EX-10.3 2 d305720dex103.htm LICENSE AGREEMENT [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...
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.]
THIS LICENSE AGREEMENT (the “Agreement”) is made and entered into effective as of December 22, 2011 (the “Effective Date”) by and between XXXXX THERAPEUTICS, INC., a Delaware corporation with a place of business at 0000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxx, Xxxxx 00000 (“MirnaRx”), and MARINA BIOTECH, INC., a Delaware corporation with a place of business at 0000 Xxxxx Xxxxx Xxxxxxx, Xxxxxxx, Xxxxxxxxxx 00000 XXX (“Marina Bio”). Marina Bio and MirnaRx are sometimes referred to herein individually as a “Party”, and collectively as the “Parties.”
ARTICLE 1
For purposes of this Agreement, the following terms shall have the meanings as set forth below:
1.1 “Additional Indication” means, with respect to a particular Licensed Product, an indication for treating or preventing a human disease or condition that is the subject of and covered by a unique NDA application and Regulatory Approval, different from and subsequent to the original Regulatory Approval for such Licensed Product.
1.2 “Affiliate” means, with respect to a particular Party, an entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, the term “control” (with correlative meanings for the terms “controlled by” and “under common control with”) means that the applicable entity has the actual power, direct or indirect, to direct and to cause the direction of the management and policies of the applicable other entity, whether through ownership of fifty
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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.]
percent (50%) or more of the voting securities of such other entity, by contract or otherwise. An entity will be an Affiliate for purposes of this Agreement only so long as it satisfies the definition set forth above in this Section.
1.3 “Applicable Law” means all applicable laws, rules, ordinances, and regulations, including any rules, regulations, guidelines or other requirements of relevant government agencies, that may be in effect from time to time in the applicable country or jurisdiction, applicable to the specific activities being undertaken pursuant to this Agreement.
1.4 “Available” means, with respect to a particular MirnaRx Compound for which MirnaRx submits a notice under Section 2.6, that at the time of such notice Marina Bio is not bound by an agreement with a Third Party that grants such Third Party exclusive license rights under the Licensed Technology with respect to such MirnaRx Compound.
1.5 “Bankrupt Party” shall have the meaning ascribed to such term in Section 10.2(b).
1.6 “Claim” means any claim, allegation, suit, complaint, action or legal proceeding.
1.7 “Commercialize” or “Commercialization” means those activities comprising or relating to the manufacturing, promotion, marketing, advertising, distribution and sale of Licensed Products, including Phase IV Trials or equivalent clinical trials conducted following Regulatory Approval as needed or useful to promote and market the Licensed Product and/or maintain such Regulatory Approval.
1.8 “Commercially Reasonable Efforts” means, with respect to particular tasks or activities hereunder in developing or Commercialization Licensed Product, a level of efforts applied to such tasks or activities reasonably consistent with the efforts commonly used by similarly-situated companies in the pharmaceutical industry to conduct such activities on products at a similar (as compared to the Licensed Product at the applicable time) stage in its product life and of similar market potential, profit potential and strategic value resulting from its own research efforts, based on information and conditions then-prevailing, including, without limitation, efficacy of the product, the competitiveness of alternative products in the marketplace, the patent and other proprietary position of the product, the likelihood of regulatory approval given the regulatory structure involved and the likelihood of adequate reimbursement. Commercially Reasonable Efforts shall be determined on a country-by-country or market-by-market basis (as most applicable) for a particular Licensed Product, and it is anticipated that the level of effort will change over time reflecting changes in the status of the Licensed Product and the country (or markets) involved.
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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.]
1.9 “Confidential Information” of a Party means all confidential or proprietary Information received or otherwise obtained by the other Party from such Party or its Affiliates pursuant to this Agreement, other than that portion of such information that:
(a) is now, or hereafter becomes, generally available to the public through no fault of the receiving Party, or its Affiliates, or any entity that obtained such information or materials from the receiving Party;
(b) the receiving Party or its Affiliates already possesses, as evidenced by its written records, prior to receipt thereof from the disclosing Party;
(c) is obtained without restriction from a Third Party that had the legal right to disclose the same to the receiving Party or its Affiliates; or
(d) has been independently developed by the receiving Party or its Affiliates without the aid, application or use of any Confidential Information of the disclosing Party, as demonstrated by competent written proof.
1.10 “Confidentiality Agreement” shall mean that certain Confidential Disclosure Agreement dated November 25, 2011, among Marina Bio, MirnaRx and [***].
1.11 “Cumulative Sublicense Fees” shall have the meaning ascribed to such term in Section 5.6.
1.12 “Default” shall mean a failure by a Party to perform one or more of its material obligations under this Agreement which, if not cured within the applicable cure period set forth in Section 10.2(c) or (d), is likely to cause material harm to the other Party.
1.13 “Dispute” shall have the meaning ascribed to such term in Section 11.1.
1.14 “Field of Use” means any use of Licensed Product for or relating to [***].
1.15 “Field Infringement” shall have the meaning ascribed to such term in Section 6.4.
1.16 “Financial Event” shall have the meaning ascribed to that term in Section 10.2(b).
1.17 “First Commercial Sale” means, with respect to a particular country, the first commercial sale of a Licensed Product by MirnaRx, its Affiliates or Sublicensees to a Third Party in a country, after all needed Regulatory Approvals for the Licensed Product have been granted in such country.
