-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, VDUghl1KZJm1YUoEmY6aMjji4+uan89ajubD/vzIW7sd85o5UDJBSjy+zHC//h5m 08yxszM56J/faGU4batWcw== 0001144204-07-035121.txt : 20070703 0001144204-07-035121.hdr.sgml : 20070703 20070703155141 ACCESSION NUMBER: 0001144204-07-035121 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20070629 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070703 DATE AS OF CHANGE: 20070703 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SCIVANTA MEDICAL CORP CENTRAL INDEX KEY: 0001093285 STANDARD INDUSTRIAL CLASSIFICATION: WHOLESALE-MEDICAL, DENTAL & HOSPITAL EQUIPMENT & SUPPLIES [5047] IRS NUMBER: 222436721 STATE OF INCORPORATION: DE FISCAL YEAR END: 1031 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-27119 FILM NUMBER: 07960713 BUSINESS ADDRESS: STREET 1: 215 MORRIS AVENUE CITY: SPRING LAKE STATE: NJ ZIP: 07762 BUSINESS PHONE: (732) 919-2799 MAIL ADDRESS: STREET 1: 215 MORRIS AVENUE CITY: SPRING LAKE STATE: NJ ZIP: 07762 FORMER COMPANY: FORMER CONFORMED NAME: MEDI HUT CO INC DATE OF NAME CHANGE: 19990816 8-K 1 v080219_8k.htm
UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
 
WASHINGTON, D.C. 20549
 
FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15 (d) of the
Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):
 
June 29, 2007
 
SCIVANTA MEDICAL CORPORATION

(Exact name of registrant as specified in charter)
 
Nevada
000-27119
22-2436721
(State or other jurisdiction of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
 
215 Morris Avenue, Spring Lake, New Jersey
07762
(Address of principal executive offices)
(Zip Code)
 
Registrant’s telephone number, including area code: (732) 282-1620
 

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

[ ]
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
[ ]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
[ ]
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
[ ]
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 

 
Section 1 - Registrant’s Business and Operations
 
Item 1.01 Entry into a Material Definitive Agreement
 
On June 29, 2007, Scivanta Medical Corporation (“Scivanta”) and Ethox International, Inc. (“Ethox”) entered into a development agreement whereby Ethox will provide Scivanta engineering and development support for the catheter component of the HCMS in exchange for the rights to manufacture the component upon regulatory approval and commercialization of the HCMS and a cash payment of $187,500 to be made in connection with the technology incentive program funding discussed below. The development agreement has a two year term which may be extended up to six additional months. The services to be provided by Ethox include: (1) the management of project costs and schedule, (2) the development of system functional specifications based on marketing inputs, (3) the development of disposable catheter specifications to achieve functional requirements, (4) the manufacturing of disposable catheters in accordance with applicable requirements for clinical trials, and (5) the provision of regulatory resources for the management of clinical submissions for marketing approval from the United States Food and Drug Administration and the European Medicines Agency. Pursuant to the development agreement, Scivanta is responsible for the selection and costs of all raw materials and for the packaging design. During the term of the development agreement and for a period of twelve months thereafter, Ethox will not participate in the design, development, creation or production of a double balloon catheter to be used as part of a cardiac monitoring system. The development agreement also contains standard provisions regarding indemnification and termination.
 
Terms for the manufacturing of the catheter component of the HCMS are contained in a supply agreement which will be entered into by Scivanta and Ethox upon regulatory approval of the HCMS. The form of the supply agreement has been attached as a schedule to the development agreement. The supply agreement will have a four year term commencing on the date of the first commercial production of the catheter component of the HCMS, and thereafter shall renew on an annual basis unless terminated by either party in accordance with the supply agreement. The supply agreement will also contain a pricing schedule and provides for an additional payment to Ethox of up to $535,000.
 
Also, on June 29, 2007, Scivanta amended its Technology License Agreement dated November 10, 2006 with The Research Foundation of the State University of New York, for and on behalf of the University of Buffalo (the “Foundation”), and Donald D. Hickey, M.D. (“Hickey”) and Clas E. Lundgren, M.D., Ph.D. (“Lundgren”). Pursuant to the amended Technology License Agreement, the Foundation, Hickey and Lundgren were permitted to enter into a non-exclusive manufacturing license agreement with Ethox, also dated June 29, 2007, whereby Ethox was granted the right to manufacture the catheter component of the HCMS for Scivanta. As a result of these agreements, the development of the HCMS will now be partially funded through a technology incentive program contract awarded by the New York State Office of Science Technology and Academic Research to the Foundation and the Foundation’s company partner, Ethox. Up to $750,000 is available under this incentive program for the development of the HCMS. Ethox is required to match the $750,000 of proceeds available under the incentive program by providing $187,500 of cash and $562,500 of in-kind contributions. Pursuant to the development agreement between Scivanta and Ethox dated June 29, 2007, Scivanta will provide Ethox with the $187,500 of cash required under the technology incentive program while Ethox will provide the $562,500 of in-kind contributions. The technology incentive program funding will primarily support the catheter and software development of the HCMS by New York State based Ethox and Applied Sciences Group, Inc. (“ASG”).
 
 
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In addition, on July 2, 2007, Scivanta entered into a development agreement with ASG. Pursuant to the terms of this agreement, ASG will provide software engineering services to Scivanta on the continuing development of the HCMS. The fees being charged by ASG related to this agreement could range between $335,000 and $400,000. Scivanta can terminate the agreement at any time upon written notification.
 
Section 9 - Financial Statements and Exhibits
 
Item 9.01. Financial Statements and Exhibits.
 
(d)  Exhibits:

Exhibit
 
Number
Description
   
10.17
Product Development Agreement, dated June 29, 2007, between Scivanta Medical Corporation and Ethox International, Inc. including Schedule 2.4 - Form of Agreement to Manufacture Disposable Catheters. Upon the request of the SEC, Scivanta agrees to furnish copies of each of the following schedules: Schedule 2.1 - Project Costs and Schedule; Schedule 2.2 - System Hardware and Software Specifications; and Schedule 2.3 - Disposable Catheter Specifications.
   
10.18
Addendum to the Technology License Agreement, dated November 10, 2006, between Scivanta Medical Corporation and The Research Foundation of State University of New York, for and on behalf of the University at Buffalo, and Donald D. Hickey, M.D. and Clas E. Lundgren, dated June 29, 2007.
   
10.19
Software Engineering Agreement, dated July 2, 2007, between Scivanta Medical Corporation and Applied Sciences Group, Inc.
   
99.1
Press Release Re: Scivanta Medical Corporation Enters into Agreements for the Development of the Hickey Cardiac Monitoring System

 
 
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SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
   
SCIVANTA MEDICAL CORPORATION
(Registrant)
     
    By:  /s/ David R. LaVance                           
   
David R. LaVance
Chairman of the Board, President and
Chief Executive Officer 
 
Date: July 3, 2007
 

 
 
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EXHIBIT INDEX
 
Exhibit
 
Number
Description
   
   
10.17
Product Development Agreement, dated June 29, 2007, between Scivanta Medical Corporation and Ethox International, Inc. including Schedule 2.4 - Form of Agreement to Manufacture Disposable Catheters. Upon the request of the SEC, Scivanta agrees to furnish copies of each of the following schedules: Schedule 2.1 - Project Costs and Schedule; Schedule 2.2 - System Hardware and Software Specifications; and Schedule 2.3 - Disposable Catheter Specifications.
   
10.18
Addendum to the Technology License Agreement, dated November 10, 2006, between Scivanta Medical Corporation and The Research Foundation of State University of New York, for and on behalf of the University at Buffalo, and Donald D. Hickey, M.D. and Clas E. Lundgren, dated June 29, 2007.
   
10.19
Software Engineering Agreement, dated July 2, 2007, between Scivanta Medical Corporation and Applied Sciences Group, Inc.
   
99.1
Press Release Re: Scivanta Medical Corporation Enters into Agreements for the Development of the Hickey Cardiac Monitoring System


EX-10.17 2 v080219_ex10-17.htm
EXHIBIT 10.17
 
SCIVANTA MEDICAL CORPORATION
 
PRODUCT DEVELOPMENT AGREEMENT
 

 
This Product Development Agreement (this “Agreement”) is made by and between Ethox International, Inc. (“Ethox”), a New York corporation with a principal place of business at 251 Seneca Street, Buffalo, NY 14204, and Scivanta Medical Corporation (“Scivanta”) a Nevada corporation with a principal place of business at 215 Morris Avenue, Spring Lake, NJ 07762, as follows:
 
1.            
Objective
 
Scivanta is hiring Ethox for the purpose of the engineering and development of the Hickey Catheter Monitoring System (“HCMS” or the “Product”) as a commercial medical device using the licensed intellectual property assigned and/or granted to Scivanta. It is the intent of the parties that Ethox shall be responsible for engineering of commercial units of the HCMS based upon specifications jointly determined by Scivanta and Ethox, creation and maintenance of all documentation, files and paperwork necessary for obtaining United States Food and Drug Administration (“FDA”) approval, European Medicines Agency (“EMEA”) approval, and all other governmental and regulatory agency approvals required for Scivanta’s exploitation of the HCMS.
 
2.            
Scope and Term
 
Scivanta hereby appoints Ethox solely and exclusively to perform the work set forth below (collectively, the “Proposal”).
 
2.1          
Management of project costs and schedule (as set forth on Schedule 2.1 attached hereto);
 
2.2          
Development of system functional specifications (“Level I requirements”) based on marketing inputs (as set forth on Schedule 2.2 attached hereto);
 
2.3          
Development of disposable catheter specifications (“Level II requirements”) to achieve functional requirements (as set forth on Schedule 2.3 attached hereto);
 
2.4          
Manufacture of disposable catheters in accordance with Level I and Level II requirements for clinical trials, system integration testing and market launch pursuant to a supply agreement in the form set forth on Exhibit 2.4 attached hereto;
 
2.5          
Provide regulatory resources for management of clinical submission of marketing approval from FDA and the EMEA;
 
All such work shall be performed in accordance with this Agreement. Any changes in scope will require a written assessment of impact on cost and schedule and written approval by both parties in advance of work commencing on such revisions. This Agreement shall begin upon the execution date set forth below (the “Effective Date”) and unless sooner terminated by the parties as set forth in Section 25 below, shall remain in effect for two (2) years from Effective Date, unless otherwise extended by parties; provided, however, that if the application for approval to market the HCMS (i.e., a 510(k) application) is pending at FDA at the time this Agreement would normally expire, then the expiration date shall be tolled for that period of time the FDA has such application under review, but not for longer than six (6) additional months.
 
 
 

 
 
3.            
Device / Design Classification
 
The device is not yet classified. It is anticipated the device will be classified as FDA Class II, pre-market approval 510(k) required.

4.            
Design Control
 
4.1          
Design control will be in accordance with Ethox standard operating procedure 151. Product and process requirements will be developed in accordance with Ethox design control procedures. Ethox represents and warrants that Ethox’s standard operating procedures (“SOP’s”), design control procedures, and validation procedures for the term of this Agreement are currently, and shall remain, in compliance with all applicable laws, government regulations, government manufacturing standards including but not limited to FDA requirements, International Organization for Standardization (“ISO”) requirements and other applicable certification standards. Upon Scivanta’s request, Scivanta or Scivanta’s designee shall have the right to audit the SOP’s and related procedures to ensure Ethox’s compliance. In the event that Scivanta’s audit reveals a variation that renders Ethox’s SOP or other procedures non-compliant, Ethox shall remedy the variance within a reasonable time period at Ethox’s cost.
 
4.2          
A design history file (“DHF”) will be compiled to document the design and development activities of the Product. Such DHF shall have all of the detail necessary for each required FDA filing and all other regulatory filings relating to the Product. All such records shall be retained and maintained by Ethox for a minimum of ten (10) years from the execution date of this Agreement. The DHF will include at a minimum a: a) approved design and development plan; b) design inputs; c) design outputs; d) design verification and validation; e) design transfer; f) design control minutes; g) design change control; and h) pertinent correspondence.
 
4.3          
The DHF shall also include laboratory notebooks, engineering study reports, interim schedules, or other documents related to the design and development plan.
 
5.            
Project Management
 
Communications are the key element to coordination of project schedules. This will be a joint effort with Scivanta and Ethox. The initial project timelines (“Design and Development Plan”) will be a collaborative effort within the defined scope of the project. Progress update meetings, held at least weekly, are required to update the project schedules. These may be held at Ethox in person or via telephone conference. Ethox's project engineer or project manager will document all meetings.
 
Ethox will, at the discretion of Scivanta, act as the project management agent of Scivanta for the hardware and software projects associated with this program. Ethox will coordinate and direct the activities of the subcontractors as required, including participation in meetings, telephone calls, presentations, emails, faxes, or other communications to insure timely completion of project and program tasks.
 
 
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6.            
Project Budget/Payment Terms
 
6.1          
Scivanta shall provide a total of One Hundred Eighty Seven Thousand Five Hundred Dollars ($187,500) in cash to Ethox as a “Company Partner” cash contribution defined by and in accordance with the Research Agreement between the Research Foundation of State University of New York and Ethox effective as of June 29, 2007 (the “Foundation Agreement”). This cash contribution shall be paid by Ethox to the University of Buffalo as Company Partner cash pursuant to Section 5 of the Foundation Agreement. Ethox will provide services related to the development of the catheter component of the HCMS as in-kind company contributions and will pay expenses in direct support of the project in accordance with the Foundation Agreement. Ethox will direct the reimbursement of project costs expenditures to Foundation according to the budget developed and submitted for the New York State Office of Science and Technology and Academic Research Technology Transfer Incentive Program Work Plan. Except as otherwise provided for in this Agreement, Scivanta shall have no obligation or liability for reimbursement of Ethox’s expenses related to this project. Further, unless otherwise agreed, Ethox shall provide Scivanta with notice of receipt of payments or funds transfers from Scivanta designated for payment to third parties and shall be responsible for making Scivanta’s payments to third parties as directed by Scivanta. Ethox agrees that it shall wire money intended for third parties within twenty-four (24) hours of the availability of funds from Scivanta. Further, Ethox shall not have any right to off-set or otherwise reduce payments made or funds delivered by Scivanta to Ethox that are intended for third parties.
 
6.2          
To the extent that other payments are due and owing between the parties, the parties agree that payment shall be made to the other party within thirty (30) days of receipt of an invoice detailing the amounts due.
 
7.            
Design Validation
 
Scivanta is responsible for determining the product functions required for clinical efficacy. Ethox will assist Scivanta to translate and document these product requirements into system and device specifications for Ethox’s prototyping and manufacturing. Ethox is responsible for engineering, testing and manufacturing of prototypes and products to assure functional specifications are met. Ethox is further responsible for the completion of all tasks necessary to obtain FDA and EMEA approval, as well as any other regulatory approval needed for the HCMS. Scivanta is responsible for clinical testing of prototypes and products to assure market requirements are met.
 
8.            
Process Validation
 
All validation activities (installation qualification, operational qualifications & process qualifications), as reasonably deemed necessary by Ethox, will be performed in accordance with Ethox's existing procedures and work instructions and shall be sufficient for FDA and EMEA qualifications. Scivanta shall have the right to overrule Ethox’s determination that a given validation activity is necessary for the project. Scivanta's written approval, where deemed necessary, will be required within five (5) business days from Scivanta’s receipt of the request for such approval. Any delay will result in possible adjustments to current project/purchase order due dates. Scivanta shall be solely responsible for any product, equipment, or regulatory non-conformances linked to Scivanta specified validations. Ethox’s and Scivanta's written approval will be required for all Scivanta specified validations.
 
