufficient to complete the installation of the first system and continued installation of the next systems. Mevion, as a development stage company manufacturing its first product, continuously analyzes its cash requirements.
· The Company has analyzed its investment potential by comparing available financial information from Mevion to financial data from initial public offerings (“IPO”) of companies with similar technologies and has determined that it could reasonably expect that the value of its investment in Mevion would exceed the cost of its investment.

 

In addition the Company considered the following:

· Much of Mevion’s unique design is based on existing technology:
o The single room PBRT concept and design, although a departure from the large scale three and four room PBRT systems on the market, is based on the existing principle of generating protons from a cyclotron. Mevion, through design innovations and advances in magnet technology, has made the cyclotron more compact such that it can be mounted on the gantry.
o A gantry mounted cyclotron, although appearing to be revolutionary, has in fact been done previously. A neutron generating gantry mounted cyclotron has successfully treated patients for over ten years at Detroit Medical Center.
o Mevion’s development approach for the Mevion S250 has been to integrate as many commercially existing components as possible into the Mevion S250. The patient couch, CT imaging and treatment planning software are all commercially available and will be integrated into the Mevion S250.

 

25
 

 

o Mevion has hired engineers and staff with many years of accelerator and proton beam experience. Personnel have been hired with prior experience at MIT’s Plasma Fusion Lab, as well as Mevion rival, Ion Beam Applications S.A. (IBA).
· Mevion has completed several significant milestones towards its manufacture and installation of its first proton beam unit:
o built the magnet and other cyclotron subsystems for the first three units
o completed the manufacture/assembly of the gantry system
o demonstrated integrated software control of all cyclotron operations on the prototype unit
o completed and passed the cold mass test on the prototype unit.
o completed the beam extraction test phase. The cyclotron module produced a full energy extracted beam, 250MEV at 1 nano Amp, which was sufficient to meet the Barnes Jewish milestone. Mevion subsequently measured and formally passed the Barnes Jewish beam test, and announced the results in May 2010. An improved cryostat to assure beam quality throughout the planned 190 o gantry rotation was delivered to Barnes Jewish in October 2011 and installation has been completed, and has achieved beam extraction.
· There were some minor problems during some of the initial tests that were rectified, but have caused delays in the scheduled delivery of the first unit. As a result, the Company’s expected delivery of its first two units has also been delayed. However, problems such as these are expected in a new technology, and do not affect the Company’s position on the viability of Mevion technology
· A respected physicist was hired by the Company as a third party consultant to perform a technical review of this project, and continues to make periodic reviews at the request of the Company. His discussions with Mevion’s chief technology officer indicated that the delays encountered have at times resulted in modifications being required, but the modifications were not significant, and he still believes that development of the PBRT machine will be completed in Mevion’s timeline. The consultant was not engaged to analyze Mevion’s financial condition.
· In the latter part of 2009 Mevion added a new CEO, strengthened its management depth, and with the new investors, increased its board strength as well. Independent board members consist of the following: Robert Wilson, Former Vice Chairman of Johnson and Johnson; Peter P. D’Angelo, President, Caxton Associates; Anders Hove, MD, Partner, Venrock Associates; Myles D. Greenberg, MD, General Partner, CHL Medical Partners; Jay Rao, MD, JD, Portfolio Manager, Green Arrow Capital Management; and Paul Volcker, Former Chairman, United States Federal Reserve. Jay Moorin of ProQuest Investments was added to Mevion’s Board of Directors in January 2012.
· Mevion added four orders during 2011 to its sites agreeing to install the Mevion S250 system, and now has 17 total sites committed to installing the Mevion S250, with 15 in the United States and two in Japan.

 

Once FDA approval is obtained, the per share investment in Mevion will likely increase to a level higher than the Company’s existing carrying value (cost). As the first unit nears completion in 2012, and FDA approval appears more imminent, the Company believes that the value of its investment will soon meet and exceed its carrying value. The estimated recovery period is anticipated to occur subsequent to the first system’s clinical treatment of patients, which would shortly follow obtaining FDA approval. The first system is projected to be ready to treat patients later in 2012. The Company has the intent and the ability to maintain its investment in Mevion until at least these milestones are met.

 

LIQUIDITY AND CAPITAL RESOURCES

 

The Company had cash and cash equivalents of $2,580,000 at December 31, 2011 compared to $1,438,000 at December 31, 2010, an increase of $1,142,000. The Company’s expected primary cash needs on both a short and long-term basis are for capital expenditures, business expansion, working capital and other general corporate purposes.

 

The Company had no short-term or long-term investments in securities at both December 31, 2011 and 2010. However, it is the Company’s intent at appropriate times to invest a portion of its cash in high-quality short to long-term fixed income marketable securities in order to maximize income on its available cash and to hold these securities until maturity. When the Company holds these securities, those with maturity dates between three and twelve months are classified as current assets and those with maturities in excess of one year are classified as long-term. At both December 31, 2011 and 2010 the Company had approximately $9,000,000 invested in a certificate of deposit with a bank. The certificate of deposit the Company holds as of December 31, 2011 matures on August 30, 2012.

 

26
 

 

Restricted cash of $50,000 at December 31, 2011 reflects cash that may only be used for the operations of GKF.

 

The Company has a $9,000,000 renewable line of credit with a bank that is secured by cash and securities. The line of credit has been in place since June 2004 and has a maturity date of August 1, 2013. As of December 31, 2011, there was $7,850,000 borrowed against the line of credit, compared to $8,500,000 as of December 31, 2010. The Company believes it has the ability, and it is the Company’s intention, to renew the line of credit at its maturity in 2012.

 

Operating activities provided cash of $6,823,000 in 2011, which is primarily due to net income of $1,489,000 increased by non-cash charges for depreciation and amortization of $6,272,000, accounts payable and other accrued liabilities of $957,000, deferred income taxes of $76,000 and stock-based compensation expense of $125,000. These were partially offset by increases in receivables of $961,000 and prepaid expenses and other assets of $1,063,000. The Company’s trade accounts receivable increased by $874,000 to $4,604,000 at December 31, 2011 from $3,730,000 at December 31, 2010, partially due to new customers that began operation in the fourth quarter. The number of days revenue (sales) outstanding (“DSO”) in accounts receivable as of December 31, 2011 increased to 86 days compared to 76 days at December 31, 2010. DSO can and does fluctuate depending on timing of customer payments received and the mix of fee per use versus retail customers. Retail sites generally have longer collection periods than fee per use sites.

 

Investing activities used $4,143,000 of cash in 2011 due to payments made towards the purchase of property and equipment of $5,613,000 and investment in convertible preferred stock of $39,000, partially offset by $1,509,000 in investments by non-controlling interests in subsidiaries of the Company.

 

Financing activities used $1,538,000 of cash during 2011, primarily due to principal payments on long-term debt of $3,695,000, principal payments towards capital leases of $2,983,000, and distributions to non-controlling interests of $996,000. This was partially offset by long term debt financing on property and equipment of $6,786,000 and advances on the line of credit of $350,000.

 

The Company had working capital at December 31, 2011 of $7,671,000 compared to working capital of $7,631,000 at December 31, 2010. This $40,000 increase was due to an increase in cash of $1,142,000, and increases in receivables of $961,000, prepaid expenses of $260,000, and current deferred tax assets of $177,000, and a reduction in accounts payable of $59,000. This was offset by increases in current portion of debt of $466,000, current portion of long term leases of $1,077,000, other accrued liabilities of $972,000 and employee compensation and benefits of $44,000.

 

The Company primarily invests its cash in certificates of deposit, money market or similar funds, and high quality short to long-term securities in order to minimize the potential for principal erosion. Cash is invested in these funds pending use in the Company’s operations. The Company believes its cash position is adequate to service the Company’s cash requirements in 2012.

 

The Company initially finances all of its Gamma Knife and radiation therapy units and anticipates that it will continue to do so with future contracts. The Company has secured financing for its projects from several lenders and anticipates that it will be able to secure financing on future projects from these or other lending sources, but there can be no assurance that financing will continue to be available on acceptable terms. The Company meets all debt covenants required under notes with its lenders, and expects that any covenants required by future lenders will be acceptable to the Company.

 

IMPACT OF INFLATION AND CHANGING PRICES

 

The Company does not believe that inflation has had a significant impact on operations because a substantial majority of the costs that it incurs under its customer contracts are fixed through the term of the contract.

 

27
 

 

CONTRACTUAL OBLIGATIONS, COMMITMENTS, CONTINGENT LIABILITIES AND OFF BALANCE SHEET ARRANGEMENTS

 

The following table presents, as of December 31, 2011, the Company’s significant fixed and determinable contractual obligations by payment date. The payment amounts represent those amounts contractually due to the recipient and do not include any unamortized premiums or discounts, hedge basis adjustments, or other similar carrying value adjustments. Further discussion of the nature of each obligation is included in the notes to the consolidated financial statements referenced below.

 

    Payments Due by Period  
    Total amounts     Less than                 After  
Contractual Obligations   committed     1 year     1-3 years     4-5 years     5 years  
                               
Long-term debt (includes interest)   $ 17,129,000     $ 4,649,000     $ 10,808,000     $ 1,672,000     $ -  
Capital leases (includes interest)     25,014,000       5,132,000       13,228,000       5,768,000       886,000  
Line of credit     7,850,000       -       7,850,000       -       -  
Future equipment purchases (1)     58,367,000       11,517,000       46,850,000       -       -  
Operating leases     1,319,000       298,000       895,000       126,000       -  
                                         
Total contractual obligations   $ 109,679,000     $ 21,596,000     $ 79,631,000     $ 7,566,000     $ 886,000  

 

(1) The Company has made cash deposits totaling $6,149,000 toward these equipment purchase commitments. The commitments include the purchase of four Gamma Knife Perfexion units, one Model 4C unit, one radiation therapy unit and three Mevion S250 proton beam units as of December 31, 2011. For the first two Mevion S250 units specifically, the Company has a commitment to total deposits of $3,000,000 per machine until FDA approval is received, at which time the remaining balance is committed. For the third Mevion S250 unit, the Company has a commitment to total deposits of $500,000 until FDA approval is received, at which time the remaining balance is committed. Two of the Perfexion units are committed to being installed at new sites in 2012 and the other two are for sites yet to be determined. Financing has been committed to the Model 4C unit and one of the Perfexion units scheduled for installation in 2012. Financing has not yet been obtained for any of the other equipment. For all equipment in this classification, term financing for these purchases will not be finalized until 2012 or later, and therefore an accurate determination of payments by period cannot be made as of December 31, 2011. For purposes of this table, these commitments are listed in the 1 year and 1-3 year categories.

 

Further discussion of the long-term debt commitment is included in Note 5, capital leases in Note 6, and operating leases in Note 12 of the consolidated financial statements.

 

The Company has no significant off-balance sheet arrangements.

 

ITEM 7A.

 

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

The table below presents information about certain market-sensitive financial instruments as of December 31, 2011. The fair values were determined based on quoted market prices for the same or similar instruments.

 

28
 

 

    Payments Due by Period                    
(amounts in thousands)   2012     2013     2014     2015     2016     There-
after
    Total     Fair
Value
 
                                                 
Fixed rate long-term debt and present value of capital leases   $ 7,617     $ 7,737     $ 7,505     $ 5,145     $ 4,208     $ 3,539     $ 35,751     $ 35,743  
                                                                 
Average interest rates     7.0 %     6.9 %     6.8 %     6.7 %     6.8 %     6.9 %     6.9 %        

 

We do not hold or issue derivative instruments for trading purposes and are not a party to any instruments with leverage or prepayment features.

 

At December 31, 2011, we had no significant long-term, market-sensitive investments.

 

We have no affiliation with partnerships, trusts or other entities whose purpose is to facilitate off-balance sheet financial transactions or similar arrangements, and therefore have no exposure to the financing, liquidity, market or credit risks associated with such entities.

 

ITEM 8.

 

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

See the Index to Consolidated Financial Statements and Financial Statement Schedules included at page A-1 of this report.

 

ITEM 9.

 

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

 

None.

 

ITEM 9A

 

CONTROLS AND PROCEDURES

 

(a) Evaluation of disclosure controls and procedures.

 

Our Chief Executive Officer and our Chief Financial Officer, after evaluating the effectiveness of the Company’s “disclosure controls and procedures” (as defined in the Securities Exchange Act of 1934 (“Exchange Act”) Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this annual report, have concluded that our disclosure controls and procedures are effective based on their evaluation of these controls and procedures required by paragraph (b) of Exchange Act Rules 13a-15 or 15d-15.

 

(b) Management’s report on internal control over financial reporting.

 

The management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting. The Company’s internal control system was designed to provide reasonable assurance to its management and Board of Directors regarding the preparation and fair presentation of published financial statements.

 

All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.

 

29
 

 

Management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2011. In making this assessment, it used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control – Integrated Framework. Based on this assessment management believes that, as of December 31, 2011, the Company’s internal control over financial reporting is effective based on those criteria.

 

(c) Changes in internal controls over financial reporting.

 

Our Chief Executive Officer and our Chief Financial Officer have evaluated the changes to the Company’s internal control over financial reporting that occurred during our last fiscal quarter ended December 31, 2011, as required by paragraph (d) of Exchange Act Rules 13a-15 and 15d-15, and have concluded that there were no such changes that materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

ITEM 9B.

 

OTHER INFORMATION

 

None.

 

PART III

 

ITEM 10.

 

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

 

Information regarding directors is incorporated herein by reference from the Company’s definitive Proxy Statement for the 2012 Annual Meeting of Shareholders (the “2012 Proxy Statement”). Information regarding executive officers of the Company, included herein under the caption “Executive Officers of the Company” in Part I, Item 1 above, is incorporated herein by reference.

 

Information concerning the identification of our standing audit committee required by this Item is incorporated by reference from the 2012 Proxy Statement.

 

Information concerning our audit committee financial experts required by this Item is incorporated by reference from the 2012 Proxy Statement.

 

Information concerning compliance with Section 16(a) of the Exchange Act required by this Item is incorporated by reference from the 2012 Proxy Statement.

 

We have adopted a Code of Ethics that is available on our website at www.ashs.com . The information on our website is not part of this report. You may also request a copy of this document free of charge by writing our Corporate Secretary.

 

ITEM 11.

 

EXECUTIVE COMPENSATION

 

Information required by this Item is incorporated herein by reference from the 2012 Proxy Statement.

 

ITEM 12.

 

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

 

Information required by this Item is incorporated herein by reference from the 2012 Proxy Statement.

 

30
 

 

ITEM 13.

 

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

 

Information required by this Item is incorporated herein by reference from the 2012 Proxy Statement.

 

ITEM 14.

 

PRINCIPAL ACCOUNTING FEES AND SERVICES

 

Information required by this Item is incorporated herein by reference from the 2012 Proxy Statement.

 

PART IV

 

ITEM 15.

 

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

 

(a) Financial Statements and Schedules.
The following Financial Statements and Schedules are filed with this Report:

Report of Independent Registered Public Accounting Firm

Audited Consolidated Financial Statements

Consolidated Balance Sheets

Consolidated Statements of Operations

Consolidated Statements of Shareholders' Equity

Consolidated Statements of Cash Flows

Notes to Consolidated Financial Statements

Financial Statement Schedules- no schedules are included since the required information is not present or is not present in amounts sufficient to require submission of the schedule, or because the information required is included in the financial statements and notes thereto.

 

(b) Exhibits.

The following Exhibits are filed with this Report.

 

Exhibit    
Number:   Description:
     
2.1   Securities Purchase Agreement, dated as of March 12, 1999, by and among Alliance Imaging, Inc.; Embarcadero Holding Corp. I; Embarcadero Holding Corp. II; American Shared Hospital Services; and MMRI, Inc. (1)
     
3.1   Articles of Incorporation of the Company, as amended. (2)
     
3.2   By-laws of the Company, as amended. (3)
     
4.6   Form of Common Stock Purchase Warrant of American Shared Hospital Services. (3)
     
4.8   Registration Rights Agreement, dated as of May 17, 1995, by and among American Shared Hospital Services, the Holders referred to in the Note Purchase Agreement, dated as of May 12, 1995 and General Electric Company, acting through GE Medical Systems. (3)
     
4.9   Rights Agreement dated as of March 22, 1999 between American Shared Hospital Services and American Stock Transfer & Trust Company as Rights Agent. (25)
     
10.1   The Company's 1984 Stock Option Plan, as amended. (4)

 

31
 

 

10.2   The Company's 1995 Stock Option Plan, as amended. (5)
     
10.3   Form of Indemnification Agreement between American Shared Hospital Services and members of its Board of Directors. (4)
     
10.4   Ernest A. Bates Stock Option Agreement dated as of August 15, 1995. (6)
     
10.5   Operating Agreement for GK Financing, LLC, dated as of October 17, 1995. (3)
     
10.6   Amendments dated as of October 26, 1995 and as of December 20, 1995 to the GK Financing, LLC Operating Agreement, dated as of October 17, 1995. (7)
     
10.7   Amendment dated as of October 16, 1996 to the GK Financing, LLC Operating Agreement, dated as of October 17, 1995. (1)
     
10.8   Amendment dated as of March 31, 1998 (“Fourth Amendment”) to the GK Financing, LLC Operating Agreement dated as of October 17, 1995. (8)
     
10.9   Amendment dated as of March 31, 1998 (“Fifth Amendment”) to the GK Financing, LLC Operating Agreement dated as of October 17, 1995. (8)
     
10.10   Amendment dated as of June 5, 1999 to the GK Financing, LLC Operating Agreement dated as of October 17, 1995. (8)
     
10.11a   Assignment and Assumption Agreement, dated as of December 31, 1995, between American Shared Radiosurgery Services (assignor) and GK Financing, LLC (assignee). (8)
     
10.11b   Assignment and Assumption Agreement, dated as of November 1, 1995, between American Shared Hospital Services (assignor) and American Shared Radiosurgery Services (assignee). (4)
     
10.11c   Amendment Number One dated as of August 1, 1995 to the Lease Agreement for a Gamma Knife Unit between The Regents of the University of California and American Shared Hospital Services.  (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended.  Omitted information has been replaced with asterisks.) (8)
     
10.11d   Lease Agreement dated as of July 3, 1990 for a Gamma Knife Unit between American Shared Hospital Services and The Regents of the University of California.  (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended.  Omitted information has been replaced with asterisks.) (8)
     
10.12   Amendment Number Two dated as of February 6, 1999 to the Lease Agreement for a Gamma Knife Unit between UCSF-Stanford Health Care and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended.  Omitted information has been replaced with asterisks.) (8)
     
10.13   Assignment and Assumption Agreement, dated as of February 3, 1996, between American Shared Radiosurgery Services (assignor) and GK Financing, LLC (assignee). (4)
     
10.14   Lease Agreement for a Gamma Knife Unit dated as of April 6, 1994, between Ernest A. Bates, M.D. and NME Hospitals, Inc. dba USC University Hospital.  (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended.  Omitted information has been replaced with asterisks.) (8)
     
10.15   Assignment and Assumption Agreement dated as of February 1, 1996 between Ernest A. Bates, M.D. and GK Financing, LLC with respect to the Lease Agreement for a Gamma Knife dated as of April 6, 1994 between Ernest A. Bates, M.D. and NME Hospitals, Inc. dba USC University Hospital. (8)

 

32
 

 

 

10.16 Lease Agreement for a Gamma Knife Unit dated as of October 31, 1996 between Hoag Memorial Hospital Presbyterian and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (8)

 

10.17 Addendum to Lease Agreement for a Gamma Knife Unit dated as of December 1, 1999 between Hoag Memorial Hospital Presbyterian and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (8)

 

10.18 Lease Agreement for a Gamma Knife Unit dated as of October 29, 1996 between Methodist Healthcare Systems of San Antonio, Ltd., dba Southwest Texas Methodist Hospital and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (8)

 

10.18a Amendment to Lease Agreement for a Gamma Knife Unit effective December 13, 2003 by and between Methodist Healthcare Systems of San Antonio, Ltd., dba Southwest Texas Methodist Hospital and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (22 )

 

10.18b Second Amendment to Lease Agreement for a Gamma Knife Unit effective December 23, 2009 by and between Methodist Healthcare Systems of San Antonio, Ltd., dba Southwest Texas Methodist Hospital and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (38 )

 

10.19 Lease Agreement for a Gamma Knife Unit dated as of April 10, 1997 between Yale-New Haven Ambulatory Services Corporation and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (8)

 

10.19a Amendment to Lease Agreement for a Gamma Knife Unit effective October 25, 2005 by and between Yale-New Haven Ambulatory Services Corporation and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (27)

 

10.19b Amendment to Lease Agreement for a Gamma Knife Unit effective June 30, 2006 by and between Yale-New Haven Ambulatory Services Corporation and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (31)

 

10.19c Second Amendment to Lease Agreement for a Gamma Knife Unit effective May 15, 2009 by and between Yale-New Haven Hospital, Inc. a/k/a Yale-New Haven Hospital and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (37)

 

33
 

 

10.20 Lease Agreement for a Gamma Knife Unit dated as of June 1, 1999 between GK Financing, LLC and Kettering Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (9)

 

10.21 Addendum to Contract with GKF and KMC/WKNI, dated June 1, 1999 between GK Financing, LLC and Kettering Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (9)

 

10.21a Purchased Services Agreement for a Gamma Knife Perfexion Unit dated November 19, 2008 between GK Financing, LLC and Kettering Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (34)

 

10.21b First Amendment to Purchased Services Agreement for a Gamma Knife Perfexion Unit dated June 11, 2009 between GK Financing, LLC and Kettering Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (34)

 

10.22 Lease Agreement for a Gamma Knife Unit dated as of October 5, 1999 between GK Financing, LLC and New England Medical Center Hospitals, Inc. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (9)

 

10.22a Addendum to Lease Agreement for a Gamma Knife unit effective April 1, 2005 between GK Financing, LLC and New England Medical Center Hospitals, Inc. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (24)

 

10.23 Equipment Lease Agreement dated as of October 29, 1999 between GK Financing, LLC and the Board of Trustees of the University of Arkansas on behalf of The University of Arkansas for Medical Sciences. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (9)

 

10.23a Amendment to Lease Agreement effective as of September 15, 2005 between GK Financing, LLC and the Board of Trustees of the University of Arkansas on behalf of The University of Arkansas for Medical Sciences. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (26)

 

10.23b Amendment to Lease Agreement effective as of October 31, 2007 between GK Financing, LLC and the Board of Trustees of the University of Arkansas on behalf of The University of Arkansas for Medical Sciences. (32)

 

10.23c Amendment Three to Lease Agreement effective as of June 11, 2010 between GK Financing, LLC and the Board of Trustees of the University of Arkansas on behalf of The University of Arkansas for Medical Sciences. (36)

 

10.24 First Amendment to Lease Agreement for a Gamma Knife Unit effective as of August 2, 2000 between GK Financing, LLC and Tenet HealthSystems Hospitals, Inc. (formerly known as NME Hospitals, Inc.) dba USC University Hospital. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (9)

 

34
 

 

10.25 Addendum Two, dated as of October 1, 2000, to Lease Agreement for a Gamma Knife Unit dated as of October 31, 1996 between Hoag Memorial Hospital Presbyterian and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (10)

 

10.26 Lease Agreement for a Gamma Knife Unit dated as of May 28, 2000 between Froedtert Memorial Lutheran Hospital and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (10)

 

10.26a First Amendment to Lease Agreement for a Gamma Knife Unit dated as of December 28, 2009 between Froedtert Memorial Lutheran Hospital and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (35)

 

10.27 Addendum dated June 24, 2000 to Lease Agreement for a Gamma Knife Unit dated as of May 28, 2000 between Froedtert Memorial Lutheran Hospital and GK Financing, LLC. (10)

 

10.28 Amendment dated July 12, 2000 to Lease Agreement for a Gamma Knife Unit dated May 28, 2000 between Froedtert Memorial Lutheran Hospital and GK Financing, LLC. (10)

 

10.29 Amendment dated August 24, 2000 to Lease Agreement for a Gamma Knife Unit dated May 28, 2000 between Froedtert Memorial Lutheran Hospital and GK Financing, LLC. (10)

 

10.30 Lease Agreement for a Gamma Knife Unit dated as of December 11, 1996 between The Community Hospital Group, Inc. dba JFK Medical Center and GK Financing, LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (11)

 

10.30a Addendum One to Lease Agreement for a Gamma Knife Unit dated January 9, 2008 between GK Financing, LLC and The Community Hospital Group, Inc. dba JFK Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks). (33)

 

10.30b Addendum Two to Lease Agreement for a Gamma Knife Unit dated January 9, 2008 between GK Financing, LLC and The Community Hospital Group, Inc. dba JFK Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks). (33)

 

10.31 Lease Agreement for a Gamma Knife Unit dated as of June 3, 1999 between GK Financing, LLC and Sunrise Hospital and Medical Center, LLC dba Sunrise Hospital and Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (12)

 

10.32 Addendum to Lease Agreement for a Gamma Knife Unit dated as of June 3, 1999 between GK Financing, LLC and Sunrise Hospital and Medical Center, LLC dba Sunrise Hospital and Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (12)

 

35
 

 

10.33 Lease Agreement for a Gamma Knife Unit dated as of November 1, 1999 between GK Financing, LLC and Jackson HMA, Inc. dba Central Mississippi Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (13)

 

10.34 Addendum to Lease Agreement for a Gamma Knife Unit dated as of November 1, 1999 between GK Financing, LLC and Jackson HMA, Inc. dba Central Mississippi Medical Center. (13)

 

10.35 Lease Agreement for a Gamma Knife Unit dated as of February 18, 2000 between GK Financing, LLC and OSF HealthCare System. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (13)

 

10.35a Addendum to Lease Agreement for a Gamma Knife Unit effective April 13, 2007, between GK Financing, LLC and OSF HealthCare System. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (30)

 

10.36 American Shared Hospital Services 2001 Stock Option Plan. (14)

 

10.37 Amendment Number Three to Lease Agreement for a Gamma Knife Unit dated as of June 22, 2001 between GK Financing, LLC and The Regents of the University of California. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (15)

 

10.38 Addendum Three to Lease Agreement for a Gamma Knife Unit dated as of October 1, 2000 between GK Financing, LLC and Hoag Memorial Hospital Presybterian. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (15)

 

10.39 Lease Agreement for a Gamma Knife Unit dated as of July 18, 2001 between GK Financing, LLC and Bayfront Medical Center, Inc.. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (16)

 

10.40 Lease Agreement for a Gamma Knife Unit dated as of September 13, 2001 between GK Financing, LLC and Mercy Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (17)

 

10.41 Addendum Number One to Contract dated September 13, 2001 between GK Financing, LLC and Mercy Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (17)

 

10.42 Lease Agreement for a Gamma Knife Unit dated as of May 22, 2002 between GK Financing, LLC and The Johns Hopkins Hospital. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (18)

 

10.43 Lease Agreement for a Gamma Knife Unit dated as of July 11, 2002 between GK Financing, LLC and Southern Baptist Hospital of Florida, Inc. D/B/A Baptist Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (19)

 

36
 

 

10.43a First Amendment to Lease Agreement for a Gamma Knife Unit dated as of June 30, 2011 between GK Financing, LLC and Southern Baptist Hospital of Florida, Inc. (40)

 

10.44 Lease Agreement for a Gamma Knife Unit dated as of February 13, 2003 between GK Financing, LLC and AHS Albuquerque Regional Medical Center LLC. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (20)

 

10.45 Lease Agreement for a Gamma Knife Unit dated as of May 28, 2003 between GK Financing, LLC and Lehigh Valley Hospital. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (21)

 

10.45a First Amendment to Lease Agreement for a Gamma Knife Unit dated November 2006 between GK Financing, LLC and Lehigh Valley Hospital. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (28)

 

10.45b Second Amendment to Lease Agreement for a Gamma Knife Unit dated effective as of March 2, 2011 between GK Financing, LLC and Lehigh Valley Hospital. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks). (42)

 

10.45c Third Amendment to Lease Agreement for a Gamma Knife Unit dated effective as of March 2, 2011 between GK Financing, LLC and Lehigh Valley Hospital. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks). (42)

 

10.46 Lease Agreement for a Gamma Knife Unit dated as of March 21, 2003 between GK Financing, LLC and Northern Westchester Hospital Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (23)

 

10.47 Amendment Four to Lease Agreement for a Gamma Knife Unit effective as of December 1, 2002 between GK Financing, LLC and Hoag Memorial Hospital Presbyterian. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (23)

 

10.48 Line of credit agreement between American Shared Hospital Services and Bank of America dated July 1, 2004 and related amendments No. 1 and No. 2 dated June 23, 2005. (23)

 

10.49 Lease Agreement for a Gamma Knife Unit dated as of May 28, 2004 between GK Financing, LLC and Mercy Health Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (24)

 

10.50 Lease Agreement for a Gamma Knife Unit dated as of August 7, 2003 between GK Financing, LLC and Baptist Hospital of East Tennessee. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (26)

 

37
 

 

10.50a Amendment No. 1 to Lease Agreement for a Gamma Knife Unit dated as of May 28, 2004 between GK Financing, LLC and Baptist Hospital of East Tennessee. (26)

 

10.51 Addendum Two to Lease Agreement for a Gamma Knife Unit dated as of November 6, 2006 between GK Financing, LLC and Jackson HMA, Inc. d/b/a Central Mississippi Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (28)

 

10.52 Amendment dated as of October 18, 2006 to the GK Financing, LLC Operating Agreement, dated as of October 17, 1995. (28)

 

10.53 Addendum Two to Lease Agreement for a Gamma Knife Unit effective January 17, 2007 between GK Financing, LLC and Sunrise Hospital Medical Center, LLC d/b/a Sunrise Hospital Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (29)

 

10.54 Amendment Five to Lease Agreement for a Gamma Knife Unit effective May 9, 2007 between GK Financing, LLC and The Regents of the University of California. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (30)

 

10.55 Addendum Two to Lease Agreement for a Gamma Knife Unit effective June 20, 2007 between GK Financing, LLC and The Regents of the University of California. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (30)

 

10.56 Agreement to Purchase Gamma Knife Perfexion Unit effective May 7, 2007 between GK Financing, LLC and The Regents of the University of California. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (30)

 

10.57 Purchased Services Agreement for a Gamma Knife Perfexion Unit dated as of March 5, 2008 between GK Financing, LLC and USC University Hospital, Inc. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks). (33)

 

10.57a First Amendment to Purchased Services Agreement for a Gamma Knife Perfexion Unit dated as of April 1, 2009 between GK Financing, LLC and USC University Hospital, Inc. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks). (34)

 

10.58 Addendum Three to Lease Agreement for a Gamma Knife Unit effective as of June 20, 2007 between GK Financing, LLC and Sunrise Hospital and Medical Center, LLC dba Sunrise Hospital and Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (37)

 

10.59 Addendum Four to Lease Agreement for a Gamma Knife Unit effective as of February 8, 2010 between GK Financing, LLC and Sunrise Hospital and Medical Center, LLC dba Sunrise Hospital and Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (37)

 

38
 

 

10.60 Lease Agreement for a Gamma Knife Unit dated as of May 1, 2010 between GK Financing, LLC and Fort Sanders Regional Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (39)

 

10.61 Purchase and License Agreement for a Gamma Knife Unit and Axesse System dated as of August 25, 2010 between Elekta Instrument AB and Baskent University, Adana, Turkey. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (40)

 

10.61a Assignment Agreement from Elekta Instrument AB to EWRS Tibbi Cihazlar Ticaret Limited Sirketi dated March 11, 2011, for Purchase and License Agreement between Elekta Instrument AB and Baskent University. (40)

 

10.62 Lease Agreement for a Gamma Knife Unit effective as of April 8, 2011 between GK Financing, LLC and Lovelace Health System, Inc., d/b/a Lovelace Medical Center. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks.) (41)

 

10.62a Assignment and Assumption of Purchase and License Agreement with Elekta, Inc., from GK Financing, LLC to Albuquerque Gamma Knife Equipment, LLC dated February 2, 2011. (40)

 

10.63 Purchased Services Agreement for a Gamma Knife Perfexion Unit effective as of August 5, 2011 between Jacksonville GK Equipment, LLC and St. Vincent’s Medical Center, Inc. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks).

 

10.63a First Amendment to Purchased Services Agreement for a Gamma Knife Perfexion Unit effective as of October 10, 2011 between Jacksonville GK Equipment, LLC and St. Vincent’s Medical Center, Inc. (Confidential material appearing in this document has been omitted and filed separately with the Securities and Exchange Commission in accordance with Rule 24b-2, promulgated under the Securities and Exchange Act of 1934, as amended. Omitted information has been replaced with asterisks).

 

21. Subsidiaries of American Shared Hospital Services.

 

23.1 Consent of Independent Registered Public Accounting Firm.

 

31. Rule 13a-14(a)/15d-14(a) Certifications.

 

32. Section 1350 Certifications (furnished and not to be considered filed as part of the Form 10-K).

 

 

(1) These documents were filed as Exhibits 2.1 and 10.13b, respectively, to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 1997, which is incorporated herein by this reference.

 

(2) This document was filed as Exhibit 3.1 to registrant’s Registration Statement on Form S-2 (Registration No. 33-23416), which is incorporated herein by this reference.

 

(3) These documents were filed as Exhibits 3.2, 4.6 and 4.8, respectively, to registrant’s Registration Statement on Form S-1 (Registration No. 33-63721) filed on October 26, 1995, which is incorporated herein by this reference.

 

(4) These documents were filed as Exhibits 10.24 and 10.35, respectively, to registrant’s Registration Statement on Form S-2 (Registration No. 33-23416), which is incorporated herein by this reference.

 

39
 

 

(5) This document was filed as Exhibit A to registrant's Proxy Statement, filed on August 31, 1995, which is incorporated herein by this reference.

 

(6) This document was filed as Exhibit B to registrant's Proxy Statement, filed on August 31, 1995, which is incorporated herein by this reference.

 

(7) These documents were filed as Exhibits 4.14 and 10.13, respectively, to the registrant’s Pre-Effective Amendment No. 1 to registrant’s Registration Statement on Form S-1 (Registration No. 33-63721) filed on March 29, 1996, which is incorporated herein by this reference.

 

(8) These documents were filed as Exhibits 10.8, 10.9, 10.10, 10.11a, 10.11c, 10.11d, 10.12, 10.14, 10.15, 10.16, 10.17, 10.18 and 10.19, respectively, to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 1999, which is incorporated herein by this reference.

 

(9) These documents were filed as Exhibits 10.20, 10.21, 10.22, 10.23, and 10.24, respectively, to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2000, which is incorporated herein by this reference.

 

(10) These documents were filed as Exhibits 10.25, 10.26, 10.27, 10.28 and 10.29, respectively, to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2000, which is incorporated herein by this reference.

 

(11) This document was filed as Exhibit 10.30 to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2000, which is incorporated herein by this reference.

 

(12) These documents were filed as Exhibits 10.31 and 10.32, respectively, to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2001, which is incorporated herein by this reference.

 

(13) These documents were filed as Exhibits 10.33, 10.34 and 10.35, respectively, to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2001, which is incorporated herein by this reference.

 

(14) This document was filed as Exhibit 10.36 to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2001, which is incorporated herein by this reference.

 

(15) These documents were filed as Exhibits 10.37 and 10.38 to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2001, which is incorporated herein by this reference.

 

(16) This document was filed as Exhibit 10.39 to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2002, which is incorporated herein by this reference.

 

(17) These documents were filed as Exhibits 10.40 and 10.41, respectively, to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2002, which is incorporated herein by this reference.

 

(18) This document was filed as Exhibit 10.42 to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2003, which is incorporated herein by this reference.

 

(19) This document was filed as Exhibit 10.43 to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2003, which is incorporated herein by this reference.

 

(20) This document was filed as Exhibit 10.44 to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2003, which is incorporated herein by this reference.

 

(21) This document was filed as Exhibit 10.45 to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2004, which is incorporated herein by this reference.

 

(22) This document was filed as Exhibit 10.18a to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2005, which is incorporated herein by this reference.

 

(23) These documents were filed as Exhibits 10.46, 10.47 and 10.48, respectively, to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2005, which is incorporated herein by this reference.

 

(24) These documents were filed as Exhibits 10.22a and 10.49, respectively, to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2005, which is incorporated herein by this reference.

 

40
 

 

(25) This document was filed as Exhibit 4 to the registrant’s Current Report on Form 8-K filed on April 1, 1999, which is incorporated herein by this reference.

 

(26) These documents were filed as Exhibits 10.23a, 10.50 and 10.50a, respectively, to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2005, which is incorporated herein by this reference.

 

(27) This document was filed as Exhibit 10.19a to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2006, which is incorporated herein by this reference.

 

(28) These documents were filed as Exhibits 10.45a, 10.51 and 10.52, respectively, to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2006, which is incorporated herein by this reference.

 

(29) This document was filed as Exhibit 10.53 to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2007, which is incorporated herein by this reference.

 

(30) These documents were filed as Exhibits 10.35a, 10.54, 10.55 and 10.56, respectively, to the registrant’s Quarterly Report on Form 10-Q for the fiscal year ended June 30, 2007, which is incorporated herein by this reference.

 

(31) This document was filed as Exhibit 10.19b to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2007, which is incorporated herein by this reference.

 

(32) This document was filed as Exhibit 10.23b to the registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2007, which is incorporated herein by this reference.

 

(33) These documents were filed as Exhibits 10.30a, 10.30b and 10.57, respectively, to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2008, which is incorporated herein by this reference.

 

(34) These documents were filed as Exhibits 10.21a, 10.21b and 10.57a, respectively, to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2009, which is incorporated herein by this reference.

 

(35) This document was filed as Exhibit 10.26a to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2009, which is incorporated herein by this reference.

 

(36) This document was filed as Exhibit 10.23c to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2010, which is incorporated herein by this reference.

 

(37) These documents were filed as Exhibits 10.19c, 10.58 and 10.59, respectively, to the registrant’s Quarterly Report on Form 10-Q /A for the quarterly period ended June 30, 2010, which is incorporated herein by this reference.

 

(38) This document was filed as Exhibit 10.18b to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2010, which is incorporated herein by this reference.

 

(39) This document was filed as Exhibit 10.60 to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2011, which is incorporated herein by this reference.

 

(40) These documents were filed as Exhibits 10.43a, 10.61, 10.61a and 10.62a to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2011, which is incorporated herein by this reference.

 

(41) These documents were filed as Exhibits 10.62 to the registrant’s Quarterly Report on Form 10-Q/A for the quarterly period ended June 30, 2011, which is incorporated herein by this reference.

 

(42) These documents were filed as Exhibits 10.45b and 10.45c to the registrant’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2011, which is incorporated herein by this reference.

 

41
 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  AMERICAN SHARED HOSPITAL SERVICES
  (Registrant)
     
March 30, 2012 By: /s/ Ernest A. Bates, M.D.
    Ernest A. Bates, M.D.
    Chairman of the Board and
    Chief Executive Officer

 

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated.