1.18 “GAAP” means generally accepted accounting principles.
1.19 “Generic Product” means, with respect to a Licensed Product, a generic product containing the applicable Selected MirnaRx Compound in a formulation similar to and substitutable for such Licensed Product.
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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.]
1.20 “Improvement Patent Claim” means any claim in a patent application filed by MirnaRx (or in any patent issuing on any such application) that: (i) claims any improvements, modifications or enhancements to the Licensed Technology invented by MirnaRx prior to the date [***] after the Effective Date in conducting manufacturing process development and scale-up with respect to the Licensed Technology under this Agreement, and (ii) cannot be practiced without infringing the Licensed Patents, and including for clarity applicable claims in continuing patent applications (such as continuations, divisions, or continuations-in-part) or in any reissue, re-examined or extended patent. For clarity, the term “Improvement Patent Claims” expressly excludes: (x) any claims in patent applications or patents covering inventions made by or on behalf of MirnaRx (or its Affiliate) prior to the Effective Date without use of any Confidential Information or materials of Marina Bio, and (y) any claims in patent applications or patents covering inventions made by or on behalf of MirnaRx (or its Affiliate) after the Effective Date but independent of work done under this Agreement, in each case without use of any Confidential Information or materials of Marina Bio.
1.21 “IND” means an Investigational New Drug application, as defined in 21 C.F.R. 312 or any successor regulation or comparable application in accordance with the Regulatory Authority in the applicable jurisdiction.
1.22 “Indemnified Party” shall have the meaning ascribed to it in Section 8.3.
1.23 “Indemnifying Party” shall have the meaning ascribed to it in Section 8.3.
1.24 “Information” means any and all data, results, improvements, processes, methods, protocols, formulas, inventions, know-how, trade secrets and any other information, patentable or otherwise, which may include (but is not limited to) scientific, research and development, manufacturing know-how, pre-clinical, clinical, regulatory, manufacturing, safety, marketing, financial and commercial information or data.
1.25 “Licensed Know-How” means any and all proprietary Information owned or controlled by Marina Bio (or its Affiliate) that relates directly to the use or practice of the Licensed Patents and/or is otherwise necessary to develop, make, use or sell Licensed Product.
1.26 “Licensed Patent” means:
(a) The patents and patent applications that are owned or controlled by Marina Bio or its Affiliate that claim or cover the Marina Bio Technology (including the manufacture or use thereof), including those patents and patent applications listed in Appendix A of this Agreement;
(b) all additional patent applications based on or relating to the patents and applications set forth in subclause (a) above;
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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.]
(c) any and all patent applications that are continuing applications (including continuations, continuations-in-part or divisionals, or any foreign equivalents thereof) of the patents and applications described in (a) or (b) above;
(d) any and all issued and unexpired patents resulting from any of the applications described in (a), (b) or (c) above;
(e) any and all issued and unexpired reissues, reexaminations, renewals, extensions (and any foreign equivalents of any of the foregoing) of any of the patents described in (a), (c) or (d) above; and
(f) any and all supplemental protection certificates (and any foreign equivalents thereof) applicable to products that, prior to the expiration of any patents listed on Appendix A or any patents included in the scope of (d) above, were covered by one or more Valid Claims of such patents.
1.27 “Licensed Product” means a pharmaceutical composition developed or sold by MirnaRx (or its Affiliate or Sublicensee) that contains a Selected MirnaRx Compound and Marina Bio Technology and is claimed or covered by the Licensed Patents, and including any improvements, enhancements or modifications to such composition.
1.28 “Licensed Technology” means the Licensed Patents and Licensed Know-How.
1.29 “Losses” means costs and expenses (including, without limitation, reasonable legal expenses and attorneys’ fees), judgments, liabilities, fines, damages, assessments and/or other losses.
1.30 “Major Market” means [***]. For clarity, obtaining Regulatory Approval of Licensed Product from [***], shall be deemed to be obtaining a Regulatory Approval in a Major Market for purposes of the applicable provisions of this Agreement.
1.31 “Manufacturing Processes” means all Information that is Controlled by Marina Bio or its Affiliates and is used to manufacture the delivery formulation in the Marina Bio Technology.
1.32 “Marina Bio Indemnitees” shall have the meaning ascribed to such term in Section 8.2.
1.33 “Marina Bio Technology” means Marina Bio’s proprietary NOV340 formulation referred to generally as SMARTICLES® liposomal delivery technology and including any Technology Improvements.
1.34 “Milestone Payment Sum” shall have the meaning ascribed to such term in Section 5.6.
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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.]
1.35 “xxXXX Compound” means a product containing, comprised of or based on a native or chemically modified RNA oligomer designed to either provide the function of a xxXXX and/or modulate a xxXXX, where xxXXX is understood to be a naturally occurring short RNA molecule found in eukaryotic cells.
1.36 “MirnaRx Compound” means any xxXXX Compound that is researched or developed by MirnaRx (or its Affiliate) for use in the Field of Use.
1.37 “MirnaRx Indemnitees” shall have the meaning ascribed to such term in Section 8.1.
