Document:

f8k0212ex10xxiiia_organovo.htm

 

Exhibit 10.22

 

SCIENTIFIC ADVISORY BOARD CONSULTING AGREEMENT

 

This consulting agreement (the "Agreement") is made and entered into as of the 30th day of June,  2008 (the "Effective Date") by and between ORGANOVO, INC., a company formed under the laws of Delaware (the "Company"), located at 11996 Darlington Ave., Los Angeles, CA, and K. Craig Kent, M.D. (the "Advisor"), an individual residing at 1320  York Avenue #33B, New

York, NY 10021. New address as of Sept. 1, 2008, 2025 Chadbourne A Madison, Wisconsin 53726

 

       RECITAL

 

The  Company  desires  to  engage  individuals  with  scientific  expertise  to  serve  on  it scientific advisory board to advise the Company regarding any of its products under development. Advisor has the requisite expertise and is willing to serve as a member of the Company's Scientific Advisory Board.

 

AGREEMENT

 

In consideration of the foregoing and the mutual promises and covenants contained in this Agreement, the Company and Advisor agree to the following:

 

1.             Engagement of Services; Compensation.

 

1.1       The Company hereby appoints Advisor as a member of its Scientific Advisory Board ("SAB").    Advisor's consultation  with the Company  will involve the field  of vascular engineering and vascular medicine (the "Field"), and requires the application of unique, special and  extraordinary  skills  and  knowledge  that  Advisor  possesses  in  the  Field.    The SAB is expected to meet at least four times per year, with at least one of those meetings to be attended in person by the Advisor.

 

1.2       Advisor  agrees  to  serve  as  a  member  of  the Company’s SAB,  meeting  with Company  employees,  consultants  and other  SAB  members,  reviewing and analyzing  product­ specific data in the Field, assisting the Company in evaluating certain  product opportunities, and providing  scientific  and  technical  advice  in the  Field, at times and  places  designated  by the Company, including a reasonable amount of informal consultation over the telephone, all as may be  requested  by  the  Company  from  time  to  time  during  the  term  of  this  Agreement  (the "Services").   Advisor will perform the foregoing Services for the Company in accordance with good scientific practices.

 

1.3      The   Company   will   compensate   Advisor   for the provision of Services in accordance with the compensation and expense reimbursement schedule set forth in Exhibit A.

 

  

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2.             Recognition of Institution Affiliation.

 

The Company acknowledges that Advisor is an employee of Weill Medical College of Cornell University (the "Institution"), located at 1300 York Avenue, Box 144, New York, NY 10021, and is further affiliated with Columbia College of Physicians and Surgeons and New York Presbyterian   Hospital, and is subject to the Institution's policies including policies concerning consulting, conflicts of interest and intellectual property.    The Company acknowledges that, to the extent that such policies conflict with the terms of this Agreement, Advisor's obligations under the Institution's policies take priority over the obligations Advisor has by reason of this Agreement; provided, however, that Advisor will advise the Company if Advisor is required by the Institution, pursuant to applicable guidelines or policies, to make any disclosure or take any action that conflicts with the Services to be provided by Advisor hereunder or that is otherwise contrary to the terms of this Agreement.

 

The Company further acknowledges that Advisor is expected to become an employee of University of Wisconsin, located at 600 Highland Avenue, Madison, Wisconsin 53792, and will be subject to that institution's policies including policies concerning consulting, conflicts of interest and intellectual property.   The Company acknowledges that, to the extent that such policies conflict with the terms of this Agreement, Advisor's obligations under that institution's policies take priority over the obligations Advisor has by reason of this Agreement; provided, however,  that  Advisor will advise the  Company if  Advisor is  required by that  institution, pursuant to applicable guidelines or policies, to make any disclosure or take any action that conflicts with the Services to be provided by Advisor hereunder or that is otherwise contrary to the terms of this Agreement.

 

3.             Proprietary Information.

 

3.1       Advisor may disclose to the Company any information that Advisor would normally freely disclose to other members of the scientific community at large, whether by publication, by presentation at seminars, or in informal scientific discussions.  Notwithstanding the foregoing, Advisor will not disclose to the Company information that is proprietary to the Institution or in violation of existing relationships and is not generally available to the public.

 

3.2       During the term of this Agreement, Advisor may receive, otherwise be exposed to or generate information relating to patents, trade secrets, technology and the business of the Company or third parties (collectively, "Proprietary Information").  By way of illustration, but not limitation, Proprietary Information includes inventions, developments, designs, applications, improvements, modifications, trade secrets, formulae, ideas, know-how, methods or processes, discoveries, techniques, analyses and data (hereinafter collectively referred to as "Inventions"), information regarding plans for research, development, new products, marketing and selling business plans, budgets and unpublished financial statements, licenses, prices and costs, suppliers and customers, and information regarding the skills and compensation of employees of the Company or third parties.

 

3.3       Notwithstanding Section 2.2, Proprietary Information will not include information generated by Advisor, alone or with others, unless the information is generated in the performance of Services or with the use of information received by Advisor in connection with this Agreement. Further, Proprietary Information will not include information that was (i) in the public domain at the time acquired by Advisor, (ii) acquired by Advisor from others who, at  the time such information was acquired by Advisor, were not subject to a confidentiality agreement with the Company, or who otherwise had a legal right to disclose the information to Advisor, (iii) already in the possession of Advisor prior to the date of its disclosure by the Company, or (iv) becomes public domain at any time through no action of the Advisor.

 

  

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3.4       Advisor agrees that (a) all Proprietary Information received or to which Advisor is exposed pursuant to this Agreement or in connection with the Services is the sole property of the Company or the applicable third party, (b) all Proprietary Information generated by Advisor in the performance of Services or with the use of information received by Advisor in connection with this Agreement, whether or not patentable or registrable under copyright law, will be the sole property of the Company, and (c) the Company or the applicable third party will be the sole owner of intellectual property and other rights relating to such Proprietary Information.