 

Signature     Title   Date
           
/s/ Ernest A. Bates     Chairman of the Board and   March 30, 2012
Ernest A. Bates, M.D.     Chief Executive Officer    
      (Principal Executive Officer)    
           
/s/ David A. Larson     Director   March 30, 2012
David A. Larson, M.D.          
           
/s/ S. Mert Ozyurek     Director   March 30, 2012
S. Mert Ozyurek          
           
/s/ John F. Ruffle     Director   March 30, 2012
John F. Ruffle          
           
/s/ Raymond C. Stachowiak     Director   March 30, 2012
Raymond C. Stachowiak          
           
/s/ Stanley S. Trotman, Jr.     Director   March 30, 2012
Stanley S. Trotman, Jr.          
           
/s/ Craig K. Tagawa     Chief Operating Officer and   March 30, 2012
Craig K. Tagawa     Chief Financial Officer    
      (Principal Accounting Officer)    

 

42
 

  

AMERICAN SHARED HOSPITAL SERVICES

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

and

CONSOLIDATED FINANCIAL STATEMENTS

 

DECEMBER 31, 2011, 2010 and 2009

 

 
 

 

Contents

 

  PAGE
   
Report of Independent Registered Public Accounting Firm 1
   
Consolidated Financial Statements  
Balance sheets 2
Statements of operations 3
Statement of shareholders’ equity 4
Statements of cash flows 5
Notes to financial statements 6 – 18

 

 
 

 

Report of Independent Registered Public Accounting Firm

 

To the Board of Directors and Shareholders

American Shared Hospital Services

 

We have audited the accompanying consolidated balance sheets of American Shared Hospital Services and subsidiaries (the “Company”) as of December 31, 2011 and 2010, and the related consolidated statements of operations, shareholders’ equity, and cash flows for each of the three years in the period ended December 31, 2011. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of American Shared Hospital Services and subsidiaries at December 31, 2011 and 2010, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2011 in conformity with accounting principles generally accepted in the United States of America.

 

/S/ MOSS ADAMS LLP

 

Stockton, California

March 30, 2012

 

1
 

 

American Shared Hospital Services
Consolidated Balance Sheets

 

    DECEMBER 31,  
    2011     2010  
ASSETS                
                 
CURRENT ASSETS                
Cash and cash equivalents   $ 2,580,000     $ 1,438,000  
Restricted cash     50,000       50,000  
Certificate of deposit     9,000,000       9,000,000  
Trade accounts receivable, net of allowance for doubtful accounts of $100,000 in 2011 and 2010     4,604,000       3,730,000  
Other receivables     158,000       71,000  
Prepaid expenses and other current assets     733,000       473,000  
Current deferred tax assets     490,000       313,000  
                 
Total current assets     17,615,000       15,075,000  
                 
PROPERTY AND EQUIPMENT, net     53,267,000       47,360,000  
                 
INVESTMENT IN PREFERRED STOCK     2,656,000       2,617,000  
OTHER ASSETS     997,000       288,000  
                 
TOTAL ASSETS   $ 74,535,000     $ 65,340,000  
                 
LIABILITIES AND SHAREHOLDERS’ EQUITY                
                 
CURRENT LIABILITIES                
Accounts payable   $ 278,000     $ 337,000  
Employee compensation and benefits     255,000       211,000  
Other accrued liabilities     1,795,000       823,000  
Current portion of long-term debt     3,940,000       3,474,000  
Current portion of capital leases     3,676,000       2,599,000  
                 
Total current liabilities     9,944,000       7,444,000  
                 
LONG-TERM DEBT, less current portion     11,428,000       8,803,000  
LONG-TERM CAPITAL LEASES, less current portion     16,707,000       14,367,000  
ADVANCES ON LINE OF CREDIT     7,850,000       8,500,000  
DEFERRED INCOME TAXES     3,435,000       3,182,000  
COMMITMENTS AND CONTINGENCIES (see Note 12)                
                 
SHAREHOLDERS’ EQUITY                
Common stock, no par value                
Authorized – 10,000,000 shares; Issued and outstanding shares – 4,611,000 in 2011 and 4,597,000 in 2010     8,606,000       8,606,000  
Additional paid-in capital     4,828,000       4,703,000  
Retained earnings     6,768,000       6,262,000  
                 
Total equity- American Shared Hospital Services     20,202,000       19,571,000  
Non-controlling interests in subsidiaries     4,969,000       3,473,000  
                 
Total shareholders’ equity     25,171,000       23,044,000  
                 
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY   $ 74,535,000     $ 65,340,000  

 

See accompanying notes

 

2
 

 

American Shared Hospital Services
Consolidated Statements of Operations

 

    YEARS ENDED DECEMBER 31,  
    2011     2010     2009  
Revenue:                        
Medical services   $ 17,237,000     $ 16,675,000     $ 16,768,000  
Equipment sales     4,984,000       -       -  
      22,221,000       16,675,000       16,768,000  
                         
Costs of revenue:                        
Maintenance and supplies     1,484,000       1,566,000       1,429,000  
Depreciation and amortization     6,127,000       5,888,000       6,378,000  
Cost of equipment sales     4,146,000       -       -  
Other direct operating costs     2,467,000       2,012,000       1,974,000  
      14,224,000       9,466,000       9,781,000  
                         
Gross margin     7,997,000       7,209,000       6,987,000  
                         
Selling and administrative expense     4,041,000       4,240,000       3,928,000  
Transaction costs     -       -       342,000  
Interest expense     2,367,000       2,104,000       2,064,000  
                         
Operating income     1,589,000       865,000       653,000  
                         
Interest and other income     108,000       107,000       60,000  
                         
Income before income taxes     1,697,000       972,000       713,000  
Income tax expense     208,000       166,000       247,000  
                         
Net income     1,489,000       806,000       466,000  
Less: net income attributable to non-controlling interests     (983,000 )     (749,000 )     (654,000 )
                         
Net income (loss) attributable to American Shared Hospital Services   $ 506,000     $ 57,000     $ (188,000 )
                         
Net income (loss) per share attributable to American Shared Hospital Services:                        
Earnings (loss) per common share- basic   $ 0.11     $ 0.01     $ (0.04 )
                         
Earnings (loss) per common share- diluted   $ 0.11     $ 0.01     $ (0.04 )

 

See accompanying notes

 

3
 

 

American Shared Hospital Services
Consolidated Statement of Shareholders’ Equity

 

    THREE YEARS ENDED DECEMBER 31, 2011  
                Additional                 Non-controlling        
    Common     Common     Paid-in     Retained     Sub-Total     Interests in        
    Shares     Stock     Capital     Earnings     ASHS     Subsidiaries     Total  
Balances at January 1, 2009     4,712,000     $ 8,877,000     $ 4,458,000     $ 6,393,000     $ 19,728,000     $ 3,210,000     $ 22,938,000  
Repurchase of common stock     (119,000 )     (271,000 )     -       -       (271,000 )     -       (271,000 )
Stock based compensation expense     2,000       -       135,000       -       135,000       -       135,000  
Cash distributions to non-controlling interest     -       -       -       -       -       (513,000 )     (513,000 )
Net income (loss)     -       -       -       (188,000 )     (188,000 )     654,000       466,000  
Balances at December 31, 2009     4,595,000       8,606,000       4,593,000       6,205,000       19,404,000       3,351,000       22,755,000  
Stock based compensation expense     2,000       -       110,000       -       110,000       -       110,000  
Cash distributions to non-controlling interest     -       -       -       -       -       (627,000 )     (627,000 )
Net income     -       -       -       57,000       57,000       749,000       806,000  
Balances at December 31, 2010     4,597,000       8,606,000       4,703,000       6,262,000       19,571,000       3,473,000       23,044,000  
Stock based compensation expense     14,000       -       125,000       -       125,000       -       125,000  
Non-controlling interest investment in subsidiaries     -       -       -       -       -       1,509,000       1,509,000  
Cash distributions to non-controlling interests     -       -       -       -       -       (996,000 )     (996,000 )
Net income     -       -       -       506,000       506,000       983,000       1,489,000  
Balances at December 31, 2011     4,611,000     $ 8,606,000     $ 4,828,000     $ 6,768,000     $ 20,202,000     $ 4,969,000     $ 25,171,000  

 

See accompanying notes

 

4
 

 

American Shared Hospital Services
Consolidated Statements of Cash Flows

 

    YEARS ENDED DECEMBER 31,  
    2011     2010     2009  
OPERATING ACTIVITIES                        
Net income   $ 1,489,000     $ 806,000     $ 466,000  
Adjustments to reconcile net income to net cash from operating activities:                        
Depreciation and amortization     6,272,000       6,001,000       6,492,000  
Loss (gain) on disposal of assets     (72,000 )     -       1,000  
Deferred income tax     76,000       168,000       409,000  
Stock-based compensation expense     125,000       110,000       135,000  
Changes in operating assets and liabilities:                        
Receivables     (961,000 )     76,000       573,000  
Prepaid expenses and other assets     (1,063,000 )     (76,000 )     (110,000 )
Accounts payable and accrued liabilities     957,000       99,000       (262,000 )
                         
Net cash from operating activities     6,823,000       7,184,000       7,704,000  
                         
INVESTING ACTIVITIES                        
Payment for purchase of property and equipment     (5,613,000 )     (315,000 )     (1,145,000 )
Investment in certificate of deposit     -       -       (9,000,000 )
Investment in subsidiaries by non-controlling interests     1,509,000       -       -  
Investment in convertible preferred stock     (39,000 )     -       -  
                         
Net cash from investing activities     (4,143,000 )     (315,000 )     (10,145,000 )
                         
FINANCING ACTIVITIES                        
Principal payments on long-term debt     (3,889,000 )     (5,381,000 )     (6,808,000 )
Principal payments on capital leases     (2,983,000 )     (2,784,000 )     (1,631,000 )
Long term debt financing on property and equipment     6,980,000       928,000       811,000  
Proceeds from capital lease financing on property and equipment     -       1,000,000       -  
Advances on line of credit     350,000       600,000       2,100,000  
Payments on line of credit     (1,000,000 )     -       (700,000 )
Distributions to non-controlling interests     (996,000 )     (627,000 )     (513,000 )
Stock repurchase     -       -       (271,000 )
                         
Net cash from financing activities     (1,538,000 )     (6,264,000 )     (7,012,000 )
                         
Net change in cash and cash equivalents     1,142,000       605,000       (9,453,000 )
                         
CASH AND CASH EQUIVALENTS, beginning of year     1,438,000       833,000       10,286,000  
                         
CASH AND CASH EQUIVALENTS, end of year   $ 2,580,000     $ 1,438,000     $ 833,000  
                         
SUPPLEMENTAL CASH FLOW DISCLOSURE                        
Cash paid for interest   $ 2,503,000     $ 2,446,000     $ 2,352,000  
Cash paid for income taxes   $ 90,000     $ 88,000     $ 31,000  
                         
SCHEDULE OF NONCASH INVESTING AND FINANCING ACTIVITIES                        
Acquisition of equipment with capital lease financing   $ 6,400,000     $ 9,706,000     $ 4,716,000  

 

See accompanying notes

 

5
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 1 – Business and Basis of Presentation

 

Business These financial statements include the accounts of American Shared Hospital Services (the “Company”) and its wholly-owned subsidiaries: OR21, Inc. (“OR21”); MedLeader.com, Inc. (“MedLeader”); and American Shared Radiosurgery Services (“ASRS”); ASRS’ majority-owned subsidiary, GK Financing, LLC (“GK Financing”); GKF’s wholly-owned subsidiaries, GK Financing U.K., Limited (“GKUK”) and Instituto de Gamma Knife del Pacifico S.A.C. (“GKPeru”); ASHS’ majority owned subsidiary, Long Beach Equipment, LLC (“LBE”), GKF’s majority owned subsidiaries, Albuquerque GK Equipment, LLC (“AGKE”), Jacksonville GK Equipment, LLC (“JGKE”) and EWRS, LLC (“EWRS”), and EWRS’ wholly owned subsidiary, EWRS Tibbi Cihazlar Ticaret Ltd Sti (“EWRS Turkey”).

 

The Company (through ASRS) and Elekta AB, the manufacturer of the Gamma Knife (through its wholly owned United States subsidiary, GKV Investments, Inc.), entered into an operating agreement and formed GK Financing, LLC (“GKF”). During 2011 GK Financing provided Gamma Knife units to twenty medical centers in the states of Arkansas, California, Connecticut, Florida, Illinois, Massachusetts, Mississippi, Nevada, New Jersey, New Mexico, New York, Tennessee, Oklahoma, Ohio, Pennsylvania, Texas and Wisconsin, and one in Adana, Turkey.

 

The Company also provides radiation therapy and related equipment directly to a medical center in Massachusetts and through GKF to a medical center in Adana, Turkey.

 

The Company has formed the subsidiaries GKUK, GKPeru, EWRS and EWRS Turkey for the purposes of expanding its business internationally into the United Kingdom, Peru and Turkey, LBE to provide proton beam therapy services in Long Beach, California, and AGKE and JGKE to provide Gamma Knife services in Albuquerque, New Mexico and Jacksonville, Florida. AGKE and EWRS Turkey began operation in second quarter 2011 and JGKE began operation in fourth quarter 2011. GKPeru, GKUK and LBE are under development .

 

OR21 will provide the product “The Operating Room for the 21st Century®”, which is currently under development.

 

MedLeader was formed to provide continuing medical education online and through videos for doctors, nurses and other healthcare workers. This subsidiary is not operational at this time.

 

All significant intercompany accounts and transactions have been eliminated in consolidation.

 

Note 2 – Accounting Policies

 

Use of estimates in the preparation of financial statements – In preparing financial statements in conformity with accounting principles generally accepted in the United States of America, management makes estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the reporting period. Significant accounting estimates reflected in the Company’s consolidated financial statements include the allowance for doubtful accounts, estimated useful lives of fixed assets and salvage values, and the fair value of financial instruments.  Actual results could differ from those estimates.

 

Cash and cash equivalents – The Company considers all liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Restricted cash is not considered a cash equivalent for purposes of the consolidated statements of cash flows.

 

Certificate of deposit – As of December 31, 2011, the Company had a $9,000,000 principal investment in a certificate of deposit with a bank with an interest rate of 0.45% and a maturity date in August 2012. As of December 31, 2010, the Company had a $9,000,000 principal investment in a certificate of deposit with a bank with an interest rate of 0.7% and a maturity date in August 2011.

 

6
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 2 – Accounting Policies (Continued)

 

Restricted cash – Restricted cash represents the minimum cash that must be maintained in GKF to fund operations.

 

Business and credit risk – The Company maintains its cash balances, which exceed federally insured limits, in financial institutions. At times, the Company’s funds are invested in short to long term fixed income securities that are not insured. Currently much of the Company’s cash is invested in a certificate of deposit. The Company has not experienced any losses and believes it is not exposed to any significant credit risk on cash, cash equivalents and securities. The Company monitors the financial condition of the financial institutions it uses on a regular basis.

 

All of the Company’s revenue was provided by twenty-one customers in 2011 and nineteen customers in 2010, and these customers constitute accounts receivable at December 31, 2011 and 2010. The Company performs credit evaluations of its customers and generally does not require collateral. The Company has not experienced significant losses related to receivables from individual customers or groups of customers in any particular geographic area.

 

Accounts receivable and doubtful accounts – Accounts receivable are recorded at net realizable value. An allowance for doubtful accounts is estimated based on historical collections plus an allowance for probable losses. Receivables are considered past due based on contractual terms and are charged off in the period that they are deemed uncollectible. Recoveries of receivables previously charged off are recorded as revenue when received.

 

Non-controlling interests - The Company reports its non-controlling interests as a separate component of shareholders’ equity. The Company also presents the consolidated net income and the portion of the consolidated net income allocable to the non-controlling interests and to the shareholders of the Company separately in its consolidated statements of income.

 

Property and equipment – Property and equipment are stated at cost less accumulated depreciation. Depreciation is determined using the straight-line method over the estimated useful lives of the assets, which for medical and office equipment is generally 3 – 15 years, and after accounting for salvage value on the equipment where indicated. Salvage value is based on the estimated fair value of the equipment at the end of its useful life. The Company capitalized interest of $136,000 and $342,000 in 2011 and 2010, respectively, as costs of medical equipment.

 

The Company leases Gamma Knife and radiation therapy equipment to its customers under arrangements typically accounted for as operating leases. At December 31, 2011, the Company held equipment under operating lease contracts with customers with an original cost of $77,147,000 and accumulated depreciation of $33,105,000. At December 31, 2010, the Company held equipment under operating lease contracts with customers with an original cost of $69,760,000 and accumulated depreciation of $33,611,000.

 

Investment in convertible preferred stock – As of December 31, 2011 the Company has convertible preferred stock representing an approximate 1.0% interest in Mevion Medical Systems, Inc. (“Mevion”), formerly Still River Systems, Inc., and accounts for this investment under the cost method. The cost of the Company’s investment in Mevion was $2,656,000 as of December 31, 2011 and $2,617,000 as of December 31, 2010. The Company reviews its investment in Mevion for impairment on a quarterly basis, or as events or circumstances might indicate that the carrying value of the investment may not be recoverable. See Note 4 – Convertible Preferred Stock Investment for further discussion.

 

Fair value of financial instruments – The carrying amounts of financial instruments, including cash and cash equivalents, securities, restricted cash, accounts receivable, accounts payable, and other accrued liabilities approximated their fair value as of December 31, 2011 and 2010 because of the relatively short maturity of these instruments. The fair value of the Company’s various debt obligations, discounted at currently available interest rates was approximately $35,743,000 and $29,178,000 at December 31, 2011 and 2010, respectively. The Company did not have any assets or liabilities that were carried at fair value on a recurring or nonrecurring basis at December 31, 2011 or 2010.

 

7
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 2 – Accounting Policies (Continued)

 

Revenue recognition - Revenue is recognized when services have been rendered and collectability is reasonably assured. There are no guaranteed minimum payments. The Company’s contracts are typically for a ten year term and are classified as either fee per use or retail. Retail arrangements are further classified as either turn-key or revenue sharing.

 

Revenue from fee per use contracts is recorded on a gross basis as determined by each hospital’s contracted rate. Under revenue sharing arrangements, the Company receives a contracted percentage of the reimbursement received by the hospital. The gross amount the Company expects to receive is recorded as revenue and estimated based on historical experience. Under turn-key arrangements, the Company receives payment from the hospital in the amount of its reimbursement from third party payors, and is responsible for paying all the operating costs of the Gamma Knife. The gross amount the Company expects to receive is recorded as revenue and estimated based on historical experience and hospital contracts with third party payors. Revenue estimates are reviewed periodically and adjusted as necessary. Revenue recognition is consistent with guidelines provided under the applicable accounting standards for revenue recognition.

 

Stock-based compensation – The Company measures all employee stock-based compensation awards at fair value and records such expense in its consolidated financial statements. See Note 9 for additional information on the Company’s stock-based compensation programs.

 

Income taxes – The Company accounts for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. See Note 8 for further discussion on income taxes.

 

Earnings per share – Basic earnings per share excludes dilution and is computed by dividing income available to common shareholders by the weighted average number of common shares outstanding for the year. Diluted earnings per share reflect the potential dilution that could occur if common shares were issued pursuant to the exercise of options or warrants. The following table illustrates the computations of basic and diluted earnings per share for the years ended December 31, 2011, 2010 and 2009.

 

8
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 2 – Accounting Policies (Continued)

 

    2011     2010     2009  
                   
Numerator for basic and diluted earnings per share   $ 506,000     $ 57,000     $ (188,000 )
                         
Denominator:                        
Denominator for basic earnings per share – weighted-average shares     4,607,000       4,596,000       4,656,000  
Effect of dilutive securities Employee stock options/restricted stock units     15,000       16,000       6,000  
                         
Denominator for diluted earnings per share – adjusted weighted- average shares     4,622,000       4,612,000       4,662,000  
                         
Earnings (loss) per share – basic   $ 0.11     $ 0.01     $ (0.04 )
                         
Earnings (loss) per share – diluted   $ 0.11     $ 0.01     $ (0.04 )

   

In 2011, options outstanding to purchase 570,000 shares of common stock at an exercise price range of $2.76 - $6.50 per share were not included in the calculation of diluted earnings per share because they would be anti-dilutive.

 

In 2010, options outstanding to purchase 355,000 shares of common stock at an exercise price range of $2.96 - $6.50 per share were not included in the calculation of diluted earnings per share because they would be anti-dilutive.

 

In 2009, options outstanding to purchase 599,000 shares of common stock were not included in the calculation of diluted earnings per share since they would be anti-dilutive due to the net loss of the Company.

 

Business segment information - The Company, which engages in the business of leasing radiosurgery and radiation therapy equipment to health care providers, has one reportable segment, Medical Services Revenue.

 

Recent accounting pronouncements – New authoritative accounting guidance under ASC Topic 810 “Consolidation”, effective January 1, 2010, amended prior guidance to change how a company determines when an entity is insufficiently capitalized or is not controlled through voting (or similar rights) should be consolidated. The determination of whether a company is required to consolidate an entity is based on, among other things, an entity’s purpose and design and a company’s ability to direct the activities of the entity that most significantly impact the entity’s economic performance. The new authoritative accounting guidance requires additional disclosures about the reporting entity’s involvement with variable-interest entities and any significant changes in risk exposure due to that involvement as well as its affect on the entity’s financial statements. This new authoritative accounting guidance did not have a significant impact on the Company’s financial statements.

 

9
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 3 – Property and Equipment

 

Property and equipment consists of the following:

 

    DECEMBER 31,  
    2011     2010  
             
Medical equipment and facilities   $ 80,647,000     $ 74,356,000  
Office equipment     692,000       685,000  
Deposits and construction in progress     4,764,000       6,479,000  
Deposits towards purchase of proton beam systems     2,500,000       2,500,000  
                 
      88,603,000       84,020,000  
Accumulated depreciation     (35,336,000 )     (36,660,000 )
                 
Net property and equipment   $ 53,267,000     $ 47,360,000  

 

The Company has equipment that is secured under capitalized leases, which is included in Medical equipment and facilities, with a total cost of $41,306,000 and associated accumulated depreciation of $15,122,000 as of December 31, 2011, and total cost of $28,727,000 and associated accumulated depreciation of $10,706,000 as of December 31, 2010.

 

As of December 31, 2011, the Company has $2,500,000 in deposits toward the purchase of three MEVION S250 proton beam radiation therapy (“PBRT”) systems from Mevion Medical Systems, Inc., a development-stage company. For the first two machines, the Company has a commitment to total deposits of $3,000,000 per machine until FDA approval is received, at which time the remaining balance is committed. The delivery dates for the first two machines are now anticipated to be in 2013 and 2014. For the third machine, the Company has a commitment to total deposits of $500,000 until FDA approval is received, at which time the remaining balance is committed. The Company has entered into a partnership agreement with a radiation oncology physician group, which has contributed $100,000 towards the deposits on the third machine. The Mevion PBRT system is not commercially proven and there is no assurance FDA approval will be received. The Company reviews the carrying value of these deposits for impairment on a quarterly basis, or as events or circumstances might indicate that the carrying value may not be recoverable. See Note 12-Commitments and Contingencies for additional discussion on purchase commitments.

 

Note 4 – Convertible Preferred Stock Investment

 

On April 10, 2006 the Company invested $2,000,000 for a convertible preferred stock interest in Mevion Medical Systems, formerly Still River Systems, Inc., a development-stage company based in Littleton, Massachusetts, which in collaboration with scientists from MIT’s Plasma Science and Fusion Center, is developing a medical device for the treatment of cancer patients using proton beam radiation therapy. The Company also has deposits towards the purchase of three Mevion PBRT systems as described more fully in Note 3. The PBRT systems are not currently FDA approved.

 

The Company’s initial investment in Mevion consisted of approximately 2,353,000 shares of Series B Convertible Preferred Stock. The Series B Convertible Preferred Stock is considered pari passu with previously issued Series A Convertible Preferred Stock.

 

On September 5, 2007 the Company invested approximately $617,000 for an additional equity interest in Mevion. This investment represents approximately 588,000 shares of Series C Convertible Preferred Stock, which is considered pari passu with the previously issued Series A and Series B Convertible Preferred Stock (all issues together “Preferred Stock”).

 

10
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 4 – Convertible Preferred Stock Investment (continued)

 

Since October 2008 Mevion has continued to offer a sequence of Series D rounds of funding to raise cash for its next phase of development and continued manufacture of the prototype model of the proton beam unit. Due to the troubled economy and scarcity of funds available during this time, these rounds were offered at a price less than the Company’s investment. Mevion has received approximately $65 million from these Series D rounds.

 

In mid-2011, Mevion performed a reverse stock split of all shares in which 100 shares were converted to one share. The reason for the reverse stock split was to move the number of outstanding shares and price per share more in line with industry norms. The reverse stock split did not change any investor’s relative ownership in Mevion.

 

In January 2012, Mevion announced that it had closed a $45 million Series E round of financing which will be used to accelerate the manufacturing and worldwide deployment of the Mevion S250. This round of financing was offered at a price per share higher than the effective price of the most recent Series D financing, and initially funded at 55%, with the remaining 45% due upon Mevion’s receipt of final FDA 510(k) clearance. The Company committed to invest an additional $70,000 in this round.

 

The Preferred Stock is convertible at any time at the option of the holder into shares of common stock of Mevion at a conversion price, subject to certain adjustments, but initially set at the original purchase price. The Preferred Stock has voting rights equivalent to the number of common stock shares into which it is convertible, and holders of the Preferred Stock, subject to certain exceptions, have a pro-rata right to participate in subsequent stock offerings. In the event of liquidation, dissolution, or winding up of Mevion, the Preferred Stock holders have preference to the holders of common stock, and any other class or series of stock that is junior to the Preferred Stock. Upon conversion of the Preferred Stock, the Company’s investment represents an approximate 1.0% interest in the common stock of Mevion as of December 31, 2011. The Company does not have a Board of Directors seat with Mevion.

 

The Company accounts for its investment in Mevion under the cost method and evaluates the investment for impairment on a quarterly basis or as events or circumstances might indicate that the carrying value of the investment may not be recoverable. The Company reviewed its investment in Mevion at December 31, 2011 in light of both current market conditions and the ongoing needs of Mevion to raise cash to continue its development of the first compact, single room PBRT system.

 

The lower price per share of the Series D and Series E offerings could be viewed as a reasonable estimate of the fair value of our cost-method investment, indicating that our investment is impaired. The Company estimates that there is currently an unrealized loss (impairment) of approximately $1.3 million based on the issuance of the Series E funding compared to the Company’s cost of its investment.

 

.In assessing whether the impairment is other than temporary, we evaluated the length of time and extent to which market value has been below cost, the financial condition and near term prospects of Mevion and our ability and intent to retain our investment for a period sufficient to allow for an anticipated recovery in the market value. Although the investment is not without certain risk, and the manufacture of the first unit has taken longer than originally anticipated, the Company believes that the current market value is a temporary situation brought on solely due to the continuing downturn of the economy, and is not a reflection on the progress or viability of Mevion or its PBRT design, and believes that our investment in Mevion is only temporarily impaired.

 

11
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 5 – Long-Term Debt

 

Long-term debt consists primarily of nine notes with financing companies, related to Gamma Knife and radiation therapy equipment, construction and installation, totaling $15,368,000, as of December 31, 2011. These notes accrue interest at fixed annual rates between 3.95% and 8.30%, are payable in 24 to 84 monthly installments, mature between April 2012 and December 2017, and are collateralized by the respective Gamma Knife units and radiation therapy equipment. As of December 31, 2010 long-term debt consisted of seven notes totaling $12,277,000. As of December 31, 2011 and December 31, 2010 the Company was in compliance with all debt covenants required under notes with its lenders. The following are contractual maturities of long-term debt by year at December 31, 2011:

 

Year ending December 31,      
2012     3,940,000  
2013     4,072,000  
2014     4,015,000  
2015     1,728,000  
2016     1,202,000  
Thereafter     411,000  
         
    $ 15,368,000  

 

Note 6 – Obligations Under Capital Leases

 

The Company has eleven capital lease obligations with four financing companies, collateralized by Gamma Knife equipment having an aggregate net book value of $26,184,000 at December 31, 2011. These obligations have stated interest rates ranging between 6.04% and 9.50%, are payable in 60 to 84 monthly installments, and mature between July 2012 and December 2018. As of December 31, 2010, the Company had nine capital lease obligations with five finance companies with an aggregate net book value of $18,021,000. Future minimum lease payments, together with the present value of the net minimum lease payments under capital leases at December 31, 2011, are summarized as follows:

 

    Net Present Value  
    of Minimum  
    Lease Payments  
Year ending December 31,        
2012   $ 5,132,000  
2013     4,828,000  
2014     4,372,000  
2015     4,028,000  
2016     3,361,000  
Thereafter     3,293,000  
Total capital lease payments     25,014,000  
Less imputed interest     4,631,000  
         
      20,383,000  
Less current portion     3,676,000  
    $ 16,707,000  

 

12
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 7 – Line of Credit

 

The Company has a $9,000,000 renewable line of credit with a bank that is secured by a certificate of deposit. The line of credit has been in place since June 2004 and has a maturity date of August 1, 2013. Borrowing under the line of credit is subject to interest expense at a rate equal to the bank’s prime rate minus 0.5 percentage point, or alternatively at the Company’s discretion, the LIBOR rate plus 1.0 percentage point. The Company is in compliance with all debt covenants required. As of December 31, 2011 and 2010, there was $7,850,000 and $8,500,000 borrowed against the line of credit, respectively.

 

Note 8 – Income Taxes

 

The Company has adopted accounting standards which prescribe a recognition threshold and measurement attribute for the financial statement recognition and measurement of uncertain tax positions taken or expected to be taken in a company’s income tax return, and also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. Additionally, these accounting standards specify that tax positions for which the timing of the ultimate resolution is uncertain should be recognized as long-term liabilities. The Company has made no reclassifications between current taxes payable and long term taxes payable under this guidance. Also, the Company had no amounts of unrecognized tax benefits that, if recognized, would affect its effective income tax rate for the years ended December 31, 2011, 2010 and 2009.

 

The Company’s policy for deducting interest and penalties is to treat interest as interest expense and penalties as taxes. As of December 31, 2011, the Company had no amount accrued for the payment of interest and penalties related to unrecognized tax benefits.

 

The tax return years 2006 through 2011 remain open to examination by the major domestic taxing jurisdictions to which the Company is subject. Net operating losses generated on a tax return basis by the Company for calendar years 1999 through 2004, and 2009 remain open to examination by the major domestic taxing jurisdictions.

 

Significant components of the Company’s deferred tax liabilities and assets as of December 31, 2011 and 2010 are as follows:

   

    DECEMBER 31,  
    2011     2010  
Deferred tax liabilities:                
Fixed assets   $ (6,839,000 )   $ (7,069,000 )
                 
Total deferred tax liabilities     (6,839,000 )     (7,069,000 )
                 
Deferred tax assets:                
Net operating loss carryforwards     3,330,000       3,784,000  
Accruals and allowances     415,000       236,000  
Tax credits     298,000       298,000  
Other – net     75,000       77,000  
                 
Total deferred tax assets     4,118,000       4,395,000  
                 
Valuation allowance     (224,000 )     (195,000 )
                 
Deferred tax assets net of valuation allowance     3,894,000       4,200,000  
                 
Net deferred tax liabilities   $ (2,945,000 )   $ (2,869,000 )

   

13
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 8 – Income Taxes (continued)

 

These amounts are presented in the financial statements as follows:

  

    DECEMBER 31,  
    2011     2010  
             
Current deferred tax assets   $ 490,000     $ 313,000  
Deferred income taxes (non-current)     (3,435,000 )     (3,182,000 )
                 
    $ (2,945,000 )   $ (2,869,000 )

 

The components of the provision for income taxes consist of the following:

 

    YEARS ENDED DECEMBER 31,  
    2011     2010     2009  
Current:                        
Federal   $ -     $ (25,000 )   $ (170,000 )
State   $ 128,000     $ 23,000     $ 8,000  
Foreign     4,000       -       -  
Total current     132,000       (2,000 )     (162,000 )
                         
Deferred:                        
Federal     305,000       142,000       348,000  
State     (229,000 )     26,000       61,000  
Foreign     -       -       -  
Total deferred     76,000       168,000       409,000  
                         
    $ 208,000     $ 166,000     $ 247,000  

     

The provision for income taxes differs from the amount computed by applying the U.S. federal statutory tax rate (34% in 2011, 2010 and 2009) to income before taxes as follows:

 

    YEARS ENDED DECEMBER 31,  
    2011     2010     2009  
                   
Computed expected federal income tax   $ 243,000     $ 76,000     $ 20,000  
State income taxes, net of federal benefit     (144,000 )     80,000       90,000  
Non-deductible expenses     41,000       39,000       48,000  
Other     68,000       (29,000 )     89,000  
                         
    $ 208,000     $ 166,000     $ 247,000  

   

At December 31, 2011, the Company had net operating loss carryforwards for federal income tax return purposes of approximately $8,989,000 which expire between 2019 and 2030. The Company has net operating loss carryforwards for state income tax purposes of approximately $4,011,000 that begin to expire in 2014. A substantial part of this carryforward is subject to separate return limitations.

   

14
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 8 – Income Taxes (continued)

 

The Company’s ability to utilize its net operating loss carryforwards and other deferred tax assets may be limited in the event of a 50% or more ownership change within any three-year period. Future federal net operating losses generated by the Company can be carried forward for 20 years.

  

In 2010 California Senate bill 858 was signed which suspends the ability to use net operating losses in the 2010 and 2011 tax years and extends the 20-year carryforward period to account for the suspension periods. Suspended net operating losses for 2008, 2009 and 2010 will be allowed additional carryover periods of three years, two years and one year respectively. This may give rise to a tax expense for any such taxable income rising out of the disallowable two year period.

 

It is the intention of the Company to reinvest the earnings of its non-U.S. subsidiaries in those operations. The company does not provide for U.S. income taxes on the earnings of foreign subsidiaries as such earnings are to be reinvested indefinitely. As of December 31, 2011, there is a minimal cumulative amount of earnings upon which U.S. income taxes have not been provided.

 

Note 9 – Shareholders’ Equity

 

Incentive Compensation Plan

 

In June 2010 shareholders approved an amendment and restatement of the Company’s stock incentive plan, renaming it the Incentive Compensation Plan (the “Plan”), and among other things, increasing the number of shares of the Company’s common stock reserved for issuance under the Plan to 1,630,000. The Plan provides that the shares reserved under the Plan are available for issuance to officers of the Company, other key employees, non-employee directors, and advisors. The Plan is a successor to the Company’s previous plans, and any shares awarded and outstanding under those plans were transferred to the Plan. No further grants or share issuances will be made under the previous plans.

 

The Plan provides for nonqualified stock options, qualified (or incentive stock options) and stock grants. The Plan has a provision to reduce the number of shares reserved for award and issuance under the Plan by a ratio of 1.59 shares of common stock for each share of common stock that is issued pursuant to a Full Value Award (stock grant). The Plan also provides for an Incentive Bonus Program with incentive bonus opportunities through performance unit awards and special cash incentive programs tied to the attainment of pre-established performance milestones.

 

Provisions of the Plan include an automatic annual grant to each non-employee director of options to purchase up to 2,000 shares on the date of the Company’s Annual Shareholder Meeting, at an exercise price equal to the market price of the Company’s common shares on that date, and an automatic annual grant of 500 restricted stock units of the Company’s common shares. Options and restricted stock units awarded under the automatic annual grant program for non-employee directors vest after one year. Other options may vest fully and immediately, or over periods of time as determined by the Plan Administrator, but no longer than seven years from the grant date. Discretionary options currently awarded under the Plan vest over a period of 5 years.

 

Under the Plan, a total of 50,000 restricted stock units have been granted, consisting of annual automatic grants to non-employee directors and the corporate secretary, compensation to employees and deferred compensation to non-employee directors.

 

15
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 9 – Shareholders’ Equity (Continued)

 

Changes in options outstanding under the Stock Option Plans during 2011 are as follows :

 

                Weighted        
          Weighted     Average        
          Average     Remaining     Aggregate  
    Number     Exercise     Contractual     Intrinsic  
Options   of Options     Price     Term (Years)     Value  
                         
Balance at December 31, 2010     610,000     $ 3.67                  
Granted     21,000     $ 3.15                  
Exercised     -     $ -                  
Forfeited     (53,000 )   $ 4.35                  
                                 
Balance at December 31, 2011     578,000     $ 3.59       3.13     $ -  
                                 
Exercisable at December 31, 2011     451,000     $ 3.70       3.00     $ -  

 

The weighted average grant-date fair value of the options granted during the years 2011, 2010 and 2009 was $1.51, $2.47, and $1.16 respectively. There was no total intrinsic value of options exercised during any of the years ended December 31, 2011 and 2010 and 2009.

 

There was no cash received from options exercised under any share-based payment arrangements for the years ended December 31, 2011, 2010 and 2009, and as a result, there was no actual tax benefit realized for tax deductions from option exercises in any of those years.

 

A summary of the status of the Company’s non-vested shares as of December 31, 2011, and changes during the year ended December 31, 2011 is presented below:

 

          Weighted  
          Average  
    Number     Grant-Date  
Nonvested Shares   of Options     Fair Value  
             
Nonvested at December 31, 2010     225,000     $ 1.06  
Granted     21,000     $ 1.51  
Vested     (108,000 )   $ 1.46  
Forfeited     (11,000 )   $ 2.06  
                 
Nonvested at December 31, 2011     127,000     $ 0.97  

   

16
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

   

Note 9 – Shareholders’ Equity (Continued)

  

At December 31, 2011, there was approximately $84,000 of unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Plan. This cost is expected to be recognized over a period of approximately five years.

 

The Company’s stock-based awards to employees are calculated using the Black-Scholes options valuation model. The Black-Scholes model was developed for use in estimating the fair value of traded options which have no vesting restrictions and are fully transferable. In addition, the Black-Scholes model requires the input of highly subjective assumptions including the expected stock price volatility. The Company’s stock-based awards have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the present value estimates. For these reasons, management believes that the existing models do not necessarily provide a reliable single measure of the fair value of its stock-based awards to employees.

 

The fair value of the Company’s option grants issued during 2011, 2010 and 2009 were estimated using assumptions for expected life, volatility, dividend yield, forfeiture rate, and risk-free interest rate which are specific to each award as summarized in the following table. The estimated fair value of the Company’s options is amortized over the period during which the optionee is required to provide service in exchange for the award, usually the vesting period.

 

The fair value of the Company’s option grants under the Plan in 2011, 2010 and 2009 was estimated assuming the following weighted-average assumptions:

 

    2011     2010     2009  
                   
Expected life (years)     7.0       7.0       7.0  
Expected forfeiture rate     2.0 - 3.7 %     0.0 - 4.6 %     0.0 - 2.0 %
Expected volatility     40 - 45 %     48 - 59 %     111 - 121 %
Dividend yield     0.0 %     0.0 %     0.0 %
Risk-free interest rate     3.0 - 3.3 %     3.0 - 4.1 %     3.3 - 3.5 %

 

Repurchase of Common Stock, Common Stock Warrants and Stock Options

 

In 1999 and 2001, the Board of Directors approved resolutions authorizing the Company to repurchase up to a total of 1,000,000 shares of its own stock on the open market, which the Board reaffirmed in 2008. There were no shares of the Company’s stock repurchased during 2011 or 2010. During 2009 the Company repurchased approximately 119,000 shares of its stock, of which 70,000 shares were purchased from two of the Company’s officers. There are approximately 81,000 shares remaining under this repurchase authorization.

