Document:

Exhibit 10.16

 

SUBLICENSE AGREEMENT

 

THIS SUBLICENSE AGREEMENT (“Agreement”) effective as of June 15, 2010 (the “Effective Date”) is by and between TROVAGENE Inc, a New York corporation having its principal office at 11055 Flintkote Ave, Suite B, San Diego CA 92121, United States of America (“TROVAGENE”) and Skyline Diagnostics BV, a Dutch corporation having its principal office at Erasmus University Medical Center, Dr. Molewaterplein 50, EE 19-71, 3015 GD Rotterdam, The Netherlands (“SKYLINE”).

 

WITNESSETH:

 

WHEREAS, TROVAGENE 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 SKYLINE 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, SKYLINE has developed and is the owner of the AML Profiler® platform, a dedicated diagnostic microarray based on the Affymetrix GeneChip platform;

 

WHEREAS, SKYLINE desires to obtain the Sublicense described above and to extend its AML Profiler ® with methods to detect mutations in NPM1 on the terms and conditions set forth herein; and

 

WHEREAS, TROVAGENE is willing to grant SKYLINE 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           “AML Profiler®” shall mean the SKYLINE owned dedicated diagnostic microarray based on, for example, the Affymetrix GeneChip platform, as manufactured by Affymetrix (USA), for the detection of several chromosomal aberrations, gene mutations and the expression of relevant prognostic genes in samples from patients with Acute Myeloid Leukemia. For the avoidance of doubt, AML Profiler® also includes any future, upgraded, updated, successor and/or

 

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otherwise amended devices SKYLINE makes or has made for the testing of AML Profiler® in patient samples.

 

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

 

1.4           “Field” shall mean Laboratory Services rendered for the testing, analysis, and interpretation of nucleophosmin (nucleolar phosphoprotein B23 numatrin) mutations as defined by Patent Rights (NPM) in human clinical samples including using the AML Profiler®.

 

1.5           “Laboratory Services” shall mean any fee for reference laboratory service, or part thereof, performed by SKYLINE or by SKYLINE authorized or subcontracted reference laboratories in the Territory that when used, commercialized or marketed in the Territory would infringe on any Valid Claim of the Patent Rights absent the Sublicense herein granted. This includes the use of the AML Profiler® in methods to test for and analyze NPM mutations but is not limited to the use of AML Profiler® by Affymetrix or another third party.

 

1.6           “Net Revenues” shall mean the gross amount received by SKYLINE or its Affiliate(s) for the Laboratory Services sold to non-Affiliate third parties less the following acceptable deductions:

 

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

(b)           sale and/or use taxes and VAT, duties and any other governmental charges directly imposed and with reference to particular sales;

(c)           amounts allowed or credited on returns;

(d)           bad debts as described below;

(e)           transportation and freight charges, including insurance and handling fees, to the extent they are included in the price charged by SKYLINE or its Affiliate(s).

 

Bad debts for which loyalties have been paid or are to be paid may be deducted from the Net Revenues; bad debt are considered sales invoiced and not paid within a period of twelve (12) months after the date of invoice. Any royalties paid against bad debts, may be deducted from the amount payable over the subsequent Reporting Period. At no time shall a deduction for bad debt exceed 5% of Gross Revenue.

 

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

 

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1.7           “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, including Canadian Patent Application 2585965 as well as all continuations, divisions, reissues, re-examinations, renewals, or extensions of such patents subject to the rights granted by Original Licensor to TROVAGENE pursuant to the Exclusive License Agreement including any improvements to the Patent Rights or improvement Patent Rights, which come into TROVAGENE right to use and sublicense as limited by this Agreement.

 

1.8           “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.

 

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

 

1.10         “Territory” shall mean either, a) the country of The Netherlands, b) “Europe” which shall be defined as including all countries of the European Union, Switzerland, Norway, Liechtenstein, and Iceland, c) all countries of the World excluding the United States and its Territories (herein after “United States”), or d) all countries of the World. At any given point during the Term of this Agreement the definition of Territory will be determined by the current status of the options exercised by SKYLINE as provided in 4.2 — 4.5 and 7.2 below.

 

1.11         “Valid Claim” shall mean a claim of an unexpired patent or patent application 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.

 

ARTICLE 2. GRANT OF RIGHTS

 

2.1           TROVAGENE hereby grants to SKYLINE, subject to all the terms and conditions of this Agreement a non-exclusive, royalty-bearing Sublicense under the Patent Rights 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 Laboratory Services in the Field, ii) make or have made the AML Profiler® with features for NPM1 analysis for use in Laboratory Services and iii) use, develop, practice, commercialize, and otherwise fully exploit the Laboratory Services and to have the Laboratory Services or part thereof carried out by or subcontracted to third party laboratories appointed by SKYLINE. For purposes of clarity the rights granted herein include the right for SKYLINE to provide the AML Profiler® for NPM1 analysis at no charge as well as other materials to the subcontracted lab, methods and know-how necessary for a third party subcontracted lab to perform the testing of the sample, but in all such cases,

 

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SKYLINE is responsible for the analysis, interpretation, billing for and reporting of results to the subcontracted laboratory for the Laboratory Services. Any fees or costs incurred by SKYLINE related to work performed by subcontractors in the course of Laboratory Services are to be borne solely by SKYLINE and shall not be deducted when calculating Net Revenues.

 

SKYLINE shall have no right to further sublicense and any third party subcontracted lab utilizing the AML Profiler®, materials, methods, and other know-how provided by SKYLINE to perform the test may do so solely for the purposes of sending the AML Profiler® data to SKYLINE for analysis, interpretation and reporting. SKLYINE may report results to the subcontracted lab and invoice the subcontracted lab for the Laboratory Services.

 

2.2           SKYLINE shall have no right during the Term to make, have made, offer to sell, sell and market Products in the Field or use Patent Rights in any way for development and commercialization of therapeutic products other than the rights granted for the Laboratory Services and pursuant to Article 2.1. For the purposes of clarity, this Sublicense specifically excludes the right to sell the AML Profiler® or any other Product(s) that when used would cause an infringement on a Valid Claim.

 

ARTICLE 3. DUE DILIGENCE

 

3.1           SKYLINE shall use diligent efforts to develop and sell licensed Laboratory Services 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 TROVAGENE with reports and payments within sixty (60) days following the close of each Reporting Period as defined below beginning with the calendar year in which the first commercial sale of Laboratory Services have been effectuated.

 

ARTICLE 4. PAYMENTS

 

4.1           In consideration of a non-exclusive license under the Patent Rights SKYLINE shall pay to TROVAGENE a royalty of (a) one percent (1%) on Net Revenues or (b) $20 per reported test, whichever is the greater. Such royalty payments shall apply for all sales of Laboratory Services in each country of the Territory where such Valid Claims to the Patent Rights exists. Royalty payments will commence on sale of the first Laboratory Service. Royalties shall be paid in US dollars. Conversion of the Euro or any other currency into US Dollars shall be made at the official exchange rate as published by the European Central Bank at the exchange rate prevailing on the day before the royalty due is paid by SKYLINE to TROVAGENE.

 

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4.2           Upon execution of this Sublicense Agreement, and within 30 days of the Effective Date, SKYLINE will pay TROVAGENE a one time upfront fee in the amount of $10,000 and Territory will be defined as a) the country of The Netherlands.

 

4.3           SKYLINE will pay TROVAGENE an additional one time milestone fee in the amount of $20,000 upon (a) receiving CE mark clearance for marketing the AML Profiler® in Europe, which includes the featuring of NPM1 analysis, or (b) first sale of Laboratory Services in Europe in a country other than the Netherlands at which time Territory will be defined as b) Europe including all countries of the European Union, Switzerland, Norway, Liechtenstein, and Iceland.

 

4.4           SKYLINE, at its sole discretion, may expand the definition of Territory to c) all countries of the World excluding the United States and will pay TROVAGENE an additional one-time milestone fee in the amount of $20,000 upon commencement of Laboratory Services in the first country outside Europe, excluding the United States, for which Valid Claims to the Patent Rights exist.

 

4.5           SKYLINE, at its sole discretion, may expand the definition of Territory to d) all countries of the World and will pay TROVAGENE an additional one-time milestone fee in the amount of $30,000 upon commencement of Laboratory Services in the United States.

