AMENDMENT TO EQUIPMENT LEASE AGREEMENT (PERFEXION UPGRADE)
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.
AMENDMENT TO EQUIPMENT LEASE AGREEMENT
(PERFEXION UPGRADE)
This AMENDMENT TO EQUIPMENT LEASE AGREEMENT (PERFEXION UPGRADE) (this “Amendment”) is dated effective as of June 8, 2012 (the “Effective Date”), and is entered into by and among (i) GK FINANCING, LLC, a California limited liability company (“GKF”), whose address is Four Xxxxxxxxxxx Xxxxxx, Xxxxx 0000, Xxx Xxxxxxxxx, XX 00000, and (ii) NORTHERN WESTCHESTER HOSPITAL CENTER, a not for profit corporation (“Hospital”), whose address is 000 Xxxx Xxxx Xxxxxx, Xxxxx Xxxxx, XX 00000.
Recitals:
A. GKF and Hospital entered into a certain Equipment Lease Agreement dated March 21, 2003 (the “Lease”), pursuant to which GKF agreed to lease to Hospital a Leksell Stereotactic Gamma Knife unit, Model C with Automatic Positioning System (the “Model C”).
B. Hospital and GKF desire to amend the Lease to provide for the replacement and upgrade of the Model C that is currently being leased by GKF to Hospital pursuant to the Lease, with a Leksell Gamma Knife Perfexion unit (such Perfexion unit leased hereunder is referred to as the “Perfexion”), which will be installed at the existing Site at which the Model C is currently installed, and contemporaneously with the de-installation of the Model C (the “Perfexion Upgrade”).
Agreement:
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:
1. Defined Terms. Unless otherwise defined herein, the capitalized terms used herein shall have the same meanings set forth in the Lease.
2. Upgrade of the Model C to the Perfexion.
a. Subject to the terms and conditions set forth herein, GKF shall acquire and hold title to the Perfexion, and install the Perfexion with new cobalt-60 sources at the Site. GKF shall use its commercially reasonable efforts to complete the Perfexion Upgrade on or around _____________ or such other time as mutually agreed to in writing by Hospital and GKF, subject to availability of the Perfexion from the equipment manufacturer, issuance of all regulatory approvals, permits and/or waivers in a timely manner, and completion of construction of the Site. The parties acknowledge that Hospital may not be able to perform Procedures for approximately one (1) month during the Perfexion Upgrade and the deinstallation of the Model C. Concurrently with the execution of this Amendment, Hospital shall enter into a new LGK Agreement with Elekta, Inc., a Georgia corporation (“Elekta”), which shall supersede and replace the previous LGK Agreement attached as Exhibit 1 to the Lease (such new LGK Agreement shall hereinafter be referred to as the "LGK Agreement," and shall be deemed attached as Exhibit 1 to the Lease). Hospital shall operate and maintain a fully functional radiation therapy department at the Site which shall include the Perfexion. Use of the Perfexion shall be made available to all neurosurgeons and radiation oncologists with Hospital privileges.
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Exhibit 10.46a
b. Subject to Section 3.a below, Hospital shall be solely responsible for the construction and preparation of the Site and the rigging and installation of the Perfexion.
c. GKF shall be solely responsible for maintenance and service, personal property taxes, and the cost of insurance coverage for the Perfexion to the same extent and at the same levels as required under the Lease.
d. In connection with the Perfexion Upgrade, Hospital shall, at Hospital’s sole cost and expense, provide GKF with Hospital personnel (including Hospital physicists) and cooperation upon request and as reasonably required by GKF, among other things, to assist with compliance with local, state and federal regulatory requirements and with nuclear regulatory compliance issues and the calibration of the Perfexion.
e. Notwithstanding the foregoing, the Perfexion Upgrade shall be performed by GKF only after all necessary and appropriate licenses, permits, approvals, waivers, consents and authorizations, and the proper handling of the Cobalt-60 (collectively, the “Permits”), have been obtained by Hospital at Hospital’s sole cost and expense.
f. Upon request by GKF and at GKF’s reasonable expense, Hospital shall execute and deliver a commercially reasonable form of consent to sublease, subordination or other documentation if such a document is reasonably requested by the third party financing company which holds a security interest in the Perfexion.
g. It is acknowledged that the Perfexion will come with two (2) new headframes. GKF agrees that Hospital shall, at no additional cost, retain its existing headframes from the Model C for use on the Perfexion, and that GKF shall, at GKF's sole cost and expense, refurbish such existing headframes for use on the Perfexion.
h. GKF, at its cost and expense, shall cover the Perfexion training tuition costs for those physicians and physicists who will be using the Perfexion. Any travel and entertainment associated with training shall not be the responsibility of GKF.
i. GKF hereby grants to Hospital a non-exclusive right and sublicense to use the "LGP Software" as defined in and contemplated under, and subject to the terms and conditions of, the LGK Agreement.