 

Note 10 – Retirement Plan

 

The Company has a defined-contribution retirement plan (the “Retirement Plan”) that allows for a matching safe harbor contribution. For 2011, the Board of Directors elected to match participant deferred salary contributions up to a maximum of 4% of the participant’s annual compensation. Discretionary profit sharing contributions are allowed under the Retirement Plan in years that the Board does not elect a safe harbor match. The Company has accrued approximately $48,000 for the estimated safe harbor matching contribution for the year ended December 31, 2011. The Company contributed $43,000 and $48,000 to the Retirement Plan for the safe harbor match for the years ended December 31, 2010 and December 31, 2009, respectively.

 

17
 

 

American Shared Hospital Services
Notes to Consolidated Financial Statements

 

Note 11 – Operating Leases

 

The Company leases office space and equipment under operating leases expiring at various dates through 2016.

 

Future minimum payments under non-cancelable operating leases having initial terms of more than one year consisted of the following:

 

Year ending December 31,      
       
2012   $ 298,000  
2013     296,000  
2014     298,000  
2015     301,000  
2016     126,000  
         
    $ 1,319,000  

 

Payments for repair and maintenance agreements incorporated in operating lease agreements are included in the future minimum operating lease payments shown above.

 

Rent expense was $423,000, $463,000, and $437,000 for the years ended December 31, 2011, 2010 and 2009, respectively, and includes the above operating leases as well as month-to-month rental and certain executory costs.

 

Note 12 – Commitments and Contingencies

 

As of December 31, 2011, the Company has commitments to purchase three PBRT systems, four Gamma Knife Perfexion systems, one Gamma Knife model 4C system, and one radiation therapy system. These commitments total approximately $58,367,000, and the Company has made deposits and progress payments totaling approximately $6,149,000 towards the purchase of this equipment. One Perfexion system is scheduled to be installed in the second quarter 2012 at a new customer site in Turkey, and another is scheduled to be installed in the third quarter at a new customer site in Florida. The Gamma Knife model 4C system is scheduled to be installed in the second quarter 2012 at the Company’s new customer site in Peru. The two other Perfexion units are for sites yet to be determined. The three PBRT systems currently have anticipated delivery dates in 2013 and later, pending FDA approval and certain construction milestones. The deposits and progress payments are classified as deposits and construction in progress under Property and Equipment.

 

Note 13 – Major Customers

 

The Company’s revenue was provided by twenty-one customers in 2011 and nineteen customers in both 2010 and 2009. In 2011, one customer accounted for approximately 25% of total revenue. In 2010, one customer accounted for approximately 13% of total revenue. In 2009, two customers accounted for approximately 14% and 10% each of the Company’s total revenue.

 

18

Exhibit 3.2

 

BYLAWS


OF

 

AMERICAN SHARED HOSPITAL SERVICES
(a California corporation)

 

Amended and Restated
as of June 9, 2011

 

 
 

 

TABLE OF CONTENTS  

      Page
ARTICLE I - Applicability 1
   
  Section 1. Applicability of By-laws.                                      1
       
ARTICLE II - Office  
   
  Section 1. Principal Offices. 1
       
  Section 2. Change in Location or Number of Offices. 1
       
ARTICLE III- Meetings of Shareholders 1
   
  Section 1. Place of Meetings. 1
       
  Section 2. Annual Meetings. 1
       
  Section 3. Special Meetings. 3
       
  Section 4. Notice of Annual, Special or Adjourned 3
    Meetings.  
       
  Section 5. Record Date. 6
       
  Section 6. Quorum. 7
       
  Section 7. Adjournment. 7
       
  Section 8. Validation of Action Taken at Defectively 7
    Called, Noticed or Held Meetings.  
       
  Section 9. Voting for Election of Directors. 7
       
  Section 10. Proxies. 8
       
  Section 11. Inspectors of Election. 9
       
  Section 12. Action by Written Consent. 9
       
ARTICLE IV - Directors 10
   
  Section 1. Number of Directors. 10
       
  Section 2. Election of Directors. 11

 

 
 

       
  Section 3. Term of Office. 11
       
  Section 4. Vacancies. 11
       
  Section 5. Removal. 12
       
  Section 6. Resignation. 12
       
  Section 7. Fees and Compensation. 12
       
ARTICLE V - Committees of the Board of Directors. 13
   
  Section 1. Designation of Committees. 13
       
  Section 2. Powers of Committees. 13
       
ARTICLE VI -Meetings of the Board of Directors and Committees Thereof. 13
   
  Section 1. Place of Meetings. 13
       
  Section 2. Organization Meeting. 14
       
  Section 3. Other Regular Meetings. 14
       
  Section 4. Special Meetings. 14
       
  Section 5. Notice of Special Meetings. 14
       
  Section 6. Waivers, Consents and Approvals. 14
       
  Section 7. Quorum; Action at Meetings; Telephone Meetings 15
       
  Section 8. Adjournment. 15
       
  Section 9. Action Without a Meeting. 15
       
  Section 10. Meetings of and Action by Committees. 15
       
ARTICLE VII - Officers 15
   
  Section I. Officers. 15
       
  Section 2. Election of Officers. 16

 

 
 

     
  Section 3. Subordinate Officers, Etc. 16
       
  Section 4. Removal and Resignation. 16
       
  Section 5. Vacancies. 16
       
  Section 6. Chairman of the Board. 16
       
  Section 7. President. 17
       
  Section 8. Vice President. 17
       
  Section 9. Secretary. 17
       
  Section 10. Chief Financial Officer. 17
       
ARTICLE VIII - Records and Reports 18
   
  Section 1. Minute Book. 18
       
  Section 2. Share Register. 18
       
  Section 3. Books and Records of Account. 18
       
  Section 4. By-laws. 18
       
  Section 5. Inspection of Records. 19
       
  Section 6. Annual Report to Shareholders. 19
       
ARTICLE IX - Miscellaneous 19
   
  Section 1. Checks, Drafts, Etc. 19
       
  Section 2. Contracts, Etc. - How Executed. 19
       
  Section 3. Certificates of Stock. 19
       
  Section 4. Lost Certificates. 20
       
  Section 5. Representation of Shares of Other Corporations. 20
       
  Section 6. Construction and Definitions. 20
       

 

 
 

  Section 8. Permissive Indemnification. 21
       
  Section 9. Payment of Expenses in Advance. 21
       
  Section 10. Indemnity Not Exclusive. 21
       
  Section 11. Insurance Indemnification. 22
       
  Section 12. Conflicts. 22
       
ARTICLE X - Amendments 22
   
  Section 1. Amendments. 22

 

 
 

 

BYLAWS


OF

 

AMERICAN SHARED HOSPITAL SERVICES
(a California corporation)

 

ARTICLE I


Applicability

 

Section 1. Applicability of By-laws. These By-laws govern, except as otherwise provided by statute or its Articles of Incorporation, the management of the business and the conduct of the affairs of the Corporation.

 

ARTICLE II

Offices

 

Section 1. Principal Offices. The Board of Directors shall fix the location of the principal executive office of the Corporation at any place within or outside the State of California. If the principal executive office is located outside this state, and the Corporation has one or more business offices in this state, the Board of Directors shall designate a principal business office in the State of California.

 

Section 2. Change in Location or Number of Offices. The Board of Directors may change any office from one location to another or eliminate any office or offices.

 

ARTICLE III


Meetings of Shareholders

 

Section 1. Place of Meetings. Meetings of the shareholders shall be held at any place within or without the State of California designated by the Board of Directors, or, in the absence of such designation, at the principal executive office of the Corporation.

 

Section 2. Annual Meetings. (a) An annual meeting of the shareholders shall be held within 180 days following the end of the fiscal year of the Corporation at a date and time designated by the Board of Directors. Directors shall be elected at each annual meeting and any other proper business may be transacted thereat.

 

 
 

 

(b) Only persons who are nominated in accordance with the procedures set forth in this paragraph (b) shall be eligible for election as directors of the Corporation. Nominations of persons for election to the Board of Directors may be made at a meeting of shareholders by the Board of Directors or by any stockholder of the Corporation entitled to vote in the election of directors at the meeting who complies with the notice procedures set forth in this paragraph (b). Any nomination by a stockholder must be made by written notice to the Secretary delivered or mailed to and received at the principal executive offices of the Corporation (i) not less than 60 days nor more than 90 days prior to the meeting, or (ii) if less than 70 days' notice of the meeting or prior public disclosure of the date of the meeting is given or made to shareholders, not later than the close of business on the tenth day following the day on which the notice of the meeting was mailed, or, if earlier, the day on which such public disclosure was made. A shareholders' notice to the Secretary shall set forth (x) as to each person whom the stockholder proposes to nominate for election or re-election as a director: (a) the name, age, business address and residence address of such person, (2) the principal occupation or employment of such person, (3) the class and number of shares of stock of the Corporation which are beneficially owned by such person (for the purposes of the regulations under Sections 13 and 14 of the Securities Exchange Act of 1934, as amended), and (4) any other information relating to such person that would be required to be disclosed in solicitations of proxies for the election of such person as a director of the Corporation pursuant to Regulation 14A under the Securities and Exchange Act of 1934, as amended, and such person's written consent to being named in any proxy statement as a nominee and to serving as a director if elected; and (y) as to the stockholder giving notice (5)   the name and address, as they appear on the Corporation's records, of such stockholder and (6) the class and number of shares of stock of the Corporation which are beneficially owned by such stockholder (determined as provided in clause (x) (3) above). At the request of the Board of Directors any person nominated by the Board of Directors for election as a director shall furnish to the Secretary that information required to be set forth in a stockholder's notice of nomination which pertains to the nominee. The chairman of the meeting at which a stockholder nomination is presented shall, if the facts warrant, determine and declare to the meeting that such nomination was not made in accordance with the procedures prescribed by this

paragraph (b), and, in such event, the defective nomination shall be disregarded.

 

2
 

 

Section 3. Special Meetings. (a) Special meetings of the shareholders may be called by the Board of Directors, the Chairman of the Board and the President, or by the shareholders upon the request of the holders of shares entitled to cast not less than 10 percent of the votes at such meeting.

 

(b)   Any request for the calling of a special meeting of the shareholders shall (1) be in writing, (2) specify the date and time thereof, which date shall be not less than 35 nor more than 60 days after receipt of the request, (3) specify the general nature of the business to be transacted thereat in accordance with Section 4(f) below and (4) be given either personally or by first class mail, postage prepaid, or other means of written communication to the Chairman of the Board, President, any Vice President or Secretary of the Corporation. The officer receiving a proper request to call a special meeting of the shareholders shall cause notice to be given, pursuant to the provisions of Section 4 of this article, to the shareholders entitled to vote thereat, that a meeting will be held at the date and time specified by the person or persons calling the meeting. If notice is not given within 20 days of the receipt of the request, the shareholders making the request may give notice of such meeting so long as the notice given complies with the other provisions of this subsection.

 

(c)   No business may be transacted at a special meeting unless the general nature thereof was stated in the notice of such meeting.

 

Section 4. Notice of Annual, Special or Adjourned Meetings. (a) Whenever any meeting of the shareholders is to be held, a written notice of such meeting shall be given in the manner described in subdivision (d) of this section not less than 10 nor more than 60 days before the date thereof, to each shareholder entitled to vote thereat. The notice shall state the place, date and hour of the meeting and (1) in the case of a special meeting, the general nature of the business to be transacted or (2) in the case of the annual meeting, those matters which the Board of Directors, at the time of the giving of the notice, intends to present for action by the shareholders, in each case in accordance with Section 4(f) below. The notice of any meeting at which directors are to be elected shall include the name of any nominee or nominees who, at the time of the notice, management intends to present for election.

 

3
 

 

(b)   Any proper matter may be presented at an annual meeting for action. However, any action to approve (1) a contract or transaction in which a director has a direct or indirect financial interest under Section 310 of the Corporations Code of California, (2) an amendment of the articles of incorporation under Section 902 of that code, (3) a reorganization of the corporation, under Section 1201 of that code, (4) a voluntary dissolution of the corporation under Section 1900 of that code, or (5) a distribution in dissolution other than in accordance with the rights of outstanding preferred shares under Section 2007 of that code may be taken only if the notice of the meeting states the general nature of the matter to be approved.

 

(c)   Notice need not be given of an adjourned meeting if the time and place thereof are announced at the meeting at which the adjournment is taken, except that if the adjournment is for more than 45 days or if after the adjournment a new record date is provided for the adjourned meeting, a notice of the adjourned meeting shall be given to each shareholder of record entitled to vote at that meeting.

 

(d)   Notice of any meeting of the shareholders shall be given personally, by first class mail, or by telegraph or other written communication, addressed to the shareholder at his address appearing on the books of the Corporation or given by him to the Corporation for the purpose of notice; or if no such address appears or is given, at the place where the principal executive office of the Corporation is located or by publication at least once in a newspaper of general circulation in the county in which the principal executive office is located. Notice shall be deemed to have been given at the time when delivered personally to the recipient, deposited in the mail, delivered to a common carrier for transmission to the recipient or sent by other means of written communication. An affidavit of the mailing or other means of giving notice may be executed by the Secretary, assistant secretary or any transfer agent of the Corporation giving the notice and shall be prima facie evidence of the giving of the notice. Such affidavits shall be filed and maintained in the minute books of the Corporation.

 

(e)   If any notice or report addressed to the shareholder at his address appearing on the books of the Corporation is returned to the Corporation by the United States Postal Service marked to indicate that the United States Postal Service is unable to deliver the notice or report to the shareholder at such address, all future notices or reports shall be deemed to have been duly given without further mailing if the same shall be available for the shareholder upon his written demand at the principal executive office of the Corporation for a period of one year from the date of the giving of the notice or report to all other shareholders.

 

4
 

 

(f) Only such business shall be conducted at an annual or special meeting of shareholders as shall have been properly brought before the meeting. For business to be properly brought before the meeting, it must be: (i) authorized by the Board of Directors and specified in the notice, or a supplemental notice, of the meeting, (ii) otherwise brought before the meeting by or at the direction of the Board of Directors or the chairman of the meeting, or (iii) otherwise properly brought before the meeting by a shareholder. For business to be properly brought before an annual or special meeting by a shareholder, the shareholder must have given written notice thereof to the Secretary, delivered or mailed to and received at the principal executive offices of the Corporation (A) in the case of an annual meeting (x) not less than 60 days nor more than 90 days prior to the meeting, or (y) if less than 70 days' notice of the meeting or prior public disclosure of the date of the meeting is given or made to shareholders, not later than the close of business on the tenth day following the day on which the notice of the meeting was mailed or, if earlier, the day on which such public disclosure was made and (B) in the case of a special meeting, as required by Section 3(b) above. A shareholder's notice to the Secretary shall set forth as to each item of business the shareholder proposes to bring before the meeting (1) a brief description of such item and the reasons for conducting such business at the meeting, (2) the name and address, as they appear on the Corporation's records, of shareholder proposing such business, (3) the class and number of shares of stock of the Corporation which are beneficially owned by the shareholder (for purposes of the regulations under Sections 13 and 14 of the Securities Exchange Act of 1934, as amended), and (4) any material interest of the shareholder in such business. No business shall be conducted at any annual or special meeting, except in accordance with the procedures set forth in this paragraph (f). The Chairman of the meeting at which any business proposed by a shareholder shall, if the facts warrant, determine and declare to the meeting that such business was not properly brought before the meeting and shall not be transacted.

 

5
 

 

Section 5. Record Date. (a) The Board of Directors may fix a time in the future as a record date for determination of the shareholders (1) entitled to notice of any meeting or to vote thereat, (2) entitled to give written consent to any corporate action without a meeting, (3) entitled to receive payment of any dividend or other distribution or allotment of any rights or (4) entitled to exercise any rights in respect of any other lawful action. The record date so fixed shall be not more than 60 nor less than 10 days prior to the date of any meeting of the shareholders nor more than 60 days prior to any other action.

 

(b) In the event no record date is fixed:

 

(1)      The record date for determining the shareholders entitled to notice of or to vote at a meeting of shareholders shall be at the close of business on the business day next preceding the day on which notice is given or, if notice is waived, at the close of business on the business day next preceding the day on which the meeting is held.

 

(2)      The record date for determining shareholders entitled to give consent to corporate action in writing without a meeting, when no prior action by the Board of Directors has been taken, shall be the day on which the first written consent is given.

 

(3)      The record date for determining shareholders for any other purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating thereto, or the 60 t11 day prior to the date of such other action, whichever is later.

 

(c) Only shareholders of record on the close of business on the record date are entitled to notice and to vote, to give written consent or to receive a dividend, distribution or allotment of rights or to exercise the rights, as the case may be, notwithstanding any transfer of any shares on the books of the Corporation after the record date.

 

(d) A determination of shareholders of record entitled to notice of or to vote at a meeting of shareholders shall apply to any adjournment of the meeting unless the Board of Directors fixes a new record date for the adjourned meeting, but the Board shall fix a new record date if the meeting is adjourned for more than 45 days from the date set for the original meeting.

 

6
 

 

Section 6. Quorum. (a) A majority of the shares entitled to vote at a meeting of the shareholders, represented in person or by proxy, shall constitute a quorum for the transaction of business thereat.

 

(b) The shareholders present at a duly called or held meeting at which a quorum is present may continue to transact business until adjournment notwithstanding the withdrawal of enough shareholders to leave less than a quorum, if any action taken (other than adjournment) is approved by at least a majority of the shares required to constitute a quorum.

 

Section 7. Adjournment. Any meeting of the shareholders may be adjourned from time to time whether or not a quorum is present by the vote of a majority of the shares represented thereat either in person or by proxy. At the adjourned meeting the Corporation may transact any business which might have been transacted at the original meeting.

 

Section 8. Validation of Actions Taken at Defectively Called, Noticed or Held Meetings. (a) The transactions of any meeting of the shareholders, however_called and noticed, and wherever held, are as valid as though had at a meeting duly held after regular call and notice, if a quorum is present either in person or by proxy, and if, either before or after the meeting, each of the persons entitled to vote thereat, not present in person or by proxy, signs a written waiver of notice or a consent to the holding of the meeting or an approval of the minutes thereof. Any written waiver of notice shall comply with subdivision (f) of Section 601 of the Corporations Code of the State of California. All such waivers, consents and approvals shall be filed with the corporate records or made a part of the minutes of the meeting.

 

(b) Attendance of a person at a meeting shall constitute a waiver of notice of and presence at such meeting, except (1) when the person objects, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened and (2) that attendance at a meeting is not a waiver of any right to object to the consideration of any matter required by the General Corporation Law of the State of California to be included in the notice but not so included, if such objection is expressly made at the meeting.

 

Section 9. Voting for Election of Directors. (a) Except as provided in subdivision (c) of this section, the affirmative vote of the majority of the shares represented and voting at a duly held meeting at which a quorum is present (which shares voting affirmatively also constitute at least a majority of the required quorum) shall be the act of the shareholders, unless the vote of a greater number is required by law or the Articles of Incorporation.

 

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(b)   Every shareholder complying with subdivision (c) of this section and entitled to vote at any election of directors may cumulate his votes and give one candidate a number of votes equal to the number of directors to be elected, multiplied by the number of votes to which his shares are normally entitled, or distribute his votes on the same principle among as many candidates as he thinks fit.

 

(c)   No shareholder shall be entitled to cumulate his votes (i.e., cast for any candidate a number of votes greater than the number of votes which such shareholder normally is entitled to cast) unless the candidate's or candidates' names for which he desires to cumulate his votes have been placed in nomination prior to the voting and the shareholder has given notice at the meeting prior to the voting of his intention to cumulate his votes. If any one shareholder has given such notice, all shareholders may cumulate their votes for candidates in nomination.

 

(d)   Elections for directors may be by voice vote or by ballot unless any shareholder entitled to vote demands election by ballot at the meeting prior to the voting, in which case the vote shall be by ballot.

 

(e)   In any election of directors, the candidates receiving the highest number of affirmative votes of the shares entitled to be voted for them, up to the number of directors to be elected by such shares, are elected as directors.

 

Section 10. Proxies. (a) Every person entitled to vote shares may authorize another person or persons to act with respect to such shares by a written proxy signed by him or his attorney-in-fact and filed with the Secretary of the Corporation. A proxy shall be deemed signed if the shareholder's name is placed on the proxy (whether by manual signature, typewriting, telegraphic transmission or otherwise) by him or his attorney-in-fact.

 

(b) Any validly executed proxy, except a proxy which is irrevocable pursuant to subdivision (c) of this section, shall continue in full force and effect until the expiration of the term specified therein or upon its earlier revocation by the person executing it prior to the vote pursuant thereto (1) by a writing delivered to the Corporation stating that it is revoked, (2) by written notice of death of the person executing the proxy, delivered to the Corporation, (3) by a subsequent proxy executed by the person executing the prior proxy and presented to the meeting or (4) as to any meeting by attendance at such meeting and voting in person by the person executing the proxy. No proxy shall be valid after the expiration of 11 months from the date thereof unless otherwise provided in the proxy. The date contained on the form of proxy shall be deemed to be the date of its execution.

 

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(c) A proxy which states that it is irrevocable is irrevocable for the period specified therein subject to the provisions of subdivisions (e) and (f) of Section 705 of the Corporations Code of the State of California.

 

Section 11. Inspectors of Election. (a) In advance of any meeting of the shareholders, the Board of Directors may appoint either one or three persons (other than nominees for the office of director) as inspectors of election to act at such meeting or any adjournments thereof. If inspectors of election are not so appointed, or if any person so appointed fails to appear or refuses to act, the chairman of any such meeting may, and on the request of any shareholder or his proxy shall, appoint inspectors of election (or persons to replace those who so fail or refuse to act) at the meeting. If appointed at a meeting on the request of one or more shareholders or the proxies thereof, the majority of shares represented in person or by proxy shall determine whether one or three inspectors are to be appointed.

 

(b) The duties of inspectors of election and the manner of performance thereof shall be as prescribed in subdivisions (b) and (c) of Section 707 of the Corporations Code of the State of California.

 

Section 12. Action by Written Consent. (a) Subject to subdivisions (b) and (c) of this section, any action which may be taken at any annual or special meeting of the shareholders may be taken without a meeting, without a vote and without prior notice, if a consent in writing, setting forth the action so taken, is signed by the holders of outstanding shares having not less than the minimum number of votes which would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted. All such consents shall be filed with the Secretary of the Corporation and maintained with the corporate records.

 

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(b)   Except for the election of a director by written consent to fill a vacancy (other than a vacancy created by removal), directors may be elected by written consent only by the unanimous written consent of all shares entitled to vote for the election of directors. In the case of an election of a director by written consent to fill a vacancy (other than a vacancy created by removal), any such election requires the consent of a majority of the outstanding shares entitled to vote for the election of directors.

 

(c)   Unless the consents of all shareholders entitled to vote have been solicited in writing, the secretary shall give prompt notice of the corporate action approved by the shareholders without a meeting. This notice shall be given in the manner specified in subdivision (d) of Section 4 of this Article III. In the case of approval of (1) contracts or transactions in which a director has a direct or indirect financial interest under Section 310 of the Corporations Code of California, (2) indemnification of agents of the corporation, under Section 317 of that code, (3) a reorganization of the corporation, under Section 1201 of that code, or (4) a distribution in dissolution other than in accordance with the rights of outstanding preferred shares, under Section 2007 of that code, notice of such approval shall be given at least ten (10) days before the consummation of any action authorized by that approval.

 

(d)   Any shareholder giving a written consent, or his proxyholders, or a transferee of the shares or a personal representative of the shareholder or their respective proxyholders, may revoke the consent by a writing received by the Corporation prior to the time that written consents of the number of shares required to authorize the proposed action have been filed with the Secretary of the Corporation, but may not do so thereafter. Such revocation is effective upon its receipt by the Secretary of the Corporation.

 

ARTICLE IV

 


Directors

 

Section 1. Number of Directors. (a) The authorized number of directors shall depend upon the number of shareholders. If there is only one shareholder, then there will only be one director. Whenever there is more than one shareholder, then there will be no less than five nor more than nine directors. The exact number of directors shall be fixed from time to time, within the limits specified in this subdivision, by an amendment of subdivision (b) of this section adopted by the Board of Directors.

 

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(b)   The exact number of directors shall be one (1) until changed as provided in subdivision (a) of this section. Notwithstanding the preceding sentence, at all times while there is one (1) shareholder of the corporation, said shareholder may, without amending these By-laws, determine that there shall be six (6) directors. Said shareholder may elect the aforementioned six (6) directors by noticing a meeting of the shareholders of the corporation.

 

(c)   The maximum or minimum authorized number of directors may only be changed by an amendment of this section approved by the vote or written consent of a majority of the shareholders; provided, however, that an amendment reducing the minimum number to a number less than 5 shall not be adopted if the votes cast against its adoption at a meeting (or the shares not consenting in the case of action by written consent) exceed 16-2/3% of such outstanding shares; and provided, further, that in no case shall the stated maximum authorized number of directors exceed two times the stated minimum number of authorized directors minus one.

 

Section 2. Election of Directors. Directors shall be elected at each annual meeting of the shareholders.

 

Section 3. Term of Office. Each director, including a director elected to fill a vacancy, shall hold office until the expiration of the term for which he is elected and until a successor has been elected, and qualified.

 

Section 4. Vacancies. (a) A vacancy in the Board of Directors exists whenever any authorized position of director is not then filled by a duly elected director, whether caused by death, resignation, removal, change in the authorized number of directors or otherwise.

 

(b) Except for a vacancy created by the removal of a director, vacancies on the Board of Directors may be filled by a majority of the directors then in office, whether or not less than a quorum, or by a sole remaining director. A vacancy created by the removal of a director shall be filled only by a person elected by a majority of the shareholders entitled to vote at a duly held meeting at which there is a quorum present or by the unanimous written consent of the holders of the outstanding shares entitled to vote at such a meeting.

 

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(c) The shareholders may elect a director at anytime to fill any vacancy not filled by the directors. Any such nomination shall comply with the requirements of Article III, Section 2(b) of these By-laws.

 

Section 5. Removal. (a) The Board of Directors may declare vacant the office of a director who has been declared of unsound mind by an order of court or convicted of a felony.

 

(b)   Any or all of the directors may be removed without cause if such removal is approved by a majority of the outstanding shares entitled to vote; provided, however that no director may be removed (unless the entire Board of Directors is removed) if whenever the votes cast against his removal, or not consenting in writing to such removal, would be sufficient to elect such director if voted cumulatively at an - election at which the same total number of votes were cast (or, if such action is taken by written consent, all shares entitled to vote were voted) and the entire number of directors authorized at the time of his most recent election were then being elected.

 

(c)   Any reduction of the authorized number of directors does not remove any director prior to the expiration of his term of office.

 

Section 6. Resignation. Any director may resign effective upon giving written notice to the Chairman of the Board, the President, the Secretary or the Board of Directors of the Corporation, unless the notice specifies a later time for the effectiveness of such resignation. If the resignation is effective at a future time, a successor may be elected to take office when the resignation becomes effective.

 

Section 7. Fees and Compensation. Directors may be paid for their services in such capacity a sum in such amounts, at such times and upon such conditions as may be determined from time to time by resolution of the Board of Directors and may be reimbursed for their expenses, if any, for attendance at each meeting of the Board. No such payments shall preclude any director from serving the Corporation in any other capacity and receiving compensation in any manner therefor.

 

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ARTICLE V


 

Committees of the Board of Directors

 

Section 1. Designation of Committees. The Board of Directors may, by resolution adopted by a majority of the authorized number of directors, designate (1) one or more committees, each consisting of two or more directors and (2) one or more directors as alternate members of any committee, who may replace any absent member at any meeting thereof. Any member or alternate member of a committee shall serve at the pleasure of the Board.

 

Section 2. Powers of Committees. Any committee, to the extent provided in the resolution of the Board of Directors designating such committee, shall have all the authority of the Board, except with respect to:

 

(a)    The approval of any action for which the General Corporation Law of the State of California also requires any action by the shareholders;

 

(b)    The filling of vacancies on the Board or in any committee thereof;

 

(c)   The fixing of compensation of the directors for serving on the Board or on any committee thereof;

 

(d)    The amendment or repeal of these By-laws or the adoption of new By-laws;

 

(e)   The amendment or repeal of any resolution of the Board which by its express terms is not so amendable or repealable;

(f)   A distribution to the shareholders of the Corporation, except at a rate or in a periodic amount or within a price range determined by the Board of Directors; or

 

(g)   The designation of other committees of the Board or the appointment of members or alternate members thereof.

 

ARTICLE VI

 


Meetings of the Board of Directors and Committees Thereof

 

Section 1. Place and Meetings. Regular meetings of the Board of Directors shall be held at any place within or without the State of California which has been designated from time to time by the Board or, in the absence of such designation, at the principal executive office of the Corporation. Special meetings of the Board shall be held either at any place within or without the State of California which has been designated in the notice of meeting or, if not stated in the notice or if there is no notice, at the principal executive office of the Corporation.

 

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Section 2. Organization Meeting. Immediately following each annual meeting of the shareholders the Board of Directors shall hold a regular meeting for the purpose of organization and the transaction of other business. Notice of any such meeting is not required.

 

Section 3. Other Regular Meetings. Other regular meetings of the Board of Directors shall be held without call at such time as shall be designated from time to time by the Board. Notice of any such meeting is not required.

 

Section 4. Special Meetings. Special meetings of the Board of Directors may be called at any time for any purpose or purposes by the Chairman of the Board or the President or any vice president or the Secretary or any two directors. Notice shall be given of any special meeting of the Board.

 

Section 5. Notice of Special Meetings. Notice of the time and place of special meetings of the Board of Directors shall be delivered personally or by telephone to each director or sent to each director by first-class mail or telegraph, charges prepaid, addressed to each director at that director's address as shown on the records of the Corporation. Such notice shall be given four days prior to the holding of the special meeting if sent by mail or 48 hours prior to the holding thereof if delivered personally or given by telephone or telegraph. The notice or report shall be deemed to have been given at the time when delivered personally to the recipient or deposited in the mail or sent by other means of written communication. Notice of any special meeting of the Board or Directors need not specify the purpose thereof.

 

Section 6. Waivers, Consents and Approvals. Notice of any meeting of the Board of Directors need not be given to any director who signs a waiver of notice or a consent to holding the meeting or an approval of the minutes thereof, whether before or after the meeting, or who attends the meeting without protesting, prior thereto or at its commencement, the lack of notice to him. All such waivers, consents and approvals shall be filed with the corporate records or made a part of the minutes of the meeting.

 

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Section 7. Quorum; Action at Meetings; Telephone Meetings. (a) A majority of the authorized number of directors shall constitute a quorum for the transaction of business. Every act or decision done or made by a majority of the directors present is the act of the Board of Directors, unless action by a greater proportion of the directors is required by law or the Articles of Incorporation.

 

(b)     A meeting at which a quorum is initially present may continue to transact business notwithstanding the withdrawal of directors, if any action taken is approved by at least a majority of the required quorum for such meeting.

 

(c)     Members of the Board of Directors may participate in a meeting through use of conference telephone or similar communications equipment so long as all members participating in such meeting can hear one another.

 

Section 8. Adjournment. A majority of the directors present, whether or not a quorum is present, may adjourn any meeting to another time and place. If the meeting is adjourned for more than 24 hours, notice of any adjournment to another time or place shall be given prior to the time of the adjourned meeting to the directors who were not present at the time of the adjournment.

 

Section 9. Action Without a Meeting.' Any action required or permitted to be taken by the Board of Directors may be taken without a meeting, if all members of the Board individually or collectively consent in writing to such action. Such written consent or consents shall be filed with the minutes of the proceedings of the Board. Such action by written consent shall have the same force and effect as a unanimous vote of such directors.

 

Section 10. Meetings of and Action by Committees. The provisions of this Article apply to committees of the Board of Directors and action by such committees with such changes in the language of those provisions as are necessary to substitute the committee and its members for the Board and its members.

 

ARTICLE VII

 

Officers

 

Section 1. Officers. The Corporation shall have as officers, a President, a Secretary and a Chief Financial Officer. The Treasurer is the chief financial officer of the Corporation unless the Board of Directors has by resolution designated a vice president or other officer to be the chief financial officer. The Corporation may also have, at the discretion of the Board, a Chairman of the Board, one or more vice presidents, one or more assistant secretaries, one or more assistant treasurers and such other officers as may be appointed in accordance with the provisions of Section 3 of this Article. One person may hold two or more offices.

 

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Section 2. Election of Officers. The officers of the Corporation, except such officers as may be appointed in accordance with the provisions of-Section 3 or Section 5 of this Article, shall be chosen by the Board of Directors.

 

Section 3. Subordinate Officers, Etc. The Board of Directors may appoint by resolution, and may empower the Chairman of the Board, if there be such an officer, or the President, to appoint such other officers as the business of the Corporation may require, each of whom shall hold office for such period, have such authority and perform such duties as are determined from time to time by resolution of the Board or, in the absence of any such determination, as are provided in these By-laws. Any appointment of an officer shall be evidenced by a written instrument filed with the Secretary of the Corporation and maintained with the corporate records.

 

Section 4. Removal and Resignation. (a) Subject to the rights, if any, of an officer under any contract of employment, any officer may be removed, either with or without cause, by the Board of Directors or, except in case of any officer chosen by the Board, by any officer upon whom such power of removal may be conferred by resolution of the Board.

 

(b) Subject to the rights, if any, of the Corporation under any contract of employment, any officer may resign at any time effective upon giving written notice to the Chairman of the Board, President, any vice president or Secretary of the Corporation, unless the notice specifies a later time for the effectiveness of such resignation.

 

Section 5. Vacancies. A vacancy in any office because of death, resignation, removal, disqualification or any other cause shall be filled in the manner prescribed in these By-laws for regular appointments to such office.

 

Section 6. Chairman of the Board. If there is a Chairman of the Board, he shall, if present, preside at all meetings of the Board of Directors, exercise and perform such other powers and duties as may be from time to time assigned to him by resolution of the Board or prescribed by these By-laws and, if there is no President, the Chairman of the Board shall be the chief executive officer of the Corporation and have the power and duties set forth in Section 7 of this Article.

 

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Section 7. President. Subject to such supervisory powers, if any, as may be given by these By-laws or the Board of Directors to the Chairman of the Board, if there be such an officer, the President shall be the chief executive officer and general manager of the Corporation and shall, subject to the control of the Board, have general supervision, direction and control of the business and affairs of the Corporation. He shall preside at all meetings of the shareholders and, in the absence of the Chairman of the Board, or if there be none, at all meetings of the Board. He shall have the general powers and duties of management usually vested in the office of president of a corporation, and shall have such other powers and duties as may be prescribed from time to time by resolution of the Board.

 

Section 8. Vice President. In the absence or disability of the President, the vice presidents in order of their rank as fixed by the Board of Directors, or, if not ranked, the Vice President designated by the Board, shall perform all the duties of the President, and when so acting shall have all the powers of, and be subject to all the restrictions upon, the President. The vice presidents shall have such other powers and perform such other duties as from time to time may be prescribed for them respectively by the Board or as the President may from time to time delegate.

 

Section 9. Secretary. (a) The Secretary shall keep or cause to be kept (1) the minute book, (2) the share register and (3) the seal, if any, of the Corporation.

 

(b) The Secretary, an assistant secretary, or, if they are absent or unable to act, any other officer shall give, or cause to be given, notice of all meetings of the shareholders and of the Board of Directors required by these By-laws or by law to be given, and shall have such other powers and perform such other duties as may be prescribed from time to time by the Board of Directors or any committee of the Board of Directors.

 

Section 10. Chief Financial Officer. (a) The Chief Financial Officer shall keep, or cause to be kept, the books and records of account of the Corporation.

 

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(b) The Chief Financial Officer shall deposit all monies and other valuables in the name and to the credit of the Corporation with such depositories as may be designated from time to time by resolution of the Board of Directors. He shall disburse the funds of the Corporation as may be ordered by the Board of Directors, shall render to the President and the Board, whenever they request it, an account of all of his transactions as Chief Financial Officer and of the financial condition of the Corporation, and shall have such other powers and perform such other duties as may be prescribed from time to time by the Board or as the President may from time to time delegate.

 

ARTICLE VIII

 

Records and Reports

 

Section 1. Minute Book. The Corporation shall keep or cause to be kept in written form at its principal executive office or such other place as the Board of Directors may order, a minute book which shall contain a record of all actions by its shareholders, Board or committees of the Board including the time, date and place of each meeting; whether a meeting is regular or special and, if special, how called; the manner of giving notice of each meeting and a copy thereof; the names of those present at each meeting of the Board or committees thereof; the number of shares present or represented at each meeting of the shareholders; the proceedings of all meetings; any written waivers of notice, consents to the holding of a meeting or approvals of the minutes thereof; and written consents for action without a meeting.

 

Section 2. Share Register. The Corporation shall keep or cause to be kept at its principal executive office or, if so provided by resolution of the Board of Directors, at the Corporation's transfer agent or registrar, a share register, or a duplicate share register, which shall contain the names of the shareholders and their addresses, the number and classes of shares held by each, the number and date of certificates issued for the same and the number and date of cancellation of every certificate surrendered for cancellation.

 

Section 3. Books and Records of Account. The Corporation shall keep or cause to be kept at its principal executive office or such other place as the Board of Directors may order, adequate and correct books and records of account.

 

Section 4. By-laws. The Corporation shall keep at its principal executive office or, in the absence of such office in the State of California, at its principal business office in the state, the original or a copy of the By-laws as amended to date.

 

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Section 5. Inspection of Records. The shareholders and directors of the Corporation shall have all of the rights to inspect the books and records of the Corporation that are specified in Section 213 and 1600 through 1602 of the Corporations Code of the State of California.

 

Section 6. Annual Report to Shareholders. The Board of Directors shall cause an annual report to be sent to the shareholders not later than 120 days after the close of the fiscal year of the Corporation. Such report shall comply with the provisions of Section 1501 of the Corporations Code of the State of California and shall be sent in the manner specified in Section 4 (d) of Article III at least 15 days prior to the annual meeting of shareholders to be held during the next fiscal year.

 

ARITCLE IX

 

Miscellaneous

 

Section 1. Checks, Drafts, Etc.- All checks, drafts or other orders for payment of money, notes or other evidences of indebtedness, and any assignment or endorsement thereof, issued in the name of or payable to the Corporation, shall be signed or endorsed by such person or persons and in such manner as, from time to time, shall be determined by resolution of the Board of Directors.

