By And Between Novartis Institutes for BioMedical Research, Inc. And MDRNA, Inc.

EX-10.3 4 dex103.htm LICENSE AGREEMENT DATED AS OF MARCH 20, 2009 License Agreement dated as of March 20, 2009

Exhibit 10.3

[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

 

License Agreement

By And Between

Novartis Institutes for BioMedical Research, Inc.

And

MDRNA, Inc.

 

 

 


[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

1.

  

DEFINITIONS AND INTERPRETATION

   1

2.

  

LICENSES

   6

3.

  

DISCLOSURE AND TRANSFER OF MDRNA KNOW-HOW AND COOPERATION

   7

4.

  

FINANCIAL PROVISIONS

   7

5.

  

PAYMENT TERMS

   7

6.

  

CONFIDENTIALITY

   8

7.

  

EVENT OF DEFAULT

   10

8.

  

TERM; RIGHTS IN BANKRUPTCY

   10

9.

  

REPRESENTATIONS, WARRANTIES AND COVENANTS

   11

10.

  

INDEMNIFICATION; LIABILITY

   15

11.

  

PUBLICATIONS AND PUBLICITY

   19

12.

  

GENERAL PROVISIONS

   20

EXHIBIT A – MDRNA PATENTS

EXHIBIT B – MICHIGAN PATENTS

EXHIBIT C – SAMPLE INVOICE

EXHIBIT D – MICHIGAN LICENSE

EXHIBIT E – GECC AGREEMENT

EXHIBIT F – PAYMENT INSTRUCTIONS


[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

LICENSE AGREEMENT

This LICENSE AGREEMENT (“Agreement”) is made as of this 20th day of March, 2009 (“Effective Date”), by and between Novartis Institutes for BioMedical Research, Inc., a Delaware corporation (“Novartis”) and MDRNA, Inc., a Delaware corporation (“MDRNA”). Novartis and MDRNA are each referred to individually as a “Party” and together as the “Parties.”

RECITALS

WHEREAS, MDRNA has developed a proprietary platform for creating novel liposomes from dialkyl-amino acids for delivery of siRNA and owns or Controls (as defined below) certain intellectual property relating thereto;

WHEREAS, Novartis wishes to obtain, and MDRNA wishes to grant, a license to such intellectual property on the terms and conditions set forth herein;

WHEREAS, MDRNA Controls certain intellectual property pursuant to the Michigan License (as defined below); and

WHEREAS, Novartis wishes to obtain, and MDRNA wishes to grant, a sublicense under the Michigan License on the terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the mutual covenants and agreements herein contained, the Parties agree as follows.

 

1. DEFINITIONS AND INTERPRETATION

 

  1.1 Definitions. Unless the context otherwise requires, the terms in this Agreement with initial letters capitalized, shall have the meanings set forth below, or the meaning as designated in the indicated places throughout this Agreement.

“Affiliate” means, with respect to a Party, any Person that controls, is controlled by, or is under common control with that Party. For the purpose of this definition, “control” shall mean, direct or indirect, ownership of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interest in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby the entity or person controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity. In the case of entities organized under the laws of certain countries, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and in such case such lower percentage shall be substituted in the preceding sentence, provided, that such foreign

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

investor has the power to direct the management and policies of such entity. In the case of Novartis, “Affiliates” shall also be deemed to include [***] (also known as [***]), [***], and their respective Affiliates.

“Agreement” shall have the meaning set forth in the preamble.

“Business Day” means any day that is not a Saturday, a Sunday, or other day (i) which is a public holiday in Cambridge, Massachusetts, or (ii) which is a recognized Federal holiday in the United States of America.

“Claims” means all Third Party demands, claims, actions, proceedings and liabilities (whether criminal or civil, in contract, tort or otherwise) for losses, damages, reasonable legal costs and other reasonable expenses of any nature whatsoever.

“Code” shall have the meaning set forth in Section 8.2(a).

“Confidential Information” means all Know-How and other proprietary information and data of a financial, commercial or technical nature which the disclosing Party or any of its Affiliates has supplied or otherwise made available to the other Party or its Affiliates, whether made available orally, in writing or in electronic form, including information comprising or relating to concepts, discoveries, inventions, data, designs or formulae in relation to this Agreement. For purposes hereof, this Agreement and the terms hereof shall not be Confidential Information of either Party.

Confidentiality Agreement means that certain Confidentiality Agreement dated as of February 10, 2009 between mdRNA and Novartis, as amended by an Amendment to Confidentiality Agreement dated February 17, 2009.

“Control” or “Controlled” means, with respect to any Know How, Patents, other intellectual property rights, or any proprietary or trade secret information, the legal authority or right (whether by ownership, license or otherwise) of a Party to grant a license or a sublicense of or under such Know How, Patents, or intellectual property rights to another Person, or to otherwise disclose such proprietary or trade secret information to another Person, without breaching the terms of any agreement with a Third Party, or misappropriating the proprietary or trade secret information of a Third Party.

“DiLA2 Data” means all data and information Controlled by MDRNA relating to the structure, activity and/or other characteristics of the lipids within the DiLA2 Platform Technology.

“DiLA2 Platform Technology” means compounds containing an amino acid core, including one or more amino acids or a peptide of two to twenty amino acid residues, and one or more lipophilic tails linked at either the N-terminus or the C-terminus of an amino

 

2


[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

acid, or at both termini for use in delivery and administration of drug agents and in drug delivery systems, as in existence as of the Effective Date.

“Effective Date” shall have the meaning set forth in the first paragraph of this Agreement.

“Encumbrance” means any claim, charge, equitable interest, hypothecation, lien, mortgage, pledge, option, license, assignment, power of sale, retention of title, right of pre-emption, right of first refusal or security interest of any kind.

“Event of Default” shall have the meaning set forth in Section 7.1.

“Field” shall mean all uses and purposes.

“Field of Use” shall have the meaning set forth in the Michigan License.

“Force Majeure Event” shall have the meaning set forth in Section 12.5.

“Indemnification Claim Notice” shall have the meaning set forth in Section 10.3(b).

“Indemnified Party” shall have the meaning set forth in Section 10.3(b).

“Indemnifying Party” shall have the meaning set forth in Section 10.3(b).

