Document:

Exhibit 10.8

 

SUBLICENSE AGREEMENT

 

THIS SUBLICENSE AGREEMENT (“Agreement”) effective as of August 27, 2007 (the “Effective Date”) is by and between XENOMICS Inc, a Florida corporation having its principal office at 420 Lexington Avenue Suite 1701 New York, NY 10170 USA, United States of America (“XENOMICS”) and IPSOGEN SAS, a French corporation having its principal office at Luminy Biotech Enterprises Case 923, 163 Avenue de Luminy 13288 Marseille cedex 9 France (“IPSOGEN”).

 

WITNESSETH:

 

WHEREAS, XENOMICS is the exclusive licensee of the Patent Rights (as defined below) relating to the Field (as defined below) under the Exclusive License Agreement (as defined below) and is willing to grant to IPSOGEN a royalty-bearing Sublicense (as defined below) in the Territory to use such Patent Rights in the Field on the terms and conditions set forth herein;

 

WHEREAS, IPSOGEN desires to obtain the Sublicense described above on the terms and conditions set forth herein; and

 

WHEREAS, XENOMICS is willing to grant IPSOGEN such Sublicense under the Patent Rights on the terms and conditions set forth herein;

 

NOW THEREFORE, in consideration of the mutual covenants herein contained and intending to be legally bound hereby, the parties hereto agree as follows:

 

ARTICLE 1. DEFINITIONS

 

1.1                                 “Affiliate(s)” shall mean any corporation or other business entity which controls, is controlled by, or is under common control with a party to this Agreement, “control” meaning the ownership, direct or indirect, of fifty percent (50%) or more of the voting stock or analogous interest in such corporation or other business entity.

 

1.2                                 “Exclusive License Agreement” shall mean the exclusive license agreement dated May 2006 (and any amendments thereto) by and between XENOMICS on the one hand, and Brunangelo Falini and Cristina Mecucci (jointly “Original Licensor”) on the other hand.

 

1.3                                 “Field” shall mean diagnosis, including monitoring of minimal residual disease, of nucleophosmin protein (“NPM1”) mutations in bone marrow or blood cells. The Field specifically excludes IVD Laboratory Services testing and use of NPM1 as a drug target. The term “diagnosis” includes the RUO (Research Use Only), IVD (in Vitro Diagnostic) and ASR (“Analyte specific reagent”) fields.

 

1.4                                 “Laboratory Services” shall mean services performed by reference laboratories in the Territory.

 

1.5                                 “Net Revenues” shall mean billings for the Products sold by IPSOGEN or its

 

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Affiliate(s) hereunder to non-Affiliate third parties less the sum of the following:

 

(a)                                                volume, formulary or other discounts allowed in amounts customary in the trade;

(b)                                               sale and/or use taxes directly imposed and with reference to particular sales;

(c)                                                outbound transportation and insurance charges on shipping of the Product prepaid or allowed; and

(d)                                               amounts allowed or credited on returns.

 

No deductions shall be made for commissions paid to individuals whether they are with independent sales agents or regularly employed by IPSOGEN and its Affiliate(s) and on their payroll, or for cost of collections. The Product shall be considered “sold” when billed out or invoiced.

 

1.6                                 “Patent Rights” shall mean Patent Application PCT/IT2005/000634 filed October 28, 2005 entitled “Nucleophosmin protein (NPM) mutants, corresponding gene sequences and uses thereof” (published as WO 2006/046270), and foreign equivalents, as well as all continuations, divisions, reissues, re-examinations, renewals, or extensions of such patents subject to the rights granted by Original Licensor to XENOMICS pursuant to the Exclusive License Agreement, as limited by this Agreement.

 

1.7                                 “Product(s)” shall mean any product or part thereof that when made, have made, used, offered to sell, sold or marketed in the Territory would infringe on any Valid Claim of the Patent Rights absent the Sublicense herein granted.

 

1.8                                 “Service” shall mean any service or part thereof that when used, commercialized or marketed in the Territory would infringe on any Valid Claim of the Patent Rights absent the Sublicense herein granted.

 

1.9                                 “Term” shall mean from the Effective Date until the expiration or abandonment of all the Patent Rights.

 

1.10                           “Territory” shall mean Europe, USA, Japan, Canada, South & Central America, including Mexico, Middle East, and Australia. Europe consists of Albania, Andorra, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Macedonia, Malta, Moldova, Monaco, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Russia, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, and Vatican City. The Middle East consists of Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Oman, the Palestinian territories, Qatar, Saudi Arabia, Sudan, Somalia, Syria, Turkey, the United Arab Emirates, and Yemen.

