Document:

ex10-12.htm

Eaton Scientific Systems, Inc. 10-K

 

Exhibit 10.12

 

CONSULTING AGREEMENT

 

CONSULTING AGREEMENT (this “Agreement”) dated as of the 1st day of January, 2013, between Eaton Scientific Systems, Inc. (the “Company”), a Nevada corporation, at 9595 Wilshire Blvd., Suite 900, Beverly Hills, CA 90212, and Huntington Chase Financial Group, LLC (the “Consultant”) a Nevada limited liability corporation at 1327 Ocean Avenue, Suite M, Santa Monica, CA 90401.

WHEREAS, the Company desires to retain Consultant to render consulting and strategic advisory services as outlined in the Scope of Work in Exhibit “A” of this Agreement on the terms and conditions set forth in this Agreement, and Consultant desires to be retained by the Company on such terms and conditions; and

WHEREAS, the Consultant has provided the Company with consulting and strategic advisory services since July 1, 2012, for which no compensation has been provided;

NOW, THEREFORE, in consideration of the services, the mutual agreements herein set forth and other good and valuable consideration, the parties agree as follows:

	
1.

	
Engagement of Consultant; Services Performed.

	
  

	
1.1.

	
The Company hereby retains Consultant to render such consulting and advisory services as the Company may request.  Consultant hereby accepts such engagement and agrees to perform such services for the Company upon the terms and conditions set forth in this Agreement.

	
  

	
1.2.

	
During the Term (as defined in Section 2), Consultant shall devote such time, attention, skill and energy to the business of the Company as may be reasonably required to perform the services required by this Agreement up to a maximum time commitment of 160 hours in any calendar month, and shall assume and perform to the best of his ability such reasonable responsibilities and duties as the Company shall assign to Consultant from time to time.

	
  

	
1.3.

	
Consultant shall perform the services hereunder from time to time at the Company’s principal office but he shall, at the Company’s expense, also be required to render the services at such other locations as the Company may specify from time to time.

	
  

	
1.4.

	
In rendering services hereunder, Consultant shall be acting as an independent contractor and not as a employee or agent of the Company.  As an independent contractor, Consultant shall have no authority, express or implied, to commit or obligate the Company in any manner whatsoever, except as specifically authorized from time to time in writing by an authorized representative of the Company, which authorization may be general or specific.  Nothing contained in this Agreement shall be construed or applied to create a partnership.  Consultant shall be responsible for the payment of all federal, state, provincial or local taxes payable with respect to all amounts paid to Consultant under this Agreement; provided, however, that if the Company is determined to be liable for collection and/or remittance of any such taxes, Consultant shall immediately reimburse the Company for all such payments made by the Company.

 

  

  

  

 

	
Eaton Scientific Systems, Inc.

	
Consulting Agreement

	
Huntington Chase Financial Group, LLC

	
Page 2 of 7

 

	
2.

	

Term.  Unless terminated at an earlier date in accordance with Section 4, this Agreement shall commence as of the date first written above and shall continue for a continuous period of three years (the “Term”).

	
3.

	
Compensation.

	
  

	
3.1.

	
Cash:

 

	
  

	
3.1.1.

	
As compensation for Consultant’s services rendered between July 1, 2012 and December 31, 2012, the Company shall pay to Consultant a one-time consulting fee of $90,000 (ninety thousand dollars); and

	
  

	
3.1.2.

	
As compensation for Consultant’s services hereunder, the Company shall pay to Consultant a consulting fee of $15,000 (fifteen thousand) dollars per month (the “Base Fee”) for the Term of the Agreement.

 

	
  

	
3.2.

	

Stock:    The Company and Consultant will work in “good faith to develop a stock incentive plan for Consultant.

 

	
4.

	
Termination By the Company.

	
  

	
4.1.

	
For Cause. Company will have the right to immediately terminate Consultant's services and this Agreement for cause.  "Cause" means:  any material breach of this Agreement by Consultant, including, without limitation, breach of Consultant’s covenants in Sections 6 and 7; any failure to perform assigned job responsibilities that continues unremedied for a period of ten (10) days after written notice to Consultant by Company; conviction of a felony or failure to contest prosecution for a felony; violation of any statute, rule or regulation, any of which in the judgment of Company is harmful to the business of the Company or to Company’s reputation; unethical practices; dishonesty; disloyalty; or any reason that would constitute cause under the laws of Nevada.  Upon termination of Consultant's engagement hereunder for cause or upon the death or disability of Consultant, Consultant will have no rights to any unvested benefits or any other compensation or payments after the termination date or the last day of the month in which Consultant’s death or disability occurred.

 

	 	
 

	
For purposes of this Agreement, “disability” means the incapacity or inability of Consultant, whether due to accident, sickness or otherwise, as determined by a medical doctor acceptable to the Board of Directors of Company and confirmed in writing by such doctor, to perform the essential functions of Consultant’s position under this Agreement, with or without reasonable accommodation (provided that no accommodation that imposes undue hardship on Company will be required) for an aggregate of ninety (90) days during any period of one hundred eighty (180) consecutive days.

 

	
  

	
4.2.