 

Section 2. Contracts, Etc. - How Executed. The Board of Directors, except as otherwise provided in these By-laws, may authorize any officer or officers, agent or agents, to enter into any contract or execute any instrument in the name of and on behalf of the Corporation, and such authority may be general or confined to specific instances; and, unless so authorized or ratified by the Board, no officer, employee or other agent shall have any power or authority to bind the Corporation by any contract or engagement or to pledge its credit or to render it liable for any purpose or to any amount.

 

Section 3. Certificates of Stock. A certificate or certificates for shares of the capital stock of the Corporation shall be issued to each shareholder when the shares are fully paid or the Board of Directors may authorize the issuance of certificates for shares as partly paid provided that these certificates shall conspicuously state the amount of the consideration to be paid for them and the amount already paid. All certificates shall be signed in the name of the Corporation by the Chairman of the Board or the President or a vice president and by the Chief Financial Officer or an assistant treasurer or the Secretary or an assistant secretary, certifying the number of shares and the class or series thereof owned by the shareholder. Any or all of the signatures on a certificate may be by facsimile signature. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate shall have ceased to be such officer, transfer agent or registrar before such certificate is issued, it may be issued by the Corporation with the same effect as if such person were an officer, transfer agent or registrar at the date of issue.

 

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Section 4. Lost Certificates. Except as provided in this section, no new certificate for shares shall be issued in lieu of an, old certificate unless the latter is surrendered to the Corporation and canceled at the same time. The Board of Directors may in case any share certificate or certificate for any other security is lost, stolen or destroyed-, authorize the issuance of a new certificate in lieu thereof, upon such terms and conditions as the Board may require, including provision for indemnification of the Corporation secured by a bond or other adequate security sufficient to protect the Corporation against any claim that may be made against it, including any expense or liability, on account of the alleged loss, theft or destruction of such certificate or the issuance of such new certificate.

 

Section 5. Representation of Shares of Other Corporations. Any person designated by resolution of the Board of Directors or, in the absence of such designation, the Chairman of the Board, the President or any vice president or the Secretary, or any other person authorized by any of the foregoing, is authorized to vote on behalf of the Corporation any and all shares of any other corporation or corporations, foreign or domestic, owned by the Corporation.

 

Section 6. Construction and Definitions. Unless the context otherwise requires, the general provisions, rules of construction and definitions contained in the Corporations Code of the State of California shall govern the construction of these By-laws.

 

Section 7. Mandatory Indemnification of Directors. The Corporation shall, to the maximum extent and in the manner permitted by the California Corporations Code ("Code"), indemnify each of its directors against expenses (as defined in Section 317(a) of the Code), judgments, fines, settlements, and other amounts actually and reasonably incurred in connection with any proceeding (as defined in Section 317 (a) of the Code), arising by reason of the fact that such person is or was an agent of the Corporation. For purposes of this Article IX, a "director" of the Corporation includes any person (i) who is or was a director of the Corporation, (ii) who is or was serving at the request of the Corporation as a director of another Corporation, partnership, joint venture, trust or other enterprise, or (iii) who was a director of a corporation which was a predecessor corporation of the Corporation or of another enterprise at the request of such predecessor corporation.

 

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Section 8. Permissive Indemnification. The Corporation shall have the power, to the extent and in the manner permitted by the Code, to indemnify each of its officers, employees and agents against expenses (as defined in Section 317(a) of the Code), judgments, fines, settlements, and other amounts actually and reasonable incurred in connection with any proceeding (as defined in Section 317(a) of the Code), arising by reason of the fact that such person is or was an agent of the Corporation.

 

For purposes of this Article IX, an "employee" or "agent" of the Corporation (other than a director, includes any person (i) who is or was an employee or agent of the Corporation, (ii) who is or was serving at the request of the Corporation as an employee or agent of another corporation, partnership, joint venture, trust or other enterprise, or (iii) who was an employee or agent of the Corporation which was a predecessor corporation of the Corporation or of another enterprise at the request of such predecessor corporation.

 

Section 9. Payment of Expenses in Advance. Expenses incurred in defending any civil or criminal action or proceeding for which indemnification is required pursuant to Section 7 or for which indemnification is permitted pursuant to Section 8 following authorization thereof by the Board of Directors, in the case of directors shall and in the case of other agents of the corporation entitled to indemnification may, be paid by the corporation in advance of the final disposition of such action or proceeding upon receipt of an undertaking by or on behalf of the indemnified party to repay such amount if it shall ultimately be determined that the indemnified party is not entitled to be indemnified as authorized in this Article IX.

 

Section 10. Indemnity Not Exclusive. The indemnification provided by this Article IX shall not be deemed exclusive of any other rights to which those seeking indemnification may be entitled under any bylaw, agreement, vote of shareholders or disinterested directors or otherwise, both as to action in an official capacity and as to action in another capacity while holding such office, to the extent that such additional rights to indemnification are authorized in the Articles of Incorporation.

 

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Section 11. Insurance Indemnification. The Corporation shall have the power to purchase and maintain insurance on behalf of any person who is or was an agent of the Corporation against any liability asserted against or incurred by such person in such capacity or arising out of such person's status as such, whether or not the Corporation would have the power to indemnify him against such liability under the provisions of this Article IX.

 

Section 12. Conflicts. No indemnification or advance shall be made under this Article IX, except where such indemnification or advance is mandated by law or the order, judgment or decree of any court of competent jurisdiction, in any circumstance where it appears:

 

(1)     That it would be inconsistent with a provision of the Articles of Incorporation, these By-laws, a resolution of the shareholders or an agreement in effect at the time of the accrual of the alleged cause of the action asserted in the proceeding in which the expenses were incurred or other amounts were paid, which prohibits or otherwise limits indemnification; or

 

(2)     That it would be inconsistent with any condition expressly imposed by a court in approving a settlement.

 

ARTICLE X

 

Amendments

 

Section 1. Amendments. New By-laws may be adopted or these By-laws may be amended or repealed by the affirmative vote or written consent of a majority of the outstanding shares entitled to vote. Subject to the next preceding sentence, Bylaws (other than a bylaw or amendment thereof specifying or changing a fixed number of directors or the maximum or minimum number, or changing from fixed to a variable board or vice versa) may be adopted, amended or repealed by the Board of Directors.

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Exhibit 10.63

 

LEKSELL GAMMA KNIFE PERFEXION

PURCHASED SERVICES AGREEMENT

 

THIS PURCHASED SERVICES AGREEMENT ("Agreement") is made and entered into as of August 5, 2011 (the "Effective Date"), by and between JACKSONVILLE GK EQUIPMENT, LLC, a Delaware limited liability company ("JGKE") and ST. VINCENT’S MEDICAL CENTER, INC., a Florida non-profit corporation, ("Medical Center"), with reference to the following facts:

 

RECITALS

 

WHEREAS, Medical Center wants to obtain the right to use (the "Service") a Leksell Gamma Knife Perfexion, including all associated and necessary software (the "Equipment"), manufactured by Elekta Instruments, Inc., a Georgia corporation ("Elekta"); and

 

WHEREAS, JGKE is willing to provide Medical Center with the right to use the Equipment which JGKE has acquired from Elekta, pursuant to the terms and conditions of this Agreement.

 

AGREEMENT

 

NOW, THEREFORE, in consideration of the mutual covenants, conditions and agreements set forth herein, and for such other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

 

1.             Right to Use the Equipment . Subject to and in accordance with the covenants and conditions set forth in this Agreement, JGKE hereby grants the right to use the Equipment to Medical Center, including all software sublicensed to Medical Center by Elekta pursuant to the End User License Agreement between Elekta and Medical Center, and Medical Center hereby accepts the right to use the Equipment from JGKE. The Equipment to be placed at the Medical Center pursuant to this Agreement shall include the Gamma Knife technology as specified in Exhibit 1 , including all hardware and software related thereto.

 

2.             LGK Agreement . Simultaneously with the execution of this Agreement, Medical Center and Elekta shall enter into that certain Leksell Gamma Knife End User Agreement pertaining to the Equipment (the "LGK Agreement"), a copy of which is attached hereto as Exhibit 2 . Medical Center shall perform, satisfy and fulfill all of its obligations arising under the LGK Agreement when and as required thereunder. Medical Center acknowledges that JGKE is a third party beneficiary of the LGK Agreement and, in that capacity, JGKE shall be entitled to enforce the terms and provisions of the LGK Agreement.

 

 
 

 

3.             Term of the Agreement . The initial term of this Agreement (the "Term") shall commence as of the date hereof and, unless earlier terminated or extended in accordance with the provisions of this Agreement, shall continue for a period of ten (10) years following the date of the performance of the first clinical Procedure (as defined in Section 8) performed on the Equipment (the "First Procedure Date") at the Site (as defined in Section 5.1). The parties agree to amend this Agreement to memorialize the First Procedure Date upon the performance of the first clinical Procedure performed on the Equipment. Medical Center’s obligation to make the "Purchased Services Payments" to JGKE for the Equipment described in Section 8 below shall commence as of the First Procedure Date.

 

4.             User License . Medical Center shall apply for and use its reasonable efforts to obtain in a timely manner a User License from the Nuclear Regulatory Commission and, if necessary, from the applicable state agency authorizing it to take possession of and maintain the Cobalt supply required in connection with the use of the Equipment during the term of this Agreement. Medical Center also shall apply for and use its best efforts to obtain in a timely manner all other licenses, permits, approvals, consents and authorizations which may be required by state or local governmental or other regulatory agencies for the development, construction and preparation of the Site, the charging of the Equipment with its Cobalt supply, the conduct of acceptance tests with respect to the Equipment, and the use of the Equipment during the Term, as more fully set forth in Article 2.1 of the LGK Agreement. JGKE shall provide all necessary assistance to the Medical Center in applying for and for obtaining all such licenses, permits, approvals, consents or authorizations. If the applicable regulatory authorities affirmatively decline to issue a required license, permit, approval, consent or authorization notwithstanding Medical Center’s best efforts to obtain the same, all parties shall be released from further performance or any obligations or duties arising under this Agreement and this Agreement shall terminate immediately with no penalty to Medical Center.

 

5.             Delivery of Equipment; Site .

 

5.1      JGKE shall coordinate with Elekta and Medical Center to have the Equipment delivered to Medical Center at the site, as described in Exhibit 5.1 of this Agreement (the "Site"), which delivery is anticipated to be on or before October 2011, a date which has been mutually agreed to by the parties, subject to all approvals and User Licenses having been obtained by Medical Center. Elekta and JGKE shall, at their cost, expense and risk, coordinate and cause all Equipment to be delivered to Medical Center FOB Destination and C.I.F. For the purposes of this Section, C.I.F. shall mean that the pricing set forth herein includes the insurance, freight, and transport costs and that risk of loss of the Equipment shall pass to Medical Center upon installation of Equipment at Site.

 

5.2      Upon advance notice and at a mutually agreeable time, Medical Center shall provide reasonable access to the Site for the delivery of Equipment. Medical Center at its cost and expense shall prepare the Site for the Equipment in accordance with Elekta’s guidelines, specifications, technical instructions and site planning criteria (which site planning criteria are attached as Exhibit 3 of this Agreement) (collectively the "Site Planning Criteria"). The location of the Site has been agreed upon by Medical Center and JGKE as described in Exhibit 3 of this Agreement.

 

 
 

 

6.             Site Preparation and Installation of Equipment and Acceptance .

 

6.1      Medical Center, at its cost, expense and risk, shall prepare all plans and specifications required to construct and improve the Site for the installation, use and operation of the Equipment during the Term. The plans and specifications shall comply in all respects with the Site Planning Criteria and with all applicable federal, state and local laws, rules and regulations. All plans and specifications prepared by or on behalf of Medical Center (and all material changes thereto following approval by JGKE and Elekta) shall be subject to the written approval of JGKE and Elekta prior to commencement of construction at the Site. Medical Center shall provide JGKE and Elekta with a reasonable period of time (not to exceed fourteen (14) days) for the review and consideration of all plans and specifications following the submission thereof for approval (and JGKE shall not unreasonably withhold or delay its approval). Following approval of the plans and specifications by JGKE and Elekta, Medical Center, at its cost and expense, shall use best efforts to obtain all permits, certifications, approvals or authorizations required by applicable federal, state or local laws, rules or regulations necessary to construct and improve the Site for the installation, use and operation of the Equipment. JGKE and Elekta will provide all necessary assistance to Medical Center in obtaining such permits and/or approvals.

 

6.2      Based upon the plans and specifications approved by JGKE and Elekta, Medical Center, at its cost, expense and risk, subject to the reimbursement provided herein, shall prepare, construct and improve the Site as necessary for the installation, use and operation of the Equipment during the Term, including, without limitation, providing all temporary or permanent shielding required for the charging of the Equipment with the Cobalt supply and for its subsequent use, selecting and constructing a proper foundation for the Equipment and the temporary or permanent shielding, aligning the Site for the Equipment, and installing all electrical systems and other wiring required for the Equipment, which are identified in the Site Planning Criteria, and secure/authorized badge entry to the Site compatible with Medical Center’s systems. In connection with the construction of the Site, Medical Center shall select, purchase and install all radiation monitoring equipment, devices, safety circuits and radiation warning signs required, if any, at the Site in connection with the use and operation of the Equipment, all in accordance with applicable federal, state and local laws, rules, regulations or custom. The foregoing construction and radiation safety products and services shall not be considered a Medical Center Direct Operating Expenses but shall be considered as part of the Program for valuation purposes.

 

6.3      Medical Center, at its cost, expense and risk, shall be responsible for the installation of the Equipment at the Site, including the positioning of the Equipment on its foundation at the Site in compliance with the Site Planning Criteria. Notwithstanding any of the above, such cost and expense shall not exceed *.

 

 
 

 

6.4      Medical Center warrants and ensures that upon completion of preparation, construction, and improvement of the Site, and delivery of Equipment, (a) the Site shall comply in all material respects with the Site Planning Criteria and all applicable federal, state and local laws, rules and regulations, and (b) with respect to those portions of the Site that are not addressed by the Site Planning Criteria, the Site shall be safe and suitable for the ongoing use and operation of the Equipment during the Term.

 

6.5      The parties shall use their reasonable efforts to satisfy their obligations under this Section 6 in a timely manner. The parties shall keep each other informed on a regular basis of the progress in the design of the Site, the preparation of plans and specifications, the construction and improvement of the Site, and the satisfaction of its other obligations under this Section 6. In all events, all construction and improvement of the Site required for the installation, positioning and testing of the Equipment shall be completed on or prior to the delivery date described in Section 5.1 above. During the Term, Medical Center, at its cost and expense, shall maintain the Site in a good working order, condition and repair, reasonable wear and tear excepted.

 

6.6       Medical Center shall have accepted the Equipment when Medical Center’s physicist has approved the Equipment in accordance with Elekta’s technical specifications which have been provided to Medical Center. Medical Center’s physicist shall use best efforts to reasonably approve the Equipment and the Equipment shall be accepted prior to any Procedures.

 

7.              Marketing .

 

7.1       Not less than ninety (90) days prior to the First Procedure Date and the commencement of each succeeding twelve (12) month period during the Term, JGKE and Medical Center shall jointly develop an annual marketing plan, budget and timeline for the clinical service to be supported by the Equipment for the succeeding twelve (12) month period of the Term (the "Plan"), which Plan shall be implemented by Medical Center based on the approved budget and timeline. The Plan shall require the approval of both JGKE and Medical Center; however, neither party’s approval of such Plan shall be unreasonably withheld or delayed. If Medical Center has not approved or disapproved the same within thirty (30) days following its receipt, Medical Center shall be deemed to have approved the same. Funds expended by Medical Center in accordance with the Plan shall be deemed "Medical Center’s Direct Operating Expenses," and shall be reimbursed from the "Gross Technical Component Collections" (as such quoted term is defined in Section 8 below); provided that (a) if the Gross Technical Component Collections during any month are insufficient to cover Medical Center’s Direct Operating Expenses, then such expenses shall be carried forward until reimbursed from future Gross Technical Component Collections; and (b) Medical Center shall make available upon request invoices (together with documentary evidence supporting the invoices) for marketing expenditures paid to unrelated third parties that are included in the Plan. The annual marketing budget will not exceed * in the aggregate.

 

Medical Center shall use commercially reasonable efforts to promote the Program and to encourage the use thereof by the public and medical community.

 

 
 

 

8.             Purchased Services Payments .

 

8.1          The parties acknowledge that the compensation payable to JGKE for the Equipment as set forth in this Agreement has been established by the parties pursuant to a fair market value appraisal by an independent, qualified appraisal firm. Based thereon, the Parties believe that the Purchased Services Payments represent fair market value for the use of the Equipment, and the other services provided hereunder.

 

8.2          In consideration for and as compensation to JGKE for the use of the Equipment by Medical Center pursuant to this Agreement, Medical Center shall pay to JGKE, on a monthly basis, the applicable "Purchased Services Payments" (as defined below) for each "Procedure" that is performed by Medical Center, whether on an inpatient or outpatient basis, and irrespective of whether the Procedure is performed on the Equipment or using any other equipment or devices. As used herein:

 

(a)       " Purchased Services Payments " shall be equal to the percentage (%) (set forth in Schedule 1 of this Agreement) of the "Net Technical Component Collections" for the applicable period relating to each Procedure performed using the Equipment and/or any other equipment or devices at the Site during the Term of this Agreement.

 

(b)       " Net Technical Component Collections " shall mean the *.

 

(c)       " Gross Technical Component Collections " means the total amount actually collected (less any uncontested returns or refunds) by Medical Center during each month from any and all payor sources, including, without limitation, patients, insurance companies, state or federal government programs or any other third party payors, including, without limitation, all copayments and deductibles, as reimbursement for the technical component of all services (including, but not limited to, treatment planning and delivery) pertaining to each Procedure performed on the Equipment and/or any other equipment or devices during the term of this Agreement . Subject to all applicable legal requirements, Medical Center agrees that it will utilize best efforts to maximize third party reimbursement for the Gamma Knife program and revenues from the Gamma Knife program; provided, however, JGKE acknowledges and agrees that Medical Center may perform Procedures on patients who qualify under Medical Center’s guidelines for free or reduced cost care regardless of such patients’ ability to pay.

 

(d)       " JGKE's Direct Operating Expenses " shall equal *.

 

 
 

 

(e)       " Medical Center's Direct Operating Expenses " shall be *.

 

(f)        " Procedure " means any treatment that involves stereotactic, external, single fraction, conformal radiation, commonly called radiosurgery, that may include one or more isocenters during the patient treatment session, delivered to any site(s) superior to the foramen magnum.

 

8.3          Within twenty (20) days after the last day of each month (or portion thereof) during the term of this Agreement, (a) Medical Center shall inform JGKE in writing as to (i) the number of Procedures performed during that month utilizing the Equipment (and, if applicable, any other equipment or devices); and (ii) the Gross Technical Component Collections during that month; and (b) each party shall inform the other party in writing as to such party's respective Direct Operating Expenses relating to that month which shall be determined in good faith in accordance with Generally Accepted Accounting Principles ("GAAP") consistently applied and the terms of this Agreement. Notwithstanding anything to the contrary contained in this Agreement, neither party shall have the right to recover its Direct Operating Expenses that are known (or reasonably should have been known) but are submitted more than six (6) months after being incurred by such party. Medical Center certifies that all claims submitted for reimbursement to the appropriate payors shall be in accordance with its standard billing and collection policies and procedures which provide that claims shall be submitted within twenty (20) days of (i) each outpatient Procedure and (ii) discharge for each inpatient Procedure. If no Gross Technical Component Collections are received during any month, then, no Purchased Services Payments shall be owing by Medical Center to JGKE for that month, subject however, to each party’s right to recover its respective Direct Operating Expenses as set forth in Section 8.5 below.

 

8.4          During the Term of this Agreement, Medical Center shall, by the twenty-fifth (25th) day of each month, remit JGKE’s aggregate Purchased Services Payment, together with JGKE's Direct Operating Expenses, for the immediately preceding month, and, for a period of twenty-five (25) months following the termination or expiration of this Agreement (the "Collections Run-Out Period"), Medical Center shall, by the twenty-fifth (25th) day of each such month, continue to remit JGKE’s aggregate Purchased Services Payment pertaining to Gross Technical Component Collections received during the Collections Run-Out Period (which Purchased Services Payments during the Collections Run Out Period shall be calculated without deduction for any Direct Operating Expenses, unless such Direct Operating Expenses were carried forward from, and relate to, any period prior to the termination or expiration of the Agreement). All or any portion of any Purchased Services Payment and/or JGKE’s Direct Operating Expenses which are not paid in full within forty-five (45) days after its due date shall bear interest at the rate of one and one-half percent (1.50%) per month (or the maximum monthly interest rate permitted to be charged by law between an unrelated, commercial borrower and lender, if less) until the unpaid Purchased Services Payment and/or JGKE’s Direct Operating Expenses, together with all accrued interest thereon are paid in full. JGKE will accept payment from Medical Center in the following forms: check and electronic funds transfer. If JGKE shall at any time accept any Purchased Services Payment and/or JGKE’s Direct Operating Expenses from Medical Center after it shall become due, such acceptance shall not constitute or be construed as a waiver of any or all of JGKE’s rights under this Agreement, including the rights of JGKE set forth in Section 19 hereof.

 

 
 

 

8.5          Notwithstanding the foregoing, with respect to any month for which Gross Technical Component Revenues are equal to or less than the sum of each party's respective Direct Operating Expenses, such Gross Technical Component Revenues shall be used to pay the pro rata portion of Medical Center's Direct Operating Expenses and JGKE's Direct Operating Expenses (which portion shall be equal to the proportion that each party's Direct Operating Expenses bears to the whole). Any shortfall in the reimbursement of each party's Direct Operating Expenses shall be carried over to the next month(s) and shall be paid in full from Gross Technical Component Revenues prior to the payment of any Purchased Services Payment to JGKE.

 

8.6           Within thirty (30) days after the close of each month, Medical Center shall provide JGKE with a written report indicating the status of billings and collections for each Procedure performed during that month using the Equipment and/or any other equipment or devices, including, without limitation, the amount of the claim submitted and the amount received for each such Procedure provided, however, Medical Center shall not identify the patient or payor.

 

8.7            Inspection of Records and Record Retention. Throughout the initial Term and any successive terms, and thereafter until final settlement of all amounts owed to or claimed by either party under this Agreement, each party, at its own expense, shall have the right upon request and from time-to-time, not more than once annually, to inspect, audit and copy the other party's books and records which relate to the accounting for and calculation of Gross Technical Component Revenues, Net Technical Component Revenues, and each party’s respective Direct Operating Expenses; provided that any patient names or identifiers shall not be disclosed. JGKE acknowledges that Medical Center's managed care contracts may contain confidentiality provisions that prohibit Medical Center from disclosing payment rates to JGKE. Accordingly, Medical Center agrees to provide payment rates to JGKE’s designated auditing firm for purposes of auditing and monitoring the Purchase Services Payments and other obligations contemplated by the parties under this Agreement. JGKE’s designated auditing firm shall agree to (i) only use the payment rate information in connection with this Agreement, and (ii) disclose to JGKE the minimum amount information regarding payment rates as necessary for JGKE to audit and monitor the Purchased Services Payments and other obligations contemplated by the parties under this Agreement; provided, however, JGKE's auditing firm shall in no case share Medical Center's payment rates with JGKE.

 

8.8           Reimbursement Rate for Gamma Knife Procedures . Medical Center shall use commercially reasonable efforts to renegotiate Medical Center's existing managed care contracts to include coverage for stereotactic radiosurgery services utilizing the Equipment to be provided through the Program and to include in new managed care contracts provisions covering such services. It is understood that certain Procedures may be performed on the Equipment for research or charity purposes. The parties shall mutually agree in advance as to the number of research procedures that will be performed.

 

8.9           Survival . The provisions of this Section 8 shall survive the termination or expiration of this Agreement.

 

 
 

 

8.10           Stark Law Compliance . The parties agree and acknowledge that pursuant to the federal Stark Law, in the event any physician(s) (or immediate family member) has a direct or indirect ownership or investment interest in JGKE at any time during the term of this Agreement, such physician-owner(s) shall not "refer" to Medical Center for any "designated health services," including but not limited to laboratory, radiology, radiation therapy, and inpatient/outpatient hospital services, and shall not direct any other physician to make a "referral" to Medical Center, and shall not control the "referrals" of any other physician to Medical Center. The parties further agree that for purposes of the Stark Law, the term "referral" does not include a request by a radiation oncologist for radiation therapy or ancillary services necessary for, and integral to, the provision of radiation therapy, if the request results from a "consultation" initiated by another physician; and (ii) the tests or services are furnished by or under the supervision of radiation oncologist or another radiation oncologist in the same group practice. A "consultation" means a professional service furnished to a patient by a physician if the following conditions are satisfied: (i) the physician's opinion or advice regarding evaluation or management or both of a specific medical problem is requested by another physician; (ii) the request and need for the consultation are documented in the patient's medical record; and (iii) after the consultation is provided, the physician prepares a written report of his or her findings, which is provided to the physician who requested the consultation. With respect to radiation therapy services provided by a radiation oncologist, a course of radiation treatments over a period of time will be considered to be pursuant to a consultation, provided that the radiation oncologist communicates with the referring physician on a regular basis about the patient's course of treatment and progress. On or before the Effective Date of this Agreement, JGKE shall cause each physician (or immediate family member) with a direct or indirect ownership or investment interest in JGKE to execute the Physician Acknowledgement attached hereto as Attachment 1 and incorporated herein.

 

9.            Use of the Equipment .

 

9.1          The Equipment shall be used by Medical Center only at the Site and shall not be removed therefrom. Medical Center shall use the Equipment only in the regular and ordinary course of Medical Center’s business operations and only within the capacity of the Equipment as determined by Elekta’s specifications, unless otherwise authorized in writing by JGKE and Elekta. Medical Center shall not use or permit the Equipment to be used in any manner or for any purpose which, the Equipment is not designed or reasonably suitable, unless otherwise authorized in writing by JGKE and Elekta.

 

9.2          Notwithstanding anything to the contrary contained in this Agreement, this is an agreement of purchasing the Service only. JGKE shall only offer to Medical Center the Service pursuant to the terms and conditions of this Agreement. Nothing herein shall be construed as conveying to Medical Center any right, title or interest in or to the Equipment, except for the express right to use the Equipment granted herein to Medical Center during the Term. All Equipment shall remain personal property (even though said Equipment may hereafter become attached or affixed to real property) and the title thereto shall at all times remain exclusively in JGKE.

 

 
 

 

9.3          During the Term, upon the request of JGKE, Medical Center shall promptly affix to the Equipment an identifying label supplied by JGKE indicating JGKE’s ownership of the Equipment, and shall keep the same affixed for the entire Term. Medical Center hereby authorizes JGKE to cause this Agreement or any statement or other instrument showing the interest of JGKE in the Equipment to be filed or recorded, or refiled or re-recorded, with all governmental agencies considered appropriate by JGKE. Medical Center also shall promptly execute and deliver, or cause to be executed and delivered, to JGKE any statement or instrument reasonably requested by JGKE for the purpose of evidencing JGKE’s interest in the Equipment, including UCC financing statements and other relevant statements and waivers with respect to rights in the Equipment from any owners or mortgagees of any real estate where the Equipment may be located.

 

9.4          At Medical Center's cost and expense, Medical Center shall use commercially reasonable efforts to (a) protect and defend JGKE’s ownership of and title to the Equipment from and against all persons claiming against or through Medical Center, (b) at all times keep the Equipment free from any and all liens, encumbrances, attachments, levies, executions, burdens, charges or legal processes imposed against Medical Center, and (c) give JGKE written notice of any matter described in this clause within five (5) business days of Medical Center’s knowledge thereof, and (d) in the manner described in Section 21 below indemnify JGKE harmless from and against any loss, cost or expense (including reasonable attorneys’ fees) with respect to any of the foregoing.

 

10.           Additional Covenants of Medical Center . In addition to the other covenants of Medical Center contained in this Agreement, Medical Center shall, at its cost and expense:

 

10.1          Provide properly trained professional, technical and support personnel and supplies required for the proper performance of Gamma Knife procedures utilizing the Equipment. In this regard, Medical Center shall make reasonable efforts to maintain on staff a minimum of two (2) Gamma Knife trained teams comprised of neurosurgeons, radiation oncologists and physicists. The Gamma Knife shall be available for use by all credentialed neurosurgeons, radiation oncologists and physicists.

 

10.2          Direct, supervise and administer the provision of all services relating to the performance of Procedures utilizing the Equipment in accordance with all applicable laws, rules and regulations.

 

10.3          Keep and maintain the Equipment and the Site secure and free from unauthorized access or use by any person to the extent that Medical Center provides security for its other radiation oncology services.

 

10.4          Operate a radiation therapy department at the Site. JGKE acknowledges that the Equipment will be located on the same campus as the radiation therapy department, in a different but physically connected building.

 

 
 

 

11.           Additional Covenants of JGKE . In addition to the other covenants of JGKE contained in this Agreement, JGKE, at its cost and expense, shall:

 

11.1          Use its best efforts to require Elekta to meets its contractual obligations to JGKE and Medical Center upon delivery of the Equipment and put the Equipment, as soon as reasonably possible, into good, safe and serviceable condition and fit for its intended use in accordance with the manufacturer’s specifications, guidelines and field modification instructions.

 

11.2          Cause Medical Center to enjoy the use of the Equipment, free of the rights of any other persons except for those rights reserved by JGKE or granted to Elekta under the LGK Agreement.

 

11.3          Cover the tuition costs for up to ten (10) Perfexion training slots for physicians and physicists who will be using the Equipment. In accordance with Medical Center’s policies, copies of which have been provided to JGKE, all documented and incurred expenses for travel, lodging, and meals associated with training course attendance shall be a JGKE Direct Operating Expense as defined in this Agreement.

 

11.4          To the extent reasonably requested by Medical Center, JGKE agrees to use best efforts to exercise JGKE’s rights to the warranty provided by Elekta to JGKE and attached hereto as Attachment 2 .

 

12.           Maintenance of Equipment; Damage or Destruction of Equipment .

 

12.1        During the Term and except as otherwise provided in this Agreement, JGKE, shall (a) maintain the Equipment in good operating condition and repair, reasonable wear and tear excepted. Medical Center shall promptly notify JGKE in the event of any damage or destruction to the Equipment or of any required maintenance or repairs to the Equipment, regardless of whether such repairs or maintenance are covered or not covered by the Service Agreement. JGKE will work with Medical Center in selecting a Service Agreement which shall be entered into by and between JGKE and the service provider and shall be a JGKE Direct Operating Expense as defined in this Agreement; provided, however, such JGKE Direct Operating Expense shall be offset by any reduction in price offered by Elekta to JGKE by virtue of Elekta's non-compliance with its uptime guarantee as set forth in more detail in Section 12.6 hereof.

 

12.2       To the extent that JGKE is provided with software updates and upgrades at no additional charge, then JGKE shall ensure that such equipment software updates and upgrades will be provided at no additional cost to Medical Center. Otherwise, Medical Center and JGKE shall mutually agree in writing to the updates and upgrades, and such updates and upgrades shall be paid pro-rata by the parties as set forth on Schedule 1 and shall not be considered either a JGKE or Medical Center Direct Operating Expenses. JGKE and Elekta shall have the right to reasonably access the Equipment for the purpose of inspection and the performance of repairs at all reasonable times, upon reasonable advance notice and with a minimum of interference or disruptions to Medical Center’s regular business operations.

 

 
 

 

12.3       JGKE shall promptly provide Medical Center with a copy of all communications from the Elekta or the FDA advising of a recall, request for a recall, market withdrawal, safety alert, or an issue of Equipment availability. JGKE shall provide Medical Center with written notice of any Class I recall, whether voluntary or initiated by the FDA, affecting any of the Equipment within twenty-four (24) hours of Elekta’s or JGKE's receipt of any such request for a recall, or shorter period of time provided in the recall strategy.

 

12.4       Medical Center shall be liable for, and in the manner described in Section 21 below shall indemnify JGKE from and against, any damage to or destruction of the Equipment caused by the intentional and wrongful or negligent acts or omissions of Medical Center’s officers, employees, agents, or contractors. In the event the Equipment is damaged as a result of the intentional and wrongful or negligent acts or omissions of Medical Center’s officers, employees, agents, or contractors, to the extent such damage is not covered by warranties or insurance, JGKE may service or repair the Equipment as needed and the cost thereof shall be paid by Medical Center to JGKE within thirty (30) day of written request. In the event that the costs are not paid to JGKE within thirty (30) days, Medical Center shall pay interest thereon at the rate of one percent (1%) per month (or the maximum monthly interest rate permitted to be charged by law between an unrelated, commercial borrower and lender, if less) and reasonable attorneys’ fees and costs incurred by JGKE in collecting such amount from Medical Center. Any work so performed by JGKE shall not deprive JGKE of any of its rights, remedies or actions against Medical Center for such damages .

 

12.5       If the Equipment is rendered unusable as a result of any physical damage to or destruction of the Equipment, Medical Center shall give JGKE written notice thereof. JGKE shall use best efforts to determine, within fifteen (15) days after it is given written notice of such damage or destruction, whether the Equipment can be repaired provided, however, if JGKE cannot determine whether the Equipment can be repaired within fifteen (15) days, then JGKE shall have such additional time as may be reasonable and necessary for such determination provided, however, JGKE shall provide Medical Center with weekly status reports. In the event JGKE determines that the Equipment cannot be repaired (a) subject to Section 12.4 above, JGKE, at its cost and expense, shall replace the Equipment as soon as reasonably possible taking into account the availability of replacement equipment from Elekta, Elekta’s other existing orders for equipment, and the then existing limitations on Elekta’s manufacturing capabilities, (b) the Term of this Agreement shall be extended for the period of time the Equipment is unusable, and (c) this Agreement shall continue in full force and effect as though such damage or destruction had not occurred. In the event JGKE determines that the Equipment can be repaired, JGKE shall cause the Equipment to be repaired as soon as reasonably possible thereafter. Medical Center shall fully cooperate with JGKE to effect the replacement of the Equipment or the repair of the Equipment (including, without limitation, providing full access to the Site) following the damage or destruction thereof.

 

 
 

 

12.6        To the extent reasonably requested by Medical Center, JGKE agrees to use best efforts to exercise JGKE’s rights to the uptime guarantee provided by Elekta to JGKE, a copy of which shall be provided to Medical Center upon request.

 

13.           Alterations and Upgrades to Equipment .

 

13.1          Medical Center shall not make any modifications, alterations or additions to the Equipment (other than normal operating accessories or controls) without the prior written consent of JGKE. Medical Center shall not, and shall not permit any person other than representatives of Elekta or any other person authorized by JGKE to, effect any inspection, adjustment, preventative or remedial maintenance, or repair to the Equipment without the prior written consent of JGKE. All modifications, alterations, additions, accessories or operating controls incorporated in or affixed to the Equipment (herein collectively called "additions" and included in the definition of "Equipment") shall become the property of the JGKE upon termination of this Agreement.

 

13.2          The necessity and financial responsibility for modifications, additions or upgrades to the Equipment, including the reloading of the Cobalt-60 source, shall be mutually agreed upon by JGKE and Medical Center in advance. If (a) JGKE and Medical Center agree to reload the Cobalt-60 source (i.e., on or around the 72 th month of the Term), then, notwithstanding any provisions to the contrary herein, the initial Term shall be automatically extended for an additional two (2) years. The necessity for modifications, additions or upgrades to the Equipment, including the reloading of the Cobalt-60 source, shall be as mutually agreed upon by JGKE and Medical Center, and the financial responsibility for such modifications, additions and upgrades (excluding repairs, which pursuant to Section 12.1 and subject to Section 12.5, are JGKE’s and Medical Center’s responsibility, respectively) shall be paid either (i) pro-rata by the parties as set forth on Schedule 1 and shall not be considered either JGKE or Medical Center Direct Operating Expenses, or (ii) shall be paid by JGKE provided that a mutually agreeable valuation firm with substantial experience in health care valuations shall assess JGKE’s modifications, additions or upgrades and shall determine whether the Purchased Services Payments need to be adjusted to ensure that Purchased Services Payments for the products and services provided by each party continues to be commensurate with their fair market value, provided the Purchased Services Payments shall not be adjusted more than annually.

 

14.           Financing of Equipment by JGKE . JGKE, in its sole discretion, may finance the Equipment. Financing may be in the form of an installment loan, a capitalized lease or other commercially available debt or financing instrument. If JGKE finances the Equipment through an installment loan, JGKE shall be required to provide the Equipment as collateral for the loan. If JGKE finances the Equipment through a capitalized lease, title shall vest with the lessor until such time as JGKE exercises its buy-out option under the lease, if any. If required by the lender, lessor or other financing entity (the "Lender"), JGKE may assign its interest under this Agreement as security for the financing. Medical Center’s interest under this Agreement shall be subordinate to the interests of the Lender.

 

 
 

 

15.           Taxes . JGKE shall pay all sales or use taxes imposed or assessed in connection with the use or purchase of the Equipment and all personal property taxes imposed, levied or assessed on the ownership and possession of the Equipment during the Term. Unless Medical Center provides JGKE with a tax exemption certificate, all other taxes, assessments, licenses or other charges imposed, levied or assessed on the Equipment during the Term for which Medical Center is not expressly exempt, shall be paid by Medical Center before the same shall become delinquent, whether such taxes are assessed or would ordinarily be assessed against JGKE or Medical Center; provided, however, Medical Center shall not be required to pay any federal, state or local income, franchise, corporation or excise taxes imposed upon JGKE's net income realized from the Purchased Services Payments of the Equipment.

 

16.           No Warranties by Medical Center and JGKE . Medical Center warrants that as of the First Procedure Date, it shall have (a) thoroughly inspected the Equipment to the best of their knowledge, (b) determined that to the best of its knowledge the Equipment is consistent with the size, design, capacity and manufacture selected by it, and (c) satisfied itself that to the best of its knowledge the Equipment is suitable for Medical Center intended purposes and is good working order, condition and repair. JGKE represents and warrants that it has and shall continue to have for the term of this Agreement, good title to the Equipment delivered to Medical Center without violating the property rights or interests of any third party inclusive of the intellectual property contained therein. JGKE will work with Medical Center in good faith to remedy any problems identified in writing by Medical Center during Medical Center's inspection. JGKE SUPPLIES THE EQUIPMENT UNDER THIS AGREEMENT IN ITS "AS IS" CONDITION. JGKE, NOT BEING THE MANUFACTURER OF THE EQUIPMENT OR THE MANUFACTURER’S AGENT, MAKES NO WARRANTY OR REPRESENTATION, EITHER EXPRESSED OR IMPLIED, AS TO THE EQUIPMENT’S MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR USE, DESIGN, CONDITION, DURABILITY, CAPACITY, MATERIAL OR WORKMANSHIP OR AS TO PATENT INFRINGEMENT OR THE LIKE. Notwithstanding the foregoing, JGKE shall (i) to the extent reasonably requested by Medical Center, use best efforts to exercise JGKE’s rights to the warranty provided by Elekta to JGKE and attached hereto as Attachment 1, and (ii) use its best efforts to ensure that all benefits under the manufacturer’s warranty shall run to the Medical Center. JGKE shall not be liable for any direct, indirect and consequential losses or damages suffered by Medical Center or by any other person, and Medical Center expressly waives any right to hold JGKE liable hereunder for, any claims, demands and liabilities arising out of or in connection with the design, manufacture, possession or operation of the Equipment, including, without limitation, injury to persons or property resulting from the failure of, defective or faulty design, operation, condition, suitability or use of the Equipment. All warranty or other similar claims with respect to the Equipment shall be made by Medical Center solely and exclusively against Elekta and any other manufacturers or suppliers, but shall in no event be asserted against JGKE. In this regard and with prior written approval of JGKE, Medical Center may, in JGKE’s name, but at Medical Center’s sole cost and expense, enforce all warranties, agreements or representations, if any, which may have been made by Elekta or manufacturers, suppliers or other third parties regarding the Equipment to JGKE or Medical Center.