 

4.             Recognition of Company's Rights; Nondisclosure.

 

4.1       During the term of this Agreement and after its termination, Advisor will keep in strictest confidence and trust all Proprietary Information. Advisor will not use or disclose to any third party Proprietary Information or anything related to such information without the prior written consent of the Company, unless such actions are required in the ordinary course of performing Services for the Company pursuant to this Agreement.   Advisor agrees not to reproduce Proprietary Information in any format, except as necessary for Advisor's performance of Services.

 

4.2      Advisor agrees not to disclose, without the prior written consent of the Company, the terms and conditions under which Advisor will provide Services under this Agreement.

 

5.             Assignment and Enforcement of Proprietary Rights.

 

5.1      Advisor agrees to disclose and assign to the Company, and hereby assigns to the Company, Advisor's entire right, title and interest in and to any and all Inventions in the Field generated as a result of, or based upon information received during, the performance of Advisor's obligations under this Agreement (the "Field Inventions"). Advisor understands and agrees that all Field Inventions are the sole property of the Company.

 

5.2      Advisor will assist the Company in obtaining and enforcing patents and other intellectual property rights claiming or relating to Field Inventions.  Advisor further agrees to execute, verify and deliver such documents and perform such other acts for the Company which are necessary to apply, obtain, sustain, and enforce such patents and other intellectual property rights and protections on Field Inventions.   Advisor's obligation to assist the Company as described in this Section 4.2 will continue beyond the termination of this Agreement.

 

5.3       If the Company is unable, after reasonable effort, to secure Advisor's signature on any document needed to apply for, prosecute or defend any patent or other intellectual property right or protection relating to a Field Invention, Advisor hereby designates and appoints the Company and its duly authorized officers and agents as Advisor's agent and attorney in fact to execute, verify and file applications, and to do all other lawfully permitted acts necessary to protect the Company's intellectual property rights in Field Inventions with the same legal force and effect as if executed by Advisor.

 

6.             Services to Third Parties.

 

The Company understands that the Advisor may be a consultant to other companies.  The Company understands that the Advisor will conduct collaborations with academic institutions in the field.    The Advisor may continue the affiliations in these areas within the confines of confidentiality regarding intellectual property of all concerned.  However, the Advisor will not provide consulting or other services to any parties with respect to the products or compounds listed in Exhibit B, except as provided herewith consulting  or  other  services  with  respect  to  (a)  academic  collaborations  conducting research only, and (b) commercialization  of products  or compounds  that arise from  currently existing research projects at Weill Cornell on resorbable grafts are specifically permitted.

 

  

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7.             No Conflicting Obligation.

 

7.1       Advisor  represents  that  Advisor's  performance   of  all  of  the  terms  of  this Agreement  and the performance  of Services  for the Company do not and will not  breach or conflict with any agreement with any third party, including an agreement to keep in confidence any proprietary information of another entity acquired by Advisor in confidence or in trust prior to the date of this Agreement.

 

7.2      Advisor hereby agrees not to enter into any agreement that conflicts with this Agreement.  Absent a conflict of interest and except as set forth in Section 6, Advisor is free to provide services to any other entity during the term of this Agreement.

 

8.             No Improper Use of Materials.

 

Advisor agrees not to bring to the Company or to use in the performance of Services any materials or documents of a present or former employer of Advisor, or of Advisor's employees, or any materials or documents obtained by Advisor under a binder of confidentiality imposed by reason of another of Advisor's contracting relationships, unless such materials or documents are generally available to the public or Advisor has authorization from such present or former employer or client for the possession  and unrestricted use of  such materials.   Advisor understands that Advisor is not to breach any obligation of confidentiality that Advisor has to present or former employers and agrees to fulfill all such obligations during the term of this Agreement.

 

9.             Independent Contractor.

 

The Company and Advisor agree that Advisor is an independent contractor and not an agent or employee of the Company. Advisor has no authority to act on behalf of the Company or obligate the Company by contract or otherwise.  Advisor understands that Advisor will not be eligible for any employee benefits.  The Company will not make deductions from Advisor's fees for taxes; therefore, the payment of any taxes related to Advisor's provision of Services under this Agreement will be the sole responsibility of Advisor.

 

10.           Term and Termination; Effect of Termination.

 

10.1     The term of this Agreement will commence on the Effective Date and will continue for four (4) years or until terminated as provided herein. Either party may terminate this Agreement at will upon thirty (30) days' written notice to the other.

 

10.2     Upon the expiration or termination of this Agreement, each party will be released from all obligations and liabilities to the other occurring or arising after the date of such termination, except that the provisions under Sections 3, 4, 5, 8, 10 and 11 will survive the expiration or termination of this Agreement, and any such expiration or termination will not relieve Advisor or the Company from any liability arising from any breach of this Agreement.

 

  

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10.3      Upon any expiration or termination of thi.s Agreement, Advisor will promptly deliver to the Company all documents and other materials containing or pertaining to any Proprietary Information pertaining to the Company or the Services in Advisor's possession. Advisor will not retain copies of any such documents or other materials after termination of this Agreement.

 

11.           Miscellaneous.

 

11.1     Assignment.  The rights and liabilities of the parties hereto will bind and inure to the benefit of their respective successors, assigns, heirs, executors and administrators, as the case may be; provided, however, that Advisor may not assign or delegate Advisor's obligations under this Agreement either in whole or in part without the prior written consent of the Company. Any purported or attempted assignment in violation of this Section 11.1 will be null and void.

11.2     Legal and Equitable Remedies.   Because Advisor's services are personal and unique and because Advisor may have access to and become acquainted with the Proprietary Information of the Company, the Company will have the right to enforce this Agreement and any of its provisions by injunction, specific performance or other equitable relief without prejudice to any other rights and remedies that the Company may have for a breach of this Agreement.

 

11.3      Governing Law.  This Agreement will be governed by the laws of the State of Delaware without regard to the conflicts of laws provisions that would require the application of the laws of a different jurisdiction.