 

4.5.1        Beginning from the date of the first sale of Laboratory Services in the United States SKYLINE will be obligated to pay annual minimum royalties in the amounts shown in the table below based on Net Revenues of Laboratory Services in the United States. Each year, in the quarter following the anniversary of the commencement of Laboratory Services in the United States, SKYLINE will report the sum of actual royalties paid against Net Revenues from Laboratory Services in the United States as required in 4.1 above and, if the actual royalties paid are less than the minimum royalty due for that year, will pay the difference between the sum of the actual royalties paid for Laboratory Services in the United States and the annual minimum royalty due for that year.

 

	
Annual Schedule for United States
    	
 
    	
Minimum Royalty Due
    	
 
    
	
1st year of Laboratory Services
    	
 
    	
$
    	
10,000
    	
 
    
	
2nd Year of laboratory Services
    	
 
    	
$
    	
15,000
    	
 
    
	
3rd year of Laboratory Services and each year   thereafter
    	
 
    	
$
    	
20,000
    	
 
    

 

4.6           In the event no Valid Claim in the Patent Rights are granted, exist, or the Valid Claims are abandoned in a country of the Territory or in the event the Laboratory Services do not fall under a Valid Claim in the Patent Rights, SKYLINE shall no longer owe TROVAGENE any royalties on Net Revenues for any such country of the Territory. In such case (s) any such country of the Territory is then excluded

 

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from royalty reporting and payments, SKYLINE will have no right to reclaim any royalty or fee payments previously made under this Sublicense.

 

4.7           In the event of any proceeding or suit (“Suit”) before any court, agency, or tribunal involving the validity, infringement or enforceability of any Valid Claim, the development and use is enjoined or otherwise prohibited, SKYLINE may for the period from the date of the filing of such Suit to the date of such injunction or prohibition from which no appeal can be taken or is taken, uphold royalty payment. If in the proceeding of such Suit any such Valid Claim has been held valid or not infringing or enforceable by a final judgment, decree or decision from which no appeal can be taken or for which no appeal is taken, the upheld royalty amounts shall be paid to TROVAGENE within 30 days of such judgment. If any such Valid Claims have been held invalid or not infringed or unenforceable by a final judgment, decree or decision from which no appeal can be taken or no appeal is taken, SKYLINE will be free of any future royalty obligation hereunder.

 

4.8           TROVAGENE agrees that to the extent it grants a new Sublicense under the Patent Rights to a third party such terms and conditions shall be substantially similar to those for which SKYLINE has been granted the Sublicense based on Territory and Field.

 

ARTICLE 5. REPORTS AND RECORDS

 

5.1           SKYLINE 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 three (3) years following the period of each report required by Section 5.2 below.

 

5.2           After the first commercial sale of the Laboratory Services, SKYLINE shall deliver to TROVAGENE within sixty (60) days following the close of each Reporting Period true and accurate reports, giving such particulars of the business conducted by SKYLINE and its Affiliate(s) during the preceding Reporting Period under this Agreement as shall be pertinent to a royalty and fee accounting hereunder. The Reporting Period and Payments of royalties are due as follows:

 

5.2.1        To the extent that Net Revenues are recorded only in The Netherlands the Reporting Period shall be annually.

 

5.2.2        At the commencement of Net Revenues recorded in any country other than The Netherlands within Europe the Reporting Period shall be semi-annually for all countries.

 

5.2.3        At the commencement of Net Revenues recorded outside of the Europe the Reporting Period shall be quarterly for all countries.

 

These reports shall include at least the following:

 

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(a)           number of the Laboratory Services sold in each country by SKYLINE and its Affiliate(s) and paid by customers either directly or indirectly through appointed third party laboratories;

(b)           Gross sales of any invoices that include any amounts received from customers for the Laboratory Services sold by SKYLINE and its Affiliate(s)

(c)           deductions applicable as provided in Section 1.6 including those for bad debt;

(d)           total royalties and fees due; and

(e)           amounts of withholding taxes.

 

5.3           Said books and records shall be kept at SKYLINE’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 TROVAGENE and reasonably acceptable to SKYLINE and/or its Affiliate(s), upon ten (10) business days advance notice and during regular business hours for the sole purpose to enable TROVAGENE to ascertain the correctness of any report and/or payment made under this Agreement. TROVAGENE shall pay the fees and expenses of the accountant engaged to perform the audit, unless such audit reveals an undisputed underpayment of five percent (5%) or more for the period examined, in which case SKYLINE shall pay within thirty (30) days the reasonable fees and expenses charged by the accountant in addition to any amounts due. Any overpayment established by the accountant shall be reimbursed by TROVAGENE within thirty (30) days from the day of the accountant’s report.

 

5.4           SKYLINE shall pay to TROVAGENE the actual royalties due and payable as provided for in Sections 4.1 and 5.2. If no actual royalties are due, SKYLINE shall so report.

 

ARTICLE 6. PATENT PROSECUTION; INFRINGEMENT

 

6.1           The prosecution, filing and maintenance of the Patent Rights in the Territory shall be the responsibility of and managed by TROVAGENE. TROVAGENE shall, twice yearly in June and December, submit to SKYLINE a full report relating to the Patent Rights, the rights granted, opposition procedures and the like for the Territory. TROVAGENE warrants and represents to use all reasonable efforts to pursue the patent applications in each country of the Territory diligently and to obtain patents at the earliest time possible in each country of the Territory.

 

6.2           In the event of any invention made by SKYLINE relating to the licensed Patent Rights (“New Inventions”), SKYLINE will be the owner of such New Inventions and has the right to file, prosecute and maintain any patent for such New

 

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Inventions in any country of its choice. Prior to any filings or applications for New Inventions SKYLINE will provide TROVAGENE with ninety (90) days written notice of its intent to file or pursue protection for such New Invention for the purposes of providing TROVAGENE the opportunity to negotiate in good faith rights or terms to participate in such action. Any such New Invention does explicitly not include any future, upgraded, updated, successor and/or otherwise amended microarray in connection with the AML Profiler®.

 

In the event the parties agree on TROVAGENE filing, prosecuting and maintaining any patent applications directed to such New Inventions that are related to Patent Rights and the terms thereto whether owned solely or jointly with SKYLINE, SKYLINE shall cooperate with TROVAGENE 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 TROVAGENE to file, prosecute and maintain such New Inventions in any country; and (b) promptly informing TROVAGENE of matters that may affect the preparation, filing, prosecution or maintenance of any such New Inventions.

 

6.3        (a)      SKYLINE agrees to provide TROVAGENE with prompt written notice after becoming aware of any infringement of any of the Patent Rights or New Inventions (if such New Inventions are filed in TROVAGENE’ name) in the Field and of any available evidence thereof.

 

(b)   TROVAGENE 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 filed in its name or to defend the Patent Rights or New Inventions filed in its name in any declaratory judgment action brought by a third party which alleges the invalidity, unenforceability or non-infringement of any Patent Rights. SKYLINE agrees to cooperate fully in any action under this Section 6.3, provided that TROVAGENE reimburses material costs and expenses incurred with providing such assistance. At all times SKYLINE, at its discretion is entitled to join in such action of TROVAGNE with its own counsel, reasonably acceptable to TROVAGENE, at its own cost. If TROVAGENE does not commence a particular infringement action within ninety (90) days, SKYLINE, after notifying TROVAGENE in writing shall have the right, but not the obligation, to bring such infringement action at its own expense and under its full control. TROVAGENE agrees to cooperate fully in any such action brought by SKYLINE.

 

(c)   If no action is brought by either party, SKYLINE is free from any future royalty obligation hereunder in respect of the country in which such infringement takes place.

 

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6.4           TROVAGENE hereby undertakes to notify SKYLINE promptly should the Patent Rights lapse for failing to meet a deadline, should the Original Licensor and/or TROVAGENE decide to stop pursuing the Patent Rights or should the Patent Rights not be allowed in any country of the Territory for any reason, and SKYLINE will be free of any royalty obligation hereunder.

