f10k2010ex10viii_scivanta.htm


EXHIBIT 10.8


 


Amended and Restated 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 Amended and Restated Technology License Agreement (this “Agreement”) is entered into this ­­14th day of February, 2011 (the “Agreement 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 license agreement as of the 10th day of November, 2006 to facilitate the development and commercialization of certain technology owned or under obligation by Licensor addressed within Foundation Docket Numbers S-409, R-5421 and R-6013 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 and Licensee amended said license agreement pursuant to an Addendum dated as of the 29th day of June, 2007, and a Second Addendum dated as of the 24th day of October, 2008, and a Third Addendum dated as of the 6th day of January, 2009, and a Fourth Addendum dated as of the 29th day of October, 2009; the said license agreement as previously so modified being hereinafter referred to as the “Original Agreement”;


 


WHEREAS, Licensee has satisfactorily completed certain obligations under the Original Agreement, including but not limited to: completion of specified Due Diligence milestones, payment of Patent Costs due, payment of cash payments and, in lieu of specified future payments, issued stock to Foundation, Hickey and Lundgren on October 28, 2008, in consideration for the rights granted in the Original Agreement;


 




  





1











  






 


WHEREAS, Licensor and Licensee again desire to modify the aforementioned Original Agreement for the mutual benefit of both parties,


 


WHEREAS, this Agreement incorporates all modifications effective as of the Agreement Effective Date.


 


NOW, THEREFORE, in consideration of the terms and considerations hereinafter set forth, the parties agree as follows:


 



	
1.  

	
DEFINITIONS












All capitalized terms used in this Agreement will have the meanings stated below or defined elsewhere in the Agreement.


 


1.1            “Affiliate” means every corporation or entity which, directly or indirectly, or through one or more intermediaries, controls, is controlled by, or is under common control with Licensee.


 


1.2             “Copyrights” means Licensor’s copyrights in any software (the “Software”) developed and/or owned by Licensor to embody or enable the technology claimed in the Patent Rights and any manuals, protocols or any other documentation, whether in electronic or print format, relating to the Software.


 


1.3             “Derivatives” means Licensee created computer software and any documentation, whether in electronic or print format, relating thereto which will include, or be based in whole or in part on, Software.


 



1.4             “Field” means all fields of use.




 


1.5             “Licensor Improvements” means any further technological developments of the Technology developed by Dr. Donald D. Hickey during the term of this Agreement and owned or controlled by Licensor and/or the Foundation, Hickey or Lundgren individually, that is not filed as a continuation-in-part application claiming priority to any patent applications listed in Exhibit A.


 


1.6             “Licensee Improvements” means any further technological developments of the Technology developed by Licensee during the term of this Agreement and owned or controlled by Licensee.


 


1.7             “Intellectual Property” means all Know-How, experimentation documentation, lab notebooks, patient documentation, source code, and any and all trade secrets relating to the Patent Rights.


 


1.7(a)        “Know How” means confidential and/or proprietary information, whether or not patented or patentable, in which Foundation has a legal interest and is free to disclose to Licensee, as set forth in Exhibit D attached hereto, which is specific to the design, development, manufacture and marketing of Technology and products, and which was developed prior to the Effective Date by the Inventor(s) at the University at Buffalo.


 




  





2











  






 






1.8              “Licensed Product” means all products that incorporate, utilize, or are made with the use of the Technology, Licensee Improvements, Licensor Improvements licensed to Licensee after the Effective Date, Software, or any part thereof and products that incorporate, utilize or are made with the use of a Derivative or Source Code.




 



1.9              “Net Sales” means the gross revenues actually received by Licensee, Affiliates and Sublicensees in the Field and Territory during the Term from the manufacture, use, sale, lease or other transfer of Licensed Product to non-sublicensee third parties, less: (a) sales and/or use taxes actually paid, import and/or export duties actually paid, excise taxes and other compulsory payments to governmental authorities, (b) outbound transportation paid, prepaid or allowed, including shipping, freight, transportation and insurance for the Licensed Product to the extent such costs are included in Licensee’s or Sublicensees’ invoice price to its customers for the Licensed Product, and (c) all bona fide allowances for returns, rebates, chargebacks, provisions for bad debts determined in accordance with U.S. G.A.A.P., and discounts actually given to and taken by non-sublicense third parties, such allowances to be adjusted to actual on a periodic basis, no less frequently than annually. In this context, gross revenues will also include the fair market value of any non-cash consideration actually received by Licensee, Affiliates and Sublicensees for the manufacture, use, sale, lease, or other transfer of Licensed Product.  Net Sales does not include the transfer price paid by a Sublicensee to the Licensee for Licensed Product.




 



1.10            “Patent Costs” means all reasonable costs incident to filing, prosecuting and maintaining the patents associated with the Patent Rights in the United States and elected foreign countries, and any and all reasonable costs incurred in filing continuations, divisional applications or related applications thereon and any re-examinations or reissue proceedings thereof.




 



1.11            “Patent Rights” means Licensor’s patent rights to any subject matter claimed in or covered by (a) any pending or issued United States or foreign patent or any patent application listed in Exhibit A attached hereto, including any reissues, reexaminations, renewals, substitutions, or extensions thereof; (b) any continuation, continuation-in-part or divisional applications of the patents and patent applications listed in Exhibit A; and (c) any patents issued on continuation or divisional applications, including reissues and reexaminations, of the patents and patent applications listed in Exhibit A.




 



1.12            “Source Code” means the source code for the Software and/or any Derivative.




 



1.13            “Sublicensing Revenue” means any payments that Licensee or an Affiliate receives from a Sublicensee in consideration of the sublicense of the rights granted Licensee and Affiliates under Article 5, including without limitation, license fees, milestone payments, license maintenance fees, and other payments, but specifically excluding royalties on Net Sales, development grants specifically for the development of Licensed Products, equity or debt sold to Sublicensee, reimbursed patent costs and expenses (may only be deducted once and for the first time collected), any payment made pursuant to the indemnification obligations of the parties, and any payment made to Licensee in connection with a cross-license of technology or similar in-kind technology transfers or exchanges directly related to the development, manufacture and sale of Licensed Product.











  





3











  






 



1.14            “Sublicensee” means any non-Affiliate sublicensee of the rights granted Licensee under Article 5, specifically excluding those non-Affiliate entities to which a sublicense is granted only in connection with a distribution agreement with the Licensee and no royalty is paid to Licensee under such distribution agreement; provided, however, that a royalty is paid by Licensee or an Affiliate to Licensor for Licensed Products sold under such distribution agreement.




 



1.15            “Technology” means (a) the Know-How (b) the Patent Rights, (c) the Copyrights, and (d) the Intellectual Property.




 



1.16            “Term” means the period of time beginning on the Effective Date and ending on the later of (i) the expiration date of the last to expire Patent Right, or (ii) seventeen (17) years from the sale of the first Licensed Product on a country by country basis.




 



1.17            “Territory” means worldwide.




 



1.18           “Valid Claim” means an unexpired claim in an issued unexpired patent or a claim of a pending patent application or supplementary protection certificate within the Patent Rights that has not been revoked, abandoned, disclaimed or withdrawn, or held unenforceable, unpatentable or invalid by a court of competent jurisdiction in a final judgment that has not been appealed within the time allowed by law or from which there is no further appeal.









2.               GRANT OF RIGHTS AND RETAINED RIGHTS


 


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.


 


2.2              Retained Rights. Licensor retains the right to use and reproduce the Technology and Software and to create derivatives of the Software for educational purposes and internal research and development only.  Unless Licensor has complied with the ‘First Look’ provision set forth in Section 2.3, Licensor will not have the right to use and reproduce the Technology and create and exploit such derivatives of the Software for any other purpose.  Unless Licensor has complied with the ‘First Look’ provision set forth in Section 2.3, Licensor will not use the Technology and/or Software to create any product that competes or has the potential to compete with the Licensed Products in the Territory.  Hickey and Lundgren each have executed a restrictive covenant agreement dated the 10th day of November, 2006, which agreements are incorporated by reference herein, and which continue in effect in accordance with their terms.