“Know-How” means all technical information, know-how and data, including inventions (whether patentable or not), discoveries, trade secrets, specifications, instructions, processes, formulae, materials, expertise and other technology applicable to compounds, biologics, formulations, compositions, products or to their manufacture, development, registration, use or commercialization or methods of assaying or testing them or processes for their manufacture, formulations containing them, compositions incorporating or comprising them and including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, preclinical and clinical data, instructions, processes, formulae, expertise and information, regulatory filings and copies thereof, relevant to the development, manufacture, use or commercialization of and/or which may be useful in studying, testing, development, production or formulation of products, or intermediates for the synthesis thereof.

“Licensed Products” shall have the meaning set forth in the Michigan License.

“Licensed Processes” shall have the meaning set forth in the Michigan License.

MAA means an application for the authorization to market a product in any country or group of countries outside the United States, as defined in the applicable laws and regulations and filed with the Regulatory Authority of a given country or group of countries.

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

MDRNA Know-How means the Know-How owned or Controlled by MDRNA or its Affiliates as of the Effective Date relating to the DiLA2 Platform Technology and condensing peptide technology. The MDRNA Know-How shall also include the DiLA2 Data. For the avoidance of doubt, MDRNA Know-How” shall not include any Know-How owned or Controlled by the University of Michigan.

MDRNA Patents means the Patents identified in Exhibit A and any other Patents owned or Controlled by MDRNA or its Affiliates as of the Effective Date that have claims covering the DiLA2 Platform Technology. For the avoidance of doubt,

MDRNA Patents” shall not include any Patents owned or Controlled by the University of Michigan.

MDRNA Technology means MDRNA Patents and MDRNA Know-How.

MDRNA Indemnitees” shall have the meaning set forth in Section 10.2.

“Michigan” means the Regents of the University of Michigan.

“Michigan License” means the License Agreement, dated as of May 7, 2008, between the Regents of the University of Michigan and MDRNA (f/k/a Nastech Pharmaceutical Company Incorporated).

“Michigan Patents” shall have the meaning given to the term PATENT RIGHTS in the Michigan License.

Novartis Indemnitees shall have the meaning set forth in Section 10.1.

“Party” shall have the meaning set forth in the preamble.

“Patents” means all patents and patent applications, author certificates, inventor certificates, utility certificates, improvement patents and models and certificates of addition and all foreign counterparts of them and including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, reissues, additions, renewals, extensions, registrations, and supplemental protection certificates and the like of any of the foregoing.

“Person” means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity.

“Regulatory Authority” means any governmental agency or authority responsible for granting regulatory approvals for products, including the United States Food and Drug Administration, the European Medicines Agency, or any successor entities thereto and any corresponding national or regional regulatory authorities.

“Regulatory Filings” means any submission to a Regulatory Authority of any appropriate regulatory application, and shall include, without limitation, any submission

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto. For the avoidance of doubt, Regulatory Filings shall include any Investigational New Drug (IND), New Drug Application (NDA) or the corresponding application in any other country or group of countries.

Sublicensee shall have the meaning set forth in the Michigan License.

“Term” means the term of this Agreement as set forth in Section 8.1.

“Territory” means all countries of the world.

“Third Party” means any Person other than a Party or an Affiliate of a Party.

“United States” or “US” means the United States of America, its territories and possessions.

“USD” or “US$” means the lawful currency of the United States.

 

  1.2 Interpretation. In this agreement unless otherwise specified:

 

  (a) “includes” and “including” shall mean respectively includes and including without limitation;

 

  (b) a Party includes its permitted assignees and/or their respective permitted successors in title to substantially the whole of its undertaking;

 

  (c) a statute or statutory instrument or any of their provisions is to be construed as a reference to that statute or statutory instrument or such provision as the same may have been or may from time to time hereafter be amended or re-enacted;

 

  (d) words denoting the singular shall include the plural and vice versa and words denoting any gender shall include all genders;

 

  (e) the Exhibits and other attachments form part of the operative provision of this Agreement and references to this Agreement shall, unless the context otherwise requires, include references to the Exhibits and attachments;

 

  (f) the headings in this Agreement are for information only and shall not be considered in the interpretation of this Agreement;

 

  (g) general words shall not be given a restrictive interpretation by reason of their being preceded or followed by words indicating a particular class of acts, matters or things; and

 

  (h)

the Parties agree that the terms and conditions of this Agreement are the result of negotiations between the Parties and that this Agreement shall not be construed in

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

 

favor of or against any Party by reason of the extent to which any Party participated in the preparation of this Agreement.

 

2. LICENSES

 

  2.1 License Grant. Subject to the terms and conditions of this Agreement, MDRNA hereby grants to Novartis and its Affiliates a non-exclusive, irrevocable, perpetual, royalty-free, fully paid-up license, with the right to grant sublicenses as permitted in Section 2.3 of this Agreement, under the MDRNA Technology to research, develop, make, have made, use, import, offer for sale, sell, have sold, commercialize and otherwise exploit any product and/or process in the Field in the Territory.

 

  2.2 Michigan Sublicense Grant.

 

  (a) Subject to the terms and conditions of this Agreement, MDRNA hereby grants to Novartis and its Affiliates a non-exclusive license under the Michigan Patents, with the right to grant sublicenses, in each case subject to the terms and conditions of the Michigan License, in the Field of Use and the Territory, to make, have made, import, use, market, offer for sale, sell and have sold Licensed Products and to practice Licensed Processes.

 

  (b) In connection with the sublicense granted pursuant to this Section 2.2 Novartis agrees to comply, as and to the extent applicable to a Sublicensee, with the following Sections of the Michigan License: [***].

 

  (c) For the avoidance of doubt, other than as specified in Section 2.2(b) above, Novartis shall not be bound by any provision of the Michigan License, including Article 5 (Diligence).

 

  (d) Novartis acknowledges, pursuant to clause (1) of Section 6.4 of the Michigan License the disclaimer of warranties and limitations on Michigan’s liability, as provided in Article 9 of the Michigan License.

 

  2.3 Sublicense Rights.

 

  (a) Novartis may sublicense to a Third Party the rights granted to it by MDRNA under Section 2.1 of this Agreement at any time at its sole discretion, but only in connection with [***]. A “Novartis Product” means any product with respect to which Novartis or any of its Affiliates has conducted research, manufacturing, development and /or commercialization activities that are material to such product.

 

  (b) Novartis may sublicense the rights granted to it by MDRNA under Section 2.2 of this Agreement as and to the extent provided in the Michigan License.

