Master Clinical Trial Agreement - IVIVI TECHNOLOGIES, INC. - 6-19-2006 by IVVI-Agreements

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									Exhibit 10.11 MASTER CLINICAL TRIAL AGREEMENT THIS MASTER CLINICAL TRIAL AGREEMENT (the "Agreement") is effective January 9, 2006 (the "Effective Date") between Cleveland Clinic Florida, a Florida not-for-profit corporation ("CCF"), and Ivivi Technologies, Inc., a New Jersey corporation ("Sponsor"), having the respective addresses as set forth below. Each of CCF and Sponsor may be referred to individually herein as a "Party," and jointly as the "Parties." WHEREAS, CCF possesses certain expertise in the field of clinical and related research and evaluation of such research; and WHEREAS, Sponsor is interested in engaging CCF in order to obtain the benefit of such expertise with respect to certain research and development projects being conducted by Sponsor into the clinical development, safety and efficacy of various medical devices being developed by Sponsor; Therefore, in consideration of the premises and undertakings set forth. herein, CCF and Sponsor agree as follows: 1. DEFINITIONS. 1.1 "CFR" means the United States Code of Federal Regulations. 1.2 "CONSENT FORM" shall have the meaning ascribed in Section 7. 1.3 "DATA" shall have the meaning ascribed in Section 14.4. 1.4 "FDA" means the United States Food and Drug Administration. 1.5 "FD&C ACT" means the United States Federal Food, Drug and Cosmetic Act, as may be amended from time to time. / 1.6 "GCP" means the Guidelines for Good Clinical Practices promulgated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1.7 "IRS" means a CCF Institutional Review Board. 1.8 "INVESTIGATOR" means the principal investigator for a Study, as specified in the applicable Work Order. 1.9 "MATERIALS" means all substances, compounds, devices and/or materials provided to CCF by or on behalf of Sponsor for use in the performance of a Study.

1.10 "PRODUCT" means a proprietary investigational device(s) of Sponsor that is(are) the subject of a Study. 1.11 "PROPRIETARY INFORMATION" means all confidential information and Materials implied or expressly identified as such in Sponsor's sole discretion, including, but not limited to know-how, trade secrets, technical data, technical specifications, testing methods, technology, expertise, any information implied or expressly designated as "Proprietary Information" under this Agreement and associated Work Orders, or any other information, whether or not patentable or copyrightable, that is disclosed or provided by Sponsor to CCF in connection with (a) this Agreement, (b) the terms of this Agreement, (c) any associated Work Order, or (d) the terms of any associated Work Order.. 1.12 "PROTOCOL" means the protocol for the conduct of a Study, as set forth in the relevant Work Order. 1.13 "Study" means one or more clinical research studies requested by Sponsor and agreed to be performed by CCF as set forth in the relevant Work Order, which may be referred to collectively as the "Studies." 1.14 "Work Order" shall have the meaning ascribed in Section 3.1(a). 2. SCOPE OF THE AGREEMENT. The Parties intend for this Agreement to allow them to contract for multiple Studies through the issuance of Work Orders without having to re-negotiate the basic terms and conditions contained herein. 3. WORK ORDERS. 3.1 The specific details of each Study under this Agreement shall be separately negotiated by the Parties and specified in writing, on terms and in a form acceptable to the Parties (each such writing, a "Work Order"). Each Work Order will include the Protocol, time line and payment schedule for such Study. A sample Work Order is attached hereto as Exhibit A. 3.2 CCF shall conduct each Study covered by each executed Work Order in accordance with the terms and conditions of such Work Order. Each executed Work Order shall be deemed to be a part of this Agreement; provided that, to the extent any terms or provisions of a Work Order conflict with the terms and provisions of this Agreement, the terms and provisions of this Agreement shall control, except to the limited extent that the applicable Work Order expressly and specifically states an intent to supersede this Agreement on a specific matter. 4. INVESTIGATORS' QUALIFICATIONS 4.1 Each Work Order shall identify the Investigator for the Study that is the subject of such Work Order (including, to the extent requested by Sponsor, detailed 2

curriculum vitae, certificates of training and description of proposed responsibilities and time commitment). 4.2 With respect to each Study, the applicable Investigator shall make the following representations to Sponsor as part of each Work Order: (a) Such Investigator has no financial interests and/or arrangements with Sponsor that will require disclosure to FDA in accordance with 21 CFR Part 54; (b) Such Investigator has not been "debarred" by the FDA under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335a (a) and (b), nor have debarment proceedings been commenced against him or her; (c) Such Investigator is aware of and agrees to be bound by the terms of this Agreement (including without limitation Articles 5, 14 and 15 hereof) and of the Work Order covering such Study. 4.3 With respect to each Study, CCF and/or the applicable Investigator shall also supply the following documents: (a) A signed investigator statement (Form FDA-1572) and curriculum vitae for all individuals listed therein, and (b) If such Investigator has been involved in an investigation or other research that has been terminated for cause, an explanation of the circumstances that led to such termination shall be attached. 5. IRB APPROVAL For each Study to be conducted hereunder, Sponsor shall provide to the applicable Investigator for submission to the IRB, adequate information (i.e. investigator's brochure, the Protocol, and sample informed consent form) for review and approval to begin such Study. If any modification of such informed consent form is required by the IRB, a copy of the form as modified shall be promptly provided to Sponsor for its approval. Any withdrawal of IRS approval shall be immediately reported to Sponsor. 6. CONDUCT OF STUDIES, GENERALLY 6.1 CCF shall commence each Study as soon as possible following receipt of IRB written approval, or as otherwise agreed upon in writing with Sponsor, and shall follow any conditions of approval imposed by the IRB. 6.2 CCF and the applicable Investigator shall conduct each Study in accordance with all applicable federal and state laws and regulations for protecting the rights, safety and welfare of human subjects and for the control of investigational drugs and devices, including 21 CFR Parts 50, 56 and 312, and all recognized medical and ethical standards for the conduct of clinical investigations, including GCP. 3

6.3 Except in the case of a medical emergency or otherwise necessary for patient safety, neither CCF nor any Investigator shall not make any changes in, nor deviate from, the applicable Protocol without Sponsor' prior written approval. 6.4 Sponsor or its designee will provide clinical monitoring for each Study. CCF and the applicable Investigator shall cooperate with Sponsor and/or its designee in the performance of its duties as clinical monitor. 6.5 Any substitutions or replacements of an Investigator during the course of a Study must first be approved in writing by Sponsor. In the event that the Investigator for a Study becomes unable or unwilling to continue to perform his or her responsibilities under such Study, CCF shall use its best efforts to provide a replacement acceptable to Sponsor as promptly as possible. If CCF in unable to replace such Investigator to Sponsor' reasonable satisfaction, Sponsor shall have the right to terminate such Study upon written notice to CCF, as set forth in Section 6.6 below. 6.6 Sponsor reserves the right to terminate any Study at any time with or without cause upon written notice to the CCF and the applicable Investigator. Upon receipt of initial notice of termination of a Study from Sponsor, CCF and the applicable Investigator shall cease the clinical investigation of the applicable Product and the enrollment of further subjects into such Study. CCF and the applicable Investigator shall continue to collect Data and prepare case report forms for subjects who received such Product prior to receipt of the termination notice as directed in writing by Sponsor. Upon termination, CCF will be reimbursed by Sponsor for (a) all fees incurred in its conduct of such Study through the effective date of such termination, and for any further Data and case report form processing as described above, in accordance with the payment schedule set forth in the applicable Work Order adjusted pro rata for actual work completed to Sponsor's satisfaction by CCF through the effective date of such termination, and (b) any reasonable, non-cancelable costs approved by Sponsor resulting from the termination following Sponsor' receipt of an itemized invoice detailing such costs. 7. INFORMED CONSENT For each Study to be conduced hereunder, and in accordance with 21 CFR Part 50 and 312.60, CCF shall inform all subjects of such Study or their legal representatives that the applicable Product is being used for clinical investigation, and shall obtain from these subjects or their legal representatives a signed written informed consent form which has been approved by the IRB and Sponsor (a "Consent Form"). Each subject shall be provided a photocopy of his or her signed Consent Form, the original of which shall be placed in the respective subject's investigational file. 4