 
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9.            
Materials
 
Material selection and specifications are the responsibility of Scivanta. Ethox will assist in this process as required within the scope of this Agreement. Scivanta is responsible for all raw material costs. Scivanta approval is required for any large minimum buy quantities for raw materials. In case of design change or project termination, Scivanta is responsible for residual material costs.
 
10.          
Tooling
 
Any such tooling and fixtures under this Agreement that are paid for by Scivanta will be the property of Scivanta. Any tooling and fixtures under this Agreement paid for by Ethox will remain the property of Ethox. Scivanta shall have the right, at any time during the term or after expiration or termination of this Agreement, to purchase any tooling owned by Ethox and used exclusively to provide the services hereunder at a price equal to the greater of fair market value (as determined by a third party selected by Scivanta and acceptable to Ethox at Ethox’s expense) or book value as recorded by Ethox in its corporate books and records, in accordance with accounting principles generally accepted in the United States of America. Upon Scivanta’s request, and at Scivanta’s cost and expense, Ethox shall pack and ship the purchased tooling and equipment to Scivanta. All tooling will be assigned a tool number for control within Ethox's tooling control systems. Periodic calibrations, if required, will be the responsibility of the owner of the tooling and fixtures. Ethox can provide calibration services on an "as quoted" basis. Routine maintenance for all tooling and fixtures at Ethox will be the responsibility of Ethox. Repairs, refurbishment, or replacement costs due to normal wear and tear will be the responsibility of the owner. Such repairs, refurbishment, or replacement that is due to negligence on the part of Ethox or its employees will be the responsibility of Ethox. Storage of tooling is the responsibility of Ethox. If tooling becomes inactive for a period of twelve (12) months or more, Ethox reserves the right to charge for such storage or to ship them to the storage location designated by the owner.
 
11.          
Equipment
 
Ethox owns and maintains a variety of manufacturing equipment. Ethox personnel will determine the suitability for use on the project. Any Ethox-owned equipment used on the project will remain the property of and responsibility of Ethox regardless of termination. If additions or modifications are required to Ethox-owned equipment, the cost for such will be the responsibility of Ethox and Ethox will own such additional parts. Ethox agrees that any equipment modification or addition, or process modification made for the project and that is useful or necessary for manufacturing the Product shall be licensed to Scivanta at Scivanta’s request. Such license from Ethox to Scivanta shall be a royalty-free, non-exclusive perpetual, worldwide license. Periodic calibrations, if required, will be the responsibility of the owner of the equipment. Ethox can provide calibration services on an "as quoted" basis. Routine maintenance for all equipment at Ethox will be the responsibility of Ethox. Repairs, refurbishment, or replacement costs due to normal wear and tear will be the responsibility of the owner. Such repairs, refurbishment, or replacement that is due to negligence on the part of Ethox or its employees will be the responsibility of Ethox. Storage of equipment is the responsibility of Ethox. If Scivanta-owned equipment becomes inactive for a period of twelve (12) months or more, Ethox reserves the right to charge for such storage or to ship them to the storage location designated by the owner.
 
 
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12.          
Facilities
 
Ethox is responsible to maintain its facilities in compliance with applicable quality, statutory and regulatory standards. Costs for facilities maintenance and repairs, refurbishment, or replacement of equipment necessary to maintain such compliance are the responsibility of Ethox. In the event that the project requires additional controls, or supplemental equipment to achieve such standards, the associated costs will be the responsibility of Scivanta; provided however, that no additional controls or supplemental equipment will be implemented without the prior written consent of Scivanta.
 
13.          
Packaging / Labeling
 
Scivanta shall be responsible for the packaging design and integrity of all Scivanta specified packaging. Scivanta shall be responsible for all labeling content, adequacy, accuracy, design, integrity, legibility, location/placement, and claims made in all labeling. Ethox shall provide guidance and assistance to Scivanta regarding the FDA packaging and labeling requirements and work with Scivanta to comply with same. Scivanta shall provide written approval for all artwork masters used to inspect and accept labeling at Ethox. All labeling will be inspected and accepted based upon Scivanta approved artwork master. Shipment of "non-sterile” Product labeled as "sterile" will be in accordance with a separate non-sterile shipping agreement. Separate non-sterile shipping agreements will be executed between Ethox and a sterilizer, and sterilizer and Scivanta. Ethox to be responsible for storage and inspection of raw materials, packaging and labeling, unless otherwise specified. Any labeling and/or packaging deviations, such as over-labeling, shall require Scivanta's written approval.
 
14.          
Testing
 
“Testing” means any inspection or laboratory service required for the approval, acceptance and release of raw materials or finished goods, up to and including testing relating to design validation, incoming inspections, quality assurance, quality control and sterility / packaging assurance.
 
Ethox provides a range of testing services for the purpose of incoming acceptance, shelf-life expiration dating, sterility assurance and biocompatibility of medical devices. So long as such testing services are available through the Ethox Laboratory Services Department or Quality Control Department, Ethox will provide such services to the Scivanta in accordance with the terms and conditions of this Agreement. It shall be the responsibility of the Ethox to organize and execute all requested testing service(s) that are offered to Scivanta. If a laboratory test is unavailable through Ethox Laboratory Services Department or Quality Control Department, Scivanta may direct Ethox to utilize an outside vendor. However, it is the sole responsibility of Scivanta to identify the vendor for such services and to accept all related charges associated with testing. Scivanta may also choose an Ethox pre-approved vendor for such services. Scivanta will be responsible for the reimbursement of all costs to Ethox for the coordination and execution of such testing services. Ethox, if contracted to do so, will execute the applicable requested testing services at the assigned price to Scivanta and to the applicable industry guidelines, standards, requirements and regulations. Scivanta agrees to make available the required material and/or finished goods to complete the requested testing and all cost shall be the responsibility of Scivanta, unless otherwise agreed to.
 
 
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Testing requiring the preparation of a study protocol and final report will require written approval by Scivanta, confirming review, understanding and acceptance of the conditions provided. Ethox will not execute any studies without Scivanta's approval. Samples submitted for testing purposes will be destroyed by Ethox at the conclusion of the test, unless Scivanta provides Ethox with written instructions for special disposal. Costs of disposal beyond general landfill will also be the responsibility of Scivanta in addition to all associated costs. Samples requiring the return to Scivanta following the completion of all testing must be done so by written request. Scivanta shall incur all costs associated with sample return including but not limited to disinfecting, sterilization, packaging and shipping.
 
15.          
Sterilization
 
“Sterilization” means the process by which all viable forms of microorganisms are destroyed. Processes include ethylene oxide (“EO”, “ETO”), gamma, electron beam (“E-beam”), steam, dry heat, and chemical sterilization.
 
Ethox provides EO sterilization services for the purpose of applying a sterility assurance level as required for the release and sale of medical devices. Ethox will provide such services at the request of Scivanta. It shall be the responsibility of Ethox to organize and execute all requested sterilization service(s) that are offered to Scivanta. If the method of process is unavailable through Ethox, Scivanta may direct Ethox to utilize an outside vendor. However, it is the sole responsibility of Scivanta to identify the vendor for such services and to accept all related charges associated with sterilization processing. Scivanta will be responsible for the reimbursement of all costs to Ethox for the coordination and execution of such services. Where undertaken by Ethox, Ethox will execute the applicable requested sterilization services at the assigned price to Scivanta and to the applicable industry guidelines, standards, requirements and regulations (See Equipment for ownership and responsibilities). Scivanta agrees to make available the required material and/or finished goods to complete required validation and routine sterilization, and all cost shall be the responsibility of Scivanta.
 
Sterilization validations require the preparation of a study protocol and final report and require written approval by Scivanta, confirming review, understanding and acceptance of the conditions provided. Ethox will not execute any validation studies without Scivanta's approval. It shall be the responsibility of Scivanta to initiate and maintain all annual or quarterly (if applicable) required validation activity.
 
16.          
Prototypes
 
A prototype or sample will be labeled as "Non-Sterile Sample, Not for Human Use" on the unit package. Clinical use prototypes will be manufactured and labeled in accordance with applicable regulations regarding the manufacture, use, and traceability of such devices.
 
17.          
Quality System And Regulatory Audits
 
Ethox agrees to manufacture products in accordance with applicable laws and regulations, including but not limited to FDA Quality System Requirements, ISO 13485, and other applicable quality system requirements Ethox deems necessary to hold and/or certify.
 
 
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Scivanta has the right to conduct audits of Ethox’s related facilities and systems from time to time to ensure compliance. Such audits must be scheduled with Ethox's personnel with reasonable notice (twenty (20) days requested). An advance copy of the audit checklist is also requested to facilitate a timely audit.
 
18.          
Regulatory / Marketing Compliance
 
The parties agree and acknowledge that Scivanta is hiring Ethox for the purpose of engineering the Product to Scivanta’s specifications and assisting Scivanta in obtaining FDA and EMEA approvals as well as any other necessary regulatory approval for the Product. Scivanta is legally responsible for each and all regulatory applications, filings, submittals, and documentation required to legally market, advertise, or otherwise sell or distribute the Product. Ethox shall be contractually responsible for the preparation and filing of all such regulatory documentation on behalf of Scivanta in accordance with the terms and conditions of this Agreement.
 
Ethox provides regulatory services for the purpose of applying for the release and sale of medical devices. Ethox will provide such services in accordance with the terms and conditions of this Agreement. It shall be the responsibility of Ethox to organize and execute such service(s) that are offered to Scivanta as set forth in this Agreement or otherwise offered to Scivanta by Ethox hereunder. If the method of process is unavailable through Ethox, Scivanta may direct Ethox to utilize an outside vendor. Scivanta may also choose an Ethox pre-approved vendor for such services. However, it is the sole responsibility of Scivanta to identify the vendor for such services and to accept all related charges associated with the outside vendor. Scivanta will be responsible for the reimbursement of all costs to Ethox for the coordination and execution of such services. If undertaken by Ethox, Ethox will execute the applicable services at the assigned price to Scivanta pursuant to a quote or contract, and to the applicable industry guidelines, standards, requirements and regulations. Scivanta agrees to make available the required material and/or finished goods to complete required testing, and all cost shall be the responsibility of Scivanta, unless otherwise agreed to.
 
19.          
Change Control
 
“Change Control” means procedures for identification, documentation, review, validation and/or verification, and approval of changes to documents, processes, or designs so as to establish and document the applicable development activities.
 
a.  
General. All changes to product, processes, components, labeling & packaging, equipment, and all associated documentation, such as specifications, drawings, Device Master Records, artwork masters, shop travelers and work instructions, will be processed in accordance with Ethox's current change control procedures and work instructions.
 
Scivanta is responsible for reviewing and evaluating impact of change(s) on the following: regulatory submissions/pre-market notification (510K impact); sales literature; Product in the field; safety & effectiveness; biocompatibility. All drafts and proposals submitted to Scivanta pursuant to this Section 18 shall be deemed “Information” subject to the limitations regarding disclosure and use set forth in Section 26 hereof.
 
Ethox is responsible to review and evaluate each change's impact on validation or re-validation. Refer to the Design Validation and Process Validation sections of this Agreement if a determination that validation or re-validation is required.
 
 
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b.  
Scivanta Request for Change. Scivanta's change request shall be signed by an officer of Scivanta and submitted to the Ethox Project Manager. Ethox's Engineering Department will evaluate Scivanta's change requests and determine Ethox Requirements and provide approval for each proposed Scivanta change. Ethox will provide Scivanta with an implementation schedule, plan, costs and any additional items required to implement change. If requested by Scivanta, Ethox will provide a copy of the approved change document after implementation at Ethox.
 
c.  
Temporary Changes. Temporary changes will be processed in accordance with Ethox’s current non-conforming material/process procedures and work instructions. Scivanta’s written approval is required for all temporary changes prior to implementation.
 
d.  
Cost Impact. Ethox will provide quotes to Scivanta for any changes impacting unit price (change to process, material, sterilization, etc.), and/or residual charges (obsolescence), and/or purchase order cancellations. Scivanta will provide a revised/new purchase order within five (5) business days from receipt of quote. Any delay will result in production and/or project stoppage until receipt of the purchase order.
 
e.  
Change Approval. Changes initiated by Ethox affecting form, fit, or function, require Scivanta's prior written approval. Scivanta will provide written approval within five (5) business days from receipt. Any delay in Scivanta’s approval may result in possible adjustments to project or applicable purchase order completion dates.
 
f.  
Schedule Impact. Ethox will review each change's impact on current orders and provide Scivanta with an effective date for the implementation of each change. If Scivanta requires an immediate change, Ethox will evaluate the impact on project/manufacturing schedule and provide Scivanta with revised due dates accordingly.
 
20.          
Force Majeure
 
No liability shall result to either party from delay in performance or from non-performance caused by circumstances beyond the control of the affected party, including, but not limited to, acts of God, fire, flood, explosion, war, acts of terrorism, governmental action or inaction or request of governmental authority, accident, strike, lockout; but each of the parties shall be diligent in attempting to remove such cause or causes and shall promptly notify the other party of its intent and probable duration. If the non-performing party who has delayed performance or not performed because of circumstances beyond its control is unable to remove the cause within thirty (30) days or if removal of the cause cannot reasonably be accomplished in thirty (30) days, has not commenced removal and diligently thereafter pursued such removal, and such cause has not been removed within ninety (90) days, the other party shall have the right to terminate this Agreement or any portion of it without penalty, except for any provisions which survive the termination of this Agreement pursuant to Section 29 hereof, but subject to both parties’ obligations as a Recipient set forth in subsection 27.
 