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

3. DISCLOSURE AND TRANSFER OF MDRNA KNOW-HOW AND COOPERATION

 

 

3.1

Disclosure and Transfer of MDRNA Know-How. As soon as reasonably possible after the Effective Date (and in any event within [***] days after the Effective Date), MDRNA, without additional consideration, shall disclose to Novartis or its designated Affiliate all MDRNA Know-How in existence as of the Effective Date and provide copies of any existing tangible embodiment thereof in written or electronic form as reasonably requested by Novartis, including delivery of an electronic copy of the DiLA2 Data in a commonly usable format. Such disclosures shall include all MDRNA Know-How and any other data, information and documents known to and Controlled by MDRNA as of the Effective Date which may be necessary or useful to Novartis to practice the licenses granted hereunder efficiently.

 

  3.2 Cooperation. Upon request by Novartis within a reasonable period after disclosure by MDRNA of the MDRNA Know-How and other data, information and documents pursuant to Section 3.1 of this Agreement, MDRNA will provide reasonable assistance to Novartis or its designated Affiliate in connection with understanding and using the MDRNA Know-How for purposes consistent with licenses and rights granted to Novartis hereunder; provided, that Novartis shall promptly pay or reimburse MDRNA for any travel or other out-of-pocket expenses incurred by MDRNA in connection with providing such assistance requested by Novartis.

 

4. FINANCIAL PROVISIONS

 

  4.1 Upfront Payment. In consideration of the licenses and rights granted to Novartis hereunder, Novartis shall pay to MDRNA a one-time upfront payment of Seven Million Two Hundred and Fifty Thousand Dollars ($7,250,000). Such upfront payment shall be paid in accordance with the instructions set forth Exhibit F within [***] Business Days after receipt by Novartis of an invoice in the form of Exhibit C, which invoice shall be issued no earlier than the Effective Date.

 

  4.2 Third Party Obligations. MDRNA shall remain responsible for the payment of all royalty, milestone and other payment obligations, if any, due to Third Parties under any Patents or Know-How which have been licensed to MDRNA and are sublicensed to Novartis under this Agreement. All such payments shall be made promptly by MDRNA in accordance with the terms of its license agreement.

 

5. PAYMENT TERMS

 

  5.1

Payment Terms. All payments from Novartis to MDRNA shall be made by wire transfer to the credit of such bank account as may be designated by MDRNA in this Agreement or in writing to Novartis. Any payment which falls due on a date which is not a Business

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

 

Day in Cambridge, Massachusetts may be made on the next succeeding Business Day in Cambridge, Massachusetts.

 

  5.2 Currency. All payments under this Agreement shall be payable in US dollars.

 

  5.3 Taxes. MDRNA will pay any and all taxes levied on account of any payments made to it under this Agreement. If any taxes are required to be withheld by Novartis, Novartis will: (a) deduct such taxes from the payment made to MDRNA; (b) timely pay the taxes to the proper taxing authority; (c) send proof of payment to MDRNA; and (d) reasonably assist MDRNA in its efforts to obtain a credit for such tax payment. Each Party agrees to reasonably assist the other Party in lawfully claiming exemptions from and/or minimizing such deductions or withholdings under double taxation laws or similar circumstances.

 

6. CONFIDENTIALITY

 

  6.1 Duty of Confidence. Subject to the other provisions of this Section 6, all Confidential Information disclosed by a Party or its Affiliates under this Agreement will be maintained in confidence and otherwise safeguarded by the recipient Party. The recipient Party may only use the Confidential Information for the purposes of this Agreement and pursuant to the rights granted to the recipient Party under this Agreement. Subject to the other provisions of this Section 6, each Party shall hold as confidential such Confidential Information of the other Party or its Affiliates in the same manner and with the same protection as such recipient Party maintains its own confidential information. Subject to the other provisions of this Section 6, a recipient Party may only disclose Confidential Information of the other Party to employees, agents, contractors, consultants and advisers of the Party and its Affiliates and sublicensees and to Third Parties to the extent reasonably necessary for the purposes of, and for those matters undertaken pursuant to, this Agreement; provided, that such Persons are bound to maintain the confidentiality of the Confidential Information in a manner consistent with the confidentiality provisions of this Agreement.

 

  6.2 Exceptions. The obligations under this Section 6 shall not apply to any information to the extent the recipient Party can demonstrate by competent evidence that such information:

 

  (a) is (at the time of disclosure) or becomes (after the time of disclosure) known to the public or part of the public domain through no breach of this Agreement by the recipient Party or its Affiliates;

 

  (b) was known to, or was otherwise in the possession of, the recipient Party or its Affiliates prior to the time of disclosure by the disclosing Party or any of its Affiliates;

 

  (c) is disclosed to the recipient Party or an Affiliate on a non-confidential basis by a Third Party who is entitled to disclose it without breaching any confidentiality obligation to the disclosing Party or any of its Affiliates; or

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

  (d) is independently developed by or on behalf of the recipient Party or its Affiliates, as evidenced by its written records, without reference to the Confidential Information disclosed by the disclosing Party or its Affiliates under this Agreement.

Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the recipient Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the recipient Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the recipient Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the recipient Party unless the combination and its principles are in the public domain or in the possession of the recipient Party.

 

  6.3 Authorized Disclosures.

 

  (a) In addition to disclosures allowed under Section 6.2, Novartis may disclose Confidential Information belonging to MDRNA or its Affiliates to the extent such disclosure is necessary in the following instances: (i) filing or prosecuting Patents as permitted by this Agreement; and (ii) in connection with Regulatory Filings for products. In addition, Novartis may disclose Confidential Information belonging to MDRNA or its Affiliates to the extent such disclosure is necessary in connection with prosecuting or defending litigation as permitted by this Agreement; provided, that Novartis (A) informs MDRNA as soon as reasonably practicable of the proposed disclosure; and (B) shall use commercially reasonable efforts (but in no event less than the efforts used by Novartis with respect to its own similar confidential information) to limit the disclosure for the required purpose and to obtain protections to maintain the confidentiality of such MDRNA Confidential Information.

 

  (b) In addition, Novartis and its Affiliates and sublicensees may disclose Confidential Information of MDRNA to Third Parties as may be necessary or useful in connection with the development, manufacture or commercialization of products and/or processes; provided, that such Third Parties are bound to maintain the confidentiality of such Confidential Information in a manner consistent with the confidentiality provisions of this Agreement.