8. SUPERVISING USE In accordance with 21 CFR Part 312.61, CCF shall permit the Product that is the subject of a Study to be used only by subjects under the applicable Investigator's supervision, or under the supervision of the associates listed on the applicable Form FDA-1572. The CCF shall not supply the Product to any person other than those authorized under this Agreement. No investigative procedures other than those set forth in the corresponding Protocol shall be undertaken with such Product on the enrolled subjects or otherwise without the prior written approval of Sponsor (and the IRB when necessary). CCF will not supply such Product, nor permit such Product to be supplied, to any third party (including, without limitation, any other investigator except the above-referenced associates) or laboratory or any clinic for use in humans or for in vitro or in vivo laboratory research, or any other use, without the prior written approval of Sponsor. 9. RECORDS 9.1 CCF shall maintain the following accurate, complete and current records with respect to each Study, and shall make such records available to Sponsor and its authorized representatives promptly upon request (a) Any and all correspondence with Sponsor, the IRB and the FDA. (b) In accordance with 21 CFR 312.62, records of receipt, use or disposition of the Product that is the subject of such Study including without limitation: (i) The date of receipt, type, quantity, lot number and other identifying marks of such Product; (ii) The names of all persons who received, used or disposed of each unit of such Product; (iii) An explanation of the reasons why any Product was returned to Sponsor (excluding the routine return of such Product upon completion or other termination of such Study). (c) In accordance with 21 CFR 312.62, source records of each subject's case history and exposure to such Product. The records shall: (i) Include copies of signed Consent Forms; (ii) Except with respect to Consent Forms, be transcribed onto Sponsor-supplied case report forms and be completed at times indicated by Sponsor; (iii) Include all observations, and other data and records pertinent to such Study, and all records concerning adverse events. (d) The applicable Protocol, and any amendments thereto, with documents showing the dates of and reasons for each deviation from such Protocol. 5

9.2 CCF shall review, sign and date the case report forms for each subject enrolled in a Study. Source documents must be available for copy and review as needed by Sponsor to audit or correct study case report forms or to respond to the FDA. CCF shall make such source documents and records available for inspection and copying at pre-Study and routine clinical monitoring visits. CCF and its staff shall cooperate with Sponsor during monitoring visits or for the resolution of questions regarding records or clinical data generated throughout the performance of this Agreement. 9.3 The parties recognize that the sharing of clinical data with Sponsor in the performance, audit or monitoring of a Study may involve disclosure of individually identifiable health information, as that term is defined under the privacy rules of the Health Insurance Portability and Accountability Act of 1996. The parties each agree to treat all individually identifiable health information disclosed as part of a Study as confidential and in accordance with the patient's written authorization and all applicable federal, state or local laws and regulations governing confidentiality and privacy of individually identifiable health information. 10. REPORTS 10.1 CCF shall prepare and submit to Sponsor or its designee the following complete, accurate and timely reports with respect to each Study: (a) Case Report Forms: CCF shall submit completed case report forms as required in the applicable Protocol or as otherwise requested by Sponsor. In the event subject follow-up is not possible for any reason, CCF shall document this fact and the circumstances thereof on a case report form and promptly submit such form. (b) Adverse Events; Any serious adverse events that occur during such Study shall be reported by CCF to Sponsor, and to the IRB if required by federal regulations (including without limitation 21 CFR 312), as soon as possible, but in no event later than twenty-four (24) hours following receipt of such information. (c) Withdrawal of IRB Approval: CCF shall report to Sponsor the IRB's withdrawal of approval of the CCF's or applicable Investigator's participation in a Study immediately following receipt of such notice from the IRB. (d) Deviations from the Protocol: CCF shall promptly notify Sponsor of any deviation from the Protocol, as permitted under Section 5.4. (e) Informed Consent CCF shall promptly notify Sponsor and the IRB of any failure to obtain informed consent from a subject in accordance with Article 7 prior to such subject's participation in a Study, within five (5) working days after discovery of such failure occurs. 6

10.2 CCF shall provide to Sponsor (i) periodic written progress reports for each Study, and (ii) a final written report for such Study, in each case as described in the applicable Work Order. 11. COMPENSATION 11.1 CCF will be compensated by Sponsor for its conduct of each Study in accordance with the payment terms and fee schedule set forth in the applicable Work Order. 11.2 Unless otherwise set forth in the applicable Work Order, CCF's payments shall be made payable to the following name and address: Cleveland Clinic Florida P.O. Box 918631 Orlando, FL 32891-8631 Each payment voucher should reflect the Sponsor's name, Protocol Number, and name of the applicable Investigator. A. Sponsor shall report any payments made to CCF under this Agreement, and shall withhold from such payments any required taxes for remittance to the applicable authority, solely to the extent required by applicable federal, state or local tax laws or regulations. CCF's Federal Tax Identification Number is 65-0003177. CCF shall be solely responsible for the filing of all forms and the payment of all taxes and withholdings in connection with amounts paid to it by the Sponsor. CCF shall indemnify the Sponsor and hold the Sponsor harmless with respect to the payment of all taxes and withholdings required to be paid by CCF in accordance with applicable federal, state or local tax laws or regulations. 12. REGULATORY ISSUES; INSPECTIONS. 12.1 Each of Sponsor and CCF shall be responsible for obtaining and maintaining, at its respective expense, all permits, licenses, approvals, authorizations and the like required for its respective performance under this Agreement. 12.2 If any governmental or regulatory authority or any entity representing such an authority (each, a "Regulatory Authority") requests access to CCF's records, facilities and/or personnel, or conducts an unannounced inspection, in each case relating to a Study, then CCF shall promptly notify the contact set forth in the Work Order covering such Study by telephone. Sponsor shall have the right to be present at any audit or inspection by a Regulatory Authority that relates to a Study. 12.3 Sponsor has the right to examine and audit the work performed by CCF pursuant to any Study at the facilities where the work is conducted, upon reasonable 7

advance notice during regular business hours, to determine that CCF is conducting the Study in accordance with the applicable Work Order and applicable regulatory requirements, and that CCF is providing adequate facilities and staffing to the satisfaction of Sponsor. 13. DISPOSING OF CLINICAL SUPPLIES In accordance with 21 CFR 312.59, upon the earlier of completion or termination of each Study or at Sponsor' request, CCF shall return to Sponsor any remaining Product (including investigational devices, if any) and other Materials from such Study, or, if so instructed by Sponsor, destroy any such remaining Product in accordance with the instructions provided by Sponsor and consistent with applicable local, state and federal guidelines and shall supply Sponsor with a certificate of such destruction. 14. CONFIDENTIALITY/INTELLECTUAL PROPERTY 14.1 CCF hereby agrees: (a) not to use any Proprietary Information except for the purpose of conducting the applicable Study or as otherwise expressly authorized in writing by Sponsor, and (b) not to disclose or transfer Proprietary Information to any person or entity, other than to those employees or agents (including without limitation Investigators) who reasonably require same for the purpose hereof and who are bound by like written obligations to protect such Proprietary Information, without the express written permission of Sponsor. (c) The obligations of this provision shall remain in effect for three (3) years following the disclosure of such Proprietary Information. 14.2 The obligations set forth in Section 14.1 shall not apply to any Proprietary Information that: (a) CCF can demonstrate by written records was known to CCF prior to its disclosure hereunder; or (b) is now or later becomes publicly available other than by breach of this Agreement; or (c) is lawfully disclosed to the recipient on a non-confidential basis by a third party who is not obligated to Sponsor or any other party to retain such Proprietary Information in confidence. 14.3 Nothing in this Agreement shall prevent CCF from disclosing Proprietary Information that is duly required to be disclosed by order of a court, government agency or the like having competent jurisdiction, provided that CCF shall promptly notify Sponsor to permit Sponsor to seek a protective order or 8

injunctive relief to protect the confidentiality of the Proprietary Information. CCF shall disclose only such portion of the Proprietary Information as is required to be so disclosed 14.4 The case report forms, progress reports, and any other reports prepared as part of the Study, as well as any other tangible manifestation of the results of the Study, shall be the sole and exclusive property of Sponsor. Nothing in this Article 14, however, shall prevent the CCF from maintaining copies of such materials to use for (i) regulatory compliance purposes and evidencing compliance with this Agreement; (ii) publishing scientific articles on the Study, as contemplated by Article 15 below; or (iii) internal research, education and patient care purposes, subject to the surviving obligations of Section 14.1. 14.5 The furnishing of Proprietary Information under this Agreement shall not constitute any grant, option or license to the CCF under any patent or other rights now or hereafter held by Sponsor. This Agreement shall not be deemed or construed to convey or transfer to CCF any rights with respect to any Product, except as insofar as necessary to permit CCF and the applicable Investigator to conduct the Study. 14.6 INVENTIONS. SPONSOR INVENTIONS (a) Notification. If the conduct of the Study results in a "Sponsor Invention" defined as an invention or discovery, whether patentable or not, that (1) relates directly to the Sponsor Product, including any that contemplate either a new use or new formulation of the Sponsor Product, (2) was made possible through use of Sponsor Confidential Information, (3) was made possible through use of Sponsor funding under the Study Protocol, this Agreement, and any subsequent amendments thereto, or (4) results from any investigation of the Sponsor Product conducted under the Study Protocol, this Agreement, and any subsequent amendments thereto, CCF will promptly inform Sponsor. (b) Assignment to Sponsor. CCF will assign all interest in any such Sponsor Invention to Sponsor, free of any obligation or consideration beyond that provided for in this Agreement. (c) Assistance. CCF will provide reasonable assistance to Sponsor in filing and prosecuting any patent applications relating to such Sponsor Invention, at Sponsor's expense. CCF INVENTIONS (d) Notification. If the conduct of Study results in any invention or discovery, whether patentable or not, that does not meet the definition of a Sponsor Invention, CCF will promptly inform Sponsor. Such an invention will be termed a 'CCF Invention" and ownership will be determined in accordance with US patent law. Sponsor will accept notification of a CCF Invention in confidence and, for a period of one year or until CCF 9