 
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21.         
Indemnification
 
a.  
Ethox shall indemnify, defend and hold harmless Scivanta and its affiliates and their officers, directors and employees from and against any and all claims, losses, damages, judgments, costs, awards, settlements, expenses (including reasonable attorneys’ fees) and liabilities of every kind (collectively, "Losses") arising directly out of or resulting directly from: (a) any breach by Ethox of any of its warranties, guarantees, representations, obligations or covenants contained herein; (b) any negligence or intentional acts or omissions by Ethox or its employees, and/or agents; (c) any actual or alleged infringement by Ethox of any patent, copyright, trade secret or other intellectual property right or other proprietary right of any third party in connection with the provision of services to Scivanta under this Agreement; (d) any product liability claim arising out of or relating to defects in Ethox’s or its employees and/or agents, workmanship, engineering or DHF documentation in regard to the Products and (e) any claim arising out of or relating to federal, state and local taxes or contributions imposed or required under unemployment insurance, social security and income tax laws with respect to the performance of services by Ethox under this Agreement. Scivanta will give Ethox prompt notice of any such claim and will cooperate with Ethox, at Ethox’s expense, in the defense of the claim. While Ethox will have sole control over the defense, Ethox may not settle the claim in the name of Scivanta without Scivanta’s prior written consent, which Scivanta will not unreasonably withhold.
 
b.  
Scivanta shall indemnify and hold harmless Ethox and its Affiliate and their officers, directors and employees from and against any and all Losses arising directly out of or resulting directly from (a) any breach by Scivanta of any of its obligations or covenants contained herein; (b) any negligence or intentional acts or omissions by Scivanta or its employees, and/or agents; (c) any actual or alleged infringement by Scivanta of any patent, copyright, trade secret or other intellectual property right or other proprietary right of any third party in connection with the Products; and (d) any product liability claim arising out of or relating to defects in the design or function of the Products hereunder.
 
c.  
At Scivanta’s expense, Scivanta will defend, indemnify and hold harmless Ethox and its Affiliates and their officers, directors and employees from any Losses arising directly out of or resulting directly from any claim that (a) the design or manufacture of any of the Products using the intellectual property assigned and/or granted to Scivanta, other than the use of any intellectual property provided to Scivanta by Ethox (b) any engineering or manufacturing processes Scivanta directs Ethox to use, or (c) any materials or components required by Scivanta to be used in or with the Products, infringes any third party’s patent, copyright, trade secret or any other intellectual property right. Ethox will give Scivanta prompt notice of any such claim after Ethox learns of it and will cooperate with Scivanta, at Scivanta’s expense, in the defense of the claim. While Scivanta will have sole control over the defense, Scivanta may not settle the claim in the name of Ethox without Ethox’s prior written consent, which Ethox will not unreasonably withhold.
 
d.  
In the event of an infringement claim described above, Ethox may stop production of the applicable Products immediately pending adequate assurances from Scivanta of Scivanta’s ability to meet the on-going indemnity outlined above.
 
e.  
Scivanta shall also indemnify and hold harmless Ethox and its Affiliates and their officers, directors and employees from and against any and all Losses arising directly out of or resulting directly from any claim regarding the claims and clinical efficacy of the device in any of its instructions or literature, and any injury or claim as a result of the realization of product design for the purposes of clinical use, except to the extent that such product design was based on intellectual property provided to Scivanta by Ethox.
 
 
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f.  
Each indemnified party agrees to give the indemnifying party prompt written notice of any matter upon which such indemnified party intends to base a claim for indemnification (an "Indemnity Claim"). The indemnifying party shall have the right to participate jointly with the indemnified party's defense, settlement or other disposition of any Indemnity Claim. With respect to any Indemnity Claim relating solely to the payment of money damages and which could not result in the indemnified party's becoming subject to injunctive or other equitable relief or otherwise adversely affect the business of the indemnified party in any manner, and as to which the indemnifying party shall have acknowledged in writing the obligation to indemnify the indemnified party hereunder, the indemnifying party shall have the sole right to defend, settle or otherwise dispose of such Indemnity Claim, on such terms as the indemnifying party, in its sole discretion, shall deem appropriate, provided that the indemnifying party shall provide reasonable evidence of its ability to pay any damages claimed and with respect to any such settlement shall have obtained the written release of the indemnified party from the Indemnity Claim. The indemnifying party shall obtain the written consent of the indemnified party, which shall not be unreasonably withheld, prior to ceasing to defend, settling or otherwise disposing of any Indemnity Claim if as a result thereof the indemnified party would become subject to injunctive or other equitable relief or the business of the indemnified party would be adversely affected in any manner.
 
22.          
Representations And Warranties
 
a.  
Ethox warrants that the Products engineered, manufactured and/or assembled for Scivanta under this Agreement will be, at the time of delivery to Scivanta, free from any liens or other defects in title, will conform to Scivanta’s specifications, and will be free from material defects in workmanship (and materials, if Ethox is responsible for procuring materials from its own sources) under normal use and service. Ethox warrants that the work shall be in accordance with Scivanta specifications and work instructions. Ethox represents and warrants that it is duly organized, validly existing and in good standing under the laws of the State of incorporation and that this Agreement has been duly authorized, executed and delivered by Ethox. Ethox represents and warrants that the terms of this Agreement and its performance of the services hereunder will not breach or conflict with any agreement or other obligation by which Ethox is bound. Ethox will not, however, be responsible for, and this warranty will not apply to, any defects in the Products arising out of design or specification or the use of materials or components that Scivanta furnished to Ethox or directed Ethox to use. A claim under this warranty must be made by Scivanta in writing within twelve (12) months from the date of delivery of the applicable unit(s) of Product. Ethox may fulfill its obligation to Scivanta under this warranty, and Scivanta’s sole remedy hereunder shall be, as follows:
 
i.  
Ethox will repair or replace without charge to Scivanta any unit of the Products found to be defective within the terms of this warranty if Scivanta returns it, freight prepaid, to Ethox. Repaired or replaced Product will carry this same warranty for the balance of the warranty period.
 
ii.  
Ethox will not be required to ship replacement Products until Ethox has confirmed through examination that the returned unit(s) is defective within the terms of this warranty. Such examination shall be completed by Ethox within fourteen (14) days of receipt of the returned unit(s). If such examination is not completed within fourteen (14) days, returned product shall be deemed defective and Ethox must repair or replace the unit(s) without charge to Scivanta in accordance with Section 21.1.1, above. Ethox will pay freight costs to ship any repaired or replacement unit(s) to Scivanta.
 
 
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iii.  
This warranty does not apply to any defect attributed to purchased components specified by Scivanta, or to any unit(s) of Product which Ethox reasonably determines has been subjected by a party other than Ethox to (i) operating or environmental conditions beyond those normally expected for the Product based upon the materials specified; or (ii) improper application, improper maintenance or repair, improper installation, alteration, accident or any other negligent act or omission in use or handling.
 
iv.  
Units of Product returned to Ethox which Ethox reasonably determines are not defective within the terms of this warranty will be returned to Scivanta, and Scivanta will reimburse Ethox upon invoice for return transportation charges and Ethox’s normal hourly charge applicable to inspection of the unit.
 
v.  
Purchased components of the Products specified by Scivanta are warranted only to the extent, and subject to the terms of the original warranty given by the manufacturer to Ethox. To the extent assignable Ethox shall assign such warranties to Scivanta. Ethox’s sole obligation with respect to such components shall be, at Scivanta’s expense, to prosecute on behalf of Scivanta all warranty claims against such component manufacturers upon receipt of written authorization of Scivanta.
 
REMEDIAL ACTION AS PROVIDED HEREIN SHALL CONSTITUTE FULFILLMENT OF ALL LIABILITIES OF ETHOX TO SCIVANTA AND SCIVANTA’S SOLE REMEDY HEREUNDER, WHETHER BASED ON CONTRACT, TORT, OR OTHERWISE. UNDER NO CIRCUMSTANCES WILL ETHOX BE LIABLE FOR REPROCUREMENT COSTS, LOST REVENUES OR PROFITS, OR FOR ANY INDIRECT, SPECIAL, INCIDENTAL, ECONOMIC OR CONSEQUENTIAL DAMAGES, EVEN IF THEY WERE FORESEEABLE OR SCIVANTA HAD INFORMED ETHOX OF THEIR POTENTIAL.
 
b.  
EXCEPT FOR THE WARRANTIES SET FORTH IN THIS SECTION 21, ETHOX MAKES NO OTHER WARRANTY OR REPRESENTATION OR ANY OTHER STATEMENT, PROMISE, WARRANTY. EXCEPT FOR FDA AND EMEA COMPLIANCE, SCIVANTA ACKNOWLEDGES IT HAS NOT RELIED UPON ANY STATEMENT OF ETHOX OR ANY EMPLOYEE, AGENT, OR REPRESENTATIVE THEREOF IN RESPECT OF THE PRODUCTS HEREUNDER. COMPLIANCE WITH THE LAW, CODES, AND REGULATIONS RELATING TO THE USE OF THE PRODUCTS REMAINS THE SOLE RESPONSIBILITY OF SCIVANTA.
 
c.  
Scivanta’s exclusive remedies with respect to Ethox’s performance or non-performance under this Agreement are those expressly stated in this Agreement and except as expressly stated in this Agreement, Ethox will not be liable for any damages claimed by Scivanta based upon any third party claim.  
 
 
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23.          
Limitation Of Liability
 
Scivanta will be solely responsible for all third party intellectual property infringement claims and liability claims related to the design, specifications, use, functionality, and safety of the Products manufactured and/or assembled by Ethox hereunder, except for personal injury claims based upon defects in Ethox’s workmanship, engineering, manufacture and/or FDA, EMEA and other regulatory compliance tasks under this Agreement. In this regard, Scivanta will defend Ethox from any and all such claims, and indemnify and hold Ethox, its affiliates, directors, officers and employees harmless from all Losses arising from or as a result of such claims. The indemnifying party’s liability under this Section is further subject to the provisions of Section 21 hereof.
 
24.          
Non Assignability
 
Ethox may not assign this Agreement nor delegate performance of its duties or obligations hereunder without the written approval of Scivanta, except to an individual or entity purchasing all or substantially all of its assets used in the performance of its obligations hereunder; provided, however, that no such assignment may be made by Ethox to any party that is or controls or is under common control with a distributor or wholesaler of cardiac monitoring equipment without the written consent of Scivanta. Sale or issuance of shares of Ethox shall not be considered an assignment hereof to the purchaser of such shares, unless the proposed sale or issuance of shares of Ethox in any amount of shares exceeding 25% of the then outstanding shares of Ethox is to be made to a party or parties controlling or under common control with a business distributing cardiac monitoring equipment. Any attempted assignment or delegations in violation of this Section shall be deemed null and void and of no force and effect. Scivanta may assign this Agreement, in whole or in part, without limitation.
 
25.          
Restrictive Covenants
 
a.  
No Solicitation. During the term of this Agreement and for a period of twelve (12) months thereafter, each party agrees that it shall not, directly or indirectly, hire, employ, recruit or solicit for employment any person who is now an employee of the other or hereafter becomes an employee of the other for a period of one hundred-eighty (180) days following the termination of employment of such person.
 
b.  
No Competition. During the term of this Agreement and for a period of twelve (12) months thereafter, Ethox shall not on its own or on the behalf of others, design, develop, create, produce or assist in the design, development, creation or production of a double-balloon catheter to be used as part of a cardiac monitoring system.
 
26.          
Termination
 
a.  
Either party shall be in default of this Agreement if such party:
 
i.  
fails to perform any provision of this Agreement in any material respect; or
 
ii.  
becomes insolvent or makes an assignment for the benefit of creditors, or a receiver or similar officer is appointed to take charge of all or part of that party’s assets.
 
 
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In the event of a default, the non-defaulting party may terminate the Agreement and any outstanding orders if the other party has failed to cure such default within thirty (30) calendar days after its receipt of a notice of default and intent to terminate (or fifteen (15) calendar days in the case of non-payment of money due and owing). Notwithstanding the previous sentence (except with respect to non-payment), if a cure is not possible within such thirty (30) days, and if the defaulting party diligently pursues a cure of such default during such thirty (30) day period and thereafter, then the cure period shall extend up to a total of ninety (90) calendar days. Notwithstanding the foregoing, in the event that a defaulting party commits an additional default during the extended cure period, the non-defaulting party may terminate this Agreement upon the defaulting party’s receipt of notice of the subsequent default.
 
b.  
If Ethox terminates this Agreement due to Scivanta’s default, Scivanta will:
 
i.  
Remove, and pay for in advance that portion of, all unused raw material that Ethox has ordered pursuant to this Agreement and which cannot be returned to its manufacturer for a refund of Ethox’s costs;
 
ii.  
Hold Ethox harmless from all vendor commitments Ethox has made pursuant to this Agreement;
 
iii.  
Remove and pay for all work in process as of the date of termination; and
 
iv.  
Pay Ethox all its costs associated with its performance of its obligations under this Agreement, including its “in-kind” contribution made in accordance with the Foundation Agreement, prior to such termination.
 
c.  
If Scivanta terminates this Agreement due to Ethox’s default, Scivanta will:
 
i.  
Remove, and pay for in advance that portion of, all unused raw material that Ethox has ordered pursuant to this Agreement and which cannot be returned to its manufacturer for a refund of Ethox’s costs;
 
ii.  
Remove all conforming finished Product inventory manufactured to Scivanta purchase orders and pay the price therefor.
 
d.  
Scivanta shall have the right to terminate this agreement upon written notice to Ethox at any time after two (2) years from the date hereof. In the event of such termination by Scivanta, Scivanta shall be obligated as set forth above in a and b of this Section.
 
e.  
During the term of this Agreement, either party may terminate this Agreement upon twenty-one (21) days prior written notice to the other party. In the event of such a termination by Scivanta, Scivanta shall be obligated as set forth above in a and b of this Section.
 
f.  
Except as expressly stated in this Agreement, neither party will be liable to the other for any damages or compensation due to the termination of this Agreement.
 
27.          
Confidential Information
 
It is anticipated that the parties may be required to exchange certain confidential information (hereafter called “Information”) to the other in the course of performing this Agreement. From the date of disclosure, and until ten (10) years following the expiration or earlier termination of this Agreement, the recipient of Information (hereafter called “Recipient”) shall maintain the Information in confidence and limit its use to the purposes contemplated under this Agreement, using at least the same degree of care as it employs to protect its own confidential information of a similar nature, but not less than a reasonable standard of care, provided the Information is identified in writing as confidential at the time of disclosure or, if orally disclosed, is identified as confidential at the time of disclosure and confirmed in writing within twenty (20) days after the oral disclosure. Recipient shall have no obligation hereunder with respect to any Information that is:
 
 
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a.  
generally known to the public at the time of disclosure, or becomes known to the public without breach of this Agreement;
 
b.  
known to the Recipient prior to the disclosure, or is independently developed by the Recipient without reference to or use of any other portion of the Information;
 
c.  
obtained by the Recipient in good faith from a third party not under obligation of secrecy to the disclosing party (hereafter called “Discloser”); or
 
d.  
the subject of a court or government agency order to disclose, provided the Recipient gives prompt notice to the Discloser to allow the Discloser to contest such order.
 
The Recipient shall have the burden of proving that any of the above exceptions apply by means of documentary evidence available at the time Recipient claims the exception first became applicable.
 
Title to all tangible forms of the Information, and all copies thereof, shall be and remain with Discloser. Recipient shall not copy or otherwise reproduce, in whole or in part, any Information without the prior written authorization of Discloser, except as may be reasonably necessary to fulfill the purpose of this Agreement. Recipient shall use reasonable efforts promptly to return or destroy all tangible forms of the Information, and copies thereof, upon Discloser’s request or termination of this Agreement, except that Recipient may retain one archival copy of the Information to be used solely for compliance with Recipient’s obligations under this Agreement.
 
It is understood, however, that Ethox has performed substantial development relating to the design, engineering and manufacture of tooling and equipment and medical devices and that Ethox has relationships with other companies, which may be Scivanta’s competitors. Except as set forth in Section 25b, above, neither this Agreement, nor receipt of Information under this Agreement, shall limit Ethox’s independent development, manufacture, or marketing of products, systems or processes involving technology or ideas similar to those disclosed in the Information. In addition, this Agreement shall not limit Ethox’s use of general ideas, concepts, or techniques contained in the Information in connection with its development, manufacture, and other businesses.
 
Ethox shall not reference its performance of services for Scivanta under this Agreement in any advertising, promotional materials, press releases and the like, without Scivanta’s prior written approval.
 