 

  (c) In the event the recipient Party is required to disclose Confidential Information of the disclosing Party by law or in connection with bona fide legal process, such disclosure shall not be a breach of this Agreement; provided, that the recipient Party (i) informs the disclosing Party as soon as reasonably practicable of the required disclosure; (ii) limits the disclosure to the required purpose; and (iii) at the disclosing Party’s request and expense, assists in an attempt to object to or limit the required disclosure.

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

  (d) Notwithstanding anything to the contrary contained in this Article 6 or Article 11 of this Agreement, MDRNA shall be permitted to disclose a copy of this Agreement to (a) MDRNA’s current or prospective banks, financial institutions, investors or other Third Parties for the purpose of raising capital or borrowing money or maintaining compliance with agreements, arrangements and understandings relating thereto, and (b) to any Person who proposes to be an assignee or to purchase or otherwise succeed (by merger, operation of law or otherwise) to all of MDRNA’s right, title and interest in, to and under this Agreement, if (1) such Person agrees to maintain the confidentiality of this Agreement pursuant to a written agreement at least as protective as the terms set forth in this Article 6 (with the exception of the term of the obligation of confidentiality, which may be for a specified term of years) and (2) any such assignment, purchase or succession would be permitted under Section 12.1 hereof.

 

7. EVENT OF DEFAULT

 

  7.1 Event of Default. The rejection of this Agreement under section 365 of the Code by MDRNA shall constitute an event of default (an “Event of Default”) by MDRNA under this Agreement.

 

8. TERM; RIGHTS IN BANKRUPTCY

 

  8.1 Term. Subject to Section 8.2, the term of this Agreement (the “Term”) is perpetual and shall continue indefinitely following the Effective Date.

 

  8.2 Termination for Event of Default. Novartis may terminate this Agreement immediately upon written notice to MDRNA upon the occurrence of an Event of Default.

 

  8.3 Rights in Bankruptcy.

 

  (a)

The Parties agree that this Agreement constitutes an executory contract under Section 365 of the US Bankruptcy Code (the “Code”) for the license of “intellectual property” as defined under Section 101 of the Code and constitutes a license of “intellectual property” for purposes of any similar laws in any other country in the Territory. The Parties further agree that Novartis, as licensee of such rights under this Agreement, will retain and may fully exercise all of its protections, rights, and elections under the Code, including, but not limited to, Section 365(n) of the Code, and any similar laws in any other country in the Territory. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against any MDRNA under the Code and any similar laws in any other country in the Territory, Novartis will be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, and the same, if not already in

 

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its possession, will be promptly delivered to it (i) upon any such commencement of a bankruptcy proceeding upon its written request therefor, unless MDRNA elects to continue to perform all of its obligations under this Agreement, or (ii) if not delivered under (i) above, following the rejection of this Agreement by or on behalf of MDRNA upon written request therefor by Novartis.

 

  (b) All rights, powers and remedies of Novartis provided for in this Section 8.3 are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation, under the Code and any similar laws in any other country in the Territory). In the event of the bankruptcy of MDRNA, Novartis, in addition to the rights, power and remedies expressly provided herein, shall be entitled to exercise all other such rights and powers and resort to all other such remedies as may now or hereafter exist at law or in equity (including, without limitation, under the Code). The Parties agree that they intend the following Novartis rights to extend to the maximum extent permitted by law, including, without limitation, for purposes of the Code: (i) the right of access to any such intellectual property (including all embodiments thereof) of MDRNA licensed or sublicensed to Novartis pursuant to this Agreement, or any Third Party with whom MDRNA contracts to perform an obligation of MDRNA under Section 3.1 of this Agreement which is necessary for the development, registration, manufacture and/or commercialization of products in the Territory; (ii) the right to contract directly with any Third Party described in (i) to complete the contracted work, and (iii) the right to cure any breach of or default under any such agreement with a Third Party and set off the costs thereof against amounts payable to MDRNA under this Agreement.

 

9. REPRESENTATIONS, WARRANTIES AND COVENANTS

 

  9.1 Representations and Warranties by Each Party. Each Party represents and warrants to the other as of the Effective Date that:

 

  (a) it is a corporation duly organized, validly existing, and in good standing under the laws of its jurisdiction of formation;

 

  (b) it has full corporate power and authority to execute, deliver, and perform this Agreement, and has taken all corporate action required by law and its organizational documents to authorize the execution and delivery of this Agreement and the consummation of the transactions contemplated by this Agreement;

 

  (c) this Agreement constitutes a valid and binding agreement enforceable against it in accordance with its terms;

 

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  (d) all consents, approvals and authorizations from all governmental authorities or other Third Parties required to be obtained by such Party in connection with this Agreement have been obtained; and

 

  (e) the execution and delivery of this Agreement and all other instruments and documents required to be executed pursuant to this Agreement, and the consummation of the transactions contemplated hereby do not and shall not (i) conflict with or result in a breach of any provision of its organizational documents, (ii) result in a breach of any agreement to which it is a party; or (iii) violate any law.

 

  9.2 Representations and Warranties by MDRNA. MDRNA represents and warrants to Novartis as of the Effective Date that:

 

  (a) Exhibit A sets forth a complete and accurate list of (i) all MDRNA Patents in existence as of the Effective Date, indicating the owner, MDRNA and/or co-owner(s) thereof if such MDRNA Patents or MDRNA Know-How is not solely owned by MDRNA and (ii) all license, assignment, distribution or other agreements relating to the MDRNA Patents and MDRNA Know-How;

 

  (b) Exhibit B sets forth a complete and accurate list of all Michigan Patents in existence as of the Effective Date, indicating the owner or co-owners thereof;

 

  (c) MDRNA (i) is the sole and exclusive owner, or exclusive licensee of all of the MDRNA Patents and is the exclusive licensee of the Michigan Patents free from Encumbrances, except (A) in the case of the Michigan Patents, which are subject to the terms and conditions of the Michigan License and Michigan’s rights with a respect thereto, and (B) for Encumbrances in favor of General Electric Capital Corporation pursuant to that certain Loan and Security Agreement, dated as of January 23, 2009, which shall be made subordinate to Novartis’ rights under this Agreement pursuant to Exhibit E, and (ii) except for the Michigan Patents, is listed in the records of the appropriate governmental agencies as the sole and exclusive owner of record or exclusive licensee for each registration, grant and application included in the MDRNA Patents;

 

  (d) MDRNA has obtained from all individuals who participated in any respect in the invention or authorship of any MDRNA Technology effective assignments of all ownership rights of such individuals in such MDRNA Technology, either pursuant to written agreement or by operation of law;