files a patent application directed to the CCF Invention, whichever occurs first, will not disclose it to any third party without written consent from CCF unless required by law (including FDA regulations). (e) Option to a License. CCF grants Sponsor an option to a worldwide royalty-bearing license for each CCF Invention. The license sought can be exclusive or non-exclusive, at Sponsor's option. Any such license will include reasonable terms, to be negotiated in good faith. (f) Option Term. Sponsor's option will remain in effect for a period of 12 months from the date CCF discloses the CCF Invention to Sponsor in writing. 14.7 Joint Technology. Subject to Section 14 all expenses incurred to obtain and maintain patents on Joint Technology defined as an invention or discovery whether patentable or not, that is mutually agreed upon by Sponsor and CCF to be owned by Sponsor and CCF, shall be divided equally between the parties and title to all such patents shall be jointly held. Subject to Section 14.8, each party shall have the right to license, with rights to sublicense, jointly owned patents to third parties, with the consent of, the other party. 14.8 License to Joint Technology. Sponsor shall have the Option and Right to exclusively license CCF's rights in Joint Technology in a Field of Use. 14.9 Patent Filing and Expenses. (a) Control Over Filings. CCF shall control the preparation and prosecution of all patent applications and the maintenance of all patents related to CCF Inventions. Sponsor shall control the preparation and prosecution of all patent applications and the maintenance of all patents related to Sponsor Inventions and Joint Technology. (b) Costs and Expenses. CCF may file patent applications covering CCF Technology at its own discretion and expense, or at the request of Sponsor at Sponsor's expense provided an agreement to license CCF technology to Sponsor can be reached pursuant to Section 14.6(d) - 14.6(f). 15. PUBLICATION OF RESULTS 15.1 Sponsor recognizes and accepts the importance of communicating medical study and scientific data and the necessity of conveying such information in a timely manner, and, therefore, encourages their publication in reputable scientific journals and at seminars or conferences. Sponsor further recognizes and accepts that under CCF's mission as an academic medical center, CCF and its investigators must have a meaningful right to publish research results without Sponsor's approval or editorial control, regardless of the Study's outcome. CCF shall submit to Sponsor for its review a copy of any proposed manuscript, paper, or poster resulting from the research thirty (30) days prior to the estimated date of submission for publication. If any proprietary Information is identified by Sponsor in good faith but according 10

to Sponsor's sole discretion, as being in the manuscript, paper, or poster, CCF warrants that the proprietary information will be deleted at Sponsor's request. Additionally, if Sponsor reasonably determines that the proposed publication contains patentable subject matter which requires protection, Sponsor may require the delay of publication for a period of time not to exceed sixty (60) days for the purpose of filing patent applications. If no written response is received from Sponsor within the applicable review period, it may be conclusively presumed that publication may proceed without delay. 15.2 Any proposed publications which are to make public any findings, data, or results of the Study shall be submitted to Sponsor for Sponsor's review and comment at least thirty (30) days prior to submission of a manuscript for publication, or at least seven (7) days prior to submission for an abstract. If any proprietary Information is identified by Sponsor in good faith but according to Sponsor's sole discretion, as being in the proposed publication, CCF warrants that the proprietary information will be deleted at Sponsors request. Additionally, if Sponsor reasonably determines that the proposed publication contains patentable subject matters which requires protection, Sponsor may require the delay of publication for a period of time not to exceed sixty (60) days for the purpose of filing patent applications. If no written response is received from Sponsor within the applicable review period, it may be conclusively presumed that publication may proceed without delay. 15.3 Notwithstanding the foregoing, if a particular Study is a part of a multi-center study, CCF agrees that the first publication of the results of such Study shall be made in conjunction with the presentation of a joint, multicenter publication by all appropriate sites. However, if such a multi-center publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study, or after Sponsor confirms there will be no multi-center Study publication, CCF and/or the Principal Investigator may proceed to publish the Study results in accordance with the above procedure. CCF and/or the Principal Investigator may thereafter publish either their own results or the combined results of all participating sites in accordance with the procedures above. 15.4 The above procedure does not apply to information on prematurely discontinued and other non-completed studies unless Sponsor has provided written consent for such use. 16. REPRESENTATIONS AND WARRANTIES 16.1 CCF hereby represents and warrants that: (a) It is under no obligation to any third party, and will not during the term of this Agreement agree to assume any obligation to any third party, that would conflict with, prohibit or otherwise interfere with its performance of its obligations under this Agreement; 11

(b) it has no financial interests and/or arrangements with Sponsor that will require disclosure to FDA in accordance with 21 CFR Part 54; (c) it has not been debarred under 21 U.S.C. Section 335(a) or 335(b), and will not use the services of any persons debarred under 21 U.S.C. Section 335(a) or 335(b) in any capacity in connection with the performance of its obligations under this Agreement; (d) neither CCF nor any CCF official or employee has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug, product, medical device, NDA, abbreviated NDA, PMA or IND; and (e) no CCF official or employee has been convicted of a felony under United States law for conduct otherwise relating to the regulation of any drug product or medical device under the FD&C Act. 16.2 Sponsor hereby represents and warrants that: (a) It is under no obligation to any third party that would interfere with its performance of its obligations under this Agreement; (b) It has not been debarred, excluded, suspended or otherwise determined to be ineligible to participate in any federal health care reimbursement programs, including the medicare and medicaid programs. 17. INDEMNIFICATION Each party (the "Indemnifying Party") shall indemnify, defend, and hold harmless the other party (the "Indemnified Party(degree)), its directors, shareholders, students, employees, trustees, officers, affiliates, and agents from and against any and all third-party claims, suits, actions, investigations, proceedings and related costs and expenses, all damages, costs, penalties, and expenses, including reasonable attorneys' fees, which may be sustained or incurred by the Indemnified Party at any time that are primarily attributable to the negligence or misconduct of the Indemnifying Party, including without limitation, breach of this Agreement or violation of federal, state, or local statutes, laws, or regulations. If either party wishes to make a claim for indemnity, such party shall provide written notice thereof to the other party. The Indemnifying Party and the Indemnified Party shall each have the right to select counsel of their own choosing at their own expense to represent them in any action resulting from a claim or suit for which indemnification is sought. The Indemnifying Party and the Indemnified Party hereby agree to cooperate fully in the resolution of any such claim or suit. The obligations created under this provision shall survive the termination of this Agreement. 18. SUBJECT INJURY Sponsor shall not be required to provide reimbursement to CCF to the extent that a Subject's injuries (1) are otherwise covered by the Subject's medical or hospital insurance coverage or other third party payment, and (2) are not primarily attributable to (i) a significant departure from the Study Protocol without good cause, (ii) the gross negligence, willful misconduct, or medical 12

malpractice of the CCF, the Principal Investigator, or any of the CCF's students, employees, trustees, officers, affiliates, or agents, (iii) the failure of the affected Subject to follow specific instructions, or (iv) a lack of effectiveness or therapeutic benefit of the Study Drug. Further, Sponsor shall not be required to reimburse the CCF for any claims of temporary pain or discomfort on the part of a Subject or for any treatment related to the natural progression of a Subject's pre-existing condition. 19. NOTICES All notices, requests, consents and other communications under this Agreement shall be in writing and shall be delivered by hand or mailed by first class, certified or registered mail, return receipt requested, postage prepaid, as follows (or to such other address as a Party hereto may notify the other in writing): In the case of Sponsor, addressed to: Ivivi Technologies, Inc. Attn: Chief Science Officer 224-S Pegasus Avenue Northvale, NJ 07647 when of a clinical nature or otherwise related to the Study, directed to the attention of: Ivivi Technologies, Inc. Attn: President 224-S Pegasus Avenue Northvale, NJ 07647 In the case of CCF, addressed to: when of a clinical nature or otherwise related to the Study, directed to the attention of the Investigator of such Study. 20. TERM AND TERMINATION 20.1 This Agreement shall become effective as of the Effective Date, and shall remain in force until the third (3rd) anniversary of the Effective Date and may be extended by mutual written agreement of the parties, unless and until terminated as set forth in Section 6.6, Section 20.2, or by written agreement of the Parties. Upon such termination, all currently on-going Studies shall terminate with the effect set forth in Section 6.6. 20.2 Either Party may terminate this Agreement if the other Party materially breaches this Agreement and such breaching Party fails to cure such breach within thirty (30) days from the receipt of written notice from the nonbreaching Party of such material breach. However, Sponsor may at any time terminate this Agreement in accordance with Section 6.6. 13