 

6.5           If during the term of this Agreement either party receives notice, claim, or proceedings from any third party alleging infringement of that third party’s intellectual property as a result of either party’s activities in relation to this Agreement or use and exploitation of the Patent Rights licensed hereunder, the party receiving notice shall (i) forthwith notify the other party of such notice, claim or proceeding; (ii) make no admission of liability; (iii) SKYLINE shall give TROVAGENE the conduct of defense of such claims or proceedings including the right to settle and (iv) SKYLINE shall uphold any royalty payment, until a final decision has been taken either by court or through settlement.

 

ARTICLE 7. TERM AND TERMINATION

 

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

 

7.2           SKYLINE 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 TROVAGENE. Should SKYLINE elect to terminate this Agreement SKYLINE will report and pay within sixty (60) days of the termination date all outstanding royalties or fees due as defined in Section 4 and shall have no right to reclaim any royalty or fee payments previously made under this Sublicense.

 

SKYLINE shall have the right to terminate only that portion of this Agreement and all the rights, privileges and the Sublicense granted hereunder as included and defined in 4.5 above by providing written notice to TROVAGENE. Upon such notice the definition of Territory shall revert to c) all the countries of the World excluding the United States, and SKYLINE shall report and pay within sixty (60) days of the notice of termination all outstanding royalties due including a prorated minimum royalty. The prorated minimum royalty will be calculated based on the notification date of termination against the anniversary date as defined in 4.5.1 above and applied as a percentage against the minimum royalty due for that year for Laboratory Services in the United States.

 

7.3           Upon any material breach or default of this Agreement by either party, including without limitation SKYLINE’s material failure to comply with Section 3 hereof,

 

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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 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.

 

7.4                                 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, (only for one year after termination of the Agreement). 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                                 TROVAGENE agrees to indemnify, hold harmless and defend SKYLINE, 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 SKYLINE, its Affiliates, subcontractors, agents and employees, based on breach of TROVAGENE’s warranties under Article 9 below, except to the extent such Losses or Third Party Claims result from the negligence or wilful misconduct of SKYLINE, its Affiliates, subcontractors, agents and employees or a breach of SKYLINE’s warranties under Article 9 below.

 

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

 

ARTICLE 9. REPRESENTATIONS, WARRANTIES AND DISCLAIMERS

 

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

 

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terms, (iv) that it is not and shall during the term of this Agreement not be in default under the Exclusive License Agreement, and there has not occurred any event which, with a lapse of time or giving of notice, or both, would constitute such a default, (v) that it shall not terminate or amend, during the term of this Agreement, the Exclusive License Agreement to the detriment of SKYLINE. There has not been any default by any party or dispute between TROVAGENE and any party under the Exclusive License Agreement, (v) as of the Effective Date, it has no actual knowledge of any conflict of any kind with any inventor(s) listed or any of the owner of the Patent Rights, which may restrict it from entering into this Agreement, granting the rights or fulfilling its obligations hereunder, (vi) as of the Effective Date, the Patent Rights are in good standing and have not lapsed for failing to meet a deadline and they have diligently been prosecuted and maintained, (vii) as of the Effective Date no person has challenged by way of a notice in writing the validity of any claim comprised within the Patent Rights, and (viii) as of the Effective Date there are no judicial, arbitral, regulatory or administrative proceedings or investigations, claims, actions or suits relating to the inventions disclosed in the Patent or their use, making, commercialization, practice or any other exploitation thereof pending against the Original Licensors, their Co-exclusive Product-right holders or, TROVAGENE, its Affiliates or any of TROVAGENE, sublicensees in any court or by or before any governmental body or agency and, to the best of TROVAGENE’ knowledge, no such judicial, arbitral, regulatory or administrative proceedings or investigations, actions or suits have been threatened against the Original Licensors, their Co-exclusive Product-right holders, TROVAGENE, its Affiliates or any of TROVAGENE’s sublicensees and; ix) the use of the AML Profiler® including features for NPM analysis manufactured by Affymetrix (USA) as a component of the laboratory developed test which is being provided as a Laboratory Service does not conflict with any of the rights under the Patent Rights of the Co-exclusive Product-right holders or any other party.

 

9.2                                 SKYLINE hereby represents and warrants to TROVAGENE 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. SKYLINE 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 Laboratory Services.

 

9.3                                 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN SECTION 9, TROVAGENE 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 OTHER WISE PROVIDED TO SUBLICENSEE HEREUNDER AND HEREBY DISCLAIMS THE SAME. TROVAGENE DOES NOT WARRANT THE VALIDITY OF THE PATENT RIGHTS SUBLICENSED HEREUNDER AND MAKES NO REPRESENTATION WHATSOEVER WITH REGARD TO THE SCOPE OF THE SUBLICENSED

 

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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, IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT. SUBLICENSEE ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR ANY LOSS OR DAMAGES CAUSED BY THE LABORATORY SERVICES, USED, DELIVERED, SOLD OR PROVIDED BY SUBLICENSEE AND ITS AFFILIATE(S) AND APPOINTEES THAT ARE SUBJECT TO THIS AGREEMENT UNLESS THE SAME HAS RESULTED FROM ANY MATERIAL BREACH OF AN OBLIGATION, REPRESENTATION, WARRANTY BY TROVAGENE UNDER THIS AGREEMENT OR ACTION, INACTIONS, OR MISREPRESENTATIONS ON THE PART OF TROVAGENE.

 

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 or overnight courier or (iii) 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 SKYLINE to TROVAGENE as provided hereunder shall be sent to:

 

TROVAGENE Inc

Attention:                                         CFO

11055 Flintkote Ave.

Suite B

San Diego, CA 92121

USA

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 SKYLINE in accordance with this Article 10.

 

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

 

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Skyline Diagnostics BV
    	
 
    	
 
    
	
Attention:
    	
Dr. Henk Viëtor (or his successor)
    	
 
    	
 
    
	
 
    	
Erasmus University Medical Center
    	
 
    	
 
    
	
 
    	
Dr. Molewaterplein 50, EE 19-71
    	
 
    	
 
    
	
 
    	
3015 GD Rotterdam
    	
 
    	
 
    
	
 
    	
The Netherlands
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
With a copy to:
    	
 
    	
 
    	
 
    
	
 
    	
SKYLINE BV.
    	
 
    	
 
    
	
 
    	
Erasmus University Medical Center
    	
 
    	
 
    
	
 
    	
Dr. Molewaterplein 50, EE 19-71
    	
 
    	
 
    
	
 
    	
3015 GD Rotterdam
    	
 
    	
 
    
	
 
    	
The Netherlands
    	
 
    	
 
    

 

or to such other individual or address as shall hereafter be furnished by written notice to TROVAGENE 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 Geneva, Switzerland. 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 New York, USA.

 

11.3                           Notwithstanding the foregoing, nothing in this Article shall he 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                           SKYLINE shall neither use nor cause its Affiliate(s) to use the name of TROVAGENE, its directors, officers, trustees, Affiliate(s), employees, or any adaptations thereof, in any advertising, promotion or sale literature without the prior written consent of TROVAGENE. With respect to reports to public agencies that are required by law, SKYLINE shall provide TROVAGENE with a reasonable opportunity to review the use of its name in such reports reasonably in advance of submission.

 

12.2                           SKYLINE 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 TROVAGENE except and to the extent required to comply with applicable laws or regulations; provided that, SKYLINE delivers prior written notice to TROVAGENE 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 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

 

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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) 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 or 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, SKYLINE agrees to mark any Laboratory Services, reports, testing results, 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

 

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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. A change in control of SKYLINE shall not be considered as an assignment of this Agreement and therefore shall not require the prior written consent of TROVAGENE. For the purpose of this Article 17, “change in control” shall mean the occurrence of any transaction that results in the sale of more than 50% of the current outstanding issued shares or interests of SKYLINE to a third party, or the sale of all or substantially all of the assets of SKYLINE.

 

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 the State of New York, USA, 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.

 

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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 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 majcure is removed.

 

[The signature page follows]

 

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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.