 

  (e)

all of its employees, officers, and consultants have executed agreements or have existing obligations under applicable laws requiring assignment to MDRNA of all inventions made during the course of and as the result of their association with MDRNA and obligating the individual to maintain as confidential MDRNA’s Confidential Information as well as confidential information of other parties

 

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(including Novartis and its Affiliates, although they may not be specifically referenced by name) which such individual may receive, to the extent required to support MDRNA’s obligations under this Agreement;

 

  (f) MDRNA has the right to grant to Novartis the licenses under the MDRNA Technology that it purports to grant hereunder;

 

  (g) MDRNA has the right to use and disclose and to enable Novartis to use and disclose (in each case under appropriate conditions of confidentiality) the MDRNA Know-How free from Encumbrances;

 

  (h) MDRNA has the right to grant to Novartis the sublicense under the Michigan License that it purports to grant hereunder;

 

  (i) to the knowledge of MDRNA, the issued patents in the MDRNA Patents and the Michigan Patents are valid and enforceable without any claims, challenges, oppositions, interference or other proceedings pending or, to MDRNA’s knowledge threatened and MDRNA has filed and prosecuted patent applications within the MDRNA Patents in good faith and, to MDRNA’s knowledge complied with all duties of disclosure with respect thereto;

 

  (j) to MDRNA’s knowledge, MDRNA has not committed any act, or omitted to commit any act, that may cause the MDRNA Patents to expire prematurely or be declared invalid or unenforceable;

 

  (k) all application, registration, maintenance and renewal fees in respect of the MDRNA Patents as of the Effective Date have been paid and all necessary documents and certificates have been filed with the relevant agencies for the purpose of maintaining the MDRNA Patents;

 

  (l) MDRNA has complied in all material respects with its obligations required to be complied with by it to date under the Michigan License and it is not (with or without the lapse of time or the giving of notice, or both) in breach or default in any respect thereunder and, to MDRNA’s knowledge, no other party to the Michigan License is (with or without the lapse of time or the giving of notice, or both) in breach or default in any respect thereunder. Following the Effective Date, Novartis will be permitted to exercise all rights of a Sublicensee under the Michigan License. MDRNA has delivered to Novartis a complete and correct copy of the Michigan License, together with all modifications and amendments thereto, which is attached as Exhibit D;

 

  (m) to MDRNA’s knowledge, the practice of the MDRNA Technology and Michigan Patents do not infringe the Patents or misappropriate the Know-How of any Third Party, nor has MDRNA received any written notice alleging such infringement or misappropriation;

 

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  (n) MDRNA has not initiated or been involved in any proceedings or claims in which it alleges that any Third Party is or was infringing or misappropriating any MDRNA Technology or Michigan Patent Rights, nor have any such proceedings been threatened by MDRNA, nor does MDRNA know of any valid basis for any such proceedings;

 

  (o) MDRNA has taken all reasonable precautions to preserve the confidentiality of the MDRNA Know-How;

 

  (p) except as disclosed in Article 2 of the Michigan License, MDRNA has not entered into a government funding relationship that would result in rights to any products residing in the US Government, National Institutes of Health, National Institute for Drug Abuse or other agency, and the licenses granted hereunder are not subject to overriding obligations to the US Government as set forth in Public Law 96-517 (35 U.S.C. 200-204), as amended, or any similar obligations under the laws of any other country;

 

  (q) MDRNA has not granted any Third Party rights that would otherwise interfere or be inconsistent with Novartis’ rights hereunder, and there are no agreements or arrangements to which MDRNA or any of its Affiliates is a party relating to the products, MDRNA Patents, MDRNA Know-How or, except as set forth in the Michigan License, the Michigan Patents that would limit the rights granted to Novartis under this Agreement or that restrict or will result in a restriction on Novartis’ ability to develop, manufacture, register, use or commercialize the products in the Territory;

 

  (r) The rights granted hereunder to Novartis and its Affiliates under this Agreement have been granted in the ordinary course of business; and

 

  (s) Notwithstanding anything to the contrary contained in this Agreement, the representations and warranties of MDRNA contained in this Agreement do not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. Notwithstanding anything to the contrary contained in this Agreement, MDRNA has not failed to disclose to Novartis any fact or circumstance known to MDRNA and relating to any of the MDRNA Technology or the Michigan License or Michigan Patents that would be reasonably material to Novartis in connection with this Agreement or the transactions contemplated herein.

 

  9.3 Covenants of MDRNA. MDRNA covenants and agrees that:

 

  (a) it will not grant any interest in the MDRNA Technology which is inconsistent with the terms and conditions of this Agreement;

 

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  (b) if, at any time after execution of this Agreement, it becomes aware that it or any employee, agent or subcontractor of MDRNA who participated, or is participating, in the performance of any activities hereunder is on, or is being added to the FDA Debarment List or any of the three (3) FDA Clinical Investigator Restriction Lists referenced in Section 14.1(f), it will provide written notice of this to Novartis within two (2) Business Days of its becoming aware of this fact;

 

  (c) it shall comply with the terms of, and shall not terminate, and it shall not take any action or omit to take action that would constitute a breach, default or event of default (with or without notice or the lapse of time or both) or terminate or give rise to the right of Michigan to terminate the Michigan License;

 

  (d) it shall not modify, amend or waive any rights under the Michigan License in any manner that would adversely affect the license or other rights of Novartis under this Agreement, without the prior written consent of Novartis; and

 

  (e) it shall maintain insurance with respect to its activities and obligations under this Agreement in such amounts as are commercially reasonable in the industry for companies conducting similar business and shall require any of its Affiliates undertaking activities under this Agreement to do the same.

 

  9.4 No Other Warranties. EXCEPT AS EXPRESSLY STATED IN THIS SECTION 9, (A) NO REPRESENTATION, CONDITION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF NOVARTIS OR MDRNA; AND (B) ALL OTHER CONDITIONS AND WARRANTIES WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE ARE HEREBY EXPRESSLY EXCLUDED, INCLUDING ANY CONDITIONS AND WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.