20.3 The following provisions shall survive termination of this Agreement: Sections 6.6, 9.3, and Articles 12, 14, 15, 17, and 18. Termination of this Agreement shall not relieve either Party of any liability which accrued hereunder prior to the effective date of such termination, nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement, nor prejudice either Party's right to obtain performance of any obligation. The remedies provided under this Agreement are cumulative, and are not exclusive of other remedies available to a Party in law or equity. 20.4 Upon receipt of notice of termination, Principal Investigator agrees to promptly terminate conduct of the Study to the extent medically permissible for any patients. In the event of termination hereunder, Sponsor, CCF and Principal Investigator will promptly enter into good faith discussions concerning an amount appropriate for those services performed in accordance with the Protocol for actual work performed through the date of termination, with any unexpected funds previously paid by Sponsor to CCF being refunded to Sponsor. 21. MISCELLANEOUS PROVISIONS 21.1 CCF shall not assign, subcontract or otherwise transfer any of its rights or obligations hereunder, or any part hereof, without the prior written consent of Sponsor. Any such assignment or transfer made without Sponsor' prior written consent shall be null and void. 21.2 CCF shall, at all times, be an independent contractor, not an agent of Sponsor, and shall have no actual, apparent or implied authority to act or make representations for, or on behalf of, or to bind or commit Sponsor in any manner or to any obligation whatsoever. 21.3 Except as may be required by law, each Party will obtain prior written permission from the other Party before using the name, symbols and/or marks of such other Party, or such Party's employees or agents, in any form of publicity. 21.4 Paragraph and section headings are included for convenience of reference only and form no part of the agreement between the parties. 21.5 Any delay in enforcing a Party's rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party's rights to the future enforcement of its rights under this Agreement, excepting only as to an express written and signed waiver as to a particular matter for a particular period of time. 21.6 If any provision of this Agreement is or becomes or is deemed to be invalid, illegal, or unenforceable in any jurisdiction, then such provision will be deemed amended to conform to applicable laws of such jurisdiction so as to be valid and enforceable. If such provision cannot be so amended without materially altering the intention of the Parties, then it will be stricken. The validity, legality and 14

enforceability of such provision will not in any way be affected or impaired thereby in any other jurisdiction, and the remainder of this Agreement will remain in full force and effect. 21.7 This Agreement, and any Work Orders executed in connection herewith, set forth the complete, final and exclusive agreement between the Parties with respect to the subject matter hereof, and all of the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to such subject matter, and supersedes and terminates all prior agreements and understandings between the parties with respect to such subject matter. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties with respect to such subject matter other than as are set forth herein and therein. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party. 21.8 By entering into this Agreement, the parties specifically intend to comply with all applicable laws, rules and regulations, including (i) the federal anti-kickback statute (42 U.S.C. 1320a-7(b)) and the related safe harbor regulations; and (ii) the Limitation on Certain Physician Referrals, also referred to as the "Stark Law" (42 U.S.C. 1395nn). Accordingly, no part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business or the ordering of items or services; nor are the payments intended to induce illegal referrals of business. In the event that any part of this Agreement is determined to violate federal, state, or local laws, rules, or regulations, the parties agree to negotiate in good faith revisions to the provision or provisions that are in violation. In the event the parties are unable to agree to new or modified terms as required to bring the entire Agreement into compliance, either party may terminate this Agreement on sixty (60) days written notice to the other party. 21.9 This Agreement and any Work Orders executed in connection herewith shall be governed by and construed in accordance with the laws of the State of New Jersey irrespective of any conflicts of law principles. IN WITNESS THEREOF, the parties have executed this Agreement as of the Effective Date.
SPONSOR CLEVELAND CLINIC FLORIDA

By: /s/ Andre' DiMino --------------------------------Print Name: Andre' DiMino ------------------------Title: Chairman -----------------------------Date: -------------------------------

By: /s/ Scott Campbell -----------------------------------Print Name: Scott Campbell ---------------------------Title: Chief Financial Officer --------------------------------Date: ----------------------------------

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EXHIBIT A FORM OF WORK ORDER WORK ORDER # 001 This Work Order is issued pursuant to the Master Clinical Studies Agreement, dated as of ______________ between IVIVI Technologies, Inc., ("Sponsor") and The Cleveland Clinic Foundation (the "Agreement"). Any capitalized terms not otherwise defined herein shall have the same meaning ascribed to them in the Agreement. PROTOCOL TITLE AND NUMBER: Use of Pulsed Electromagnetic Fields For Ischemic Cardiomyopathy Therapy: A Randomized, Double-Blind, Parallel, Placebo-Controlled, Prospective Trial (EFFECT TRIAL) (the "Study"). A copy of the Protocol is attached hereto as Schedule 1 and incorporated herein by this reference. PRINCIPAL INVESTIGATORS) NAME: Micheal Shen, MD, MS, FACC ("Investigator(s)") Correspondence to Investigator can be addressed to the following: Cleveland Clinic Florida 2950 Cleveland Clinic Blvd. Weston, FL 33331 Phone: 954-659-500 Facsimile: 954-659-5291 E-mail: chenm@cf.org A copy of the Investigator's Certification is attached hereto as Schedule 2, and is incorporated herein by this reference. SPONSOR' CLINICAL LEADER: Correspondence to Sponsor' Clinical Leader can be addressed to the following:

Phone: Facsimile: E-mail: 16

STUDY SCHEDULE: 1. Study Initiation and Completion. (a) All contractual and regulatory documentation must be completed, executed and received by Sponsor no later than _____________________ (b) The Study shall be initiated no later than _____________ ("Initiation Date") and shall be completed no later than. ("Completion Date"). 2. Enrollment. (a) It is anticipated that the Principal Investigator(s) may enroll 40 patients into the Study (the "Site Maximum"). Patient enrollment shall be completed on or before _______________. Enrollment of each patient over the Site Maximum requires the agreement of Sponsor. (b) Notwithstanding whether the Site Maximum has been reached, the Investigator(s) agrees to immediately cease enrolling patients upon notice from Sponsor that Sponsor' target enrollment for the Study has been achieved. STUDY BUDGET, PAYMENT RECIPIENT AND MAILING ADDRESS (NOTE: Specific Payment terms may vary dependent upon the nature of the Study and the work being performed under the Protocol.) This Work Order is entered into and made effective as of ______________________.
ACCEPTED AND AGREED TO BY: SPONSOR ------------------------------------Signature THE CLEVELAND CLINIC FLORIDA ---------------------------------------Signature

------------------------------------Typed Name and Title Date: --------------------------------

---------------------------------------Typed Name and Title Date: -----------------------------------

17

Exhibit 10.17 STOCK OPTION AGREEMENT This Stock Option Agreement (this "Agreement") is made as of the 16th day of June 2006, by and between Ivivi Technologies, Inc., a New Jersey corporation (the "Corporation"), and Steven M. Gluckstern (the "Optionee"). WITNESSETH: WHEREAS, the Optionee has agreed to serve as the Chairman of the Board of Directors of the Corporation (the "Board"), effective as of the date (the "Effective Date") the Corporation's Registration Statement on Form SB-2 (Registration No. 333-122768) (the "Registration Statement") relating to the initial public offering (the "IPO") of the Corporation's common stock, no par value per share (the "Common Stock"), is declared effective by the Securities and Exchange Commission; WHEREAS, the Corporation intends to effect a stock split of 1.625 shares for each outstanding share of Common Stock simultaneously with the effectiveness of the Registration Statement (the "Stock Split"); and WHEREAS, the Board has approved the grant to the Optionee of an option to purchase up to 775,000 shares of the Common Stock (after giving effect to the Stock Split), subject to the terms and conditions of this Agreement. NOW, THEREFORE, in consideration of the foregoing and the mutual agreements herein contained, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, agree as follows: 1. Grant of Option. The Corporation hereby grants the Optionee an option (the "Option") to purchase from the Corporation an aggregate of up to 775,000 shares of Common Stock (after giving effect to the Stock Split) (collectively, the "Option Shares"), in the manner and subject to the terms and conditions provided in this Agreement. The Option is a non-statutory stock option and is not intended to qualify as an incentive stock option under Section 422 of the Internal Revenue Code of 1986, as amended, and the regulations thereunder. For the avoidance of doubt, the Option is not being issued under the Ivivi Technologies, Inc. 2004 Amended and Restated Stock Option Plan. 2. Exercise Price. The per share exercise price of the Option (the "Option Price") shall be $5.11 (after giving effect to the Stock Split). 3. Exercise of Option. (a) Subject to such further limitations as are provided in this Agreement, the Option may be exercised during the Option Term (as defined below) as follows: (i) from and after the earlier to occur of the consummation of the IPO (the "IPO Closing") and the consummation of a Qualified Offering (as defined below), provided that in each case the Optionee is then serving as Chairman of the Board (the "Vesting Date"), until the first anniversary of the Vesting Date, the Option may be exercised as to 258,334 of the Option Shares;