 

11.4    Severability. If any provision of this Agreement is found by a court of competent jurisdiction to be unenforceable, then such provision will be construed, to the extent feasible, so as  to  render  the  provision  enforceable, and  if  no  feasible  interpretation  would  save  such provision, it will be severed from the remainder of this Agreement.  The remainder of this Agreement will remain in full force and effect, unless the severed provision is essential and material to  the rights or  benefits received by either  party.   In such event, the parties will negotiate, in good faith, and substitute a valid and enforceable provision or agreement that most nearly implements the parties' intent in entering into this Agreement.

 

11.5     Complete Understanding; Modification.     This Agreement, together with Exhibits A and B which are attached hereto and incorporated herein, constitutes the final, exclusive and complete understanding and agreement of the parties hereto and supersedes all prior understandings and agreements. This Agreement is entered into without reliance upon any representation, whether oral or written, not stated herein.   Any waiver, modification or amendment of any provision of this Agreement will be effective only if in writing and signed by Advisor and a Company officer.

 

11.6     Use of Name. The Company may use Advisor's name, and in doing so may cite Advisor's relationship with the Institution, so long as any such usage (i) is limited to reporting factual events or occurrences only, and (ii) is made in a manner that could not reasonably constitute an endorsement of the Company or of any Company program, product, or service. Notwithstanding the foregoing, the Company will not use Advisor's or the Institution's name in any press release, or quote Advisor in any company materials, or otherwise use Advisor's name or the Institution's name in a manner not specifically permitted by the preceding sentence, unless in each case the Company obtains in advance the written consent of Advisor or the Institution, as the case may be.

 

  

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11.7     Status   of the Institution.   Advisor and the Company acknowledge that (a) Advisor is entering into this Agreement in his/her individual capacity and not as an employee or agent of the Institution, and (b) the Institution is not a party to this Agreement and has no liability or obligation hereunder.

 

11.8     Counterparts. This Agreement may be executed in two (2) or more counterparts each of which will be deemed an original, but all of which together will constitute one (1) and the same instrument.

 

11.9     Waiver.   No provision of this Agreement can be waived except by the express written consent of the party waiving compliance. Except as specifically provided for herein, the waiver from time to time by either party of any of its rights or its failure to exercise any remedy will not operate or be construed as a continuing waiver of same or of any other of such party's rights or remedies provided in this Agreement.

 

11.10   Notices.   Any notices required or permitted hereunder will be given to the appropriate party at the address specified below or at such other address as the party will specify in writing.  Such notice will be deemed given upon personal delivery to the appropriate address or sent by certified or registered mail, three days after the date of mailing.

 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the Effective Date.

 

	ORGANOVO,INC. 	 	ADVISOR
	 	 	 	 	 
	By:	
/s/Keith Murphy

	 	By:	
/s/K.Craig Kent

	Title:	
Chief Executive Officer

	 	Print Name	
K.Craig Kent

	 	
 

	 	Address:	
1320 York Ave. 33B

	 	 	 	 	New York, NY 10021

  

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EXHIBIT A

 

COMPENSATION

 

 

Restricted Stock:

 

Subject to the approval of the Company's Board of Directors, Advisor will be granted 325 shares of the Company's common stock pursuant to Company's 2008 Equity Incentive Plan (the "Stock").  The Stock will vest 25% on the first anniversary of the Effective Date and in equal quarterly installments over the following three years; provided in each case that this Agreement has not been terminated as of such vesting date.  The Stock will be issued pursuant to and its vesting will be governed by a Restricted Stock Agreement in a form provided by the Company.

 

Direct Compensation:

 

The Advisor will be additionally compensated at the rate of $7,000 per year for a maximum of four years.  The amount will be payable semi-annually in installments of$3,500 twice per year, beginning six (6) months subsequent to the Effective Date of this agreement.  The later installment due dates will occur on the date twelve (12) months following the Effective Date and every six (6) months thereafter.  In no case will more than eight (8) installments or $28,000 total be construed to be due under this agreement.

 

Upon termination of this agreement by either party prior to four years subsequent to the Effective Date of this agreement, a partial portion of one installment will be calculated to be due based upon proration from the date of the previous installment due date to the date of termination of the agreement.  This prorated installment will be due six (6) months subsequent to the previous installment due date.  No subsequent installments will be due, and the partial installment will be considered sufficient consideration to terminate the agreement.

Expense Reimbursement:

 

The Company will reimburse Advisor any travel and other reasonable out-of-pocket expenses incurred in performing the Services under the terms of the Agreement pursuant to the Company's standard policies. Such reimbursement will be delivered within 180 days of a reasonable accounting of expenses being provided to the Company by the Advisor.

 

  

 

  

 

EXHIBIT B

 

PRODUCTS

 

Tissue engineered blood vessels for transplant or graft use in conditions of Coronary Artery Disease, Peripheral Artery Disease, hemodialysis patients (arteriovenous shunt for dialysis access), or other conditions.f8k0212ex10xxiiib_organovo.htm

Exhibit 10.23

 

LICENSE AGREEMENT

 

THIS AGREEMENT is made and entered into this 24th day of March, 2009 ("EFFECTIVE DATE"), by and between THE CURATORS  OF THE UNIVERSITY  OF MISSOURI, a public corporation of the State of Missouri having a principal office at The Office of Technology Management & Industry Relations, 340 Bond Life Sciences Center, Columbia, MO  65211, ("UNIVERSITY") and Organovo having offices at 11180 Roselle St., Suite H, San Diego, CA  92121 ("LICENSEE").

 

WHEREAS, UNIVERSITY has a part ownership interest in PATENT RIGHTS related to LICENSED SUBJECT MATTER; and

 

WHEREAS, UNIVERSITY has obtained certain rights that allows UNIVERSITY to offer an exclusive license for PATENT RIGHTS pursuant to an Inter-Institutional Agreement with the MUSC Foundation for Research Development, a non-profit organization that manages and owns the intellectual property of the Medical University of South Carolina ("MUSC"); and

 

WHEREAS, the LICENSED SUBJECT MATTER was developed in part under a research program sponsored by the National Aeronautics and Space Administration and the National Science Foundation. Therefore, this Agreement is subject to the terms and conditions of Public Law 96-517 and 98-620 as amended; and

 

WHEREAS, LICENSEE is desirous of obtaining a license to practice the LICENSED SUBJECT MATTER; and

 

WHEREAS, UNIVERSITY is desirous of granting such a license to LICENSEE in accordance with the terms of this Agreement.