 

1.11                           “Valid Claim” shall mean a claim of an unexpired patent of the Patent Rights that has neither been withdrawn, canceled, or disclaimed, nor held invalid or unenforceable by a court of competent jurisdiction in an unappealed or unappealable decision.

 

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ARTICLE 2. GRANT OF RIGHTS

 

2.1                                 XENOMICS hereby grants to IPSOGEN, subject to all the terms and conditions of this Agreement a co-exclusive, royalty-bearing Sublicense in the Territory in the Field during the Term. “Sublicense” as used herein means a license to use the Patent Rights to i) make, have made, use, offer to sell, sell and market the Products in the Field ii) use, develop, practice, commercialize, and otherwise fully exploit the Services. The term “co-exclusive” as used under this Agreement shall operate to mean that only two sub-licensees shall be authorized to sell Products and Services in any country in Territory, provided IPSOGEN complies with the other terms of this Agreement. IPSOGEN shall have no right to further sublicense. IPSOGEN will be informed of any changes in the identity of its co-exclusive competitor if any such changes are made known to XENOMICS.

 

2.2                                 IPSOGEN shall have no right during the Term to offer Laboratory Services or use Patent Rights in any way for development and commercialization of therapeutic products.

 

2.3                                 IPSOGEN acknowledges and agrees that the Sublicense granted to it hereunder is subject to the terms and conditions of the Exclusive License Agreement.

 

2.4                                 XENOMICS agrees that to the extent it grants to a third party any other co-exclusive sub-license in the Territory, such co-exclusive sublicense shall be granted on  terms no more favorable than granted to IPSOGEN pursuant to this Agreement. IPSOGEN acknowledges that the terms negotiated in the ASURAGEN co-exclusive sublicense agreement (attached) on the Patent Rights are equivalent for the purposes of this section. Any changes made to the Asuragen contract as attached cannot be more favorable to Asuragen.

 

ARTICLE 3. DUE DILIGENCE

 

3.1                                 IPSOGEN shall use diligent efforts to develop, seek registration and sell licensed products derived from the Patent Rights into the commercial market as soon as practicable, consistent with sound and reasonable business practice and judgment, and shall provide XENOMICS with yearly reports within thirty (30) days following the close of each calendar year.

 

3.2                                 XENOMICS shall provide IPSOGEN with the technical information in its possession that may be useful for the development of a Product or Service in the Field. Such technical information shall at least include protocols for NPM1 mutation diagnosis and follow-up as well as verbal assistance that IPSOGEN may from time to time request from XENOMICS. XENOMICS scientists shall be credited for their contributions as appropriate.

 

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ARTICLE 4. PAYMENTS

 

4.1                                 IPSOGEN shall pay to XENOMICS during the Term a royalty of ten percent (10%) on Net Revenues. Royalty payments will commence on sale of first product in any category (RUO, ASR, IVD) and shall be payable quarterly.

 

4.2                                 IPSOGEN shall pay to XENOMICS an initial licensing fee of $120,000 USD upon execution of this Agreement.

 

4.3                                 IPSOGEN shall pay to XENOMICS the following milestones:

 

(1)               $150,000 upon issuance of a patent by the European Patent Office or the US patent office with one or more claims that cover substantially the same subject matter as the claims pending in Patent Rights as of the Effective Date;

 

(2)          $40,000 upon regulatory approval of a Product or Service; and

 

(3)          $40,000 payable 6 months after the first commercial sale of a Product or Service.

 

4.4                                 Beginning from the date of the first Product Launch date, in each year during the Term of this Agreement, the royalties due to XENOMICS from IPSOGEN under Section 4.1 hereof, in the aggregate, shall equal or exceed the following amounts:

 

	
 
    	
 
    	
Minimum Royalty Payment (United States
    
	
Anniversary of Product Launch
    	
 
    	
dollars)
    
	
1st Year
    	
 
    	
10,000
    
	
2nd Year
    	
 
    	
25,000
    
	
3rd Year and each Year thereafter
    	
 
    	
50,000
    

 

If the actual royalty payments to XENOMICS in any year are less than the minimum payment required for that year hereunder, IPSOGEN shall pay XENOMICS the difference between the actual payment and the minimum payment in full satisfaction of its obligations under this Section 4.1, provided such minimum payment is made to XENOMICS within thirty (30) days after the conclusion of each calendar quarter. If, after 2010, royalty payments to XENOMICS do not exceed the Minimum Royalty Payment in any two consecutive years, then XENOMICS may terminate the Sublicense.