(ii) from and after the first anniversary of the Vesting Date until the second anniversary of the Vesting Date, the Option may be exercised as to 516,667 of the Option Shares; and (iii) from and after the second anniversary of the Vesting Date, the Option may be exercised as to all of the Option Shares; provided, however, if at any time during the period from the Vesting Date until the second anniversary of the Vesting Date (the "Vesting Period"): (i) the Optionee ceases to serve as Chairman of the Board due to his death or Disability (as defined below) or due to a termination without Cause (as defined below), the Option shall immediately become exercisable as to all of the Option Shares; or (ii) there is a Change of Control (as defined below) and the Optionee is then serving as the Chairman of the Board, the Option shall become exercisable as to all of the Option Shares immediately prior to the consummation of the Change of Control (the "Change of Control Vesting Date"). (b) For purposes of this Agreement, the following terms shall have the following meanings: (i) "Cause" means the Optionee's (i) conviction of, plea of guilty or nolo contendre to, or confession of guilt of, a felony or criminal act involving moral turpitude, (ii) commission of a fraudulent, illegal or dishonest act in respect of the Corporation or any of its affiliates or subsidiaries, (iii) willful misconduct or gross negligence that reasonably could be expected to be injurious in the reasonable discretion of the Board to the business, operations or reputation of the Corporation or any of its affiliates or subsidiaries (monetarily or otherwise), (iv) material violation of the Corporation's policies or procedures in effect from time to time, (v) continued failure to perform the Optionee's duties as Chairman of the Board after a written warning and a period of 20 days immediately thereafter to cure such non-performance or (vi) resignation from his position as Chairman of the Board. (ii) "Change of Control" means: (A) any "person" (as such term is used in Section 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the "Exchange Act")) becomes the "beneficial owner"(as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of the Corporation representing more than 50% of the total voting power represented by the Corporation's then outstanding voting securities; provided, however, the consummation of the IPO or a Qualified Offering and/or the exercise or conversion, as the case may be, of any options, warrants, convertible notes or other instruments issued by the Company as of the IPO Closing shall not be deemed a Change of Control; (B) the consummation of a merger or consolidation of the Corporation with any other entity, other than a merger or consolidation which would result in the voting securities of the Corporation outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity) at least 50% of the total voting power represented by the voting securities of the Corporation or such surviving entity outstanding immediately after such merger or consolidation; or (C) the consummation of the sale or disposition by the Corporation of all or substantially all of the Corporation's assets. 2

(iii) "Disability" means a mental or physical impairment of the Optionee that is expected to result in death or that has lasted or is expected to last for a period of at least 120 consecutive days in any 12-month period or 150 non-consecutive days in any 12-month period and that causes the Optionee to be unable to perform his duties as Chairman of the Board, as determined in the sole discretion of the other members of the Board. (iv) "Qualified Offering" means an offering of the Corporation's securities, whether in a private or public offering, in which the Corporation raises gross proceeds of at least $5,000,000. 4. Termination of Option. (a) The term of the Option (the "Option Term") shall be for a period of ten (10) years from the Vesting Date, subject to earlier termination as hereinafter provided. To the extent not exercised prior to the expiration of the Option Term, the Option shall automatically terminate and be canceled upon the expiration of the Option Term. Except to the extent provided in paragraphs (b) and (c) below, upon the cessation of the Optionee's service as Chairman of the Board for any reason, the Option, whether or not exercisable to any extent and to the extent not previously exercised, shall automatically terminate and be canceled. (b) If after the Vesting Date the Optionee ceases to be Chairman of the Board due to his death or Disability, the Option may thereafter be immediately exercised by the legal representative of the estate or the legatee of the Optionee under the will of the Optionee or the Optionee, as the case may be, for a period of one year from the date of such cessation until the expiration of the Option Term, whichever period is shorter. If after the Vesting Date the Optionee ceases to be Chairman of the Board due to a termination without Cause, the Option may thereafter be immediately exercised by the Optionee from the date of such cessation until the expiration of the Option Term. (c) If after the Vesting Date there is a Change of Control and the Optionee is then serving as the Chairman of the Board, the Option may be immediately exercised by the Optionee from and after the Change of Control Vesting Date until a date following the Change of Control Vesting Date specified by the Board (the "Change of Control Vesting Expiration Date"). 5. Non-Transferability. The Option shall not be transferable otherwise than by will or the laws of descent and distribution, in which case the transferee must agree as a condition precedent to such transfer to be bound by the terms hereof to the same extent that the Optionee is so bound, and the Option may be exercised, during the lifetime of the Optionee, only by the Optionee. In furtherance but without limiting the generality of the foregoing, the Option may not be assigned, transferred (except as provided above), pledged or hypothecated in any way, nor shall it be assignable by operation of law or subject to execution, attachment or similar process. Any attempted assignment, transfer, pledge, hypothecation, or other disposition of the Option contrary to the provisions hereof, and the levy of any execution, attachment, or similar process upon the Option, shall be null and void and without effect. 6. Restrictions on Disposition. The Optionee hereby acknowledges that none of the Option Shares are registered under the Securities Act of 1933, as amended (the "Securities Act"), and the Corporation shall not be required to so register any of the Option Shares. The Option Shares acquired by the Optionee pursuant to this Agreement shall be subject to the restrictions on sale, encumbrance and other disposition provided by Federal or State law, including, without limitation Rule 144 of the Securities Act. As a condition precedent to receiving Option Shares upon the exercise of this Option, the Corporation may require that the Optionee submit a letter to the Corporation stating that (i) the Optionee is an "accredited investor," as such term is defined in Rule 501 of Regulation D promulgated under the 3

Securities Act, and (ii) the Option Shares are being acquired for investment and not with a view to the distribution thereof. The Corporation shall not be obligated to sell or issue any shares of Common Stock pursuant to this Agreement unless, on the date of sale and issuance thereof, the Option Shares are either registered under the Securities Act, and all applicable state securities laws, or are exempt from registration thereunder. All Option Shares issued to the Optionee pursuant to this Agreement may bear a restrictive legend summarizing any restrictions on transferability applicable thereto, including those imposed by Federal and state securities laws. 7. Not a Contract of Service. Nothing in this Option Agreement shall confer upon the Optionee any right to serve, or continue to serve, as Chairman of the Board or interfere in any way with the right of the Corporation to terminate the services of the Optionee at any time. 8. Method of Exercise. Subject to the terms and conditions of this Agreement, the Option may be exercised, in whole or in part, by written notice, together with payment in full of the Option Price for the shares of Common Stock to be purchased, to the Chief Financial Officer of the Corporation at the principal office of the Corporation. Such notice shall state the number of shares of Common Stock for which the Option is exercised. The date of such exercise shall be the date on which the Corporation receives such notice and payment. The Option Price for any shares purchased upon the exercise of the Option or any portion thereof shall be payable in cash or by check made payable to the order of the Corporation. The Option may not be exercised for a fraction of a share of Common Stock. 9. Withholding Requirements. Upon exercise of the Option by the Optionee and prior to the delivery of shares purchased pursuant to such exercise, the Corporation shall have the right to require the Optionee to remit to the Corporation cash in an amount sufficient to satisfy applicable Federal and state tax withholding requirements. The Corporation shall inform the Optionee as to whether it will require the Optionee to remit cash for withholding taxes in accordance with the preceding sentence within two (2) business days after receiving from the Optionee written notice that such Optionee intends to exercise all or a portion of the Option in accordance with Section 8. 10. No Rights as a Stockholder. Neither the Optionee nor the Optionee's executor, administrator, heirs or legatees shall have any rights as a stockholder or any claim to dividends with respect to any shares of Common Stock until the proper exercise of the Option as required hereby, the payment of the purchase price for the applicable number of shares of Common Stock and the issuance by the Corporation of a stock certificate representing such shares of Common Stock so purchased upon exercise. 11. Adjustment in Case of Stock Splits, Stock Dividends, Etc. (a) The number of shares, class of stock of the Corporation and Option Price covered by this Option shall be adjusted by the Board or a proper committee thereof, whose good faith determination with respect thereto shall be conclusive, to reflect any stock dividend, common stock split, share combination, exchange of shares, merger, consolidation, recapitalization, separation, reorganization, liquidation or extraordinary dividend payable in stock of a corporation other than the Corporation, all for the purpose of providing dilution protection for the Common Stock, such that the Optionee shall be entitled to purchase the number of shares which the Optionee would have been entitled to receive immediately following such event had this Option been exercised in full immediately prior to such event. (b) The parties hereto hereby acknowledge and agree that the number of shares of Common Stock and Option Price covered by the Option give effect to the Stock Split, and if the Stock Split is not effected prior to the Vesting Date, such number of shares of Common Stock and Option Price shall be adjusted in accordance with Section 11(a) to reflect that the Stock Split was not effected, such 4