 

 
 

 

17.         Termination for Economic Justification . If, following the initial twenty four (24) months after the First Procedure Date and following each subsequent twelve (12) month period thereafter during the Term, based upon the utilization of the Equipment and other factors considered relevant by JGKE in the exercise of its reasonable discretion, within a reasonable period of time after JGKE’s written request, Medical Center does not provide JGKE with a reasonable economic justification to continue this Agreement and the utilization of the Equipment at the Medical Center, then and in that event, JGKE shall have the option to terminate this Agreement by giving a written notice thereof to Medical Center not less than ninety (90) days prior to the effective date of the termination designated in JGKE’s written notice . Without limiting the generality of the foregoing, for purposes of this Section, "reasonable economic justification to continue this Agreement" shall not be deemed to exist (and JGKE shall have the option to terminate this Agreement) if, during the twelve (12) month period immediately preceding the issuance of JGKE’s written notice of termination, the "Net Cash Flow" is negative. As used herein, "Net Cash Flow" shall mean, for the applicable period, (a) the aggregate Purchased Services Payments actually received by JGKE during such period, minus the sum of the aggregate debt service on the Equipment during such period. In the event of such termination, Medical Center shall have no further obligation hereunder, except for obligations accruing and becoming payable prior to the date of termination.

 

18.          Options to Extend Agreement . As of the end of the Term, Medical Center shall have the option to:

 

18.1          Extend the Term of this Agreement for a specified period of time and upon such other terms and conditions as may be agreed upon by JGKE and Medical Center;

 

18.2          Purchase the Equipment from JGKE or to assume JGKE’s rights under any lease of the Equipment upon expiration of the Term, provided, however, the price, terms and conditions of the purchase or assumption shall be negotiated as an arms-length transaction; or

 

18.3          Terminate this Agreement as of the expiration of the Term. Upon the expiration of the Term and within a reasonable time thereafter, JGKE, at its cost and expense, may enter upon the Site under Medical Center supervision and remove the Equipment.

 

18.4          Medical Center shall exercise one (1) of the three (3) options referred to above by giving an irrevocable written notice thereof to JGKE at least one hundred eighty (180) days prior to the expiration of the initial Term. Any such notice shall be sufficient if it states in substance that Medical Center elects to exercise its option and states which of the three (3) options referred to above Medical Center is exercising. If Medical Center fails to exercise the option granted herein at least one hundred eighty (180) days prior to the expiration of the initial Term, the option shall lapse and this Agreement shall expire as of the end of the initial Term. Further, if Medical Center exercises either option specified in Sections 18.1 or 18.2 above and the parties are unable to mutually agree upon the price , terms or conditions applicable to such option prior to the expiration of the Term, this Agreement shall expire as of the end of the initial Term.

 

 
 

 

19.           Events of Default and Remedies .

 

19.1        Medical Center Event of Default. The occurrence of any one of the following shall constitute a Medical Center event of default under this Agreement (a "Medical Center Event of Default"):

 

19.1.1          Medical Center fails to pay any Purchased Services Payment when due pursuant to Paragraph 8 above and such failure continues for a period of thirty (30) days after written notice thereof is given by JGKE or its assignee to Medical Center; however, if Medical Center cures the Purchased Services Payment default within the applicable thirty (30) day period, such default shall not constitute an Event of Default.

 

19.1.2          Medical Center attempts to remove, sell, transfer, encumber, assign, sublet or part with possession of the Equipment or any items thereof, except as expressly permitted herein or as otherwise authorized by JGKE in writing.

 

19.1.3          Medical Center fails to observe or perform any of its covenants, duties or obligations arising under this Agreement or the LGK Agreement and such failure continues for a period of thirty (30) days after written notice thereof by JGKE to Medical Center; however, if Medical Center cures the default within the applicable thirty (30) day period or if the default reasonably requires more than thirty (30) days to cure, Medical Center commences to cure the default during the initial thirty (30) day period and Medical Center diligently completes the cure within sixty (60) days following the end of the thirty (30) day period, such default shall not constitute a Medical Center Event of Default; provided that the foregoing cure periods shall not apply to a Medical Center Event of Default under Subsections 19.1.1 or 19.1.2.

 

19.1.4          Medical Center ceases doing business, makes an assignment for the benefit of creditors, admits in writing its inability to pay its debts as they become due, files a voluntary petition in bankruptcy, is adjudicated bankrupt or insolvent, files a petition seeking for itself any reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar arrangement under any present or future statute, law or regulation or files an answer admitting the material allegations of a petition filed against it in any such proceeding, consents to or acquiesces in the appointment of a trustee, receiver, or liquidator of it or of all or any substantial part of its assets or properties, or it or its shareholders shall take any action looking to its dissolution or liquidation.

 

19.1.5            Medical Center is suspended or terminated from participation in the Medicare program.

 

 
 

 

19.2          JGKE Event of Default . The occurrence of any one of the following shall constitute a JGKE event of default under this Agreement (a "JGKE Event of Default"):

 

19.2.1         JGKE causes Medical Center’s quiet enjoyment and use of the Equipment pursuant to this Agreement to be materially interfered with (other than by reason of a Medical Center Event of Default or in connection with servicing, maintenance or repairs as contemplated in this Agreement), and JGKE fails to cure such default within thirty (30) days after written notice thereof is given by Medical Center or its assignee to JGKE; however, if JGKE cures such default within the applicable thirty (30) day period, such default shall not constitute an JGKE Event of Default.

 

19.2.2         JGKE fails to pay or reimburse Medical Center for any monies payable by JGKE to Medical Center pursuant to this Agreement and such failure continues for a period of thirty (30) days after written notice thereof is given by Medical Center or its assignee to JGKE; however, if JGKE cures the default within the applicable thirty (30) day period, such default shall not constitute a JGKE Event of Default.

 

19.2.3         JGKE fails to observe or perform any of its covenants, duties or obligations arising under this Agreement and such failure continues for a period of thirty (30) days after written notice thereof by Medical Center to JGKE; however, if JGKE cures the default within the applicable thirty (30) day period or if the default reasonably requires more than thirty (30) days to cure, JGKE commences to cure the default during the initial thirty (30) day period and JGKE diligently completes the cure within sixty (60) days following the end of the thirty (30) day period, such default shall not constitute a JGKE Event of Default; provided that the foregoing cure periods shall not apply to a JGKE Event of Default under Subsections 19.2.1 or 19.2.2.

 

19.2.4         JGKE ceases doing business, makes an assignment for the benefit of creditors, admits in writing its inability to pay its debts as they become due, files a voluntary petition in bankruptcy, is adjudicated a bankrupt or insolvent, files a petition seeking for itself any reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar arrangement under any present or future statute, law or regulation or files an answer admitting the material allegations of a petition filed against it in any such proceeding, consents to or acquiesces in the appointment of a trustee, receiver, or liquidator of it or of all or any substantial part of its assets or properties, or it or its shareholders shall take any action looking to its dissolution or liquidation.

 

19.2.5         JGKE is suspended or terminated from participation in the Medicare program or any other federal or state health care program.

 

19.3        Upon the occurrence of a Medical Center Event of Default or a JGKE Event of Default, the non-breaching party may at its option do any or all of the following:

 

 
 

 

19.3.1         By written notice to JGKE, Medical Center may at its option immediately terminate this Agreement as to the Equipment, wherever situated, but only upon the occurrence of a JGKE Event of Default under Subsections 19.2.1 or 19.2.2. As a result of such termination, Medical Center may, at its option and upon written notice to JGKE, demand that JGKE immediately enter upon the Site and remove the Equipment at JGKE’s sole cost and expense. For the avoidance of doubt, Medical Center shall not have the right to terminate this Agreement by reason of a JGKE Event of Default, other than due to the occurrence of a JGKE Event of Default under Subsections 19.2.1 and/or 19.2.2.

 

19.3.2         By written notice to Medical Center, JGKE may at its option immediately terminate this Agreement as to the Equipment, wherever situated, but only upon the occurrence of any of the Medical Center Events of Default as set forth in Subsections 19.1.1 and 19.1.2, 19.1.5 and/or noncompliance with Sections 10.1 and/or 10.4 above (which noncompliance has not been cured within the periods set forth in Section 19.1.3 above) (collectively, the “Termination Defaults”). For the avoidance of doubt, but without limiting JGKE’s rights under Section 17 above (Termination for Economic Justification), JGKE shall not have the right to terminate this Agreement by reason of a Medical Center Event of Default, other than due to the occurrence of any Termination Default. As a result of such termination pursuant to any Termination Default, JGKE may (a) provide reasonable notice to Medical Center of its intention to remove the Equipment, and upon such date as provided by notice, JGKE may then enter upon the Site and remove the Equipment in a manner and at a time that causes the least amount of disruption to patient care, or, at Medical Center’s election, Medical Center shall remove and return the Equipment to JGKE, but in either event at Medical Center’s sole cost and expense; and (b) may exercise any other rights pursuant to this Agreement or permitted by law, equity or otherwise.

 

19.3.3         With respect to all other Medical Center Events of Default, JGKE may:

 

A.              Sell, dispose of, hold, use or lease the Equipment (other than on the premises of the Medical Center), as JGKE in its sole and absolute discretion may determine (and JGKE shall not be obligated to give preference to the sale, lease or other disposition of the Equipment over the sale, lease or other disposition of similar Equipment owned or leased by JGKE).

 

B.              Exercise any other right or remedy which may be available to JGKE under the Uniform Commercial Code or any other applicable law or proceed by appropriate court action, without affecting JGKE’s title or right to possession of the Equipment, to enforce the terms hereof or to recover damages for the breach hereof or to cancel this Agreement as to the Equipment.

 

 
 

 

19.3.4         Upon termination of this Agreement or the exercise of any other rights or remedies under this Agreement or available under applicable law following a Medical Center Event of Default, Medical Center shall, without further request or demand, pay to JGKE all Purchased Services Payments and other sums owing under this Agreement. However, Medical Center acknowledges that JGKE shall have no obligation to sell the Equipment. Medical Center shall in any event remain fully liable for all damages as may be provided by law and for all costs and expenses incurred by JGKE on account of such default, including but not limited to, all court costs and reasonable attorneys’ fees.

 

19.3.5         Subject to Section 17 above, each party shall in any event remain fully liable to the other non-defaulting party for all damages as may be provided by law and for all costs and expenses incurred by the non-defaulting party on account of such default, including but not limited to, all court costs and reasonable attorneys’ fees.

 

19.3.6         Subject to Sections 19.3.1 and 19.3.2 above (regarding limitations on the right to terminate this Agreement), the rights and remedies afforded a non-defaulting party under this Agreement shall be deemed cumulative and not exclusive, and shall be in addition to any other rights or remedies available to the non-defaulting party provided by law or in equity.

 

20.           Insurance .

 

20.1         During the Term and during the construction of the Site and prior to the First Procedure Date, JGKE shall, at its cost and expense, purchase and maintain in effect an all risk property and casualty insurance policy covering the Equipment and general liability and professional liability insurance coverage/policies covering JGKE and its officers, directors, agents, employees, or contractors. The general liability and professional liability insurance policies shall provide coverage in amounts not less than One Million Dollars ($1,000,000.00) per occurrence and Five Million Dollars ($5,000,000.00) annual aggregate. The all risk property and casualty insurance policy shall be for an amount not less than the replacement cost of the Equipment. Medical Center shall be named as an additional insured party on the all risk property and casualty insurance policy to the extent of its interest in the Equipment arising under this Agreement and under the general liability insurance coverage/policy to be maintained by hereunder by JGKE. The coverage/policies to be maintained by JGKE hereunder shall be evidenced by a certificate of insurance or other reasonable documentation which shall be delivered by JGKE to Medical Center upon request following the commencement of this Agreement and as of each annual renewal of such policy during the Term.

 

20.2          During the Term, Medical Center shall, at its cost and expense, purchase, and maintain in effect general liability and professional liability insurance coverage/policies covering the Medical Center and the use or operation of the Equipment by Medical Center or its officers, directors, agents, employees, or contractors. The general liability and professional liability insurance policies shall provide coverage in amounts not less than One Million Dollars ($1,000,000.00) per occurrence and Five Million Dollars ($5,000,000.00) annual aggregate. JGKE shall be named as additional insured party on the general liability insurance coverage/policies to be maintained hereunder by Medical Center. The coverage/policies to be maintained by Medical Center hereunder shall be evidenced by a certificate of insurance or other reasonable documentation which shall be delivered by Medical Center upon request to JGKE no later than the First Procedure Date and as of each annual renewal of such policies during the Term. Medical Center shall require any physicians using the Equipment to show evidence of professional liability insurance consistent with Medical Center’s Medical Staff Bylaws.

 

 
 

 

20.3          During the construction of the Site and prior to the First Procedure Date, Medical Center, at its cost and expense, shall purchase, and maintain a general liability insurance policy which conforms with the coverage amounts and other requirements described in Section 20.2 above and which names JGKE as an additional insured party. The policy to be maintained by Medical Center hereunder shall be evidenced by a certificate of insurance or other reasonable documentation which shall be delivered by Medical Center to JGKE prior to the commencement of any construction at the Site.

 

20.4          During the Term, Medical Center and JGKE shall purchase and maintain all workers compensation insurance to the maximum extent required by applicable law.

 

20.5          Medical Center may maintain any insurance policies or coverage required of it by this Agreement through a self-insurance program.

 

21.           Indemnification .

 

21.1          Medical Center shall be liable for and shall indemnify, defend, protect and hold JGKE and its members, managers, officers, employees, agents and contractors (collectively "JGKE") harmless from and against all losses, claims, damages, liabilities, assessments, deficiencies, actions, proceedings, orders, judgments, liens, costs and other expenses (including reasonable attorney’s fees) of any nature or kind whatsoever asserted against or incurred by JGKE (collectively "Damages") which in any manner arise out of or relate to (a) the failure by Medical Center to fully perform, observe or satisfy its covenants, duties or obligations contained in this Agreement or in the LGK Agreement; (b) negligent, intentional or wrongful acts or omissions by Medical Center or any of its officers, directors, agents, contractors (or their subcontractors), or employees in connection with the use and operation of the Equipment during the Term; (c) Damages to the Equipment caused by the negligent or wrongful acts or omissions of Medical Center, its agents, officers, employees or contractors (if the Equipment is destroyed or rendered unusable, subject to Section 21.7 below, this indemnity shall extend up to (but not exceed) the full replacement value of the Equipment at the time of its destruction less salvage value, if any); or (d) the events or occurrences described in Article 7.3 of the LGK Agreement to the same extent that Medical Center agrees to indemnify Elekta thereunder (other than with respect to the failure of the Site to comply with the Site Planning Criteria or defective maintenance of the Equipment under the Service Agreement).

 

 
 

 

21.2          JGKE shall be liable for and shall indemnify, defend, protect and hold Medical Center and its directors, members, managers, officers, employees, agents and contractors (collectively "Medical Center") harmless from and against all losses, claims, damages, liabilities, assessments, deficiencies, actions, proceedings, orders, judgments, liens, costs and other expenses (including reasonable attorney’s fees) of any nature or kind whatsoever asserted against or incurred by Medical Center (collectively "Damages") which in any manner arise out of or relate to (a) the failure by JGKE to fully perform, observe or satisfy its covenants, duties or obligations contained in this Agreement; (b) negligent, intentional or wrongful acts or omissions by JGKE or any of its officers, directors, agents, contractors (or their subcontractors), or employees in connection with the installation, or removal of the Equipment, (c) the failure by JGKE to maintain the Equipment as provided in this Agreement; and (d) any other matters for which JGKE has specifically agreed to indemnify Medical Center pursuant to this Agreement.

 

21.3          Upon the occurrence of an event for which JGKE or Medical Center is entitled to indemnification under this Agreement ("Indemnitee"), such party shall give written notice thereof to the other party setting forth the type and amount of Damages. If the indemnity relates to a Third Party Claim (as defined in Section 21.4 below), the matter shall be subject to Section 21.4 below. If the indemnity relates to any Damages other than a Third Party Claim, not more than thirty (30) days after written notice is given, the indemnifying party shall acknowledge its obligation in writing to the Indemnitee to indemnify hereunder and pay the Damages in full to the Indemnitee.

 

21.4          JGKE or Medical Center, as Indemnitee, shall give written notice to the other party as Indemnitor as soon as reasonably possible after the Indemnitee has knowledge of any third party claim or legal proceedings ("Third Party Claim") for which the Indemnitee is entitled to indemnification under this Section 21. Indemnitor shall (a) immediately assume, at its sole cost and expense, the defense of the Third Party Claim with legal counsel approved by the Indemnitee (which approval will not be unreasonably withheld, delayed or conditioned), and (b) as soon as reasonably possible after Indemnitee’s written notice is given to the Indemnitor, acknowledge in writing to Indemnitee its obligation to indemnify Indemnitee in accordance with the terms of this Agreement. If either party as the Indemnitor fails to assume the defense of a Third Party Claim or fails to timely acknowledge in writing its obligation to indemnify the Indemnitee, then, the Indemnitee may assume the defense of the Third Party Claim in the manner described in Section 21.5 below. Each party shall cooperate with the other in the defense of any Third Party Claim. Any settlement or compromise of a Third Party Claim to which either party is a party shall be subject to the express written approval of the other party, which approval shall not be unreasonably withheld, delayed or conditioned as long as an unconditional term of the settlement or compromise is the full and absolute release of the Indemnitee from all Damages arising out of the Third Party Claim. Either party as Indemnitee, at its own cost and expense, may participate on its own behalf with legal counsel of its own selection in the defense of any Third Party Claim which may have a material impact on it.

 

21.5          If either party having the obligation as Indemnitor fails to promptly assume the defense of any Third Party Claim, the Indemnitee may assume the defense of the Third Party Claim with legal counsel selected by the Indemnitee, all at the Indemnitor’s cost and expense. The defense of an action by an Indemnitee under this Section 21.5 shall not impair, limit or otherwise restrict Indemnitor’s indemnification obligations arising under this Section 21 or Indemnitee’s right to enforce such obligations.

 

 
 

 

21.6          The indemnity obligations under this Section 21 shall expire on the expiration of the applicable statute of limitations relating to the underlying claim that is the subject of the indemnification claim. Any indemnification obligation shall be in proportion to the amount of responsibility found attributable to the Indemnitor.

 

21.7          The indemnification obligations set forth in this Agreement are intended to supplement, and not supersede, supplant or replace, any coverage for Damages which may be available under any insurance policies that may be maintained by JGKE or Medical Center. In the event any Damages may be covered by insurance policies, the parties shall exercise good faith and use their best efforts to obtain the benefits of and apply the available insurance coverage to the Damages subject to indemnification under this Agreement. In the event that an insurer provides coverage under an insurance policy on the basis of a "reservation of rights," the indemnification obligations under this Agreement shall apply to all Damages which are finally determined as not being covered under the insurance policy.

 

21.8          JGKE acknowledges Medical Center’s obligations to comply with certain laws and regulations as well as the need for JGKE’s employees, agents, and contractors to comply with reasonable requests, standard rules, and regulations of Medical Center regarding personal and professional conduct, including the use of an identification badge or personal protective equipment and the adherence to health care facility laws or regulations, including in some instances, criminal background checks, credit checks, health screening, vaccinations and testing, and general safety practices or procedures, generally applicable to such facilities. JGKE shall provide Medical Center with reasonable assistance in ensuring JGKE employee, agent, and contractor compliance with (i) laws and regulations affecting Medical Center’s facility(ies) and (ii) Medical Center’s facility rules and regulations. JGKE warrants and represents that it has enforceable written agreements with all of its employees, agents, and contractors involved during the course of this Agreement in any provision of services and Equipment under this Agreement, obligating such employees and contractors upon terms and conditions no less restrictive than contained herein, not to use or disclose any confidential information, proprietary rights, or information learned or acquired during the course of such employment or engagement. To the extent an employee of JGKE has access to Protected Health Information as such is defined in HIPAA, JGKE warrants that it will educate such employees about the obligation imposed by the HIPAA regulations. Medical Center may, after written notice including an explanation of its concerns and a fifteen (15) day cure period, require JGKE to replace any personnel provided by JGKE, including any contractor personnel, if such personnel does not perform satisfactorily, does not comply with Medical Center’s security requirements or other rules and regulations applicable to the conduct of Medical Center’s employees or contractors, or for other good cause. JGKE shall be solely responsible for the acts and omissions of its employees, agents, and contractors hereunder.

 

 
 

            

21.9          JGKE and its employees, agents, and contractors shall comply with and abide by Medical Center’s rules, policies and/or procedures for vendor credentialing, copies of which are available upon request. JGKE expressly acknowledges and agrees that as a condition of access to Medical Center, JGKE and its employees, agents, and contractors shall cooperate and work with any third party vendor credentialing services entity with which Medical Center has a contract and from which Medical Center requests JGKE and its employees, agents, and contractors to obtain credentialing. No representatives of JGKE will be given access to Medical Center absent successful completion of Medical Center’s vendor credentialing program and continued strict compliance with Medical Center’s rules, standards, policies and procedures (e.g., immunization policies, identification requirements, HIPAA compliance, appointment requirements, etc.). JGKE expressly agrees that it shall instruct all of its representatives of the above requirements, and the fact that each representative, prior to admission to Medical Center, must have a scheduled appointment in place. No standing appointments are permissible or will be allowed. Nothing herein shall be construed as granting a representative access or permission to any locations within Medical Center, other than the main lobby of Medical Center. Any JGKE representatives seeking access to Medical Center for the purpose of performing Services must have a scheduled appointment with Medical Center’s Director of Materials Management. Any JGKE representative that does not comply with the above, will be removed from Medical Center and may be sanctioned and/or permanently prohibited from access to Medical Center. Notwithstanding the provisions of 21.8 and 21.9, Medical Center will use all reasonable efforts to assist and promptly respond to JGKE, so as to ensure reasonable access to the Medical Center, Equipment and all affiliated persons.

 

22.           Miscellaneous .

 

22.1          Binding Effect and Assignment. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns, neither party may assign, subcontract, delegate, or otherwise transfer this Agreement or any of its rights or obligations hereunder except as contemplated herein, without the other party’s written consent; provided, however that the Medical Center may assign this Agreement without prior written consent of JGKE to an entity controlled by, controlling, or under common control with the Medical Center and which entity is the holder of the general acute care hospital license for the facility at which the Equipment is located, and provided further, that such entity shall have credit rating and financial position equivalent to or higher than that of Medical Center as reasonably determined by JGKE . Unless otherwise agreed to in writing by the parties, an assignment or sublease shall not relieve a party of any liability for performance of this Agreement during the remainder of the Term. Any purported assignment or sublease made without the other party’s prior written consent shall be null, void and of no force or effect .

 

22.2          Agreement to Perform Necessary Acts. Each party agrees to perform any further acts and execute and deliver any further documents which may be reasonably necessary or otherwise reasonably required to carry out the provisions of this Agreement.

 

22.3          Validity. If for any reason any clause or provision of this Agreement, or the application of any such clause or provision in a particular context or to a particular situation, circumstance or person, should be held unenforceable, invalid or in violation of law by any court or other tribunal of competent jurisdiction, then the application of such clause or provision in contexts or to situations, circumstances or persons other than that in or to which it is held unenforceable, invalid or in violation of law shall not be affected thereby, and the remaining clauses and provisions hereof shall nevertheless remain in full force and effect.

 

 
 

 

22.4           Compliance with Anti-Terrorism Plan. JGKE acknowledges that Medical Center has in place an Anti-Terrorism Plan (“Plan”), a copy of which has been provided to JGKE, and JGKE further acknowledges that the Equipment and Cobalt source shall be in compliance with such Plan at all times. JGKE shall use its best efforts to make any repairs or updates to the Equipment as soon as practicable in order for such Equipment to be operating in accordance with the Plan.

 

22.5          Entire Agreement; Amendment. This Agreement together with the Exhibits attached hereto constitutes the full and complete agreement and understanding between the parties hereto concerning the subject matter hereof and shall supersede any and all prior negotiations written and oral agreements and understandings between the parties with regard to such subject matter. This Agreement may be modified or amended only by a written instrument executed by all of the parties hereto. The parties agree that the electronic signature provisions of the Electronic Signatures in the Global and National Commerce Act shall not be applicable to this Agreement.

 

22.6          Number and Gender. Words in the singular shall include the plural, and words in a particular gender shall include either or both additional genders, when the context in which such words are used indicates that such is the intent.

 

22.7          Effect of Headings. The titles or headings of the various paragraphs hereof are intended solely for convenience or reference and are not intended and shall not be deemed to modify, explain or place any construction upon any of the provisions of this Agreement.

 

22.8          Counterparts. This Agreement may be executed in one or more counterparts each bearing a handwritten signature of an authorized official, collectively which shall constitute one and the same instrument. All counterparts shall be construed together and shall constitute one agreement.

 

22.9          Governing Law. This Agreement shall be interpreted and enforced in accordance with the internal laws, and not the law of conflicts, of the State of Florida. Each party irrevocably agrees that any claim brought by it in any way arising out of this Agreement must be brought solely and exclusively in state or federal courts located in the Jacksonville, Duval County, Florida and each party irrevocably accepts and submits to the sole and exclusive jurisdiction of each of the aforesaid courts in personam, generally and unconditionally with respect to any action, suit, or proceeding brought by it or against it by the other party. THE EXCLUSIVE JURISDICTION REQUIREMENT SET FORTH IN THIS SECTION SHALL NOT APPLY IN THE EVENT THAT THERE IS THIRD PARTY JOINDER BY EITHER PARTY OR A THIRD PARTY INSTITUTES AN ACTION AGAINST ANY PARTY TO THIS AGREEMENT, AND SUCH THIRD PARTY IS NOT AMENABLE TO JOINDER IN AN ACTION BROUGHT IN THE STATE OR FEDERAL COURTS LOCATED IN JACKSONVILLE, DUVAL COUNTY, FLORIDA.

 

 
 

 

22.10          Exhibits. All exhibits attached hereto and referred to in this Agreement are hereby incorporated by reference herein as though fully set forth at length.

 

22.11          Priority of Documents. This Agreement shall take priority over all agreements relating to Services executed prior to the Effective Date between JGKE and Medical Center except to the extent JGKE and Medical Center expressly agree otherwise. Except to the extent expressly agreed by Medical Center and JGKE, the terms of this Agreement shall not be modified or conflicted by subsequent agreements between JGKE and Medical Center. In the event of a conflict between this Agreement and related documents, the terms of this Agreement shall be given effect. The terms of any pre-printed form documents, including invoices and purchase orders, between JGKE and Medical Center shall have no effect on the relationship of the parties. The terms of this Agreement shall supersede the terms and conditions on any purchase orders, invoices, price quotes or other documents or agreements JGKE may utilize with Medical Center relating to the Services covered under this Agreement. The general rule that ambiguities are to be construed against the drafter shall not apply to this Agreement. In the event that any provision of this Agreement is found to be ambiguous, each party shall have an opportunity to present evidence as to the actual intent of the parties with respect to such ambiguous provision.

 

22.12          Representations. Each of the parties hereto represents: (a) that no representation or promise not expressly contained in this Agreement has been made by any other party hereto or by any of its agents, employees, representatives or attorneys; (b) that this Agreement is not being entered into on the basis of, or in reliance on, any promise or representation, expressed or implied, other than such as are set forth expressly in this Agreement; (c) that it has been represented by counsel of its own choice in this matter or has affirmatively elected not to be represented by counsel; (d) it is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization; (e) it has full power and authority to execute, deliver and perform this Agreement; and (f) the execution, delivery and performance of this Agreement has been duly authorized by all necessary corporate or other similar action.

 

22.13         Publicity. JGKE agrees that it shall not, without prior written consent of Medical Center in each instance, use in advertising, publicity, or otherwise, the name of Medical Center, or any partner or employee of Medical Center, or any trade name, trademark, trade device, or simulation thereof owned by Medical Center, or represent, directly or indirectly, that any product or any service provided by JGKE has been approved, recommended, certified, or endorsed by Medical Center. In addition to the foregoing, the content and timing of any public announcement including, but not limited to, any press release regarding the arrangements outlined under this Agreement, shall require the mutual agreement of the parties.

 

 
 

 

22.14         Non-Waiver. No failure or delay by a party to insist upon the strict performance of any term, condition, covenant or agreement of this Agreement, or to exercise any right, power or remedy hereunder or under law or consequent upon a breach hereof or thereof shall constitute a waiver of any such term, condition, covenant, agreement, right, power or remedy or of any such breach or preclude such party from exercising any such right, power or remedy at any later time or times.

 

22.15         Notices. All notices, requests, demands or other communications required or permitted to be given under this Agreement shall be in writing and shall be delivered to the party to whom notice is to be given either (a) by personal delivery (in which case such notice shall be deemed to have been duly given on the date of delivery), (b) by next business day air courier service (e.g., Federal Express or other similar service) (in which case such notice shall be deemed given on the business day following deposit with the air courier service), or (c) by United States mail, first class, postage prepaid, registered or certified, return receipt requested (in which case such notice shall be deemed given on the third (3rd) day following the date of mailing), and properly addressed as follows:

  

To JGKE: Four Embarcadero Center

Suite 3700

San Francisco, CA 94111

Attn: Chief Executive Officer

 

To Medical Center: St. Vincent’s Medical Center

1 Shircliff Way

Jacksonville, FL 32204

Attn: Chief Executive Officer 

 

A party to this Agreement may change his, her or its address for purposes of this Section by giving written notice to the other parties in the manner specified herein.

 

22.16      Special Provisions Respecting Medicare and Medicaid Patients

 

22.16.1       Medical Center and JGKE shall generate such records and make such disclosures as may be required, from time to time, by the Medicare, Medicaid, TriCare, HCAP and other third party payment programs with respect to this Agreement in order to meet all requirements for participation and payment associated with such programs, including but not limited to the matters covered by Section 1861(v)(1)(I) of the Social Security Act.

 

 
 

 

22.16.2       For the purpose of compliance with Section 1861(v)(1)(I) of the Social Security Act, as amended, and any regulations promulgated pursuant thereto, both parties agree to comply with the following statutory requirements (a) Until the expiration of four (4) years after the termination of this Agreement, both parties shall make available, upon written request to the Secretary of Health and Human Services or, upon request, to the Comptroller General of the United States, or any of their duly authorized representatives, the contract, and books, documents and records of such party that are necessary to certify the nature and extent of such costs, and (b) if either party carries out any of the duties of the contract through a subcontract with a value or cost of $10,000 or more over a twelve month period, with a related organization, such subcontract shall contain a clause to the effect that until the expiration of four (4) years after the furnishing of such services pursuant to such subcontract, the related organization shall make available, upon written request to the Secretary, or upon request to the Comptroller General, or any of their duly authorized representatives the subcontract, and books, documents and records of such organization that are necessary to verify the nature and extent of such costs.

 

22.17       Force Majeure. Failure to perform by either party will be excused in the event of any delay or inability to perform its duties under this Agreement directly or indirectly caused by conditions beyond its reasonable control, including, without limitation, fires, floods, hurricane, tropical storm, earthquakes, snow, ice, disasters, acts of God, accidents, riots, wars, operation of law, strikes, governmental action or regulations, shortages of labor, fuel, power, materials, manufacturer delays or transportation problems. Notwithstanding the foregoing, all parties shall make good faith efforts to perform under this Agreement in the event of any such circumstance. Further, once such an event is resolved, the parties shall again perform their respective obligations under this Agreement. Should either party to this Agreement be notified by any governmental agency or its counsel that performance under this Agreement creates a substantial risk of violation of any material state or federal law or regulation, such party shall notify the other party, and the parties shall, in good faith, attempt to amend this Agreement in all respects necessary to comply with such laws or regulations. If such amendment is not in compliance with applicable legal requirements in the written opinion of counsel for either party to this Agreement, or if the parties cannot agree on an alternative acceptable arrangement, then this Agreement may be terminated by either party upon the delivery of written notice to the other party thirty (30) days prior to the date of termination and all of the rights and obligations of the parties hereunder shall cease and this Agreement shall become null and void.

 

22.18       Independent Contractor. It is mutually understood and agreed that nothing in this Agreement is intended nor shall be construed to create between JGKE and Medical Center, with respect to their relationship hereunder, an employer/employee relationship, a partnership or joint venture relationship, or a landlord/tenant relationship.

 

22.19       Anti-Kickback Statute. The sole purpose of this Agreement is to enter into a commercially reasonable and fair market value arrangement. The parties in good faith believe that this Agreement fully complies with the provisions of 42 U.S.C. 1320a-7b (the "Anti-Kickback Statute"). Neither Medical Center nor JGKE are, by virtue of this Agreement or otherwise, willfully offering, paying, soliciting, or receiving remuneration in return for referring an individual to or from each other for the furnishing of any item or service reimbursed under the Medicare or state health care programs. Pricing hereunder does not take into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under Medicare or a state health care program.

 

 
 

 

22.20       Each party represents and warrants to the other party that neither it, nor any of its employees or other contracted staff (collectively referred to in this paragraph as "employees") has been or is about to be excluded from participation in any Federal Health Care Program (as defined herein). Each party agrees to notify the other party within five (5) business days of receipt of notice of intent to exclude or actual notice of exclusion from any such program. The listing of either party or any of its employees on the Office of Inspector General’s exclusion list (OIG website), the General Services Administration’s Lists of Parties Excluded from Federal Procurement and Nonprocurement Programs (GSA website) for excluded individuals or entities, any state Medicaid exclusion list, or the Office of Foreign Assets Control’s (OFAC’s) blocked list shall constitute "exclusion" for purposes of this paragraph. In the event that either party is excluded from any Federal Health Care Program or placed on the OFAC’s blocked list, it shall be a material breach and this Agreement shall immediately terminate without penalty to the other party, unless the other party elects in writing to continue this Agreement. For the purpose of this paragraph, the term "Federal Health Care Program" means the Medicare program, the Medicaid program, TRICARE, any health care program of the Department of Veterans Affairs, the Maternal and Child Health Services Block Grant program, any state social services block grant program, any state children’s health insurance program, or any similar program.

 

22.21        Each party shall keep strictly confidential all Non-Public Information disclosed by the other party. For the purposes of this Agreement "Non-Public Information" shall include the terms of this Agreement and all information disclosed by the parties, inclusive of Medical Center purchasing information and characteristics. The parties expressly acknowledge that Medical Center is a member or affiliate of Ascension Health. The parties further agree that, notwithstanding anything to the contrary herein, Medical Center may disclose Non-Public Information to Ascension Health and its health ministries, affiliates, business partners, consultants and those third-party entities with whom Ascension Health and/or Medical Center have an agreement requiring the third-party entity to maintain the confidentiality of such Non-Public Information and to only use such Non-Public Information for the benefit of Ascension Health and Medical Center. Each party shall use best efforts to return any confidential information to the disclosing party upon request. Medical Center and JGKE may freely disclose this Agreement internally within their respective organizations and to their professional advisors.

 

22.22       Medical Center has in place a Corporate Responsibility Program ("Program") which has as its goal to ensure that Medical Center complies with federal, state and local laws and regulations, a copy of which is available for review at jaxhealth.com in the Patients and Visitors section. The Program focuses on risk management, the promotion of good corporate citizenship, including the commitment to uphold a high standard of ethical and legal business practices, and the prevention of misconduct. JGKE acknowledges Medical Center's commitment to Corporate Responsibility and agrees that it will not act or conduct business in a manner that requires Medical Center to violate or act in a manner that contravenes any legal requirement.

 

 
 

 

22.23       The parties acknowledge that the operations of Medical Center and its affiliates are in accordance with the Ethical and Religious Directives for Catholic Health Care Services, as promulgated by the United States Conference of Catholic Bishops, Washington, D.C., of the Roman Catholic Church or its successor ("Directives") and the principles and beliefs of the Roman Catholic Church is a matter of conscience to Medical Center and its affiliates. The Directives are located at http://www.usccb.org/bishops/directives.shtml. It is the intent and agreement of the parties that neither this Agreement nor any part hereof shall be construed to require Medical Center or its affiliates to violate said Directives in their operation and all parts of this Agreement must be interpreted in a manner that is consistent with said Directives.

 

22.24       JGKE represents and warrants that the Equipment, to JGKE’s knowledge, complies with the requirements of all applicable federal, state and local laws, ordinances, regulations and codes including those relating to the privacy or security of information including, but not limited to, the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and corresponding regulations. The parties agree that based upon and in reliance upon the representations, warranties and covenants set forth in this Section, JGKE is not a Business Associate of Medical Center as defined in HIPAA. JGKE represents, warrants and covenants that in the provision of Equipment under this Agreement, JGKE does not require and shall not request access to, or attempt to access, any Protected Health Information of Medical Center or any of its affiliates. If JGKE inadvertently comes in contact with Protected Health Information, JGKE will keep such information confidential and not further access, use or disclose it. If JGKE becomes a Business Associate, it agrees to comply with all applicable provisions of HIPAA and agrees to sign Medical Center's then-current business associate agreement. For purposes of this Section, Protected Health Information has the meaning set forth in 45 CFR §160.103.

 

22.25        Restrictive Covenants . During the term of the Agreement: (1) JGKE covenants that it and any affiliate of JGKE will not be involved in any way in the ownership, management, or operation of, or investment in, any gamma knife models that perform Procedures within twenty-five (25) miles of Medical Center, and (2) Medical Center covenants that St. Luke’s Hospital will not be involved in any way in the ownership, management, or operation of, or investment in, any gamma knife models on St. Luke's Hospital campus, located in Jacksonville, Florida. Notwithstanding the above, the parties agree that as affiliates of JGKE, Dr. Scot Akerman and Dr. Paul Ossi shall be permitted to continue to perform Procedures on the current stereotactic radiosurgery system which is owned by Iridium Holdings, Inc. as of the date of this Agreement, provided such radiosurgery system shall not be modified, upgraded or replaced during the term of this Agreement. In the event that this restrictive covenant (or element thereof) shall be determined to be over-broad, then the terms of this Section 22.25 may be either stricken or reduced by a court of competent jurisdiction to the extent such court deems reasonable, and this Section 22.25 may then be enforced in accordance with any remaining and revised language of this Section 22.25.

 

 
 

  

IN WITNESS WHEREOF , the parties hereto have caused this Agreement to be executed as of the date first set forth above.