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Exhibit 10.46a
j. Upon receipt of Elekta’s report on the results of the Acceptance Tests (as defined in the LGK Agreement), Hospital shall have three (3) business days to review and validate the results of the Acceptance Tests to confirm that the Perfexion meets the manufacturer’s specifications and documentation. If Hospital fails to respond within such three (3) business day period, Hospital shall be deemed to have validated and confirmed the results of the Acceptance Tests.
3. Model C; No Ownership Interests; Allocation of Shared Costs. Subject to Section 3.a below, GKF shall de-install, remove and retain all ownership rights and title to the existing Model C. Notwithstanding anything to the contrary set forth in the Lease or this Amendment, Hospital shall have no ownership interest (or option to purchase any ownership interest) in the Model C and/or the Perfexion.
a. Allocation of Shared Costs. Notwithstanding anything set forth herein to the contrary, Hospital shall contribute the aggregate sum of * (the "Hospital Contribution") towards the costs payable to third parties pertaining to the construction and preparation of the Site, the rigging and installation of the Perfexion, and the de-installation and removal of the existing Model C (collectively, the "Shared Costs"), which Hospital Contribution shall be paid as set forth herein irrespective of the final aggregate amount of the Shared Costs. In furtherance of the foregoing, * of the Hospital Contribution (i.e., *) shall be paid to GKF upon the commencement of the deinstallation of the Model C, and the remaining * of the Hospital Contribution (i.e., *) shall be paid to GKF upon the successful completion of the Acceptance Tests as set forth in Section 2.j above. For the avoidance of doubt, Shared Costs shall only include direct costs actually paid to unaffiliated third parties, without administrative overhead or markup.
4. Extension of Lease Term. In consideration of GKF’s agreement to perform the Perfexion Upgrade, the Term is hereby extended to the date that is ten (10) years following the “First Perfexion Procedure Date” (as hereinafter defined).
5. Lease Payments.
a. It is understood and agreed that Section 8.1 of the Lease (Per Procedure Payments) shall remain in full force and effect with respect to all Procedures performed prior to the de-installation of the Model C, and that all rent or lease payments pertaining to Procedures performed prior to the de-installation of the Model C shall continue to be calculated in accordance Section 8.1 of the Lease and shall be paid by Hospital to, and retained solely by, GKF. However, effective from and after the date the first Procedure is performed at the Site using the Perfexion (the “First Perfexion Procedure Date”), (i) the first paragraph only of Section 8.1 of the Lease shall be substituted and replaced with the following; and (ii) the remainder of Section 8.1 of the Lease (Per Procedure Payments) shall remain in full force and effect and shall apply to the Perfexion:
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Exhibit 10.46a
"8.1 Per Procedure Payments. As rent for the lease of the Perfexion to Hospital pursuant to this Agreement, commencing from and after the First Perfexion Procedure Date, Hospital shall pay to GKF the sum as stipulated in Exhibit “A” attached hereto (under the caption, "Per Procedure Payments") for each “Procedure” that is performed by Hospital or its representatives or affiliates at the Site or within the State of New York at the direction of Hospital or any of its affiliates, whether on an inpatient or outpatient basis, or “under arrangement” (as used in the Medicare billing context), and irrespective of whether the Procedure is performed on the Perfexion or using any other equipment or devices. As used herein, a “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. Hospital’s obligation to make Lease Payments pursuant to this Section 8.1 shall be expressly limited by Section 8.2, 8.3, and 8.4 hereof.