 

10. INDEMNIFICATION; LIABILITY

 

  10.1 Indemnification by MDRNA. MDRNA shall defend, indemnify, and hold Novartis, its Affiliates, and their respective officers, directors, employees and agents, and all successors and assigns of any of the foregoing (“Novartis Indemnitees”) harmless from and against any Claims against them to the extent arising or resulting from:

 

  (a) the negligence or willful misconduct of MDRNA or any of its Affiliates; or

 

  (b) the breach of any of the covenants, representations or warranties made by MDRNA to Novartis under this Agreement;

provided, however, that MDRNA shall not be obliged to so indemnify, defend and hold harmless the Novartis Indemnitees for any Claims to the extent that Novartis has an obligation to indemnify MDRNA Indemnitees pursuant to Section 10.2 or to the extent

 

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that such Claims arise from the breach, negligence or willful misconduct of Novartis or a Novartis Indemnitee.

 

  10.2 Indemnification by Novartis. Novartis shall defend, indemnify, and hold MDRNA, its Affiliates, and their respective officers, directors, employees and agents, and all successors and assigns of any of the foregoing (“MDRNA Indemnitees”) harmless from and against any Claims against them to the extent arising or resulting from:

 

  (a) the negligence or willful misconduct of Novartis or any of its Affiliates or sublicensees;

 

  (b) the breach of any of the covenants, representations or warranties made by Novartis to MDRNA under this Agreement; or

 

  (c) any product liability Claim relating to any product or process covered by the MDRNA Technology and/or the Michigan Patents (whether such Claim is based upon negligence, strict liability or other theory of liability), which is made or sold by Novartis, its Affiliates or sublicensees of the license or sublicense granted under this Agreement.

provided, however, that Novartis shall not be obliged to so indemnify, defend and hold harmless the MDRNA Indemnitees for any Claims to the extent that MDRNA has an obligation to indemnify Novartis Indemnitees pursuant to Section 10.1 or to the extent that such Claims arise from the breach, negligence or willful misconduct of MDRNA or the MDRNA Indemnitee.

 

  10.3 Indemnification Procedure.

 

  (a) For the avoidance of doubt, all indemnification claims in respect of a Novartis Indemnitee or MDRNA Indemnitee shall be made solely by Novartis or mdRNA, respectively, on behalf of the Novartis Indemnitee or MDRNA Indemnitee, as the case may be.

 

  (b)

A Party seeking indemnification hereunder (“Indemnified Party”) shall notify the other Party (“Indemnifying Party”) in writing reasonably promptly after the assertion against the Indemnified Party of any Claim or fact in respect of which the Indemnified Party intends to base a claim for indemnification hereunder (“Indemnification Claim Notice”), but the failure or delay to so notify the Indemnifying Party shall not relieve the Indemnifying Party of any obligation or liability that it may have to the Indemnified Party, except to the extent that the Indemnifying Party demonstrates that its ability to defend or resolve such Claim is adversely affected thereby. The Indemnification Claim Notice shall contain a description of the claim and the nature and amount of the Claim (to the extent that the nature and amount of such Claim is known at such time). Upon the request of the Indemnifying Party, the Indemnified Party shall furnish promptly to the

 

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Indemnifying Party copies of all correspondence, communications and official documents (including court documents) received or sent in respect of such Claim.

 

  (c) Subject to the provisions of sub-Section (d) below, the Indemnifying Party shall, within [***] days after receipt of the Indemnification Claim Notice assume the defense and handling of such Claim, at the Indemnifying Party’s sole expense. The assumption of the defense of a Claim by the Indemnifying Party shall not be construed as acknowledgement that the Indemnifying Party is liable to indemnify any indemnitee in respect of the Claim, nor shall it constitute a waiver by the Indemnifying Party of any defenses it may assert against any Indemnified Party’s claim for indemnification. In the event that it is ultimately decided that the Indemnifying Party is not obligated to indemnify or hold an Iindemnitee harmless from and against the Claim, the Indemnified Party shall reimburse the Indemnifying Party for any and all reasonable costs and expenses (including attorneys’ fees and costs of suit) incurred by the Indemnifying Party in its defense of the Claim.

 

  (d)

Upon assumption of the defense of a Claim by the Indemnifying Party: (i) the Indemnifying Party shall have the right to and shall assume sole control and responsibility for dealing with the Claim; (ii) the Indemnifying Party may, at its own cost, appoint as counsel in connection with conducting the defense and handling of such Claim any law firm or counsel reasonably selected by the Indemnifying Party and reasonably satisfactory to the Indemnified Party (such consent not to be unreasonably withheld or delayed); (iii) the Indemnifying Party shall keep the Indemnified Party informed of the status of such Claim; and (iv) the Indemnifying Party shall have the right to settle the Claim on any terms the Indemnifying Party chooses; provided, however, that it shall not, without the prior written consent of the Indemnified Party, agree to a settlement of any Claim which could lead to liability or create any financial or other obligation on the part of the Indemnified Party for which the Indemnified Party is not entitled to indemnification hereunder or which admits any wrongdoing or responsibility for the claim on behalf of the Indemnified Party. The Indemnified Party shall cooperate with the Indemnifying Party at the Indemnifying Party’s expense. In particular, the Indemnified Party shall furnish such records, information and testimony, provide witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith; subject to the right of the Indemnified Party to obtain reasonable confidentiality protection in connection therewith. Such cooperation shall include access during normal business hours by the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Claim, and making the Indemnified Party, the Novartis Indemnitees or mdRNA Indemnitees, as the case may be, and its and their employees and agents available on a mutually convenient basis to provide additional information and explanation of any records or information provided.

 

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  The Indemnified Party shall be entitled to participate in, but not control, the defense of such Claim with its own counsel and at its own expense; provided, however, that if the litigants in any such action include both the Indemnified Party and the Indemnifying Party and legal counsel for the Indemnified Party shall have reasonably concluded in a written legal opinion delivered to the Indemnifying Party that, by reason of certain bona fide defenses available to the Indemnified Party which are different from or additional to those available to the Indemnifying Party, the interests of the Indemnified Party materially conflict with the interests of the Indemnifying Party such that it would be unethical under applicable rules relating to attorney conflicts of interest for the Indemnifying Party and such Indemnified Party to be represented by the same counsel with respect to such defense, the Indemnified Party shall have the right to select one separate counsel and to assume such legal defenses, with the reasonable expenses and fees of such separate counsel to be reimbursed by the Indemnifying Party as and when incurred.