 

NOW, THEREFORE, in consideration of the foregoing premises and the covenants, representations and warranties contained herein, the Parties agree as follows:

 

ARTICLE I

 

DEFINITIONS

 

	
1.01

	
"AFFILIATE" means any business entity more than fifty percent (50%) owned by LICENSEE, any business entity which owns more than fifty percent (50%) of LICENSEE, or any business entity that is more than fifty percent (50%) owned by a business entity that owns more than fifty percent (50%) of LICENSEE.

 

04UMC007 UM- Organovo License final

  

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1.02

	
"KNOW-HOW" means research and development information, unpatented inventions, methods and techniques, formulae, biological materials and substances, processes and technical data, whether or not patentable or copyrightable, which are needed to produce LICENSED PRODUCT  and are not otherwise in the public domain.

 

	
1.03

	
"LICENSED FIELD" means each of the following business areas: 

 

(a)   all fields of use.

 

	
1.03 

	
"LICENSED PRODUCT" means any product or part thereof where such product or part, and any result of a method, or the practice of a method, comprising LICENSED SUBJECT  MATTER pursuant to this Agreement, is Sold by LICENSEE or a SUBLICENSEE.

 

	
1.04 

	
"LICENSED SUBJECT MATTER" means inventions and discoveries covered by TECHNOLOGY  and PATENT RIGHTS, if any, within LICENSED FIELD.

 

	
1.05 

	
"LICENSED TERRITORY" means worldwide.

 

	
1.06

	
"NET SALES" means the amount billed or invoiced for the Sale of LICENSED PRODUCTS, less:

 

(a)  Customary trade, quantity or cash discounts;

 

(b)  Amounts repaid or credited by reason of rejection or return; and/or

 

(c)  Charges for transportation  or delivery to be paid by or on behalf of LICENSEE's customer, to the extent such charges are separately stated on purchase orders, invoices or other documents of Sale.

 

1.07      "PATENT  RIGHTS"  means UNIVERSITY's  rights in any of the following:   the United  States patent  application  (serial  number  10/590,446,  titled  "Self-Assembling  Cell  Aggregates  and  Methods  of Making Engineered  Tissue  Using the Same"  and serial number 61/132,977,  titled  "Intermediate Cellular Unit,  Fabrication,   and  Use  Thereof')  disclosing   and  claiming  the  TECHNOLOGY;  and  continuing applications thereof including divisions, substitutions, continuations, continuations-in-part derived from Organovo   sponsored   research;    and   any   patents   issuing   on   said   applications    including   reissues, reexaminations and extensions;  and any corresponding foreign applications or patents. All of the foregoing will  be  automatically  incorporated  in and  added  to  this  Agreement  and  shall  periodically  be  added  to Appendix A attached to this Agreement and made part thereof.

 

1.08      "Sale", Sell", or "Sold" means the use, transfer, distribution or disposition of a LICENSED PRODUCT for value to a party other than LICENSEE, or SUBLICENSEE  as the case may be.

 

1.09      "SUBLICENSEE" means any person or entity to whom LICENSEE transfers any right or interest granted to LICENSEE by UNIVERSITY  under this Agreement.

 

04UMC007 UM- Organovo License final

  

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1.10 

	
"TECHNOLOGY" means

 

	
1.

	
the information, discoveries or know how developed by Gabor Forgacs, Karoly Jakab, and Adrean Neagu at UNIVERSITY  and Vladimir Mironov at MUSC prior to the date of this Agreement as disclosed in UM Disclosure No. 04UMC007 entitled "Bioink  for Organ Printing" dated August 6, 2003; and

 

	
2.

	
the information, discoveries or know how developed by Gabor Forgacs, Francoise Marga, and Cyrille Norotte at UNIVERSITY  prior to the date of this Agreement as disclosed in UM Disclosure No. 08UMC050 entitled "Engineering Custom-Shaped Biological Constructs" dated February 19, 2008.

 

ARTICLE II

 

 GRANT

 

2.01      UNIVERSITY hereby grants to LICENSEE and LICENSEE accepts, subject to the terms and conditions hereof, a royalty-bearing, exclusive license under LICENSED SUBJECT  MATTER to make, have made, use, Sell, have Sold, import, distribute, or otherwise transfer LICENSED PRODUCT within the LICENSED TERRITORY  for use within LICENSED FIELD for a term of the last to expire patent covered under PATENT RIGHTS.  UNIVERSITY also grants to LICENSEE, a royalty free, non-exclusive license to KNOW-HOW with the right to grant sublicenses in concurrence with a sublicense to a SUBLICENESEE in accordance with 2.02 below.

 

2.02      The license granted in Section 2.01 above shall include the right to grant sublicenses, and the right of SUBLICENSEE  to grant further sublicenses subject to approval of LICENSEE.,   LICENSEE must deliver to UNIVERISTY a true and correct copy of each fully executed sublicense granted by LICENSEE or SUBLICENSEE,  and any modification or termination thereof, within thirty (30) days after execution, modification, or termination. LICENSEE shall, at such times as UNIVERSITY  directs and at UNIVERSITY's expense, request the inspection of the sublicensee's records by an independent certified public accountant.

 

2.03      UNIVERSITY shall have the right to make and to use the LICENSED SUBJECT MATTER for research and educational purposes only, and to grant nonexclusive licenses to non-profit third parties to make and to use the LICENSED SUBJECT MATTER, for research and educational  purposes only.

 

2.04      LICENSEE agrees that UNIVERSITY shall have a right to publish the research results related to the LICENSED SUBJECT  MATTER in accordance with UNIVERSITY's general policies and that this Agreement shall not restrict, in any fashion, UNIVERSITY's right to publish.