  





4











  










 


2.3           “First Look" Right. Subject to any existing obligations to third parties and so long as Licensee is not in default of any of its obligations hereunder, Licensor hereby grants to Licensee a "first look" right as to any Licensor Improvements.  "First Look" right means the exclusive right to negotiate a definitive license agreement for an exclusive, royalty bearing, worldwide license to use and otherwise commercially exploit Licensor’s intellectual property rights to any Improvements.  This "first look" right will commence on the date that Licensor discloses the Improvements to Licensee, and Licensee has sixty (60) days (“Notice Period”) to provide Licensor written notice (“First Look Notice”) of its interest in entering into negotiations for a license under Licensor’s intellectual property rights to make, have made, use, sublicense, sell, offer for sale products that make use of the Improvements. If and when Licensor receives the First Look Notice, the parties will promptly and in good faith commence license negotiations. The first look right will terminate (1) at the end of the Notice Period if Licensee has not notified Licensor of its interest in negotiating a license, or (2) one hundred fifty (150) days after Licensor receives the First Look Notice if the parties have not yet finalized a definitive license agreement. In the event that the parties are unable to agree on terms for a complete license agreement for the Licensor Improvement within ninety (90) days of the notification of the “first look”, Licensee, may at its discretion, refer any outstanding issues to a mutually agreed upon mediator.  The mediator will, based upon and consistent with the terms and conditions of this Agreement, upon the parties’ prior offers to one another, and upon custom and practice in transactions between medical device companies and universities, make recommendations to both parties for resolution of any outstanding issues.  If, after thirty (30) days of mediation, the parties still have not reached agreement, the “first look” right will expire.  Disclosure to Licensee of any confidential or proprietary information relating to any Improvements will be considered “Confidential Information” subject to Section 16 of this Agreement. Subject to any existing or hereafter incurred obligations to third parties, Licensor will not undertake to negotiate entering into any exclusive license under its intellectual property rights to make, have made, use, sell, offer for sale products that make use of the Licensor Improvements with any other party until after termination of Licensee’s “First Look” right.







2.4           Consulting.  Hickey and Lundgren may provide consulting services requested by Licensee for a consulting fee to be determined by the parties.  Licensee will be responsible for and advance or promptly reimburse Hickey and Lundgren for any out-of-pocket costs associated with the consulting services requested by Licensee, such as travel, food and lodging.







2.5           No Compulsory Package License.  The parties agree and acknowledge that Licensor requested that Licensee license all of the licensed patents together under a single license and that the Licensor did not request that Licensee license any patent individually.







2.6           Transfer of Tangible Assets.  Licensor has previously delivered or otherwise provided to Licensee all of Licensor’s tangible assets relating to the Licensed Products, Intellectual Property, Software, Source Code, Licensor Improvements and Derivatives, including but not limited to those items set forth on Exhibit B attached hereto and incorporated herein.  Title ownership of the items listed in Exhibit B will remain with Licensor.  Licensor may request that any item listed in Exhibit B be returned to Licensor by Licensee for Licensor’s use under Section 2.2 Retained Rights according to a mutually agreeable schedule, and any such item must be returned upon termination of this Agreement for any reason.


 




  





5











  






 



	
3.  

	
COMPENSATION AND PAYMENT TERMS












3.1           Royalties on Net Sales. Licensee will pay Licensor a royalty on annual Net Sales at a rate set forth below in Section 3.1 (a) and Section 3.1 (b) (“Royalty Rate”).  Earned royalties due on Net Sales made in the United States will be paid to Foundation, and earned royalties on Net Sales made outside of the United States will be paid to Hickey and Lundgren.


 


(a)            Licensee will pay to Licensor an earned royalty of five percent (5%) of Net Sales of Licensed Products, where one or more Valid Claims reads on the manufacture, use, or sale of such Licensed Product.


 


(b)           Licensee will pay to Licensor an earned royalty of four and one half percent (4.5%) of Net Sales of Licensed Products, where no Valid Claims read on the manufacture, use, or sale of such Licensed Product.







3.2           Reduction in Royalty Rate. Notwithstanding the foregoing, Licensee will have the right to reduce the Royalty Rate owed to Licensor hereunder Section 3.1 in the following circumstances and in accordance with the following calculations:







(a)           Licensee will have the right to reduce the Royalty Rate paid to Licensor for a Licensed Product in the event that Ethox International, Inc. or its employees (collectively “Ethox”) has any intellectual property right or claim or any other legal right with respect to the Technology and such right(s) were developed, owned, assigned or originated by Ethox prior the execution of this Agreement and such right(s) prevent or otherwise limit Licensee’s ability to exploit the Technology.  The royalty rate payable to Ethox may be deducted from the Royalty Rate specified under Section 3.1 but in no case will the Royalty Rate specified in Section 3.1 be reduced by more than one percent (1%). For example, if the royalty rate payable to Ethox is 1%, the Royalty Rate specified in Section 3.1 will be reduced to 4%.







(b)           In the event that a competitor of Licensee or Sublicensee sells a product in a country where there is no patent protection, which is competitive with a Licensed Product and captures twenty-five percent (25%) or more of the market in such country for esophageal balloon catheter-based cardiac performance measurement, then the royalties otherwise payable in such country as set forth in this section after any adjustments made under 3.2  (a), (b) or (c) will be reduced by 35%.  In order to make such an adjustment to the royalty for sales in a country where there is no patent protection, Licensee must provide to Licensor i) evidence of sales of the competitive product in that country and ii) reasonably demonstrate the capture of twenty-five percent (25%) of the market by providing to Licensor third party market tracking service data, if available.  If third party market tracking service data is not available, the licensee will make reasonable efforts to demonstrate the capture of twenty-five percent (25%) of the market through other means.


 




  





6











  






 


(c)           The Royalty Rate payable by Licensee on Net Sales by Sublicensees may be reduced according to the adjustments provided in this Section 3.2, provided that any incremental royalty rate paid by a Sublicensee to Licensee is similarly reduced under the same circumstances and in accordance with the same calculations provided for in this Section 3.2.







Each such Royalty Rate or payment reduction will be indicated in the quarterly and annual reports provided to Licensor pursuant to Section 7.2, below.







3.3           Annual Minimum Royalty. Beginning with the first full calendar year of sales of Licensed Product in the United States and for two years thereafter, Licensee will pay Licensor an Annual Minimum Royalty payment of $100,000 against which any Royalty on Net Sales paid in the same calendar year for sales in the United States will be credited.  Subject to Section 10.3, beginning with the first full year of sales of Licensed Product outside of the United States (“Non U.S.”) and for two years thereafter, Licensee will pay Licensor an Annual Minimum Royalty payment of $100,000 against which any Royalty on Net Sales paid in the same calendar year for sales outside the United States will be credited.  The Annual Minimum Royalty for a given year will be due at the time payments are due for the calendar quarter ending on December 31.







The Annual Minimum Royalty due on sales made in the United States will be paid to Foundation and Annual Minimum Royalty due on sales made outside of the United States will be paid to Hickey and Lundgren.







3.4           Sublicensing Fees. Licensee will pay Hickey and Lundgren 18.75%  of Sublicensing Revenue, and Licensee will pay Foundation 6.25% of Sublicensing Revenue (Licensor will in the aggregate receive 25% of the Sublicensing Revenue, and such amount will be considered “Sublicensing Fees”).







3.5           Milestone Payments.  Licensee will satisfy or has satisfied the Original Agreement milestone payment obligations through certain cash payments, as set forth in Section 3.10 and through the issuance of stock, as set forth in Section 3.11.







3.6           Payment Terms. All dollar amounts referenced herein will refer to U.S. Dollars. Payments with designated payment dates are due and payable on or before those dates. Earned royalty payments will be made within thirty (30) days after the end of each calendar quarter for the calendar quarter. All invoiced payments will be paid within thirty (30) days of Licensee’s receipt of invoice. When Licensed Products are sold for currencies other than U.S. Dollars, earned royalties will first be determined in the foreign currency of the country in which the Licensed Products were sold and then converted into equivalent U.S. Dollars. The exchange rate is that rate quoted in the Wall Street Journal on the last business day of the reporting period and is quoted as local currency per U.S. Dollar.







3.7           Payment Address for Foundation. All payments due Foundation will be made payable to “The Research Foundation of State University of New York” and will be sent to the below address:







UB Office of Science, Technology Transfer & Economic Outreach 

UB Technology Incubator


Baird Research Park


1576 Sweet Home Road


Amherst, NY 14228


Attn: Licensing Specialist




 




  





7











  






 


3.8           Payment Address for Hickey and Lundgren. Any payments due Hickey or Lundgren will be made payable to Hickey or Lundgren as required and either wired or paid by check in accordance with written instructions provided by Hickey or Lundgren, and currently in effect at the time payment is due.







3.9           Foreign Charges. Royalties due on Net Sales that occur in any country outside the United States may not be reduced by any deduction of withholding, value-added taxes, fees, or other charges imposed by the government of such country, except as permitted in the definition of Net Sales. Licensee is responsible for all bank transfer charges.







3.10         Cash Payment. Licensee will pay Hickey a cash payment of $30,000 on or before April 30, 2011.  Licensee will pay Hickey a second cash payment of $105,000 on or before the date that is thirty (30) days after the first commercial sale of a Licensed Product by the Licensee.  If the Licensee fails to make the second payment pursuant to this Section 3.10 on or before the due date, then interest shall accrue on any outstanding balance at a rate that is equal to the lesser of the maximum rate allowed by law or 1.5% per month but in any case each cash payment and any accrued interest must be paid in full no later than July 31, 2012.