 

	
TROVAGENE INC
    	
 
    	
SKYLINE DIAGNOSTICS BV
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/ Bruce Huebner
    	
 
    	
By:
    	
/s/ Henk Viëtor
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Bruce Huebner
    	
 
    	
Name:
    	
Henk Viëtor
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
President & CEO
    	
 
    	
Title:
    	
CEO
    

 

18Exhibit 10.20

 

EXCLUSIVE LICENSE AGREEMENT

 

This Exclusive License Agreement (this “Agreement”) is made effective as of December 12, 2011 (the “Effective Date”) by and between Columbia University, 412 Low Memorial Library 535 West 116th St., Mail Code 4308, New York, NY 10027 (“Licensor”), and Trovagene, Inc., located at 11055 Flintkote Ave., Suite B, San Diego, CA 92121 (“Licensee”). Licensor and Licensee are each hereafter referred to individually as a “Party” and together as the “Parties”.

 

WHEREAS, Licensor is the owner of or otherwise controls certain proprietary Licensed Patents (as defined below); and

 

WHEREAS, Licensee desires to obtain an exclusive license from Licensor under Licensor’s rights to Licensed Patents to develop and commercialize Licensed Products; and

 

WHEREAS, Licensor desires to grant such license to Licensee on the terms and subject to the conditions of this Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereby agree as follows.

 

1.                                      DEFINITIONS

 

Whenever used in the Agreement with an initial capital letter, the terms defined in this Article 1 shall have the meanings specified.

 

1.1                                 “Affiliate” shall mean” shall mean any corporation or other entity that, as of the Effective Date, directly or indirectly controls, is controlled by, or is under common control with, another corporation or entity. Control means direct or indirect ownership of, or other beneficial interest in, fifty percent (50%) or more of the voting stock, other voting interest, or income of a corporation or other entity.

 

1.2                                 “Confidential Information” shall mean with respect to a Party (the “Receiving Party”), all information which is disclosed by the other Party (the “Disclosing Party”) to the Receiving Party hereunder or to any of its employees, consultants, Affiliates, licensees or sublicensees, except to the extent that the Receiving Party can demonstrate by written record or other suitable physical evidence that such information, (a) as of the date of disclosure is demonstrably known to the Receiving Party or its Affiliates other than by virtue of a prior confidential disclosure to such Party or its Affiliates; (b) as of the date of disclosure is in, or subsequently enters, the public domain, through no fault or omission of the Receiving Party; (c) is obtained from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the Disclosing Party; or (d) is independently developed by or for the Receiving Party without reference to or reliance upon any Confidential Information of the Disclosing Party.

 

1.3                                 “First Commercial Sale” shall mean, on a country-by-country basis, the date of the first arm’s length transaction, transfer or disposition for value to a Third Party of a

 

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Licensed Product pursuant to regulatory approval in a Major Market by or on behalf of Licensee or any Affiliate or Sublicensee of Licensee in such country.

 

1.4                                 “FDA” shall mean the United States Food and Drug Administration and any successor agency or authority thereto.

 

1.5                                 “Indemnitees” and “Indemnifying Party” shall mean a Party, its Affiliates and their respective directors, officers, employees, stockholders and agents and their respective successors, heirs and assigns.

 

1.6                                 “Licensed Field” shall mean all fields of use.

 

1.7                                 “Licensed Patent Rights” shall mean any of the patents and patent applications described in Schedule A attached hereto, and any divisional, continuation, continuation-in-part (to the extent that the continuation-in-part is entitled to the priority date of an initial patent or patent application which is the subject of this Agreement), reissue, reexamination, confirmation, revalidation, registration, patent of addition, renewal, extension or substitute thereof, or any patent issuing therefrom or any supplementary protection certificates related thereto.

 

1.8                                 “Licensed Product” shall mean any product sold by or on behalf of Licensee or its Affiliates or Sublicensees that, absent the license in the Licensed Field provided in this Agreement, would be an infringement of a Valid Claim of the Licensed Patent Rights.

 

1.9                                 “Major Market” shall mean the Unites States, European Union, or Japan.

 

1.10                           “Net Sales” shall mean the amount received by Licensee for all Licensed Products sold by Licensee, its Affiliates or Sublicensees to Third Parties throughout the Territory during each calendar quarter, less the following amounts actually incurred or actually paid by Licensee or its Affiliates or Sublicensees during such calendar quarter with respect to sales of Licensed Products regardless of the calendar quarter in which such sales were made: (a) normal and customary quantity and/or cash discounts and sales returns and allowances, including, without limitation, those granted on account of price adjustments, billing errors, rejected goods, damaged goods, returns, rebates actually allowed and taken, administrative or other fees or reimbursements or similar payments to wholesalers or other distributors, buying groups, or other institutions; (b) sales commission fees paid to Third Parties (excluding sales personnel, sales representatives and sales agents who are employees or consultants of the selling party); (c) freight, postage, shipping, and insurance expenses (if separately identified in such invoice and not paid by a Third Party customer); (d) customs or excise duties or other duties directly imposed and related to the sales making up the gross invoice amount; (e) any rebates or similar payments made with respect to sales paid for by any governmental or regulatory authority such as, by way of illustration and not in limitation of the parties’ rights hereunder, Federal or state Medicaid, Medicare or similar state program or equivalent foreign governmental program; (f) sales and other taxes and duties directly related to the sale, to the extent that such items are included in the gross invoice price (but not including taxes assessed against the income derived from such sale); (g) fully loaded manufacturing costs, materials, labor, overhead and costs of distribution.

 

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“Net Sales” shall not include sales or transfers between Licensee and its Affiliates or Sublicensees, unless the Licensed Product is consumed by the Affiliate or Sublicensee.

 

1.11                           “Regulatory Approval” shall mean any and all approvals (including pricing and reimbursement approvals), product and establishment licenses, registrations or authorizations of any kind of the FDA or any Foreign Regulatory Authority necessary for the development, pre-clinical and/or human clinical testing, manufacture, quality testing, supply, use, storage, importation, export, transport, marketing and sale of a Licensed Product (or any component thereof) for use in the Field in any country or other jurisdiction in the Territory.

 

1.12                           “Term” shall mean, with respect to each Licensed Product, the period commencing on the Effective Date and continuing on a country-by-country, and product-by-product basis until last to expire of the Licensed Patent Rights covering the Licensed Product.

 

1.13                           “Sublicensee” shall mean any Third Party to whom Licensee grants a sublicense of some or all of the rights granted to Licensee under this Agreement.

 

1.14                           “Territory” shall mean all countries and jurisdictions of the world.

 

1.15                           “Third Party” shall mean any person or entity other than Licensee, Licensor and their respective Affiliates.

 

1.16                           “Valid Claim” shall mean a claim in an issued, unexpired patent or in a pending patent application within the Licensed Patent Rights that (a) has not been finally cancelled, withdrawn, abandoned or rejected by any administrative agency or other body of competent jurisdiction. (b) has not been revoked, held invalid, or declared unpatentable or unenforceable in a decision of a court or other body of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, (c) has not been rendered unenforceable through disclaimer or otherwise, and (d) is not lost through an interference proceeding.

 

2.                                      GRANT OF RIGHTS

 

2.1                                 License to Licensee.

 

2.1.1                        Grant of License. Licensor hereby grants to Licensee an exclusive license under Licensor’s rights (even as to Licensor, but subject to 2.1.3), including the right to grant sublicenses in accordance with Section 2.1.2, to the Licensed Patent Rights to develop, have developed, make, have made, use, have used, sell, offer for sale, have sold, import, have imported, export and have exported, Licensed Products in the Territory, for any and all uses within the Licensed Field, subject to the terms and conditions of this Agreement.

 

2.1.2                        Right to Sublicense. Licensee shall have the right to grant sublicenses to any Sublicensee to all or any portion of its rights under the license granted pursuant to this Section 2. Licensee to provide Columbia with written notice within thirty (30) days of any sublicenses granted to any Sublicensee.

 

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2.1.3                        Retained Rights. Subject to the other terms of this Agreement, Licensor retain the right to use and practice the Licensed Patent Rights in the Field for academic research and educational purposes and to permit other non-profit entities or individuals to practice and use such Licensed Patents Rights for academic research and educational purposes in the Field. Columbia shall obtain from all entities or individuals who are given permission to practice and use such Licensed Patents Rights an agreement in writing to limit such use to academic research and educational purposes.