	
Without Cause.  Company may terminate Consultant's engagement under this Agreement without cause and without advance notice; provided, however, that Company will continue to pay, as severance pay, Consultant’s Base Fee at the rate in effect on the termination date for a period of six (6) months; provided, further, that Company will be entitled to offset any severance pay otherwise payable to Consultant by the amount of any compensation or consulting fees being paid to Consultant by another party while severance pay would otherwise be payable.  Such payments will be at usual and customary pay intervals of Company and will be subject to all appropriate deductions and withholdings.

 

  

  

  

 

	
Eaton Scientific Systems, Inc.

	
Consulting Agreement

	
Huntington Chase Financial Group, LLC

	
Page 3 of 7

  

	
  

	
4.3.

	
Termination By Consultant. Consultant may terminate Consultant’s engagement under this Agreement for any reason provided that Consultant gives Company at least thirty (30) days’ notice in writing.  Company may, at its option, accelerate such termination date to any date at least two weeks after Consultant’s notice of termination.  Company may, at its option, relieve Consultant of all duties and authority after notice of termination has been provided.  All compensation, payments will cease on the termination date.

	
5.

	
Expenses.  In addition to the payment of consulting fees set forth above, the Company shall reimburse Consultant all actual out-of-pocket costs for long-distance telephone services, facsimile transmissions, photocopying, courier services and postage, and all reasonable travel, lodging and per diem expenses, that he shall incur in connection with the rendering of Consultant’s services; provided that the Company shall have no obligation to reimburse any of such expenses except upon provision by Consultant of adequate documentation thereof in such form as the Company shall reasonably request; and provided further, that the Company shall have no such obligation in respect of any travel, lodging or per diem expenses unless the travel to which such expenses relate shall have been authorized in advance by the Company.

	
6.

	
Protection of Trade Secrets, Know-How and/or Other Confidential Information of the Company.

	
  

	
6.1.

	
Confidential Information.  Except as permitted or directed by the Company, during the Term or at any time thereafter Consultant shall not divulge, furnish or make accessible to anyone or use in any way (other than in the ordinary course of the business of the Company) any confidential or secret knowledge or information of the Company that Consultant has acquired or become acquainted with or will acquire or become acquainted with during the Term or during engagement by the Company prior to the Term, whether developed by Consultant or by others, concerning any trade secrets, confidential or secret designs, processes, formulae, products or future products, plans, devices or material (whether or not patented or patentable) directly or indirectly useful in any aspect of the business of the Company, any customer or supplier lists of the Company, any confidential or secret development or research work of the Company, or any other confidential information or secret aspects of the business of the Company.  Consultant acknowledges that the above-described knowledge or information constitutes a unique and valuable asset of the Company acquired at great time and expense by the Company and its predecessors, and that any disclosure or other use of such knowledge or information other than for the sole benefit of the Company would be wrongful and would cause irreparable harm to the Company.  Both during and after the Term, Consultant will refrain from any acts or omissions that would reduce the value of such knowledge or information to the Company.  The foregoing obligations of confidentiality, however, shall not apply to any knowledge or information which is now published or which subsequently becomes generally publicly known in the form in which it was obtained from the Company, other than as a direct or indirect result of the breach of this Agreement by Consultant.

	
  

	
6.2.

	
Know-How and Trade Secrets.  All know-how and trade secret information conceived or originated by Consultant which arises out of the performance of the services hereunder or any related material or information shall be the property of the Company, and all rights therein are hereby assigned to the Company.

	
  

	
6.3.

	
Return of Records.  Upon termination of this Agreement, Consultant shall deliver to the Company all property that is in his possession and that is the Company’s property or relates to the Company’s business, including, but not limited to records, notes, data, memoranda, software, electronic information, models, equipment, and any copies of the same.

 

  

  

  

 

	
Eaton Scientific Systems, Inc.

	
Consulting Agreement

	
Huntington Chase Financial Group, LLC

	
Page 4 of 7

  

	
7.

	
Miscellaneous.

	
  

	
7.1.

	
Entire Agreement.  This Agreement (including any exhibits, schedules and other documents referred to herein) contains the entire understanding between the parties hereto with respect to the subject matter hereof and supersedes any prior understandings, agreements or representations, written or oral, relating to the subject matter hereof.

	
  

	
7.2.

	
Counterparts.  This Agreement may be executed in separate counterparts, each of which will be an original and all of which taken together shall constitute one and the same agreement, and any party hereto may execute this Agreement by signing any such counterpart.

	
  

	
7.3.

	
Severability.  Whenever possible, each provision of this Agreement shall be interpreted in such a manner as to be effective and valid under applicable law but if any provision of this Agreement is held to be invalid, illegal or unenforceable under any applicable law or rule, the validity, legality and enforceability of the other provision of this Agreement will not be affected or impaired thereby.

	
  

	
7.4.

	
Successors and Assigns.  This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective heirs, personal representatives and, to the extent permitted by subsection (e), successors and assigns.

	
  

	
7.5.

	
Assignment.  This Agreement and the rights and obligations of the parties hereunder shall not be assignable, in whole or in part, by either party without the prior written consent of the other party.

	
  

	
7.6.

	
Modification, Amendment, Waiver or Termination.  No provision of this Agreement may be modified, amended, waived or terminated except by an instrument in writing signed by the parties to this Agreement.  No course of dealing between the parties will modify, amend, waive or terminate any provision of this Agreement or any rights or obligations of any party under or by reason of this Agreement.

	
  

	
7.7.