 

4.5                                 If IPSOGEN reasonably determines that to i) make, have made, use, offer to sell, sell or market the Products in the Field ii) use, develop, practice, commercialize, and otherwise fully exploit the Services throughout the Territory infringes patent rights of a third party that are granted in the Territory, and as a result thereof, IPSOGEN enters into a license and pays a royalty for such patent rights or is required by court order or otherwise to pay a royalty to a third party, then such royalty payment shall be creditable against the royalties and the other considerations owed to IPSOGEN hereunder, but in no event shall such sums paid to XENOMICS be reduced by more than twenty-five percent (25%) and in no event shall payment ever be reduced below the Minimum Royalty Payment.

 

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ARTICLE 5. REPORTS AND RECORDS

 

5.1                                 IPSOGEN shall maintain and cause its Affiliate(s) to maintain true, accurate and complete books of account, records and files containing an accurate record of all data reasonably necessary for the full computation and verification of sales and the determination of the amounts payable under Article 4 hereof for a period of at least five (5) years following the period of each report required by Section 5.2 below.

 

5.2                                 After the first commercial sale of the Products, IPSOGEN shall deliver to XENOMICS each year true and accurate reports, giving such particulars of the business conducted by IPSOGEN and its Affiliate(s) during the preceding year under this Agreement as shall be pertinent to a royalty accounting hereunder. These shall include at least the following:

 

(a)                                       number of the Products sold by IPSOGEN and its Affiliate(s);

(b)                                      total sales amounts invoiced to customers for the Products sold by IPSOGEN and its Affiliate(s);

(c)                                       deductions applicable as provided in Section 1.5;

(d)                                      total royalties due; and

(e)                                       amounts of withholding taxes.

 

5.3                                 Said books and records shall be kept at IPSOGEN’s and/or its Affiliate(s) principal place of business and shall be in accordance with generally accepted accounting principles, consistently applied. Said books and records, to the extent not previously audited, shall be available for inspection and copying by an independent certified public accountant selected by XENOMICS and reasonably acceptable to IPSOGEN and/or its Affiliate(s), upon ten (10) business days advance notice and during regular business hours in order to enable XENOMICS to ascertain the correctness of any report and/or payment made under this Agreement. XENOMICS shall pay the fees and expenses of the accountant engaged to perform the audit, unless such audit reveals an underpayment of five percent (5%) or more for the period examined, in which case IPSOGEN shall pay all reasonable costs and expenses incurred by XENOMICS in the course of making such determination, including, without limitation, the fees and expenses of the accountant.

 

5.4                                 IPSOGEN shall pay to XENOMICS the actual royalties due and payable as provided for in Section 4.1 on a quarterly basis. If no actual royalties are due, IPSOGEN shall so report, and shall make pay the Minimum Royalty Payment.

 

ARTICLE 6. PATENT PROSECUTION; INFRINGEMENT

 

6.1                                 The prosecution, filing and maintenance of the Patent Rights in the Territory shall be managed by XENOMICS. XENOMICS agrees to renegotiate the terms of this Agreement if XENOMICS is unable to secure issuance of one or more claims that cover substantially the same subject matter as the claims pending in Patent Rights as of the Effective Date in one or more patents in the Territory.

 

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6.2                                 XENOMICS will file, prosecute and maintain any patent applications directed to improvements on inventions that are related to Patent Rights (“New Inventions”), whether owned solely or jointly with IPSOGEN and IPSOGEN shall cooperate with XENOMICS in the filing, prosecution and maintenance of all such New Inventions. Such cooperation includes, without limitation, (a) promptly executing all papers and instruments or requiring its employees to execute such papers and instruments as reasonable and appropriate so as to enable XENOMICS to file, prosecute and maintain such New Inventions in any country; and (b) promptly informing XENOMICS of matters that may affect the preparation, filing, prosecution or maintenance of any such New Inventions.

 

6.3                                 (a) IPSOGEN agrees to provide XENOMICS with prompt written notice after becoming aware of any infringement of any of the Patent Rights or New Inventions in the Field and of any available evidence thereof.

 

(b) XENOMICS shall have the right, but not the obligation, under its control and at its sole expense, to prosecute any third party infringement of the Patent Rights or New Inventions or to defend the Patent Rights or New Inventions in any declaratory judgment action brought by a third party which alleges the invalidity, unenforceability or non-infringement of any Patent Rights. IPSOGEN agrees to cooperate fully in any action under this Section 6.3, provided that XENOMICS reimburses material costs and expenses incurred with providing such assistance.