28.          
Intellectual Property Rights
 
28.1  All intellectual property created by Ethox for Scivanta, jointly or independently, in connection with Ethox’s services hereunder, shall be owned exclusively by Scivanta. Scivanta shall have the absolute right to assign or transfer or sublicense to any third party any intellectual property owned by Scivanta hereunder and any intellectual property owned by or licensed to Scivanta necessary for the use of any of the devices created pursuant to this Agreement.
 
 
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28.2  Ethox agrees: (a) to disclose and assign to Scivanta as its exclusive property all discoveries, inventions and improvements which Ethox or its employees or contractors develop or conceive, solely or in conjunction with others that are based on or involve or relate to or affect the use of Scivanta’s intellectual property; (b) to the extent legally able to do so, assign or sublicense to Scivanta Ethox’s licensed rights to any and all third party intellectual property utilized by Ethox solely in connection with the project or its services for Scivanta hereunder; (c) to execute all necessary documents, including, without limitation, confirmatory documents of assignment, and to provide Scivanta (at Scivanta’s expense) sufficient assistance to confirm, secure and obtain patent, copyright and other legal protections for any such inventions, discoveries and improvements, and to make and maintain reasonably detailed accurate records of any such inventions, discoveries and improvements necessary to accomplish said purpose; and (d) to deliver to Scivanta upon termination or expiration of this Agreement all materials which relate to the business of, or belong to, Scivanta or its clients, or by which their nature are for use of Scivanta’s employees, contractors or consultants.
 
28.3  Ethox hereby assigns to Scivanta all of its right, title and interest in and to any and all “New Technology” (as such terms is defined in the Foundation Agreement) made in part by any person using the State University of New York facilities and in part by Ethox employees, agents, consultants or collaborators without use of the State University of New York facilities.
 
28.4  Nothing in this Section 28 shall diminish Scivanta’s rights to intellectual property as set forth in Section 11 of this Agreement.
 
29.          
Insurance.
 
Each party agrees that it will keep in force and effect the following insurance naming the other as an insured and loss payee during the term of this Agreement: (a) statutory required workers’ compensation insurance, (b) general liability insurance in the amount of $2 Million for each occurrence.
 
30.          
Survival.
 
Sections 4.2, 20, 21, 22, 24, 25, 26, 27, 29 and 30 shall survive the termination, expiration or cancellation of this Agreement.
 
31.          
General
 
a.  
This Agreement, including all of its referenced Schedules attached hereto, constitutes the entire agreement between Scivanta and Ethox with respect to the activities described in the scope of this Agreement. Any terms or conditions contrary hereto contained on printed forms submitted as part of a purchase order, sales acknowledgment or invoice are hereby rejected. It also supersedes all previous oral or written communications between Scivanta and Ethox regarding the development of Products and services described in this Agreement. This Agreement may not be modified except by a written document signed by the party against whom enforcement is sought. If any provision of this Agreement is held invalid, all other provisions will remain valid, unless such invalidity would frustrate the purpose of this Agreement.
 
b.  
No provision of this Agreement shall be deemed waived and no breach excused unless such waiver is made in writing signed by a duly authorized representative of the party making such waiver or consent.
 
 
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c.  
The parties acknowledge and agree that they have thoroughly reviewed this Agreement and bargained over its terms. Accordingly, this Agreement shall be construed without regard to the party responsible for its preparation or form, and shall be deemed to have been prepared jointly by the parties.
 
d.  
This Agreement will be governed by and construed in accordance with the laws of the State of New York without regard to its conflict of laws rules. The parties specifically agree that the United Nations Convention on the International Sale of Goods shall not apply to this Agreement.
 
e.  
This Agreement shall be binding on each party’s respective successors and permitted assigns.
 
f.  
The parties agree that in the event of a dispute between them arising out of, concerning or in any way relating to this Agreement, including its interpretation, which cannot be settled by a good faith effort by the parties to resolve such issue, will be submitted to binding arbitration under the Federal Arbitration Act as amended and in accordance with the Commercial Arbitration Rules then prevailing of the American Arbitration Association (“AAA”). The arbitration will be held in New York County, New York by a panel of three (3) arbitrators appointed pursuant to the AAA rules and judgment upon the award rendered by the arbitrators may be entered into any court having jurisdiction thereof.
 
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives, all intending to be legally bound hereby.
 
 
ETHOX INTERNATIONAL, INC.
SCIVANTA MEDICAL CORPORATION
   
By: /s/ Thomas J. Bienias                                      
By: /s/ Thomas S. Gifford                            
   
Name: Thomas J. Bienias                                       
Name: Thomas S. Gifford                             
   
Title: President & CEO                                           
Title: Executive Vice President & CFO      
   
Date: June 29, 2007                                                 
Date: June 29, 2007                                       

 
 
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Schedule 2.4

Form of Agreement to Manufacture Disposable Catheters

SCIVANTA MEDICAL CORPORATION
 
SUPPLY AGREEMENT
 

This Supply Agreement (this “Agreement”) is made by and between Ethox International, Inc., (“Ethox”), a New York corporation having a place of business at 251 Seneca Street, Buffalo, NY 14204, and Scivanta Medical Corporation (“Scivanta”), a Nevada corporation having a place of business at 215 Morris Avenue, Spring Lake, New Jersey 07762, as follows:

Section 1 Scope of Work

1.1 Ethox and Scivanta agree that the following terms and conditions will govern the purchase by Scivanta of the disposable two balloon esophageal catheter (“Products) to be used as part of the Hickey Cardiac Monitoring System developed under the Product Development Agreement entered into by the parties on June 29, 2007 and the manufacture of certain tooling and equipment (“Tooling and Equipment”) required to manufacture and/or assemble the Products by Ethox hereunder. All Attachments referenced in this Agreement are an integral part of this Agreement. Only the terms of this Agreement will apply to orders for Products or Tooling and Equipment. Pre-printed or other terms and conditions contained in either party’s purchase orders shall not bind the other party and Ethox and Scivanta each objects to and rejects all such provisions therein.

1.2 This Agreement is for Scivanta’s requirements for Products and Scivanta agrees that it shall obtain and purchase Products solely and exclusively from Ethox during the initial term and any renewal term hereof provided that Ethox is able to complete Scivanta’s orders for products in a timely and commercially viable manner.

1.3  All changes to Products, processes, components, labeling and packaging, equipment and all associated documentation, including, but not limited to, specifications, drawings, Device Master Records, art work masters, shop travelers and work instruction and the impact of any such changes on regulatory submissions/premarket notification, sales literature, Product in the field, safety and effectiveness and bio compatibility shall be subject to the review and approval of Scivanta. Any Scivanta request for change shall be in writing signed by an officer of Scivanta. Upon receipt of the requested change, Ethox will provide Scivanta with an implementation schedule, plan, costs and any additional items required to implement the change.

1.4  The parties acknowledge and agree that the Products will be subject to the regulatory requirements of the United States Food and Drug Administration (the “FDA”) and other governmental agencies in all territories in which the Products may be sold or are manufactured, which potentially includes the entire world. Scivanta, as the owner of the Products, shall have certain responsibilities prescribed by such regulatory agencies concerning the Products. Scivanta agrees to establish and maintain such systems, methods and practices as are required to conform
 
 
 

 
 
to such regulations concerning the Products. Ethox, as the manufacturer of the Products pursuant to this Agreement, agrees to be bound by and comply with all applicable governmental regulations, including, without limitation, FDA regulations and the regulations of foreign governmental agencies, concerning the manufacture, record-keeping, quality control and similar regulations. To the extent it is reasonably possible to do so, the parties will accept the systems, methods and practices of Ethox in meeting the respective regulatory obligations, it being understood and agreed that if Scivanta confronts a regulatory issue that is not adequately resolved by the systems, methods and practices then employed by Ethox, the parties will meet and agree as soon as reasonably possible on an alternative course of action to be compliant with the prevailing regulation and will implement such action in a reasonable and timely fashion. The parties further agree that with respect to actions concerning patient safety, product reliability, adverse events and similar events that may occur during the course of the Products’ commercial availability, they will devise and agree upon mutually acceptable, timely and compliant methods and procedures for addressing such matters.

Section 2 Tooling and Equipment - Procurement and Transfer

2.1  Tooling and Equipment manufactured by Ethox in connection with the manufacture of the Product shall have an expected useful life of at least five hundred thousand (500,000) operations or five (5) years, whichever expires first (“Useful Life Period”) and shall meet the specifications of the project. During the Useful Life Period, Ethox shall be responsible for all refurbishment and preventative maintenance of such tooling and equipment. After the expiration of the Useful Life Period, Scivanta shall be responsible for refurbishment of such Tooling and Equipment, as set forth in Section 9 below. Except as specifically set forth above, the Tooling and Equipment are furnished “as is” and Ethox shall have no additional responsibility or liability with respect to the Tooling and Equipment.

2.2  Upon expiration or termination of this Agreement, for any reason by either party hereto, Scivanta shall promptly remove the Tooling and Equipment from Ethox facilities.

2.3 Upon expiration or termination of this Agreement for any reason by either party hereto, Scivanta shall purchase any tooling owned by Ethox and used exclusively to provide Products hereunder at a price equal to the greater of fair market value (as determined by a third party selected by Scivanta and acceptable to Ethox at Ethox’s expense) or book value as recorded by Ethox in its corporate books and records, in accordance with accounting principles generally accepted in the United States of America. All handling, storage, crating, rigging, and labor for the preparation and shipment of the Tooling and Equipment and Ethox’s tooling and equipment used solely in connection with the Products shall be the full responsibility of the Scivanta.

2.4 Except as provided in Section 2.3, any Ethox-owned equipment used on the project will remain the property of and responsibility of Ethox regardless of expiration or termination. If additions or modifications are required to Ethox-owned equipment, the cost for such will be the responsibility of Ethox and Ethox will own such additional parts. Ethox agrees that any equipment modification or addition, or process modification made for the Project and that is useful or necessary for manufacturing only the Product shall be licensed to Scivanta upon termination or expiration of this Agreement and at Scivanta’s request. Such license from Ethox to Scivanta shall be a royalty-free, perpetual, worldwide license.

 
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Section 3 Forecasts and Orders

3.1  Commencing on the date of this Agreement, and at the beginning of each month thereafter during the term of this Agreement, including any extensions thereof, Scivanta shall deliver to Ethox a rolling twelve-month forecast of Scivanta’s requirements for the Products beginning on the first day of each month thereafter.1  The requirements for the first three-month period of each rolling forecast shall constitute a firm and binding purchase order for that quantity of Products. The requirements for the subsequent periods of each rolling forecast shall constitute non-binding forecasts of Product requirements for the period described. Any increase in firm and binding purchase order quantities over forecasted quantities for a given month shall be at Ethox’s reasonable discretion. At the time of initial order, delivery schedules shall be mutually agreed, but shall not be less than ninety (90) days from the date of order, nor more than one hundred-twenty (120) days from the date of order.

Section 4 Pricing

4.1  Subject to adjustments due to changes in design, specifications, or quality standards, and adjustments described in this Section 4 hereof, the prices for the Products shall be determined as set forth in Attachment A and will be based on the Fully Burdened Cost of Ethox to manufacture the Products, as agreed to by the parties, plus 30%. Fully Burdened Cost shall include: (a) direct material cost (direct material rollup from bill of materials);
(b) direct labor (direct labor rate x labor hours); (c) premium labor (premium labor for some operations such as molding labor to be calculated as premium labor hours x premium labor rate); (d) overhead allocation (a portion of the overhead will be allocated as a percentage of direct labor while the remaining amount of overhead will be allocated on a per release basis utilizing activity based costing); (e) scrap as a percentage of direct material and labor cost; (f) inbound freight for raw materials, as a percentage of material costs; (g) sterilization cost; (h) freight to sterilizer; and (i) selling, general and administration cost allocation (selling, general and administrative cost as a percentage of direct cost).

4.2. The prices set forth in Attachment A do not include taxes, duties and other governmental charges, and Scivanta will pay such taxes, duties and other charges or reimburse Ethox for any thereof imposed upon Ethox in connection with the performance or manufacture of the Products.

4.3 The prices for Products are based upon production and provisions for the minimum of number of units per month of each of the Products as set forth in Attachment A, and Scivanta will pay Ethox the full price of such minimum quantities, less avoidable costs, plus any incremental costs associated with Scivanta’s failure to take delivery of the minimum number of units in any month.
 
_______________________
1 For example, the twelve month forecast to be provided in the beginning of January of any year during the term hereof shall forecast Scivanta’s requirements for the twelve month period commencing April 1 of that year.
 
 
 
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4.4 Prices will be adjusted up or down semi-annually each year to reflect changes in those raw materials or purchased component prices, during the immediately preceding six (6) month period. Ethox will produce invoices for raw material and purchased components if requested by Scivanta to support pricing. Ethox will use all reasonable efforts to secure the best raw material and component prices.

4.5  Ethox will keep complete, true and accurate books of account containing reasonable particulars that may be necessary for the purpose of showing the amounts payable by Scivanta hereunder and for the purpose of showing compliance with all other obligations under this Agreement. Said books and the supporting data will be available at all reasonable times for five (5) years following the end of the calendar year to which they pertain, to confidential inspection by Scivanta or its agents, upon reasonable notice to Ethox, for the purpose of verifying amounts due or compliance in other respects with this Agreement. Scivanta and its agents may make copies of relevant information during the course of an inspection. In addition, Ethox agrees to provide copies to Scivanta of relevant records upon request of Scivanta. Each party will promptly pay or credit the other for any underpayment or overpayment discovered during an inspection. Should such inspection lead to the discovery of a greater than 5% discrepancy in reporting to Scivanta’s detriment, Ethox will pay (a) the full cost of the inspection, and (b) accrued interest at the lesser of the maximum rate allowed by law or 1 ½ % per month.

4.6 As an additional incentive to Ethox, Scivanta agrees to pay to Ethox during the original term of this Agreement a “Development Surcharge” as follows:

a.  
The Development Surcharge will be paid as an additional charge per unit added to the selling price of the Products from Ethox to Scivanta.
   
b.  
The Development Surcharge will be equal to the Ethox in-kind contribution of up to $535,000, as described in Section 6 of the Product Development Agreement between Scivanta and Ethox, divided equally by the total minimum of number of units to be produced during the term of this Contract as set forth in Attachment A.
   
c.  
To the extent that the sales of the minimum quantities are not achieved, Scivanta will make an annual payment to Ethox equal to the Development Surcharge times the shortfall for the annual sales period.
   
d.  
The obligation of Scivanta to pay a Development Surcharge to Ethox shall cease upon Scvianta’s payment to Ethox of up to an aggregate of five hundred thirty-five thousand dollars ($535,000) of Development Surcharge.
 
Section 5 Payment

5.1 Within thirty (30) calendar days after the date of Ethox’s invoice, Scivanta shall pay to Ethox all amounts due under the invoice, without deduction or offset, in United States dollars delivered to Ethox at the address stated on the invoice.
 
 
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5.2 Scivanta shall pay all reasonable costs, including, without limitation, attorneys’ fees and disbursements, incurred by Ethox to collect any amounts not paid when due including amounts payable pursuant to Section 4.5 hereof.

Section 6 Inspection, Delivery and Risk of Loss

6.1 Products will be subject to inspection and acceptance by Scivanta prior to being placed into distribution. Acceptance shall be in accordance with mutually agreed acceptance criteria set forth in Attachment C.