	
Notices.  All notices, consents, requests, instructions, approvals or other communications provided for herein shall be in writing and delivered by personal delivery, overnight courier, mail, electronic facsimile or e-mail addressed to the receiving party at the address set forth herein.  All such communications shall be effective when received.

Any party may change the address set forth above by notice to each other party given as provided herein.

 

	 	
To:

	
Eaton Scientific Systems, Inc.

	 	  	
9595 Wilshire Blvd., Suite 900

	 	  	
Beverly Hills, CA 90212

	 	  	  
	 	
To:

	
Huntington Chase Financial Group, LLC

	 	  	
Edward W. Withrow III

	 	  	
1327 Ocean Avenue Suite M

	 	  	
Santa Monica, CA 90401

  

  

  

  

 

	
Eaton Scientific Systems, Inc.

	
Consulting Agreement

	
Huntington Chase Financial Group, LLC

	
Page 5 of 7

  

	
  

	
7.8.

	
Headings.  The headings and any table of contents contained in this Agreement are for reference purposes only and shall not in any way affect the meaning or interpretation of this Agreement.

	
  

	
7.9.

	
Governing Law.  ALL MATTERS RELATING TO THE INTERPRETATION, CONSTRUCTION, VALIDITY AND ENFORCEMENT OF THIS AGREEMENT SHALL BE GOVERNED BY THE INTERNAL LAWS OF THE STATE OF NEVADA, WITHOUT GIVING EFFECT TO ANY CHOICE OF LAW PROVISIONS THEREOF.

	 	
7.10.

	
Third-Party Benefit.  Nothing in this Agreement, express or implied, is intended to confer upon any other person any rights, remedies, obligations or liabilities of any nature whatsoever.

 

	 	
7.11.

	

No Waiver.  No delay on the part of the Company in exercising any right hereunder shall operate as a waiver of such right.  No waiver, express or implied, by the Company of any right or any breach by Consultant shall constitute a waiver of any other right or breach by Consultant.

 

	 	
7.12.

	

Jurisdiction and Venue.  THIS AGREEMENT MAY BE ENFORCED IN ANY FEDERAL COURT OR STATE COURT SITTING IN CALIFORNIA, AND EACH PARTY CONSENTS TO THE JURISDICTION AND VENUE OF ANY SUCH COURT AND WAIVES ANY ARGUMENT THAT VENUE IN SUCH FORUM IS NOT CONVENIENT.  IF ANY PARTY COMMENCES ANY ACTION UNDER ANY TORT OR CONTRACT THEORY ARISING DIRECTLY OR INDIRECTLY FROM THE RELATIONSHIP CREATED BY THIS AGREEMENT IN ANOTHER JURISDICTION OR VENUE, ANY OTHER PARTY TO THIS AGREEMENT SHALL HAVE THE OPTION OF TRANSFERRING THE CASE TO THE ABOVE-DESCRIBED VENUE OR JURISDICTION OR, IF SUCH TRANSFER CANNOT BE ACCOMPLISHED, TO HAVE SUCH CASE DISMISSED WITHOUT PREJUDICE.

 

	 	
7.13.

	

Remedies.  The parties agree that money damages may not be an adequate remedy for any breach of the provisions of this Agreement and that any party may, in its discretion, apply to any court of law or equity of competent jurisdiction for specific performance and injunctive relief in order to enforce or prevent any violations this Agreement, and any party against whom such proceeding is brought hereby waives the claim or defense that such party has an adequate remedy at law and agrees not to raise the defense that the other party has an adequate remedy at law.

 

[ Signature Page Immediately Following ]

 

  

  

  

 

	
Eaton Scientific Systems, Inc.

	
Consulting Agreement

	
Huntington Chase Financial Group, LLC

	
Page 6 of 7

  

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date set forth in the first paragraph.

 

	EATON SCIENTIFIC SYSTEMS, INC.	 
	 	 	 
	By: 	/s/ Michael Borkowski	 
	 	Michael Borkowski  	 
	Its: 	Chief Executive Officer 	 

 

	
HUNTINGTON CHASE FINANCIAL GROUP, LLC

	 
	 	 	 
	
By  

	/s/ Edward W. Withrow III	 
	 	Edward W. Withrow III	 
	Its: 	
Managing Member

	 
	 	 	 

 

  

  

  

 

	
Eaton Scientific Systems, Inc.

	
Consulting Agreement

	
Huntington Chase Financial Group, LLC

	
Page 7 of 7

 

EXHIBIT “A”

Scope of Work Provided by Consultant

 

	
  

	
1.

	
Advise on strategic business opportunities;

 

	
  

	
a.

	
Review potential strategic opportunities

 

	
  

	
b.

	
Review and consult on valuations

 

	
  

	
c.

	
Review and advise management of market potential of opportunity of targeted business opportunities.

 

	
  

	
2.

	
Advise on capitalization matters and financings;

 

	
  

	
a.

	
Perform or review due diligence on capital sources

 

	
  

	
b.

	
Introduce Company to potential strategic partners.

 

	
  

	
c.

	
Develop capitalization materials and interface with the financial community

 

	
  

	
3.

	
Advise on Marketing related matters;

 

	
  

	
a.