 

"JGKE" JACKSONVILLE GK EQUIPMENT, LLC
  By: /s/ Ernest A. Bates, M.D.
    Title: Manager
    Date: August 5, 2011
     
"MEDICAL CENTER" ST. VINCENT’S MEDICAL CENTER, INC.
     
  By: /s/ Moody Chisholm
    Title: President & CEO
    Date: August 5, 2011

  

 
 

 

Exhibit 1

 

 

 

 
 

 

Exhibit 2

 

 

 

Saint Vincent’s Medical Center

Jacksonville, Florida

 

August 4, 2011

 

 
 

 

 

LEKSELL GAMMA KNIFE® END USER AGREEMENT

THIS LEKSELL GAMMA KNIFE® END USER AGREEMENT ("AGREEMENT") is entered into as of the_______day of 2011 by and between ELEKTA, INC., a corporation organized and existing under the laws of Georgia (hereinafter referred to as "Elekta"). and SAINT VINCENT'S MEDICAL CENTER, INC., (hereinafter referred to as "End User").

 

WITNESSETH:

 

WHEREAS, Elekta has agreed to sell the "Leksell Gamma Knife®" system (hereinafter defined and referred to as the "LGK®") to Jacksonville GK Equipment, LLC, hereinafter referred to as 'Buyer"); and

 

WHEREAS, Buyer has agreed to provide the right to use the LGK® to End User under the Leksell Gamma Knife Perfexion Purchased Services Agreement ("Purchased Services Agreement"), and

 

WHEREAS, Elekta and End User wish to enter this Agreement for their mutual benefit;

 

NOW THEREFORE, in consideration of the mutual covenants and obligations, warranties and indemnities herein contained and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

 

TERMS AND CONDITIONS

 

ARTICLE I. DEFINED TERMS

 

The following words and terms shall have the meanings set forth opposite them in this Article I:

 

" Acceptance Tests" are those tests which demonstrate that the LGK® meets the manufacturer's specification and which are defined in the Purchased Services Agreement between Buyer and Elekta.

 

" Charging " means all handling of the Cobalt Supply at the Site and the installation of such Cobalt Supply in the LGK®.

 

"Cobalt Supply" means the supply of the Cobalt-60 sources to be installed in the LGK®.

 

"Effective Date" is the date of execution of this Agreement by the End User, as indicated in this Agreement.

 

"End User Data" means all data and information, including but not limited to End User Confidential Information, Customer whether in written or electronic form, submitted to Elekta by End User or a user, or obtained by Elekta in connection with the LGP Software, including, without limitation, information relating to End User's or an affiliate's users, vendors, employees, technology, operations, facilities, consumer markets, products, capacities, systems, procedures, security practices, research, development, business affairs and finances, business methodologies, improvements, trade secrets, copyrightable subject matter and other proprietary information, activities, and any ideas, concepts, innovations, inventions and designs of End User.

 

"Hardware" shall mean that computer hardware and related equipment described in the Specification.

 

"Installation Test Protocol" shall mean the manufacturer's instructions to install and test the LGK® and LGP Software which are performed by Elekta under the supervision of the Buyer and/or End User's Radiation Safety Officer which, once completed satisfactorily demonstrates the LGK ® complies with the Specification.

 

" LGK® " is the device, which is technically specified in Exhibit A hereto, to be sold, delivered, and installed by Elekta at the Site.

 

"LGP Software" means the dose planning software for the LGK®, which is described in the Specification and the software and software add-on's as attached hereto as ExhrlD4 A (including but not limited to Standard LGP for Perfexion License, Retreatment License, Warpseed Real-time Dose Update License, Functional Planning License, lmagemerge License and a Color Pet License).

 

"Site" shall mean that location described on the Exhibit B hereto.

 

" Site Planning Criteria" are the requirements which the Site must meet to properly accommodate the LGK® and are defined in the Purchased Services Agreement between Elekta and Buyer.

 

" Specification " refers to the technical standards with which the LGK® shall comply, as described in Exhibit A hereto.

  

 
 

 

 

ARTICLE II . PERMITS

 

2.1 Permits . End User shall obtain any license (the "User License") from the Nuclear Regulatory Commission (or relevant state agency if the Site is located in an - Agreement State") authorizing it to lake possession of the Cobalt Supply and shall obtain such other licenses, permits, approvals, consents and authorizations which may be required by local governmental or other regulatory agencies for the Site, its preparation, the Charging of the LGK® with its Cobalt Supply, the conduct of Acceptance Tests, and the use of the LGK®. End User shall not run, operate, or otherwise use the LGK®, except for the purpose of conducting the Acceptance Tests, until the Acceptance Tests have been successfully completed.

 

ARTICLE III. OPERATION, TRAINING, AND INTELLECTUAL PROPERTY.

 

3.1 Operation. End User warrants and covenants that the LGK® shall not be run, operated or otherwise used, except by qualified employees, agents, independent contractors, or physicians, who are suitably skilled and experienced to use the LGK®.

 

3.2 Technical Training . Elekta shall provide as set forth in Exhibit A to four (4) persons designated by End User instruction relating to the technical operation and maintenance of the LGK®. Such instruction shall not exceed two (2) consecutive days and will be provided on-site by installation personnel at the time of install.

 

3.3 Introductory Clinical Training Program. Elekta shall reimbursement the tuition costs for persons designated by End User in a Clinical Training Program addressing indications, technique, literature, and other related areas as noted in Exhibit A attached hereto.

 

3.4 Post Clinical Start Up Site Visit. Elekta shall provide a one (1) day Site visit from one (1) Clinical Applications representative. The visit must be arranged within 3-6 months post clinical start up. The commitment will expire thereafter unless documented alternate arrangements are made. The purpose is to ensure the End User is comfortable using all features in the LGP Software.

 

3.5 LGP Software. Elekta hereby consents to Buyer's sublicense to End User of the LGP Software, to be utilized for the purpose of planning dosages of treatments to be performed with the LGP Software and as otherwise may set forth in this Agreement A copy of the LGP Software License from Elekta to Buyer is attached hereto as Exhibit D. End User agrees that its sublicense to the LGP Software shall be subject to the terms and conditions of Exhibit D hereto. End User agrees. in favor of Elekta, to perform the obligations assigned to Buyer in Exhibit D hereto. In the event the sublicense of the LGP Software from Buyer to End User is terminated due to an act or omission of Buyer and without fault of the End User, then End User shall have the right to obtain, at no additional cost, from Elekta a direct royalty-free license to utilize the LGP Software on the same terms and conditions set forth herein.

 

3.6 Intellectual Property.

 

(a) End User hereby acknowledges that the trademarks Gamma Knife® and Leksell Gamma Knife® (collectively, the "Mark") are protected by United States federal registrations and the Mark constitutes valuable intellectual property of an affiliate of Elekta in which it has established substantial goodwill. End User hereby acknowledges that proper use of the Mark in any advertising of End User's own surgical services performed with the LGK® surgical instrument is highly important to maintaining such value and goodwill.

 

(b) Subject to the terms and conditions of this section, Elekta, as agent for Elekta AB. of Geneva, Switzerland, the owner of the Mark, hereby grants End User a non-exclusive, royalty-free license without right to sublicense solely for the purpose of using the Mark in connection with the promotion and advertising of any of End User's own services to be performed by use of the LGK® surgical instrument.

 

(c) End User, in the conduct of End User's business, is strictly prohibited from using the Mark in or as its official legal name. However, End User may use the trademark as part of the following fictitious trade name:

 

“Gamma Knife® Center of ____________________”

 

As long as End User utilizes a fictitious trade name which includes the Mark, End User shall not perform radiosurgical services with any equipment other than the LGK®. If End User performs any radiosurgical service with any equipment other than the LGK® or if End User ceases to perform radiosurgical services with the LGK®. End User shall immediately cease utilizing the Mark as part of its fictitious trade name.

 

(d) In advertising, references to the Mark must include the registration symbol O and such symbol must be used at least once per piece of advertising material along with the words "Gamma Knife® and Leksell Gamma Knife® are U.S. federally registered trademarks of Elekta AB" somewhere in the advertisement. Elekta reserves the right to require End User to discontinue the use of advertising that does not conform to such requirements.

 

(e) End User may use the words "Gamma Knife® Center of [add distinctive name)" and/or "Add Distinctive Name" Gamma Knife® Center as part of any intemet domain name, or URL, telephone number or other communications address or symbol provided that the full name, "Gamma Knife® Center of [add distinctive name)" is used. User may use a variation or abbreviation of such term only after obtaining Elekta's prior written consent, to the proposed use in question. User may not under any circumstances, use the words "Gamma Knife®" alone, for any intemet domain name, or URL, telephone number or other communications address or symbol.

 

 
 

 

 

(f) All advertising or promotional materials in which the mark is utilized shall comply with all applicable laws and regulations as well as the standards of proper advertising.

 

(g) Elekta shall have the right to terminate the license granted in this section with immediate effect if End User violates any provision of this section or utilizes the Mark in any manner which, in the sole opinion of Elekta, presents a reasonable possibility of damage to the Mark, and does not cure the violation to the satisfaction of Elekta or provide a written plan to cure the violation that is satisfactory to Elekta within ten (10) business days following written notice from Elekta.

 

(h) Upon termination of the license granted by this section. End User shall immediately cease all use of the Mark, including, but not limited to, the use permitted under subsection (e) of this section.

 

(i) End User acknowledges that a breach of any of its covenants or agreements hereunder may cause immediate and irreparable harm to Elekta and Elekta Instrument S.A. End User acknowledges and agrees that there may be no adequate remedy at law for any such breach, and End User acknowledges that in the event of such a breach Elekta may be entitled to seek Injunctive relief and such other relief as any court with jurisdiction may deem just and proper.

 

(j) Notwithstanding anything to the contrary, End User shall retain all right, title, and interest in all of the End User intellectual property.

 

3.7. Remote Access. Remote access to any End User's systems for maintenance and support of LGP Software and for any other purpose allowed by this Agreement is subject to compliance with the End User's remote access and other security requirements attached as Exhibit F. Elekta's access may require prior certification by the End User that Elekta complies with the End User's security policies and standards. End User may modify these security requirements and Elekta must comply with the most recent version of the End User's security requirements. Elekta must ensure that each of its personnel having access to any part of a End User's computer system: (i) is assigned a separate log-in ID by the End User and uses only that ID when logging on to the End User's system; (ii) logs-off the End User's system immediately upon completion of each session of service; (iii) does not allow other individuals to access the End User's computer system; and (iv) keeps strictly confidential the log-in ID and all other information that enables access. If End User revises the requirements for access to its computer system, then the End User must notify Elekta of the changed or additional requirements and Elekta must conic*/ with them as a prerequisite to further access. Any End User may require each individual who is to be allowed access to that End User's computer system to acknowledge the individual's responsibilities in connection with the access.

 

ARTICLE IV. CONFIDENTIALITY

 

4.1 End User shall treat and maintain as confidential all technical information and know-haw to it pursuant to this Agreement (including LGP Software), except for know-how specifically designated as non-confidential pursuant to this Agreemant or otherwise so designated by the Elekta. End User shall not disclose any aspect of such know-how (including the LGP Software) to any other person, includ:ng any corporation or governmental or quasi-governmental agency. provided that, End User shall have the right to disclose such know-how to its employees, agents and independent contractors to the extent necessary for use of the LGKCI, but End User shall be responsible to ensure that such know-how is not disclosed by such persons.

 

4.2 Elekta agrees that it shall not disclose or verify to any third party any End User Data which it learned or had access to during the course of its performance of this Agreement without the prior written consent of End User. This obligation shall survive the cancellation or other termination of this Agreement. The parties agree that any information furnished to one by the other that is marked "confidential" or 'proprietary" or which consists of or relates to patient information, a party's initiatives, business plans or intellectual property, and employee and medical staff information, constitutes the sole and exclusive proprietary information of the providing party ("Confidential Information"). ''Confidential Information" shall also include any information concerning a disclosing party (whether prepared by a disclosing party or its representatives or otherwise and irrespective of the form of communication (i.e., whether written or oral)) which is furnished to a receiving party or to its representatives now or in the future by or on behalf of a disclosing party, including, without limitation, any business, technical (including but not limited to patented or patent-pending information), marketing, financial, patient, customer, vendor, employee, manufacturing, marketing, sales, research and development, or other Information which is communicated by or on behalf of a disclosing party to a receiving party orally, in writing or other physical form. "Confidential Information" shall also be deemed to include any notes, analyses, compilations. studies, forecasts, interpretations or other documents prepared by a receiving party or its representatives that contain, in whole or in part, the information furnished to such receiving party or its representatives pursuant hereto. Elekta and End User each agree to not disclose the other party's Confidential Information for the benefit of itself or any other person or entity except as expressly provided in this Agreement,

 

4.3 Elekta acknowledges that it will not acquire any rights in any of End User Data. Any grant by End User of rights in its End User Data, including, without limitation, for statistical analyses, must be approved by End User in writing in advance. Elekta acknowledges that it may not use any of End User Data, even if it is in 'cleansed" or "deidentified" form, for any purpose other than to fulfill its contractual obligations to End User and, if applicable, for other purposes that have been agreed to by End User and approved in a writing separate from and referencing this Agreement.

 

 
 

 

 

4.4 The provisions of this Article IV shall survive the termination of this Agreement and shall apply with equal force to any technical information or know-how concerning the LGK® acquired by End User other than pursuant to this Agreement.

 

4.5 The obligations of confidentiality and restriction of access pursuant to this Article IV shall not apply to any trade secret or confidential information that was (a) in the public domain at the time of such access or subsequently came in to the public domain through no fault of the person subject to the provisions of Article IV; (b) rightfully known to the person given to such access or developed independently by the person given such access; (c) received by the person given such access as a matter of right from a source other than a person subject to the provisions of this Article IV; or (d) required to be disclosed by subpoena or court order, but End User shall give immediate notice of such subpoena or court order to Elekta and shall request the court to grant confidential treatment to the confidential information disclosed pursuant to such subpoena or court order.

 

ARTICLE V. WARRANTY

 

5.1 Elekta provides the warranty for the LGK® and LGP Software set forth in Exhibit C hereto.

 

ARTICLE VI. EXCUSABLE DELAYS

 

6.1 If the performance of this Agreement by Elekta or End-User, or any obligation of Elekta or End-User hereunder is prevented, restricted or interfered with by reason of fire. explosion, acts of God, labor disputes or accidents affecting performance under this Agreement, or war, mobilization, civil commotions, blockade or embargo, or any law, regulation, ordinance or requirement of any government or regulatory agency. or any other act whatsoever similar to those above enumerated, or any other circumstance being beyond the reasonable control of Elekta or End-User, then and in that event Elekta or End-User, as the case may be, shall promptly notify the other parties hereto of the resulting difficulties there from, and any of the foregoing events shall excuse any performance required under this Agreement.

 

ARTICLE VII. LIMITATION OF LIABILITY & INDEMNIFICATION.

 

7.1 The remedies of End User and Elekta's liabilities for breaches of this Agreement shall include but not be limited to those specifically provided for in Section 5.1 and in this Article VII. Except for acts of willful misconduct, gross negligence, breaches of confidentiality, breaches of the Business Associate Addendum, and indemnification obligations, in no event shall Elekta be liable to End User for loss of revenue or profit, or for any other indirect, incidental or consequential damage, whether arising in contract, tort or otherwise.

 

7.2 Elekta shall defend and indemnify End User and its affiliates, agents, servants and employees. and hold them harmless from and against all damages, losses claims, judgments and liabilities by or to third parties (plus litigation costs incurred) resulting from injury to or death of any person or physical loss or damage to property arising out of defective materials, workmanship, or manufacture of the LGK® or the defective maintenance of the LGK® (but, with respect to maintenance, only to the extent performed by or on behalf of Elekta). The foregoing indemnification obligations require that: (i) End User shall notify Elekta in writing of a claim within a reasonable period of time after becoming aware of such claim or Elekta’s potential capability: (ii) Elekta has primary control of the defense and all related settlement negotiations: (iii) in the case of real or tangible property, limiting such indemnification and save harmless obligations to the cost of repair of such property or if repair is not practicable. to the replacement cost of such property; and (iv) in the case of destroyed data, limiting such indemnification and save harmless obligations to complete recovery or input of lost data. Failure of the foregoing obligations shall affect the indemnification obligation only to the extent such failure materially and adversely impacts the ability of Elekta to successfully defend against the claims. Elekta agrees that any settlement of such claim or cause of action shall release End User and the Indemnitees fully, absolutely, and finally from any liability related to such cause of action. Elekta shall use commercially reasonable efforts to minimize, to the extent possible, publicity adverse to End User or an Indemnitee associated with any such settlement. Elekta shall not agree to a settlement which names End User or an Indemnitee as culpable absent the prior written consent of such Indemnitee. In the event that Elekta, in the reasonable judgment of End User, lacks the financial resources to adequately and timely defend such claim or if Elekta has indicated in writing its unwillingness to so defend such claim, End User may defend and Elekta shall reimburse, all costs related to such defense.

 

7.3 If a third party claim is made or an action brought alleging that the LGP Software infringes a U.S. Patent, or any copyright, trademark, trade secret or other proprietary right, Elekta snail indemnify, hold harmless and defend End User against such claim and shall pay ongoing and resulting costs of the infringement claim, if any, including reasonable attorneys' and expert fees. End User shall promptly notify Elekta in writing of the claim, and Elekta shall have sole control of the defense and all related settlement negotiations. End User shall reasonably cooperate in such defense so long as there is no expense to End User. If the LGP Software, in whole or in part, or the use or operation thereof, becomes or in the reasonable option of Elekta is likely to become, the subject of such a claim. Elekta shall, at its sold expense, either procure the right for Customer to continue using the LGP Software or, at the option of Elekta at Elekta sole expense, replace or modify the same so that it becomes non-infringing (provided such replacement or modification maintains the same material functionality and does not adversely affect End User's use of the LGP Software as contemplated hereunder). If neither of the alternatives is available on terms which are reasonable in Elekta’s sole judgment, Elekta shall refund to End User, upon receipt of the infringing LGP Software, all fees paid for such infringing LGP Software, depreciated on a five (5) year straight line basis.

 

 
 

 

 

 

ARTICLE VIII. MISCELLANEOUS PROVISIONS.

 

8.1 Assignment. No party hereto shall assign its respective rights or obligations under this Agreement (including the LGP Software License) in whole or in part to any person without the prior written consent of the other party, except as provided in this Section 8.2 hereinafter. In the event of any assignment or transfer by End User of its rights or duties under this Agreement or the Lease or of any sale, transfer, lease or sublease of the LGK® or any component thereof to a third party, End User shall obtain the prior approval of Elekta of the proposed transferee (such approval not to be unreasonably withheld) and cause such transferee, prior to such transfer, to sign ('.) an agreement that any acquired interest In the LGK® System is subject to the terms and conditions of this Agreement and evidencing such transferee's agreement to be bound, to the same extent as End User, by the then-surviving provisions of this Agreement, including but not limited to the technical and scientific information provisions (Section 3.3), the confidentiality provisions (Article IV), the provisions of Articles V and VII hereof, and the provisions of the LGK® Software License or (2) a similar agreement otherwise approved by the Elekta, which approval shall not be unreasonably withheld.

 

8.2 Subcontractors. Elekta shall be entitled to appoint subcontractors or any other third parties for the performance or fulfillment in whole or in part of Elekta's obligations under this Agreement without the consent of End User, and Elekta shall be fully responsible and liable for the performance, acts, and omissions of entities it appoints to perform Elekta's obligations hereunder. Elekta shall be entitled to assign any of its rights or obligations hereunder to any of its affiliates without the consent of End User, but Elekta agrees that it will be fully responsible for any obligations assigned to Elekta's Affiliates hereunder.

 

8.3 Entire Agreement. This Agreement constitutes the entire agreement between the parties hereto and supersedes any prior or contemporaneous agreements, negotiations or discussions between the parties with respect to the subject matter hereof. No amendment of the provisions of this Agreement will be valid unless made in writing and signed by both parties hereto.

 

8.4 Additional Obligations. Elekta acknowledges End User's obligations to comply with certain laws and regulations as well as the need for Elekta's employees, agents, and contractors to comply with reasonable requests, standard rules, and regulations of End User regarding persona! and professional conduct as attached in Exhibit G, including the use of an Identification badge or personal protective equipment. Elekta will ensure that it's employees, agents, and contractors comply to End User's facility laws or regulations, and general safety practices or procedures, generally applicable to such facilities. Elekta will perform, as applicable, criminal background checks, credit checks, health screening. vaccinations and testing on its employees, agents. and contractors and agrees to provide written verification to End User of any such required checks, tests and screenings, and shall provide End User with reasonable assistance in ensuring Elekta employee, agent, and contractor compliance with (i) laws and regulations affecting End User's facllity(ies) and (ii) End User's facility rules and regulations. Elekta warrants and represents that it has enforceable written agreements with all of its employees, agents, and contractors involved during the course of this Agreement in any provision of services and Equipment under this Agreement, obligating such employees and contractors upon terms and conditions no less restrictive than contained herein, not to use or disclose any confidential information, proprietary rights, or information learned or acquired during the course of such employment or engagement, Elekta warrants and represents that any services performed by Elekta or by a permitted subcontractor or agent of Elekta shall be performed in a professional manner, consistent with industry standards and in a diligent, workmanlike, and expeditious manner.

 

8.5 Personnel Requirements. Elekta and its employees, agents, and contractors shall cum.* with and abide by End User's rules, policies and/or procedures for vendor credentialing including those attached as Exhibit H. to the extent allowed by law. Elekta expressly acknowledges and agrees that as a condition of access to End User, Elekta and its employees, agents, and contractors shall cooperate and work with any third party vendor credentialing services entity with which End User has a contract and from which End User requests Elekta and its employees, agents, and contractors to obtain credentialing. No representatives of Elekta will be given access to End User absent successful completion of End User's vendor credentialing program and continued strict compliance with End User's rules, standards, policies and procedures. End User's vendor credentialing program requires Elektra to provide the following information to End User, which shall be kept on file at End User's Radiation Oncology Department: (i) a criminal background check; (ii) verification of Excluded Provider status; (iii) licensure verification, if any; (Iv) PPD test (tuberculosis) within ninety (90) days of first visit and annually thereafter; (v) a copy of a valid state photo identification; and (vi) a complete orientation packet and confidentiality statement. End User acknowledges and agrees that all information provided to End User by Elekta pursuant to this Section 8.5 (i) through (v) shall be Confidential Information as defined herein and subject to the restrictions and obligations set forth in Article IV above. Elekta expressly agrees that it shall instruct all of its representatives of the above requirements, and the fact that each representative, prior to admission to End User, must have a scheduled appointment in place. End User may, in its sole discretion, require Elekta to replace any personnel provided by Elekta, including any contractor personnel, should they not comply with End User's security requirements or other rules and regulations applicable to the conduct of End User's employees or contractors while such Elekta personnel are performing their obligations hereunder at the End User's °remises. No standing appointments are permissible or will be allowed. Nothing herein shall be construed as granting a representative access or permission to any locations within End User, other than the main lobby of End User. Any Elekta representatives seeking access to End User for the purpose of performing Services must have a scheduled appointment with End User's Director of Materials Management. Any Elekta representative that does not comply with the above, will be removed from End User and may permanently prohibited from access to End User.

 

 
 

 

 

8.6 Governing Law. This Agreement shall be interpreted and enforced in accordance with the internal laws, and not the law of conflicts, of the State of Florida.

 

8.7 Independent Contractor. It is mutually understood and agreed that nothing in this Agreement is intended nor shall be construed to create between Elekta and End User, with respect to their relationship hereunder, an employer/employee relationship, a partnership or joint venture relationship, or a landlord/tenant relationship.

 

8.8 Excluded Provider. Elekta represents and warrants that neither it nor any of its employees or other contracted staff (collectively referred to in this paragraph as "employees") has been or is about to be excluded from participation in any Federal Health Care Program (as defined herein). Elekta agrees to notify End User within five (5) business days of Elekta's receipt of notice of intent to exclude or actual notice of exclusion from any such program. The listing of Elekta or any of its employees on the Office of Inspector General's exclusion list (01G website) the General Services Administration's Lists of Parties Excluded from Federal Procurement and Nonprocurement Programs (GSA website) for excluded individuals or entities, any state Medicaid exclusion list or the Office of Foreign Assets Control's (OFAC's) blocked list shall constitute "exclusion" for purposes of this paragraph. In the event that Elekta or any of its employees is excluded from any Federal Health Care Program or placed on the OFAC's blocked list, it shall be a material breach and this Agreement shall immediately terminate without penalty to End User, unless End User elects in writing to continue this Agreement. For the purpose of this paragraph, the term "Federal Health Care Program" means the Medicare program, the Medicaid program, TRICARE, any health care program of the Department of Veterans Affairs, the Maternal and Child Health Services Block Grant program any state social services block grant program, any state children's health insurance program, or any similar program.

 

8.9 Corporate Responsibility Program. End User has in place a Corporate Responsibility Program ("Program") which has as its goal to ensure that End User complies with federal, state and local laws and regulations, a copy of which is available for review at jaxhealth.com in the Patients and Visitors section. The Program focuses on risk management, the promotion of good corporate citizenship, including the commitment to uphold a high standard of ethical and legal business practices, and the prevention of misconduct. Elekta acknowledges End User's commitment to Corporate Responsibility.

 

8.10 Religious and Ethical Directives. The parties acknowledge that the operations of End User and its affiliates are in accordance with the Ethical and Religious Directives for Catholic Health Care Services, as promulgates by the United States Conference of Catholic Bishops Washington, D.C. of the Roman Catholic Church or its successor ("Directives") and the principles and beliefs of the Roman Catholic Church is a matter of conscience to End User and its affiliates. The Directives are located at http://www.usccb.org/bishops/directives.shtn -d. It is the intent of the parties that neither this Agreement nor any part hereof shall be construed to require End User or its affiliates to violate said Directives in their operation.

 

8.11 Compliance with Laws. Elekta acknowledges that the equipment and LGP Software complies with the requirements of all applicable federal, state and local laws, ordinances, regulations and codes relating to the privacy or security of information including, but not limited to, the Health Insurance Portability and Accountability Act of 1996 "HIPAA" and corresponding regulations. To the extent Elekta receives Individually Identifiable Health Information ("11HI") as such term is used in 45 C.F.R. § 160.103, Elekta shall execute the Business Associate Addendum ("BAA") attached hereto as Exhibit E, and further agrees to execute any amendments thereto reasonably requested by End User to meet End User's regulatory obligations. In the event of a conflict between the BAA, as may be amended, and this Agreement, the BAA shall be given priority.

 

8.12 Insurance. Throughout the term of this Agreement Elekta shall maintain in force, at a minimum, the insurance coverages described below. Elekta shall obtain or otherwise arrange  for appropriate levels of insurance coverage for all subcontractors providing services that shall also comply with required insurance requirements as set forth below.

 

(a) commercial general liability insurance, including products/completed operations, personal and advertising injury coverage, in a form equivalent to CG0001 1207 or CG0002 1207, with a minimum combined single limit of $1 million per occurrence and minimum general aggregate and products/completed operations aggregate limits of $3 million;

 

(b) comprehensive automobile liability insurance covering use of all owned, non-owned and hired automobiles with a minimum combined single limit of $1 million per accident for bodily injury and property damage liability;

 

(c) worker's compensation insurance and employer's liability insurance or any alternative plan or coverage as permitted or required by applicable law, with a minimum employer's liability limit of $1 million each accident, each employee for disease, and policy limit for disease;

 

 
 

 

 

(d) umbrella/excess liability insurance, with underlying coverage in subsections (a) through (c) above, with a minimum limit of $5 million per occurrence and minimum aggregate amount of $15 million, said amounts being in excess of the named primary coverages;

 

(e) Elekta agrees to provide a certificate of insurance to End User upon written notice of such a request.

 

IN WITNESS WHEREOF, the parties hereto have signed this Agreement in duplicate as of the date first written above.

 

ELEKTA INC.

 

By: /s/ Michelle Crawley   Title: VP Contract Administration
         
      Date:  08/04/11

 

SAINT VINCENT’S MEDICAL CENTER, INC.

 

By : /s/ Moody Chisholm   Title: President & CEO
         
      Date: 8/11/11

 

 
 

 

 

EXHIBIT A

SCOPE OF SUPPLY

 

Leksell Gamma Knife® PERFEXION TM

 

 

PRODUCT SPECIFICATION

Standard turn-key system

  

Qty Description       Article no.
1   Leksell Gamma Knife® PERFEXION TM  

715000

2   Leksell® Coordinate Frame TM Kit for PERFEXION TM   1002407
1   Leksell GammaPlan®   in BOM
1   PERFEXION TM system tool kit    
1   LSS Spare Part Kit for Leksell® Coordinate Frame TM   1002406
I   Skull scaling instrument   A0202-01
1   CT planning kit    
1   MRI planning kit    
I   X-ray planning kit    
1   Set of Co 60 sources   2000000
    Cobalt loading    
    Site planning    
    Installation and commissioning    
         
1   Support and Education & Training for PERFEXION TM   SER PERFEXION
        0001

 

 
 

 

 

Leksell Gamma Knife ® PERFEXION TM

 

Radiation unit

-With radiation shielding doors and collimator system.

 

Patient Positioning System TM

-Patient couch and automatic Patient Positioning System.

 

Covers for radiation unit and Patient Positioning System

 

Electric cabinet

-Electric cabinet with cabling

-ECU - central unit and safety system electronic board, circuit breakers and cabling.

-SDU - sector drive electronic board, circuit breakers and cabling

-PPC 1- software

-PPC 2- software

-Medical UPS

 

Operator area

-Office cabinet

-Keyboard and mouse

-Operator console with patient and operator audio/video, power supply, opto insulators, cabling and connectors

Flat screen monitors

Office UPS

 

MCU kit

MCU PC with USB CAN
MCU software

 

Treatment couch

Height adjustable mattress

Manual controls for treatment setup

 

Frame adapter

Model "Standard G". For interfacing between Leksell Coordinate Frame model G and Leksell Gamma Knife PERFEXION TM .

 

Clearance check tool

Document set

Installation and supplementary documents

2 instructions for use

2 emergency routines

Signs and labels

 

 
 

 

 

Leksell® Coordinate Frame® Kit for PERFEXION TM

 

Includes:

 

Qty Consists Of: Article No.
     
1 Frame with Feet and Straight Front Piece 50487-01
1 Front Piece, Curved 60638-01
2 Insulated Fixation Post, Anterior 912462
2 Insulated Fixation Post, Short Posterior 912463
2 Insulated Fixation Post, Long Posterior 912862
6 Locking Screw, 5 x 19 mm, Titanium 60490-03
6 Locking Piece for Fixation Post 60497-01
1 Ear Plug Holder, Right 50498-01
I Ear Plug Holder, Left 50498-02
2 Ear Plug 60136-01
1 Fixation Screws, Titanium, kit of 20 pairs 907999
2 Instrument Screw Driver, Double 50146-02
1 Sterilizing Tray for Frame 50151-03
4 Disposable Inserts, 25x4 pieces 912464
1 Instruction for Use, Leksell® Coordinate Frame kit 003818  
1 Instructions for Use, Insulated Fixation Posts 012594
1 Quick Reference Guide 014611

 

PERFEXION TM system tool kit

Includes:

QA tool 1001182
-For radiation focus precision check.  
Frame Cap 717960

 -The frame cap is used during patient preparation for a treatment with Leksell
Gamma Knife ® PERFEXION TM .

 

LSS Spare Part Kit for Leksell® Coordinate Frame TM

Consists of 4 pieces of each of the following;

-Locking Screw, 5 x 19 mm, Titanium

-Locking Piece for Fixation Post

-Screw, 4 x 10 mm, Titanium

 

Skull scaling instrument

For measurement of skull shape for Leksell GammaPlan® modeling

 

CT planning kit

Includes:

CT indicator A0800-11
-Fiducial box for CT imaging procedure  
CT adapter A0400-04
-Fixating the stereotactic frame to the CT table fixation  
CT table fixation A0401-XX

-Fixating the CT adapter to specified CT table.

 

 
 

 

 

 

MRI planning kit

Includes:

MR adapter A0420-XX
-Fixating the stereotactic frame to specified MR table.  
MR indicator A0820-07

-Fiducial box for MR imaging procedure

 

X-ray planning kit

Includes:

X-ray indicator A0860-04
-Fiducial box for angiography imaging procedure  
X-ray adapter and support A0440-XX

-Fixating the stereotactic frame to specified angiography table.

 

Standard LGP for LGK PERFEXION

Includes one (1) Leksell GammaPlan® (LOP) license for creating new treatment plans for Leksell Gamma Knife® PERFEXION TM . This main license allows the addition, management and storage of an unlimited number patient records and treatment plans. LGP also allows the visualization of treatment plans created at other LGK units.

 

Leksell GammaPlan® for Leksell Gamma Knife® PERFEXION TM includes:

 

1 STANDARD LGP FOR PERFEXION LICENSE

 

Includes one (1) Leksell GammaPlan® (LGP) license for creating new treatment plans for Leksell Gamma Knife® PERFEXION TM .This main license allows the addition, management and storage of an unlimited number patient records and treatment plans. LGP also allows the visualization of treatment plans created at other LGK units.

 

1 RETREATMENT TM LICENSE

 

This software add-on facilitates planning of treatments days before surgery, the assessment of treatments and re-treatments. Users are free to plan days ahead of treatment, to prepare tomorrow's follow-ups and plan additional treatment. Re-Treatment TM also lets any user to integrate images and vital treatment information from previous plans. It is a powerful tool to import and display previous key treatment data in the new treatment images. Imported data are user defined regions (targets, risk structures) and prescription isodose. It increases the customer confidence when treating new lesions after an initial treatment.

 

1 WARPSPEED TM , REAL-TIME DOSE UPDATE LICENSE

 

This add-on speeds up planning by allowing the update of isodoses instantly during planning. Isodoses displayed in any workspace are instantly updated whenever one or several isocenters are added, modified, or removed. It is possible to fully apprehend the potential of composite shots, while also simplifying the elaboration of new dose plans. WarpSpeed TM provides a shorter learning curve, more intuitive and faster planning.

 

1 FUNCTIONAL PLANNING TM LICENSE

This software add-on allows users to perform some functional procedures based on the definition on the AC-PC line the visualization of functional targets based on functional target formulas.

 

 
 

 

  

1 IMAGEMERGE TM LICENSE

 

This software add-on allows an automatic or manual co-registration of any frameless image studies with a frame based reference study. Once co-registered, the frameless image can be used in LGP like any other study. Supports MR, CT and PET images (requires the optional module ColorPET TM ).

 

1 COLOR PET TM LICENSE

 

The ColorPET TM software add-on help users to can combine the physiological data of PET images with the anatomical data of CT and MR images using predefined color lookup tables. Requires the ImageMerge software add-on.

 

Color Printer 110V

Network color laser printer with

-     Ethernet connector, minimum speed 10/100

-     Support for Postscript Level 3 printing

-     Power supply 110 V

-     English menus and labels

-     Support for printing A4, US letter, US executive and US legal
Delivered model: HP Color Laser Jet or similar

 

1 LGP — DICOM RT License

DICOM RT provides an exclusive possibility to share treatment information with any DICOM RT compatible system. It includes:

IMPORT of DICOM RT STRUCT allows displaying any user-defined region/volume created on a DICOM RT system. Volumes can be target volumes, organ at risks, isodoses or any other region of interest defined by the user.

EXPORT of treatment data via DICOM RT STRUCT and DICOM RT DOSE allows sharing information with any compatible systems to perform dose comparison or dose addition.

 

Additional Training for Leksell Gamma Knife ® PERFEXION TM

 

10 Clinical Training
Principle and practice of Gamma Knife Surgery, clinical lectures, treatment planning, patient treatment —5 days. Arranged by Elekta in collaboration with participating End User.

 

 
 

 

Technical Specifications

 

Workflow
Automatic positioning system.  Couch integrated
Typical repositioning time  < 3 s
Typical collimator size setup time  <- 3 s
Blocked collimation setup time < 3 s
Mixed collimation setup time (Composite shot)  < 3 s
Check and verify 100%
QA procedure Automatic
Accuracy
Radiological accuracy  < 0.5 mm
   
Positioning repeatability  < 0.05 mm
Maximum patient weight 210 kg (460 pounds)
Treatment planning
Treatment planning system PC/Linux based
Dynamic shaping Yes
Remote planning Yes
Image co-registration Yes
PET supported Yes
Mechanical treatment range X/Y/Z 160/180/220 mm
Shape of accessible volume Cylindrical
Real collimator sizes 4,8,16 mm diameter
Radiation data
Total cobalt-60 activity at loading (approx.) < 6,600 Curie (2.44 x 10 14 Bq)
Number of radiation sources 192
Radiation dose rate at focal point at loading > 3 Gy/min
Physical data
Overall length, including cover  4.46 m
Overall width, including cover  2.12 m
Overall height, including cover  1.91 m
Total weight (approximate)   20,000 kg

 

 
 

 

 

Radiation unit

The radiation unit is the radiation delivery system. It houses 192 Cobalt-60 sources and the collimator system that directs the radiation to the focus point. The radiation unit incorporates the management of the shielding doors and electro-mechanics of the source sectors.

 

The following section describes selected components within the radiation unit.

All components are chosen from well-recognized suppliers to secure reliability and to optimize performance of the system.

 

Collimator body with radiation shielding
Collimator body Tungsten body with 576 collimator channels.
Collimators Tungsten collimator inserts.
Pre-collimator 576 lead pre-collimator channels.
Outer shielding Cast iron.
Inner shielding Tungsten and lead.
Bearing for collimator body Crossed roller bearing. Static axial load 680000 N
Shielding doors Steel.
Shielding strips Stainless Steel.
Servo Controller High precision, fully digital servo drive with embedded intelligence.
Motor DC motor with 2000 line encoder
Linear guide
Linear guide blocks Caged ball technology.
Gear Planetary gear
Clutch Ratchetting clutch
8 source carrying sector units
Sector Aluminum. 24 source housing
Shafts Induction hardened stainless steel.
Bearings Graphite bushings
Motor 24V DC motor
Encoder 500 impulses/turn
Linear guide unit Repeatability ±0.003mm.
Linear encoder Absolute Linear encoder.
Solenoid Photo-micro sensor
Servo controllers Intelligent servo card

 

 

 
 

 

 

Patient Positioning System

The Patient Positioning System is the component of the PERFEXION TM system that the patient reclines on for treatment and is positioned relative the point of focus in the radiation unit.

 

The following section describes selected components within the Patient Positioning System.

All components are chosen from well-recognized suppliers to secure reliability and to optimize the performance of Leksell Gamma Knife PERFEXION.