3.11         Stock Grant.   Licensee issued 1,001,920 shares of its common stock, par value $0.001 per share (“Common Stock”) dated October 23, 2008, as follows:  (a) 412,860 shares of Common Stock were issued to the Foundation; (b) 162,500 shares of Common Stock were issued to Hickey; and (c) 426,560 shares of Common Stock were issued to Lundgren.  Each certificate representing the shares of Common Stock to be issued pursuant to this Section 3.11 contained a restrictive legend on transfer and the Licensee has no obligation to register any of the shares of Common Stock under the Securities Act of 1933, as amended.








	
4.0

	
DUE DILIGENCE







 


4.1           Licensee will use commercially reasonable efforts to commercialize and market Licensed Products as soon as practicable and in accordance with the milestone events set forth herein.







4.2           Unless there is “good reason” that such milestones cannot be reached with commercially reasonable efforts, Licensee undertakes to reach the following milestones in the timeframes set forth below:


 



	
(a)  

	
On or before July 31, 2011, Licensee will commence a clinical trial in the U.S.













	
(b)  

	
On or before January 31, 2012, Licensee will:







 



	
i.  

	
make application for 510(k) pre-market notification with the FDA for approval to market the Licensed Product in the U.S. and take the equivalent action within the EU;







 




  





8











  






 



	
ii.  

	
make contact with and engage in an initial meeting with the governing agencies in Japan, India and China to seek guidance on obtaining approval to market the Licensed Product in each of said countries; and







 



	
iii.  

	
negotiate a manufacturing contract for the production of the Licensed Product to be marketed commercially.













	
(c)  

	
Within six months of receiving approval to market the Licensed Product in the U.S. or EU, Licensee will:







 



	
i.  

	
be       capable of manufacturing, or having manufactured, commercial versions of the Licensed Product for sale;







 



	
ii.  

	
have developed a sales force or distribution capability in the territory in which approval to market was received for the Licensed Product, either internally or per a third party service or distributor; and







 



	
iii.  

	
have established a service capability, either internally or per a third party service or distributor, to provide customer service for the Licensed Product for each jurisdiction in which the Licensed Product is approved by the appropriate governing authority to be marketed.













	
(d)  

	
Within eight (8) months of receiving approval to market the Licensed Product in the U.S. or EU, Licensee will make a first commercial sale of Licensed Product.













	
(e)  

	
Within eighteen (18) months from the date the Licensed Product is approved by the FDA for marketing in the U.S., Licensee will, on its own or through a Sublicensee, file for approval to market the Licensed Product in Japan, India and China.












As used herein, the term “good reason” will include:








	
1.  

	
Events of force majeure bearing on the ability of Licensee to make, use or sell the device in the respective jurisdiction(s);







 



	
2.  

	
The performance of the device in such a fashion that it is deemed to be dangerous or to incur undo risk for the user or patient or is medically unreliable;







 



	
3.  

	
A determination by a governmental agency that the device will require clinical trials that reasonably cannot be completed before the milestone is reached;







 



	
4.  

	
A challenge, claim, suit or interference to the Patent Rights or division of a patent that raises a significant commercial risk unless resolved;







 



	
5.  

	
A determination that the device will require the filing of a PMA (by FDA in the U.S., or by similar determination by a governing agency in another jurisdiction) or that FDA has amended the requirements for approval as a 510(k) device;







 



	
6.  

	
The revelation of facts concerning the state of development of the device, the clinical or biological results pertaining thereto, the ownership of the device or other significant facts bearing on the commercial viability of the device, which are contrary to or in conflict with the statements and/or representations of the Licensor or its agents concerning the device; or







 




	
7.  

	
Adverse events or other clinical results suggesting a change in design or manufacture.









 




  





9











  






 


 


Except with respect to the occurrence of the events set forth in either 4 or 6 above, in the event of failure to meet the milestones for “good reason”, Licensee and Licensor will negotiate in good faith to amend the milestones, taking into account the “good reason” event that has occurred, in order to establish a revised set of commercially reasonable milestones and timeframes to be met by Licensee going forward.







In the event that: (i) a challenge, claim, suit interference to the Patent Rights that raises a significant commercial risk unless resolved, or is incapable of being resolved, or (ii) the revelation of facts concerning the state of development of the device, the clinical or biological results pertaining thereto, the ownership of the device or other significant facts bearing on the commercial viability of the device, which are contrary to or in conflict with the statements and/or representations of the Licensor or its agents concerning the device, Licensee will have the right to terminate this Agreement in accordance with Section 10.3.


 


4.3           The Foundation (on behalf of the Licensors) will have the right to request a monthly teleconference meeting with the Licensee, including as appropriate representatives from each of the catheter, software, hardware and clinical trial vendors involved in the development and testing of Licensed Products, to brief the Licensors on the status of product development and related clinical trials for the Licensed Product.  The meetings will be conducted via teleconference, however, the Foundation will have the right to request that up to six (6) of these monthly meetings be held in-person in Buffalo, New York.  Prior to any in-person meeting being held, a mutually agreeable agenda will be developed by the Foundation (on behalf of the Licensors) and the Licensee as well as a list of participants required to attend the meeting in-person.  The first in-person meeting will be held within one month of the Licensee closing on its current round of financing.  This right of the Licensors will expire upon the Licensee’s submission of an application for approval of the Licensed Product to the FDA that contains the contractility feature of the device or upon the Licensee’s determination that the contractility feature is not commercially reasonable.







In the event that the Licensee determines that the contractility feature of the Licensed Product is not commercially reasonable, Licensee agrees to return all rights licensed to the Licensee under the Technology License Agreement pertaining to the contractility feature of the Licensed Product to the Licensor, including pertinent technology, software, know-how and developments that would allow Licensor to develop and market a device solely for the measurement of cardiac contractility.  All details of said return of rights will be subject to the mutual agreement of the Licensee and Licensor or in the event that no agreement can be reached, established per the arbitration provisions of Paragraph 17.1 of the Technology License Agreement.


 




  





10











  






 


4.4           The Foundation is granted the right to have one person observe the Licensee’s board of directors meetings.  The person designated by the Foundation will be subject to the approval of the Licensee, which approval will not be unreasonably withheld.  The Licensee approves Jeffrey A. Dunbar, or his successor at the Foundation, as the Foundation’s designee to observe the Licensee’s board meetings.  Mr. Dunbar shall be notified of all board meetings at the same time as other Licensee board members and will be provided the same materials for each board meeting as the other directors of the Licensee.  This right of the Foundation will expire upon the Licensee receiving FDA approval to market the Licensed Product in the U.S.  Observer rights will not extend to discussions or topics involving attorney-client privilege or matters which, in the opinion of legal counsel for the Licensee, represent a conflict of interest between Licensors and Licensee








	
5.0  

	
SUBLICENSING












The license granted in this Agreement includes the right of Licensee to grant sublicenses to third parties during the Term. With respect to sublicenses granted pursuant to Article 5, Licensee will:








	
  

	
(a)

	
not receive, or agree to receive, anything of value in lieu of cash as considerations from a third party under a sublicense granted pursuant to Article 5 without the express written consent of Licensor, unless such consideration is a cross-license of technology by Sublicensee to Licensee for Licensee’s exploitation of the Patent Rights;







 



	
  

	
(b)

	
to the extent applicable, include all of the rights of and obligations due to Licensor and contained in this Agreement;







 



	
  

	
(c)

	
promptly provide Licensor with a copy of each sublicense issued; and







 



	
  

	
(d)

	
use commercially reasonable efforts to collect all payments due, directly or indirectly, to Licensor from Sublicensees and summarize and deliver all reports due, directly or indirectly, to Licensor from Sublicensees.







 


Upon termination of this Agreement for any reason, Licensor, at its sole discretion, will determine whether Licensee will cancel or assign to Licensor any and all sublicenses.







6.           PATENT PROSECUTION AND PATENT COSTS







6.1           Patent Costs Incurred Pre-Effective Date.  Licensee satisfied pre-Effective Date Patent Cost obligations under the Original Agreement.







6.2           Patent Rights Management. Licensor will control and manage all future preparation, filing, prosecution and maintenance of the Patent Rights; provided however, that Licensor will (a) cause its patent counsel to timely copy Licensee on all official actions and written correspondence with, and received from, any patent office, and (b) allow Licensee a reasonable opportunity to comment and advise Licensor on all filings and communications to be made with any patent office and Licensor will consider and reasonably incorporate all comments and advice, provided they are consistent with Licensor’s interests.  In the event that Licensor’s patent counsel fails to perform legal services in accordance with professional standards or performs services in a manner that may jeopardize the Patent Rights, Licensee will notify Licensor that new patent counsel should be selected and the parties will cooperate in the joint selection of new patent counsel acceptable to both parties.  If Licensee is not satisfied with the services performed by Licensor’s patent counsel for any reason other than those stated above, Licensee may notify Licensor of the issue with patent counsel and Licensor will seek to resolve the issue in a timely manner, not to exceed thirty (30) days from the date of such notice.  If the issue is not resolved to the satisfaction of Licensee within said time period, then Licensee may request the selection of new patent counsel.  The parties will cooperate in the selection of new patent counsel, which counsel will be mutually acceptable to both parties.  The selection of the new counsel will be made within thirty (30) days of the date Licensee requests new patent counsel.  Both parties agree to be reasonable in the selection of new patent counsel.  When the new counsel is agreed upon by the parties, Licensor will dismiss the original patent counsel and request a transfer of all legal files to the new patent counsel with as much speed as is reasonable, but in not more than fifteen (15) days.