1.38 “NDA” means a New Drug Application, as defined in 21 C.F.R. 314, and any other appropriate application or registration submitted to the appropriate Regulatory Authority in a particular country in the Territory to seek Regulatory Approval for sale of Licensed Product in such country.
1.39 “Net Sales” means, with respect to a certain time period, all revenues recognized, and deductions applied, in accordance with GAAP consistently applied, based on invoices for the sales of Licensed Products sold by MirnaRx or its Affiliate to Third Parties (but not including sales relating to transactions between MirnaRx, its Affiliates and/or its respective Sublicensees and agents) during such time period, less the total of the following estimated and/or incurred charges or expenses with respect to such sales: (a) [***]; (b) [***]; (c) [***]; (d) [***]; (e) [***]; (f) [***]; and (g) [***].
Any disposal of Licensed Products for, or use of Licensed Products in, clinical or pre-clinical trials, given as free samples, including, without limitation, sample cards, or distributed for indigent programs shall not be included in Net Sales.
Upon any sale or other disposal of any Licensed Product that should be included within Net Sales for any consideration other than an exclusively monetary consideration on bona fide arm’s-length terms, then for purposes of calculating the Net Sales under this Agreement, [***].
1.40 “Option Compound” means any of the MirnaRx Compounds on the list in the Side Letter (not to exceed [***] compounds, but subject to the substitution rights in Section 2.6), or, for any such MirnaRx Compound, any other MirnaRx Compound that has at least [***]% sequence homology with such compound.
1.41 “Phase IV Trial” means a clinical trial of a pharmaceutical product initiated in a country in an approved indication after receipt of Regulatory Approval for such product in such indication in such country, intended to delineate additional information about such product’s risks, benefits and/or optimal use.
1.42 “Prosecution” shall have the meaning ascribed to such term in Section 6.3.
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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.]
1.43 “Regulatory Approval” means all approvals (including supplements, amendments, pre- and post-approvals and price approvals), licenses, registrations or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the distribution, use or sale of a Licensed Product in the applicable country or regulatory jurisdiction.
1.44 “Regulatory Authority” means any regulatory agency, department, bureau, commission, council or other governmental entity involved in granting approvals, registrations or licenses for the development, manufacturing, marketing, reimbursement and/or pricing of a Licensed Product in a particular country or regulatory jurisdiction.
1.45 “Regulatory Documents” means all regulatory documents and filings, correspondence with Regulatory Authorities, annual reports and amendments thereto related to a Licensed Product.
1.46 “Royalty Term” means, as to a particular Licensed Product sold in a country, the period from the date of First Commercial Sale of such Licensed Product in such country until the later of: (i) the date of expiration of the last to expire patent included in the Licensed Patents having a Valid Claim that claims the Licensed Product in such country, or (ii) [***] after such First Commercial Sale of the Licensed Product in such country.
1.47 “Royalties Report” shall have the meaning ascribed to such term in Section 5.7.
1.48 “Selected MirnaRx Compound” means: (a) the MirnaRx Compound known as [***] (the sequence of which is set forth in the Side Letter); or (b) any other MirnaRx Compound that MirnaRx selects, as provided in Section 2.6, to combine with the Marina Bio Technology and to develop (or have developed) as a Licensed Product, and including, for any such Selected MirnaRx Compound, any other MirnaRx Compound that has at least [***]% sequence homology with such Selected MirnaRx Compound.
1.49 “Side Letter” means that certain letter agreement between the Parties dated as of the Effective Date.
1.50 “Sublicensee” means a sublicensee, direct or indirect, of MirnaRx under MirnaRx’s rights pursuant to Section 2.1.
1.51 “Sublicense Fees” shall have the meaning as ascribed to such term in Section 5.6.
1.52 “Sublicensing Revenues” means all consideration received by MirnaRx (or its Affiliate) from a Sublicensee in consideration of the grant of a sublicense under the Licensed Patents to such Sublicensee (which may include upfront fees, milestone payments, royalties and other similar fees), but excluding: (a) any amounts paid as reimbursement of research or development costs and expenses incurred by MirnaRx or its Affiliate (including past and ongoing costs and expenses) relating to Licensed Product; (b) direct reimbursement of patent prosecution or enforcement costs; (c) payments of a share of amounts recovered in enforcing
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patent or other intellectual property rights (except to the extent such share is calculated or treated as royalties under the terms of such sublicense); (d) transfer price payments for sale of compounds or products ([***] of actual fully-burdened cost of goods; (e) bona fide loans on commercial terms; and (f) any payments made to purchase equity in MirnaRx or a MirnaRx Affiliate at fair market value.
1.53 “Technology Improvement” means any improvements, enhancements or modifications to the Marina Bio Technology created solely by Marina Bio within [***] of the Effective Date of the Agreement and which are not created pursuant to any agreement between Marina Bio and a Third Party, but excluding agreements with a contract research organization or consultant (or similar organization) that is contracted to improve the technology on behalf of Marina Bio and where Marina Bio owns or has exclusive license rights to the improvements made under such agreement.
1.54 “Term” means the term of this Agreement as set forth in Section 10.1.
1.55 “Territory” means [***].
1.56 “Third Party” means any entity or person other than Marina Bio or MirnaRx or an Affiliate of either of them.
1.57 “Third Party Claim” means any claim, action, allegation, suit or legal proceeding brought by a Third Party against another entity or person.