 

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2.05      LICENSEE understands that the LICENSED SUBJECT MATTER was developed under a funding agreement with the Government of the United States of America and that the Government may have certain rights relative thereto. This Agreement shall be exclusive, to the extent allowed in accordance  with Public Laws 96-517 and 98-620, in the LICENSED FIELD and is explicitly made subject to the Government's rights under such Government funding agreement and any applicable law or regulation. If there is a conflict between the Government funding agreement, applicable law or regulation and this Agreement, the terms of the Government funding agreement, applicable law or regulation shall prevail. LICENSEE agrees to take any actions necessary to enable UNIVERSITY to satisfy its obligations with the United States Government relating to the LICENSED SUBJECT MATTER. LICENSEE agrees, during the period of exclusivity of this license in the United States, that any LICENSED PRODUCT produced for Sale in the United States will be manufactured substantially in the United States.

 

ARTICLE III

 

PAYMENTS

 

	
3.01 

	
License Payments:   In consideration of rights granted by UNIVERSITY to LICENSEE under this Agreement, LICENSEE will pay UNIVERSITY the following:

 

	
a.

	
[***];

 

	
b.

	
[***].; and

 

	
c.

	
[***]

 

3.02      Sublicense Payments:   In consideration of rights granted by UNIVERSITY to LICENSEE under this Agreement, LICENSEE further agrees to pay UNIVERSITY the following after the execution of a sublicense hereunder:

 

	
a.

	
[***].

 

04UMC007 UM- Organovo License final

  

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3.03      All payments to the UNIVERSlTY pursuant to this Agreement shall be paid in U.S. dollars. Conversion of foreign currency toU. S. dollars shall be made at the conversion rate existing in the United States (as reported in the in the Wall Street Journal) on the last working day of each royalty period.  Such payments shall be without deduction of exchange, collection or other charges.  Such payments shall be made payable to The Curators of the University of Missouri and shall be mailed to Office of Technology Management & Industry Relations, 340a Bond Life Sciences Center, Columbia, MO 65211.

 

3.04      Unless stipulated otherwise, all payments due the University hereunder shall be made within thirty (30) days after the end of each calendar quarter.  Late payments shall be subject to an interest charge of one and one half percent (1 1/2%) per month.

 

3.05      Taxes and/or other governmental charges or fees shall not be levied on SALES ROYALTY payments made to UNIVERSITY and shall not be deducted from SALES ROYALTY  payments due UNIVERSITY.

 

ARTICLE IV

 

REPORTING

 

4.01      Prior to signing this Agreement, LICENSEE has provided to UNIVERSITY a written plan (hereinafter "COMMERCIALIZATION PLAN") for LICENSED PRODUCT within the respective LICENSED FIELD and within the respective country or countries of the LICENSED TERRITORY  to be introduced by LICENSEE into commercial use. The COMMERCIALIZATION PLAN shall include, without limitation, 1) planned research and development activities, 2) milestones and evidence of sufficient financial resources to successfully implement the COMMERCIALIZATION PLAN and ensure that LICENSED PRODUCT  will be kept reasonably available to the public, and 3) projection of Sales and proposed marketing efforts,  Such COMMERCIALIZATION PLAN is incorporated as Appendix B.

 

 

4.02      LICENSEE shall report to UNIVERSITY the date of first Sale of LICENSED PRODUCTS  in each country of LICENSED TERRITORY  within thirty (30) days of occurrence.

 

04UMC007 UM- Organovo License final

  

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4.03      Within 30 days after each March 31, June 30, September 30, and December 31following the firstSale of LICENSED PRODUCT,  whether Sold by LICENSEE or its SUBLICENSEE, if any exists, LICENSEE must deliver to UNIVERSITY  a true and accurate written report, even if no payments are due UNIVERSITY,  giving the particulars of the business conducted by LICENSEE and its SUBLICENSEE(s), during the preceding three (3) calendar months under this Agreement as are pertinent to calculating payments hereunder. This report will include at least:

 

	
a. 

	
the quantities of LICENSED PRODUCT that it has produced;

 

	
b.

	
the total NET SALES;

 

	
c.

	
the calculation  of royalties thereon;

 

	
d.

	
offsets of minimum annual royalties or other offsets allowed under this Agreement; and 

 

	
e.

	
the total SALES ROYALTY computed and due UNIVERSITY.

 

This report shall identify the issued patents and/or patent applications under PATENT RIGHTS that cover the particular LICENSED PRODUCT  being reported.  LICENSEE shall provide sufficient data for UNIVERSITY  to verify the calculations, including gross Sales and allowable deductions to derive NET SALES figures, and any reasonable additional information UNIVERSITY  requires to determine LICENSEE's satisfaction of the reporting requirements hereunder or to clarify the information contained in reports provided by LICENSEE. LICENSEE shall provide such additional information within thirty (30) days of receiving a request from UNIVERSITY.  Simultaneously with the delivery of each report, LICENSEE must pay to UNIVERSITY the amount, if any, due for the period of each report.

 

4.04      On or before each anniversary of the EFFECTIVE DATE, irrespective of having a first Sale or offer for Sale, LICENSEE must deliver to UNIVERSITY  a written annual report as to LICENSEE's (and any SUBLICENSEE's) efforts and accomplishments  during the preceding year in diligently commercializing LICENSED PRODUCT  in the LICENSED FIELD, including but not limited to, progress on research and development, regulatory approvals, manufacturing, sublicensing, marketing and Sales and LICENSEE's (and, if applicable,  SUBLICENSEE's) commercialization plans for the upcoming year. LICENSEE shall also provide any reasonable additional information UNIVERSITY requires to evaluate LICENSEE'S performance under this Agreement.

 

4.05      LICENSEE agrees to keep records for a period of three (3) years following termination of this Agreement showing the manufacturing, Sales, use, sublicense, and other disposition of LICENSED PRODUCT, Sold or otherwise disposed of under the license herein granted in sufficient detail to enable the royalties payable hereunder by LICENSEE to be determined. LICENSEE agrees to permit UNIVERSITY or its representatives, at UNIVERSITY's expense, to periodically examine its books, ledgers, and records during regular business hours for the purpose of and to the extent necessary to verify any report required under this Agreement. If the amounts due to UNIVERSITY are determined to have been underpaid, LICENSEE will pay the amount of such underpayment and interest on the amount of such underpayment, calculated in accordance  with Section 3.05 with interest accruing from the date such payment was originally due the UNIVERSITY. Such examination is to be made by UNIVERSITY  at the expense of UNIVERSITY, except in the event that the results of the audit reveal a discrepancy in UNIVERSITY's favor of five percent (5%) or more, then the audit fees shall be paid by LICENSEE.