	
Interface with outside marketing vendors.ex10-13.htm

Eaton Scientific Systems, Inc. 10-K

Exhibit 10.13

 

	EATON SCIENTIFIC SYSTEMS	
HOMATROPINE PROTOCOL

PI/SPO#

  

CLINICAL TRIALS/STUDY AGREEMENT

This Agreement is made as of 04/08/2013 by and between Eaton Scientific Systems Inc. ("Sponsor"), a Nevada Corporation, having its principal place of business at Eaton Scientific Systems, Inc., Michael Borkowski Chief Executive Officer, at 9595 Wilshire Blvd Suite 900, Beverly Hills, CA 90212 and American Institute of Research (“AIR”) at 15111 E. Whittier Blvd., Ste. 216 Whittier, CA 90603 represented by Tarek Dessouky, M.D., MBA, MPH, Chief Executive Officer

SPO Number:  0408HOM

Project Title:  Homatropine

Principal Investigator:  Dr. Michael Guice

Effective Date:

End Date:

 

I.             BACKGROUND

WHEREAS, Sponsor conducts business in the development of therapeutic products, compounds, and reagents; and

 

WHEREAS, Sponsor has developed a protocol and desires AIR to conduct a clinical research study (hereinafter “Study”); and

WHEREAS, the performance of the Study is of mutual interest to Sponsor and AIR, and will be conducted with the Good Clinical Practices; and

WHEREAS, AIR is in the business of conducting and managing Clinical Trials.

The Parties therefore agree as follows:

 

II.            STATEMENT OF WORK

AIR agrees to use reasonable efforts to perform the Study entitled “An Open Label Escalating Study to Determine Maximum Necessary Dose (MND) of Homatropine Methylbromide needed for Palliation of Hot Flashes in Menopausal Women”, as described in Exhibit A, attached hereto and incorporated herein by this reference (“Protocol”). AIR’s independent contractor, Dr. Michael Guice will serve as Principal Investigator for the Study (“Principal Investigator”).

The Parties agree to conduct the Study based upon the terms and conditions contained in this Agreement and in accordance with the Protocol, and:

	
(i)

	
Sponsor will conduct an evaluation of the planned facilities to be used by AIR for the Study (“Study Site”) before the performance of the Study and before implementation of the Study.

 

	Page 1 of14	Rev 04/16 dls

  

  

  

 

	EATON SCIENTIFIC SYSTEMS	
HOMATROPINE PROTOCOL

PI/SPO#

 

	
(ii)  

	
Because such studies have implications for the commitment of resources by both parties, there will be frequent and full interchange between the personnel of the Sponsor and AIR regarding the Study.

 

Compliance. Each Study shall be conducted in accordance with the Protocol, Sponsor’s written instructions, and all laws and regulations applicable to performance of a clinical study, including but not limited to 21 CFR §50, 54, 56 and 812 and the requirements of the Federal Food, Drug, and Cosmetic Act (the FDCA) or any similar or successor legislation. AIR will conduct the Study in accordance with any conditions imposed by FDA or the Institutional Review Board (IRB).  If Sponsor’s written instructions are inconsistent with the Protocol, the Protocol approved by the IRB will govern the conduct of the Study.

 

III.           PERIOD OF PERFORMANCE

The Study is effective on the ____ day of ______, 2013 and continues until the study is completed at AIR.  The Parties agree that no patient enrollment will occur until there is IRB approval of the Protocol at AIR.

IV.           BUDGET AND PAYMENTS

	
__.1

	
Payments.  Sponsor will reimburse AIR for all direct and indirect costs in connection with the Study not to exceed $ 5,037.50 per completed patient, for a total of 50 patients, and in accordance with the Budget and Payment Schedule attached to this Agreement as Exhibit B (“Budget”).   In addition, Sponsor will pay start-up fees which include an IRB preparation fee, pharmacy set-up fee, and/or clinical administration fees in the amount of $6000 (“Start-up Fees”).

	
__.2

	
Study Budget.  This Agreement is based on an estimated per-patient basis.  The Budget is based upon the reasonable costs for similar studies at like AIRs in the same geographic area. AIR has not been induced to participate in this Study based on financial or other inducements from Sponsor.  The Parties estimate that the Budget is sufficient to support the Study.  However, AIR may submit to Sponsor a revised budget requesting additional funds at such time as costs may reasonably be projected to exceed the Budget.  Sponsor will not be liable for any payment in excess of the Budget except upon Sponsor's written agreement.

	
__.3

	
Payment Address. Sponsor will pay by check, which will be made payable to AIR and will be sent to:

	 	
  

	
American Institute of Research, Inc.

	 	
  

	
15111 E. Whittier Blvd., Ste. 216

	 	
  

	
Wittier, CA 90603

	 	
  

	
Attention: Ansaga Dominguez

 

	Page 2 of14	Rev 04/16 dls

  

  

  

 

	EATON SCIENTIFIC SYSTEMS	
HOMATROPINE PROTOCOL

PI/SPO#

 

	
First Class Mail

	
Certified or overnight mail

(*Federal Express ONLY)

	
Wire Transfer

	
Domestic or Foreign

 

	  	
Swift Code:Sort/Routing/ABA:

All checks should reference the Principal Investigator’s name and SPO Number for reference purposes.