 




  





11











  






 


6.3           Post-Effective Date Patent Costs.  Licensee will be directly responsible for payment of all Patent Costs incurred after the Effective Date.  Licensor will instruct respective patent counsels to set up direct billing arrangements with Licensee under terms and conditions satisfactory to the Licensee and consistent with industry practices between similar entities.  Licensee will directly negotiate billing terms and legal fees with Licensor’s patent counsel.  Licensor will request copies of all invoices from patent counsel and Licensee will copy Licensor on all payments to patent counsel.

 


6.4           Declinations.  Licensee may elect to terminate its payment obligations with respect to any patent application or patent in Patent Rights upon three (3) months written notice to Licensor. Licensor will use reasonable efforts to curtail further Patent Costs for such application or patent when such notice of termination is received from Licensee.  Licensee is responsible for paying any Patent Cost incurred prior to the end of the three (3) month notice period.  Licensor, in its sole discretion and at its sole expense, may continue prosecution and maintenance of said application or patent, in which case Licensee’s license under such patent and other rights related to Technology relating to such patent in such country or territory will terminate.  Non-payment of any portion of Patent Costs with respect to any application or patent may be deemed by Licensor as an election by Licensee to terminate its payment obligations with respect to such application or patent. The failure of Licensee to pay any such fee or costs within one-hundred twenty (120) days of receipt of an invoice for same will cause Licensee to, upon receipt of notice from Licensor, lose all rights for such patent in the country or territory for which fees or costs were due, unless Licensor receives notice from Licensee that such invoice is in dispute.  In the event of a dispute regarding an invoice, Licensee’s rights will not be subject to termination for non-payment of the disputed invoice in accordance with this section.  Licensor and Licensee will make good faith efforts to resolve any such dispute with the respective patent counsel.  Following the loss of all rights in any country or territory by Licensee, Licensor will be free to exploit or contract with third parties to exploit the Technology rights to (a) make, have made, use, sell and offer for sale Licensed Products, and (b) use and reproduce Software, create Derivatives, and distribute Software to end users in such jurisdiction.  Nothing herein will obligate Licensor to apply for, prosecute or maintain any patent or copyright registration in any jurisdiction other than those set forth in Exhibit A (List of Patents).









  





12











  






 


7.           BOOKS, RECORDS AND REPORTS







7.1           Books and Records. Licensee will keep complete, true and accurate books of account containing reasonable particulars that may be necessary for the purpose of showing the amounts payable to Licensor hereunder and for the purpose of showing compliance with all other obligations under this Agreement. Licensee will use reasonable efforts to require any Affiliate and Sublicensee to comply with this Section.  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 (subject to Foundation’s obligations relating to internal reporting and accounting requirements) by Licensor or its agents, upon reasonable notice to Licensee, for the purpose of verifying Licensee’s royalty statement or compliance in other respects with this Agreement. Licensor and its agents may make copies of relevant information during the course of an inspection. In addition, Licensee agrees to provide copies to Licensor of relevant records upon request of Licensor. 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 Licensor’s detriment, Licensee 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 1⁄2 % per month.


 


7.2           Reports. After an initial sale of Licensed Product by Licensee, Affiliate or Sublicensee in a given country, within sixty (60) days after the end of each calendar quarter during the term of the Agreement, Licensee will provide reports containing the following information relating to the quarter: (a) number and type of Licensed Products made by or for Licensee and any Sublicensees; (b) number and type of Licensed Products sold by Licensee, Affiliates and Sublicensees; (c) Net Sales (and the calculation of Net Sales); (d) royalties due under Section 3.1; (e) Sublicensing Revenue (and the calculation of Sublicensing Revenue, including documentation of any allowed exclusions under Section 1.14); (f) Sublicensing Fees due under Section 3.3, (g) the total amount (royalties and Sublicensing Fees) due for such quarter; and (h) justification for any reduction in Royalty Rate under Section 3.2 . Within ninety (90) days after the end of each calendar year during the term of the Agreement, Licensee will also provide reports containing the following information relating to the calendar year: (a) progress on the commercialization of the Technology and the development of Licensed Products (i.e., new product development, product evaluation and testing, marketing plans, sales forecasts, significant commercialization events and progress related to completion of the milestones set forth in Section 4.2); and (b) any Net Sales adjustments for allowances according to Section 1.9.  The foregoing will be provided on a country-by-country basis.







7.3           Report Certification. Each report will be signed by an officer of Licensee, and all reports will be prepared in accordance with U.S. G.A.A.P. If no royalties are due for a fiscal quarter, Licensee will submit a report to Licensor that states this.


 




  





13











  






 


8.           PATENT RIGHTS INFRINGEMENT







Upon either Party becoming aware of any potential infringement of the Patent Rights, Software, Technology, Derivatives, Licensor Improvements, or other intellectual property relating to the Licensed Products in the Territory, such Party will promptly give notice thereof to the other Party which notice will contain all information possessed by the Party, giving such notice relating to such potential infringement.  Licensee will have the right but not the obligation, in its own name, to institute infringement proceedings against third parties based on any such potential or actual infringement.  If Licensee does not institute infringement proceedings against such third parties within thirty (30) days after its knowledge of such potential infringement, Licensor will have the right, but not the obligation, to institute such proceedings.  The expenses of such proceedings, including legal fees, will be borne by the Party instituting suit.  Each Party will execute all necessary and proper documents and take all other appropriate action to allow the other Party to institute and prosecute such proceedings.  Any award paid by third parties as a result of such proceedings (whether by way of settlement or otherwise) will be applied as follows:








	
(a)  

	
first, toward reimbursement for the legal fees and expenses incurred by the Party or Parties that instituted and prosecuted suit;







 



	
(b)  

	
second, after payment of the amount set forth in clause (a) above, thirty percent (30%) of any remainder may be retained by the Party or Parties that instituted and prosecuted the suit; and







 



	
(c)  

	
third, after payment of the amount set forth in clauses (a) and (b) above, any remainder will be treated as Net Sales under this Agreement.  In the event that Licensor receives an award, Licensor will deduct the appropriate royalty payment in accordance with Section 3.3 and pay Licensee the balance of the award within thirty (30) days of Licensor’s receipt of such award.







 


The indemnifications obligations under this Section 8 will be applicable to any counterclaims of infringement asserted in connection with any legal proceeding arising under Section 9.







9.           INDEMNIFICATION


 


9.1           Licensee will defend, indemnify and hold Licensor, its officers, trustees, employees and agents harmless from and against any and all claims, actions, suits, loss, injury, expenses, damages, liability, cost and expenses (including reasonable attorneys’ fees) of any kind or nature arising out of, or resulting from, the exercise or practice of the license granted under this Agreement, including without limitation, liabilities arising from the production, manufacture, sale, use, lease, or advertisement of Licensed Products, Technology and/or Software provided that Licensor provides prompt written notice to Licensee of such claim. Any settlement will require Licensor’s prior written approval, which approval will not be unreasonably withheld.  Licensee will carry product liability insurance which covers Licensed Product having such coverage limits appropriate to the risk involved in marketing the Licensed Products and will list Foundation, Hickey and Lundgren as additional named insured.   Licensee will carry product liability insurance (upon market launch) and clinical trial insurance (upon the commencement of any clinical trial) which covers the Licensed Product having such coverage limits appropriate to the risk involved in marketing and testing the Licensed Product and will list Foundation, Hickey and Lundgren each as an additional named insured.


 




  





14











  






 


9.2           Foundation will defend, indemnify and hold Licensee, Hickey, Lundgren and their respective officers, trustees, employees and agents harmless from and against any and all claims, actions, suits, loss, injury, expenses, damages, liability, cost and expenses (including reasonable attorneys’ fees) of any kind or nature arising out of, or resulting from, any production, manufacture, sale, use, lease, advertisement, development, testing and/or clinical trial of the Technology or Software or any product created from the Technology prior to the Effective Date, including without limitation any product liability claim or other claim of any kind relating to the use of a device that was manufactured using the Technology prior to this Agreement and used prior to the Effective Date of this Agreement.  Foundation will also indemnify and hold Licensee, Hickey, Lundgren and their respective officers, trustees, employees and agents harmless from and against any and all claims, actions, suits, loss, injury, expenses, damages, liability, cost and expenses (including reasonable attorneys’ fees) of any kind or nature arising out of, or resulting from its use of the Technology or Software under Section 2.2 Retained Rights.