 

ARTICLE 7. TERM AND TERMINATION

 

7.1                                 If XENOMICS, acting reasonably, determines that IPSOGEN has ceased to develop or to carry on the sale of the Products or Services, XENOMICS may notify the IPSOGEN in writing of such determination. IPSOGEN shall thereafter have three (3) months from its receipt of such notice to demonstrate to XENOMICS’s satisfaction that it has resumed such business. If XENOMICS is not satisfied that IPSOGEN has resumed such business, XENOMICS may, in XENOMICS’ sole discretion, either terminate this Sublicense or convert the co-exclusive Sublicense granted to IPSOGEN hereunder to a non-exclusive Sublicense immediately by written notice to IPSOGEN.

 

7.2                                 Should IPSOGEN fail to pay XENOMICS any amounts due hereunder, XENOMICS shall have the right to terminate this Agreement on forty-five (45) days prior written notice, unless IPSOGEN shall pay XENOMICS within said forty-five (45) day period such delinquent amounts and interest within said period.

 

7.3                                 IPSOGEN shall have the right to terminate this Agreement and all rights, privileges and the Sublicense granted hereunder at any time upon sixty (60) days prior written notice to XENOMICS.

 

7.4                                 Upon any material breach or default of this Agreement by either party, including without limitation IPSOGEN’s material failure to comply with Section 3 hereof, the other party shall have the right to terminate this Agreement upon sixty (60) days written notice to the breaching/defaulting party. Such termination shall become effective

 

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immediately at the conclusion of such notice period unless the breaching/defaulting party shall have cured any such breach or default prior to the expiration of said sixty (60) day period.

 

7.5                                 Upon termination of this Agreement for any reason, nothing herein shall be construed to release either party from any obligation that matured prior to the effective date of such termination. The provisions of Articles 4 (with respect to any payments outstanding as of the termination date), 5, 6, 7, 8, 9, 10, 11, 13, 15, 18 and 20, shall survive the expiration or any earlier termination of this Agreement.

 

ARTICLE 8. INDEMNIFICATION

 

8.1                                 XENOMICS agrees to indemnify, hold harmless and defend IPSOGEN, its Affiliates, agents and employees from and against any and all liabilities, losses, damages, costs, fees and expenses, including reasonable legal expenses and attorneys’ fees (collectively, “Losses”) arising out of suits, claims, actions, or demands, brought or made by a third party (“Third Party Claim”) against IPSOGEN, its Affiliates, agents and employees, based on breach of XENOMICS’s warranties under Article 9 below, except to the extent such Losses or Third Party Claims result from the negligence or wilful misconduct of IPSOGEN or a breach of IPSOGEN’s warranties under Article 9 below.

 

8.2                                 IPSOGEN agrees to indemnify, hold harmless and defend XENOMICS, its Affiliates, agents and employees from and against any and all Losses arising out of any Third Party Claims against XENOMICS, its Affiliates, agents and employees based on (i) IPSOGEN’S breach of IPSOGEN’s warranties under Article 9 below, or (ii) the manufacture, use, handling, storage, sale or other disposition of Products or Services by IPSOGEN, its Affiliates, agents, employees or sublicensees, all except to the extent such Losses or Third Party Claims result from the negligence or wilful misconduct of XENOMICS, or a breach of XENOMICS’s warranties under Article 9 below.

 

ARTICLE 9. REPRESENTATIONS, WARRANTIES AND DISCLAIMERS

 

9.1                                 XENOMICS represents and warrants to IPSOGEN (i) that it has the right to sublicense the Patent Rights in Territory and that XENOMICS has received the appropriate written authorization from the Original Licensors to enter into this Agreement, and (ii) that, subject to the Exclusive License Agreement, it has the right and power to extend the rights and the Sublicense granted herein and to perform its obligations hereunder, and (iii) that this Agreement is a valid and binding agreement, enforceable in accordance with its terms.

 

9.2                                 IPSOGEN hereby represents and warrants to XENOMICS that it has the right and power to enter into this Agreement and to perform its obligations, and that this Agreement is a valid and binding agreement, enforceable in accordance with its terms. IPSOGEN agrees that it shall comply and cause its Affiliate(s) to comply with all applicable local laws and regulations in Territory relating to the design, sale, use, delivery in commerce and promotion of the Products and Services.

 

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9.3                                 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN SECTION 9, XENOMICS MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT RIGHT, TRADEMARK, SOFTWARE, NON-PUBLIC OR OTHER INFORMATION, OR TANGIBLE RESEARCH PROPERTY, LICENSED OR OTHERWISE PROVIDED TO SUBLICENSEE HEREUNDER AND HEREBY DISCLAIMS THE SAME. XENOMICS DOES NOT WARRANT THE VALIDITY OF THE PATENT RIGHTS SUBLICENSED HEREUNDER AND MAKES NO REPRESENTATION WHATSOEVER WITH REGARD TO THE SCOPE OF THE SUBLICENSED PATENT RIGHTS OR THAT SUCH PATENT RIGHTS MAY BE EXPLOITED BY SUBLICENSEE OR ITS AFFILIATE(S) WITHOUT INFRINGING ON OTHER PATENTS.