6.2 Before delivering Products to Scivanta, Ethox will perform the factory inspection and quality assurance tests on the Products as prescribed and as set forth in Attachment C. If Scivanta requests, Ethox will either certify that Ethox has completed those tests or permit Scivanta’s representatives to witness them. Scivanta’s acceptance of the Products will not waive any of Scivanta’s warranty rights under this Agreement.

6.3 Unless Scivanta furnishes Ethox with special written instructions regarding shipment, Ethox will choose the method of shipment and carrier to be used. Ethox may make partial shipments to Scivanta and invoice Scivanta for them. All shipments shall be freight on board Ethox’s shipping point and risk of any loss or damage shall pass to Scivanta upon delivery to the carrier. Costs of delivery shall be paid by Scivanta.

6.4 Ethox will use reasonable commercial efforts to meet the delivery dates Scivanta requests. Under no circumstances shall Ethox be responsible for delays in or failure to deliver the Products due to acts beyond its control, such as, but not limited to, fires, floods, riots, strikes, freight embargos, transportation delays, shortage of labor, inability to secure fuel, materials, supplies or power at current prices or as a result of shortages of any thereof or other circumstances included in Section 15 hereof. (“Force Majeure”)

6.5 Scivanta shall be responsible for the design and integrity of all Product packaging. Scivanta shall be responsible for all labeling content, adequacy, accuracy, design, integrity, legibility, location/placement, and claims made in all labeling. Ethox shall provide guidance and assistance to Scivanta regarding the FDA packaging and labeling requirements and work with Scivanta to comply with same. Scivanta shall provide written approval for all artwork masters used to inspect and accept labeling at Ethox. All labeling will be inspected and accepted based upon Scivanta approved artwork master. Shipment of "non-sterile” Product labeled as "sterile" will be in accordance with a separate non-sterile shipping agreement. Separate non-sterile shipping agreements will be executed between Ethox and sterilizer, and sterilizer and Scivanta. Any labeling and/or packaging deviations, such as over-labeling, shall require Scivanta's written approval.

Section 7 Warranty

7.1  Ethox warrants only that the Products manufactured and/or assembled for Scivanta under this Agreement will be, at the time of delivery to Scivanta, free from any liens or other defects in title, will conform to the applicable specifications set forth in Attachment B, and will be free
 
 
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from material defects in workmanship (and materials, if Ethox is responsible for procuring materials from its own sources) under normal use and service. Ethox will not, however, be responsible for, and this warranty will not apply to, any defects in the Products arising out of Scivanta’s design or the use of materials or components that Scivanta furnished to Ethox or directed Ethox to use. A claim under this warranty must be made by Scivanta in writing within fifteen (15) months from the date of delivery of the affected unit(s) of Product to Scivanta’s customer. In no case shall the warranty extend beyond the labeled shelf life/expiration date of the Product. Additionally, such warranty period shall be extended by the time period that the Products are repaired or replaced by Ethox.
 
7.2  Ethox’s sole obligation to Scivanta and Scivanta’s exclusive remedies under this warranty is as follows:

a.  
Ethox will, at its option, repair or replace without charge to Scivanta any unit of the Products found to be defective within the terms of this warranty if Scivanta returns it, freight prepaid, to Ethox. At Ethox’s option, however, Ethox may also elect to accept return of the unit and refund to Scivanta the purchase price Scivanta paid for it. Repaired or replaced Product will carry this same warranty for the balance of the warranty period, such warranty period shall be extended by the time required for repair or replacement. Prepaid freight on Product found to be defective or replaced under warranty shall be reimbursed to Scivanta.

b.  
Ethox will not be required to ship replacement Products until Ethox has confirmed through examination that the returned unit(s) is defective within the terms of this warranty. Ethox will pay freight costs to ship any repaired or replacement unit(s) to Scivanta. Ethox shall have ten (10) days to inspect the Products and determine that each Product is defective. If Ethox is unable to repair or replace the returned unit(s) within thirty (30) days of its determination that the Product is defective, then Scivanta will be entitled to the refund of its purchase price for that unit(s).

c.  
This warranty does not apply to any defect attributed to purchased components specified by Scivanta, or to any unit(s) of Product which Ethox determines has been subjected by a party other than Ethox to (i) operating or environmental conditions beyond those normally expected for the Product based upon the materials specified; or (ii) improper application, improper maintenance or repair, improper installation, alteration, accident, use of Product inconsistent with approved labeling or any other negligent act or omission in use or handling.

d.  
Units of Products returned to Ethox which Ethox determines are not defective within the terms of this warranty will be returned to Scivanta, and Scivanta will reimburse Ethox upon invoice for return transportation charges and Ethox’s normal hourly charge applicable to inspection of the unit.

e.  
Purchased components of the Products specified by Scivanta are warranted only to the extent, and subject to the terms of the original warranty given by the manufacturer to Ethox. Ethox’s sole obligation with respect to such components shall be, at Scivanta’s expense, to prosecute on behalf of Scivanta all warranty claims against such component manufacturers upon receipt of written authorization of Scivanta.
 
 
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f.  
The inability of Ethox to repair or replace returned units resulting in refunds of purchase price as per 7.2 (b) above without consent of Scivanta is a substantial failure to perform a material provision of this Agreement as described in section 13.1, entitling Scivanta to invoke its rights under section 13 of this Agreement.

FOR PURPOSES OF THIS SUPPLY AGREEMENT ONLY, REMEDIAL ACTION AS PROVIDED HEREIN SHALL CONSTITUTE FULFILLMENT OF ALL LIABILITIES OF ETHOX TO SCIVANTA AND SCIVANTA’S SOLE REMEDIES HEREUNDER, WHETHER BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE. Under no circumstances will Ethox be liable for reprocurement costs, lost revenues or profits, or for any indirect, special, incidental, economic or consequential damages, even if they were foreseeable or Scivanta had informed Ethox of their potential.

7.3  FOR THE PURPOSES OF THIS SUPPLY AGREEMENT ONLY, EXCEPT FOR THE WARRANTY SET FORTH IN SECTION 7.1 HEREOF, SELLER MAKES NO WARRANTY OR REPRESENTATION THAT THE PRODUCTS ARE SUITABLE FOR THE PURPOSES AND USES INTENDED OR ANY OTHER STATEMENT, PROMISE OR WARRANTY, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND SCIVANTA ACKNOWLEDGES IT HAS NOT RELIED UPON ANY STATEMENT OF ETHOX OR ANY EMPLOYEE, AGENT OR REPRESENTATIVE THEREOF IN RESPECT OF THE PRODUCTS. COMPLIANCE WITH LAW, CODES AND REGULATIONS RELATING TO THE USE OF THE PRODUCTS REMAINS THE SOLE RESPONSIBILITY OF SCIVANTA.

7.4 Ethox’s total liability to Scivanta for damages under this Agreement shall not exceed the total price Scivanta paid Ethox for the affected Products or Tooling and Equipment at issue. This limitation will apply regardless of the form of the action (i.e. whether the lawsuit is in contract, tort (including negligence) or otherwise).

Section 8 Product Liability and Indemnity

Subject to only the warranties set forth in Section 7.1 hereof, Scivanta will be solely responsible for all third party liability claims related to the design, specifications, manufacture, assembly, use, functionality, and safety of the Products manufactured and/or assembled by a third party, In this regard, Scivanta will defend Ethox from any and all such claims, and indemnify and hold Ethox harmless from all judgments or awards, and any related costs (including attorneys’ fees and other expenses associated with litigation or dispute resolution proceedings) arising out of such claims.

Section 9 Tooling and Equipment Maintenance

9.1 Tooling

 
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9.1.1 Except as set forth in Section 2.3 hereof, all tooling and fixtures paid for by Ethox will remain the property of Ethox regardless of termination by Scivanta or expiration hereof.

9.1.2 All tooling will be assigned a tool number for control within Ethox’s tooling  control systems.

9.1.3 Periodic calibrations, if required, will be the responsibility of the owner of the  tooling and fixtures. Ethox can provide calibration services on an “as quoted” basis.

9.1.4 Routine maintenance for all tooling and fixtures at Ethox will be the  responsibility of Ethox.

9.1.5 Repairs, refurbishment, or replacement costs due to normal wear and tear will  be the responsibility of the owner. Such repairs, refurbishment, or replacement that is  due to negligence on the part of Ethox or its employees will be the responsibility of  Ethox.

9.1.6 Storage of tooling is the responsibility of Ethox. If tooling becomes inactive for a period of twelve (12) months or more, Ethox reserves the right to charge for such storage or to ship them to the storage location designated by the owner.

9.2          Equipment
 
9.2.1 Any Ethox owned equipment used on the project will remain the property  of and responsibility of Ethox regardless of termination by Scivanta or expiration hereof.

9.2.2  If additions or modifications are required to Ethox  owned equipment, the  cost for such will be the responsibility of Ethox and Ethox will own such additional  parts.

9.2.3 Periodic calibrations, if required, will be the responsibility of the owner of the  equipment. Ethox can provide calibration services on an “as quoted” basis. Routine  maintenance for all equipment at Ethox will be the responsibility of Ethox.

9.2.4 Repairs, refurbishment, or replacement costs due to normal wear and tear will  be the responsibility of the owner. Such repairs, refurbishment, or replacement that is  due to negligence on the part of Ethox or its employees will be the responsibility of  Ethox.

9.2.5 Storage of equipment is the responsibility of Ethox. If Scivanta owned equipment becomes inactive for a period of twelve (12) months or more, Ethox reserves the right to charge for such storage or to ship them to the storage location designated by the owner.

 
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Section 10 Non-Recurring Engineering 

If required, Ethox will furnish non-recurring engineering services required in connection with the manufacture of the Products or the Tooling and Equipment and related charges as outlined in Attachment E.

Section 11 Indemnity

11.1 Scivanta will defend, indemnify and hold Ethox harmless from any claim that (a) the design or manufacture of any of the Products using the intellectual property of or licensed to Scivanta, (b) any engineering or manufacturing processes Scivanta directs Ethox to use, or (c) any materials or components required by Scivanta to be used in or with the Products, infringes any third party patent, copyright, trade secret or any other intellectual property right. Scivanta will pay all judgments, warrants, losses, damages, costs, awards, settlements, expenses, (including reasonable attorneys’ fees), and liabilities of every kind (such judgments, warrants, losses, damages, costs, awards, settlements, expenses, (including reasonable attorneys’ fees), and liabilities of every kind, collectively, “Losses”) awarded against Ethox which result directly from or arise directly out of any such claim. Ethox will give Scivanta prompt notice of any such claim after Ethox learns of it and will cooperate with Scivanta, at Scivanta’s expense, in the defense of the claim. While Scivanta will have sole control over the defense, Scivanta may not settle the claim in the name of Ethox without Ethox’s prior written consent.
 
11.2  In the event of any claim described in Paragraph 11.1, Ethox may stop production of the applicable Products immediately pending adequate assurances from Scivanta of Scivanta’s ability to meet the on-going indemnity outlined in Paragraph 11.1 above or a license from the claimant.

11.3  Ethox will indemnify, defend and hold harmless Scivanta and its Affiliates and their officers, directors and employees from and against Losses arising directly out of or resulting directly from: (a) any breach by Ethox of any of its warranties, guarantees, representations, obligations or covenants contained herein; (b) any negligence or intentional acts or omissions by Ethox or its employees and (c) any claim arising out of or relating to federal, state and local taxes or contributions imposed or required under unemployment insurance, social security and income tax laws with respect to the performance of services by Ethox under this Agreement. Scivanta will give Ethox prompt notice of any such claim and will cooperate with Ethox, at Ethox’s expense, in the defense of the claim. While Ethox will have sole control over the defense, Ethox may not settle the claim in the name of Scivanta without Scivanta’s prior written consent, which Scivanta will not unreasonably withhold.

11.4  Scivanta shall indemnify and hold harmless Ethox and its Affiliate and their officers, directors and employees from and against any and all Losses arising directly out of or resulting directly from (a) any breach by Scivanta of any of its obligations or covenants contained herein; and (b) any negligence or intentional acts or omissions by Scivanta or its employees, and/or agents. Notwithstanding the foregoing, under no circumstance shall Scivanta defend, indemnify and hold harmless Ethox from any Losses arising out of or relating to engineering defects.
 
 
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11.5  Each indemnified party agrees to give the indemnifying party prompt written notice of any matter upon which such indemnified party intends to base a claim for indemnification (an "Indemnity Claim"). The indemnifying party shall have the right to participate jointly with the indemnified party's defense, settlement or other disposition of any Indemnity Claim. With respect to any Indemnity Claim relating solely to the payment of money damages and which could not result in the indemnified party's becoming subject to injunctive or other equitable relief or otherwise adversely affect the business of the indemnified party in any manner, and as to which the indemnifying party shall have acknowledged in writing the obligation to indemnify the indemnified party hereunder, the indemnifying party shall have the sole right to defend, settle or otherwise dispose of such Indemnity Claim, on such terms as the indemnifying party, in its sole discretion, shall deem appropriate, provided that the indemnifying party shall provide reasonable evidence of its ability to pay any damages claimed and with respect to any such settlement shall have obtained the written release of the indemnified party from the Indemnity Claim. The indemnifying party shall obtain the written consent of the indemnified party, which shall not be unreasonably withheld, prior to ceasing to defend, settling or otherwise disposing of any Indemnity Claim if as a result thereof the indemnified party would become subject to injunctive or other equitable relief or the business of the indemnified party would be adversely affected in any manner.
 
Section 12 Term/Renewal

This Agreement shall commence on the date set forth above, and shall continue for an initial period of four (4) years from the date of commencement of the first commercial production of the Products hereunder and shall continue on a year to year basis thereafter until terminated by either party by written notice of termination given to the other at least 180 days prior to the end of the initial four (4) year term or any one (1) year renewal term hereof.

Section 13 Termination

13.1  
Either party shall be in default of this Agreement if such party:

a.
substantially fails to perform any material provision of this Agreement; or

b.
becomes insolvent or makes an assignment for the benefit of creditors, or a receiver or similar officer is appointed to take charge of all or part of that party’s assets

In the event either party shall fail to pay accounts due hereunder within fifteen (15) days of the date when due, the non-defaulting party may terminate this Agreement upon written notice to the defaulting party. In the event of a default other than non-payment, the non-defaulting party may terminate the Agreement and any outstanding orders if the other party has failed to cure such default within thirty (30) calendar days after its receipt of a written notice of default and intent to terminate. Except with respect to non-payment, if a cure is not possible within such thirty (30) days, and if the defaulting party commences a cure of such default during such thirty (30) day period and thereafter diligently pursues such cure, then the cure period shall extend up to a total of one hundred-twenty (120) calendar days after receipt of notice of default. The failure to manufacture or deliver Product in accordance with the Product forecast shall constitute a substantial failure to perform a material provision of this Agreement, and should such an event occur a second time during the term of this Agreement after Scivanta has once given notice of default under this paragraph, then such second default must be cured within thirty (30) days of such second notice, with no ability of the defaulting party to extend the cure period for up to an additional one hundred-twenty (120) days.
 