"Subject to the satisfaction in full of all of the "Payment Reduction Option Conditions," Hospital shall have the one-time option (the "Payment Reduction Option") in its sole discretion to effect a reduction to the Lease Payment, which reduction shall be in the amount of * per Procedure (i.e., if exercised, the Lease Payment would be as stipulated in Exhibit “A” attached hereto under the caption, "Per Procedure Payments With Payment Reduction Option"). As used herein, the "Payment Reduction Option Conditions" shall include all of the following: (a) Hospital shall have given prior written notice to GKF of Hospital's intent to exercise the Payment Reduction Option, which notice shall be given to GKF not less than sixty (60) days prior to the date of shipment of the Perfexion from Sweden (the "Perfexion Shipment Date"); (b) on or prior to the Perfexion Shipment Date, Hospital shall have paid to GKF by wire transfer a capital cost reduction payment in the amount of *; (c) no Hospital Event of Default (as defined in Section 20) has occurred and is then continuing, and no act or omission has occurred and is then continuing which, with the giving of notice and/or the passage of time, would constitute a Hospital Event of Default; and (d) Hospital is then in compliance and continues to be in compliance with all of the requirements set forth in this Agreement, including, without limitation, this Section."
b. The parties acknowledge that the compensation payable by Hospital for the Perfexion as set forth in this Amendment has been negotiated by the parties at arm’s length based upon reasonable and jointly derived assumptions regarding the capacity for clinical services available from the Perfexion, Hospital’s capabilities in providing high quality radiation oncology services, market dynamics, GKF’s risk in providing the Perfexion, and the provision to GKF of a reasonable rate of return on its investment in support of the Perfexion. Based thereon, the Parties believe that the rent payments (including the reduced rent payments, if exercised) represent fair market value for the use of the Perfexion, the de-installation and removal of the Model C, the Perfexion Upgrade, maintenance and service, personal property taxes, cost of insurance coverage for the Perfexion, educational support, the capital cost reduction payment (if applicable), and any other additional services and costs to be provided or paid for by GKF pursuant to this Amendment. Hospital undertakes no obligation to perform any minimum number of procedures on the Perfexion, and the use of the Perfexion for the performance of procedures is wholly based upon the independent judgment of physicians who order such procedures to meet the medical needs of their patients.
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Exhibit 10.46a
6. Cobalt Reloading of the Perfexion. Subject to scheduling availability, around the end of the sixth (6th) year following the First Perfexion Procedure Date, the Perfexion shall be reloaded with new cobalt-60 that meets the manufacturer’s radioactivity level specifications (the “Reload”), subject to the following terms and conditions:
a. Hospital shall be solely responsible for the rigging and installation of the Perfexion in connection with the Reload. The Reload shall be performed only after all necessary and appropriate licenses, permits, approvals, consents and authorizations, including, without limitation, the proper handling of the cobalt-60 (collectively, the “Reload Permits”), have been obtained by Hospital at Hospital’s sole cost and expense. The timing and procedure for such Reload shall be as mutually agreed upon between the parties.
b. GKF makes no representation or warranty to Hospital concerning the Reload, and GKF shall have no obligation or liability to pay any damages to Hospital resulting therefrom, including, without limitation, any lost revenues or profits during the period of time that the Perfexion is unavailable to perform procedures due to the Reload process.
c. Upon request and as required by GKF, Hospital, at Hospital’s cost and expense, shall provide GKF with Hospital personnel (including Hospital’s physicists) and services in connection with the Reload, among other things, to oversee, supervise and assist with construction and compliance with local, state and federal regulatory requirements and with nuclear regulatory compliance issues and the calibration of the Perfexion.
d. Subject to Section 6.a above, GKF shall be solely responsible for the actual costs of the Reload paid or payable to third parties; provided that Hospital shall not be entitled to reimbursement for its own respective personnel costs, internal costs or overhead.
e. Upon completion of the Reload, the Term (as extended pursuant to Section 4 above) shall be automatically further extended by an additional two (2) years (i.e., to the date that is twelve (12) years following the First Perfexion Procedure Date), plus the period of time that the Perfexion is unavailable to perform procedures due to the Reload (which is estimated to take approximately three (3) weeks for the Reload).
7. Educational Support. Hospital’s obligations with respect to community and physician education regarding the Perfexion shall continue in the same manner and with the same amounts as set forth in Section 7 of the Lease; provided that community education activities may be expanded to the general public (in addition to physicians).