 

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ARTICLE V 

 

DUE DILIGENCE

 

5.01      LICENSEE shall use reasonable efforts to effect introduction of the LICENSED PRODUCT into the commercial market as soon as practicable, consistent with sound and reasonable  business practices and judgment; thereafter, until the expiration of this Agreement, LICENSEE shall keep LICENSED PRODUCT reasonably available to the public.

 

5.02      UNIVERSITY shall have the right, at UNIVERSITY's sole discretion, to either terminate or render this license nonexclusive  in an individual LICENSED FIELD and/or individual country or countries within the LICENSED TERRITORY  if LICENSEE or its SUBLICENSEE:

 

(a)       Has not within one (1) year of the EFFECTIVE DATE presented to and obtained UNIVERSITY'S  approval, which approval shall not be unreasonably withheld, a new COMMERCIALIZATION PLAN for LICENSED PRODUCT within the respective LICENSED FIELD and within the respective country or countries of the LICENSED TERRITORY  not previously introduced by LICENSEE into commercial use, , or

 

(b)      Has not within one (1)  year of the EFFECTIVE DATE received capital investments totaling two hundred fifty thousand dollars ($250,000),  or

 

(c)       Has not within 10 years submitted a regulatory filing for approval to commercialize  products in any country within LICENSED  TERRITORY.

 

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ARTICLE VI

 

LIABILITY, WARRANTIES AND INSURANCE

 

6.01      LICENSEE shall at all times during the term of this Agreement and thereafter, indemnify, defend and hold UNIVERSITY, the MUSC Foundation for Research Development and its related entities (including the Medical University of South Carolina, the Medical University Hospital Authority, and the University Medical Associates, and their agents, assigns, employees, affiliated companies, subsidiaries, departments, wholly owned companies, and contractors) (collectively, "MUSC"), and their respective current or former Curators, officers, employees and affiliates (each individually an "Indemnified Party," and collectively the "Indemnified Parties") harmless from any judgments and against all claims and expenses, including legal expenses and reasonable attorneys' fees, arising out of the death of or injury to any person or persons or out of any damage to property and against any other claim, proceeding, demand, expense and liability of any kind whatsoever resulting from 1) the development, manufacture, use, or Sale of LICENSED PRODUCT by LICENSEE, its subsidiaries, and SUBLICENSEEs, or 2) from the use by the end users of LICENSED PRODUCT, or 3) arising from any obligation of LICENSEE hereunder. If any such claims or causes of action are made, Indemnified Parties shall be defended by counsel selected by LICENSEE, subject to each Indemnified Party's approval, which shall not be unreasonably withheld. Each Indemnified Party reserves the right to be represented by its own counsel at its own expense.

 

6.02      At such time as any product, process, or service relating to, or developed pursuant to, this Agreement is being commercially distributed  or Sold (other than for the purpose of obtaining regulatory approvals) by LICENSEE, a SUBLICENSEE, or a subsidiary or agent of LICENSEE, LICENSEE shall at its sole cost and expense, procure and maintain comprehensive  general liability insurance in amounts not less than $1,000,000 per incident and naming the UNIVERSITY,  its Curators, trustees, officers, agents, employees and affiliates,  as additional insureds.  Such commercial general liability insurance shall provide (i) product liability coverage and (ii) broad form contractual  liability coverage for LICENSEE's indemnification  under this Agreement. Such insurance will be considered  primary as to any other valid and collectible insurance, but only as to acts of the named insured. Any carrier providing coverage shall have a minimum "Best" rating of "A-XII". The minimum amounts of insurance coverage required shall not be construed to create a limit of LICENSEE's  liability with respect to its indemnification  under this Agreement.

 

LICENSEE shall maintain such commercial general liability insurance beyond the expiration or termination of this Agreement during (i) the period that any product, process, or service, relating to, or developed pursuant to this Agreement is being commercially distributed or Sold by LICENSEE, or its SUBLICENSEE, subsidiary or agent of LICENSEE and (ii) a reasonable period after the period referred to in (i) above which in no event shall be less than fifteen (15) years.

 

LICENSEE shall provide Workers' Compensation coverage for any employee of LICENSEE that visits UNIVERSITY  premises for matters relating to this Agreement.  In addition, Employers' Liability coverage shall be provided to such employee in an amount no less that $1,000,000  per occurrence.

 

LICENSEE shall provide UNIVERSITY with written evidence of the insurance requirements of this Section 6.02 within thirty (30) days after execution of this Agreement.  LICENSEE shall provide UNIVERSITY with written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance; if LICENSEE does not obtain replacement insurance providing comparable  coverage within such fifteen (15) day period, UNIVERSITY shall have the right to terminate this Agreement effective at the end of such fifteen (15) day period without notice or any additional waiting periods. It is agreed that the insurance required is required in the public interest and the UNIVERSITY  does not assume any liability for acts of LICENSEE, their officers, agents, and employees or of a SUBLICENSEE,  their officers, agents, and employees, in connection with the granting of this Agreement.

 

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LICENSEE shall require in any sublicense in which LICENSEE grants to a third party the right to make, have made, use, import, offer to Sell or Sell any LICENSED PRODUCT, provisions that provide the UNIVERSITY, its Curators, trustees, officers, agents, employees and affiliates, comparable  protections as those provided the UNIVERSITY in this Article VI.

 

6.03      EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS LICENSE, UNIVERSITY AND MUSC MAKE NO REPRESENTATIONS AND EXTEND NOWARRANTIES OF ANY KIND, EITHER  EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE, AND VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING, OR THAT THE MANUFACTURE, USE, OR SALE OF THE LICENSED SUBJECT MATTER WILL NOT INFRINGE  ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS.