 

9.4                                 NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, XENOMICS ADDITIONALLY DISCLAIMS ALL OBLIGATIONS ON THE PART OF XENOMICS FOR DAMAGES, INCLUDING BUT NOT LIMITED TO DIRECT, INDIRECT, SPECIAL AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES AND EXPENSES, AND COURT COSTS ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, DELIVERY, SALE AND PROVISION OF THE PRODUCTS UNDER THIS AGREEMENT. SUBLICENSEE ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR ANY LOSS OR DAMAGES CAUSED BY THE PRODUCTS MANUFACTURED, USED, DELIVERED, SOLD OR PROVIDED BY SUBLICENSEE AND ITS AFFILIATE(S) THAT ARE SUBJECT TO THIS AGREEMENT UNLESS THE SAME HAS RESULTED FROM ANY MATERIAL BREACH OF AN OBLIGATION, REPRESENTATION, WARRANTY BY XENOMICS UNDER THIS AGREEMENT OR ACTION, INACTIONS, OR MISREPRESENTATIONS ON THE PART OF XENOMICS.

 

ARTICLE 10. NOTICE

 

10.1                           Any consent, notice or report required or permitted to be given or made under this Agreement shall be in writing, delivered (i) by certified or registered mail (postage prepaid, return receipt requested), (ii) by facsimile (and promptly confirmed by personal delivery, courier or next business day service of a nationally recognized courier service of good repute), (iii) by a next business day service of a nationally recognized courier service of good repute (with evidence of delivery) or (iv) by courier (postage prepaid and signature required), and in any case addressed to the other party at its address set forth in this Article 10, and shall be effective upon receipt by the addressee.

 

10.2                           Reports, notices and other communication from IPSOGEN to XENOMICS as provided hereunder shall be sent to:

 

XENOMICS Inc

Attention:                                                     Chairman
 420 Lexington Avenue Suite 1701
 New York, NY 10170
 USA

With a copy to:

Ivor Elrifi

MINTZ LEVIN

 

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666 Third Avenue

New York, NY 10017

 

or to such other individual or address as shall hereafter be furnished by written notice to IPSOGEN in accordance with this Article 10.

 

10.3                           Reports, notices and other communications from XENOMICS to IPSOGEN as provided hereunder shall be sent to:

 

	
Ipsogen SAS
    	
 
    	
 
    
	
Attention:
    	
 
    	
Vincent FERT (or his successor)
    
	
 
    	
 
    	
Luminy Biotech Enterprises
    
	
 
    	
 
    	
Case 923
    
	
 
    	
 
    	
163 Avenue de Luminy
    
	
 
    	
 
    	
13288 Marseille cedex 9 France
    

 

or to such other individual or address as shall hereafter be furnished by written notice to XENOMICS in accordance with this Article 10.

 

ARTICLE 11. DISPUTE RESOLUTION

 

11.1.                        Any dispute, controversy or claim arising under, out of or relating to this contract and any subsequent amendments of this contract, including, without limitation, its formation, validity, binding effect, interpretation, performance, breach or termination, as well as non-contractual claims, shall be submitted to mediation in accordance with the World Intellectual Property Organization (“WIPO”) Mediation Rules. The place of mediation shall be Geneva, Switzerland. The language to be used in the mediation shall be English.

 

11.2                           If, and to the extent that, any such dispute, controversy or claim has not been settled pursuant to the mediation within 60 days of the commencement of the mediation, it shall, upon the filing of a Request for Arbitration by either party, be referred to and finally determined by arbitration in accordance with the WIPO Expedited Arbitration Rules. Alternatively, if, before the expiration of the said period of 60 days, either party fails to participate or to continue to participate in the mediation, the dispute, controversy or claim shall, upon the filing of a Request for Arbitration by the other party, be referred to and finally determined by arbitration in accordance with the WIPO Expedited Arbitration Rules. The place of arbitration shall be Paris, France if initiated by XENOMICS, or the New York, USA if initiated by IPSOGEN. The language to be used in the arbitral proceedings shall be English. The dispute, controversy or claim referred to arbitration shall be decided in accordance with the laws of England and Wales.

 

11.3                           Notwithstanding the foregoing, nothing in this Article shall be construed to waive any rights or timely performance of any obligations existing under this Agreement.