 

2.2         All rights not specifically granted herein are reserved to Columbia. Except as expressly provided under this Section 2, no right or license is granted (expressly or by implication or estoppel) by Columbia to Company or its Affiliates or Sublicensees under any tangible or intellectual property, materials, patent, patent application, trademark, copyright, trade secret, know-how, technical information, data or other proprietary right.

 

3.                                      COMMERCIALIZATION OF LICENSED PRODUCTS.

 

3.1                                 Commercialization.

 

3.1.1                        Responsibility. From and after the Effective Date, Licensee shall have full control and authority over the development and commercialization of Licensed Products in the Licensed Field in the Territory. Licensee shall own all data, results and all other information arising from any such activities under this Agreement. All activities relating to development and commercialization under this Agreement shall be undertaken at Licensee’s sole cost and expense.

 

3.1.2                        Diligence. Licensee will exercise commercially reasonable efforts to develop a Licensed Product that incorporates the Licensed Patent Rights or Licensed Technology, such commercially reasonable efforts to take into account the competitiveness of the marketplace, the proprietary position of the Licensed Product, the relative potential safety and efficacy of the Licensed Product, the cost of goods and availability of capacity to manufacture and supply the Licensed Product at commercial scale, the profitability of the applicable Licensed Product, and other relevant factors including, without limitation, technical, legal, scientific or medical factors.

 

4.                                      PAYMENTS

 

4.1                                 License Fee. In consideration of the grant of the license described in Section 2.1 hereof, Licensee hereby agrees to pay Licensor (collectively, not individually) an upfront license fee in the amount of One Thousand Dollars ($1,000), which shall be paid within 30 days of the execution of this Agreement.

 

4.2                                 Royalty Payments. In further consideration of the grant of the license by Licensor hereunder and subject to the other terms and conditions of this Agreement, Licensee shall make royalty payments to Licensor (collectively, not individually) in the amount of 0.5% on Net Sales if such sales are made by or on behalf of Licensee or its Affiliates or in the amount of 5% on sublicense income received by Licensee if sales are made by Sublicensee. Royalty payments shall commence on date of first Commercial Sale (payable quarterly in arrears) and

 

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shall expire on a country by country basis upon expiry of the Licensed Patent Rights in that country.

 

4.5                                 Reports and Payments. 

 

Within thirty (30) days after the first business day of each calendar quarter of each License Year of this Agreement, Company shall submit to Columbia a written report with respect to the preceding calendar quarter (the “Payment Report”) stating:

 

(i)                                     Gross and Net Sales of Products by Company, Sublicensees, Designees and their Affiliates during such quarter, together with detailed information sufficient to permit Columbia to verify the accuracy of reported Net Sales, including Product names, country where manufactured, country where sold, actual selling price, units sold, an identification of all Patent claims that any Patent Product is Covered By, and an identification of Materials and Technical Information used or incorporated in the discovery, development, manufacture, use, sale, offering for sale, importation, exportation, distribution, rental or lease of any Other Product;

 

(ii)                                  Amounts accruing to, and amounts received by, Company from its Sublicensees during such quarter together with the respective payment reports received by Company from any Sublicensees; and

 

(iii)                               A calculation under Section 4 of the amounts due to Columbia, making reference to the applicable subsection thereof.

 

Simultaneously with the submission of each Payment Report, Company shall make payments to Columbia of the amounts due for the calendar quarter covered by the Payment Report. Payment shall be by check payable to The Trustees of Columbia University in the City of New York and sent to the following address:

 

The Trustees of Columbia University in the City of New York

Columbia Technology Ventures

P.O. Box 1394

New York, NY 10008-1394

 

or to such other address as Columbia may specify by notice hereunder, or, if requested by Columbia, by wire transfer of immediately available funds by Company to:

 

Wells Fargo Bank

375 Park Avenue, 6th Floor

MAC J0127-063

New York NY 10152

 

(This is the bank’s address not Columbia University’s. Do not use this address for correspondence to Columbia University.)

Routing/Transit (ABA) #: 121000248 (use for domestic wires)

Swift #: WFBIUS6S (use for foreign wires)

CHIPS UID: 0407

Columbia Account #: 2000039431790

 

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Beneficiary: Columbia University FBO Tech Ventures, Finance

Other identifying info: include invoice #, contract #

ACH Routing/Transit (ABA) #: 026012881

 

or to such other bank and account identified by notice to Company by Columbia. Company is required to send the quarterly royalty statement whether or not royalty payments are due.

 

Within thirty (30) days after the date of termination or expiration of this Agreement, Company shall pay Columbia any and all amounts that are due pursuant to this Agreement as of the date of such termination or expiration, together with a Payment Report for such payment in accordance with Section 4.5 hereof, except that such Payment Report shall cover the period from the end of the last calendar quarter prior to termination or expiration to the date of termination or expiration. Nothing in the foregoing shall be deemed to satisfy any of Company’s other obligations under this Agreement upon termination or expiration.

 

With respect to revenues obtained by Company in foreign countries, Company shall make royalty payments to Columbia in the United States in United States Dollars. Royalty payments for transactions outside the United States shall first be determined in the currency of the country in which they are earned, and then converted to United States dollars using the buying rates of exchange quoted by Citibank, N.A. (or its successor) in New York, New York for the last business day of the calendar quarter in which the royalties were earned. Any and all loss of exchange value, taxes, or other expenses incurred in the transfer or conversion of foreign currency into U.S. dollars, and any income, remittance, or other taxes on such royalties required to be withheld at the source shall be the exclusive responsibility of Company, and shall not be used to decrease the amount of royalties due to Columbia. Royalty statements shall show sales both in the local currency and US dollars, with the exchange rate used clearly stated.

 

Company shall maintain at its principal office usual books of account and records showing its actions under this Agreement, and sufficient to determine Company’s compliance with its obligations hereunder. Upon reasonable notice, but not more than once per calendar year, Columbia may have a certified public accountant or auditor, and an attorney (each as to whom Company has no reasonable objection) inspect and copy such books and records for purposes of verifying the accuracy of the amounts paid under this Agreement. The review may cover a period of not more than seven (7) years before the first day of the calendar quarter in which the review is requested. In the event that such review shows that Company has underpaid royalties by five percent (5%) or more with respect to any calendar quarter, or if such underpayment is in excess of $5,000.00 for any calendar quarter, or an aggregate of $10,000 for any calendar year, Company shall pay, within ten days after demand by Columbia, the costs and expenses of such review (including the fees charged by Columbia’s accountant and attorney involved in the review), in addition to amount of any underpayment and any interest thereon. Company agrees to cooperate fully with Columbia’s accountant or auditor and attorney in connection with any such review. During the review, Company shall provide Columbia’s accountant or auditor and attorney with all information reasonably requested, including without limitation, information relating to sales, inventory, manufacturing, purchasing, transfer records, customer lists, invoices, purchase orders, sales orders, shipping documentation, third-party royalty reports, cost information, pricing policies, and agreements with third parties (including Sublicensees, Designees, Affiliates of Company, Sublicensees and Designees, and customers).

 

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Notwithstanding anything to the contrary in this Agreement, and without limiting any of Columbia’s rights and remedies hereunder, any payment required hereunder that is made late (including unpaid portions of amounts due) shall bear interest, compounded monthly, at the rate of 9% per annum. Any interest charged or paid in excess of the maximum rate permitted by applicable law shall be deemed the result of a mistake and interest paid in excess of the maximum rate shall be credited or refunded (at the Company’s option) to Company.

 

Company shall reimburse Columbia for any costs and expenses incurred in connection with collecting on any arrears of Company with respect to its payment and reimbursement obligations under this Agreement (such as Section 11b of this Agreement), including the costs of engaging any collection agency for such purpose.