 

ARTICLE VII

 

DOMESTIC  AND FOREIGN PATENT FILING AND MAINTENANCE

 

7.01      LICENSEE shall reimburse UNIVERSITY for all out-of-pocket expenses UNIVERSITY has incurred prior to the execution of this Agreement for the preparation, filing, prosecution and maintenance of PATENT RIGHTS (hereinafter "PATENT  EXPENSES")  within one year of execution of this Agreement. All PATENT EXPENSES UNIVERSITY incurs during the first year following the execution of this Agreement shall be reimbursed by LICENSEE within two (2) years following the execution of this agreement.  PATENT EXPENSES  incurred by UNIVERSITY beginning in the second year following execution of this agreement shall be reimbursed by LICNESEE on an ongoing basis following receipt of invoice by UNIVERSITY for such PATENT EXPENSES.  All reimbursements for PATENT EXPENSES shall be received as a separate payment apart from any royalties or other revenues owed UNIVERSITY. Late payment of invoices of PATENT EXPENSES received by LICENSEE from UNIVERSITY shall be subject to interest charges of one and one-half percent (1 1/2%) per month.  A payment under this Section 7.01 is considered late if payment is not received by UNIVERSITY  within thirty (30) days from LICENSEE's receipt of an invoice from UNIVERSITY.

 

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7.02      UNIVERSITY shall be solely responsible for the preparation, filing, prosecution and maintenance of any and all U.S. and foreign patent applications and patents included in PATENT RIGHTS mutually agreed upon by UNIVERSITY and LICENSEE.  UNIVERSITY shall first consult with LICENSEE as to the preparation, filing, prosecution, and maintenance of such patent applications and patents and shall furnish to LICENSEE copies of documents relevant to any such preparation, filing, prosecution or maintenance.

 

7.03      If LICENSEE elects not to continue paying future PATENT EXPENSES,  LICENSEE shall notify UNIVERSITY  immediately in writing, but in no event less than sixty (60) days prior to any deadline which should or must be met in order to maintain the patent or patent application in force (a "deadline" includes a date by which an action must be taken to avoid payment of a late fee).  Such notice by LICENSEE shall constitute a waiver of and relinquishment of all of LICENSEE's rights under this Agreement related to such patent or patent application.

 

  ARTICLE VIII 

 

INFRINGEMENT

 

8.01      LICENSEE, at its expense, shall have the right to enforce PATENT RIGHTS against infringement by third parties and it is entitled to retain the recovery from such enforcement, including any cash or other consideration received by way of judgment, settlement or compromise (hereinafter "RECOVERY"). However, any RECOVERY, less direct out-of-pocket legal expenses incurred by LICENSEE for such enforcement, shall be considered  lost Sales and LICENSEE shall pay UNIVERSITY a SALES ROYALTY on such lost Sales. Before LICENSEE commences a formal legal proceeding with respect to any infringement of PATENT RIGHTS, LICENSEE shall consult with UNIVERSITY regarding the potential effects such legal proceeding may have on the public interest. LICENSEE shall keep UNIVERSITY informed on all actions taken by LICENSEE in its enforcement against an infringer and shall furnish to UNIVERSITY  copies of all documents related thereto.

 

8.02      In any infringement suit or dispute, UNIVERSITY  agrees to cooperate reasonably with LICENSEE. At the request and expense of LICENSEE, the UNIVERSITY  will permit access to all relevant personnel, records, papers, information, samples, specimens, etc., during regular business hours on UNIVERSITY premises as reasonably necessary for LICENSEE to vigorously conduct such proceeding. In the event that travel is required, LICENSEE agrees to reimburse UNIVERSITY for such travel.

 

8.03      In the event that LICENSEE elects not to exercise its right to prosecute an infringement of the PATENT RIGHTS pursuant to the above paragraphs, UNIVERSITY  may do so at its own expense, controlling such action and retaining all RECOVERY therefrom. LICENSEE agrees to cooperate reasonably with UNIVERSITY in any such infringement suit or dispute.

 

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ARTICLE IX 

 

CONFIDENTIALITY

 

9.01      LICENSEE agrees that all patent prosecution information and all other information contained in documents marked "confidential"  received from UNIVERSITY  shall (i) be received in strict confidence, (ii) be used only for the purposes of this Agreement, and (iii) not be disclosed by LICENSEE, its employees, agents, successors or assigns,  without the prior written consent of UNIVERSITY, except to the extent that the LICENSEE can establish competent written proof that such information:

 

	
a.

	
was in the public domain at the time of disclosure;

 

	
b.

	
later became part of the public domain through no act or omission of LICENSEE,  its employees, agents, successors or assigns;

 

	
c.

	
was lawfully disclosed to LICENSEE by a third party having the right to disclose it;

 

	
d.

	
was already known by LICENSEE at the time of disclosure;

 

	
e. 

	
was independently developed by LICENSEE; or f. is required by law or regulation to be disclosed.

 

9.02      LICENSEE's obligation of confidence hereunder shall be fulfilled by using at least the same degree of care with UNIVERSITY's confidential information as LICENSEE uses to protect its own confidential information, but not less than reasonable care. This obligation shall exist during the term of this Agreement and for a period of five (5) years thereafter.

 

ARTICLE X

 

TERM AND TERMINATION

 

10.01    This Agreement shall become effective upon the EFFECTIVE DATE and, unless sooner terminated in accordance with any of the provisions herein, shall remain in full force in the LICENSED  TERRITORY during the life of the last to expire patents under PATENT RIGHTS.

 

10.02    In the event that either Party defaults or breaches any of the provisions of this Agreement, the other Party shall have the right to terminate this Agreement by giving written notice to the defaulting Party; provided, however, that if the said defaulting Party cures said default within thirty (30) days after said notice shall have been given, this Agreement shall continue in full force and effect.  The failure on the part of either of the Parties hereto to exercise or enforce any right conferred upon it hereunder shall not be deemed to be a waiver of any such right nor operate to bar the exercise or enforcement thereof at any time or times thereafter.