 

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ARTICLE 12. RESTRICTION ON USE OF NAME

 

12.1                           IPSOGEN shall neither use nor cause its Affiliate(s) to use the name of XENOMICS, its directors, officers, trustees, Affiliate(s), employees, or any adaptations thereof, in any advertising, promotion or sale literature without the prior written consent of XENOMICS. With respect to reports to public agencies that are required by law, IPSOGEN shall provide XENOMICS with a reasonable opportunity to review the use of its name in such reports reasonably in advance of submission.

 

12.2                           IPSOGEN shall neither disclose nor cause its Affiliate(s) to disclose this Agreement or any of the terms or conditions of this Agreement to any third party without the prior written consent of XENOMICS except and to the extent required to comply with applicable laws or regulations; provided that, IPSOGEN delivers prior written notice to XENOMICS of any disclosure required by applicable laws or regulations and takes all reasonable and lawful actions to obtain confidential treatment for such disclosure and, if possible, to minimize the extent of such disclosure.

 

ARTICLE 13. CONFIDENTIALITY

 

13.1                           During the term of this Agreement, each party (the “disclosing party”) may communicate to the other party (the “receiving party”) information which it considers to be confidential (“Confidential Information”). All Confidential Information shall be specifically designated as confidential. Such Confidential Information may include, without limitation, trade secrets, know-how, inventions, technical data or specifications, testing methods, business or financial information, research and development activities, product and marketing plans, and customer and supplier information. Confidential Information that is disclosed in writing shall be marked with a legend indicating its confidential status. Confidential Information that is disclosed orally or visually shall be documented in a written notice prepared by the disclosing party and delivered to the receiving party within thirty (30) days of the date of disclosure; such notice shall summarize the Confidential Information disclosed to the receiving party and reference to the time and place of disclosure.

 

13.2                           The receiving party agrees that it shall: (a) maintain all Confidential Information in strict confidence, except that the receiving party may disclose or permit the disclosure of any Confidential Information to its directors, officers, employees, consultants, and advisors who are obligated to maintain the confidential nature of such Confidential Information and who need to know such Confidential Information for the purpose set forth in this Agreement; (b) use all Confidential Information solely for the purpose set forth in this Agreement; and (c) allow its directors, officers, employees, consultants, and advisors to reproduce the Confidential Information only to the extent necessary to effect the purposes set forth in this Agreement, with all such reproductions being considered Confidential Information.

 

13.3                           The obligations of the receiving party under Section 13.2 above shall not apply to the extent that the receiving party can demonstrate that certain Confidential Information: (a)

 

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was in the public domain prior to the time of its disclosure under this Agreement; (b) entered the public domain after the time of its disclosure under this Agreement through means other than an unauthorized disclosure resulting from an act or omission by the receiving party; (c) was independently developed or discovered by receiving party without use of the Confidential Information; (d) is or was disclosed to the receiving party at any time, whether prior to or after the time of its disclosure under this Agreement, by a third party having no fiduciary relationship with the disclosing party and having no obligation of confidentiality with respect to such Confidential Information; or (e) is required to be disclosed to comply with application laws or regulation, or with a court or administrative order, provided that, the disclosing party receives prior written notice of such disclosure and that the receiving party takes all reasonable and lawful actions to obtain confidential treatment for such disclosure and, if possible, to minimize the extent of such disclosure.

 

13.4.                        The obligations set forth in this Article 13 shall remain in effect for a period of five (5) years after the expiration or the earlier termination of this Agreement.

 

ARTICLE 14. PATENT MARKING

 

14.                                 If required by laws or regulations, IPSOGEN agrees to mark any Products, promotional material, technical literature and the like with all applicable patent numbers, and where appropriate, to indicate “Patent Pending” status in accordance with each applicable country’s patent laws.

 

ARTICLE 15. INDEPENDENT CONTRACTOR

 

15.                                 For the purpose of this Agreement and all services to be provided hereunder, both parties shall be, and shall be deemed to be, independent contractors and not agents or employees of the other. Neither party shall have authority to make any statements, representations or commitments of any kind, or to take any action, that will be binding on the other party.

 

ARTICLE 16. SEVERABILITY

 

16.                                 If any one or more of the provisions of this Agreement shall be held to be invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions of this Agreement shall not in any way be affected or impaired thereby unless the invalid provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the parties would not have entered into this Agreement without the invalid provisions.

 

ARTICLE 17. NON-ASSIGNABILITY

 

17.                                 Neither this Agreement nor any part hereof shall be assignable by either party without the express prior written consent of the other, which shall not be unreasonably withheld. Any attempted assignment without such consent shall be void.