1.58 “Trademark” means any trade name, service xxxx, logo or trademark (whether or not registered), together with all goodwill associated therewith, and any renewals, extensions or modifications thereto.
1.59 “True-Up Payment” shall have the meaning ascribed to such term in Section 5.6.
1.60 “Valid Claim” means an unexpired claim of an issued patent within the Licensed Patents that has not been ruled to be unpatentable, invalid or unenforceable by a court or other authority in the country of the patent with competent jurisdiction, from which decision no appeal is taken or can be taken.
ARTICLE 2
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Licensed Patents and Licensed Know-How solely to make and conduct research on compositions containing MirnaRx Compound, but excluding any rights to conduct clinical development on or to sell, offer for sale or otherwise commercialize any such compositions.
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ARTICLE 3
PRODUCT DEVELOPMENT AND REGULATORY MATTERS
(a) drug product research and development is uncertain and has many risks and potential problems (including efficacy and toxicity issues), and that the development program on Licensed Products may produce no results, or unpredictable or inaccurate results, or results that cannot support Regulatory Approval or further development or commercial activity;
(b) Neither Party gives to the other any warranty or assurance that the development program for Licensed Products will have any particular result, that Regulatory Approval(s) will be obtained, or that such product development or Commercialization will be successful;
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(c) For the avoidance of doubt, deviations from or changes to the development program on Licensed Product due to unexpected, unpredictable, inaccurate, or otherwise undesirable results (including results indicating toxicity issue or a lack of efficacy) shall not be considered a failure of MirnaRx to meet its obligations hereunder and it shall not be deemed a material breach to this Agreement per Section 10.2(c) of this Agreement.
ARTICLE 4
COMMERCIALIZATION; MANUFACTURING
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conduct such Commercialization activities of a Licensed Product in the Field of Use in the Major Markets and in such other countries in the Territory where MirnaRx determines it is commercially reasonable to do so. MirnaRx may satisfy the foregoing diligence obligation through activities of its Affiliates, subcontractors and/or Sublicensees. MirnaRx (and its Affiliates and Sublicensees) shall have sole control over all decisions regarding Commercialization, including pricing and marketing strategies.
4.3 Manufacturing. MirnaRx (and/or its Affiliate or Sublicensee) shall have the sole responsibility for conducting all manufacturing process development and scale-up, as needed to have an appropriate manufacturing process for Licensed Products sufficient to meet all expected demand for Licensed Products. Marina Bio shall provide all reasonable assistance to MirnaRx as reasonably requested by MirnaRx in such manufacturing scale-up efforts with respect to the Marina Bio Technology components of the applicable Licensed Product. MirnaRx shall reimburse Marina Bio for its reasonable expenses in providing the above assistance, at agreed rates that reflect the actual internal costs of such assistance.
ARTICLE 5
CONSIDERATION; PAYMENTS; REPORTS
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(a) In part consideration of the license rights granted by Marina Bio under this Agreement, MirnaRx shall pay to Marina Bio a milestone payment upon first achievement by MirnaRx (independent of work done by or in collaboration with a Sublicensee) of the applicable milestone event set forth in the table below, such payments to be in the listed amounts for the applicable milestone event:
Milestone Event | Milestone Payment | |||
(i) For each Licensed Product: | ||||
(1) [***] | $ | [***] | ||
(2) [***] | $ | [***] | ||
(3) [***] | $ | [***] | ||
(4) [***] | $ | [***] | ||
(ii) For each Additional Indication for the Licensed Product, up to total of [***] Additional Indications: | ||||
(1) [***] | $ | [***] |
For clarity each of the above milestone payments shall be paid only once for a particular Licensed Product, regardless if any such Milestone Event is achieved more than once, [***]. Further, if a particular Licensed Product achieves a particular Milestone Event under subclause (i) of the above table without having achieved a previous Milestone Event in such subclause (i), then such previous Milestone Event shall be deemed also achieved, and the Milestone Payment associated with such Milestone Event shall then be paid with the achievement of the subsequent Milestone Event. For illustrative purposes only, if the [***] Milestone Event as set forth in (i)(3) in the table above is not achieved for a Licensed Product but the [***] Milestone Event as set forth in (i)(4) above is achieved for such Licensed Product, then the Milestone Payment for achievement of the Milestone Event in clause (i)(3) ($[***]) will be paid when the Milestone Payment for (i)(4) is paid. The total amount of milestone payments payable for a particular Licensed Product under the above shall not, in any event, exceed $[***] under subclause (i) of the above table and $[***] in total. For additional clarity, if MirnaRx (or its Affiliate) enters into a sublicense Agreement under which the applicable Sublicensee is granted sublicense rights to Commercialize a Licensed Product, then achievement of any of the above Milestone Events by
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such Sublicensee, or by MirnaRx or its Affiliate working in collaboration with such Sublicensee under the sublicense agreement, shall not create a Milestone Payment obligation, but instead MirnaRx shall have the obligation to share Sublicense Revenues received under such sublicense agreement as provided in Section 5.6 below.
(b) MirnaRx shall promptly notify Marina Bio of the achievement of any Milestone Event for each Licensed Product. All Milestone Payments under subsection (a) above are non-refundable and non-creditable, and shall be due within [***] of achievement of the applicable Milestone Event.