10.           TERMINATION







10.1          Termination for Licensee Breach. If Licensee should (a) materially violate or fail to perform any covenant, condition or undertaking of the Agreement, or (b) have a bankruptcy action filed against it, or (c) have a receiver appointed for it; then Licensor may give written notice of such default to Licensee. If Licensee should fail to cure such default within ninety (90) days of notice of such default, then this Agreement may, at Licensor’s option, be terminated by a second written notice to Licensee.







10.2          Automatic Termination. If Licensee (a) will cease to attempt to carry on its business with respect to the rights granted in the Agreement for a period of sixty (60) days, (b) has filed a bankruptcy action seeking liquidation, (c) becomes financially unable to continue operations as a going concern, or (d) makes an assignment for the benefit of creditors, this Agreement will terminate upon thirty (30) days prior written notice to Licensee.







10.3          Termination by Country.  If either party materially breaches its obligations under this Agreement, only in respect of a particular country or particular countries within the Territory, then the non-breaching party may terminate the obligations of the parties under this Agreement with respect to each such country, in accordance with the notice procedure set forth in Section 10.1 above, provided that the non-breaching party will expressly identify, in the notice of termination, the country or countries subject to such termination.  Upon a termination of this Agreement solely with respect to a particular country pursuant to this Section 10.3, the Agreement will continue in full force and effect, provided that the definition of the term “Territory” will be deemed to exclude the country or countries in respect of which the Agreement was terminated.  Additionally, Licensee will immediately assign or cause to be transferred to Licensor, at Licensor’s cost and expense, all regulatory approvals and all licenses and all registered user, distributor and other rights Licensee may have acquired with respect to the Licensed Products, in such country, and Licensee will cease to use and have no further rights thereto in such country.  To the extent assignment or transfer of approvals, licenses, registered user, distribution and other rights is not permitted under local law in such country, Licensee will co-operate in their cancellation or abandonment, and in their reissuance to Licensor.


 




  





15











  






 


10.4           Termination for Licensor Breach.  If Licensee discovers (i) a challenge, claim, suit interference to the Patent Rights that raises a significant commercial risk unless resolved, or is incapable of being resolved, or (ii) the revelation of facts concerning the state of development of the device, the clinical or biological results pertaining thereto, the ownership of the device of other significant facts bearing on the commercial viability of the device, which are contrary to or in conflict with the statements and/or representations of the Licensor or its agents concerning the device, Licensee will have the right to terminate this Agreement upon written notice to Licensor. At Licensee’s option, such termination can be for the entire Agreement or only in respect of certain countries or territories, as set forth in Section 10.3, above.  Upon such termination, any and all obligations of Licensee in respect of the Licensed Products and Technology will cease, including but not limited to Licensee’s obligations to pay Annual Minimum Royalties, and any and all Technology rights granted to Licensee by Licensor will also cease.







10.5           New Intellectual Property. Any new intellectual property related to the Technology (including Licensee Improvements and Derivatives) developed by or owned by Licensee will be assigned by Licensee to Licensor if the entire Agreement (i.e. does not include Section 10.3 Termination By Country) is terminated for any reason prior to its scheduled expiration; provided however, that if Licensee challenges a termination by Licensor before a court or arbitrator of competent jurisdiction, the assignment will only be made if such court or arbitrator determines that Licensee is in breach of this Agreement. Any manufacturing, engineering or technical consulting contracts entered into by Licensee or its Affiliates related to the Technology and the development of Licensed Products will include terms requiring that the contracted party must assign all intellectual property rights to Licensee such that Licensee may fulfill its obligations under this Section.







10.6           Technology Related Property. Documentation, technical information and property of any kind relating to the Technology and developed by or for Licensee during the Term (collectively, “Technology Related Property”) will be provided to and become the property of Licensor if the Agreement is terminated for any reason prior to its scheduled expiration; provided however, that if Licensee challenges a termination by Licensor before a court or arbitrator of competent jurisdiction, the assignment will be made only if such court or arbitrator determines that Licensee is in breach of this Agreement. Technology Related Property includes, but is not limited to, product designs and specifications, software, test data, laboratory and clinical trial data, market research results, and dies for making Licensed Products.







10.7           Accrued Obligations. Termination of this Agreement will not relieve either party of any obligation or liability accrued hereunder prior to such termination, or rescind or give rise to any right to rescind any payments made or other consideration given to Licensor hereunder prior to the time such termination becomes effective. Such termination will not affect in any manner any rights of Licensor arising under this Agreement prior to the date of such termination. Licensee will pay all attorneys’ fees and costs incurred by Licensor in enforcing any obligation of Licensee or accrued right of Licensor.


 




  





16











  






 


10.8           Disposition of Licensed Products. Upon expiration or termination of this Agreement by either party, Licensee will provide Licensor with a written inventory of all Licensed Products in process of manufacture, in use or in stock. Licensee may dispose of any such Licensed Products within the one hundred and fifty (150) day period following such expiration or termination, provided, however, that Licensee will pay royalties and render reports to Licensor thereon in the manner specified herein.







10.9           Survival. The provisions Section 1 (Definitions), Section 7 (Books, Records and Reports), Section 9 (Indemnification), Section 10.3 (New Intellectual Property), Section 10.4 (Technology Related Property), Section 10.6 (Disposition of Licensed Products), Section 10.7 (Survival), Section 11 (Warranty and Liability), Section 14 (Non-Use of Names), Section 16 (Confidentiality) and Section 17 (Miscellaneous) will survive termination of this Agreement.







11.           WARRANTY AND LIABILITY


 


11.1           Authority.  As of the Effective Date, each party represents and warrants to the other that (a) it has the corporate power and authority to enter into this Agreement and perform its obligations hereunder; (b) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (c) the Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid and binding obligation of such party and is enforceable against it in accordance with its terms.


 


11.2           Intellectual Property. As of the Effective Date, Licensor represents and warrants to Licensee that to the best of its knowledge (a) it owns, free and clear of any liens, all right, title and interest in the Technology, patents, trade secrets, know-how, copyrights, and other intellectual property that are licensed to Licensee under this Agreement, (b) it has all rights and licenses necessary to enable it to grant the licenses granted hereunder, (c) it is not aware of any pending or threatened litigation (and has not received any communication relating thereto) which alleges that Licensor’s activities with respect to the Patent Rights, Technology or otherwise related to this Agreement have infringed or misappropriated, or that by conducting the activities as contemplated herein Licensor would infringe or misappropriate, any of the intellectual property rights of any other third party, (d) none of the licensed Patents have been subject to a judicial or administrative judgment, order or decree holding any of the licensed Patents to be invalid or unenforceable, (e) all maintenance fees and/or annuity payments required to prevent abandonment of any of the licensed Patents have been paid as of the date of this Agreement, (f) it has no knowledge of any charges that the licensed Patents infringe on any rights of any third parties, and (g) it has no knowledge of any infringement of any of the licensed Patents.


 


11.3           No Consents or Approvals.  Except as otherwise described in this Agreement, each party represents and warrants to the other that all necessary consents, approvals and authorizations of all governmental authorities and other persons or entities required to be obtained by such party in connection with entry into this Agreement have been obtained.


 


11.4           Clinical Trials.  Licensor represents and warrants, to the best of its knowledge and understanding, that Exhibit C, attached hereto, is a true and accurate list of all of the clinical trials that were conducted worldwide by Licensor, its agents or subcontractors or third parties in respect of the Technology.


 




  





17











  






 


11.5           No Conflict.  Each party represents and warrants to the other that the execution and delivery of this Agreement by such party and the performance of such party's obligations hereunder (a) do not conflict with or violate any requirement of applicable law or regulation or any provision of articles of incorporation or bylaws of such party in any material way, and (b) do not conflict with, violate, breach, constitute a default or require any consent under, any contractual obligation or court or administrative order by which such party is bound.


 


11.6           EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN, LICENSOR MAKES NO ADDITIONAL REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING.







11.7           Other than the provisions of Sections 11.1, 11.2, 11.3, 11.4 and 11.5 above, Licensor makes no further warranty or representation that anything made, used, sold or commercially transferred under the terms of this Agreement will be free from infringement of any third party patents, copyright or other intellectual property claims.







11.8           EXCEPT WITH RESPECT TO THE INDEMNITY OBLIGATIONS SET FORTH IN SECTION 9.2, IN NO EVENT WILL LICENSOR BE LIABLE FOR ANY INCIDENTAL, SPECIAL PUNITIVE OR CONSEQUENTIAL DAMAGES RESULTING FROM THE EXERCISE OF THIS LICENSE OR THE USE OF THE TECHNOLOGY, SOFTWARE, LICENSED PRODUCT OR LICENSED METHOD, INCLUDING FOR LOST PROFITS, OR FOR LOST DATA OR DOWNTIME, WHETHER OR NOT LICENSOR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.