 

5.                                      TREATMENT OF CONFIDENTIAL INFORMATION

 

5.1                                 Confidential Obligations. Licensor and Licensee each recognize that the other Party’s Confidential Information constitutes highly valuable and proprietary confidential information. Licensor and Licensee each agree that during the Term and for five (5) years thereafter, it will keep confidential, and will cause its employees, consultants, Affiliates and sublicensees to keep confidential, all Confidential Information of the other Party. Neither Licensor nor Licensee nor any of their respective employees, consultants, Affiliates or sublicensees shall use Confidential Information of the other Party for any purpose whatsoever other than exercising any rights granted to it or reserved by it hereunder. Without limiting the foregoing, each Party may disclose information to the extent such disclosure is reasonably necessary to (a) file and prosecute patent applications and/or maintain patents which are filed or prosecuted in accordance with the provisions of this Agreement, (b) file, prosecute or defend litigation in accordance with the provisions of this Agreement, or (c) comply with applicable laws, regulations or court orders; provided, however, that if a Party is required to make any such disclosure of the other Party’s Confidential Information in connection with any of the foregoing, it will give reasonable advance notice to the other Party of such disclosure requirement and will use reasonable efforts to cooperate with such other Party in efforts to secure confidential treatment of such information required to be disclosed.

 

5.2                                 Limited Disclosure and use. Licensor and Licensee each agree that any disclosure of the other Party’s Confidential Information to any officer, employee, consultant or agent of the other Party or any of its Affiliates or Sublicensees shall be made only if and to the extent necessary to carry out its rights and responsibilities under this Agreement, shall be limited to the maximum extent possible consistent with such rights and responsibilities and shall only be made to the extent any such persons are bound by written confidentiality obligations to maintain the confidentiality thereof and not to use such Confidential Information except as expressly permitted by this Agreement. Licensor and Licensee each further agree not to disclose or transfer the other Party’s Confidential Information to any Third Parties under any circumstance without the prior written approval from the other Party (such approval not to be unreasonably withheld), except as otherwise required by law, and except as otherwise expressly permitted by this Agreement. Each Party shall take such action, and shall cause its Affiliates or Sublicensees to take such action, to preserve the confidentiality of each other’s Confidential Information as it would customarily take to preserve the confidentiality of its own Confidential

 

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Information, using, in all such circumstances, not less than reasonable care. Each Party, upon the request of the other Party, will return all the Confidential Information disclosed or transferred to it by the other Party pursuant to this Agreement, including all copies and extracts of documents and all manifestations in whatever form, within sixty (60) days of such request or, if earlier, the termination or expiration of this Agreement; provided however, that a Party may retain (a) any Confidential Information of the other Party relating to any license which expressly survives such termination and (b) one (1) copy of all other Confidential Information in inactive archives solely for the purpose of establishing the contents thereof.

 

5.3                                 Publicity. Neither Party may publicly disclose the existence or terms or any other matter of fact regarding this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed; provided, however, that either Party may make such a disclosure (a) to the extent required by law or (b) with respect to Licensee, to any prospective Sublicensees or transferees or to investors, prospective investors, lenders and other potential financing sources who are obligated to keep such information confidential.

 

6.                                      PROVISIONS CONCERNING THE FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS

 

6.1                                 Patent Filing, Prosecution and Maintenance. Subject to the other terms of this Section 6.1, Licensee shall be responsible for preparing, filing, prosecuting, obtaining and maintaining at its sole cost, expense and discretion, all Licensed Patent Rights in the Territory using patent counsel chosen by Licensee. Licensee shall direct such outside counsel to keep both parties informed of its activities related to the Licensed Patent Rights, to copy both Parties on all material prosecution filings and activities and to reasonably consider and incorporate the comments of each Party with respect thereto. Notwithstanding the dispute resolution procedures set forth in Article 10.1, in the event of disagreement between the Parties over a course of action with respect to prosecution, the following procedure shall control: (i) the Parties shall first engage in good faith discussions to resolve the issue, and Licensee will reasonably consider Licensor’s comments and concerns; and (ii) if, despite such good faith efforts, the Parties are unable to reach agreement on a course of action hereunder, Licensee shall have final decision-making authority. The Parties agree that consultation between the Parties relating to the Licensed Patent Rights under this Section 6.1 shall be pursuant to a common interest in the validity, enforceability and scope of the Licensed Patent Rights. If Licensee determines that it desires to abandon prosecution of a patent application and/or patent in Licensed Patent Rights in a particular country, it will give at least sixty (60) days’ written notice to Licensor (but in any event not less than ninety (90) days’ written notice prior to any due date for response to a Patent Office action). Licensor shall thereafter have the right to assume complete control of all further patent prosecution in that country at its sole expense. Licensee shall at the request of Licensor freely execute any documents necessary to vest the maximum legally-permissible control of the applicable patent application(s) or patent(s) in Licensee (e.g., by assignment or exclusive license).

 

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6.2                                 Notice of Infringement. if either Party learns of any actual, alleged or threatened infringement by a Third Party of any Licensed Patent Rights under this Agreement, such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such infringement.

 

6.3                                 Infringement of Patent Rights. Licensee shall have the first right (but not the obligation), at its own expense and with legal counsel of its own choice, to bring suit (or take other appropriate legal action) against any actual, alleged or threatened infringement of the Licensed Patent Rights in the Licensed Field. Licensor shall have the right, at its own expense, to be represented in any such action by Licensee using counsel of Licensor’s own choice; provided, however, that under no circumstances shall the foregoing affect the right of Licensee to control the suit as described in the first sentence of this Section 6.3. Any damages, monetary awards or other amounts recovered, whether by judgment or settlement, pursuant to any suit, proceeding or other legal action taken under this Section 6.3, shall be allocated as follows: (i) first, the Parties shall be reimbursed, on a pro rata basis, for all costs incurred in connection with such proceeding paid by the Parties; and (ii) second, any remainder that represents compensation for lost sales, a reasonable royalty or lost profits with respect to a Licensed Product, shall be retained by or paid to Licensee; provided, however, that any such amounts shall be subject to the royalty obligations set forth in Section 4.2. If Licensee brings any such action or proceeding hereunder, Licensor agrees to he joined, at Licensee’s expense, as Party plaintiff if necessary to prosecute such action or proceeding, and to give Licensee reasonable assistance and authority to file and prosecute the suit.

 

7.                                      REPRESENTATIONS AND WARRANTIES; LIMITED LIABILITY

 

7.1                                 Licensor Representations. Licensor represents and warrants to Licensee that as of the Effective Date and to the knowledge of its Office of Technology Ventures:

 

(a)                             the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate Licensor corporate action;

 

(b)                            this Agreement is a legal and valid obligation binding upon Licensor and enforceable in accordance with its terms, and the execution, delivery and performance of this Agreement by the Parties does not materially conflict with any written agreement or written instrument to which Licensor is a Party or by which it is bound;

 

(c)                             as of the Effective Date (i) the named inventor Raul Rabadan on the Licensed Patent filed with any patent office has assigned or is under an obligation to assign all of his right, title and interest in and to such inventions claimed in the Licensed Patent Rights to Columbia; and (ii) no claim, action, case, suit, litigation, arbitration, inquiry or proceeding is pending or threatened by any Third Party, that seeks to challenge Columbia’s ownership of the Licensed Patent Rights or the ability of Columbia to grant the licenses hereunder. ;

 

7.2                                 Licensee Representations. Licensee represents and  warrants to Licensor that:

 

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(a)                             the execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate Licensee corporate action; and

 

(b)                            this Agreement is a legal and valid obligation binding upon Licensee and enforceable in accordance with its terms, and the execution, delivery and performance of this Agreement by the Parties does not conflict with any agreement, instrument or understanding to which Licensee is a Party of or by which it is bound.

 

7.3                                 No Warranties. LICENSOR IS LICENSING THE LICENSED PATENT RIGHTS ON AN “AS IS” BASIS. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY OTHER REPRESENTATION OR EXTENDS ANY ADDITIONAL WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO: ANY WARRANTIES OF MERCHANTABILITY, TITLE, FITNESS, ADEQUACY OR SUITABILITY FOR A PARTICULAR PURPOSE, USE OR RESULT; ANY WARRANTIES AS TO THE VALIDITY OF ANY PATENT; AND ANY WARRANTIES OF FREEDOM FROM INFRINGEMENT OF ANY DOMESTIC OR FOREIGN PATENTS, COPYRIGHTS, TRADE SECRETS OR OTHER PROPRIETARY RIGHTS OF ANY PARTY.