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Exhibit 10.46a
8. Charity/Excluded Procedures.
a. As a means to permit Hospital to perform care for persons who are not covered by insurance programs and who do not have the means to pay for such procedures based upon Hospital’s adopted standards of indigency, GKF shall waive the per procedure Lease Payment for not more than * Perfexion procedure to be performed for an indigent person meeting the foregoing qualifications (a “Charity Procedure”) for each * paid Perfexion procedures (without counting any Charity Procedures) for which a per procedure Lease Payment is made to GKF. For purposes of counting the number of Perfexion procedures to determine the number of Charity Procedures allowed, there shall be no retroactive counting of procedures performed prior to the date of the First Perfexion Treatment Date. Hospital shall be solely responsible (and GKF shall not in any manner be or become responsible) for determining (i) whether any person described herein requires a Perfexion procedure, (ii) who shall receive a Perfexion procedure hereunder if more than * person described herein requires a Perfexion procedure, and (iii) whether any person meets the standards of indigency. Hospital shall provide reasonable written documentation evidencing satisfaction of the conditions set forth herein to GKF at or prior to the expected time of treatment.
b. As a means of accommodating differing medical judgment and medical preference for alternative treatment modalities, for each annual period commencing from and after the First Perfexion Procedure Date, GKF shall waive the per procedure Lease Payment for not more than * procedures that are performed using equipment or devices other than the Perfexion (each, an “Excluded Procedure”).
9. Supplier and Owner of Perfexion. The parties hereto agree that, notwithstanding anything to the contrary set forth herein, the Lease is and shall be treated and interpreted as a "finance lease," as such term is defined in Article 2A of the Uniform Commercial Code, that GKF shall be treated as a finance lessor who is entitled to the benefits and releases from liability accorded to a finance lessor under Article 2A of the Uniform Commercial Code. In furtherance of the foregoing, Hospital acknowledges that, before signing this Amendment, GKF has informed Hospital in writing (a) that Elekta is the entity supplying the Perfexion, (b) that Hospital is entitled (under Section 2A of the Uniform Commercial Code) to the promises and warranties, including those of any third party, provided to GKF by Elekta which is the entity supplying the goods in connection with or as part of the contract by which GKF acquired the Perfexion or the right to possession and use of the Perfexion, and (c) that Hospital may communicate with Elekta and receive an accurate and complete statement of those promises and warranties, including any disclaimers and limitations of them or of remedies. Hospital also acknowledges that Hospital has selected Elekta to supply the Perfexion and has directed GKF to acquire the Perfexion or the right to possession and use of the Perfexion from Elekta.
10. Miscellaneous. This Amendment (a) shall be governed by and construed under the laws of the State of New York, without reference to its principles of conflicts of law; and (b) may be executed in separate counterparts, each of which when so executed and delivered shall be an original, but all of which counterparts shall together constitute the same instrument. The captions and paragraph headings used herein are for convenience only and shall not be used in construing or interpreting this Amendment. This Amendment constitutes the full and complete agreement and understanding between the parties hereto concerning the subject matter hereof and shall supersede any and all prior written and oral agreements with regard to such subject matter.
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Exhibit 10.46a
11. Full Force and Effect; Except as amended by this Amendment, all of the terms and provisions of the Lease shall remain unchanged and in full force and effect and, together with this Amendment, represent the entire agreement of the parties with respect to the Perfexion and its use by Hospital. Unless the context requires otherwise, with respect to the Perfexion, all references in the Lease to (i) the “Agreement” shall be deemed to mean the Lease as amended by this Amendment; (ii) the “Equipment” shall be deemed to mean the Perfexion; (iii) the “LGK Agreement” shall be deemed to refer to the new LGK Agreement to be executed by Hospital relating to the Perfexion; and (iv) the “Term” shall be deemed to refer to the Term, as extended pursuant to this Amendment. To the extent any of the terms of the Lease conflict with the terms of this Amendment as it pertains to the Perfexion and the Perfexion Upgrade, the terms and provisions of this Amendment shall prevail and control. Where not different or in conflict with the terms and provisions of this Amendment, all applicable terms and provisions set forth in the Lease are incorporated within this Amendment as is if set forth herein and shall apply with equal force and effect to the Perfexion. Notwithstanding anything to the contrary set forth herein, no term or condition of this Agreement shall be effective to the extent it causes Hospital to breach the LGK Agreement or otherwise violate or infringe upon the rights of Elekta. Nothing set forth in this Amendment shall relieve either party from any or all of its obligations under the Lease with respect to the Model C, including, without limitation, the obligation to pay rent or lease payments and the service, insurance and property tax expenses associated with the Model C until de-installation.