 

  (e) If the Indemnifying Party fails to assume or conduct the defense and handling of any Claim in good faith as provided in Section 10.3(d) above, the Indemnified Party may, at the Indemnifying Party’s expense, select counsel reasonably acceptable to the Indemnified Party in connection with conducting the defense and handling of such Claim and defend or handle such Claim in such manner as it may deem appropriate; provided, that the foregoing shall not be construed as a limitation on the Indemnified Party’s right to claim that the Indemnifying Party has breached its obligations pursuant to this Section 10. In such event, the Indemnified Party shall keep the Indemnifying Party timely apprised of the status of such Claim and the Indemnified Party shall have the right to settle the Claim on any terms the Indemnified Party chooses; provided, however, that the Indemnified Party shall not, without the prior written consent of the Indemnifying Party, agree to a settlement of any Claim which could lead to liability or create any financial or other obligation on the part of the Indemnifying Party, other than its liability for indemnification of the Indemnified Party as provided in this Article 10, or which admits any wrongdoing or responsibility for the claim on behalf of the Indemnifying Party.

 

  10.4 Mitigation of Loss. Each Indemnified Party will take and will procure that its Affiliates take all such reasonable steps and action as are necessary or as the Indemnifying Party may reasonably require in order to mitigate any Claims (or potential losses or damages) under this Section 10. Nothing in this Agreement shall or shall be deemed to relieve any Party of any common law or other duty to mitigate any losses incurred by it.

 

  10.5

Special, Indirect and Other Losses. NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR PUNITIVE DAMAGES OR FOR ANY ECONOMIC LOSS OR

 

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LOSS OF PROFITS SUFFERED BY THE OTHER PARTY, EXCEPT TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS SECTION 10.

 

  10.6 No Exclusion. Neither Party excludes any liability for death or personal bodily injury caused by its or its Affiliate’s (or, in the case of Novartis, its sublicensee’s) negligence or that of their respective employees, agents or sub-contractors.

 

11. PUBLICATIONS AND PUBLICITY

 

  11.1 Publications

 

  (a) For a period of [***] days after the Effective Date (which [***] day period shall be extended for an additional [***] days at Novartis’ option), any proposed public disclosure (whether written, electronic, oral or otherwise) by MDRNA relating to any products and/or processes relating to the MDRNA Technology or Licensed Products shall require the prior written consent of Novartis (such consent not to be unreasonably withheld or delayed); provided, that the foregoing shall not apply to information which is in the public domain or any public disclosure required by law or governmental regulation or by the rules of any recognized stock exchange

 

  (b) For the avoidance of doubt, Novartis or any of its Affiliates may, without any required consents from MDRNA but subject to its confidentiality obligations under Article 6 of this Agreement with respect to the Confidentiality Information of MDRNA, (i) issue press releases and other public statements as it deems appropriate in connection with the development and commercialization of the products and/or processes under this Agreement; and (ii) publish or have published information about clinical trials related to the products, including the results of such clinical trials

 

  11.2 Publicity

 

  (a) Neither Party shall use the name, symbol, trademark, trade name or logo of the other Party or its Affiliates in any press release, publication or other form of public disclosure without the prior written consent of the other Party in each instance (such consent not to be unreasonably withheld or delayed), except for those disclosures for which consent has already been obtained. Notwithstanding the foregoing, Novartis shall be entitled, upon reasonable prior notice to MDRNA, to use the name of MDRNA to the extent necessary or useful in connection with the development or commercialization of the products, including in connection with sublicensing and subcontracting transactions.

 

  (b)

Each Party agrees not to issue any press release or other public statement, whether oral or written, disclosing the existence of this Agreement, the terms hereof or any

 

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  information relating to this Agreement without the prior written consent of the other Party; provided, however, that Novartis may issue press releases and other public statements as it deems appropriate in connection with the development and commercialization of products under this Agreement.

 

  (c) Notwithstanding the foregoing, each Party may make any disclosures required of it to comply with any duty of disclosure it may have pursuant to law or governmental regulation or pursuant to the rules of any recognized stock exchange. In the event of a disclosure required by law, governmental regulation or the rules of any recognized stock exchange, the Parties shall coordinate with each other with respect to the timing, form and content of such required disclosure. If so requested by the other Party, the Party subject to such obligation shall use commercially reasonable efforts to obtain an order, agreement or other governmental or Third Party action protecting to the maximum extent possible the confidentiality of such provisions of this Agreement as reasonably requested by the other Party. If the Parties are unable to agree on the form or content of any required disclosure, such disclosure shall be limited to the minimum required as determined by the disclosing Party in consultation with its legal counsel. Without limiting the foregoing, each Party shall consult with the other Party on the provisions of this Agreement, together with exhibits or other attachments attached hereto, to be redacted in any filings made by MDRNA or Novartis with the Securities and Exchange Commission (or other regulatory body) or as otherwise required by law. MDRNA also may file or submit such redacted version of this Agreement with NASDAQ in connection with maintaining its NASDAQ listing.

 

12. GENERAL PROVISIONS

 

  12.1 Assignment. Neither Party may assign its rights and obligations under this Agreement without the other Party’s prior written consent, except that (a) a Party may assign its rights and obligations under this Agreement or any part hereof to one or more of its Affiliates without the consent of the other Party; and (b) either Party may assign this Agreement in its entirety to a successor to all or substantially all of its business or assets to which this Agreement relates. The assigning Party shall provide the other Party with prompt written notice of any such assignment pursuant to clause (b) above. Any permitted assignee shall assume all obligations of its assignor under this Agreement (or related to the assigned portion in case of a partial assignment to an Affiliate), and no permitted assignment shall relieve the assignor of liability hereunder. Any attempted assignment in contravention of the foregoing shall be void. Subject to the terms of this Agreement, this Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns.

 

  12.2

Extension to Affiliates; Subcontractors. Novartis shall have the right to extend the rights, immunities and obligations granted in this Agreement to one or more of its Affiliates. All applicable terms and provisions of this Agreement shall apply to any such Affiliate to

 

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which this Agreement has been extended to the same extent as such terms and provisions apply to Novartis. Novartis shall remain primarily liable for any acts or omissions of its Affiliates. In addition, Novartis may subcontract to Third Parties the performance of any tasks and obligations relating to its exercise of the license and other rights under this Agreement as Novartis deems appropriate, subject to its confidentiality obligations pursuant to Article 6 of this Agreement.

 

  12.3 Severability. Should one or more of the provisions of this Agreement become void or unenforceable as a matter of law, then this Agreement shall be construed as if such provision were not contained herein and the remainder of this Agreement shall be in full force and effect, and the Parties will use their commercially reasonable efforts to substitute for the invalid or unenforceable provision a valid and enforceable provision which conforms as nearly as possible with the original intent of the Parties.