 
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13.2        
   Upon expiration or termination of this Agreement due to Scivanta’s default, Scivanta will:
 
a.  
pay for and remove all conforming finished Product inventory manufactured to Scivanta purchase orders and pay the price therefor;

b.  
pay for and remove all unused raw material that Ethox has ordered in reasonable anticipation of its performance under this Agreement and which cannot be returned to its manufacturer for a refund of Ethox’s costs;

c.  
hold Ethox harmless from all vendor commitments Ethox has made inaccordance with Ethox’s obligations to Scivanta and upon Scivanta’s approval under this Agreement;

d.  
remove all work in process as of the date of termination; and

e.  
subject to minimum quantities required to be purchased hereunder, pay Ethox all its reasonable unrecovered costs associated with its performance of its obligations under this Agreement prior to such termination, including costs associated with materials and inventory obtained or produced in furtherance of manufacturing for the then existent Product forecast which has been authorized by Scivanta. Ethox shall eliminate all costs that can be avoided after notice of termination or upon expiration.

13.3        
   If Scivanta terminates this Agreement due to Ethox’s default, Scivanta will:

a.  
pay for and remove all conforming finished Product inventory manufactured to Scivanta purchase orders and pay the price therefor;

b.  
pay for and remove all unused raw material that Ethox has ordered in reasonable anticipation of its performance under this Agreement and which cannot be returned to its manufacturer for a refund of Ethox’s costs;

c.  
hold Ethox harmless from all vendor commitments Ethox has made in accordance with Ethox’s obligations made upon Scivanta’s approval under this Agreement or incurred in furtherance of the then existent Product forecast authorized by Scivanta;
 
d.  
remove all work in process as of the date of termination; and

e.  
subject to minimum quantities required to be purchased hereunder, pay Ethox all its reasonable unrecovered costs associated with its performance of its obligations under this Agreement prior to such termination, including costs associated with materials and inventory obtained or produced in furtherance of manufacturing for the then existent Product forecast which has been authorized by Scivanta. Ethox shall eliminate all costs that can be avoided after notice of termination or upon expiration.
 
 
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13.4  Upon expiration or termination of this Agreement by either party, for any reason, all existing vendor commitments shall be assigned by Ethox to Scivanta upon request, along with any rights and warranties with respect thereto.

13.5  Except as expressly stated in this Agreement, neither party will be liable to the other
for any damages or compensation due to the termination of this Agreement.

Section 14 Confidential Information

14.1     It is anticipated that the parties may be required to exchange certain confidential information (hereafter called “Information”) to the other in the course of performing this Agreement. From the date of disclosure, and until five (5) years following the expiration or earlier termination of this Agreement, the recipient of Information (hereafter called “Recipient”) shall maintain the Information in confidence and limit its use to the purposes contemplated under this Agreement, using at least the same degree of care as it employs to protect its own confidential information of a similar nature, but not less than a reasonable standard of care, provided the Information is identified in writing as confidential at the time of disclosure or, if orally disclosed, is identified as confidential at the time of disclosure and confirmed in writing within twenty (20) days after the oral disclosure. Recipient shall have no obligation hereunder with respect to any Information that is:

a.  
generally known to the public at the time of disclosure, or becomes known to the public without breach of this Agreement;

b.  
known to the Recipient prior to the disclosure, or is independently developed by the Recipient without reference to or use of any other portion of the Information;

c.  
obtained by the Recipient in good faith from a third party not under obligation of secrecy to the disclosing party; or

d.  
the subject of a court or government agency order to disclose, provided the Recipient gives prompt notice to the party disclosing such information to allow the other party to contest such order.

The Recipient shall have the burden of proving that any of the above exceptions apply by means of documentary evidence available at the time Recipient claims the exception first became applicable.

14.2  Title to all tangible forms of the Information, and all copies thereof, shall be and remain with the other party disclosing such information. Recipient shall not copy or otherwise reproduce, in whole or in part, any Information without the prior written authorization of the party disclosing such information, except as may be reasonably necessary to fulfill the purpose of this Agreement. Recipient shall use reasonable efforts promptly to return or destroy all tangible forms of the Information, and copies thereof, upon request by the party disclosing such information or termination of this Agreement, except that Recipient may retain one archival copy of the Information to be used solely for compliance with Recipient’s obligations under this Agreement.

 
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14.3      It is understood, however, that Ethox has performed substantial development relating to the design, engineering and manufacture of tooling and equipment and medical devices and that Ethox has relationships with other companies which may be Scivanta’s competitors. Neither this Agreement, nor receipt of Information under this Agreement, shall limit Ethox’s independent development, engineering, manufacture, or marketing of products, systems or processes involving technology or ideas similar to those disclosed in the Information. In addition, this Agreement shall not limit Ethox’s use of general ideas, concepts, or techniques contained in the Information in connection with its development, engineering, manufacture, and other businesses.

Section 15 Force Majeure

Neither party shall be liable for any delay or failure to perform under this Agreement if the delay or failure is caused by acts of God or other causes beyond the reasonable control of and without fault or negligence by the delayed or failing party.

Section 16 Notices

Any notice required under this Agreement will be in writing and will be hand delivered, or sent by prepaid registered or certified mail, postage prepaid, return receipt requested (if available), or sent by facsimile and confirmed by such mail, addressed to the other party at the address shown at the beginning of this Agreement. The notice address may be changed by proper notice as set forth above.

Section 17 Intellectual Property

Scivanta shall have the absolute right to assign or transfer or sublicense to any third party any intellectual property owned by Scivanta hereunder and any intellectual property owned by or licensed to Scivanta necessary for the design, use, manufacture or sale of any of the devices created pursuant to this Agreement. Ethox agrees: (a) to disclose and assign to Scivanta as its exclusive property all discoveries, inventions, technical and business innovations and improvements which Ethox or its employees or contractors develop or conceive, solely or in conjunction with others: (i) that are based solely on or involve solely Scivanta’s intellectual property, or (ii) that relate to, constitute, result from or include work in which Ethox will be engaged solely on behalf of Scivanta or its clients; (b) assign or sublicense to Scivanta Ethox’s licensed rights to any and all third party intellectual property utilized by Ethox in connection with the Project or its services to Scivanta hereunder; and (c) to execute all necessary documents, including, without limitation, confirmatory documents of assignment, and to provide Scivanta (at Scivanta’s expense) sufficient assistance to confirm, secure and obtain patent, copyright and other legal protections for any such inventions, discoveries and improvements, and to make and maintain reasonably detailed accurate records of any such inventions, discoveries and improvements necessary to accomplish said purpose; and (d) to deliver to Scivanta upon termination or expiration of this Agreement all materials which related to the business of, or belong to, Scivanta or its clients, or by which their nature are for use of Scivanta’s employees, contractors or consultants.

 
 

 
Section 18 Independent Contractors

Each party is an independent contractor and not an agent, joint venture, or representative of the other, and neither party may create any obligation or responsibility on behalf of, or in the name of, the other without expressed written agreement.

Section 19 General

19.1  This Agreement, including all of its referenced Attachments, constitutes the entire
agreement between Scivanta and Ethox with respect to Ethox’s manufacture and/or assembly of Scivanta’s requirements for Products or Tooling and Equipment and any previous oral or written communications between Scivanta and Ethox regarding the manufacture and/or assembly of Products or Tooling and Equipment are merged herein. No waiver, alteration or modification of any of the provisions hereof shall be binding on Ethox unless made in writing and the provisions hereof may not be explained or supplemented by course of dealing, usage of trade or course of performance or varied or contradicted by parole evidence without the written consent of Ethox. This Agreement may not be modified except by a written document signed by the party against whom enforcement is sought. If any provision of this Agreement is held invalid, all other provisions will remain valid, unless such invalidity would frustrate the purpose of this Agreement.

19.2 This Agreement will be governed by and construed in accordance with the laws of the
State of New York without regard to its conflict of laws rules and in the event of any dispute hereunder, including disputes that may arise following termination hereof, Scivanta acknowledges and agrees that this paragraph serves as a material inducement for Ethox to enter into this Agreement.

19.3 The parties specifically agree that the United Nations Convention on the International Sale of Goods shall not apply to this Agreement.

19.4  Ethox may not assign this Agreement nor delegate performance of its duties or obligations hereunder without the written approval of Scivanta, except to an individual or entity purchasing all or substantially all of its assets used in the performance of its obligations hereunder; provided, however, that no such assignment may be made by Ethox to any party that is or controls or is under common control with a distributor or wholesaler of cardiac monitoring equipment without the written consent of Scivanta. Sale or issuance of shares of Ethox shall not be considered an assignment hereof to the purchaser of such shares, unless the proposed sale or issuance of shares of Ethox in any amount of shares exceeding 25% of the then outstanding shares of Ethox is to be made to a party or parties controlling or under common control with a business distributing cardiac monitoring equipment. Any attempted assignment or delegations in violation of this Section shall be deemed null and void and of no force and effect. Scivanta may assign this Agreement, in whole or in part, without limitation.. This Agreement shall be binding on each party’s respective successors and permitted assigns.
 
 
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19.5  The parties agree that in the event of a dispute between them arising out of, concerning or in any way relating to this Agreement, including its interpretation, which cannot be settled by a good faith effort by the parties to resolve such issue, will be submitted to binding arbitration under the Federal Arbitration Act as amended and in accordance with the Commercial Arbitration Rules then prevailing of the American Arbitration Association (“AAA”). The arbitration will be held in New York County, New York by a panel of three (3) arbitrators appointed pursuant to the AAA rules and judgment upon the award rendered by the arbitrators may be entered into any court having jurisdiction thereof.
 
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives, all intending to be legally bound hereby.
 

ETHOX INTERNATIONAL, INC.
SCIVANTA MEDICAL CORPORATION
   
By: ______________________________
By: ______________________________
   
Name: ____________________________
Name: ____________________________
   
Title: _____________________________
Title: _____________________________
   
Date: _____________________________
Date: _____________________________
 

 
 
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EX-10.18 3 v080219_ex10-18.htm
EXHIBIT 10.18
 
Addendum to the Technology License Agreement
 
between
 
The Research Foundation of State University of New York
for and on behalf of University at Buffalo
 
and
 
Donald D. Hickey, M.D.
 
and
 
Clas E. Lundgren, M.D., Ph.D.
 
and
 
Scivanta Medical Corporation

This Addendum to the Technology License Agreement (this “Agreement”) is entered into this 29th day of June, 2007 (the “Effective Date”) by and between The Research Foundation of State University of New York, for and on behalf of University at Buffalo, a non-profit corporation organized and existing under the laws of the State of New York (the “Foundation”), Donald D. Hickey, M.D. (“Hickey”) and Clas E. Lundgren, M.D., Ph.D. (a/k/a Claes Lundgren and referenced herein as “Lundgren”) and Scivanta Medical Corporation (formerly Medi-Hut Co., Inc.), a corporation duly organized under the laws of the State of Nevada, and having its principal place of business at 215 Morris Avenue, Spring Lake, New Jersey 07762 (“Licensee”). Foundation, Hickey and Lundgren will be collectively referenced herein as “Licensor”.
 
WHEREAS, Licensor and Licensee entered into an exclusive Technology License Agreement on November 10, 2006, to facilitate the development and commercialization of certain technology owned by Licensor so that this technology may be utilized to the fullest extent for the benefit of Licensee, Licensor, the inventor(s) and the public;
 
WHEREAS, Licensor has or will enter into a “Research Agreement” and a “Manufacturing License Agreement” with Ethox International, Inc. (“Ethox”) to further facilitate the development and commercialization of the licensed technology (“Scivanta Ethox Agreements”);
 
WHEREAS, Licensee has or will enter into a “Project Development Agreement” and a “Supply Agreement” with Ethox (the “Scivanta Ethox Agreements”) to set forth the terms and conditions under which Ethox shall engineer, develop and manufacture key components of the Hickey Cardiac Monitoring System (“HCMS”);
 
WHEREAS, Licensor and Licensee desire to modify the aforementioned Technology License Agreement for the mutual benefit of both parties;
 

NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein and good and valuable consideration, the receipt of which is hereby acknowledged, the parties agree as follows:
 
1.    
The modifications of the Technology License Agreement herein will be effective as of the Effective Date and will remain in effect for the duration of the Technology License Agreement unless further modified in writing by the parties hereto.

2.    
Section 2.1 of the Technology License Agreement will be replaced with:

2.1 Exclusive License. Licensor grants to Licensee an exclusive license under its Technology rights to (a) develop, make, have made, use, sell and offer for sale or otherwise exploit the Licensed Products, and (b) use and reproduce Software, create Derivatives, and distribute Software to end-users through the normal channels of distribution, in the Field and Territory during the Term. Licensee will have the unrestricted right to develop Licensee Improvements relating to the Licensed Products in the United States for distribution and exploitation of the Licensed Products either in the United States or outside of the United States. Licensee will also have the unrestricted right to develop Licensee Improvements relating to the Licensed Products in any foreign country for distribution and exploitation of the Licensed Products in any other country, including the U.S. Notwithstanding the exclusive license granted to Licensee, Licensee hereby consents to Licensor’s grant of a limited, non-exclusive license to Ethox for the sole purpose of the engineering, development and manufacture of the catheter component of the Hickey Cardiac Monitoring System (“HCMS”) in accordance with the Scivanta Ethox Agreements. Licensor and Licensee agree that such limited licensed rights will be granted only to Ethox under a separate manufacturing license agreement (“Ethox Agreement”) and no other party. If for any reason the Ethox Agreement or the Scivanta Ethox Agreements are terminated or expire, the limited license granted to Ethox hereunder will immediately terminate and all exclusive license rights will remain with Licensee.
 
3.    
Section 6.1 of the Technology License Agreement will be amended to change the November 1, 2008, Payment Amount to Hickey and Lundgren from $109,578 to $108,235.

4.    
Other than as specifically modified in this Addendum, all other terms, conditions and covenants of the Technology License Agreement entered into on November 10, 2006 shall remain in full force and effect.

 
2

IN WITNESS WHEREOF, the undersigned duly authorized representatives of the parties have executed this Agreement, effective on the date first written above.
 

SCIVANTA MEDICAL CORPORATION
THE RESEARCH FOUNDATION OF
STATE UNIVERSITY OF
NEW YORK
   
By: /s/ David R. LaVance                                   
By: /s/ Woodrow Maggard                                  
       David R. LaVance
       Woodrow Maggard
   
Title: President and Chief Executive Officer
Title: Assistant Vice Provost, STOR
   
Date: June 29, 2007
Date: June 29, 2007
   
   
DONALD D. HICKEY, M.D.
CLAS E. LUNDGREN, M.D., Ph.D.
   
By: /s/ Donald D. Hickey, M.D.                        
By: /s/ Clas E. Lundgren, M.D., Ph.D.                
       Donald D. Hickey, M.D.
       Clas E. Lundgren, M.D., Ph.D.
   
Date: June 29, 2007
Date: June 29, 2007


 
3

EX-10.18 4 v080219_ex10-19.htm
EXHIBIT 10.19



Hickey Cardiac Monitoring System
 
A Proposal for Services to
 
Scivanta Medical Corporation
 





















Presented To:   
Scivanta Medical Corporation
David LaVance
Tom Gifford
215 Morris Ave
Spring Lake, NJ 07762
   
 
 
 

 
 
Hickey Cardiac Monitoring System
 
Section I: Scope of Work
 
Applied Sciences Group, Inc. (“ASG”) will provide the software engineering services as defined in this proposal.
 