 

Couch framework with X/Y/Z drive
Framework 20 mm zinc chromated steel
Motors DC motors with 2000 line encoders.
Gear X/Y-axis Planetary gear 30:1 Z-axis Planetary gear 4:1
Ball screws Bearing houses Support bearings X/Z -axis.
Screw jack Y-axis: Integrated safety nut.
Linear guides  
Linear guide blocks Caged ball technology.
Solenoid Y-axis: Photo-micro sensor.
Linear encoders Absolute Linear encoders. Accuracy grade +/- 0.005mm.
Servo Controllers High precision. fully digital: servo drive. with embedded intelligence.
Frame fixation Hardened stainless steel
Comfort system  
Mattress support Sandwich structure with aluminum honeycomb core and steel sheets
Actuator  DC actuator
Ball bearing Stainless steel.
Covers  
Radiation unit and couch covers 3 layers glass reinforced polyester. Meets ASTM E84 with flame spread index less than 75. Flammability rating V-0 according to UL 94.

 

 

 
 

 

 

Control System

Office Cabinet

 

Includes:

 

MCU - Main Computer Unit

 

Office UPS – Uninterrupted Power Supply

 

Ethernet Switch

 

Operators Console

Includes:

CIU - Connection and Isolation Unit

The CIU is powered by the office UPS and the internal power supply converting 100-250VAC to 24VDC.

PSS - Patient Surveillance system

The PSS is included in the operator console as a separate unit and handles the video/audio signals of the PERFEXION TM system. It is possible to connect a video recorder on the 'auxiliary' outputs.

External audio system. e.g., patients MP3 player, can be connected and played over the sound system integrated in the radiation unit covers.

 

MCU Monitor

19" Flat screen, UL-approved.

The MCU Monitor shows the Graphical User Interface of the MCU.

 

PSS Monitor

19" Flat screen, UL-approved.

The PSS monitor shows the video from the patient camera and provides the sound from the patient microphone.

 

Treatment room Monitor

19" Flat screen. UL-approved.

The treatment room monitor displays the same information as the MCU monitor on the operators console.

 

Treatment room Camera

The treatment room camera provides video to the PSS Monitor in the Operators Area. Medical Cabinet

 

Includes: SDU -Sector Drive Unit

 

The SDU contains 8 servo controllers (one for each sector).

 

ECU - Electronic Control Unit

The Control Unit consists of two complete Power PCs (PPC) with peripherals (RAM. ROM, inputs, outputs, CAN interfaces).

 

Medical UPS - Uninterrupted Power Supply

The medical UPS delivers 24VDC and 48VDC needed for the PERFEXION TM system. It is approved for medical use.

 

Radiation Phantom

The Radiation Phantom with Cassettes is used for calibrating the absorbed dose rate of Leksell Gamma Knife®.

 

 
 

 

 

Support and Education & Training for PERFEXION TM

Education & Training Services

 

On-site Clinical Start-Up

One week on-site application training with Gamma Knife experienced neurosurgeon and/or radiation physicist certified by Elekta.

4 spaces in total selecting between the following two courses:

I) Leksell Gamma Knife® PERFEXION TM Clinical Introductory Course

Principle and practice of Gamma Knife Surgery, clinical lectures, treatment planning, patient treatment 4-5 days. Arranged by Elekta in collaboration with participating hospital.. Elekta pays for the tuition at an approved Elekta training site.

2) Leksell GammaKnife® PERFEXION TM Technical / Application training

For use, care and maintenance of the equipment.

Stereotactic imaging, physics, dosimetry, treatment planning, technical training on unloaded machine, QA procedures - 4 day arranged in Elekta Sweden. Elekta pays for the tuition at an approved Elekta training site.

 

Support Services

The following support services are delivered in addition to parts warranty during the term of the Purchased Services Agreement.

 

Maintenance System Management

Customization of the maintenance schedule for maximum equipment availability, performance and safety with minimum disruption to clinical patient flow.

 

Planned Maintenance

Scheduled preventive maintenance inspections in accordance with Elekta recommended maintenance intervals and procedures performed by Elekta certified engineers. The service includes installation of software maintenance releases and software upgrades. Also included is a service report detailing outstanding service needs and/or recommended parts replacement to sustain equipment performance at original design specifications. Parts, software and further service activities are not included. The customer is responsible for equipment availability for inspections at a mutually agreed time during regular Elekta office hours.

 

Remote Technical Support

Unlimited remote technical support, via phone, e-mail, fax or suitable equivalent, during regular Elekta office hours.

 

On-site Technical Support

Preplanned corrective maintenance by Elekta certified engineers to resolve technical issues on-site during regular Elekta office hours. This service includes a service report detailing the maintenance actions completed and recommending further service actions to eliminate the root cause of the problem(s). It is at the discretion of Elekta to determine whether an on-site visit is required to solve the technical issue. Parts and further service activities not included.

 

Remote Application Support

Unlimited remote application support, via phone, e-mail, fax or a suitable equivalent, during regular Elekta office hours.

 

Leksell GammaPlan ® , remote application support

Unlimited remote application support. via phone, e-mail, fax or a suitable equivalent, during regular Elekta office hours.

 

 
 

 

 

EXHIBIT B

DESCRIPTION OF SITE

 

Saint Vincent's Medical Center

1 Shircliff Way

Jacksonville, Florida 32204

 

 
 

 

 

EXHIBIT C

ELEKTA'S WARRANTY

1. Subject to the exceptions set forth below, Elekta warrants to End User that for one (1) year from the date of completed Installation Test Protocol, the LGK® will perform consistently with the Specification and the LGK® will be free from defects in design, materials, and workmanship which result in non-compliance with the Specification, except as otherwise provided herein below. Notwithstanding the foregoing, Elekta's warranty set forth in this Section 1 does not cover:

 

(i) defects arising out of materials or parts provided, modified or designed by End User;
(ii) defects emanating from End User's improper use or maintenance;
(iii) normal deterioration or normal wear and tear, including radioactive decay of the Cobalt Supply;
(iv) defects resulting from repairs or service of the LGK® supplied other than by Elekta or its authorized representative;
(v) defects in the Hardware (and its operating software) (the warranty for which is regulated in Section 7 below) or the LGP Software (the warranty for which is regulated in Section 2 below).
(vi) the training referred to in Subsection 3.2 of the Terms and Conditions; or
(vii) defects in positioning or in the Site.

 

2. Elekta warrants that the LGP Software will, for a period of one (1) year from the date of the completed Installation Test Protocol, perform substantially in accordance with the Specification, and the documentation delivered with such LGP Software and the Specifications. The warranty set forth in this Section 2 shall not apply if the LGP Software is subject to unauthorized repair or modification, improper application, improper installation by a party other than Elekta or Elekta's authorized agents, accidental damage, negligence in use, improper storage, acts of God, electrical power damage, equipment malfunction. or abnormal operating conditions, and in the event of any of the foregoing, End-User shall be responsible to pay Elekta's then standard charges for any repairs, replacements or services performed by Elekta.

 

3. In the event that the LGK® or any part or component thereof shall fail to conform with the relevant warranty described herein, Elekta shall (or cause one of its affiliates to) promptly repair or replace, at its option and at its expense, the defect in the LGK® or component thereof. Repair or replacement parts furnished or work performed under this warranty shall be warranted for a period of one (1) year from and after the date of such repair of replacement, but in no event shall any such warranty with respect to repair or replacement work or parts extend past that date which is two (2) years from and after the date of completion of the Installation Test Protocol. The defective LGK® or part thereof which is replaced in accordance with this warranty shall be the property of Elekta, and Elekta will notify Buyer and End User in writing immediately after repair or replacement as to what disposition Elekta desires of such LGK® or part thereof, all at Elekta's cost.

 

4. In order to avail itself of its rights under this warranty, End User shall immediately notify Elekta in writing of any defects that appear under the warranty and shall give Elekta every reasonable opportunity of inspecting and remedying such defects.

 

5. Year 2000 Compliance Warranty Elekta further warrants that the equipment, LGP Software and use of data will be year 2000 compliant and accommodate a full year calculation in its software. Licensor will guarantee that the equipment and software will accept all data and perform to comply with the year 2000 warranties, assuring that the full four (4) positions (e.g. 1997) year is utilized.

 

 
 

 

 

6. THE WARRANTIES SET FORTH HEREIN ARE EXCLUSIVE AND GIVEN AND ACCEPTED IN LIEU OF ALL OTHER WARRANTIES OF ELEKTA OR ITS REPRESENTATIVES WITH RESPECT TO QUALITY, PERFORMANCE AND OPERATION OF THE LGK®, WRITTEN OR ORAL, EXPRESSED OR IMPLIED. ALL OTHER WARRANTIES OF ELEKTA OR ITS REPRESENTATIVES, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY EXPRESSLY DISCLAIMED. EXCEPT FOR ACTS OF WILLFUL MISCONDUCT, GROSS NEGLIGENCE, BREACHES OF CONFIDENTIALITY, BREACHES OF THE BUSINESS ASSOCIATE ADDENDUM AND INDEMNIFICATION OBLIGATIONS, IN NO EVENT SHALL ELEKTA BE LIABLE FOR LOSS OF REVENUE OR PROFIT, OR FOR ANY OTHER, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGE ARISING IN ANY RESPECT FROM THE LGK® OR ITS USE, OPERATION OR PERFORMANCE. THE PROVISIONS OF THIS PARAGRAPH SHALL SURVIVE THE TERMINATION OF THIS AGREEMENT.

 

7. Elekta shall assign to End User all of Elekta's rights under the warranty or warranties provided by the manufacturer (the "Computer Manufacturer") for the Hardware and operating software included in the LGK®. In the event the Hardware or operating software exhibit defects which are covered by the warranty of the Computer Manufacturer, End User may notify Elekta of the nature of such defects. In such case, Elekta shall promptly inform the Computer Manufacturer thereof and use its best efforts to arrange prompt repair service by the Computer Manufacturer pursuant to the terms of the Computer Manufacturer's warranty or warranties Elekta shall furnish End-User with such reasonable cooperation as End User may request with respect to the purchase by Buyer of any extended warranty or maintenance contract offered by the Computer Manufacturer.

 

8. Elekta represents and warrants that at the time of delivery, the LGP Software does not and shall not contain any lock clock, timer trojan horse easter egg, time bomb, counter copy protection feature replication devices or defect ("virus" or "worm" as such terms are commonly used in the computer industry) CPU serial number references, or other device which: (i) might lock, disable or erase the LGP Software; (ii) prevent End User from fully utilizing the LGP Software; (iii) require action or intervention by Elekta or other persons or entities to allow End User to utilize the LGP Software; or (iv) might damage End User's network, data, computer equipment or other property as a result of accessing the LGP Software.

 

 
 

 

 

EXHIBIT D

LEKSELL GAMMAPLAN® PFX™ SOFTWARE LICENSE

1. LGP Software

 

1.1 Elekta hereby licenses to Buyer the LGP Software at no additional cost, to be utilized only for the purpose of planning dosages of treatments to be performed with the LGK®. In case Buyer already has an existing Leksell Gamma Knife® Buyer may also retain one license to the old Leksell Gamma Plan® software for archival purposes. Such license is also subject to the license terms and conditions set out in this Exhibit D. Such license is for the use by Buyer of the software at one (1) workstation.

 

1.2 Buyer shall not: (a) use LGP Software except in connection with the radiosurgical operations performed with the LGK® at the Site; (b) except as otherwise agreed upon in writing, make any modification to, adapt, translate, decompile, disassemble or create derivative works based on LGP Software or merge LGP Software into any other software; (c) reproduce LGP Software (or any portion thereof) or any materials related thereto except for one (1) back-up copy made as part of Buyer's regular computer software maintenance routines; (d) transfer, assign or sublicense LGP Software to any person except to an assignee of all of Buyer's rights in this Agreement in a manner permitted by Section 8.1 of the Terms and Conditions of this Agreement: or (e) use LGP Software in connection with any access terminal other than the Hardware which has been specifically approved by Elekta in writing.

 

1.3 All right, title, interest and ownership of, in and to LGP Software, including but not limited to all trademarks, service marks, registrations, copyrights, and all other proprietary rights not expressly granted in this License, shall at all times remain the exclusive property of Elekta. Elekta shall retain all rights to LGP Software recorded on the original disk(s) and all subsequent copies of LGP Software, in whatever form recorded.

 

1.4 The term of Buyers license to LGP Software shall continue until the earlier of: (a) any sublicense, assignment or transfer or attempted sublicense, assignment or transfer by Buyer of LGP Software without the consent of Elekta; (b) the transport, movement or attempted transport or movement by the Buyer of LGP Software, or the Hardware on which LGP Software is installed, from the Site without prior written consent of Elekta; (c) any modification or adaptation of LGP Software for use with any equipment other than the LGK®, (d) the use of LGP Software in connection with more than one access terminal unless Buyer has obtained the written consent of Elekta to the use of more than one access terminal at the same time or in connection with any access terminal other than the Hardware which has not been specifically approved by Elekta in writing; or (E) the mutual written consent of Buyer and Elekta.

 

2 . Buyer's Responsibilities Concerning Hardware and LGP Software:

 

2.1 To facilitate E-Mail/Internet support, Buyer shall provide for E-Mail/Internet connectivity.

 

2.2 If Buyer elects to transfer images by a data network, then:

 

(a) Buyer shall provide the format to and right to read the diagnostic images generated by the user's diagnostic equipment and planned to be used as input for LGP Software. The Buyer shall provide a sample image in digital and hard copy form in the orientation intended for clinical use.
(b) Buyer is responsible for obtaining up-to-date and accurate scanner image formals and any other scanner or PACS information from vendors necessary to integrate images into LGP Software and providing this to Elekta.

 

 
 

 

 

(c) The Hardware used to run LGP Software must be used solely for this and related purpose. All changes and additions to LGP Software and/or Hardware running LGP Software must receive prior written approval of Elekta.
(d) Buyer shall provide the images via an Ethernet connection using TCP/IP protocol and will provide all physical cabling to the LGP Hardware compatible with 100-Base-T or 1000-Base-T at the Installation location of the LGK®.
(e) Buyer shall provide all TCP/IP networking parameters such as IP address, net mask, gateway address etc. for the HP workstation included as a part of the Hardware.

 

 
 

 

 

EXHIBIT E

 

HIPAA Business Associate Addendum

 

THIS HIPAA BUSINESS ASSOCIATE ADDENDUM (the "Addendum") is entered into effective the 4 th day of August , 2011 (the "Effective Date"), by and between Elekta, Inc., ("Business Associate") and Saint Vincent's Medical Center, on behalf of itself and its affiliates, if any (individually and collectively, the "Covered Entity") and adds to the Leksell Gamma Knife® End User Agreement dated 8/4/11(the "Agreement") entered into between Business Associate and Covered Entity.

 

Pursuant to the Agreement, Business Associate may perform functions or activities on behalf of Covered Entity involving the use and/or disclosure of protected health information received from, or created or received by, Business Associate on behalf of Covered Entity ("PHI"). Therefore, if Business Associate is functioning as a business associate to Covered Entity, Business Associate agrees to the following terms and conditions set forth in this HIPAA Business Associate Addendum.

 

1. Definitions. For purposes of this Addendum, the terms used herein, unless otherwise defined, shall have the same meanings as used in the Health Insurance Portability and Accountability Act of 1996, and any amendments or implementing regulations ("HIPAA"), or the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009), and any amendments or implementing regulations ("HITECH").

 

2. Compliance with Applicable Law. The parties acknowledge and agree that, beginning with the relevant effective dates , Business Associate shall comply with its obligations under this Addendum and with all obligations of a business associate under HIPAA, HITECH and other related laws, as they exist at the time this Addendum is executed and as they are amended, for so long as this Addendum is in place.

 

3. Permissible Use and Disclosure of Protected Health Information. Business Associate may use and disclose PHI to carry out its duties to Covered Entity pursuant to the terms of the Agreement. Business Associate may also use and disclose PHI (i) for its own proper management and administration, and (ii) to carry out its legal responsibilities. If Business Associate discloses Protected Health Information to a third party for either above reason, prior to making any such disclosure, Business Associate must obtain: (i) reasonable assurances from the receiving party that such PHI will be held confidential and be disclosed only as required by law or for the purposes for which it was disclosed to such receiving party; and (ii) an agreement from such receiving party to immediately notify Business Associate of any known breaches of the confidentiality of the PHI.

 

4. Limitations on Uses and Disclosures of PHL Business Associate shall not, and shall ensure that its directors, officers, employees, and agents do not, use or disclose PHI in any manner that is not permitted or required by the Agreement, this Addendum, or required by law. All uses and disclosures of, and requests by Business Associate, for PHI are subject to the minimum necessary rule of the Privacy Standards and shall be limited to the information contained in a limited data set, to the extent practical, unless additional information is needed to accomplish the intended purpose, or as otherwise permitted in accordance with Section 13405(b) of HITECH and any implementing regulations.

 

 
 

 

 

5. Required Safeguards To Protect PHI. Business Associate agrees that it will implement appropriate safeguards in accordance with the Privacy Standards to prevent the use or disclosure of PHI other than pursuant to the terms and conditions of this Addendum.

 

6. Reporting of Improper Use and Disclosures of PHI. Business Associate shall promptly, but no later than five (5) business days, report to Covered Entity a use or disclosure of PHI not provided for in this Addendum by Business Associate, its officers, directors, employees, or agents, or by a third party to whom Business Associate disclosed PHI.

 

7. Reporting of Breaches of Unsecured PHI. Business Associate shall promptly, but no later than five (5) business days, report to Covered Entity a breach of unsecured PHI, in accordance with 45 C.F.R. §§ 164.400-414. Business Associate shall cooperate with Covered Entity's breach notification and mitigation activities, and shall be responsible for all actual and direct costs, which shall include credit monitoring services for affected individuals, incurred by Covered Entity for those activities.

 

8. Mitigation of Harmful Effects. Business Associate agrees to mitigate, to the extent practicable, any harmful effect of a use or disclosure of PHI by Business Associate in violation of the requirements of this Addendum, including, but not limited to, compliance with any state law or contractual data breach requirements.

 

9. Agreements by Third Parties. Business Associate shall enter into an agreement with any agent or subcontractor of Business Associate that will have access to PHI. Pursuant to such agreement, the agent or subcontractor shall agree to be bound by the same restrictions, terms, and conditions that apply to Business Associate under this Addendum with respect to such PHI.

 

10. Access to Information. Within ten (10) business days from receipt of a written request by Covered Entity for access to PHI about an individual contained in a Designated Record Set, Business Associate shall make available to Covered Entity such PHI for so long as such information is maintained by Business Associate in the Designated Record Set, as required by 45 C.F.R. § 164.524. In the event any individual delivers directly to Business Associate a written request for access to PHI, Business Associate shall within five (5) days forward such request to Covered Entity.

 

11. Availability of PHI for Amendment. Within ten (10) business days from receipt of a written request from Covered Entity for the amendment of an individual's PHI or a record regarding an individual contained in a Designated Record Set (for so long as the PHI is maintained in the Designated Record Set), Business Associate shall provide such information to Covered Entity for amendment and incorporate any such amendments in the PHI as required by 45 C.F.R. § 164.526. In the event any individual delivers directly to Business Associate a written request for amendment to PHI, Business Associate shall within five (5) days forward such request to Covered Entity.

 

12. Documentation of Disclosures . Business Associate agrees to document disclosures of PHI and information related to such disclosures as would be required for Covered Entity to respond to a request by an individual for an accounting of disclosures of PHI in accordance with 45 C.F.R. § 164.528.

 

 

 
 

 

 

13. Accounting of Disclosures. Within ten (10) days from receipt of written notice by Covered Entity to Business Associate that it has received a request for an accounting of disclosures of PHI regarding an individual during the six (6) years prior to the date on which the accounting was requested, Business Associate shall make available to Covered Entity information to permit Covered Entity to respond to the request for an accounting of disclosures of PHI, as required by 45 C.F.R. § 164.528. In the case of an electronic health record maintained or hosted by Business Associate on behalf of Covered Entity, the accounting period shall be three (3) years and the accounting shall include disclosures for treatment, payment and healthcare operations, in accordance with the applicable effective date of Section 13402(a) of HITECH. In the event the written request for an accounting is delivered directly to Business Associate, Business Associate shall within five (5) business days forward such request to Covered Entity.

   

14. Electronic PHI. To the extent that Business Associate creates, receives, maintains or transmits electronic PHI on behalf of Covered Entity, Business Associate shall:

 

(a) Comply with 45 C.F.R. §§164.308, 310, 312, and 316 in the same manner as such sections apply to Covered Entity, pursuant to Section 13401(a) of HITECH, and otherwise implement administrative, physical and technical safeguards that reasonably and appropriately protect the confidentiality, integrity and availability of electronic PHI;

 

(b) Ensure that any agent to whom Business Associate provides electronic PHI agrees to implement reasonable and appropriate safeguards consistent with industry standards designed to protect it; and

 

(c) Report to Covered Entity any security incident of which Business Associate becomes aware.

 

15 . Judicial and Administrative Proceedings. In the event Business Associate receives a subpoena, court or administrative order or other discovery request or mandate for release of PHI, Covered Entity shall have the right to control Business Associate's response to such request. Business Associate shall notify Covered Entity of the request as soon as reasonably practicable, but in any event within two (2) business days of receipt of such request.

 

16. Availability of Books and Records. Business Associate hereby agrees to make its internal practices, books, and records relating to the use and disclosure of PHI available to the Secretary of the Department of Health and Human Services for purposes of determining compliance with the Privacy Standards.

 

17. Breach of Contract by Business Associate. In addition to any other rights Covered Entity may have in the Agreement, this Addendum or by operation of law or in equity, Covered Entity may i) immediately terminate the Agreement if Covered Entity determines that Business Associate has violated a material term of this Addendum, or ii) at Covered Entity's option, permit Business Associate to cure or end any such violation within the time specified by Covered Entity. Covered Entity's option to have cured a breach of this Addendum shall not be construed as a waiver of any other rights Covered Entity has in the Agreement, this Addendum or by operation of law or in equity.

 

18. Effect of Termination of Agreement. Upon the termination of the Agreement or this Addendum for any reason, Business Associate shall return to Covered Entity or, at Covered Entity's direction, destroy all PHI received from Covered Entity that Business Associate maintains in any form, recorded on any medium, or stored in any storage system. This provision shall apply to PHI that is in the possession of Business Associates or agents of Business Associate. Business Associate shall retain no copies of the PHI. Business Associate shall remain bound by the provisions of this Addendum, even after termination of the Agreement or Addendum, until such time as all PHI has been returned or otherwise destroyed as provided in this Section.

 

 
 

 

 

19. Injunctive Relief. Business Associate stipulates that its unauthorized use or disclosure of PHI while performing services pursuant to this Addendum may cause irreparable harm to Covered Entity, and in such event, Covered Entity shall be entitled to institute proceedings in any court of competent jurisdiction to obtain damages and injunctive relief.

 

20. Indemnification. Business Associate agrees to defend and indemnify Covered Entity for any actual direct damage or loss ("Loss"), including reasonable attorneys' fees and costs, incurred by the Covered Entity as a direct result of Business Associate's unlawful use or disclosure of PHI or electronic PHI; except to the extent such Loss is caused by or contributed to by the Covered Entity. Business Associate will reimburse the Covered Entity for such Loss following determination of the Loss, including its causation.

 

21. Exclusion from Limitation of Liability. To the extent that Business Associate has limited its liability under the terms of the Agreement, whether with a maximum recovery for direct damages or a disclaimer against any consequential, indirect or punitive damages, or other such limitations, all limitations shall exclude any damages to Covered Entity arising from Business Associate's breach of its obligations relating to the use and disclosure of PHI hereunder.

 

22. Owner of PHI. Under no circumstances shall Business Associate be deemed in any respect to be the owner of any PHI used or disclosed by or to Business Associate by Covered Entity.

 

23. Third Party Rights. The terms of this Addendum do not grant any rights to any parties other than Business Associate and Covered Entity.

 

24. Independent Contractor Status. For the purposed of this Addendum, Business Associate is an independent contractor of Covered Entity, and shall not be considered an agent of Covered Entity.

 

25. Changes in the Law. The parties shall amend this Addendum to conform to any new or revised legislation, rules and regulations to which Covered Entity is subject now or in the future including, without limitation, HIPAA, HITECH, the Privacy Standards, Security Standards or Transactions Standards.

 

26. Conflicts. If there is any direct conflict between the Agreement and this Addendum, the terms and conditions of this Addendum shall control.

 

BUSINESS ASSOCIATE:   COVERED ENTITY:
         
By: /s/ Michelle Crawley   By: /s/ Moody Chisholm
Name: Michelle Crawley   Name: Moody Chisholm
Title: VP Contract Administration   Title: President & CEO
Date: 8/4/11   Date: 8/11/11

 

 
 

  

 

EXHIBIT F

 

End User Information Services Security Policy

 

 
 

 

 

ST. VINCENT'S

HEALTHCARE

ADMINISTRATIVE MANUAL
Subject: INFORMATION SERVICES    24.20
    SECURITY POLICY  

 

Original Date:       April 2005 References: 45 CFR Parts 160, 162 and 164
Present Date:         January 2010
Review Date:          December 2011 Supersedes:

Applicable To:

SVHC & Affiliate Companies x    SVMC x    SCLM x    SLH x    FCPC x

 

GENERAL

St. Vincent's HealthCare (SVHC) is committed to the protection of its electronic information. Information is one of the most valuable assets of SVHC. Electronic information is to be protected from accidental or intentional, unauthorized use, disclosure, modification or destruction. The intent of the Information Services Security Policy is to provide a basis for an information security program that would restrict electronic access to authorized individuals only, and provide for patient privacy and the protection of the confidentiality of clinical and business information. The following policy statements (Appendix A) have been developed to protect the confidentiality, integrity and availability of SVHC's electronic data.

 

The following policy statements (Appendix A) have been developed to protect the confidentiality, integrity and availability of SVHC's electronic data.

 

The SVHC Information Services Security Policy defines the minimum set of required security policies for SVHC security program. SVHC and its affiliates are required to be in compliance with this policy.

 

PURPOSE

1. To protect SVHC applications, computer systems, networks, and electronic data by ensuring adherence to all Health System information services security policies.

 

2. To protect the confidentiality, integrity, and availability of SVHC Electronic Protected Health Information (ePHI) in compliance with the Security regulations set forth in the Health Insurance Portability and Accountability Act of 1996 ("HIPAA").

 

3. To minimize the potential exposure to SVHC, its affiliates and its associates from damages which may result from unauthorized use of SVHC resources. Potential damages include, but are not limited to the loss and or unauthorized modification of Protected Health Information (PHI), confidential Health System data or intellectual property, damage to public image, damage to critical SVHC internal systems, fines, civil monetary penalties, and criminal penalties.

 

 
 

 

 

SCOPE

This policy applies to all SVHC associates, physicians, contractors, consultants, volunteers and any other individuals or entities with access to SVHC applications, systems, networks and/or electronic data. These personnel will be referred to as the "workforce" throughout the policy.

 

ENFORCEMENT

Any associate found to have violated this policy will be subject to disciplinary action pursuant to Administrative Policies 15.10 & 15.11 and may be subject to civil and/or criminal penalties pursuant to local, state and/or federal law. Any non-employed individual or non-owned entity found to be in violation of this policy will be subject to loss of SVHC and its affiliates network access privileges, confiscation of device with removal of data and potential civil and/or criminal penalties pursuant to local, state and/or federal law.

 

DEFINITIONS

Access Control List (ACL): A list of users, programs, and/or processes and the specifications of access categories to which each is assigned.
   
Administrative Safeguards: Administrative actions, policies and procedures to manage the selection, development, implementation and maintenance of security measures to protect ePHI and to manage the conduct of the Business Associate's workforce in relation to the protection of that information.
   
Availability: The ability of an authorized person to use or access objects, resources, data, or information when needed, without undue delay.
   
Breach: The successful defeat of security controls which could result in a penetration of a system or network. A violation of controls of a particular information system such that information assets or system components are unduly exposed.
   
Business Associate: An individual or organization who (1.) performs on behalf of SVHC and its affiliates any function or activity involving the use or disclosure of protected health information, and (2.) is not a member of SVHC workforce.
   
Computer System: Hardware and software components that together allow a computer to operate.
   
Confidentiality: The property that data or information is not made available or disclosed to unauthorized persons or processes.
   
Covered Entity: A health care provider, health plan, or clearing house required by federal law to comply with the requirements of the HIPAA Privacy Rule and the HIPAA Security Standards.
   
Data Backup: Process of copying all electronic data to media for applications and computer systems for recovery purposes.
   
Data Classification Matrix: A chart which denotes security features that must be invoked for specific classes of data.

 

 
 

 

 

Disaster: An event that would result in complete or near complete loss of computer systems or any event that creates an inability of an organization's part to provide critical business functions for some predetermined period of time.
   
Electronic Protected Health Information (ePHI):  
  All individually identifiable health information that is transmitted by electronic media or maintained in electronic media.
   
Encryption: To modify or code data so that it is illegible without specific key to decode it.
   
ePHI Application: Any application that creates, modifies, processes or stores electronic protected health information.
   
HIPAA: Health Insurance Portability and Accountability Act of 1996:  
  HIPAA has been established to enforce standards for electronic health information, enhance the security and privacy of health information, curtail healthcare fraud and abuse, and assure health insurance portability for employed persons.
   
Individually Identifiable Health Information:  
  Information that is a subset of protected health information, including demographic information collected from an individual, and: (1) Is created or received by a health care provider, health plan, employer, or healthcare clearinghouse; and (2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present or future payment for the provision of health care to an individual; and (i) That identifies the individual; or (ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual. (42 C.F.R Section 160.103.)
   
Information Systems Security Policies:  
  A defined course of action or behavior that is to be followed with respect to the acquisition, deployment, implementation, retirement, or use of information technology resources. They are rules or regulations to be followed and enforced.
   
Integrity: The property that data or information have not been altered or destroyed in an unauthorized manner.
   
Least Privileges/Minimum Necessary Information Requirements:  
   
  Access rules based on the principle that security and privacy are best maintained by providing individuals with access only to the information and functionality they need to perform their jobs.
   
Malicious software: Programs written and distributed with the intent to cause damage to or disrupt network, systems, devices, servers and/or data, including, but not limited to viruses, worms, Trojan horses and email bombs.

 

 
 

 

 

 

Malware: Malicious software, including viruses, worms, Trojans, Denial of Service and other such attacks.
   
Mobile Device: Any portable computer/device that allows for storing, accessing and organizing digital information. A mobile device may feature a scaled-down keyboard, a pen-like stylus, or both. This includes, but is not limited to, PDAs, laptop computers, palmtop computers, USB memory sticks, wireless tablets, Blackberries or cell phones with this capability.
   
Modality: A medical tool with electronic communication capability. Examples would be a Computed Tomography (CT) scanner or fetal monitor.
   
Perimeter Defense Access System:  
   
  A defined security access method that could include firewall type systems that restricts external unauthorized access through a variety of access control methods.
   
Physical Safeguards: Physical measures, policies, and procedures to protect an organization's electronic information systems and related buildings and equipment, from natural and environmental hazards, and unauthorized intrusion.
   
Procedures: Procedures are documented step-by-step instructions to accomplish specific tasks. Procedures may change frequently due to changes in technology, products, or business processes. Documented procedures help ensure that systems are implemented and maintained consistently across the organization. Procedures support Standards in that they tell specifically how a Standard will be implemented.
   
   
Protected Health Information (PHI):  
  All individually identifiable health information created, used, stored, maintained, or transmitted by any covered entity.
   
Public Network: All systems, servers, routers and lines not owned or controlled by SVHC or any of its affiliates that can be accessed through public access methods, including dial-up, DSL, ISDN, cable, wireless and other connection methods.
   
Risk: The possibility of suffering harm or loss.
   
Risk Analysis: Assessment of threats to, impacts on, and vulnerabilities of information and information processing facilities and the likelihood of their occurrence.
   
Sanction: A penalty that acts to ensure compliance or conformity; the penalty for noncompliance specified in a law or decree.

 

 
 

 

 

 

Security Incident: The attempted or successful unauthorized access, use, disclosure, modification or destruction of information or interference with system operations in an information system.
   
Server: A computer or device on a network that manages network resources.
   
Standards: Specific approaches, solutions, methodologies, products, or protocols that must be adhered to in the acquisition, deployment, implementation, retirement, or use of system or procedures.  Standarts are intended to establish uniformity for technology infrastructures, applications, procedures, or data.  Standards may be developed as a subset of, and within the context of, a broader technology policy.  Standards may define or limit the tools, proprietary product offerings or technical solutions that may be used, developed or deployed by the organization.  There may be business case exceptions where standards cannot be followed.  These exceptions must be approved by the appropriate level of management.  Standards provide specifics in support of more generic Policies.
   
System Administrator: The person in charge of managing a multi-user computer system.
   
Technical Safeguards: The technology and the policy and procedures for its use that protect ePHI and control access to it.

 

PROCEDURE

1. General

 

A. The workforce is accountable for information security, and is required to know, understand, and follow all SVHC Information Services Security policies and associated standards and procedures.

 

B. The designated Information Security Officer is required to carry out the duties of development, implementation, and enforcement of policies and procedures, and to oversee SVHC's overall information security program.

 

C. SVHC empowers its affiliates and departments to write and approve additional information systems security policies that are intended to protect SVHC applications, computer systems, networks, and electronic data (including ePHI) and/or ensure adherence to regulatory requirements. These policies must meet or exceed the minimum standards set in the SVHC Information Services Security Policy, and must be periodically reviewed for compliance.

 

D. Any attempt to compromise information systems security measures is prohibited. Proper documentation must be submitted and approved by SVHC Information Services management to obtain authorization for any attempts to compromise information systems security for testing purposes.

 

E. All personnel must immediately report suspected or verified information systems security breaches or policy violations to the appropriate SVHC management, who is then responsible for escalating/reporting the violation to the Information Security Officer.

 

 
 

 

 

 

F. Any attempts to bypass information systems security measures or any activities involving the compromise of information systems security measures are prohibited.

 

G. SVHC management reserves the right to monitor, inspect, or examine at any time all SVHC information systems without the consent, presence, or knowledge of the involved users. The types of information systems subject to this right of monitoring and access include, but are not limited to, electronic mail system files, access and resource usage reports, personal computer hard drives, personal and/or shared network directories, and voicemail messages. All examinations of this nature must be conducted after appropriate approval has been obtained in accordance with SVHC Electronic Investigation Policy. SVHC management retains the right to permanently remove from its information systems any material it deems offensive, potentially illegal, inappropriate, or not consistent with the mission or values of the organization.

 

II. Acceptable Use

 

A. Any individual using SVHC applications, systems, networks and/or electronic data must restrict their activities to SVHC business purposes only. All activities on SVHC information systems are subject to monitoring.
B. Use of SVHC applications, systems, networks and/or electronic data must be protected to provide necessary assurance of confidentiality, integrity, and availability by anyone entrusted with such use.
C. Under no circumstance is anyone authorized to use SVHC applications, systems, networks, and/or electronic data for activities that are contrary to the SVHC and Ascension Health Standards of Conduct or illegal under local, state, federal or international law.

 

III. Authorization & Access Management

 

A. All access requests must be documented and approved, using the appropriate forms located on the Intranet, according to SVHC procedures.

 

B. Authorization and access management procedures must follow the least privileges /minimum necessary information requirements of the HIPAA Privacy Rule.

 

C. Access must be granted and used only for authorized business purposes.

 

D. User IDs and passwords, or other authentication methods must uniquely identify individuals accessing ePHI.

 

E. Sharing a user ID or using another user's ID is prohibited.

 

F. Users are responsible for all activities performed under their user IDs.

 

G. All user passwords must be kept confidential, must be periodically changed, and are not to be shared with any other individual.

 

 
 

 

 

 

H. Passwords must be at least 8 characters in length or the maximum length allowed by an application. The configuration and/or use of strong passwords are required when technically and operationally feasible.

 

I. A password must be changed if the security of the password is believed to be breached or compromised.

 

J. Whenever possible, user IDs must not give any indication of administrative privilege level assigned to the account.

 

K. Users must log out or invoke a password protected screen saver or equivalent when leaving a workstation unattended.

 

L. Auto logoff must be implemented whenever technically feasible.

 

IV. Application Security

 

A. Any individual or group responsible for an ePHI Application must demonstrate compliance with the HIPAA Security Standards.

 

B. Any individual or group using SVHC applications to create/maintain/inquire electronic documents containing ePHI is required to keep those documents confidential.

 

C. Any individual or group responsible for selection of a new ePHI Application must ensure the application demonstrates compliance with the HIPAA Security Standards.

 

V. Audit Controls

 

A. SVHC will implement hardware, software, and/or procedures that record and examine activity in information systems that contain or use ePHI.

 

B. The content and level of detail included in the activity logs must be based on an assessment of system events that are most likely to be correlated with risks to the confidentiality, integrity, and availability of the information contained in the system.

 

C. The auditing mechanisms should record information such as the user identification associated with the event, the program or command used to initiate the event, and the time/date of the event.

 

D. Security-related events or actions to consider logging include, but are not limited to the following:

1. Log on attempts (including failed ones);
2. Changes to security settings or parameters (e.g., minimum password length);
3. User accounts added, changed (privileges), deactivated, and deleted; and
4. Password resets

 

VI. Business Associate, Non-Disclosure, and Confidentiality Agreements /Contracts

 

 
 

 

 

A. Business Associate Agreements/Contracts (BAA/BAC) must be completed by organizations that create, receive, maintain or transmit ePHI on behalf of SVHC and its affiliates.

 

B. The Business Associate must agree to:

 

1. Implement administrative, physical and technical safeguards that reasonably protects the confidentiality, integrity and availability of the ePHI;
2. Ensure that any agent, including a subcontractor, to whom it provides ePHI agrees to implement reasonable and appropriate safeguards to protect it; and
3. Report to SVHC any security incident of which the Business Associate becomes aware.

 

C. Non-Disclosure/Confidentiality agreements must be completed by organizations that create, receive, maintain or transmit other (non-ePHI) confidential data on behalf of SVHC or its affiliates.

 

VII. Contingency Operations

 

A. SVHC and its affiliates must have an overall contingency plan and supporting procedures for responding to an emergency (i.e. system failure, fire, natural disaster, vandalism, etc) that compromises the confidentiality, integrity and/or availability of ePHI, or other mission critical, confidential and/or proprietary data contained in their environment.

 

B. This plan must be documented and must include procedures for data backup, periodic system criticality analysis, disaster recovery plan (DRP), emergency mode operations plan, and procedures for periodic testing and revision of the contingency plan.

 

VIII. Data Backup and Storage

 

A. SVHC and its affiliates will implement procedures to create, maintain and verify retrievable exact copies of ePHI.

 

B. The frequency, retention and the storage location of data backups should be based on criteria including but not limited to the following:

 

1. Patient care impact;
2. Governmental regulations;
3. Business operations; and
4. Security best practices.

 

C. Data backups of ePHI must be performed before movement of equipment as appropriate.

 

D. Backup media must be stored in a safe environment, preferably in a different location, and must be available in the event of a system failure or other disaster.

 

E. The security of the media must be maintained at all times during transport and storage.

 

 
 

 

 

 

IX. Data Classification

 

A. SVHC will define a data classification scheme which classifies data with respect to levels of sensitivity and confidentiality of the data. Security mechanisms for storage, transmission, handling, and destruction must be implemented to have a direct correlation to the classification of the data.