(a) For sales of License Product in country(ies) where such sale would infringe, absent the license granted in Section 2.1, a Valid Claim of an issued Licensed Patent, MirnaRx shall pay to Marina Bio royalties equal to [***]% of the Net Sales revenue recognized by MirnaRx or any of its Affiliates from such sales;
(b) For sales of License Product in country(ies) where either (i) there is no Valid Claim in an issued Licensed Patent that would be infringed, absent the license granted in Section 2.1, by such sale of the Licensed Product, or (b) there are sales of Generic Products during the same royalty period as such sales of Licensed Product, then MirnaRx shall pay to Marina Bio royalties equal to [***]% of the Net Sales revenue recognized by MirnaRx or any of its Affiliates from such Licensed Product sales.
5.5 Anti-Stacking Provisions. If MirnaRx or its Affiliate owes to one or more Third Parties, under license agreement(s) granting MirnaRx (or its Affiliate or Sublicensee) license rights covering patents (or other intellectual property rights) that are needed to make, use, sell or otherwise Commercialize the Licensed Technology as contained in the Licensed Product, royalties or similar payments on sales of such Licensed Products, then MirnaRx may reduce the royalties owed to Marina Bio under Section 5.4 based on such sales of Licensed Product by [***]% of the royalty or similar payments actually paid to such Third Parties, provided that MirnaRx shall not reduce any particular royalty payment to Marina Bio by more than [***]% of the amount otherwise owed under the royalty provisions of Section 5.4 for the applicable royalty period.
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5.6 Sublicense Fees. In part consideration of the license rights granted by Marina Bio under this Agreement and the right to sublicense such licenses, MirnaRx shall pay to Marina Bio an amount (“Sublicense Fees”) equal to a percentage of any Sublicensing Revenue received by MirnaRx (or its Affiliate) from any Sublicensee based on the grant to such Sublicensee of sublicense rights under MirnaRx’s license rights under the Licensed Patents. Such percentage shall be determined based on the development stage of the applicable Licensed Product (that is covered by the sublicense) at the time that the particular sublicense agreement is executed by the parties thereto, as follows:
[***] | Percentage of Sublicense Revenue | |||
[***] | [***] | % | ||
[***] | [***] | % | ||
[***] | [***] | % | ||
[***] | [***] | % | ||
[***] | [***] | % |
If, as to a particular Licensed Product being developed by a Sublicensee, such Sublicensee first achieves, with respect to such Licensed Product, one of the Milestone Events in the milestone table in Section 5.3(a) above, then in no event will the cumulative amount (the “Cumulative Sublicense Fees”, as of the applicable date) of Sublicense Fees paid to Marina Bio by MirnaRx under this Section 5.6, by the date [***] after the date that such Milestone Event is achieved, with respect to Sublicense Revenues received by MirnaRx from such Sublicensee, be less than the cumulative amount (the “Milestone Payment Sum”, as of the applicable date) of the Milestone Payments that would have been due under Section 5.3(a) by such date, for all Milestone Events achieved by such Sublicensee (as of such date), had MirnaRx achieved such Milestone Events. If, as to a Sublicensee that first achieves a particular Milestone Event for the applicable Licensed Product sublicensed to such Sublicensee, the Cumulative Sublicense Fees paid by MirnaRx to Marina Bio based on Sublicense Revenues received from such Sublicensee, by the date that is [***] after the date when such Milestone Event is achieved, is less than the Milestone Payment Sum effective as of such date, then MirnaRx will by such date also pay to Marina Bio the amount of such difference (such amount, the “True-Up Payment” as to the applicable Milestone Event achieved by such Sublicensee). An example of the calculation of such amounts and the determination of such difference (if any) is given in Appendix B of this Agreement. For clarity, any such True-Up Payment shall be deemed a Sublicensee Fee payment for all purposes of this Agreement. Further, if in the sublicense agreement between MirnaRx and a particular Sublicensee, the definition of “Major Markets” (or equivalent definition) is different from the definition in Section 1.27 of this Agreement, then the definition in such sublicense agreement will be used with respect to the achievement of the Milestone Event in subclause (i)(4) of the milestone table in Section 5.3(a) above, for the purpose of determining whether any “True-Up Payment” is owed by MirnaRx based on the Sublicensee achieving Regulatory Approval of the applicable Licensed Product in a Major Market.