that the Optionee shall be entitled to purchase the number of shares which the Optionee would have been entitled to receive without giving effect to the Stock Split. 12. Corporation Authority. The existence of the Option herein granted shall not affect in any way the right or power of the Corporation or its shareholders to make or authorize any adjustments, recapitalizations, reorganizations or other changes in the Corporation's capital structure or business, any merger or consolidation of the Corporation, any issue of bonds, debentures, preferred or prior preference stock ahead of or affecting the Common Stock or the rights thereof, the dissolution or liquidation of the Corporation, or any sale or transfer of all or any part of the Corporation's assets or business, or any other corporate act or proceeding, whether of a similar character or otherwise. 13. Reservation of Shares. The Corporation shall at all times during the Option Term reserve and keep available such number of shares of Common Stock as will be sufficient to satisfy the requirements of this Agreement. 14. Termination. Notwithstanding anything contained herein to the contrary, if the Vesting Date does not occur by June __, 2007, this Agreement shall automatically terminate and the Option shall automatically terminate and be canceled. 15. Miscellaneous Provisions. (a) Additional Documents. The Optionee hereby agrees to execute and deliver such further documents and instruments as may be necessary or as may reasonably be requested in order to effectuate fully the purposes, terms and conditions of this Agreement, whether before, at or after the exercise of the Option. (b) Notices. All notices, demands, requests, or other communications that may be or are required to be given, served, or sent by a party pursuant to this Agreement shall be in writing and shall be (i) personally delivered, (ii) mailed by first-class, registered or certified mail, return receipt requested, postage prepaid or (iii) sent by overnight delivery carrier, addressed as follows:
If to the Corporation: Ivivi Technologies, Inc. 224-S Pegasus Avenue Northvale, NJ 07647 Attention: Chief Financial Officer Steven M. Gluckstern c/o The Ajax Group of Companies 44 Laight St. #1A New York, NY 10013

If to the Optionee:

Each party may designate by notice in writing, in the manner described above, a new address to which any notice, demand, request, or communication required or permitted by this Agreement may be sent. Any notice, demand, request, or communication that shall be delivered, mailed or transmitted in the manner described above shall be deemed given, served, sent or received for all purposes when it is delivered to the addressee. An affidavit of personal delivery, the return receipt, or the delivery receipt shall be deemed conclusive, but not exclusive, evidence of such delivery or when delivery is refused by the addressee upon presentation. (c) Severability. The invalidity of any one or more provisions hereof or of any other agreement or instrument given pursuant to or in connection with this Agreement shall not affect the 5

remaining portions of this Agreement or any such other agreement or instrument or any part thereof; and if one or more of the provisions contained herein or therein should be invalid, or should operate to render this Agreement or any such other agreement or instrument invalid, this Agreement and such other agreements and instruments shall be construed as if such invalid provisions had not been inserted. (d) Survival. Subject to the immediately preceding sentence, it is the express intention and agreement of the parties hereof that all covenants and agreements made in this Agreement shall survive the execution and delivery of this Agreement and the exercise (if any) of the Option. (e) Waivers. Neither the waiver by a party of a breach of or a default under any of the provisions of this Agreement, nor the failure of a party, on one or more occasions, to enforce any of the provisions of this Agreement or to exercise any right, remedy, or privilege hereunder shall thereafter be construed as a waiver of any subsequent breach or default of a similar nature, or as a waiver of any such provisions, rights, remedies, or privileges hereunder. (f) Binding Effect. Subject to any provisions hereof restricting transfer, encumbrance and assignment, this Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective heirs, personal representatives, successors, and assigns. (g) Limitation on the Benefit of this Agreement. It is the explicit intention of the parties hereto that no person or entity other than the parties hereof is or shall be entitled to bring any action to enforce any provisions of this Agreement against any parties hereto, and that the covenants, undertakings, and agreements set forth in the Agreement shall be solely for the benefit of, and shall be enforceable only by, the parties hereto and their respective heirs, personal representatives, successors and permitted assigns as permitted hereunder. (h) Entire Agreement. This Agreement contains the entire agreement among the parties with respect to subject matter hereof, and supersedes all prior oral or written agreements, commitments, or understandings with respect to the matters provided for herein and therein. (i) Headings. Article, section and subsection headings contained in this Agreement are inserted for convenience of reference only, shall not be deemed to be part of this Agreement for any purpose, and shall not in any way define or affect the meaning, construction or scope of any of the provisions hereof. (j) Governing Law. This Agreement shall be construed, and legal relations between the parties hereto shall be determined, in accordance with the laws of the State of New Jersey applicable to contracts solely executed and wholly to be performed within the State of New Jersey without giving effect to the principles of conflicts of laws. (k) Counsel. THE OPTIONEE REPRESENTS THAT HE AND/OR HIS OTHER PROFESSIONAL ADVISORS HAVE HAD THE OPPORTUNITY TO REVIEW THIS AGREEMENT. [Remainder of Page Intentionally Left Blank] 6

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first written above. IVIVI TECHNOLOGIES, INC.
By: /s/ David Saloff -----------------------------------Name: David Saloff Title: President and Chief Executive Officer

OPTIONEE
/s/ Steven M. Gluckstern ---------------------------------------Name: Steven M. Gluckstern

7

Exhibit 10.18 SHARE PURCHASE RIGHT AGREEMENT This SHARE PURCHASE RIGHT AGREEMENT, is effective as of the 8th day of November, 2005 (the "Effective Date"), among Steven Gluckstern ("Mr. Gluckstern") and the shareholders (collectively, the "Shareholders") of Ivivi Technologies, Inc., a New Jersey corporation (the "Company"), set forth on Exhibit A hereto. WITNESSETH: WHEREAS, the Shareholders are the record owners of shares of common stock, no par value, of the Company (the "Common Stock"); and WHEREAS, the Shareholders believe it to be in the best interests of the Company and the Shareholders that Mr. Gluckstern have the right to purchase the number of shares of Common Stock owned of record by the Shareholders set forth under the heading "Purchasable Shares" on Exhibit A hereto (collectively, the "Purchasable Shares") pursuant to the terms and conditions of this Agreement. NOW, THEREFORE, in consideration of the mutual covenants contained herein, and intending to be legally bound, the parties hereto agree as follows: ARTICLE I GRANT OF RIGHT; EXERCISE OF RIGHT Section 1.1. Grant of Right. Subject to the terms and conditions of this Agreement, each Shareholder hereby grants Mr. Gluckstern the right (each, a "Right") to purchase up to the number of Purchasable Shares of such Shareholder set forth on Exhibit A hereto at any time and from time to time during the period commencing on the Effective Date and terminating at 5:00 P.M. on November 7, 2010 (the "Expiration Date"),. Section 1.2. Exercise Price. The exercise price (the "Exercise Price") of each Purchasable Share shall be equal to the lesser of (i) initial public offering price (the "IPO Price") of the Common Stock in the initial public offering (an "IPO") and (ii) $8.30 (subject to adjustment for any recapitalization, stock-split or other similar event); provided, however, that if an IPO is not consummated on or before the six-month anniversary of the Effective Date, the Exercise Price of each Purchasable Share shall be $7.00 and shall be decreased by $.50 each month after the six-month anniversary of the Effective Date until the earlier to occur of (i) the twelve-month anniversary of the Effective Date and (ii) the date a registration statement with respect to an IPO is declared effective by the Securities and Exchange Commission. Notwithstanding the foregoing, in no event shall the Exercise Price be less than $1.00 per share. Section 1.3. Method of Exercise. (a) In the event Mr. Gluckstern desires to exercise all or any portion of the Rights, Mr. Gluckstern shall deliver an exercise notice (the "Exercise Notice") to each Shareholder in the manner provided by Section 5.6. The Exercise Notice, which shall be signed by Mr. Gluckstern, shall state Mr. Gluckstern's election to exercise all or any portion of the Rights and the number of Purchasable Shares in respect of which the Rights are being exercised. The number of Purchasable Shares to be purchased by Mr. Gluckstern upon exercise of all or any portion of the Rights of the Shareholders shall be allocated among such Shareholders pro rata in accordance