Payments by check or Electronic Funds Transfer (EFT) will be made within 10 days of receipt of invoice.  Checks or accompanying  letter will reference this Agreement and the Principal Investigator’s name and will be sent to:

American Institute of Research

15111 E. Whittier Blvd., Ste. 216

Whittier, CA 90603

Tax ID No: 20-8940081

Or thru EFT

Friendly Hills Bank

16011 E. Whittier Blvd.

Whittier, CA 90603

Bank Account # 0013001318

ABA# 122244249

Account Name: American Institute of Research

Tax ID: 20-8940081

The initial payment of Twenty Five Thousand Dollars ($25,000.00) will be paid upon execution of the Clinical Trials/Study Agreement.  This initial payment includes the Non-refundable Study Start-Up Fee of Six Thousand Dollars ($6,000.00) and a portion of the first payment which is equivalent to 40% of the total contracted amount.  The first payment is an advance payment (“Advance”) against payments which are anticipated to be due to the Institution as a result of work performed under this Agreement.  The Advance shall be payable to Institution by invoice before the start of enrollment. This Advance shall be recovered in the form of a credit against subsequent payments until the entire Advance is recovered.

 

In the event that the project is cancelled by Eaton Scientific Systems, Inc. before the start of enrollment, Eaton Scientific Systems, Inc. will not be liable for any additional funding.  The contract will be considered terminated and the initial payment will be deemed non-refundable. Enrollment in the Trial will not commence without the approval of Eaton Scientific Systems, Inc. and a full 40% of the total contracted trial budget has been paid to AIR.

 

	Page 3 of 14	Rev 04/16 dls

  

  

  

 

	EATON SCIENTIFIC SYSTEMS	
HOMATROPINE PROTOCOL

PI/SPO#

 

V.            INTELLECTUAL PROPERTY

	
__.1

	
Sponsor will own as its sole property any invention developed under the Protocol ("Sponsor Technology").

	
__.2

	
AIR will not retain rights to use Sponsor Technology for internal research, educational and archival purposes.

	
__.3

	
AIR will not obtain patent and copyright agreements to effectuate the purposes of this Agreement from all individuals who perform any part of the Study.

 

VI.          DATA AND BIOLOGICAL MATERIAL

 

	
__.1

	
Study Data.  The data generated as a result of this Study will be owned by the Sponsor for the purposes identified in the patient authorization/informed consent and this Agreement. Copies of records and documents pertaining to the conduct of this Study, including case report forms, source documents, consent forms, regulatory documents, clinical laboratory results or reports (including, but not limited to all local and central laboratory results and ECG reports), and medication inventory records in all formats (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) must be retained by the Principal Investigator for a period of at least fifteen (15) years after Study completion, unless local regulations or Institute policies require a longer retention period or otherwise notified in writing by the Sponsor.

	
__2.  

	
The Principal Investigator will permit access to any documentation relating to the Study upon request of the Sponsor or applicable regulatory authorities.  If the Principal Investigator for the Study retires, relocates, or for other reasons withdraws from the responsibility of keeping the Study records, custody must be transferred to a suitable alternate custodian employee of Institute or to a suitably qualified and responsible third party.

 

VII.         COMPLIANCE WITH LAW

	
__.1

	
FDA Regulations:  AIR, Principal Investigator and Sponsor will comply with all applicable federal, state, and local laws, regulations and guidelines including, but not limited to, the FDCA, as amended, and regulations promulgated thereunder ("the Act") and the United States Food and Drug Administration ("FDA") regulations governing the protection of human subjects and regulations governing clinical investigators.

 

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	EATON SCIENTIFIC SYSTEMS	
HOMATROPINE PROTOCOL

PI/SPO#

 

	
__.2

	
Debarment:  AIR certifies that neither AIR nor any person employed or engaged by AIR in the Study has been debarred pursuant to sections 306(a) or (b) of the Federal FDCA (21 U.S.C. Section 335(a) and 335(b)) and that no debarred person will in the future be employed or engaged by AIR in connection with services to be performed by AIR for Sponsor. AIR further certifies that it will notify Sponsor immediately in the event of any debarment or threat of debarment occurring during the period of this Agreement.

	
__.3

	
HIPAA: In connection with research studies, AIR may collect “Protected Health Information” (“PHI”) as defined in the Health Insurance Portability and Accountability Act (“HIPAA”) 45 C.F.R. section 164.501 or “Medical Information”  as defined under Cal. Civil Code section 56.5, both terms hereinafter referred to as “PHI”.  AIR will obtain a patient authorization/informed consent from study subjects to allow AIR to disclose the PHI to Sponsor.   Sponsor will use the PHI in accordance with the patient authorization/informed consent.  If either Party de-identifies PHI in accordance with the standards as set forth in 45 C.F.R. sections 164.514, either Party may use and disclose the de-identified information as allowed by law.

 

	
VIII.

	
HUMAN RESEARCH PROTECTION PROGRAM

	
__.1

	
Sponsor acknowledges that AIR has a Human Research Protection Program ("HRPP") established in accordance with the principles and standards of the Association for the Accreditation of Human Research Protection Programs that is applicable to all clinical research studies, including the Study, that includes: (i) their submittal for prospective and continuing review to the Institutional Review Board ("IRB") as required by the FDA regulations governing the protection of human research subjects, (ii) obtaining of consent from human research subjects as required by the FDA regulations governing the protection of human research subjects, (iii) conducting them in accordance with ethical standards such as the Belmont Report.