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Royalty Term applicable to such Licensed Product in such country. All such royalty payments are non-refundable and non-creditable and shall be due within [***] of the end of each calendar quarter and are payable in immediately available funds. The Sublicense Fees owed under Section 5.6 shall be paid, with respect to particular Sublicense Revenue received by MirnaRx, within [***] of MirnaRx’s receipt of the applicable revenues, and are payable in immediately available funds. MirnaRx shall notify Marina Bio in writing promptly upon the first commercial sale of Licensed Product in each country and thereafter MirnaRx shall furnish Marina Bio with a written report (the “Royalties Report”) for each completed [***] showing, on a country-by-country basis, according to the volume of units of Licensed Product sold in each such country (by SKU) during the reporting period (whether Product is sold by MirnaRx or its Affiliates or Sublicensees): (a) the gross invoiced sales of the Product sold in each country during the reporting period, and the amounts deducted therefrom to determine Net Sales from such gross invoiced sales; (b) the royalties payable in dollars, if any, which shall have accrued hereunder based upon Net Revenues from sales of Product; and (c) the withholding taxes, if any, required by Applicable Law to be deducted in respect of such sales (provided that, as to sales by Sublicensees, MirnaRx shall report only the net sales numbers (using the definition for such term in the applicable sublicense agreement) as reported by the Sublicensee, if such Sublicensee does not report gross invoiced sales numbers). With respect to sales of Licensed Product invoiced in US dollars, the gross invoiced sales, Net Revenues and royalties payable shall be expressed in the Royalties Report in US Dollars. With respect to sales of Licensed Product invoiced in a currency other than US dollars, the gross invoiced sales, Net Sales and royalties payable shall be expressed in the Royalties Report in the domestic currency of the party making the sale as well as in the US dollar equivalent of the Royalty payable and the exchange rate used in determining the amount of US dollars. The US dollar equivalent shall be calculated on a calendar-month basis using the average monthly interbank rate listed in the Wall Street Journal.
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ARTICLE 6
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18 | Execution Version |
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ARTICLE 7
REPRESENTATIONS, WARRANTIES AND COVENANTS
(e) Disclaimer. EXCEPT FOR THE WARRANTIES EXPRESSLY SET FORTH ABOVE IN THIS SECTION 7.1, MARINA BIO MAKES NO OTHER REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, OF ANY KIND, INCLUDING AS TO MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR NON-INFRINGEMENT OF THE LICENSED TECHNOLOGY OR THE LICENSED PRODUCTS.
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(a) Corporate Existence and Power. MirnaRx is a corporation duly organized, validly existing and in good standing under the laws of Delaware, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted.
(b) Authority and Binding Agreement. MirnaRx has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder. MirnaRx has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder. The Agreement has been duly executed and delivered by MirnaRx and constitutes a legal, valid and binding obligation of MirnaRx that is enforceable against it in accordance with its terms.
(d) EXCEPT FOR THE WARRANTIES EXPRESSLY SET FORTH ABOVE IN THIS SECTION 7.2, MIRNARX MAKES NO OTHER REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, OF ANY KIND, INCLUDING AS TO MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR NON-INFRINGEMENT, OR THAT THE DEVELOPMENT OR COMMERCIALIZATION OF ANY LICENSED PRODUCT WILL BE SUCCESSFUL.
ARTICLE 8
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8.2 Indemnification by MirnaRx. MirnaRx hereby agrees to defend, hold harmless and indemnify Marina Bio and its Affiliates, and each of their respective officers, directors and employees (collectively, the “Marina Bio Indemnitees”), from and against any and all Losses arising out of any Third Party Claim based upon or resulting from: (i) any of MirnaRx’s representations and warranties set forth in Section 7.2 of this Agreement being untrue in any material respect when made; (ii) MirnaRx’s or its Affiliate’s failure to perform, in any material respect, any covenant or obligation of MirnaRx set forth in this Agreement; (iii) the exercise or practice by MirnaRx, its Affiliates or Sublicensees of the licenses granted to MirnaRx under Sections 2.1 (excluding any such Claim that alleges that the exercise or practice of the Licensed Technology infringes a patent or misappropriates other intellectual property of the Third Party); or (iv) the development, manufacture or Commercialization of any Licensed Product by or for MirnaRx, its Affiliates or Sublicensees; except, in each case, to the extent any such Losses result from the gross negligence or willful misconduct of Marina Bio Indemnitees or from the breach of any representation or warranty or covenant or obligation under this Agreement by Marina Bio.
21 | Execution Version |
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ARTICLE 9
(a) If, based upon the advice of legal counsel skilled in the subject matter, a Party is required to disclose specific Confidential Information of the other Party to comply with an applicable law, regulation, legal process, or order of a government authority or court of competent jurisdiction, the Party may disclose such Confidential Information only to the entity or person required to receive such disclosure; provided, however, that the Party required to disclose such Confidential Information shall (a) to the extent permitted by such law, regulation, process, order or rules, first have given prompt (but in no event less than five (5) business days) advance notice to such other Party to enable it to seek any available exemptions from or limitations on such disclosure requirement and shall reasonably cooperate in such efforts by the other Party, (b) furnish only the portion of the Confidential Information which is legally required to be disclosed; (c) use all reasonable efforts to secure confidential protection of such Confidential Information, and (d) continue to perform its obligations of confidentiality and non-use set out in this Article 9.
(b) MirnaRx (and its Affiliates and Sublicensees) may disclose Confidential Information of Marina Bio to Regulatory Authorities to the extent such disclosure is reasonably necessary in regulatory filings required for the development and/or commercialization of Licensed Products. In addition, each Party may disclose Confidential Information of the other Party to the extent such disclosure is reasonably necessary in the following instances: filing or prosecuting patents as permitted by this Agreement; and disclosure to Affiliates and Sublicensees and potential Sublicensees or other similar commercial partners, who need to know such information for the development, manufacture and commercialization of Licensed Products, to bankers, lawyers, accountants, agents or other Third Parties in connection with due diligence or similar investigations, and to potential Third Party investors in confidential financing documents or potential acquirers or merger partners in confidence pursuant to due diligence; provided that any such Sublicensee, licensee, contractor, employee, consultant, banker, lawyer, accountant,
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agent or Third Party is bound by obligations of confidentiality and non-use at least as restrictive as those set forth herein. In the case of each disclosure, the Party making such disclosure shall use reasonable efforts to obtain confidential treatment of any such disclosure, and shall not disclose Confidential Information of the other Party other than is reasonably necessary.