As a provider of engineering solutions in the areas of factory automation, high tech and project management since 1993, ASG is a qualified provider for the Hickey Cardiac Monitoring System project in accordance with the mission of the company:
 
ASG will provide technically superior engineering solutions for applications involving research, industrial and manufacturing environments, design-oriented engineering services, technical project management and training. Our service will be easily integrated by our customers, as we will blend into their structure while illustrating outstanding business ethics and superior technical expertise.
 
Problem Statement
 
Scivanta Medical Corporation (“Scivanta”), Ethox International, Inc. (“Ethox”) and ASG have been charged with developing an FDA-validated instrument to measure key cardiac parameters, based on an esophageal catheter and associated instrumentation. ASG’s role is to provide the control, data capture, data processing and display software for the instrument.
 
Approach
 
Over the past several months, task details have been developed and presented to Scivanta and Ethox based on the agreed-to roles and responsibilities of each involved party. In summary:
 
·    
Ethox will provide overall engineering program management, quality assurance, design and development of the catheter component;
·    
A hardware developer, to be determined, will provide instrument electronics development and board-level software to provide a pump and electronics interface to the high-level software;
·    
ASG will develop the software algorithms to run the instrument, the data collection function and the user interface.
 
All parties will participate in engineering meetings, testing and validation efforts. Some travel will be required and is included in this proposal.
 
The following tables outline the major software engineering development tasks that must be completed prior to FDA product approvals. Many of these tasks are dependent on the hardware developer’s schedule and availability of development equipment (see assumptions below).
 
Phase I Tasks: Catheter Position Algorithm, Requirements Definition and High-Level Design
 
Phase I Tasks, as defined in this proposal, are those tasks whose levels of effort can be accurately estimated. Four tasks have been identified that fit into this category. These tasks include the engineering review of the original prototype’s software functionality, engineering analysis and
 
 
2

 
 
re-design of the original prototype’s catheter positioning algorithm (and requisite data collection effort), the new product’s requirements analysis and specification, and the high-level design efforts. These tasks are specified in the table below.
 
Phase I: ASG Engineering Estimates (Fixed Price Tasks)
Effort (Hours)
   
 Review and Document Existing Software
·  Pump Control
·  Display Functionality
·  Dispatch Functionality
·  Watchdog Functionality
·  Data Analysis
·  Configuration
·  Communications Interfaces
224
 Re-Analyze and Develop Catheter Positioning Algorithm
·  Perform Engineering Analysis of previous prototype software, review signal processing
        algorithms, collect data for analysis, analyze results and provide design recommendations,
        and document results.
·  Review software interaction with Pump Control process, Dispatch and Communications
         Processes, provide design recommendations, and document results.
308
 Develop System Specification(s)
·  Meetings to discuss quality and project plans
·  Determine system and software requirements
·  Perform risk/hazard analysis on all software requirements
·  Perform traceability study
·  Generate system-level test plan
·  Generate standards documentation
236
 Perform High-Level Design
·  Specify HW platform, SW tools and configuration management system
·  Determine processor allocations (CPU, memory, storage)
·  Develop hardware and software interface design specification
·  Update risk/requirements documents based on findings
·  Create high-level software definition
·  Perform design reviews
244
 Total Phase I (Fixed Price) Tasks (hours)
1008
 Phase I Duration (Weeks)
13
 Phase I Engineering Cost
$80,640
 Phase I PM/QA Cost
$22,100
 Phase I Travel Cost (Estimated)
$2,500
 Phase I Total
$105,240
 
Note: The Phase I catheter position analysis requires timely Independent Review Board (or other) approval so that collection of subject data, needed for subsequent analysis, can proceed. Currently there are only two data sets available, and these will not be enough to test algorithm robustness. 8-20 data sets would be more appropriate for robustness testing.
 
 
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Phase II Tasks: Low-level Design, Coding, Testing and Validation
 
Phase II Tasks, as defined in this proposal, are those tasks whose levels of effort cannot be accurately estimated until after all requirements and high-level design issues have been addressed. This is due to the unknowns associated with the experimental nature of this project. ASG believes that new or changed requirements - and their impact on the overall design - will be minimal and therefore is comfortable estimating the remaining level of effort to ±12%. Prior to the performance of any of the Phase II Tasks outlined herein, the parties shall execute a written agreement setting forth the terms and conditions, including the pricing, relating to the Phase II Tasks. Such written agreement may either be in the form of an amendment to this Agreement or an additional agreement between the parties.
 
These tasks are specified in the table below.
 
Phase II: ASG Engineering Estimates by Task
Effort (Hours)
   
 Low-Level Design Effort
·  Low-level software definition
·  Coding and module testing
·  Traceability analysis
·  Design reviews
·  Code reviews
1792 ±12%
 Design Verification
·  Integrate to target platform
·  Low-level regression testing
·  Function validation - test execution
·  Function validation - Evaluation
·  Function validation - Test Report
212 ±12%
 Beta Design
·  Redesign for optimization
·  Re-validation
520 ±12%
 Total Phase II Tasks (hours)
2524 ±12%
 Phase II Duration (Weeks)
35
 Phase II Engineering Cost
Approx. $201,920 ±12%
 Phase II PM/QA Cost
$59,500
 Phase II Travel Cost (Estimated)
$5,250 to $7,500
 Phase II Total
$230,100 to $293,560
   
 Project Duration in Months
10 to 12
 
One concern with the Phase II tasks is that the hardware developer will probably not be able to deliver a breadboard prototype unit until well into the Alpha Development phase. ASG and the hardware developer will work to determine if a generic or partially-functional development board can be made available for ASG’s use, so that coding tasks are not impacted by board availability.
 
Notes and Assumptions
 
Reasonable non-labor expenses (travel expenses, meals, hotel) will be billed to Scivanta at cost.
 
 
4

 
 
Several engineering assumptions were clarified during the project kickoff meeting. ASG’s assumption that the hardware developer would assume responsibility for the low-level software (electronics interface and pump control) is correct; ASG does not reflect any hours in our schedule to perform those tasks. All other ASG assumptions have not changed, and include:
 
·    
ASG assumes that the device will be regarded for FDA purposes as a minor level of concern. This significantly shortens the coding/testing phase as code modules are not as stringently controlled, documented and tested as they would be under more moderate levels of concern. Functional testing - testing to the system requirements - is still required for all software.
·    
ASG assumes that IRB (or equivalent) approvals will be in place in a timely manner so that the Catheter Position algorithm can be tested and developed with more than the two data sets currently available for analysis.
·    
ASG assumes that for program continuity, if outside FDA consultants are hired that they will be hired at the program management level (we assume that Ethox is likely to take this role and provide FDA consultants, if necessary, to the project). Ethox may defer this role to the instrument manufacturer or to ASG. The level of effort for an FDA consultant can probably be measured as a fraction of a week (20-40%) for the duration of the project.
·    
Additional engineering hours for support during Pilot manufacturing runs are not included, nor is any manufacturing support software development effort included in this estimate.
 
Please note that any time on site at customer’s facility during which the system is not available for ASG personnel to perform the quoted work will be billed as “out of scope” and shall be billed to Scivanta at an hourly rate of $80 per hour and $85/hr for Project management or Quality assurance tasks. However, before proceeding to provide such out of scope effort the ASG engineer will obtain prior written approval from Scivanta.

Any on site work will be limited to a period of no more than 8 hours per day, 40 hours per week, Monday through Friday. Working hours are during the customer’s normal day shift operations.
 
Use of Proprietary Material
 
All equipment, procedures and documentation made available to ASG and its representatives in connection with this project shall be considered proprietary to Scivanta, and the Confidential Information of Scivanta. Such Confidential Information shall only be disclosed to employees of ASG, the hardware developer or Ethox as needed to perform the duties in connection with this scope of work. ASG agrees that it shall (i) hold the Confidential Information in strictest confidence to avoid disclosure and (ii) not use the Confidential Information for any purpose except as expressly contemplated under this Agreement.
 
Safety Issues
 
Personal safety issues with regard to any on-site work will be determined and addressed prior to the start of any on-site work. ASG employees will be made aware of all safety requirements, documentation and/or personal protective equipment (PPE) that may be necessary to insure their safety while on site. ASG shall be solely responsible for insuring employee safety on-site and complying with any and all federal, state and local workplace laws and regulations.
 
 
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Post -Delivery Support
 
ASG’s shall provide continuing software support and to be available to perform additional work review for a period of 7 years following delivery of the software.
 
Section II: Engineering/Programming Estimate
 
The following table indicates the requirements for the Hickey Cardiac Monitoring System. Upon award of contract, specific dates will be assigned to each item, with all dates reviewed by ASG and Ethox program management, and approved by Scivanta.
 
Phase I:
 
Task
 
 Fixed-Price Tasks
 
Cost
 
1
   
Review and Document Existing Software
 
$
17,920
 
2
   
Re-Analyze and Develop Catheter Positioning Algorithm
 
$
24,640
 
3
   
Develop System Specification(s)
 
$
18,880
 
4
   
Develop and Document High-Level Software Design
 
$
19,520
 
   
PM/QA associated with above tasks 
 
$
22,100
 
   
Travel associated with above tasks 
 
$
2,500
 
   
Totals 
 
$
105,240
 

Phase II:
 
Task    
Estimated Cost Tasks 
   
Estimated Cost
 
           
Low
   
High
 
5
   
Develop and Document Low-Level Design, Coding and Testing
 
$
112,230
 
$
162,560
 
6
   
Design Verification (Validation Testing and Documentation)
 
$
14,720
 
$
19,200
 
7
   
Beta Redesign
 
$
19,200
 
$
19,200
 
8
   
Beta Revalidation
 
$
19,200
 
$
25,600
 
9
   
PM/QA associated with above tasks
 
$
59,500
 
$
59,500
 
10
   
Travel associated with above tasks
 
$
5,250
 
$
7,500
 
   
Totals (PM/QA/Travel) 
 
$
230,010
 
$
293,560
 
                     
   
Grand Total 
 
$
335,250
 
$
398,800
 
                     
 
Section III: Deliverables
 
All source code will become the property of Scivanta, and all code will be adequately developed in accordance with FDA standards for a minor level of concern device.
 
Deliverables will include
 
·    
Reports associated with all invoices indicating task completion status
·    
Source code that will meet the requirements as specified by the design team (Scivanta, Ethox, the hardware developer and ASG) during the Phase I tasks (see section I, above)
·    
Design History File associated with software development
·    
Test procedures
·    
Test reports demonstrating that the software was tested against those procedures
 
 
6

 
 
Section IV: Terms and Conditions
 

Billing:  
Phase I - Fixed Cost Contract;
Phase II - Time & Materials Contract;
·   Progress Payments electronically invoiced biweekly for the duration of
     contract.
Payment:  
Net 30 days upon receipt of invoice. A 1.5% late fee will be assessed beyond net 30 days and every 30 days thereafter.
Terms:  
See Attachment A, “2007 Standard Terms and Conditions”; This proposal is valid for 30 days.
Billing Rates:  
Engineering at   $80 per hour
PM/QA at          $85 per hour
Estimated Engineering Hours:  
3,040 to 4,032
 
Engineering Estimate, Phase I:  
$80,640
 
PM/QA Estimate, Phase I:  
$22,100
 
Travel Estimate, Phase I:  
$2,500
 
Phase I Subtotal:  
$105,240
 
Engineering Estimate, Phase II  
$165,260 to $226,560
 
PM/QA Estimate, Phase II  
$59,500
 
Travel Estimate, Phase II  
$5,250 to $7,500
 
Phase II Subtotal:  
$230,010 to $293,560
 
Estimated Total, Both Phases:  
$335,250 to $398,800
 
 
Should you have any questions, or require additional information, please feel free to contact me at your convenience at (716) 626-5100.
 
Respectfully,
 
/s/ Ben Castro
Ben Casto        2 July 2007
Sales Manager
 
Applied Sciences Group, Inc.
305 Cayuga Rd., Suite 100
Buffalo, NY 14225
Phone  (716) 626-5100
Fax       (716) 626-0629

Accepted:

Scivanta Medical Corporation

By: /s/ Thomas S. Gifford                                                     
       Executive Vice President and Chief Financial Officer

Date:  July 2, 2007
 
 
7

 
 
Attachment A: Applied Sciences Group, Inc.
 
2007 Standard Terms & Conditions
 
 
The following terms and conditions constitute a part of all Applied Sciences Group, Inc. (“ASG”) quotations or proposals and shall apply to any resulting purchase orders or contracts unless otherwise acknowledged in writing by ASG. Scivanta Medical Corporation (the “Purchaser”), by placement of an order, acknowledges their agreement to these Terms and Conditions.
 
1.        
Scope of Work. Any changes to the scope of the work post-award may be subject to additional charges and must be approved, in writing, by ASG. Any items not expressly included in the proposal are excluded. Any changes in drawings and/or specifications as to any material and/or work covered by Purchaser’s Order, resulting in a difference in price or time for performance resulting from such changes shall be equitably adjusted and the order and/or schedule shall be modified in writing signed by the parties accordingly.
 
2.        
Billing. Progress payments will be invoiced at specified intervals for the duration of the contract, as outlined in the proposal. Changes must be agreed to in writing by ASG. In the event Purchaser suspends or cancels a project after the start of work, Purchaser shall be responsible for all work performed and costs incurred by ASG prior to such suspension or cancellation.
 
3.        
Payment. Unless otherwise agreed in writing, payment for goods and services delivered by ASG shall be net 30 days after the invoice date for such goods and services. A 1.5% late fee will be assessed beyond net 30 days and every 30 days thereafter. Should ASG obtain the services of a collection agency or attorney to resolve payments over 90 days late, any collection agency or attorney fees will be the responsibility of the Purchaser.
 
4.        
Schedule. Quoted schedules are subject to change at the time of order placement based on current ASG backlog. ASG shall notify Purchaser at the time of order if any such delay due to backlog will occur. Quoted schedules exclude weekends or holidays unless otherwise stated and exclude customer review time unless otherwise stated. Every effort will be made to hold delivery dates. ASG shall not be liable for delays or defaults in deliveries due to causes beyond its control and without its fault or negligence. If at any time ASG has reason to believe that delivery will not be made as scheduled, written notice setting forth, the causes of the anticipated delay will be given immediately to the Purchaser and project team. Any delay due to fault of subcontractors will be excusable, only if beyond the control and without the fault or negligence of both ASG and its subcontractor and only if ASG established that it could not obtain supplies or services from any other source in time to meet the delivery schedule.
 
5.        
Acceptance. This quotation does not constitute an acceptance by ASG of any terms and conditions not stated herein. References in this quotation or resulting contract or purchase order, to any offer, counter offer, or other document shall in no way constitute a modification of any of the terms and conditions of this quotation. ANY ATTEMPTED ACKNOWLEDGEMENT OF THIS QUOTATION CONTAINING TERMS AND CONDITIONS INCONSISTENT WITH, OR IN ADDITION TO, THE TERMS AND CONDITIONS PRESENTED HEREIN IS NOT BINDING UPON ASG UNLESS EXPRESSLY ACCEPTED BY ASG IN WRITING.
 