with such Shareholders' respective Proportionate Share or in such other proportions as are mutually agreed to in writing by such Shareholders. For purposes of this Agreement, the term "Proportionate Share" means, with respect to a Shareholder, a fraction, the numerator of which is the total number of Purchasable Shares of such Shareholder (excluding any and all Purchasable Shares previously sold upon the exercise of any Right in accordance with this Agreement), and the denominator of which is the total number of Purchasable Shares of all of the Shareholders (excluding any and all Purchasable Shares previously sold upon the exercise of any Right in accordance with this Agreement). (b) Each closing (the "Closing") of the purchase of the Purchasable Shares upon exercise of Rights by Mr. Gluckstern in accordance with this Section 1.3 shall take place on such date, not later than ten (10) business days following the delivery of the Exercise Notice to all of the Shareholders or as otherwise may be agreed to by Mr. Gluckstern and the Shareholders. The Closing shall be held at the principal office of the Company, or at such location as may otherwise be agreed to by Mr. Gluckstern and the Shareholders. At the Closing: (i) the Shareholders shall deliver to Mr. Gluckstern certificates representing the Purchasable Shares then being sold, together with fully executed stock powers; (ii) Mr. Gluckstern shall pay in full to each Shareholder, the Exercise Price (as of the date of the Exercise Notice) for each Purchasable Share being sold by such Shareholder in accordance with the provisions of this Article III in immediately available funds by check or wire transfer of funds to an account designated by such Shareholder at or prior to the Closing; and (iii) each of Mr. Gluckstern and the Shareholders shall execute such other documents and take such other action as reasonably shall be necessary for the purpose of carrying out the terms and conditions and reflecting the intention of and transactions contemplated by this Agreement. (c) Mr. Gluckstern hereby acknowledges that the Purchasable Shares of each Shareholder are subject to a lockup agreement between Maxim Group, LLC. ("Maxim") and that such Purchasable Shares shall remain subject to such lock-up agreement following the purchase by Mr. Gluckstern; provided, that the lock-up period provided under such lock-up agreement shall be no longer than the shortest period for which any officer or director of the Company is prohibited from selling, contracting to sell or otherwise disposing of any his or her shares of Common Stock or other securities of the Company pursuant to a Maxim lock-up agreement immediately following the consummation of the initial public offering of shares of Common Stock. Section 1.4. Transfer of Rights. Mr. Gluckstern may not transfer, sell, assign, pledge, hypothecate give, create a security interest in or lien on, place in trust (voting or otherwise), transfer by operation of law, grant a proxy with respect to or in any other way encumber or dispose of, directly or indirectly, whether or not voluntarily (each, a "Transfer") any of the Rights other than to a trust or other entity designed as an element of Mr. Gluckstern's estate planning objectives; provided, that in the event of any such Transfer, the Rights so Transferred shall remain subject to this Agreement and prior to any such Transfer, the transferee (each, a "Transferee") of such Rights shall execute an instrument agreeing to be bound by all of the terms and provisions of this Agreement. In furtherance of the foregoing, and not in limitation thereof, by taking and holding any such Rights, the Transferee thereof shall be deemed to have agreed to be bound by and to comply with all of the terms and provisions of this Agreement. The terms of this Agreement shall be binding upon the executors, administrators, heirs, successors and assigns of Mr. Gluckstern.

ARTICLE II TRANSFER RESTRICTIONS During the term of this Agreement, no Shareholder shall Transfer any of the Purchasable Shares other than to a trust or other entity designed as an element of such Shareholder's estate planning objectives; provided, that in the event of any such Transfer, the Purchasable Shares so Transferred shall remain subject to this Agreement and prior to any such Transfer, the Transferee shall execute an instrument agreeing to be bound by all of the terms and provisions of this Agreement. In furtherance of the foregoing, and not in limitation thereof, by taking and holding any such Purchasable Shares, the Transferee thereof shall be deemed to have agreed to be bound by and to comply with all of the terms and provisions of this Agreement. The terms of this Agreement shall be binding upon the executors, administrators, heirs, successors and assigns of each of the Shareholders. ARTICLE III REPRESENTATIONS AND WARRANTIES The Shareholders, severally but not jointly, hereby make the following representations and warranties to Mr. Gluckstern, Mr. Gluckstern's successors and assigns, and acknowledges and confirms that Mr. Gluckstern is relying upon such representations and warranties in connection with the execution, delivery and performance of this Agreement and the transactions contemplated hereby, notwithstanding any investigation made by Mr. Gluckstern or on Mr. Gluckstern's behalf: Section 3.1. Authorized and Issued Shares. Each of the Shareholders is the sole and exclusive owner of the Purchasable Shares held by such Shareholder. All Purchasable Shares of the Shareholders have been properly issued by the Company and are fully paid and non-assessable. Except for the Voting Agreement dated as of January 5, 2004 among the Company, the Shareholders and Fifth Avenue Capital Partners (the "Voting Agreement"), there are no outstanding subscriptions, warrants, options, agreements or other commitments or contractual rights pursuant to which any of the Purchasable Shares are subject. Each of the Shareholders hereby acknowledges and agrees that none of the Purchasable Shares shall be subject to the Voting Agreement upon any Transfer thereof in accordance with the terms and conditions of this Agreement. Section 3.2. Authority to Sell. Each of the Shareholders has, and throughout the term of this Agreement will have, the full right, power and authority to sell, transfer, convey and deliver to Mr. Gluckstern the Purchasable Shares agreed to be sold, transferred, conveyed and delivered by the Shareholders hereunder, free and clear of any statutory, contractual or other limitation of any kind, type or nature whatsoever, and the Purchasable Shares are not, nor will they be at any time during the term of this Agreement, subject to any lien, pledge, hypothecation or any encumbrance or interest of any third party whatsoever (each, an "Encumbrance"), except as may be expressly provided herein. The sale provided for herein will vest in Mr. Gluckstern all right, title and interest in and to the Purchasable Shares, free and clear of any and all Encumbrances, other than any Encumbrances resulting from actions taken or failed to be taken by Mr. Gluckstern. In addition, Mr. Gluckstern acknowledges that upon the sale of the Purchasable Shares to him, such Purchasable Shares will be subject to restrictions under the Securities Act of 1933, as amended, and state securities laws.

Section 3.3. Enforceability. Each of the Shareholders represents that (i) this Agreement constitutes a legally valid and binding agreement, enforceable against each Shareholder in accordance with its terms, subject to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws of general applicability relating to or affecting creditors' rights and to general equity principles; and (ii) the execution and delivery by each of the Shareholders of this Agreement does not, and the performance by each of the Shareholders of the transactions contemplated hereby will not, violate any of the provisions of any contract or agreement to which any of the Shareholders is a party or by which the Purchasable Shares are bound, or any order, writ, injunction, or decree applicable to any of the Shareholders or the Purchasable Shares. Section 3.4. No Violation. Neither the execution and delivery of this Agreement by the Shareholders nor the consummation by the Shareholders of the transactions contemplated hereby will result in the creation or imposition of any Encumbrance upon any of the Purchasable Shares under, any agreement or commitment to which any of the Shareholders is a party or by which any of the Purchasable Shares are subject, or violate any statute or law or any judgment, decree, order, writ, injunction, regulation or rule of any domestic or foreign court or government authority applicable to any of the Shareholders or the Purchasable Shares. Section 3.5. Litigation, Judgments and Decrees. There currently is no action, suit or proceeding or any claim or investigation of any nature whatsoever, at law or in equity or both, by or before any domestic or foreign court or government or other regulatory or administrative agency, arbitration tribunal, board, bureau, authority or commission pending or threatened against or involving any of the Shareholders or any of the Purchasable Shares, or which would question or challenge the validity of this Agreement or any action taken or to be taken by any of the Shareholders pursuant to this Agreement or in connection with the transactions contemplated hereby. Section 3.6. Requirements for Notification or Approval. The execution and delivery of this Agreement by the Shareholders, the consummation of the transaction contemplated hereby and the performance of any obligations hereunder does not require notice, registration, report or other filing or qualification with, or consent, waiver, approval, license or authority of any third party or public authority except for such as have been duly and validly obtained prior to the date hereof. Section 3.7. Accuracy of Representations and Warranties. No representation or warranty of the Shareholders specifically contained herein or information with respect to the Purchasable Shares specifically contained herein contains or will contain any untrue statement of fact. ARTICLE IV SURVIVAL OF REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION Section 4.1. Survival of Representations. All representations, warranties and covenants contained in this Agreement shall survive. Section 4.2. Indemnification by the Shareholders. The Shareholders, severally but not jointly, agree to indemnify, defend and hold Mr. Gluckstern harmless, at any time after the date hereof, from and against all losses, costs, damages, liabilities, interest, penalties, settlements, judgments or expenses, including, but not limited to, reasonable attorneys' fees and expenses, asserted against, resulting from, imposed upon or incurred by Mr. Gluckstern directly or indirectly,