 

7.4                                 In no event shall Licensor have any liability to Licensee, Sublicensees, or Affiliates of the foregoing, or any Third Party arising out of the use, operation or application of the Licensed Patents Rights or anything discovered, developed, manufactured, used, sold, offered for sale, imported, exported, distributed, rented, leased or otherwise disposed of under any license granted hereunder by Licensee, Sublicensees, or Affiliates of the foregoing, or any Third Party for any reason. In no event shall Licensor’s liability to Licensee exceed the payments made to  Licensor by Licensee under this Agreement.

 

7.5                                 In no event will either Party be liable to the other or any Third Party, for any consequential, incidental, special or indirect damages (including, but not limited to, from any destruction to property or from any loss of use, revenue, profit, time or good will) based on activity arising out of or related to this Agreement, whether pursuant to a claim of breach of contract or any other claim of any type.

 

8.                                      INDEMNIFICATION

 

8.1                                 Indemnification.

 

8.1.1                        Licensee Indemnity. Licensee shall indemnify, defend and hold harmless Licensor, its Affiliates and their respective directors, officers, employees, stockholders and agents and their respective successors, heirs and assigns (the “Licensor Indemnitees”) from and against any liability, damage, loss or expense (including reasonable attorneys’ fees and expenses of litigation) incurred by or imposed upon such Licensor Indemnitees, or any of them, in connection with any Third Party claims, suits, actions, demands or judgments to the extent arising out of (a) the development, testing, production, manufacture, supply, promotion, import, sale or use by any person of any Licensed Product (or any component thereof) manufactured or sold by Licensee or any Affiliate or Sublicensee under this Agreement, (b) any material breach

 

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of this Agreement by Licensee, or (c) the negligence or willful misconduct on the part of Licensee, except to the extent caused byLicensor’s gross negligence or willful misconduct.

 

8.2                                 Indemnification Procedures. In the event that any Indemnitee is seeking indemnification under Section 8.1 above from Licensee (the “Indemnifying Party”), the Licensor shall notify the Indemnifying Party of such claim with respect to such Indemnitee as soon as reasonably practicable after the Indemnitee receives notice of the claim, and Licensee (on behalf of itself and such Indemnitee) shall permit the Indemnifying Party to assume direction and control of the defense of the claim (including the right to settle the claim solely for monetary consideration) and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim. The indemnification obligations under Article 8 shall not apply to any harm suffered as a direct result of any delay in notice to the Indemnifying Party hereunder or to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnifying Party, which consent shall not be withheld or delayed unreasonably. The Indemnitee, its employees and agents, shall reasonably cooperate with the Indemnifying Party and its legal representatives in the investigation of any claim, demand, action or other proceeding covered by Section 8.1.

 

9.                                      TERM AND TERMINATION

 

9.1                                 Term; Expiration. The term of this Agreement (“Term”) shall expire upon the expiration of the last patent to expire in Licensed Patent Rights. Upon the expiration of the Term of this Agreement, Licensee shall have a fully paid-up, irrevocable, freely transferable and sublicensable license in the Territory under the Licensed Patent Rights to develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, import and have imported any and all Licensed Products.

 

9.2                                 Termination Rights for Breach and Voluntary Termination.

 

9.2.1                        Termination for Breach. Subject to the other terms of this Agreement, this Agreement and the rights and options granted herein may be terminated by either Party upon any material breach by the other Party of any material obligation or condition, effective ninety (90) days after giving written notice to the breaching Party of such termination in the case of any other breach, which notice shall describe such breach in reasonable detail. The foregoing notwithstanding, if such material breach is cured or remedied or shown to be non-existent or not to be material within the aforesaid ninety (90) day period, the notice shall be automatically withdrawn and of no effect.

 

9.2.2                        Voluntary Termination. Licensee shall have the right to terminate this Agreement at any time for commercially reasonable reason (such as a reasonable belief by Licensee that it is not commercially or scientifically appropriate to further develop the Licensed Patent Rights and Licensed Technology) upon prior written notice to Licensor.

 

9.3                                 Termination for Bankruptcy. In the event that either Party files for protection under bankruptcy laws, makes an assignment for the benefit of creditors, appoints or suffers appointment of a receiver or trustee over its property, files a petition under any

 

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bankruptcy or insolvency act or has any such petition filed against it which is not discharged within sixty (60) days of the filing thereof, then the other Party may terminate this Agreement effective immediately upon written notice to such Party.

 

9.4                                 Effects of Termination.

 

9.4.1                        Termination for Licensee Breach. Upon any termination of this Agreement by Licensor under Section 9.2.1 by Licensee or pursuant to Section 9.2.2, as of the effective date of such termination all relevant licenses and sublicenses granted by Licensor to Licensee hereunder shall terminate automatically. Notwithstanding the foregoing, (a) no such termination of this Agreement shall be construed as a termination of any valid sublicense of any Sublicensee hereunder, and thereafter each such Sublicensee shall be considered a direct licensee of Licensor, provided that (i) such Sublicensee is then in full compliance with all terms and conditions of its sublicense and agrees to perform all obligations of the sublicense agreement for the benefit of Columbia, (ii) all accrued payments obligations to Licensor have been paid, (iii) Columbia’s obligations under such sublicense is consistent with and does not exceed Columbia’s obligations to Company under this Agreement, and (iv)such Sublicensee agrees in writing to assume all applicable obligations of Licensee under this Agreement, and (b) Licensee and its Affiliates and Sublicensees shall have the right, for twelve (12) months or such longer time period on which the Parties mutually agree in writing, to sell or otherwise dispose of all Licensed Products then on hand, with royalties to be paid to Licensor on all Net Sales of such Licensed Products as provided for in this Agreement.

 

9.4.2                        Termination for Licensor Breach. Upon any termination of this Agreement by Licensee under Section 9.2.1 or 9.3, as of the effective date of such termination, Licensee thereafter automatically shall have a fully sublicensable and transferable, fully paid up, exclusive license in the Territory under the Licensed Patent Rights, to develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, import and have imported any and all Licensed Products in the Territory.

 

9.5                                 Remedies. Except as otherwise expressly set forth in this Agreement, the termination provisions of this Article 9 are in addition to any other relief and remedies available to either Party at law.

 

9.6                                 Surviving Provisions. Notwithstanding any provision herein to the contrary, the rights and obligations of the Parties set forth in Sections 2.2, 4.5, 5, 6, 7, 8, 9.4, 10, and 11 (to the extent relevant) as well as any rights or obligations otherwise accrued hereunder prior to termination or expiration (including any accrued payment obligations), shall survive the expiration or termination of the Term. Without limiting the generality of the foregoing, Licensee shall have no obligation to make any payment to Licensor that has not accrued prior to the effective date of any termination or expiration of this Agreement, but shall remain liable for all such payment obligations accruing prior to the effective date of such termination or expiration.

 

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10.                               DISPUTES

 

10.1                           Dispute Resolution. In the event of any controversy or claim arising out of or relating to any provision of this Agreement or the breach thereof, the parties shall try to settle such conflict amicably between themselves.

 

10.2                           Except as otherwise expressly provided herein, the Parties agree that any dispute not resolved internally by the Parties pursuant to this Section 10.1, shall be resolved through binding arbitration in accordance with the then prevailing Commercial Arbitration Rules of the American Arbitration Association, except as modified in this Agreement, applying the substantive law specified in Section 11.3. A Party may initiate an arbitration by written notice to the other Party of its intention to arbitrate, and such demand notice shall specify in reasonable detail the nature of the dispute. Each Party shall select one (1) arbitrator, and the two (2) arbitrators so selected shall choose a third arbitrator (and all such arbitrators shall be experienced in the development and commercialization of biotechnology/pharmaceutical products) to resolve the dispute, and all three (3) shall serve as neutrals. If a Party fails to nominate its arbitrator, or if the Parties’ arbitrators cannot agree on the third arbitrator, the necessary appointments shall be made in accordance with the then prevailing Commercial Arbitration Rules. Each Party agrees to use reasonable efforts to make all of its current employees available, if reasonably needed, and agrees that the arbitrators may deem any party as “necessary.” The arbitrators shall be instructed and required to render a written, binding, non appealable resolution and award on each issue that clearly states the basis upon which such resolution and award is made. Each Party agrees that, notwithstanding any provision of applicable law or of this Agreement, it will not request, and the arbitrators shall have no authority to award, punitive or exemplary damages against any Party. The written resolution and award shall be delivered to the Parties as expeditiously as possible, but in no event more than ninety (90) days after conclusion of the hearing, unless otherwise agreed by the Parties. Judgment upon such award may be entered in any competent court or application may be made to any competent court for judicial acceptance of such an award and order for enforcement. The award of the arbitration tribunal shall be final. In the event Licensee requests arbitration, the arbitration proceedings shall be conducted in New York, NY; in the event Licensor requests arbitration, the arbitration proceedings shall be conducted in San Diego, California. The Parties agree that they shall share equally the cost of the arbitration filing and hearing fees, and the cost of the arbitrator. Each Party shall bear its own attorneys’ fees and associated costs and expenses.Notwithstanding the foregoing, either Party may, without recourse to arbitration, assert against the other Party a third Party claim or cross-claim in any action brought by a third Party, to which the subject matter of this Agreement may be relevant.