 

  12.4 Governing Law and Jurisdiction. This Agreement shall be governed by and construed under the laws of New York, without giving effect to the conflicts of laws provision thereof. Any disputes between the Parties relating to this Agreement shall be subject to the exclusive jurisdiction and venue of the federal courts located in the Southern District of New York (without restricting any right of appeal), and the Parties hereby waive any objection which they may have now or hereafter to the laying of venue of any proceedings in such courts and to any claim that such proceedings have been brought in an inconvenient forum, and further agree that a judgment or order in any such proceedings shall be binding upon each of them and may be enforced in the courts of any other jurisdiction.

 

  12.5 Force Majeure. Neither Party shall be responsible to the other for any failure or delay in performing any of its obligations under this Agreement or for other nonperformance hereunder if such delay or nonperformance is caused by strike, stoppage of labor, lockout or other labor trouble, fire, flood, accident, war, act of terrorism, act of God or of the government of any country or of any local government, or by other cause unavoidable or beyond the reasonable control of any Party hereto (a “Force Majeure Event”). Notwithstanding the foregoing, in no event shall a Party’s inability to obtain funding for its obligation hereunder constitute a Force Majeure Event.

 

  12.6 Waivers and Amendments. The failure of any Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party. No waiver shall be effective unless it has been given in writing and signed by the Party giving such waiver. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party.

 

  12.7

Relationship of the Parties. Nothing contained in this Agreement shall be deemed to constitute a partnership, joint venture, or legal entity of any type between MDRNA and Novartis, or to constitute one as the agent of the other. Moreover, each Party agrees not

 

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to construe this Agreement, or any of the transactions contemplated hereby, as a partnership for any tax purposes. Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give any Party the power or authority to act for, bind, or commit the other.

 

  12.8 Notices. All notices, consents, waivers, and other communications under this Agreement must be in writing and will be deemed to have been duly given when: (a) delivered by hand (with written confirmation of receipt); (b) sent by fax (with written confirmation of receipt), provided, that a copy is immediately sent by an internationally recognized overnight delivery service (receipt requested); or (c) when received by the addressee, if sent by an internationally recognized overnight delivery service (receipt requested), in each case to the appropriate addresses and fax numbers set forth below (or to such other addresses and fax numbers as a Party may designate by notice):

If to MDRNA:

mdRNA, Inc.

3830 Monte Villa Parkway

Bothell, WA 98021

Attn: Mr. J. Michael French, President and CEO

Fax: (425)  ###-###-####

with a copy to:

Sills Cummis & Gross

One Riverfront Plaza

Newark, NJ 07102

Attn: Ira A. Rosenberg, Esq.

Fax: (973)  ###-###-####

If to Novartis:

Novartis Institutes for BioMedical Research, Inc.

220 Massachusetts Avenue

Cambridge, Massachusetts 02139

Attn: General Counsel

Fax: (617)  ###-###-####

 

  12.9 Further Assurances. Novartis and MDRNA hereby covenant and agree without the necessity of any further consideration, to execute, acknowledge and deliver any and all such other documents and take any such other action as may be reasonably necessary to carry out the intent and purposes of this Agreement.

 

  12.10

Compliance with Law. Each Party shall perform its obligations under this Agreement in accordance with all applicable laws. No Party shall, or shall be required to, undertake

 

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any activity under or in connection with this Agreement which violates, or which it believes, in good faith, may violate, any applicable law.

 

  12.11 No Third Party Beneficiary Rights. The provisions of this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they shall not be construed as conferring any rights to any Third Party (including any third party beneficiary rights).

 

  12.12 English Language. This Agreement is written and executed in the English language. Any translation into any other language shall not be an official version of this Agreement and in the event of any conflict in interpretation between the English version and such translation, the English version shall prevail.

 

  12.13 Expenses. Except as otherwise expressly provided in this Agreement, each Party shall pay the fees and expenses of its respective lawyers and other experts and all other expenses and costs incurred by such Party incidental to the negotiation, preparation, execution and delivery of this Agreement.

 

  12.14 Entire Agreement. This Agreement, together with its Exhibits, sets forth the entire agreement and understanding of the Parties as to the subject matter hereof and supersedes all proposals, oral or written, and all other prior communications between the Parties, including the Confidentiality Agreement, with respect to such subject matter. In the event of any conflict between a substantive provision of this Agreement and any Exhibit hereto, the substantive provisions of this Agreement shall prevail.

 

  12.15 Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

  12.16 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

 

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IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives.

 

NOVARTIS INSTITUTES FOR

BIOMEDICAL RESEARCH, INC.

    MDRNA, INC.
By:   /s/ Mark C. Fishman     By:   /s/ J. Michael French
Name:   Mark C. Fishman     Name:   J. Michael French
Title:   President and CEO     Title:   President and CEO

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

EXHIBIT A

MDRNA PATENTS

[***]

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

EXHIBIT B

MICHIGAN PATENTS

[***]

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

EXHIBIT C

SAMPLE INVOICE

 

Sender’s Logo      

INVOICE

 

INVOICE DATE:            

                        200            

 

INVOICE No.: XXXX

  

 

Street

Town, Country

Phone and Fax Nr.

        
        
        
        
Bill To:    For:      

 

And via fax to no. +1 ###-###-####   

DESCRIPTION [Please specify the event for which the invoice is due]

     AMOUNT (USD)
   US$ 000,000.00

Novartis Contract Code

  

Please remit by wire transfer within 60 days to:

  

Receiving Bank -                             

  

Swift Code -                             

  

ABA Number -                             

  

Credit Account -                             

  

Beneficiary -                             

  

TOTAL

   US$ 000,000.00

If you have any questions concerning this invoice, contact                                 

or e-mail to                             

VAT -Reg. No. Xxxxxxxxxx (if applicable)

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

EXHIBIT D

MICHIGAN LICENSE

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

EXHIBIT E

GECC AGREEMENT

 

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]

 

EXHIBIT F

PAYMENT INSTRUCTIONS

The payment set forth in Section 4.1 shall be paid as follows: (a) Four Million Seven Hundred and Fifty Thousand Dollars ($4,750,000) to MDRNA; and (b) Two Million Five Hundred Thousand Dollars ($2,500,000) to General Electric Capital Corporation, on behalf of MDRNA.

 

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