23 | Execution Version |
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ARTICLE 10
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MirnaRx cure such Default, which cure period shall be not shorter than thirty (30) days of Marina Bio’s notice for any Default of a payment obligation under this Agreement, or ninety (90) days of Marina Bio’s notice for any other Default. In the event MirnaRx shall not have cured the Default by the end of the applicable cure period, Marina Bio may terminate this Agreement immediately upon written notice to MirnaRx. Notwithstanding the foregoing cure period, non-payment of the upfront license fee set forth in Section 5.1 by [***], shall automatically and immediately terminate this Agreement.
ARTICLE 11
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referred to the Executive Officers for discussion and resolution. If such personnel are unable to resolve such Dispute within [***] of initiating such negotiations, unless otherwise agreed by the Parties, such dispute shall be finally settled under Section 11.2.
11.2 Arbitration. For any Dispute involving amounts owed under the Agreement, or whether a Party has breached its obligations under the Agreement (and/or has cured such breach), such Dispute (if not resolved by the Parties under Section 11.1) shall be resolved by final and binding arbitration in accordance with this Section 11.2, under the Commercial Arbitration Rules and Supplementary Procedures for Large Complex Disputes of the American Arbitration Association (“AAA”) by a single arbitrator. Either Party may, following the end of the good faith negotiation period referenced in Section 11.1, refer any such Dispute to arbitration by submitting written notice to the other Party. Within [***] of delivery of such notice, the Parties shall meet and discuss in good faith and agree on (a) an arbitrator to resolve the issue, which arbitrator shall be neutral and independent of both Parties and all of their respective Affiliates, shall have significant experience and expertise in licensing and partnering agreements in the pharmaceutical industry and other relevant experience and (b) any changes in these arbitration provisions or the rules of arbitration which are herein adopted, in an effort to expedite the process and otherwise ensure that the process is appropriate given the nature of the dispute and the values at risk. If the Parties cannot agree on such arbitrator within [***] of request by a Party for arbitration, then such arbitrator shall be appointed by AAA, which arbitrator must meet the foregoing criteria. The arbitration shall be held in New York, New York, and the proceedings shall be conducted in the English language. The arbitrators may proceed to an award, notwithstanding the failure of either Party to participate in the proceedings. The arbitrator shall be instructed that time is of the essence in the arbitration proceeding. The arbitrator shall, within [***] after the conclusion of the arbitration hearing, issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded (if applicable). The arbitrator shall be authorized to award compensatory damages, but shall not be authorized to (i) award non-economic or punitive damages to the extent expressly excluded under this Agreement, or (ii) reform, modify or materially change this Agreement or any other agreements contemplated hereunder; provided, however, that the damage limitations described in part (i) of this sentence will not apply if such damages are statutorily imposed. Judgment on the award rendered by the arbitrator may be enforced in any court having competent jurisdiction thereof, or application may be made to the court for a judicial recognition of the award or an order of enforcement as the case may be, subject only to revocation on grounds of fraud or clear bias on the part of the arbitrator. Notwithstanding anything contained in this Section 11.2 to the contrary, either Party shall have the right to seek equitable relief or interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding. The Parties agree that the arbitration shall be kept confidential and that the existence of the proceeding and any element of its (including any pleadings, briefs or other documents submitted or exchanged, any testimony or other oral submissions and any awards) shall not be disclosed beyond the arbitrator, the Parties, their counsel and any person necessary to the conduct of the proceeding, except as may lawfully be required in judicial proceedings relating to the arbitration or otherwise.
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ARTICLE 12
For MirnaRx: | Xxxxx Therapeutics, Inc. | |
0000 Xxxxxxxx Xx., Xxxxx 000 | ||
Xxxxxx, XX 00000 | ||
Attn: Chief Executive Officer | ||
Tel : (000) 000-0000 | ||
Fax : (000) 000-0000 | ||
With a copy to: | Xxxxxx LLP | |
Five Palo Alto Square | ||
0000 Xx Xxxxxx Xxxx Xxxx Xxxx, XX 00000-0000 | ||
Attn: Xxxxxxx Xxxxx Xxxx, Esq. | ||
Facsimile: (000) 000-0000 | ||
For Marina Bio: | Marina Bio Biotech, Inc. | |
0000 Xxxxx Xxxxx Xxxxxxx | ||
Xxxxxxx, Xxxxxxxxxx 00000 | ||
Attn: President & CEO | ||
Facsimile: (000) 000-0000 |
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With a copy to: | Xxxxx Xxxxxxx LLP | |
0 Xxxxx Xxxxxx | ||
Xxx Xxxx, XX 00000 | ||
Attn: Xxxxxxxx Xxxxxx | ||
Facsimile: (000) 000-0000 |
12.3 Governing Law. This Agreement shall be governed and construed in accordance with the laws of the State of New York, without regard to any applicable principles of conflicts of law.