 

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ARTICLE 18. ENTIRE AGREEMENT

 

18.                                 This Agreement constitutes the entire agreement between the parties with respect to the subject matter and supersedes any prior agreements and understandings between the parties relating to the subject matter hereof. No verbal agreement, conversation or representation between any officers, agents or employees of the parties hereto either before or after the execution of this Agreement shall affect or modify any of the terms or obligations herein contained.

 

ARTICLE 19. MODIFICATIONS IN WRITING

 

19.                                 No change, modification, extension, termination or waiver of this Agreement, or any of the provisions herein contained, shall be valid unless made in writing and signed by a duly authorized representative of each party.

 

ARTICLE 20. GOVERNING LAW

 

20.                                 The validity and interpretation of this Agreement and the legal reactions of the parties to it shall be governed by the laws of England and Wales, without regard to the conflict of laws provisions thereunder, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent was granted.

 

ARTICLE 21. CAPTIONS

 

21.                                 The captions are provided for convenience and are not to be used in construing this Agreement.

 

ARTICLE 22. CONSTRUCTION

 

22.                                 Each of the parties agrees that this Agreement is the result of mutual negotiation and therefore the language herein shall not be presumptively construed against either of them.

 

ARTICLE 23. COUNTERPARTS

 

23.                                 This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original, and all of which together shall be deemed to be one and the same instrument.

 

ARTICLE 24. BINDING EFFECT

 

24.                                 This Agreement shall be binding upon and inure to the benefit of the parties and their respective permitted successors and assigns.

 

ARTICLE 25. FORCE MAJEURE

 

25.                                 If either party’s performance of any obligation under this Agreement is prevented, restricted, interfered with or delayed by reason of any force majeure cause such as floods, fires, riots, insurrections, explosions, other natural disasters or serious labor disputes beyond the reasonable control of the party required to perform, the party so

 

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affected, upon giving written notice and written evidence of such force majeure to the other party, shall be excused from such performance to the extent of such prevention, restriction, interference, or delay; provided that the affected party shall use its commercial reasonable efforts to avoid or remove such causes of non-performance and shall continue performance with the utmost dispatch whenever the force majeure is removed.

 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their respective duly authorized representatives as of the date first above written.

 

	
XENOMICS INC
    	
 
    	
IPSOGEN SAS
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By: 
    	
/s/ David J. Robbins
    	
 
    	
By:
    	
/s/ Vincent Fert
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
David J. Robbins, Ph.D.
    	
 
    	
Name:
    	
Vincent Fert
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
Vice President, Product Development
    	
 
    	
Title:
    	
CEO
    

 

13Exhibit 10.9

 

AMENDMENT TO CO-EXCLUSIVE SUBLICENSE AGREEMENT

 

This Amendment (“Amendment”), is made September 1, 2010 (the “Effective Date”) between Ipsogen SAS, a French corporation having its principal office at Luminy Biotech Enterprises Case 923, 163 Avenue de Luminy 13288 Marseille cedex 9 France (IPSOGEN”), and Trovagene, Inc. (“TROVAGENE”), a Delaware corporation having its principal place of business at 11055 Flintkote Ave., San Diego, CA 92121, which collectively may be referred to herein as the “Parties”  and individually as a “Party”.

 

RECITALS

 

WHEREAS, TROVAGENE is the named exclusive licensee of Patent Rights by virtue of the merger of Xenomics, Inc., with and into TrovaGene, Inc. and TrovaGene, Inc. is the surviving entity.

 

WHEREAS, TROVAGENE and IPSOGEN are Parties to a CO-EXCLUSIVE SUBLICENSE AGREEMENT (“Agreement”) executed August 27, 2007 in which Ipsogen is granted certain of those Patent Rights, and

 

WHEREAS, the Parties, by mutual agreement, wish to modify the terms of the Agreement.

 

NOW THEREFORE, for the consideration herein expressed, as well as consideration of the covenants, conditions and undertakings hereinafter set forth, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree to amend the Agreement as follows:

 

AMENDMENT

 

1.   DEFINITIONS

 

A.  Section 1.3 of the Agreement is hereby amended to read as follows:

 

“Field” shall mean diagnostic products that assay for nucleophosmin protein (“NPM1”) mutants, corresponding nucleic acid sequences and uses thereof, including research use only (“RUO”), analyte specific reagent (“ASR”) and in vitro diagnostics (“IVD”) products. For the avoidance of doubt, the Field specifically excludes therapeutic uses.

 

B.  Section 1.10 of the Agreement is hereby amended to read as follows:

 

“Territory” shall mean all countries in the world covered by any Patent Rights

 

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C.  Section 1.12 is hereby added to the Agreement.