	
__.2

	
In furtherance of AIR’s HRPP, Sponsor agrees:  (a)  to promptly notify  the Principal Investigator and/or the IRB directly of (i) non-compliance with the Protocol or applicable laws, particularly those laws related to human research subjects, that could impact the safety or welfare of participating subjects, (ii) serious adverse events that have been reported to the FDA or other governmental agency in relation to the Study at AIR or any other site, (iii) unanticipated problems in the Study at AIR or any other site that could relate to risks to participating subjects, and (iv) circumstances that could affect subjects’ willingness to continue to participate in the Study or the IRB’s continuing approval of the Study, and (b) to develop a plan of communication to subjects with the Principal Investigator that is acceptable to the IRB when new findings or results of the Study might impact the willingness of subjects to continue to participate in the Study or directly affect their current or future safety or medical care.

 

	Page 5 of14	Rev 04/16 dls

  

  

  

 

	EATON SCIENTIFIC SYSTEMS	
HOMATROPINE PROTOCOL

PI/SPO#

 

IX.           ACCESS

	
__.1

	
Either Sponsor or FDA, as required by FDA regulations, must have reasonable access to Principal Investigator and other project personnel, project facilities, drug records, subject records, case reports, and other records, subject to applicable laws and regulations.  Sponsor agrees to provide at least seventy-two (72) hours notice prior to a Study site visit and will schedule such visit during normal business hours upon AIR’s consent.  Sponsor or CRO on behalf of Sponsor will limit the number of Site visits to those outlined in the Protocol.  If Sponsor exceeds the number of reasonable Site visits, Sponsor will reimburse AIR for reasonable costs and expenses to make Study personnel available.

	
__.2

	
If there is a FDA audit, AIR agrees to provide Sponsor with prompt notice of the FDA audit.  AIR is free to respond to any FDA inquiries and will provide Sponsor with a copy of any final response or documentation to the FDA regarding the Study.  Sponsor will reimburse AIR for the reasonable costs incurred by Study personnel in responding to a FDA audit or investigation.

	
__.3

	
Sponsor will provide Principal Investigator with all Sponsor’s relevant information pertaining to the Study, including potential adverse reactions of subjects to study drug, control drug and/or study device.

 

X.           CONFIDENTIAL INFORMATION

	
__.1

	
AIR understands that there is no dissemination of information. In addition, AIR researchers may not be able to publish the results of the Study.

	
__.2

	
Sponsor and AIR recognize that conducting the Study may require the transfer of confidential or proprietary information between the parties.  All documents, information, materials and data provided to AIR by Sponsor will be considered confidential information of the Sponsor if marked as Confidential ("Sponsor Confidential Information").  All documents, information, materials and data provided by AIR to Sponsor will be considered information of AIR if marked as Confidential ("AIR Confidential Information").  In consideration of the disclosure of any Confidential Information to the other, Sponsor and AIR agree that, for a period of five (5) years from the date of this Agreement, they will:

 

	 	
(a)

	

Make no use of Sponsor’s Confidential Information so designated in writing as confidential or proprietary by the disclosing party except as allowed in this Agreement;

	 	
(b)

	

Make no use of AIR Confidential Information without an appropriate patient authorization and/or consent and as allowed in this Agreement.

	
  

	
(b)

	
Not disclose to third parties any of the Confidential Information belonging to the other party without express written consent of the disclosing party except in accordance with paragraph 10; and

	
  

	
(c)

	
Take precautions as normally taken with the receiving party's own confidential and proprietary information to prevent disclosure to third parties.

 

The obligation of confidentiality does not apply to study results, supporting data or to information that:

 

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	EATON SCIENTIFIC SYSTEMS	
HOMATROPINE PROTOCOL

PI/SPO#

 

	
  

	
(a)

	
Is publicly available through no fault of recipient;

	
  

	
(b)

	
Is disclosed to the recipient by a third party;

	
  

	
(c)

	
Is already known to the recipient at the time of disclosure; or

	 	
(d)

	

Is developed by the recipient without reference to the Confidential Information.

	 	
(e)

	

Is required to be disclosed by law, regulation, or court order.

 

XI.           SUPPLIES, CASE REPORT FORMS, EQUIPMENT

	
__.1

	
STUDY DRUG.  The Study Drug for this Study is Homatropine Methyl bromide, which does have FDA approval for other indications. Sponsor will provide to AIR at no cost with a sufficient quantity of Study Drug to conduct the Study, as well as any other compounds, materials, equipment, and information which the Protocol specifies Sponsor will deliver or which Sponsor deems necessary to conduct the Study.  All such Study Drug, compounds, materials, and equipment are the sole property of Sponsor and will be returned to Sponsor, if applicable, at Sponsor’s expense at the end of the Study

	
__.2

	
CRFs:  Sponsor will provide AIR with a sufficient quantity of Case Report Forms ("CRF's") and necessary questionnaires or documentation to conduct the Study.  All original CRF's will be the sole property of Sponsor.  All other original records of the work completed under this Agreement, including patient medical records, laboratory records and reports, scans, films and information on pre-existing AIR databases will be AIR property.  AIR will retain a copy of all Study documents for internal research, teaching and archival purposes.

 

XII.         PUBLICATION

	
__.1

	
Research:  The basic objective of research activities at AIR is the generation of new knowledge and its expeditious dissemination for FDA approval.