IN WITNESS WHEREOF, the parties have executed this Amendment effective as of the Effective Date.
| GKF: | Hospital: | ||
| GK FINANCING, LLC | NORTHERN WESTCHESTER HOSPITAL CENTER | ||
| By: | /s/ Xxxxxx X. Xxxxx, MD | By: /s/ Xxxx Xxxxxxxx | |
| Xxxxxx X. Xxxxx, M.D. | Xxxx Xxxxxxxx | ||
| Policy Committee Member | President and CEO | ||
| Date: June 15, 2012 | Date: 6/13/12 | ||
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Exhibit 10.46a
Exhibit “A”
PER PROCEDURE PAYMENTS
| Annual Paid Procedures Performed | Per Procedure Payment | |
| * | * per Procedure | |
| * | * per Procedure | |
| * | * per Procedure |
PER PROCEDURE PAYMENTS
WITH PAYMENT REDUCTION OPTION
| Annual Paid Procedures Performed | Per Procedure Payment | |
| * | * per Procedure | |
| * | * per Procedure | |
| * | * per Procedure |
Notwithstanding anything to the contrary set forth herein, for purposes of determining the Per Procedure Payments, (a) only those Procedures performed on or after the First Perfexion Procedure Date shall be counted; (b) the number of annual Procedures performed on the Perfexion or using any other equipment or devices shall be reset to zero (0) at the commencement of each anniversary of the First Perfexion Procedure Date; (c) Charity Procedures and Excluded Procedures shall not be counted towards the annual Procedures performed; and (d) there shall be no retroactive adjustment of the Per Procedure Payments irrespective of whether the number of Procedures performed reaches a lower Per Procedure Payment level. For example, if during an annual measuring period, the number of annual counted Procedures totals *, then, the Per Procedure Payments for the first * Procedures would remain at * per Procedure while the Per Procedure Payments for the next * procedures (i.e., for Procedures * through *) would be * per Procedure (assuming the Payment Production Option has not been exercised). There are no minimum volume requirements.
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Exhibit 10.46a
Prepared for
Northern
Westchester Hospital
000 Xxxx Xxxx Xxxxxx
Xxxxx Xxxxx, XX 00000-0000
April 16, 2012
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LEKSELL GAMMA KNIFE® END USER AGREEMENT
THIS AGREEMENT is entered into as of the 8 day of June 2012 by and between ELEKTA, INC., a corporation organized and existing under the laws of Georgia (hereinafter referred to as “Elekta”), and Northern Westchester Hospital,. (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 GK Financing, LLC., hereinafter referred to as “Buyer”), and
WHEREAS, Buyer has agreed to lease the LGK® to End User under separate agreement.
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:
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 Purchase 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.
Hardware shall mean that computer hardware and related equipment described in the Specification.
Lease Agreement shall mean the Agreement between Buyer and End User pursuant to which Buyer shall lease the LGK® to End User.
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.
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 Purchase 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 take 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 AND TRAINING.
3.1 Operation. End User warrants and covenants that the LGK® shall not be run, operated or otherwise used, except by and to qualified employees or physicians, who are suitably skilled and experienced to use the LGK®.
3.2 Technical Training. Elekta shall provide to four (4) persons on the Buyer’s staff instruction relating to the technical operation and maintenance of the LGK. Such instruction shall not exceed two consecutive days and will be provided on site by installation personnel at the time of install.
3.3 Introductory Clinical Training. Introductory Clinical Training Program. Indications, Technique, Literature, etc. Length of training is 5 consecutive days. Up to four (4) training spaces included (Tuition only). May be substituted for Technical/Applications training course at Elekta Sweden as noted on Exhibit A.
3.4 Post Clinical Start Up Site Visit. Elekta shall provide a one-day site visit from one 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 customer is comfortable using all features in the Leksell GammaPlan® PFXTM software.
3.5 LGK® Software. Elekta hereby consents to Buyer’s sublicense to End User of the LGK® Software, to be utilized only for the purpose of planning dosages of treatments to be performed with the LGK®. A copy of the LGK® Software License from Elekta to Buyer is attached hereto as Exhibit D End User agrees that its sublicense to the LGK® Software shall be subject to the terms and conditions of Exhibit D hereto. End User grees, in favor of Elekta, to perform the obligations assigned to Buyer in Exhibit D hereto. In the event the sublicense of the LGK® 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 from Elekta a direct royalty-free license to utilize the LGK® Software on the terms and conditions described in Exhibit D hereto.