 

“Notice Recipient” means any third party with which TROVAGENE or Xenomics or their representatives communicated either orally or in writing wherein such communication included (i) an assertion or suggestion that such third party does or may require a license from TROVAGENE or Xenomics to perform laboratory testing services, together with (ii) an assertion or suggestion that an IPSOGEN Product does not convey to such third party a right to use such IPSOGEN Product.

 

2.  GRANT OF RIGHTS

 

A.  Section 2.2 of the Agreement is hereby amended to read as follows:

 

IPSOGEN shall have no right during the Term to sublicense the Patent rights to a 3rd party, use the Patent Rights to offer Laboratory Services, or use Patent Rights in any way for development and commercialization of therapeutic products. Notwithstanding the foregoing, the sublicensed rights do specifically include the right to convey Patent Rights to IPSOGEN customers for the purposes of offering or performing Laboratory Services based on use of IPSOGEN Products. The Parties agree that the sublicensed rights referred to above shall extend to IPSOGEN customers that purchased Product from IPSOGEN any time on or after August 27, 2007. In addition, TROVAGENE agrees to provide IPSOGEN within ten (10) days of the Effective Date of this Amendment, an example letter that TrovaGene may send to the Notice Recipient indicating that the Notice Recipient will not be required to obtain any additional licenses from TROVAGENE to use an IPSOGEN Product or Service. Such letter shall be substantially in the form set forth in Exhibit A.

 

B.  Section 2.4 of the Agreement is hereby deleted in its entirety.

 

3.  PAYMENTS

 

A.  Section 4.1 of the Agreement is hereby amended to read as follows:

 

IPSOGEN shall pay to TROVAGENE during the Term prior to September 1, 2010, a royalty of ten percent (10%) on Net Revenues. Royalty payments will commence onsale of first product in any category and shall be payable quarterly.

 

4.1.1 Beginning September 1, 2010, a royalty of (a) 20% of Net Revenues or (b) eighteen (18) dollars per test, whichever is the larger amount, on Products sold in the United States of America and its Territories with no specific regulatory labeling, labeled for “research use only” (RUO), labeled as Analyte Specific Reagents (ASR), or labeled “investigational use only”(IUO) (the “Uncleared Products”). If, however, the royalty payment on Uncleared Products made in any quarter as described in Section 5.4 is greater than 30% of the Net Revenues of the Uncleared Products in such quarter, the Parties agree that royalty for Uncleared Products for that quarter shall be reduced and calculated to equal 30% of Net Revenues of such Uncleared Products. If, during any four consecutive quarters, IPSOGEN is calculated to be

 

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paying an average royalty for Uncleared Products of greater than 20% of Net Revenues of Uncleared Products, the Parties agree to meet, either telephonically or in person, to negotiate in good faith the reduction of the royalty rates for Uncleared Products as set forth above.

 

4.1.2 A royalty of 10% of Net Revenues for Products sold in the United States of America and its Territories with labeling indicating the Product has received FDA clearance for market,

 

4.1.3 A royalty of 10% of Net Revenues for Products sold ex-U.S.

 

4.1.4 The amended royalty are payable quarterly and commence on sales beginning September 1, 2010 and are not retroactive to the Effective Date of the Agreement.

 

4.4 The Minimum Royalty payment(United States dollars) will be reduced beginning in the 3rd year to $40,000. The minimum royalty payment for the 4th year will also be $40,000. The minimum royalty payment for the 5th year and each Year thereafter will be $50,000.

 

4.  NOTICE

 

A.  Section 10.2 of the Agreement is hereby amended to read as follows:

 

Reports, notices and other communication from IPSOGEN to TROVAGENE as provided hereunder shall be sent to:

 

TROVAGENE Inc.

 

	
Attention:
    	
PRESIDENT
    
	
 
    	
11055 Flintkote Ave.
    
	
 
    	
Suite B
    
	
 
    	
San Diego, CA 92121
    
	
 
    	
 
    
	
 
    	
 
    
	
With a copy to:
    	
 
    
	
 
    	
Ivor Elrifi
    
	
 
    	
MINTZ LEVIN
    
	
 
    	
666 Third Avenue
    
	
 
    	
New York, NY 10017
    

 

or to such other individual or address as shall hereafter be furnished by written notice to IPSOGEN in accordance with this Article 10.

 

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IN WITNESS WHEREOF, IPSOGEN and TROVAGENE have caused this Amendment to be executed by their duly authorized representatives as of the date first written above.

 

 

IPSOGEN SAS.

 

 

	
By: Vincent Fert, CEO
    	
 
    
	
/s/ Vincent Fert
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
TROVAGENE, Inc.
    	
 
    
	
 
    	
 
    
	
By: Andreas Braun, Acting President
    	
 
    
	
/s/ A. Braun
    	
 
    

 

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