 

B. Appropriate security measures must be implemented that correspond with the classification of the data.

 

X. Email Use

 

A. Email users are required to use the SVHC email systems in a professional, ethical and lawful manner, and in accordance with the SVHC and Ascension Health Standards of Conduct.

 

B. SVHC and its affiliates reserve the right to monitor, access, review, copy or delete email messages, created on, received by, transmitted from or stored on SVHC systems. In approved situations, SVHC may disclose such messages to others, even when stored with a password.

 

C. Authorized users have no legitimate expectation of privacy in their use of SVHC email systems. Email messages sent from or received by an SVHC system belong to SVHC and are not considered private, even if they are accessed via a personal access code.

 

D. Use of SVHC systems and hardware constitutes consent to email monitoring, review, reproduction, and/or deletion. Any email message generated or received by an SVHC system is subject to inspection, disclosure, scheduled retention and disposition.

 

Xl. Facility Access Control

 

A. All servers and network electronics must be stored in environmentally safe and secure areas.

 

B. Persons responsible for facilities that house servers or network electronics must have documented standards and procedures for gaining access.

 

C. Persons requiring access to SVHC facilities that house electronic information systems must follow established, documented procedures for gaining physical entry.

 

D. Facility access control lists must be reviewed on a periodic basis.

 

E. A visitor log must be maintained for all non-employed staff (or individuals that would not normally require access) entering secured computer facilities.

 

F. Management must practice appropriate security measures for terminated and transferred employees to maintain site security, data integrity and confidentiality.

 

XII. Incident Handling, Tracking and Response

 

 
 

 

 

 

A. SVHC will implement procedures to identify and respond to suspected or verified security incidents; mitigate to the extent practical, harmful effects of security incidents that are known to SVHC Information Services; and document security incidents and their outcomes.

 

B. Any known security incidents that may impact SVHC or its affiliates must be reported to the Information Security Officer as soon as possible.

 

C. Documentation of each incident must be maintained for a period required by local, state and federal regulations.

 

XIII. Internet Use

 

A. Use of the Internet must be conducted in a professional, ethical manner and in accordance with the SVHC and Ascension Health Standards of Conduct.

 

B. Use of the Internet that would violate any local, state, or federal law is strictly prohibited.

 

C. Downloading of applications, files or software must adhere to SVHC policies.

 

XIV. Malicious Software / Anti-virus

 

A. SVHC will deploy and maintain a current up-to-date anti-virus solution in their environments.

 

B. With the exception of authorized security testing, any intentional creation or deployment of malicious software on a SVHC and/or affiliates electronic device is prohibited.

 

C. Any electronic devices (including medical devices) that are susceptible to malicious code attacks must be protected or be isolated from the SVHC devices.

 

D. Infected devices that have the potential to infect other devices must be immediately removed or isolated from the network until they are verified as virus-free and have been updated with current security fixes and/or patches.

 

XV. Media Disposal & Re-use

 

A. Any individual responsible for the disposal or redeployment of electronic devices or media that contain ePHI or other sensitive, confidential, or protected data must be done in a manner that ensures that data cannot be recreated or recovered.

 

XVI. Mobile Device Security

 

A. The individual in possession of a mobile device that contains SVHC data is responsible for ensuring the physical security of that device.

 

B. Individuals must take appropriate measures to prevent unauthorized access to mobile devices that contain SVHC data.

 

 
 

 

 

 

C. All mobile devices must utilize access management procedures as defined in the SVHC Information Services Remote Access policy.

 

D. When exchanging data between mobile devices, precautions must be taken to ensure the integrity and confidentiality of the information being exchanged.

 

XVII. Perimeter Defense

 

A. Any individual connecting an SVHC network device to a public network is required to deploy a firewall or similar perimeter defense system.

 

B. Firewall devices must be configured to grant access to the SVHC network based on least privilege / minimum necessary information requirements.

 

C. Periodic maintenance and review of firewall configurations (including rule sets) and vulnerability testing must be conducted to ensure continued protection.

 

D. Any individual with a non-owned/non-supported device, or modality, is prohibited from attaching to an SVHC network port or wireless access point without proper authorization from Senior IT Management.

 

E. Once deployed, firewall device access logs must remain on file for an appropriate pre-determined timeframe and be reviewed on a periodic basis.

 

F. With the exception of authorized security testing, any attempt to circumvent the SVHC firewalls or other perimeter defenses is prohibited.

 

XVIII. Remote Access

 

A. All remote access requests must follow the procedures outlined by SVHC access approval process.

 

B. Establishing a remote connection to or through an SVHC network from a public network requires the use of an approved secure remote access method.

 

C. With the exception of authorized security testing, any attempt to bypass information systems security measures and/or any activities involving the compromise of information systems security measures is prohibited.

 

D. Anyone given remote access privileges to the SVHC network must only access the applications, systems and/or electronic data as defined in an approved access request. Any unauthorized attempt to access applications, systems and/or electronic data is prohibited.

 

E. Remote access users must follow the access management procedures as defined in the SVHC Information Services Remote Access policy.

 

 
 

 

 

 

F. All point-to-point connections must connect through a SVHC perimeter security device.

 

XIX. Risk Analysis & Risk Management

 

A. SVHC will perform a periodic risk analysis that identifies all known risks associated with their systems containing ePHI and other confidential information.

 

B. After identifying the risks associated with the systems, SVHC will develop, document and implement a risk management program that either identifies strategies to mitigate these risks or documents the justification on why these risks are being accepted.

 

X.X. Sanctions

 

A. SVHC associates that do not adhere to SVHC and Ascension Health policies will be subject to disciplinary actions as defined in SVHC Administrative Policies 15.10 and 15.11 - Human Resources corrective action / sanction policies.

 

XXI. Security Awareness & Training

 

A. St. Vincent will implement a security awareness and training program for all members of its workforce.

 

XX11. Terminations & Transfers

 

A. All system or application owners and administrators providing or controlling access to SVHC electronic data or physical security are responsible for documenting and following standards and procedures for terminating, disabling, and modifying access of the system(s) or application(s) they are responsible for. These responsible parties are accountable for removing access or changing access level rights for the terminated or transferred individual in a timely manner once notification of the termination and/or transfer is received.

 

B. Managers/Supervisors of terminated or transferred associates, physicians, contractors, volunteers, etc, must initiate the termination or transfer request immediately upon notification of the termination or transfer or by the effective date of the termination or transfer.

 

C. Managers/Supervisors must ensure that appropriate access levels are given to or removed from individuals they supervise based on least privileges and minimum necessary information requirements.

 

D. Managers/Supervisors are responsible for recovering 1D badges and other SVHC property (i.e. keys, pagers, cell phones, laptop PCs, proximity cards, and other SVHC assigned assets) from terminated individuals.

 

 
 

 

 

 

E. All termination and transfer requests are to be considered confidential. All groups and individuals involved in the termination/transfer process must treat all such requests as confidential.

 

XXIII. Transmission Security

 

A. Highly sensitive data, including ePHI, transmitted over public networks must be protected against unauthorized access. When appropriate, mechanisms to encrypt and verify the integrity of highly sensitive data must be implemented.

 

B. Sensitive data, including ePHI, transmitted over public networks must use any of the listed methods to ensure the integrity of the data and protect against unauthorized access. The recommended methods are IPSEC, ESP, MD5, SHA I, 3DES, HMAC or AES; other methods may be used with the approval of the Information Security Officer (ISO).

 

XXIV. Vulnerability Management

 

A. SVHC will implement a process and procedures for identifying IT security vulnerabilities; determining their applicability within the infrastructure; defining an appropriate response; and implementing corrective action. The goal of this process is to prevent exposures to the SVHC environment caused by allowing vulnerabilities to go unmanaged.

 

XXV. Wireless Access

 

A. Any individual using a wireless device is prohibited from attaching the device to any SVHC wireless network without proper authorization from the Director of Information Technology or his designate.

 

B. All wireless access to the SVHC network must use strong passwords and encryption methods.

 

C. With the exception of authorized security testing, any attempt to circumvent the SVHC wireless security systems for wireless access to or though the SVHC network is prohibited.

 

XXVI. Workstation/Printer Use & Security

 

A. Physical safeguards that restrict access to authorized users must be implemented for all workstations that access ePHI.

 

B. Placement of all workstations and printers accessing and/or printing PHI/ePHI should be in areas that are away from the general public whenever possible so that unauthorized individuals cannot readily read nor have access to ePHI.

 

C. Any stationary computer screens that display ePHI within clear view of unauthorized individuals must be equipped with privacy screens.

 

D. Documents containing PHI or other sensitive information must be removed from printers and fax machines in a timely manner to avoid any possible unauthorized viewing.

 

 
 

 

 

E. Workstations in areas that are vulnerable to theft must be protected using appropriate protection procedures and/or anti-theft technologies.

 

F. All users are prohibited from installing unlicensed software on any SVHC system or device.

 

 
 

 

 

EXHIBIT G

 

Ascension Health Vendor Access Policy

Purpose:

 

The purpose of this policy is to set forth guidelines for relationships with Health Care Industry Representatives (HCIR). Ascension Health desires to provide a safe and effective environment for patients, associates, physicians and other allied health professionals, while complying with regulatory guidelines. This Vendor Access Policy is part of a continual processes improvement towards that end.

 

Objectives:

a. To establish a structured system throughout Ascension Health for education, training, and introduction of products, procedures, techniques, technology, and equipment to our associates and physicians.

 

b. Define conditions and requirements HCIRs must abide by to provide training, knowledge transfer, expertise, products and/or services within Ascension Health facilities.

 

Definitions:

Ascension Health: This term will be used throughout this document and is intended to include Ascension Health as a multi-hospital health system, each of our Health Ministries and/or individual locations dependent on the context of its use.

 

Associate(s): Includes practicing health care professionals and employees working at Ascension Health facilities.

 

Supply Chain Lead: An Ascension Health Associate responsible for managing vendors within the Health Ministry or facility.

Vendor Credentialing Service (VCS): VCS is the Ascension Health contracted vendor management/vendor credentialing system.

 

Health Care Industry Representative (HCIR): This is an industry accepted term used to refer to a sales or service professional that represents a company or companies to Ascension Health associate(s) including: physicians, nurses, buyers, purchasing agents, executives and other associates that may be general users or influencers of the company's product. HCIRs represent manufacturers, distributors, service companies, and other organizations. HCIRs generate sales, manage contracts, provide quotes, demonstrate products, make repairs, consult, and perform many other duties generally associated with representing their company. For the purposes of this policy, three (3) classifications of HCIRs are defined:

 

Classification 1: Non-clinical, Credentialed, Health Care Industry Representatives: HCIRs that do not serve primarily in clinical support roles but engage Ascension Health associates in a manner that requires some level of credentialing.

 

Classification 2: Clinical, Credentialed, Health Care Industry Representatives: HCIRs that may serve in clinical support roles. The roles of these HCIRs require them to typically work in patient care areas, and/or provide assistance to or consult with patient care associates.

 

Classification 3: Non-Credentialed Representatives: These representatives are typically delivery personnel or visiting administration. This classification will be utilized on an exception only basis.

 

 
 

 

 

Ascension Health's selected vendor credentialing system, VCS, further defines classifications by access levels. The VCS level definitions incorporate contracted personnel. (See addendum A)

 

Policy

 

Key points and rules

 

a. It is the responsibility of each HCIR to properly register with VCS and be credentialed at the appropriate VCS Level for access to Ascension Health facilities and personnel.

 

b. HCIRs will not be provided free or unlimited access to any floor, area, suite, or operating room within Ascension Health. No standing appointments are permitted. HCIRs will only be permitted to meet with associates in the Supply Chain Department. Access to Ascension Health non-supply chain personnel will only be permitted through VCS scheduling with approval of the Supply Chain Lead.

 

c. HCIRs must bring any instrument and/or implant to the sterile processing department for wrapping and sterilizing 24 hours in advance of procedure. Flash sterilization is prohibited except in the event of an emergency.

 

d. Any HCIR seeking access to an Ascension Health Ministry for the purpose of performing maintenance services must have an appointment, scheduled at least thirty (30) days in advance, with the Supply Chain Lead, or his or her designee.

 

e. HCIRs are not permitted access to any operating room or surgical suite within Ascension Health without written request from a physician. Such request must specify and demonstrate a critical clinical need for the presence of the representative

 

f. In-services will require authorization from the Supply Chain Lead. HCIRs will schedule an in-service at least 30 days in advance with the Supply Chain Office. All in-services will be conducted in the Supply Chain Department or designated education area.

 

a. All associates attending in-services will be provided CEUs by the HCIR's education department and the appropriate accrediting organization.

 

g. Any distribution of samples and literature shall be coordinated and arranged through the Supply Chain Lead.

 

h. HCIRs are strictly prohibited from providing demonstration model or loaner equipment to Ascension Health without having submitted a proposal for such equipment to the Supply Chain Lead and having received a zero dollar purchase order for such equipment prior to its arrival on the premises. All equipment brought in for demonstration/evaluation must have a safety check completed by biomedical engineering before the equipment can be used at Ascension Health.

 

i. Vendor Products and/or services not expressly included within a contract executed between Ascension Health, one of its Health Ministries, or a designated GPO, vendor or product for which no purchase order was issued in advance (collectively referred to herein as "off contract products") may not be introduced or provided to the members of the medical staff or associates of Ascension Health for use. Any off contract products that are provided to and used by associates in violation of Ascension Health policy shall be deemed vendor donated product. Vendor shall not invoice for, nor receive any reimbursement for such off contract product from Ascension Health.

 

 
 

 

 

a. Ascension Health recognizes that there may be instances where patient care dictates use of an off contract product. In such rare circumstances, the Health Ministry physician requesting use of the off contract product, with assistance from the HCIR, may apply for an exception to the off contract product policy. Please be aware that the exception process is time consuming and may take up to one hundred and eighty (180) days to resolve.

 

j. Ascension Health initiates business with vendors by seeking bids or proposals from potential sources and awards contracts based on a variety of criteria. Copies of bids, quotations, special offers, etc. must only be submitted to Ascension Health Supply Chain or the Health Ministry's Supply Chain Leader regardless of the original requestor.

 

k. Vendors shall submit all product recall notices to the Supply Chain Leads and to the attention of the appropriate hospital department designee within three days of notice. Please refer to Health Ministry's specific protocol.

 

l. HCIRs are not permitted to take still or video pictures within the hospital without prior authorization from Ascension Health's legal department.

 

m. Gifts and/or gratuities of any kind are prohibited. Displays and food items are also prohibited unless formally approved by the Supply Chain Lead. Approval shall be provided on an exception only basis.

 

Before Arriving

 

a. HCIRs must log in to VCS and generate an appointment request prior to each requested appointment. All vendor appointment requests will be reviewed by the Supply Chain Lead through the use of the VCS tool. Information required of vendor for successful appointment request will minimally include:

 

i. Date of HCIR visit

 

ii. Purpose of the visit

 

iii. HCIR destination at the facility

 

iv. Time of entry to the facility

 

v. Time of exit from the facility by the HCIR

 

b. No HCIRs shall be given access to Ascension Health without the successful completion of the Ministry's vendor credentialing program and strict continued compliance to Ascension Health rules, standards, policies, and procedures.

 

c. HCIRs visiting Ascension Health must have an approved appointment prior to arrival on the premises.

 

d. HCIRs must review Ascension Health parking policies for any visit.

 

Upon Arrival

 

a. HCIRs must comply with Ascension Health parking policies.

 

b. A vendor credentialing system will usually be located in the Supply Chain Department, which may be at a different location than the main campus. An additional system with limited access will also be located in the Operating Room.

 

 
 

 

 

c. HCIRs must register in at Ascension Health's designated VCS access point in Supply Chain or, when circumstance permits, near the operating room to receive their time/date sensitive identification for the appointment.

 

d. HCIRs are required to wear at all times the time stamped badge while on the Ascension Health Campus.

 

While at the Ascension Health facility

 

a. HCIR is required to wear the time sensitive badge generated by the VCS system throughout their visit to the facility.

 

b. Category 2 HCIRs are required to comply with department specific policies.

 

c. Medical staff, house staff, other associates, and visitors shall not be approached on the Ascension Health premises outside of Supply Chain. HCIR activities outside of approved appointments are prohibited.

 

Before Leaving

 

a. HCIRs must log out at a VCS access point at the conclusion of each scheduled appointment.

  

Non-Compliance Ramifications

  

a. HCIR non-compliance to this policy will result in the following consequences:

 

i. First Violation: Supply Chain Lead will notify Ascension Health Regional Supply Chain Officer and the System Office of HCIR non compliance of policy. HCIR will be placed on probation for 30 days during which time they will not be able to conduct business at any Ascension Health facility.

 

ii. Second violation: HCIR will be suspended from further business with Ascension Health.

 

iii. Repeated violations by multiple HCIRs from the same company will result in all HCIRs from that company being banned for a period of one year from all Ascension Health facilities, or indefinitely if warranted.

 

b. Based on the severity of the violation, the Supply Chain Lead may determine an immediate suspension is warranted. Any HCIR found in the violation of this policy or found to be inappropriately visiting a Health Ministry location may be charged with trespassing regardless of the number of violations.

HCIR signature/VCS acknowledgment of policy

 

I HAVE READ AND UNDERSTAND THE ABOVE REQUIREMENTS AND AGREE TO THE TERMS STATED THEREIN.

 

SIGNATURE: ___________________________________ DATE: ______________________

 

PRINT NAME: __________________________________ POSITION: _______________________________

 

COMPANY: _________________

 

 
 

 

 

Addendum A to Exhibit G

 

Classification 1: Non-Clinical, Credentialed, Health Care Industry Representative

 

VCS Level 1 (Red badge): Access to general hospital areas, non patient care or procedure areas.

Examples: Pharmaceutical representatives and managers, general medical sales representatives, laboratory representatives, distributor representatives and service technicians.

 

VCS Level 7: (White badge): Reserved Pharmaceutical representatives that access doctor offices but do not access hospitals. Pharmaceutical representatives that access hospitals will need to be credentialed as a level 1 vendor. Hospitals often require different policies and credentials.

 

Classification 2: Clinical, Credentialed, Health Care Industry Representative

 

VCS Level 2: (Blue badge) — Access to general hospital areas, patient care areas and procedure areas. Examples: Medical device representatives, technicians and company consultants. The required credentials allow you to be in live procedures.

 

VCS Level 3: (Green badge) — Access to general hospital areas and patient care areas. Vendor does not have access to procedure areas or live procedures.

 

VCS Level 6: Agency nurses, technicians, and any contracted representatives that access patient care areas and have patient contact. Health Ministry will require contractor to provide a competency document.

 

Classification 3: Non-Credentialed Representatives

 

VCS Level 4: (Yellow badge) — Administration and Delivery: Administrative and Delivery representatives and GPO representatives that access general hospital areas. Non vendors.

 

VCS Level 5: (Black badge) — Facilities Management: Maintenance, design and construction workers that access general hospital grounds

 

VCS Level 8: Representatives that have access to Protected Health Information (PHI). A Business Associate Agreement (BAA) is required. Examples: IT, Legal, Financial, Consultants, Interpreters, etc. If accessing remotely you will only need to sign policies.

 

 
 

 

 

EXHIBIT H

Visiting Vendor Policy

St. Vincent’s HealthCare

Medical Imaging Department Policy and Procedure Manual

Subject:

VENDOR/SERVICE ENGINEER

VISITOR PASSES

#HR-04

 

Directive #: HR.04   Present Date: March 2011
Original Date: July 2005   Review Date: February 2012

Applicable To:

SVHC & Affiliated Companies   £       SVMC    S        SCLM       £       SLH      S        FCPC   £

  Approval:

  

POLICY:

  

Requirement for service engineers and vendors entering the Medical Imaging Department to have a visitor/vendor badge.

 

PURPOSE:

 

To identify vendors/contractors as they provide services in the Medical Imaging Department and to ensure safety of our associates and patients.

 

PROCEDURE:

 

1. Vendors and engineers scheduled to perform service on equipment, have been contracted by St. Vincent's/St. Luke's to work in the Medical Imaging Department, or have a scheduled appointment are requested to report to the Security Department upon their arrival at St. Vincent's or St. Luke's.

 

2. Security will provide the vendor or engineer with a badge that must be worn while in the Medical Imaging Department.

 

3. The vendor or engineer will be required to outline the hours he/she plans to be on site and must return the badge at the end of each day.

 

4. If the vendor or engineer plans to be on site for more than one day, the badge must be returned before leaving and reissued upon arrival the next day.

 

5. If the vendor or engineer will be on-site after normal working hours, Security should be notified with the name, company, and duration of the visit.

 

6. A vendor must have a scheduled appointment with the Director, manager, or team leader prior to entering the Medical Imaging Department.

 

 
 

 

 

 

7. Upon arrival to the Medical Imaging Department, the vendor or engineer must check in at the X-Ray waiting area in the hospital. The Medical Imaging manager or team leader will be contacted to escort the visitor to the appropriate area.
     
8. No vendors will be seen by any Medical Imaging staff without a pre-scheduled appointment.

 

9. Managers and Team Leaders are responsible for instructing vendors and contractors as to the content of this policy and all associates are responsible for enforcing this policy.

 

[END OF DOCUMENT]

 

 
 

 

 

Exhibit 3

 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

   

Exhibit 5.1

 

St. Vincent's Medical Center

1 Shircliff Way

Jacksonville, FL 32204

 

 
 

 

Schedule 1

 

The Purchased Services Payment percentage and pro-rata share for capital expenditures are as follows:

 

 

Purchased Services Payment

Percentage

Pro-rata Share for

Capital Expenditures

     
  *

Medical Center *

JGKE *

 

 
 

 

Attachment 1

 

Physician Acknowledgement

 

I, Paul Ossi, M.D., as an (direct or indirect) owner or investor in JGKE, hereby represent and warrant that during the term of this Agreement, pursuant to the federal Stark Law, I will not (i) "refer" to Medical Center for any "designated health services," including but not limited to laboratory, radiology, radiation therapy, and inpatient/outpatient hospital services, and/or (ii) direct any other physician to make a "referral" to Medical Center, and/or (iii) control the "referrals" of any other physician to Medical Center. For purposes of the Stark Law, I agree and acknowledge that the term "referral" does not include a request by a radiation oncologist for radiation therapy or ancillary services necessary for, and integral to, the provision of radiation therapy, if the request results from a "consultation" initiated by another physician; and (ii) the tests or services are furnished by or under the supervision of radiation oncologist or another radiation oncologist in the same group practice. I further understand and acknowledge that a "consultation" means a professional service furnished to a patient by a physician if the following conditions are satisfied: (i) the physician's opinion or advice regarding evaluation or management or both of a specific medical problem is requested by another physician; (ii) the request and need for the consultation are documented in the patient's medical record; and (iii) after the consultation is provided, the physician prepares a written report of his or her findings, which is provided to the physician who requested the consultation. With respect to radiation therapy services provided by a radiation oncologist, I understand and acknowledge that a course of radiation treatments over a period of time will be considered to be pursuant to a consultation, provided that the radiation oncologist communicates with the referring physician on a regular basis about the patient's course of treatment and progress.

 

  Paul Ossi, M.D.
   
  Signed:  /s/ Paul Ossi, M.D.
  Date:     8/8/11

 

 
 

 

Attachment 1

 

Physician Acknowledgement

 

I, Scot N. Ackerman, M.D., as an (direct or indirect) owner or investor in JGKE, hereby represent and warrant that during the term of this Agreement, pursuant to the federal Stark Law, I will not (i) "refer" to Medical Center for any "designated health services," including but not limited to laboratory, radiology, radiation therapy, and inpatient/outpatient hospital services, and/or (ii) direct any other physician to make a "referral" to Medical Center, and/or (iii) control the "referrals" of any other physician to Medical Center. For purposes of the Stark Law, I agree and acknowledge that the term "referral" does not include a request by a radiation oncologist for radiation therapy or ancillary services necessary for, and integral to, the provision of radiation therapy, if the request results from a "consultation" initiated by another physician; and (ii) the tests or services are furnished by or under the supervision of radiation oncologist or another radiation oncologist in the same group practice. I further understand and acknowledge that a "consultation" means a professional service furnished to a patient by a physician if the following conditions are satisfied: (i) the physician's opinion or advice regarding evaluation or management or both of a specific medical problem is requested by another physician; (ii) the request and need for the consultation are documented in the patient's medical record; and (iii) after the consultation is provided, the physician prepares a written report of his or her findings, which is provided to the physician who requested the consultation. With respect to radiation therapy services provided by a radiation oncologist, I understand and acknowledge that a course of radiation treatments over a period of time will be considered to be pursuant to a consultation, provided that the radiation oncologist communicates with the referring physician on a regular basis about the patient's course of treatment and progress.

 

  Scot N. Ackerman, M.D.
   
  Signed:  /s/ Scot N. Ackerman, M.D.
Date:       8/8/11

 

 
 

 

Attachment 2

 

Purchase and License Agreement

 

EXHIBIT C
TERMS AND CONDITIONS FOR HARDWARE

 

C 1. Definitions. The following terms used in this Agreement shall have the meaning set forth below:

C 1.1 "Contractual Delivery Date" means the date provided by Supplier at a reasonable time before Delivery specifying the date for delivery.

 

C 1.2 "Requested Delivery Date" means the tentative date of delivery of Hardware as requested by Customer in the Cover Page.

C 1.3 "Site Planning Criteria" are the technical data required for installation of the Hardware set forth in general terms in the site planning criteria (if any) provided by Supplier separately.

 

 

 
 

 

Purchase and License Agreement

 

C 8.       Warranty.

C 8.1    Supplier warrants that the Hardware will perform in accordance with the Scope of Supply and the Hardware will be free from defects in design, materials, and workmanship which result in non-compliance with the Scope of Supply for a period of twelve (12) months from:

(a)       the date that the Acceptance Test Protocol has been successfully completed in accordance with this Agreement;

(b)       if no Acceptance Test Protocol has been designated by Supplier, the Delivery of the Hardware;

(c)       in case of deferred installation, the date as per 6.1 (e).

 

C 8.2 Notwithstanding the foregoing, Supplier's warranty does not cover:

(a)       defects arising out of materials or parts provided, modified or designed by the Customer;

(b)       preventative maintenance;

(c)       defects emanating from the Customer's improper performance of this Agreement or improper use or maintenance of the Hardware;

(d)       normal deterioration, decay or wear and tear;

(e)       storage or environmental conditions at the Site that induce premature failure;

(f)       defects resulting from repairs or service of the Hardware supplied by other than by Supplier or its authorized representative; or

(g)       Deliverables other than Hardware.

 

 
 

 

Purchase and License Agreement

 

C 8.3 In the event that the Hardware or any part or component thereof shall fail to conform to the warranty, Supplier shall (or cause one of its Affiliates to) promptly repair or replace, at its option and at its expense, the defect in the Hardware or component thereof. Repair or replacement parts furnished or work performed under this warranty shall be warranted for:

(a)     the remainder of the original Warranty Period; or

(b)     for a period of ninety (90) days from and after the date of such repair or replacement.; whichever period of (a) and (b) that is the longer period.

 

C 8.4 The defective Hardware or part thereof which is replaced in accordance with this warranty shall be the property of Supplier. Supplier may, at its sole discretion replace parts with refurbished or modified parts of equal quality as the original parts.

 

C 8.5 In order to avail itself of its rights under this warranty, the Customer shall immediately notify Supplier in writing during the Warranty Period of any defects that appear under the warranty and shall give Supplier every opportunity of inspecting and remedying such defects.

 

 
 

 

Purchase and License Agreement

 

EXHIBIT D

TERMS AND CONDITIONS FOR SOFTWARE

 

D 1. Definitions. The following terms used in this Agreement shall have the meaning set forth below:

D 1.1 "Designated Equipment" means collectively the designated network and authorized workstation terminals, including but not limited to desktops, laptops, and/or PDAs operated by or associated with the Customer and/or as identified in the Scope of Supply.

 

D 1.2 "Documentation" means the specifications and other documentation relating to the use and performance of the Software (if any), provided by Supplier, in effect at the time such Software is licensed by the Customer.

 

D 1.3 "License Fee(s)" means the price for the Software license(s), if any, as specified in the Scope of Supply for the Software.

 

 
 

 

Purchase and License Agreement

 

D 5. Warranty.

D 5.1 Supplier warrants that the Software will perform substantially as described in the Documentation for a period of twelve (12) months from:

(a)      the date that the Acceptance Test Protocol has been successfully completed in accordance with the terms of this Agreement; or

(b)      if no Acceptance Test Protocol has been designated by Supplier for the Software, from the date of its acceptance in accordance with the acceptance procedure for Software described in 8.2 of these Terms and Conditions for Software.

 

D 5.2 Notwithstanding the foregoing, Supplier's warranty does not cover:

(a)      defects arising out of unauthorized repair, alteration or modification;

(b)     defects emanating from improper application, the Customer's improper performance of this Agreement, improper installation, installation and operation on other equipment than Designated Equipment;

(c)      accidental damage, negligence in use, improper storage, electrical power damage, Deliverables malfunction; abnormal operating conditions; or

(d)      Deliverables other than Software.

 

D 5.3 In the event that the Software shall fail to conform with the warranty, Supplier's sole liability to the Customer (subject to section D 5.4 below) shall be to (or cause one of its Affiliates to) provide such assistance as is necessary to cause the Software to perform substantially in accordance with Supplier's Documentation by providing a suitable "fix," "patch," or "work around" for the problem or a statement that an appropriate "fix" will be included in a future release of the Software, the time period within which the release is expected to be issued and a commitment to provide the release at no cost to the Customer.

 

D 5.4 If Supplier is unable, after reasonable effort, to cause the Software to perform substantially in accordance with the Documentation, then this Agreement may be terminated with respect to the Software at the option of either Party hereto without further obligation or liability and such termination shall (subject to section D 5.5 below) be the Customer's exclusive remedy and Supplier's sole liability in connection with the failure to remedy the breach of warranty.

 

D 5.5 In the event of termination during the warranty period as per section D 5.4 above, Supplier shall refund to the Customer all License Fee paid by the Customer for the affected Software. No refund shall be made if the License Fee is included in the Scope of Supply for the Hardware.

 

D 5.6 In order to avail itself of its rights under this warranty, the Customer shall immediately notify Supplier in writing during the Warranty Period of any defects that appear under the warranty, adequately describe any such failure encountered by the Customer and shall give Supplier every opportunity of inspecting and remedying such defects.

 

D 5.7 Supplier does not warrant that any Software is error-free or that its use will be uninterrupted.

 

D 5.8 Supplier shall not be obligated to remedy any Software defect which cannot be adequately repeated. Further in the event the Supplier spends time looking for a defect that cannot be found/repeated it shall be entitled to charge the Customer for the time spent at its list price in force at that time for such services.

 

D 6. DISCLAIMER OF WARRANTY.

D 6.1 EXCEPT AS EXPRESSLY PROVIDED IN SECTION 5. ABOVE, THE SOFTWARE IS PROVIDED "AS-IS" WITHOUT ANY OTHER WARRANTY WHATSOEVER. ALL IMPLIED WARRANTIES; INCLUDING IMPLIED WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY, SATISFACTORY QUALITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY EXCLUDED.

 

 
 

 

Purchase and License Agreement

 

EXHIBIT F

TERMS AND CONDITIONS FOR SERVICES

 

F 1. Definitions. The following terms used in this Agreement shall have the meaning set forth below:

 

F 1.1 "Hardware Maintenance and Support Service Fee" means the Supplier's price for the Services for the Hardware. The Hardware Maintenance and Support Service Fee for the current year is specified in the Cover Page.

 

F 1.2 "Service Fee" means individually or collectively the fee for Hardware Maintenance and Support Service and/or Software Maintenance and Support Service.

F 1.3 "Software Maintenance and Support Service Fee" means the Supplier's price for the Services for the Software. The Software Maintenance and Support Service Fee for the current year is specified in the Cover Page.

 

 
 

 

Purchase and License Agreement

 

 
 

 

Purchase and License Agreement

 

F 8. Warranties.

F 8.1 Supplier warrants that the Services will be carried out in a competent and professional manner and with all reasonable care and skill.

 

F 8.2 Supplier warrants that all replacement parts installed outside of the original Hardware warranty issued by Supplier are covered by a 90-day parts only warranty unless otherwise stated. Any replacement parts installed within the original Hardware warranty provided by Supplier are covered for the reminder of the Hardware warranty for both parts and labor.

 

F 8.3 Supplier reserves the right to replace any spare parts with new, modified or refurbished parts of substantially equal quality as the original parts in the course of providing the Services and any defective part which is replaced when providing the Services shall be the property of Supplier if Supplier so requests.

 

F 8.4 To the extent the Services specified in the Scope of Supply includes that the Hardware and/or Software shall perform substantially in accordance with its Scope of Supply and/or Documentation, whichever is applicable, and if Supplier is unable, after reasonable effort, to cause the Hardware and/ or Software subject to the Services to perform substantially in accordance with its Scope of Supply and/or Documentation, whichever is applicable, then the Services may be terminated with respect to the Hardware and/ or Software so affected at the option of either Party hereto without further obligation or liability. Such termination shall be the Customer's exclusive remedy and Supplier's sole liability in connection with the Services related to any such Hardware and/or Software.

 

F 8.5 Supplier shall not be obligated to remedy any Hardware and/or Software defect, failure, or error that cannot be adequately repeated.

 

F 8.6 New software products are not included in Supplier's standard Services and will be offered by Supplier to the Customer at Supplier's then current published prices and on such other terms and conditions as are acceptable to Supplier.

 

 

  

 

Exhibit 10.63a

 

1 st AMENDMENT TO THE LEKSELL GAMMA KNIFE PERFEXION PURCHASED

SERVICES AGREEMENT

 

This 1 ST AMENDMENT TO THE LEKSELL GAMMA KNIFE PERFEXION PURCHASED SERVICES AGREEMENT (" Amendment ") is effective as of October 10, 2011, by and between Jacksonville GK Equipment, LLC (" JGKE ") and St. Vincent's Medical Center, Inc (" Medical Center ").

 

RECITALS

 

WHEREAS , JGKE and Medical Center entered into that certain Leksell Gamma Knife Perfexion Purchased Services Agreement dated August 5, 2011 (the " Agreement "); and

 

WHEREAS , under Section 6 of the Agreement, Medical Center agreed, at its cost, to prepare, construct and improve the Site and install the Equipment provided, however, such cost would not exceed * (the " Cap "); and

 

WHEREAS , the cost to prepare, construct and improve the Site and install the Equipment exceeded the Cap by *; and

 

WHEREAS , JGKE agrees to pay the *; and

 

WHEREAS , for both equitable and regulatory compliance purposes the parties desire to Amend the Purchased Services Payment percentages pursuant to the existing methodology to take into account JGKE' s contribution of the additional * to the program.

 

NOW, THEREFORE , JGKE and Medical Center agree as follows:

 

1. JGKE shall contribute * to the preparation, construction and improvement of the Site and installation of the Equipment.

 

2. Schedule 1 of the Agreement is hereby deleted and replaced with the attached Schedule 1.

 

3. All capitalized terms that are not specifically defined in this Amendment are defined in the Agreement.

 

IN WITNESS WHEREOF, the parties have executed this Amendment as of the date indicated below.

 

Jacksonville GK Equipment, LLC   St. Vincent’s Medical Center, Inc.
     
By: /s/ Ernest A. Bates, M.D.   By: /s/ Moody Chisholm
Ernest A. Bates, Manager   President & CEO
Date: 11/15/11   Date: 11/15/11

  

 
 

 

Schedule 1

 

The Purchased Service Payment percentage and pro-rata share for capital expenditures are as follows:

 

Purchased Service Payment Pro-rata Share for
Percentage Capital Expenditures
   
* Medical Center = *
   
   JGKE = *

 

 

 

 

Exhibit 21

 

The subsidiaries of American Shared Hospital Services are :

 

MedLeader.com, Inc.

A California corporation

 

OR21, Inc.

A California corporation

 

Long Beach Equipment, LLC

A Delaware limited liability company

 

American Shared Radiosurgery Services

A California corporation

 

Subsidiaries of American Shared Radiosurgery Services

 

GK Financing, LLC

A California limited liability company

 

Subsidiaries of GK Financing, LLC

 

Albuquerque GK Equipment, LLC

A Delaware limited liability company

 

Jacksonville GK Equipment, LLC

A Delaware limited liability company

 

Instituto de Gamma Knife del Pacifico S.A.C.

A Peruvian company

 

GK Financing U.K. LTD

An England and Wales private limited company

 

EWRS, LLC

A Delaware limited liability company

 

EWRS Tibbi Cihazler Ticaret Ltd. Sti.

A Turkish company

 

 

 

 

Exhibit 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

We consent to the incorporation by reference in the Registration Statements on Form S-8 (Nos. 333-170650, 333-139446, 333-81138, 333-73172 and 333-08009) and Form S-3 (No. 333-12879) of our report dated March 30, 2012 relating to the consolidated financial statements appearing in the Annual Report on Form 10-K of American Shared Hospital Services and subsidiaries for the year ended December 31, 2011.

 

/S/ MOSS ADAMS LLP

 

Stockton, CA

March 30, 2012

 

 

 

 

 

Exhibit 31 (a)

 

CERTIFICATION

 

I, Ernest A. Bates, M.D., as chief executive officer of American Shared Hospital Services, certify that:

 

1. I have reviewed this annual report on Form 10-K for the period ended December 31, 2011 of American Shared Hospital Services;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any changes in the registrant’s internal control over financial reporting that occurred during registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting .

 

March 30, 2012 

 

/s/ Ernest A. Bates, M.D.  
Ernest A. Bates, M.D.
Chief Executive Officer
 

 

 

 

Exhibit 31 (b)

 

CERTIFICATION

 

I, Craig K. Tagawa, as chief financial officer of American Shared Hospital Services, certify that:

 

1. I have reviewed this annual report on Form 10-K for the period ended December 31, 2011 of American Shared Hospital Services;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any changes in the registrant’s internal control over financial reporting that occurred during registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting

 

March 30, 2012 

 

/s/ Craig K. Tagawa  
Craig K. Tagawa
Chief Financial Officer
 

 

 

 

Exhibit 32

 

March 30, 2012 

 

Securities and Exchange Commission

450 Fifth Street, N.W

Washington, D.C. 20549

 

Ladies and Gentlemen:

 

The certification set forth below is being submitted to the Securities and Exchange Commission solely for the purpose of complying with Rule 13a-14(b) and Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code. This certification is not to be deemed filed pursuant to the Exchange Act and does not constitute a part of the Annual Report on Form 10-K (the “Report”) accompanying this letter.

 

Ernest A. Bates, M.D., the Chief Executive Officer and Craig K. Tagawa, the Chief Financial Officer of American Shared Hospital Services, each certifies that, to the best of his knowledge:

 

1. the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

2. the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of American Shared Hospital Services.

 

  /s/ Ernest A. Bates, M.D.
  Ernest A. Bates, M.D.
  Chief Executive Officer
   
  /s/ Craig K. Tagawa
  Craig K. Tagawa
  Chief Financial Officer