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3.6 Intellectual Property.
(a) End User hereby acknowledges that the trademarks Gamma Knife® and Leksell Gamma Knife® (collectively, the “Xxxx”) are protected by United States federal registrations and the Xxxx 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 Xxxx 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 Instrument, S.A. of Geneva, Switzerland, the owner of the Xxxx, hereby grants End-User a non-exclusive, royalty-free license without right to sublicense solely for the purpose of using the Xxxx 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 Xxxx 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 Northern Westchester Hospital”
As long as End User utilizes a fictitious trade name which includes the Xxxx, 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 Xxxx as part of its fictitious trade name.
(d) In advertising, references to the Xxxx must include the registration symbol ® 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 Instrument S.A.., Geneva, Switzerland” 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]” as part of any internet 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 internet domain name, or URL, telephone number or other communications address or symbol.
(f) All advertising or promotional materials in which the xxxx 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 Xxxx in any manner which, in the sole opinion of Elekta, presents a reasonable possibility of damage to the Xxxx.
(h) Upon termination of the license granted by this section, End User shall immediately cease all use of the xxxx, including, but not limited to, the use permitted under subsection (e) of this section.
(i) Buyer acknowledges that a breach of any of its covenants or agreements hereunder will cause immediate and irreparable harm to Elekta and Elekta Instrument S.A. End User acknowledges and agrees that no adequate remedy at law exists for any such breach, and End User agrees that in the event of such a breach Elekta shall be entitled to injunctive relief and such other relief as any court with jurisdiction may deem just and proper.
ARTICLE IV. CONFIDENTIALITY
4.1 End User shall treat and maintain as confidential all technical information and know-how to it pursuant to this Agreement (including LGK® Software), except for know-how specifically designated as non-confidential pursuant to this Agreement or otherwise so designated by the Elekta. End User shall not disclose any aspect of such know-how (including the LGK® Software) to any other Person, including any corporation or governmental or quasi-governmental agency; provided that, End User shall have the right to disclose such know-how to its employees and resident physicians to the extent necessary for use of the LGK®, but End User shall be responsible to ensure that such know-how is not disclosed by such persons.
4.2 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.
4.4 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 such access prior 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 Buyer 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 AND REPAIR SERVICE AGREEMENT
5.1 Elekta provides the warranty for the LGK® set forth in Exhibit C hereto.
5.2 On the date on which the Installation Test Protocol is completed, a Repair Service Agreement shall be in effect for five (5) years with the purpose of providing repair parts and services for the LGK® as per the Purchase Agreement between Buyer and Elekta.
ARTICLE VI. EXCUSABLE DELAYS
If the performance of this Agreement by Elekta or Buyer or any obligation of Elekta or Buyer 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 Buyer, then and in that event Elekta or Buyer, as the case may be, shall promptly notify the other parties hereto of the resulting difficulties therefrom, and any of the foregoing events shall excuse any performance required under this Agreement.
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ARTICLE VII. LIMITATION OF LIABILITY; INDEMNIFICATION.
7.1 The exclusive remedies of End User and Elekta’s sole liabilities for breaches of this Agreement shall be limited to those specifically provided for in Section 5.1 (and Exhibit E hereto) and in this Article VII. In no event shall Elekta be liable to End User for loss of use, revenue or profit, or for any other direct, indirect, incidental or consequential damage, whether arising in contract or tort.
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, 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).
7.3 End User shall defend and indemnify Elekta and its Affiliates, agents, servants, and employees and hold them harmless from and against all damages, 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 the operation or medical use or misuse of the LGK® by or for End User (but which is not attributable to defective materials, workmanship or manufacture of the LGK®), the defective maintenance of the LGK® by or for End User (but only to the extent not performed by or on behalf of the Elekta), the failure of the Site to comply with the Site Planning Criteria, or the training provided by Elekta.
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 (1) 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 of other entities. 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 Arbitration. All disputes arising in connection with this Agreement shall be finally resolved by arbitration in Atlanta, Georgia under the Commercial Arbitration Rules of the American Arbitration Association. Judgment upon the award rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of such award and an order of enforcement as the case may be. The parties hereby agree the rendering of an award by the arbitrator or arbitrators shall be a condition precedent to the initiation of any legal proceeding with respect to any dispute arising in connection with this Agreement. This Agreement shall be governed by and construed in accordance with the laws of the State of Georgia and the United States.