	
__.2

	
Sponsor Publication:  If Sponsor elects to publish the results from AIR’s participation, Sponsor agrees to provide AIR with a copy of the proposed publication at least thirty (30) days prior to publication and agrees to acknowledge AIR’s participation in the Study as appropriate for peer review publications.

 

XIII.        WIND DOWN

Either party may terminate this Agreement upon thirty-days (30) written notice.  In the event of any termination of this Agreement prior to the End Date, Sponsor will pay the reasonable costs incurred by AIR in winding down and terminating the Study, including the costs of the Study during the wind down period and all costs and non-cancelable commitments made prior to termination.

 

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XIV.       NOTICES

Any notices given under this Agreement will be in writing and delivered by mail, by hand, or by facsimile addressed to the parties as follows:

	
AIR 

	
Sponsor

 

	
American Institute of Research

	
Eaton Scientific Systems, Inc.

	
15111 E. Whittier Blvd. Ste. 216

Whittier, CA 90603

Dr. Tarek Dessouky, CEO

	
9595 Wilshire Blvd Suite 900

Santa Monica, CA

Michael Borkowski, President

	
www.airesearch.us

 

	
www.eatonscientific.com

mikeb@eatonscientific.com

	
(Tel) 562.693.4477

	
(Tel) 310.281.6923

	
(Fax) 562.696.8681

	
(fax) 888.329.5351

 

XVI.       PUBLICITY

Publicity:  Neither party will identify the other in any promotional advertising or other promotional materials to be disseminated to the public or use the name of any faculty member, employee,or any trademark, service mark, trade name, or symbol , without the other's prior written consent. (“Eaton is a Public Company and as such will need to file a Public Announcement”)

Clinicaltrials.Gov, Clinical Trials Directory Website:  Notwithstanding anything to the contrary, Sponsor agrees to allow the following information to appear on the Clinical Trials Directory website:  study title, study status, trial type, study phase, study category and subcategory, study objectives and designs, conditions treated, treatment(s) or intervention(s), key eligibility criteria and exclusion criteria.

 

XVII.      INDEMNIFICATION

	
__.1

	
Indemnity:

	
  

	
Sponsor agrees to indemnify, defend and hold harmless the Principal Investigator, Sub-Investigators, and the Institute (AIR), its directors, officers, agents and employees (collectively “Indemnitees”) from any and all direct expenses, liability, losses or damages asserted by third parties (collectively “Claims”) to the extent such Claims result from the use or administration of the Investigational Product in accordance with the Protocol, provided, however, that Sponsor shall not be responsible for any Claims to the extent such Claims result from:

 

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a.

	
the failure of the Institute or the Principal Investigator to adhere to the terms of the Protocol or Sponsor's written instructions relative to the use of the Investigational Product or the conduct of the Study;

 

	
  

	
b.

	
the failure of the Institute or the Principal Investigator to comply with any applicable FDA or other government requirements, including, without limitation, any federal, state or local laws or regulations, with respect to the conduct of the Study at the Institute’s facilities;

 

	
  

	
c.

	
any negligence or willful misconduct by the Principal Investigator or the Institute, including the Institute’s directors, officers, agents and employees.

Sponsor agrees to provide the reasonable costs of medical treatment required by any participant in the activities contemplated by the Protocol for any illness or condition to the extent caused by or derived from (i) Sponsor's Investigational Product or (ii) the Investigational Product’s use or administration as stated in the Protocol, or (iii) any procedures stated in the Protocol, to the extent not covered by the participant's private medical insurance; provided that Sponsor shall not be responsible for such costs arising from any matter as set forth in subclauses (a), (b), or (c), (d) of the preceding paragraph.

Institute agrees that each Indemnitee shall provide Sponsor prompt notification of any Claim as to which indemnification may be sought hereunder.  Sponsor shall have the right to assume and control the defense of any such Claim with counsel of its choice, except that Sponsor will not admit liability or fault on behalf of any Indemnitee hereunder without such party’s prior written consent, which consent shall not be unreasonably withheld.  Institute shall fully cooperate in the investigation and defense of any such Claims.

	
__.2

	
Notice of Claims:  AIR will promptly notify Sponsor of any such claim and will cooperate with Sponsor in the defense of the claim.  Sponsor agrees, at its own expense, to provide attorneys reasonably acceptable to AIR to defend against any claim with respect to which Sponsor has agreed to provide indemnification hereunder.  Sponsor agrees not to settle any claim against AIR with an admission of liability against AIR without AIR’s written consent.  This indemnity shall not be deemed excess coverage to any insurance or self-insurance AIR may have covering a claim.  Sponsor's indemnity shall not be limited by the amount of Sponsor's insurance.

	
__.3

	
Notice of Claims:  Sponsor will promptly notify AIR of any such claim and will cooperate with AIR in the defense of the claim.  AIR agrees, at its own expense, to provide attorneys reasonably acceptable to Sponsor to defend against any claim with respect to which AIR has agreed to provide indemnification hereunder.  AIR agrees not to settle any claim against Sponsor with an admission of liability against Sponsor without Sponsor’s written consent.   This indemnity shall not be deemed excess coverage to any insurance or self-insurance AIR may have covering a claim.  AIR's indemnity shall not be limited by the amount of AIR's insurance.

	
__.4

	
The provisions of this clause shall survive termination of this Agreement.