 

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10.03    Upon termination of this Agreement, LICENSEE's interest in sublicenses granted by it under this Agreement shall at UNIVERSITY's option, terminate or be assigned to UNIVERSITY.  LICENSEE shall make provision for the UNIVERSITY's rights under the preceding sentence to be included in all sublicenses granted by it under this Agreement.

 

10.04    In the event that LICENSEE shall become insolvent, shall make an assignment for the benefit of creditors, or shall have a petition in bankruptcy filed for or against it, this Agreement shall automatically terminate.

 

10.05    Termination of this Agreement for any reason shall not release either Party from any obligation theretofore accrued. Articles III, VI, and IX and Sections 4.03, 4. 05, 10.03, 11.07, and 11.13 shall survive the termination of this Agreement.

ARTICLE XI 

 

GENERAL

 

11.01    Prior to the issuance of patents under PATENT RIGHTS, LICENSEE agrees to mark LICENSED PRODUCTS (or their containers or labels) Sold by LICENSEE, or a SUBLICENSEE,  under the license granted in this Agreement with the words "Patent Pending," and following the issuance of one or more patents under PATENT RIGHTS, with the words "Patent No.  "

 

11.02    LICENSEE agrees to comply with all applicable federal, state, and local laws and regulations. In particular, it is understood and acknowledged that the transfer of certain commodities and technical data is subject to United States laws and regulations controlling the export of such commodities and technical data, including all Export Administration Regulations of the United States Department of Commerce. These laws and regulations among other things, prohibit or require a license for the export of certain types of technical data to certain specified countries. LICENSEE hereby agrees and gives written assurance that it will comply with all United States laws and regulations controlling the export of commodities and technical data, that it will be solely responsible for any violation of such by LICENSEE, its AFFILIATE, or SUBLICENSEES, and that it will defend and hold UNIVERSITY harmless in the event of any legal action of any nature occasioned by such violation.

 

11.03    LICENSEE agrees not to identify UNIVERSITY or MUSC in any promotional advertising or other promotional materials to be disseminated to the public or any portion thereof or to use the name of any UNIVERSITY or MUSC faculty member, employee, or student or any trademark, service mark, trade name, or symbol of UNIVERSITY  or MUSC, without UNIVERSITY'S and MUSC's prior written consent.

 

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11.04    Except in connection with the sale of substantially all of LICENSEE's assets to a third party, this Agreement may not be assigned by LICENSEE without the prior written consent of UNIVERSITY, which will not be unreasonably withheld.

 

11.05    If LICENSEE desires UNIVERSITY participation in performing research and development activities directed towards PATENT RIGHTS, negotiation for such assistance shall be separate and apart from this Agreement, and shall be performed according to UNIVERSITY'S  procedures related to research grant and contract activities.

 

11.06    In the event LICENSEE wishes to engage the inventors as consultants, such an arrangement shall be separate and apart from this Agreement, but shall be in keeping with UNIVERSITY'S and MUSC's policy on consulting and ownership of intellectual property developed by UNIVERSITY and MUSC employees.

 

11.07    Any payment, notice, or other communication given under this Agreement (except for correspondence relating to patent filing, prosecution and/or maintenance matters under Article VII herein) shall be in writing and shall be deemed delivered when sent by certified first class mail, registered mail, or overnight courier, or by facsimile, provided that a copy of such facsimile is promptly sent by certified first class mail, registered or overnight courier, addressed to the Parties as follows (or at such other addresses as the Parties may notify each other in writing):

 

If to UNIVERSITY:

 

Office of Technology Management & Industry Relations

340A Bond Life Sciences Center

Columbia, MO  65211

 

Attn.: Director

 

If to LICENSEE: Organovo

11180 Roselle St., Suite H San Diego, CA  92121

 

Attn.: CEO

 

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11.08    This Agreement constitutes the entire and only agreement between the Parties for LICENSED SUBJECT MATTER and all other prior negotiations, representations, agreements, and understandings are superseded hereby. No agreements altering or supplementing the terms hereof may be made except by a written document signed by both Parties.

 

11.09    None of the terms, covenants, and conditions of this Agreement can be waived except by the written consent of the Party waiving compliance.

 

11.10    A failure by one of the Parties to this Agreement to assert its rights for or upon any breach or default of this Agreement shall not be deemed a waiver of such rights nor shall any such waiver be implied from acceptance of any payment.  No such failure or waiver in writing by any one of the Parties hereto with respect to any rights, shall extend to or affect any subsequent breach or impair any right consequent thereon.

 

11.11    If any sentence, paragraph, clause or combination of the same is found by a court of competent jurisdiction to be in violation of any applicable law or regulation, or is unenforceable or void for any reason whatsoever, such sentence, paragraph, clause or combinations of the same shall be severed from the Agreement and the remainder of the Agreement shall remain binding upon the Parties.

 

11.12    The headings of the paragraphs of this Agreement are inserted for convenience only and shall not constitute a part hereof.

 

11.13    This Agreement shall be construed, interpreted, and applied in accordance with the laws of the State of Missouri.  Any action to enforce the provisions of the Agreement shall be brought in a court of competent jurisdiction and proper venue in the State of Missouri.

 

IN WITNESS  WHEREOF,  the Parties hereto have executed this Agreement  in duplicate  originals by their duly authorized officers or representatives.

 

	 	THE CURATORS OF THE 	 	 	 
	 	UNIVERSITY OF MISSOURI	 	LICENSEE	 
	 	 	 	 	 
	BY: 	/s/ Christopher M. Fender	BY: 	/s/Keith Murphy	 
	NAME:	Christopher M. Fender	NAME:	Keith Murphy	 
	TITLE:	Interim Director, OTMIR	TITLE:	Chief Executive Officer	 
	DATE:	
March 24, 2009

	DATE:	March 24, 2011	 

 

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EXHIBIT A

 

US Patent Application No. 10/590,446, titled "Self-Assembling  Cell Aggregates and Methods of Making Engineered Tissue Using the Same"

 

US Patent Application No. 61/132,977, titled "Intermediate  Cellular Unit, Fabrication, and Use Thereof'

 

 

 15

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