8.4 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..
IN WITNESS WHEREOF, the parties hereto have signed this Agreement in duplicate as of the date first written above.
ELEKTA INC.
| By: | /s/ Xxxxxxx X. Xxxxxxxx | |
| Title: | Secretary and Legal Counsel | |
| Date: | 8/13/2012 | |
| END USER | ||
| By: | /s/ Xxxx Xxxxxxxx | |
| Title: | President | |
| Date: | 6/15/12 | |
| - 4 - |
EXHIBIT A
SPECIFICATION
Leksell Gamma Knife® PERFEXIONTM
PRODUCT SPECIFICATION
Standard turn-key system
| Qty | Description | Article no. | ||
| 1 | Leksell Gamma Knife® PERFEXIONTM | 715000 | ||
| 2 | Leksell® Coordinate FrameTM Kit for PERFEXIONTM | 1002407 | ||
| 1 | Leksell GammaPlan® | in BOM | ||
| 1 | PERFEXIONTM system tool kit | |||
| 1 | LSS Spare Part Kit for Leksell® Coordinate FrameTM | 1002406 | ||
| 1 | Skull scaling instrument | A0202-01 | ||
| 1 | CT planning kit | |||
| 1 | MRI planning kit | |||
| 1 | X-ray planning kit | |||
| 1 | Set of Co60 sources | 2000000 | ||
| Cobalt loading | ||||
| Site planning | ||||
| Installation and commissioning | ||||
| 1 | Support and Education & Training for PERFEXIONTM | SER PERFEXION 0001 |
| - 5 - |
Leksell Gamma Knife® PERFEXIONTM
Radiation unit
- With radiation shielding doors and collimator system.
Patient Positioning SystemTM
- 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
- PPC1- software
- PPC2- 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 PERFEXIONTM.
Clearance check tool
Document set
Installation and supplementary documents
2 instructions for use
2 emergency routines
Signs and labels
| - 6 - |
Leksell® Coordinate Frame® Kit for PERFEXIONTM
| 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 | ||
| 1 | Ear Plug Holder, Left | 50498-02 | ||
| 2 | Ear Plug | 60136-01 | ||
| 1 | Fixation Screws, Titanium, kit of 20 pairs | 000000 | ||
| 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 |
PERFEXIONTM 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® PERFEXIONTM.
LSS Spare Part Kit for Leksell® Coordinate FrameTM
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. |
| - 7 - |
| 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® (LGP) license for creating new treatment plans for Leksell Gamma Knife® PERFEXIONTM .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® PERFEXIONTM includes:
1 STANDARD LGP FOR PERFEXION LICENSE
Includes one (1) Leksell GammaPlan® (LGP) license for creating new treatment plans for Leksell Gamma Knife® PERFEXIONTM .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 RETREATMENTTM 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. ReTreatmentTM 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 WARPSPEEDTM, 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. WarpSpeedTM provides a shorter learning curve, more intuitive and faster planning.
1 FUNCTIONAL PLANNINGTM 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 IMAGEMERGETM 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 ColorPETTM).
1 COLOR PETTM LICENSE
The ColorPETTM 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.
| - 8 - |
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® PERFEXIONTM
| 6 | Clinical Training |
Principle and practice of Gamma Knife Surgery, clinical lectures, treatment planning, patient treatment - 5 days. Arranged by Elekta in collaboration with participating hospital.
| - 9 - |
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 Xxxxx (2.44 x 1014 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 |
| - 10 - |
Patient Positioning System
The Patient Positioning System is the component of the PERFEXIONTM 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 xxxx | 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 PERFEXIONTM 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.
| - 11 - |
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 PERFEXIONTM 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®.
INFORMATION TO BE FURNISHED BY BUYER
Not later than six months prior to the Contractual Delivery Date or two weeks after the Effective Date, whichever occurs later, Buyer shall inform Seller in writing of:
(i) the orientation of the LGK
(ii) the minimum lengths of cables required to connect the LGK at the Site; and
(iii) the manufacturer and model numbers of the CT, MRI and angiographic equipment which Buyer intends to use in connection with the LGK.
| - 12 - |
Support and Education & Training for PERFEXIONTM
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:
1) Leksell Gamma Knife® PERFEXIONTM 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. We pay for the tuition at an approved Elekta training site.