 

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XVIII.     SUBJECT INJURY

Sponsor agrees that it, and not AIR, is responsible for the costs of diagnosis, care and treatment of any undesirable side effects, adverse reactions, illness or injury to a participant in the Study, which in the reasonable judgment of the Principal Investigator or AIR result from participation in the Study, except for such costs that arise directly from (i) the negligent activities, reckless misconduct or intentional misconduct of AIR, the Principal Investigator or his/her staff or (ii) their failure to adhere to the terms of the Protocol.  This section is not intended to create any third-party contractual benefit for any participants in the Study.

 

XIV.       INSURANCE

	
__.1

	
Worker’s Compensation.  AIR will maintain Worker's Compensation insurance or other coverage on its employees as required by California law, and will self-insure or maintain insurance covering its liability under this Agreement.

	
__.2

	
Coverage.  Sponsor will procure and maintain during the term of this Agreement comprehensive liability, clinical trial and product liability insurance to the full amount of Sponsor’s insurance limits, but in no event less than $5,000,000 per occurrence and $10,000,000 annual aggregate, with a reputable and financially secure insurance carrier.  Insurance should be placed with carriers with ratings with at least A-, X as rated by A.M. Best.

 

	
__.3

	
Certificate of Insurance and Additional Insured Endorsement.  Prior to the effective date of this agreement, Sponsor shall provide AIR with a Certificate of Insurance and Additional Insured Endorsement evidencing primary coverage and advise AIR of any deductibles to Sponsor’s insurance.

	
__.4

	
Notice of Cancellation.  Sponsor shall provide AIR with thirty (30) days written notice of cancellation or material change.  Sponsor will advise AIR in writing that it maintains excess liability coverage (following form) over primary insurance for at least the minimum limits set forth above.  Conditions of the Certificate of Insurance will be subject to approval in advance by AIR's Office of Risk Management.

	
__.5

	
Primary Coverage.  Sponsor's insurance will be primary coverage with respect to its indemnification responsibilities under Paragraph __.  AIR's insurance or self-insurance will be excess and noncontributory.

	
__.6

	
Tail Coverage.  If Sponsor's insurance is written on a claims made basis, as opposed to an occurrence basis, Sponsor shall guarantee that it will purchase "tail" coverage and/or a retrospective coverage provision to provide continuation and uninterruption of coverage of all claims.

 

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XV.

	
MISCELLANEOUS

	
__.1

	

Arbitration. Any dispute between the parties in connection with this Agreement, which cannot be resolved, by mutual agreement will be finally settled through arbitration under the Commercial Arbitration Rules of the American Arbitration Association by one or more arbitrators appointed in accordance with those Rules.  Arbitration will be held in Santa Monica, California, or at any other mutually agreeable location.

	
__.2

	
Assignment.  Neither party may assign this Agreement without the prior written consent of the other party.

	
__.3

	

Divisibility. If any provision of this Agreement becomes or is declared illegal, invalid, or unenforceable, such provision will be divisible from this Agreement and will be deemed to be deleted from this Agreement.  If such deletion substantially alters the basis of this Agreement, the parties will negotiate in good faith to amend the provisions of this Agreement to give effect to the original intent of the parties.

	
__.4

	
Independent Contractors.  AIR and Sponsor are independent contractors and neither is an agent, joint venture, or partner of the other.

	
__.5

	
Research Freedom.  This Agreement is not to be construed to limit the freedom of individuals participating in this Study to engage in any other Study.

	
__.6

	
Choice of Laws.  This Agreement is governed by the laws of the State of California without regard to conflict of law principles.  Any legal action involving this Agreement or the Study under it will be adjudicated in the State of California at a mutually agreeable location.

	
__.7

	
Order of Precedence.  In the event of any inconsistency between the terms of this Agreement and the documents referenced or incorporated herein or any other agreement concerning this Study between the Parties and their employees, the terms of this Agreement will prevail.

	
__.8

	
Entirety.  This Agreement represents the entire agreement and understanding between the parties and their employees with respect to its subject matter and supersedes any prior and/or contemporaneous discussions, representations, or agreements, whether written or oral, of the parties regarding this subject matter.

	
__.9

	
Amendments.  Amendments or changes to this Agreement must be in writing and signed by duly authorized representatives of the parties.

 

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IN WITNESS WHEREOF, these duly authorized representatives of the parties hereby execute this Agreement, including all the terms and conditions which follow.

 

	
Eaton Scientific Systems, Inc.

	  	
American Institute of Research, Inc.

	 	 	 
	
Signature

	
/s/ Michael Borkowski

	  	
Signature

	
/s/ Tarek Dessouky MD

	
Name

	Michael Borkowski	  	
Name

	Tarek Dessouky, M.D., MBA, MPH
	
Title

	Chief Executive Officer	  	
Title

	Chief Executive Officer
	
Date

	April 14, 2013	  	
Date

	April 14, 2013
	 	 	 	 	 	 	 

 

The Principal Investigator acknowledges his/her responsibilities to carry out this Agreement.

 

READ AND UNDERSTOOD:

 

	
By:

	
/s/ Dr. Michael Guice, MD

	  
	  	
Dr. Michael Guice, MD

	  
	  	
Principal Investigator

	  

 

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EXHIBIT A

Study Protocol

 

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EXHIBIT B

Budget and Payment Schedule

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