 
8

 
 
6.        
Warranty for Engineering and Programming Design Services, Limitation of Liability. ASG warrants that the services it provides shall be performed in a competent and professional manner and in conformance with agreed upon standards. Purchaser’s sole remedy shall be the reperformance of services to provide corrective action or refund amounts paid for the services, at Purchaser’s option,. IN NO EVENT WILL ASG BE RESPONSIBLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES EVEN IF THE COMPANY WAS AWARE OF THE POTENTIAL FOR SUCH DAMAGES. ALL OTHER WARRANTIES ARE EXPRESSLY DISCLAIMED.
 
7.        
Warranty for Commercial Goods, Limitation of Liability. ASG warrants that all goods sold by the Company shall be of good quality and free from defects in workmanship and materials and shall perform in accordance with the product specifications as of the date of delivery to the F.O.B. point. IN NO EVENT WILL ASG BE RESPONSIBLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES EVEN IF THE COMPANY WAS AWARE OF THE POTENTIAL FOR SUCH DAMAGES. ALL OTHER WARRANTIES ARE EXPRESSLY DISCLAIMED. Warranty claims must be made in writing within 90 days from the date of delivery to the F.O.B. point. ASG shall repair, replace or refund amounts paid, at its discretion, for any claims covered by this warranty. This warranty is limited to the sale of goods and materials only and does not apply to services. This warranty does not apply to product deficiencies resulting from designs or specifications which have been provided by the Purchaser.

8.        
Assignment - No contract or any interest therein, resulting from this quotation, shall be assigned or transferred by either party except as expressly authorized in writing by the other party, and any attempted assignment without such consent shall be void. Notwithstanding the foregoing, Scivanta may assign this Agreement to an affiliate or in connection with any merger, reorganization or sale of substantially all of Scivanta assets or other change of control transaction without any consent from ASG.

9.        
Federal, State, and Local Taxes - Except as expressly provided in this quotation, prices exclude Federal, State and Local taxes and duties. Such taxes or duties, if collected by ASG, will appear as a separate charge on the invoice.

10.      
Disputes - In the event that any dispute, arising under or relating to a contract resulting from this quotation, cannot be resolved by settlement between the parties or by an Alternative Dispute Resolution technique agreed to by all parties, either party may litigate any such dispute. Purchaser agrees to the exclusive jurisdiction and venue of the courts presiding in Monmouth County, New Jersey for all disputes arising hereunder.

11.      
Applicable Law - It is agreed that contracts associated with this quotation shall be construed, interpreted and governed by the internal Laws of the State of New York, without regard to principals of conflicts of law.

12.      
Permits and Compliance to Applicable Rules/Regulations - Except as otherwise agreed to by ASG, the Purchaser shall procure all necessary permits or licenses required due to the special nature of services requested by the Purchaser, and abide by all applicable laws, regulations and ordinances of the United States and the State, territory and political subdivision in which the work under contract is performed.
 
 
9

 

 
13.      
Intellectual Property - It is the responsibility of the Purchaser to ensure that products or services provided by ASG at the Purchaser’s request or direction do not violate any patents existing or pending. Moreover, the Purchaser assumes full liability for any such patent infringements, and agrees to indemnify and defend ASG against any such liability. Purchaser’s liability to ASG relating to a patent infringement claim shall be limited to the amounts paid to ASG hereunder.

To the extent that ASG utilizes its own pre-existing intellectual property, including but not limited to methods, processes, or inventions (the “ASG Intellectual Property”), ASG represents and warrants that the ASG Intellectual Property utilized in performing the services provided to Scivanta hereunder and the results of such services will not infringe upon any patent, copyright, trademark, trade secret or other intellectual property right of any third party. ASG shall indemnify defend, and hold harmless Scivanta, including its officers, directors, and employees, agents and contractors, from and against any and all judgments, liabilities, claims, demands, expenses, losses or costs (including attorneys’ fees) arising from or relating to any third party intellectual property infringement claim in connection with the ASG Intellectual Property or ASG’s provision of services hereunder.

14.      
Invention and Assignment- ASG agrees that all right, title and interest in and to all information, data, inventions, discoveries, developments, creative works, ideas, products, systems, computer programs, object code, source code, computer algorithms and related documentation, including improvements or modifications thereto, and works of authorship, whether or not patentable, copyrightable or subject to other forms of protection, made, created, developed, written or conceived by ASG or ASG employees during the term of this Agreement in the performance of duties relating to the subject matter of this Agreement (collectively the “Intellectual Property”), to the greatest extent permitted by law, constitute works for hire and are the sole and exclusive property of Scivanta from the moment of its creation.

To the extent that any Intellectual Property created by ASG in the performance of its duties hereunder does not constitute a work for hire, or does not constitute the sole and exclusive property of Scivanta, as provided above, ASG hereby assigns and agrees to assign to Scivanta all of ASG’s right, title, and interest in and to all such Intellectual Property.

ASG agrees that it shall, at Scivanta’s expense, execute a specific assignment of title to the Intellectual Property to Scivanta and do anything else reasonably necessary or desirable to enable Scivanta to secure a patent, copyright or other form of protection for or otherwise exploit, preserve, defend or enforce any Intellectual Property right anywhere in the world.

ASG’s obligations under this Section 14 shall survive the termination of ASG’s engagement by Scivanta for any reason.
 
 
10

 

 
15.      
Insolvency - If Purchaser ceases to conduct its operations in the normal course of business, including inability to meet its obligations as they mature, or if any proceeding under the bankruptcy or insolvency laws is brought by or against Purchaser, or a receiver for Purchaser is appointed or applied for, or an assignment of creditors is made by the Purchaser, ASG, to the extent permitted by law, may terminate the contract without liability.

16.      
Cancellation - If the Purchaser chooses to cancel any contract or order associated with this quotation, written notice must be given to and acknowledged by ASG during normal work hours. ASG will stop work in progress, whereupon it will invoice the Purchaser for all applicable services rendered, including labor, materials, outside services, and fees, up to the time of cancellation. Labor charges will be calculated based on ASG’s standard hourly rates. Payment shall be due within 15 working days of such cancellation.

17.      
Order of Precedence - In the event of an inconsistency between the provisions of these terms and conditions and the provisions of any other documents exchanged, or agreements made between the parties, these terms and conditions shall supersede any inconsistent provision in such other documents or agreements, unless expressly amended by a written agreement making specific reference to the provisions being amended.

18.      
Attorneys’ Fees and Costs - In connection with any litigation arising out of the Agreement, the prevailing party shall be entitled to recover all of its costs and expenses incurred including actual attorneys’ fees for services rendered in connection with such litigation, including its proceedings and post-judgment proceedings. As used herein, the term “attorneys’ fees” shall be deemed to include charges for paralegal law clerks and other staff members operating under the supervision of an attorney and for all sales and/or use taxes imposed thereon by an appropriate governmental authority.

19.      
LIMITATION OF WARRANTIES - THE WARRANTIES STATED IN PARAGRAPHS 6 AND 7 OF THESE TERMS AND CONDITIONS ARE GIVEN IN PLACE OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY, FITNESS FOR USE, OR OTHERWISE. NO PROMISE OR AFFIRMATION OF FACT MADE BY ANY AGENT OR REPRESENTATIVE OF ASG SHALL CONSTITUTE A WARRANTY BY ASG OR GIVE RISE TO ANY LIABILITY OR OBLIGATION. ASG SHALL NOT BE LIABLE IN ANY EVENT FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES AS THOSE TERMS ARE DEFINED IN ARTICLE 2 OF THE NEW YORK UNIFORM COMMERCIAL CODE. The warranties granted by ASG are terminated and ASG shall not be liable to Purchaser or any other person for any damage, injury or loss arising out of the use of any goods or services, whether by reason of any defect in the goods or services furnished hereunder or otherwise, if, prior to such damage, injury or loss, the goods or services are (a) damaged or misused after tender of delivery, (b) repaired, altered or modified without ASG’s written consent, or (c) not used, maintained, operated or applied in strict compliance with instructions supplied by ASG.

20.      
Force Majeure - ASG shall not be liable for nonperformance or delay in performance due wholly or partly to commercial impracticability or any cause not wholly or exclusively in its control or which it could not by reasonable diligence have avoided. Upon the occurrence of any such contingency, ASG shall have the right to suspend or reduce deliveries during the period of such contingency, and the total quantity deliverable under this contract shall, at ASG’s election, be reduced by the quantities so omitted. The following shall not be considered wholly or exclusively within ASG’s control: fire; flood; earthquake; storm; acts of God; labor controversies; court decrees; inability to use the full capacity of plants or facilities as a result of government action, and inability to obtain fuel, power, raw materials, labor, containers or transportation facilities, without litigation or the payment of penalties.
 
 
11

 

 
21.      
NON-Recruitment Clause: When ASG and Purchaser enter this contract, in which various employees of the ASG will be performing services at the Purchaser’s premises and/or other such locations, Purchaser recognizes and agrees that such employees of ASG are of great value to ASG and that the loss of their services to ASG would cause substantial damage to ASG for which there would be no adequate remedy at law. Purchaser therefore agrees that during the time ASG is performing services for the Purchaser, and for a period of one year thereafter, the Purchaser will not:
·    
solicit for employment (directly or through a third party), as the Purchaser’s employee or as an independent consultant, any ASG’s employee who provided services to the Purchaser;
·    
Employ any ASG’s employee as the Purchaser’s employee or an independent consultant.

Purchaser further agrees that in the event this agreement is violated, ASG shall be entitled to an injunction restraining any further violation - in addition to any other right or remedy to which the ASG might be entitled in law or in equity. However, in the event that both the Purchaser and ASG agree that it is in ASG’s employee’s best interest to entertain a job offer from the Purchaser, then ASG will be compensated by the Purchaser as follows:
·    
When a job offer is accepted by the ASG’s employee, the Purchaser shall pay a lump sum equal to 20% of the employee’s first year’s salary, plus any training and recruitment costs incurred by ASG in the 12 months prior to the offer being accepted.

22.      
Entire Agreement - This Contract constitutes the entire agreement between the parties and may be modified only in writing and the agreed to by both parties. Neither ASG nor the Purchaser will be bound by any oral agreement or representation irrespective of whom or when made.
 

 
 
12

 
EX-99.1 5 v080219_ex99-1.htm
 

EXHIBIT 99.1
 
SCIVANTA MEDICAL CORPORATION ENTERS INTO AGREEMENTS FOR THE DEVELOPMENT OF THE HICKEY CARDIAC MONITORING SYSTEM

Signs development agreements with Ethox International and Applied Sciences Group regarding the catheter and software components of the Hickey Cardiac Monitoring System

SPRING LAKE, N.J., July 3, 2007 -- Scivanta Medical Corporation (OTCPK: SCVM) announced today that it has entered into development agreements regarding the Hickey Cardiac Monitoring System (HCMS). Effective June 29, 2007, Scivanta and Ethox International, Inc. entered into a development agreement whereby Ethox will provide Scivanta engineering and development support for the catheter component of the HCMS in exchange for the rights to manufacture the component upon regulatory approval and commercialization of the HCMS. Manufacturing terms will be subject to a supply agreement which will be entered into by Scivanta and Ethox upon regulatory approval of the HCMS.
 
Also, effective June 29, 2007, Scivanta amended its Technology License Agreement dated November 10, 2006 with The Research Foundation of the State University of New York, for and on behalf of the University of Buffalo, and Donald D. Hickey, M.D. and Clas E. Lundgren, M.D., Ph.D. Pursuant to the amended Technology License Agreement, the Foundation, Hickey and Lundgren were permitted to enter into a non-exclusive manufacturing license agreement with Ethox, also dated June 29, 2007, whereby Ethox was granted the right to manufacture the catheter component of the HCMS for Scivanta. As a result of these agreements, the development of the HCMS will now be partially funded through a technology incentive program contract awarded by the New York State Office of Science Technology and Academic Research to the Foundation and the Foundation’s company partner, Ethox. Up to $750,000 is available under this incentive program for the development of the HCMS. Ethox is required to match the $750,000 of proceeds available under the incentive program by providing $187,500 of cash and $562,500 of in-kind contributions. Pursuant to the development agreement between Scivanta and Ethox dated June 29, 2007, Scivanta will provide Ethox with the $187,500 of cash required under the technology incentive program while Ethox will provide the $562,500 of in-kind contributions. The technology incentive program funding will primarily support the catheter and software development of the HCMS by New York State based Ethox and Applied Sciences Group, Inc. (ASG).
 
In addition, effective July 2, 2007, Scivanta entered into a development agreement with ASG. Pursuant to the terms of this agreement, ASG will provide software engineering services to Scivanta for the continuing development of the HCMS. The fees being charged by ASG related to this agreement could range between $335,000 and $400,000.
 
David LaVance, President and Chief Executive Officer of Scivanta commented, “Entering into these development agreements with Ethox and ASG is an important step in commercializing the HCMS. We believe that the expertise each company possesses will be extremely valuable to Scivanta as we work towards gaining regulatory approval and commercializing the HCMS. We are also excited that Ethox and the Foundation will be able to utilize the proceeds from the technology incentive program contract to help offset the development costs associated with the HCMS.”
 
 
 

 
About Scivanta Medical Corporation
 
Scivanta is focused on acquiring and developing medical technologies and products which offer advantages over available medical procedures and treatments. The company has acquired the exclusive worldwide rights to develop, make and sell certain proprietary technologies known as the Hickey Cardiac Monitoring System, a minimally-invasive two-balloon esophageal catheter system used to monitor cardiac performance. The HCMS is expected to provide the primary measurements of cardiac performance in a minimally invasive and cost-effective manner and is designed to be used outside of an intensive care setting. The HCMS is currently under development and must receive the appropriate regulatory approvals prior to commercialization. As Scivanta develops the HCMS, it expects to continue to review for acquisition other medical technologies and products that are sold, or capable of being sold, in a specialty or niche market.
 
About Ethox International, Inc. (www.ethoxint.com)

Ethox is a global manufacturer and provider of medical products and laboratory services. With a singular focus on servicing the needs of the worldwide healthcare industry for 40 years, Ethox offers the medical device and pharmaceutical industry a single source for all contract service needs, and provides a wide range of products to the hospital market.

About Applied Sciences Group, Inc. (www.asgrp.com)
 
ASG provides software engineering solutions for applications involving research, industrial and manufacturing environments, design-oriented engineering services, technical project management and training. ASG maintains a staff of engineers who provide expertise across the full spectrum of its engineering disciplines: software engineering, software quality and systems integration.
 
Forward-Looking Statements
 
Statements about the Scivanta's future expectations and all other statements in this press release other than historical facts are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as that term is defined in the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from expected results. Among these risks, trends and uncertainties are economic conditions both generally and within the industries in which Scivanta may participate; competition within Scivanta’s chosen industries, including competition from much larger competitors; technological advances; available capital; regulatory approval; and failure by Scivanta to successfully develop or acquire products and form new business relationships. Scivanta intends that such forwarding-looking statements shall be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Scivanta's actual results could differ materially from expected results.
 
 
 

 
Contact:
 
Scivanta Medical Corporation    
Tom Gifford, Chief Financial Officer   
Tel.: (732) 282-1620 x15    
Fax: (732) 282-1621     
 
The Investor Relations Group  
Investor Relations
James Carbonara/Dan Berg, 212-825-3210
Media Relations
Bill Douglass/Hayden Lynch, 212-825-3210
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