arising out of or in connection with (i) the breach or inaccuracy of any of the representations or warranties of the Shareholders made in or pursuant to this Agreement and; (ii) any breach or non-fulfillment of any covenant or agreement of the Shareholders contained in this Agreement. Section 4.3. Remedies Cumulative. The remedies provided for herein shall be cumulative and shall not preclude assertion by any party of any other rights or the seeking of any other remedies against any other party. Nothing contained in this Section 4.3 shall be construed in any way to limit, impair or modify the provisions of this Agreement or otherwise impose any liability or obligation on any party at any time for any liability, obligation, debt or commitment of the other party. ARTICLE V MISCELLANEOUS Section 5.1. Recapitalization, Exchanges, etc. Affecting the Common Stock. The provisions of this Agreement shall apply to the full extent set forth herein with respect to (a) the Purchasable Shares and (b) any and all shares of capital stock of the Company or any successor or assign of the Company (whether by merger, consolidation, sale of assets or otherwise) which may be issued in respect of, in exchange for, or in substitution for the Purchasable Shares, by reason of any stock dividend, split, reverse split, combination, recapitalization, reclassification, merger, consolidation or otherwise. In the event of any change in the capitalization of the Company, as a result of any stock split, stock dividend or stock combination, the provisions of this Agreement shall be appropriately adjusted. Section 5.2. No Joint Venture or Partnership. No party hereto shall have any authority to bind or commit any other party hereto and no such authority shall be implied by the provisions hereof. Nothing herein shall be deemed or construed to create a joint venture, partnership or agency relationship between any of the parties hereto for any purpose. Section 5.3. Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors, assigns and legal representatives. This Agreement shall be for the sole benefit of the parties to this Agreement and their respective successors, permitted assigns and legal representatives and is not intended, nor shall be construed, to give any person or entity, other than the parties hereto and their respective successors, permitted assigns and legal representatives, any legal or equitable right, remedy or claim hereunder. This Agreement may not be assigned by operation of law or otherwise, and any attempted assignment shall be null and void, except that Mr. Gluckstern and any Shareholder may assign his or her rights hereunder, in whole but not in part, in connection with a Transfer of Purchasable Shares made in strict compliance with all of the provisions of this Agreement, including, without limitation Article II of this Agreement. Section 5.4. Expenses. Each of the parties hereto shall pay its own expenses incident to this Agreement and the transactions contemplated hereby. Section 5.5. Amendment; Waiver. (a) This Agreement may be amended only by a written instrument duly executed by all of the parties hereto.

(b) No failure by any party to insist upon the strict performance of any covenant, duty, agreement or condition of this Agreement or to exercise any right or remedy consequent upon breach thereof shall constitute a waiver of any such breach or of any other covenant, duty, agreement or condition, any such waiver being effective only if contained in a writing executed by the waiving party. Section 5.6. Notices. Except as otherwise provided in this Agreement, all notices, requests, claims, demands, waivers and other communications hereunder shall be in writing and shall be deemed to have been duly given to any party hereto when delivered by hand, when delivered personally or by courier, three days after being deposited in the mail (registered or certified mail, postage prepaid, return receipt requested), or when received by facsimile transmission if promptly confirmed by one of the foregoing means, to such party at the address or facsimile transmission number specified below his or her name on the signature pages hereto or to such other address or facsimile transmission number specified in a notice given in accordance with this Section 5.6. Section 5.7. Applicable Law. This Agreement shall be governed, and construed in accordance with, the internal laws of the State of New York, without reference to the choice of law principles thereof. Section 5.8. Headings. The descriptive headings of the several sections in this Agreement are for convenience only and do not constitute part of this Agreement and shall not affect in any way the meaning or interpretation of this Agreement. Section 5.9. Integration. This Agreement and the other writings referred to herein or delivered pursuant hereto which form a part hereof contain the entire understanding of the parties with respect to its subject matter. This Agreement supersedes all prior agreements and understandings between the parties with respect to its subject matter. There are no restrictions, agreements, promises, representations, warranties, covenants or undertakings with respect to its subject matter other than those expressly set forth or referred to herein. Section 5.10. Severability. If any term or provision of this Agreement or any application thereof shall be declared or held invalid, illegal or unenforceable, in whole or in part, whether generally or in any particular jurisdiction, such provision shall be deemed amended to the extent, but only to the extent, necessary to cure such invalidity, illegality or unenforceability, and the validity, legality and enforceability of the remaining provisions, both generally and in every other jurisdiction, shall not in any way be affected or impaired thereby. Section 5.11. Consent to Jurisdiction. Each of the parties hereto hereby (i) irrevocably consents and submits to the sole exclusive jurisdiction of the United States District Court for the District of New York or the Supreme Court of New York (and of the appropriate appellate courts therefrom) in connection with any suit, action or other proceeding arising out of or relating to this Agreement, (ii) irrevocably waives, to the fullest extent permitted by law, any objection that it may now or hereafter have to the laying of the venue of any such suit, action or proceeding in any such court or that any such suit, action or proceeding which is brought in any such court has been brought in an inconvenient forum, and (iii) agrees that service of any summons, complaint, notice or other process relating to such suit, action or other proceeding may be effected in the manner provided by Section 5.6 of this Agreement.

Section 5.12. Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which shall together constitute one and the same instrument. [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

SHARE PURCHASE RIGHT AGREEMENT SIGNATURE PAGE IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed as of the day and year first above written.
/s/ Steven Gluckstern ---------------------------------------Steven Gluckstern

---------------------------------------Street Address ----------------City WITNESS: ----------State -------Zip

/s/ Susan Pasi -------------------------------------

SHARE PURCHASE RIGHT AGREEMENT SIGNATURE PAGE

/s/ Andre' Dimino ------------------------------------------------------------------------------Street Address ----------------City WITNESS: ----------State -------Zip

/s/ Ed Hammel -------------------------------------

SHARE PURCHASE RIGHT AGREEMENT SIGNATURE PAGE

/s/ S. Hagberg ------------------------------------------------------------------------------Street Address ----------------City WITNESS: ----------State -------Zip

/s/ Ed Hammel -------------------------------------

SHARE PURCHASE RIGHT AGREEMENT SIGNATURE PAGE

/s/ Ed Hammel ------------------------------------------------------------------------------Street Address ----------------City WITNESS: ----------State -------Zip

/s/ David Saloff -------------------------------------

SHARE PURCHASE RIGHT AGREEMENT SIGNATURE PAGE

/s/ Arthur Pilla ------------------------------------------------------------------------------Street Address ----------------City WITNESS: ----------State -------Zip

/s/ Ed Hammel -------------------------------------

SHARE PURCHASE RIGHT AGREEMENT SIGNATURE PAGE

/s/ David Saloff ------------------------------------------------------------------------------Street Address ----------------City WITNESS: ----------State -------Zip

/s/ Ed Hammel -------------------------------------

EXHIBIT A SHAREHOLDERS NAME ------------Andre' DiMino Sean Hagberg Ed Hammel Arthur Pilla David Saloff TOTAL: PURCHASABLE SHARES -----------------10,000 5,000 5,000 11,000 19,000 -----50,000 ======

Exhibit 16.3 June 16, 2006 Securities and Exchange Commission 100 F Street, N.E. Washington, DC 20549 Re: Ivivi Technologies, Inc. Commissioners: We have read the statements by Ivivi Technologies, Inc. ("the Company") contained under the caption "Changes In And Disagreements With Accountants on Financial And Accounting Disclosure" appearing in the Company's Form SB-2/A filed with the Securities and Exchange Commision on or about June 16, 2006. Stonefield Josephson, Inc. agrees with the statements in the first paragraph under that caption that we were appointed as the Company's independent registered public accounting firm on July 1, 2005 and that we were dismissed by the Company on March 7, 2006, however we have no basis to agree or disagree with the other comments in that paragraph. We agree with the statements regarding Stonefield Josephson in the second paragraph, however we have no basis to agree or disagree with the Company's statement that they have subsequently revised the 2005 financial statements. We agree with the statements regarding Stonefield Josephson in the third paragraph. We agree with the statement regarding us in the first sentence of the eighth paragraph, however we have no basis to agree or disagree with the statements in the remainder of that paragraph. We have no basis to agree or disagree with the statements in the fourth, fifth, sixth, seventh and ninth paragraphs. Very truly yours,
/s/Stonefield Josephson, Inc. Stonefield Josephson, Inc.

Exhibit 23.1 INDEPENDENT AUDITORS' CONSENT We consent to the use in the Registration Statement of Ivivi Technologies Inc. on Form SB-2 (Pre-Effective Amendment No. 4) to be filed with the Securities and Exchange Commission on June 15, 2006 of our report dated June 2, 2006, appearing in the Prospectus which is part of the Registration Statement. We also consent to the reference to us under the headings "Experts" in such Prospectus.
/s/ Raich Ende Malter & Co. LLP Raich Ende Malter & Co. LLP Certified Public Accountants June 16, 2006


								
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