11.9           THIS AGREEMENT DOES NOT CONFER BY IMPLICATION, ESTOPPEL, OR OTHERWISE ANY LICENSE OR RIGHTS TO ANY OTHER LICENSOR PROPERTY OTHER THAN THOSE RIGHTS EXPRESSLY STATED HEREIN.







11.10           Each party to this Agreement, by execution hereof, acknowledges, covenants and agrees that it has not been induced in anyway by one or more of the other parties, or any of their employees, to enter into this Agreement, and further warrants and represents that (i) it has conducted sufficient due diligence with respect to all items and issues pertaining to this Article 11 and all other matters pertaining to this Agreement; and (ii) has adequate knowledge and expertise, or has utilized knowledgeable and expert consultants, to adequately conduct due diligence, and agrees to accept all risks inherent herein.







12.           ASSIGNMENT


 


This Agreement will not be assignable by a party hereto without the express written consent of the other party, except that either party may assign or otherwise transfer this Agreement and the rights and obligations hereunder, without the other party’s consent, to a successor to all or substantially all of its business or assets to which this Agreement pertains, whether by merger, sale, operation or law or otherwise.  This Agreement will be binding upon and inure to the benefit of the permitted successors and assigns of the parties.  The foregoing will not be construed to preclude either party from retaining subcontractors or distributors in connection with each party’s performance under this Agreement, without notice or consent of the other party, provided, however, that each party will be responsible for the performance of its subcontractors to the same extent as if such performance had been made by such party.


 




  





18











  






 


13.           OBLIGATIONS TO FEDERAL GOVERNMENT AND OTHER SPONSORS


 


The Agreement will be subject to the rights of the United States Government, if any, resulting from any funding of the Technology by the United States Government.  This Agreement will also be subject to the rights of any other entities that may have contributed funding to development of the Technology, if any. Licensee acknowledges that such rights, if applicable to Technology, may reserve to the United States Government, a royalty-free, non-exclusive, non-transferable license to practice or have practiced on it’s behalf any government-funded invention claimed within any associated patents or patent applications as well as other rights.


 


14.           NON-USE OF NAMES







Licensee agrees that it will not use any Licensor name or State University of New York, or University at Buffalo, adaptation thereof (including logos and symbols associated with Foundation and “State University of New York, and “University at Buffalo”) (collectively “SUNY”), or the names of the scientists, researchers or others employed at or with SUNY in any advertising, promotional or sales literature without first obtaining Licensor’s prior written consent, or in the case of the names of such researchers, scientists or employees the prior written consent of the individuals, except that Licensee may state that it is a licensee of the Licensor.


 


15.           COMPLIANCE WITH LAWS







15.1         General Compliance. Licensee will ensure compliance with all applicable county, state, federal or foreign laws, rules, and regulations governing the production, use, marketing, sale, and distribution of Licensed Products.







15.2         Registration of this Agreement. When required by local or national law, Licensee will register this Agreement, pay all costs and legal fees connected therewith, and otherwise insure that the local/national laws affecting this Agreement are fully satisfied.







15.3         Export Control Laws. The Export Administration Regulations of the U.S. Department of Commerce (15 CFR Parts 770 and 785) prohibit, except under a special validated license, the exportation from the United States of technical data relating to certain commodities (listed in the Regulations), unless the exporter has received certain written assurance from the foreign importer. In order to facilitate the exchange of technical information under this Agreement, therefore, Licensee gives its assurance to Licensor that Licensee will not knowingly, unless prior authorization is obtained from the U.S. Office of Export Controls, re-export directly or indirectly any technical data received from Licensor under this Agreement and will not export directly Licensed Product or technical data to any restricted country in each case, except in compliance with all U.S. laws and regulations. Licensor neither represents that a license is or is not required nor that, if required, it will be issued by the U.S. Department of Commerce.


 




  





19











  






 


16.           CONFIDENTIALITY


 


16.1           Confidential Information. As used in this Agreement, “Confidential Information” will mean confidential or proprietary information exchanged between the parties hereunder and relating to the Technology Rights or the performance of the obligations set forth herein. Confidential Information will include, but not be limited to: (a) written or other tangible information marked as confidential or proprietary, (b) orally disclosed information that is identified as confidential and summarized in a notice delivered within thirty (30) days of the disclosure, and (c) information that should reasonably be considered confidential under the context in which the disclosure is made including but not limited to, Improvements information disclosed pursuant to Section 2.3 hereunder, reports provided to Licensor pursuant to Section 7.2, information relating to payments made by Licensee in respect of the Licensed Products, nonpublic patenting information and nonpublic infringement information.







16.2           Confidentiality Obligations. Each party agrees to (a) maintain the other party’s Confidential Information in confidence, and (b) not disclose the other party’s Confidential Information to any other party, without the prior written consent of the disclosing party. Each party agrees to limit its use of the other party’s Confidential Information to the purposes permitted by this Agreement.  To the extent that either party is required to disclose the Confidential Information of the other party pursuant to interrogatories, requests for information or documents in legal proceedings, subpoena, civil investigative demand or other similar process, such party will provide the other party with prompt written notice of any such request.  The owner of the Confidential Information may then seek a protective order or other appropriate remedy and/or waive compliance with Section 16 of this Agreement. Nothing in this confidentiality obligation will restrict Licensee’s ability to disclose information required by the SEC or other governmental regulatory agency.







16.3           Termination and Expiration of Confidentiality Obligations. The obligations of Section 16.2 will terminate with respect to any particular portion of the Confidential Information which (a) was in the receiving party’s possession prior to disclosure to it by the disclosing party; (b) is or hereafter becomes, through no fault of the receiving party, part of the public domain by publication or otherwise; (c) is furnished to the receiving party by a third party after the time of disclosure hereunder as a matter of right and without restriction on its disclosure; or (d) is independently developed by employees or agents of the receiving party independently of and without reference to Confidential Information received from the disclosing party.


 


17.           MISCELLANEOUS


 


17.1           Arbitration.  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, but specifically excluding disputes involving ownership of Technology, which can not 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.  The parties agree that any dispute with respect to the ownership of the Technology will be brought in the Southern District of New York and the parties hereby consent and agree to the exclusive jurisdiction of that court.


 




  





20











  






 


17.2           Governing Law. This Agreement will be construed, governed, interpreted and applied in accordance with the laws of the State of New York, except that questions affecting the construction and effect of any patent will be determined by the law of the country in which the patent was granted.







17.3           Entire Agreement. This Agreement, including any Exhibits or attachments hereto, embodies the entire agreement and understanding among the parties to this Agreement and supersedes all prior agreements and understandings relating to the subject matter of this Agreement. None of the terms or provisions of this Agreement may be altered, modified, or amended except by the execution of a written instrument signed by the parties hereto.


 


17.4           Severability. The provisions of this Agreement are severable, and in the event that any provisions of this Agreement are determined to be invalid or unenforceable under any controlling body of law, such invalidity or unenforceability will not in any way affect the validity or unenforceability of the remaining provisions hereof.







17.5           Notices. All notices, requests, consents and other communications to be provided under this Agreement must be in writing and will be delivered in person or sent overnight delivery by a nationally recognized courier or by certified or registered mail, return receipt requested to the addresses provided below, and will be deemed to have been given when hand delivered, one (1) day after mailing when mailed by overnight courier or five (5) days after mailing by registered or certified mail:







If to Licensee, to:







Scivanta Medical Corporation


215 Morris Avenue


Spring Lake, New Jersey 07762


Attn:  Thomas S. Gifford, Executive Vice President and Chief Financial Officer


 


and







Giordano, Halleran and Ciesla


125 Half Mile Road


P.O. Box 190


Middletown, New Jersey  07748


Attn:  Paul T. Colella


 




  





21











  











If to Licensor, to:







UB Office of Science, Technology Transfer and Economic Outreach (STOR)


University at Buffalo Technology Incubator


Baird Research Park


1576 Sweet Home Road


Amherst, NY 14228


Attn: Director







and









Donald D. Hickey, M.D.


33 Burbank Drive


Snyder, New York 14226







and







Clas Lundgren, M.D., Ph.D.


42 Burroughs Drive


Snyder, New York 14226







17.6           Waiver. No waiver by either party hereto of any breach or default of any of the covenants or agreements herein set forth will be deemed a waiver as to any subsequent and/or similar breach or default.







17.7           Patent Marking. Licensee will mark all Licensed Products made, used or sold under the terms of this Agreement, or their containers, in accordance with all applicable patent marking laws.









[Signature page to follow]








  





22











  








IN WITNESS WHEREOF, the undersigned duly authorized representative of the parties have executed this Agreement, effective as of the Agreement Effective Date.