2) Leksell GammaKnife® PERFEXIONTM 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. We pay for the tuition at an approved Elekta training site.
Support Services
The following support services are delivered in addition to parts warranty during the first year.
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.
| - 13 - |
EXHIBIT B
DESCRIPTION OF SITE
Northern
Westchester
000 Xxxx Xxxx Xxxxxx
Xxxxx Xxxxx, XX 00000-0000
| - 14 - |
EXHIBIT C
ELEKTA'S WARRANTY
| 1. | Subject to the exceptions set forth below, Elekta warrants to Buyer that for one 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 Buyer; |
| (ii) | defects emanating from Buyer’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 year from the date of the completed Installation Test Protocol, perform substantially in accordance with the documentation delivered with such LGP Software. 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, 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, Buyer 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 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 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, Buyer shall immediately notify Elekta in writing of any defects that appear under the warranty and shall give Elekta every opportunity of inspecting and remedying such defects. |
| 5. | Year 2000 Compliance Warranty. Elekta further warrants that the equipment, 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 FOREGOING WARRANTIES 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. CORRECTION OF NON-CONFORMITIES OR DEFECTS AS PROVIDED ABOVE SHALL BE BUYER’S EXCLUSIVE REMEDY AND SHALL CONSTITUTE FULL AND FINAL FULFILLMENT OF ALL LIABILITIES OF ELEKTA, WHETHER IN WARRANTY, CONTRACT, NEGLIGENCE, STRICT LIABILITY, TORT OR OTHERWISE WITH RESPECT TO THE LGK. IN NO EVENT SHALL ELEKTA BE LIABLE FOR LOSS OF USE, REVENUE OR PROFIT, OR FOR ANY OTHER DIRECT, 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 Buyer 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, Buyer 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 Buyer with such reasonable cooperation as Buyer may request with respect to the purchase by Buyer of any extended warranty or maintenance contract offered by the Computer Manufacturer. |
| - 15 - |
EXHIBIT E
LEKSELL GAMMAPLAN® PFXTM SOFTWARE LICENSE
| 1. | LGP Software |
| 1.1 | Elekta hereby licenses to Buyer at no additional cost beyond the Purchase Price, the LGP Software, 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 E. Such license is for the use by Buyer of the software at one (1) workstation. |
| 1.2 | Buyer shall not: (a) use LGP except in connection with the radiosurgical operations performed with the LGK at the Site; (b) make any modification to, adapt, translate, decompile, disassemble or create derivative works based on LGP or merge LGP into any other software; (c) reproduce LGP (or any portion thereof) or any materials related thereto except for one back-up copy made as part of Buyer’s regular computer software maintenance routines; (d) transfer, assign or sublicense LGP 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; or (e) use LGP 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, 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 recorded on the original disk(s) and all subsequent copies of LGP, in whatever form recorded. |
| 1.4 | The term of Buyer’s license to LGP shall continue until the earlier of: (a) any sublicense, assignment or transfer or attempted sublicense, assignment or transfer by Buyer of LGP without the consent of Elekta; (b) the transport, movement or attempted transport or movement by the Buyer of LGP, or the Hardware on which LGP is installed, from the Site without prior written consent of Elekta; (c) any modification or adaptation of LGP for use with any equipment other than the LGK; (d) the use of LGP 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 |
| 2.1 | To facilitate E-Mail/Internet support, Buyer shall provide for E-Mail/Internet connectivity. |
| 2.2 | Buyer shall assign a system manager who will undergo the appropriate training on the operating system HP-UX and /or already have sufficient UNIX system administrator experience. Such training will be provided by the Hardware manufacturer and Elekta shall pay the fee therefore. Buyer shall pay all travel and other expenses associated with such training. |
| 2.3 | 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. 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 formats and any other scanner or PACS information from vendors necessary to integrate images into LGP and providing this to Elekta. |
| (c) | The Hardware used to run LGP must be used solely for this purpose. All changes and additions to LGP and/or Hardware running LGP 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, netmask, gateway address, etc. for the HP workstation included as a part of the Hardware. |
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EXHIBIT E
END USER AGREEMENT AMENDMENTS
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