 

10.3                           Subject Matter Exclusion. Notwithstanding the provisions of Section 10.2, any dispute not resolved internally by the Parties pursuant to Section 10.1 that involves the validity, enforceability or infringement of a Licensed Patent Right (a) that is issued in the United States shall be subject to actions before the United States Patent and Trademark Office and/or submitted exclusively to the federal court located in the jurisdiction of the district where any of the defendants resides; and (b) that is issued in any other country shall be brought before an appropriate regulatory or administrative body or court in that country, and the Parties hereby consent to the jurisdiction and venue of such courts and bodies.

 

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11.                               MISCELLANEOUS

 

11.1                           Notification. All notices, requests and other communications hereunder shall be in writing, shall be addressed to the receiving Party’s address set forth below or to such other address as a Party may designate by notice hereunder, and shall be either (i) delivered by hand, (ii) made by facsimile transmission (to be followed with written confirmation sent by nationally-recognized overnight courier service, providing evidence of receipt), (iii) sent by nationally-recognized overnight courier service providing evidence of receipt, or (iv) sent by registered or certified mail, return receipt requested, postage prepaid. The addresses and other contact information for the parties are as follows:

 

	
If   to Licensor:
    	
Columbia University

Executive Director

Columbia Technology Ventures

Columbia University

80 Claremont Avenue, #4F, Mail Code

9606New York, NY 10027-5712

Telephone: (212) 854-8444

Facsimile: (212) 854-8643
    
	
 
    	
 
    
	
If   to Licensee:
    	
Trovagene, Inc.

11055 Flintkote Ave., Suite B,

San Diego, CA 92121

Tel: 858 217 4838

Fax: 858 217 4768

Attention: President
    

 

All notices, requests and other communications hereunder shall be deemed to have been given either (i) if by hand, at the time of the delivery thereof to the receiving Party at the address of such Party set forth above, (ii) if made by telecopy or facsimile transmission, at the time that receipt thereof has been acknowledged by the recipient, (iii) if sent by nationally-recognized overnight courier, on the day such notice is delivered to the recipient, or (iv) if sent by registered or certified mail, on the fifth (5th) business day following the day such mailing is made.

 

11.2                           Language. This Agreement has been prepared in the English language and the English language shall control its interpretation.

 

11.3                           Governing Law and Venue. This Agreement will be construed and interpreted in accordance with the laws of the State of New York and the venue of any action brought shall be in New York, New York.

 

11.4                           Limitations. Except as expressly set forth in this Agreement, neither Party grants to the other Party any right or license to any of its intellectual property.

 

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11.5                           Entire Agreement. This is the entire Agreement between the Parties with respect to the subject matter hereof and supersedes all prior representations, understandings and agreements between the Parties with respect to the subject matter hereof. No modification shall be effective unless in writing with specific reference to this Agreement and signed by the Parties.

 

11.6                           Waiver. The terms or conditions of this Agreement may be waived only by a written instrument executed by the Party waiving compliance. The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at a later time to enforce the same. No waiver by either Party of any condition or term shall be deemed as a continuing waiver of such condition or term or of another condition or term.

 

11.7                           Headings. Section and subsection headings are inserted for convenience of reference only and do not form part of this Agreement.

 

11.8                           Assignment. Neither this Agreement nor any right or obligation hereunder may be assigned, delegated or otherwise transferred, in whole or part, by Licensor without the prior express written consent of Licensee. Any permitted assignee shall assume in writing all obligations of assignor under this Agreement. Any purported assignment in violation of this Section 11.8 shall be void. Licensee may freely assign, the rights granted under this Agreement by sending notice of such assignment with a copy of the permitted assignees written agreement to assume and be bound by this Agreement to the Licensor. The terms and conditions of this Agreement shall be binding upon and inure to the benefit of the permitted successors and assigns of the parties.

 

11.9                           Force Majeure. Neither Party shall be liable for failure of or delay in performing obligations set forth in this Agreement, and neither shall be deemed in breach of its obligations, if such failure or delay is due to natural disasters or any causes beyond the reasonable control of such Party. In event of such force majeure, the Party affected thereby shall use reasonable efforts to cure or overcome the same and resume performance of its obligations hereunder.

 

11.10                     Construction. The Parties hereto acknowledge and agree that: (i) each Party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (ii) the rule of construction to the effect that any ambiguities are resolved against the drafting Party shall not be employed in the interpretation of this Agreement; and (iii) the terms and provisions of this Agreement shall be construed fairly as to all Parties hereto and not in favor of or against any Party, regardless of which Party was generally responsible for the preparation of this Agreement.

 

11.11                     Severability. If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable law from time to time in effect during the Term hereof, it is the intention of the Parties that the remainder of this Agreement shall not be affected thereby provided that a Party’s rights under this Agreement are not thereby materially diminished, The Parties hereto covenant and agree to renegotiate any such term, covenant or application thereof in good faith

 

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in order to provide a reasonably acceptable alternative to the term, covenant or condition of this Agreement or the application thereof that is invalid, illegal or unenforceable, it being the intent of the Parties that the basic purposes of this Agreement are to be effectuated.

 

11.12                     Status. Nothing in this Agreement is intended or shall be deemed to constitute a partner, agency, employer-employee, or joint venture relationship between the Parties.

 

11.13                     Section 365(n). All licenses granted under this Agreement are deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined in Section 101 of such Code. The Parties agree that Licensee may fully exercise all of its rights and elections under the U.S. Bankruptcy Code, regardless of whether either Party files for bankruptcy in the United States or other jurisdiction. The Parties further agree that, in the event Licensee elects to retain its rights as a licensee under such Code, Licensee shall be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology. Such embodiments of the technology shall be delivered to the Licensee not later than:

 

(a)                                  the commencement of bankruptcy proceedings against the licensor, upon written request, unless the licensor elects to perform its obligations under the Agreement, or

 

(b)                                 if not delivered under Section 11.13(a) above, upon the rejection of this Agreement by or on behalf of Licensee, upon written request.

 

11.14                     Further Assurances. Each Party agrees to execute, acknowledge and deliver such further instructions, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

11.15                     Counterparts. This Agreement may be executed simultaneously in one or more counterparts, and by facsimile or electronic transmission, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

[Remainder of page intentionally left blank]

 

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1N WITNESS WHEREOF, the Parties have caused this Exclusive License Agreement to be executed by their duly authorized representative.

 

 

	
LICENSOR:
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Orin Herskowitz
    	
 
    	
 
    
	
 
    	
Name:
    	
Orin Herskowitz
    	
 
    	
 
    
	
 
    	
Title:
    	
Executive Director
   VP of intellectual Property
   And Technology Transfer
   Columbia Technology Ventures
    	
 
    	
 
    
	
 
    	
TTs #: 40692
    	
 
    	
 
    

 

	
licensee:
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
TROVAGENE, INC.
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Gabriel Cerrone
    	
 
    	
 
    
	
Name:
    	
Gabriel Cerrone
    	
 
    	
 
    
	
Title:
    	
Director
    	
 
    	
 
    

 

17

 

Schedule A

 

Licensed Patent Rights

 

USSN 61/484330, filed May 10, 2011, entitled Hairy Cell Leukemia Biomarkers and Methods of Using Same.

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