 





	 SCIVANTA MEDICAL CORPORATION                                                                           	 	THE RESEARCH FOUNDATION OF STATE UNIVERSITY OF NEW YORK	 
	 	 	 	 	 	 
	By: 	 /s/  David R. LaVance  	
 

	
By: 

	 /s/  Woodrow W. Maggard	 
	 	David R. LaVance  	 	 	Woodrow W. Maggard	 
	Title:	President and Chief Executive officer	 	Title: 	Associate Vice Provost, STOR	 
	 	 	 	 	 	 
	DONALD D. HICKEY, M.D.     	 	CLAS E. LUNDGREN, M.D., Ph.D.	 
	 	 	 	 	 	 
	 By:	/s/  Donald D. Hickey	 	 By: 	/s/  Clas E. Lundgren	 
	 	Donald D. Hickey, M.D.	 	 	Clas E. Lundgren, M.D., Ph.D.	 









  





23











  








 




EXHIBIT A


 


PATENTS


 



	
Patent or Application Number


 

	
Location


 

	 	
Title (RF Docket Number)


 

	 	
 


Filed


 

	
Issued


 

	
 


 


Expires

	
Assignee


 

	
Inventor


 

	
Sponsor


 


	
5,048,532

	
U.S. Patent

	 	
Method and Apparatus for Measuring Blood Pressure (S-409)

	 	
9/18/1989

	
9/17/1991

	
Expired on 9/18/2009

	
Research Foundation

	
Hickey

	
None


	
5,181,517

	
U.S. Continuation in Part Patent

	 	
Method and Apparatus for the Measurement of Atrial Pressure (S-409)

	 	
6/25/1991

	
1/26/1993

	
Expired on 1/26/2010

	
Research Foundation

	
Hickey

	
None


	
PCT/US


  91/04504

	
Corresponds to U.S. 5,181,517

	 	
Method and Apparatus for the Measurement of Atrial Pressure (S-409)

	 	
6/24/1991

	
N/A

	
N/A

	
Hickey and Lundgren

	
Hickey

	
None


	
2,111,094

	
Canada

	 	
Method and Apparatus for the Measurement of Atrial Pressure (S-409)

	 	
6/24/1991

	
5/4/1999

	
6/24/2011

	
Hickey and Lundgren

	
Hickey

	
None


	
615,422

	
Netherlands, France, United Kingdom, Italy

	 	
Method and Apparatus for the Measurement of Atrial Pressure (S-409)

	 	
6/24/1991

	
1/19/2000

	
6/24/2011

	
Hickey and Lundgren

	
Hickey

	
None


	
69131931.6

	
Germany

	 	
Method and Apparatus for the Measurement of Atrial Pressure (S-409)

	 	
6/24/1991

	
1/19/2000

	
6/24/2011

	
Hickey and Lundgren

	
Hickey

	
None


	
3289898

	
Japan

	 	
Method and Apparatus for the Measurement of Atrial Pressure (S-409)

	 	
6/24/1991

	
1/10/2002

	
6/24/2011

	
Hickey and Lundgren

	
Hickey

	
None


	
665747

	
Australia

	 	
Method and Apparatus for the Measurement of Atrial Pressure (S-409)

	 	
6/24/1991

	
7/18/1996

	
6/24/2011

	
Hickey and Lundgren

	
Hickey

	
None


	
180459

	
Mexico

	 	
Method and Apparatus for the Measurement of Atrial Pressure (S-409)

	 	
7/30/1991

	
1/3/1996

	
7/30/2011

	
Hickey and Lundgren

	
Hickey

	
None


	
NI-59518

	
Taiwan

	 	
Method and Apparatus for the Measurement of Atrial Pressure (S-409)

	 	
7/5/1991

	
2/1/1992

	
7/4/2011

	
Hickey and Lundgren

	
Hickey

	
None


	
184,960

	
India

	 	
Method and Apparatus for the Measurement of Atrial Pressure (S-409)

	 	
7/8/1991

	
7/6/2001

	
7/8/2011

	
Hickey and Lundgren

	
Hickey

	
None







 




  





A-1











  






 



	
Patent or Application Number


 

	
Location


 

	 	
Title (RF Docket Number)


 

	 	
 


Filed


 

	
Issued


 

	
 


 


Expires

	
Assignee


 

	
Inventors


 

	
Sponsor


 


	
5,263,485

	
U.S. Continuation in Part Patent

	 	
Combination Esophageal Catheter for the Measurement of Atrial Pressure (S-409)

	 	
11/23/1992

	
11/23/1993

	
Expired on 11/23/2010

	
Research Foundation

	
Hickey

	
None


	
5,398,692

	
U.S. Continuation  in Part Patent

	 	
Combination Esophageal Catheter for the Measurement of Atrial Pressure (S-409))

	 	
8/31/1993

	
3/21/1995

	
Expired on 9/17/2008

	
Research Foundation

	
Hickey

	
None


	
5,551,439

	
U.S. Continuation in Part Patent

	 	
Method of Determining a Mean Pressure from a Source within a Body (S-409)

	 	
2/24/1995

	
9/3/1996

	
9/3/2013

	
Research Foundation

	
Hickey

	
None


	
5,570,671

	
U.S. Continuation in Part Patent

	 	
Method for Positioning Esophageal Catheter for Determining Pressures Associated with the Left Atrium (S-409)

	 	
6/7/1995

	
11/5/1996

	
11/5/2013

	
Research Foundation

	
Hickey

	
None


	
5,697,375

	
U.S. Continuation in Part Patent

	 	
Method and Apparatus Utilizing Heart Sounds for Determining Pressure Associated with the Left Atrium (S-409)

	 	
1/24/1995

	
12/16/1997

	
12/16/2014

	
Research Foundation

	
Hickey

	
None


	
5,921,935

	
U.S. Divisional Patent

	 	
Method and Apparatus for Utilizing Heart Sounds For Determining Pressures Associated with the Left Atrium (S-409)

	 	
9/2/1997

	
7/13/1999

	
Expired on 9/18/2009

	
Research Foundation

	
Hickey

	
None


	
PCT/US


  96/17617

	
Corresponds to U.S. ‘671, ‘375, ‘935

	 	
Method and Apparatus for Determining Pressures Associated with the Left Atrium (S-409)

	 	
11/4/1996

	
N/A

	
N/A

	
Hickey and Lundgren

	
Hickey

	
None


	
2,270,978

	
Canada

	 	
Apparatus for Determining Pressures Associated with the Left Atrium (S-409)

	 	
11/4/1996

	
6/3/2008

	
11/4/2016


 

	
Hickey and Lundgren

	
Hickey

	
None







 




  





A-2











  






 



	
Patent or Application Number


 

	
Location


 

	 	
Title (RF Docket Number)


 

	 	
 


Filed


 

	
Issued


 

	
Expires

	
Assignee


 

	
Inventors


 

	
Sponsor


 


	
69635830

	
Germany

	 	
Apparatus for Determining Pressures Associated with the Left Atrium (S-409)

	 	
11/4/1996

	
2/15/2006

	
11/4/2016

	
Hickey and Lundgren

	
Hickey

	
None


	
957,755

	
France

	 	
Apparatus for Determining Pressures Associated with the Left Atrium (S-409)

	 	
11/4/1996

	
2/15/2006

	
11/4/2016

	
Hickey and Lundgren

	
Hickey

	
None


	
957,755

	
Italy

	 	
Apparatus for Determining Pressures Associated with the Left Atrium (S-409)

	 	
11/4/1996

	
2/15/2006

	
11/4/2016

	
Hickey and Lundgren

	
Hickey

	
None


	
957,755

	
Netherlands

	 	
Apparatus for Determining Pressures Associated with the Left Atrium (S-409)

	 	
11/4/1996

	
2/15/2006

	
11/4/2016

	
Hickey and Lundgren

	
Hickey

	
None


	
957,755

	
United Kingdom

	 	
Apparatus for Determining Pressures Associated with the Left Atrium (S-409)

	 	
11/14/1996

	
2/15/2006

	
11/4/2016

	
Hickey and Lundgren

	
Hickey

	
None


	
H10-521,324

	
Japan

	 	
Apparatus for Determining Pressures Associated with the Left Atrium (S-409)

	 	
11/4/1996

	
6/5/2006

	
11/4/2016

	
Hickey and Lundgren

	
Hickey

	
None


	
2005-375167

	
Japan


(Divisional of H10-521,324)

	 	
Apparatus for Determining Pressures Associated with the Left Atrium (S-409)

	 	
12/27/2005

	
N/A

	
11/4/2016

	
Research Foundation

	
Hickey

	
None


	
6,120,442

	
U.S. Patent

	 	
Method and Apparatus for Noninvasive  Determination of Cardiac Performance Parameters (R-5421)

	 	
6/12/1998

	
9/19/2000

	
6/12/2018

	
Research Foundation

	
Hickey

	
None


	
6,238,349

	
U.S. Divisional Patent

	 	
Method and Apparatus for Noninvasive Determination of Cardiac Performance Parameters (R-5421)

	 	
7/25/2000

	
5/29/2001

	
6/12/2018

	
Research Foundation

	
Hickey

	
None







 




  





A-3











  






 



	
Patent or Application Number


 

	
Location


 

	 	
Title (RF Docket Number)


 

	 	
 


Filed


 

	
Issued


 

	
Expires

	
Assignee


 

	
Inventors


 

	
Sponsor


 


	
PCT/US


   98/12505

	
Corresponds to U.S. ‘442 and ‘349

	 	
Method and Apparatus for Noninvasive  Determination of Cardiac Performance Parameters (R-5421)

	 	
6/12/1998

	
N/A

	
N/A

	
Hickey and Lundgren

	
Hickey

	
None


	
2,294,998

	
Canada

	 	
Non-Invasive Monitoring of Cardiac Performance (‘442 and ‘349 Patents)

	 	
6/12/1998

	
4/20/2010

	
6/12/18

	
Hickey and Lundgren

	
Hickey

	
None


	
98932763.0

	
Europe designating Germany, United Kingdom, France, Italy, Spain, Switzerland, Liechtenstein

	 	
Non-Invasive Monitoring of Cardiac Performance (‘442 and ‘349 Patents)

	 	
6/12/1998

	
Pending

	
Will expire 6/12/18, if granted.

	
Hickey and Lundgren

	
Hickey

	
None


	
742481

	
Australia

	 	
Non-Invasive Monitoring of Cardiac Performance (‘442 and ‘349 Patents)

	 	
6/12/1998

	
4/18/2002

	
6/12/2018

	
Hickey and Lundgren

	
Hickey

	
None


	
6,432,059

	
U.S. Continuation in Part Patent

	 	
Method and Apparatus for More Precisely Determined Mean Left Atrial Pressure (R-5421)

	 	
5/15/2001

	
8/13/2002

	
6/12/2018

	
Research Foundation

	
Hickey

	
None


	
60/691,561

	
U.S. Provisional Application

	 	
Esophageal Catheter for Monitoring Cardiac Performance (R-6013)

	 	
6/17/2005

	
N/A

	
N/A

	
Research Foundation

	
Hickey

	
None


	
7,527,599

	
U.S. Patent

	 	
Method of Determining Cardiac Indicators (R-6013)

	 	
6/19/2006

	
5/5/2009

	
6/19/2026

	
Research Foundation

	
Hickey

	
None


	
TBD

	
U.S. Provisional Application

	 	
Method for Positioning Esophogeal Catheter (Docket TBD)

	 	
TBD

	
N/A

	
Research Foundation

	
TBD

	
NYS CAT

	
TBD







 




  





A-4











  






 


EXHIBIT B


 


TANGIBLE PROPERTY




 



	
1.  

	
One prototype two-balloon esophogeal catheter.







 



	
2.  

	
One prototype system control box.







 



	
3.  

	
One copy of Source Code.







 



	
4.  

	
One laptop with operational Source Code, which will be returned to Licensor within ninety (90) days of the transfer, unless otherwise mutually agreed to by the parties.







 



	
5.  

	
One Dynamap Blood Pressure Monitor, which will be returned to Licensor within ninety (90) days of the transfer, unless otherwise mutually agreed to by the parties.







 



	
6.  

	
One ECG device compatible with the system, which will be returned to Licensor within ninety (90) days of the transfer, unless otherwise mutually agreed to by the parties.







 




  





  











  








EXHIBIT C


 


CLINICAL TRIALS WORLDWIDE TO DATE




 



	
1.  

	
Lab subjects.  Healthy volunteers used for testing and development of device at University at Buffalo physiology lab.  21 individuals.  Testing from 1986 to 2001.  No sponsor.













	
2.  

	
Intensive care unit patients in Millard Fillmore Hospital, buffalo, N.Y. 25 individuals from July 1991 to April 1992.  No sponsor.













	
3.  

	
Open heart surgery patients in Millard Fillmore Hospital, Buffalo, N.Y.  16 individuals from November 1993 to July 1994.  Sponsored by Cobe Cardiovascular.













	
4.  

	
Cobe Cardiovascular conducted catheter experiments in patients in Florida sometime around 1994 under a license agreement then in effect.  Neither Dr. Hickey or, to the best of Licensor’s knowledge, any other employee or agent of the Licensor was privy to the protocol, had anything to do with the conduct of the experiments or has knowledge of the patient enrollment, results or outcomes of the study.  The study may have been done in open heart surgery.











  





  











  








 


EXHIBIT D


 


FOUNDATION SOFTWARE AND KNOW-HOW








	
1.  

	
Prototype Hickey Cardiac Monitoring System (pictured), including:








	
a.  

	
Two-balloon catheter and design specifications








	
b.  

	
Hardware ‘box’ for inflation, deflation and signal detection








	
c.  

	
Operating software for system operation, hardware control, signal collection, signal processing, monitoring and reporting.








	
d.  

	
All related specifications








	
e.  

	
All data, reports, specifications and software generated by Applied Sciences Group (ASG) under contract with UB in the performance of the Center for Advanced Technology grant.  All background know-how provided to ASG by Hickey in the course of developing this prototype and encompassed in the finished elements.  Also UB CAT Award documentation, including letters, award notice and ASG project proposal for funding was used to develop the prototype.








	
f.  

	
All ASG know-how developed under the CAT funded project described above that was subsequently transferred to Scivanta and/or Ethox and/or the hardware vendors contracted by Scivanta in the course of executing the work plan under the NYSTAR TTIP grant.








	
g.  

	
Certifications of originality and ownership of control software for 3rd and 4th generation MLAP hardware (Michael Zaharkin 7/8/96 and 8/28/02).













	
2.  

	
Catheter and Catheter Test Equipment








	
a.  

	
Catheter prototypes, including dual balloon, single balloon and dual electrode versions, and know-how generated from their development and testing that was factored into the final prototype and commercial product designs.








	
b.  

	
Know-how generated through the use of catheter testing equipment residing in UB CRESE that was used by ASG to develop the prototype, including high frequency ventilator, pressure test chamber, and acoustic frequency generator.








	
c.  

	
Cather positioning techniques and know-how, including:








	
i.  

	
Esophageal ECG (dual and single electrode)








	
ii.  

	
Heart sounds








	
iii.  

	
Anthropomorphic based on height, weight and sex








	
iv.  

	
Esophageal Thermister








	
v.  

	
Simple pressure system








	
vi.  

	
Pressure spectral analysis













	
3.  

	
Hickey Cardiac Monitoring System Prospectus.








	
a.  

	
Developed by UB STOR for marketing and presenting the technology and business opportunity.








	
b.  

	
Related Adult Model Release: Signed by Frank G. Modlich (the model in the picture with the current HCMS prototype) on May 19, 2004.













	
4.  

	
Market Research U.S. Potential for The Hickey Catheter: Report on Primary Research carried out in February 1999; Peter Simpson and Associates.







 




  





  











  






 



	
5.  

	
PowerPoint presentation prepared by Dr. Hickey and provided to Scivanta, and also presented by Dr. hickey to Scivanta and Scivanta consultants, and all know-how contained therein.













	
6.  

	
COBE Documents (Note that these relate to COBE research for the single balloon version only.)








	
a.  

	
Market Research Report with cover letter dated January 28, 1992.








	
b.  

	
“Preliminary Thoughts, Ideas, Observations and Findings From The Market Research Trips For The Left Atrial Pressure Catheter”. No date.








	
c.  

	
Memo dated November 1, 1991, regarding “Market Research On LAP Catheter At ASA Meeting”.








	
d.  

	
“Minimally Invasive Left Atrial Pressure Device”.  No date.













	
7.  

	
Abstract published in Critical Care Medicine Supplement, December 2001.













	
8.  

	
Animal and Human Studies:








	
a.  

	
Dog Study: HCMS vs. Direct Catheterization








	
b.  

	
Baboon Study: HCMS vs. Swan-Ganz








	
c.  

	
Human Study: HCMS vs. Swan-Ganz in Surgical ICU and Open Heart Unit








	
d.  

	
Human Study: HCMS vs. Swan-Ganz in Open Heart Patients in OR













	
9.  

	
Technical, medical and business know-how contributions by Hickey, Lundgren and Dunbar to “product Definition” developed during November 7, 2006 meeting and Ethox International.  All technical, medical and business know-how provided before and thereafter.







 



	
10.  

	
NYSTAR TTIP Agreement with UB, dated December 1, 2005, and copy of Proposal













	
11.  

	
All UB IRB documentation, reports and letters delivered in the Due Diligence Materials submitted by UB STOR to Scivanta (formerly Medi-Hut).







 



	
12.  

	
Any other know-how delivered in the Due Diligence Materials submitted by UB STOR to Scivanta (formerly Medi-Hut).







 



	
13.  

	
All Tangible Property in Exhibit B.