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29 | Execution Version |
[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.]
[Signature page follows]
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MARINA BIOTECH, INC. | XXXXX THERAPEUTICS, INC. | |||||||||||
By: | /s/ J. Xxxxxxx Xxxxxx | By: | /s/ Xxxx Xxxxxxx | |||||||||
Print Name: | J. Xxxxxxx Xxxxxx | Print Name: | Xxxx Xxxxxxx | |||||||||
Title: | President and CEO | Title: | President and CEO |
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APPENDIX A
LIST OF CERTAIN LICENSED PATENTS
Case No. | Title | Jurisdiction | Application Number | Filing Date | Patent Number | Date Issued | Estimated Expiration Date | Status | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
A-1 |
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Case No. | Title | Jurisdiction | Application Number | Filing Date | Patent Number | Date Issued | Estimated Expiration Date | Status | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | ||||||||
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
A-2 |
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APPENDIX B
EXAMPLE OF CALCULATION OF CUMULATIVE SUBLICENSE FEES
The following is an example of the calculation of payment of Sublicense Fees under Section 5.6, under a hypothetical sublicense agreement under this Agreement:
Based on the foregoing assumptions (and understanding that this is just a hypothetical example and provides no precedence or assumption of the terms of an actual sublicense deal), MirnaRx would pay to Marina Bio Sublicense Fees in the following amounts and times under such hypothetical:
• | Sublicense Fee of $[***], by the date [***] after the upfront sublicense fee is paid ([***]% of the upfront) |
• | Sublicense Fee of $[***], by the date [***] after the [***] milestone for [***] is achieved by Sublicensee (the “True-Up Payment” of $[***] equal to the difference between the “[***]” milestone payment amount under Section 5.3(a)(i)(2) and the “Cumulative Sublicense Fees” paid to Marina Bio up to that point for such product) |
• | Sublicense Fee of $[***], by the date [***] after [***] (equal to [***]% of the milestone payment made by the Sublicensee, plus a “True-up Payment” of $[***], such that the Cumulative Sublicensee Fees as of such date (such cumulative amount equal to $[***] after such True-Up Payment) equals the Milestone Payment Sum as of such date (which is $[***], including the milestone payment amount under Section 5.3(a)(i)(3) for achieving a [***] milestone) |
• | Sublicense Fee of $[***] by the date [***] after [***] ([***]% of the milestone payment paid by Sublicensee to MirnaRx for [***]) |
• | Sublicense Fee of $[***], by the date [***] after [***] (equal to [***]% of the milestone payment by the Sublicensee, plus a “True-up Payment” of $[***], such that the Cumulative Sublicensee Fees as of such date (such cumulative amount equal to $[***] after such True-Up Payment) equals the Milestone Payment Sum as of such date (which is $[***], including the milestone payment amount under Section 5.3(a)(i)(4) for [***] |
B-1 |
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APPENDIX C
JOINT PRESS RELEASE
Marina Biotech and Xxxxx Therapeutics Announce License
Agreement for the Development of microRNA-based Therapeutics
- Xxxxx Therapeutics will develop oncology-focused compounds utilizing their proprietary microRNAs combined with Marina Biotech’s novel SMARTICLES® liposomal delivery technology -
Bothell, WA and Austin, TX December 23, 2011 – Marina Biotech, Inc. (Nasdaq: MRNA), a leading oligonucleotide-based drug discovery and development company, and Xxxxx Therapeutics, Inc. (Xxxxx), a privately-held biotechnology company pioneering microRNA (xxXXX) replacement therapy for cancer, announced today that they have entered into a license agreement regarding the development and commercialization of microRNA-based therapeutics utilizing Mirna’s proprietary microRNAs and Marina Biotech’s novel SMARTICLES liposomal delivery technology. Xxxxx will have full responsibility for the development and commercialization of any products arising under the Agreement and Marina Biotech will support pre-clinical and process development efforts. Under terms of the Agreement, Marina Biotech could receive up to $63 million in total upfront, clinical and commercialization milestone payments, as well as royalties on sales, based on the successful outcome of the collaboration. Further terms of the Agreement were not disclosed.
“Given the challenge of effectively delivering oligonucleotides to target tissues, we devoted considerable effort to identifying an optimal delivery technology that would allow for systemic administration of our potent xxXXX tumor suppressors and which is already in clinical testing,” said Xxxx Xxxxxxx, M.D., X.Xx., President and CEO of Xxxxx Therapeutics. “With the dramatic in vivo results achieved with our xxXXX mimics, we believe the SMARTICLES technology solves the delivery challenge for us, and we are now looking forward to bringing our xxXXX mimics into the clinic in the next 18 months as promising targeted cancer therapeutics.
“We are extremely pleased to have entered into this relationship with a company as well respected in the area of microRNA-based therapeutics as Xxxxx Therapeutics,” stated J. Xxxxxxx Xxxxxx, President and CEO of Marina Biotech. “We are excited to see the continued advancement of oligonucleotide-based therapeutics and to be able to provide a technology capable of effectively delivering, in this case, systemically administered xxXXX mimetics. We look forward to the rapid advancement of Xxxxx Therapeutics’ clinical pipeline and the opportunity to bring novel therapeutics to patients in need.”
In a recent poster entitled “The Development of a xxXXX-based Therapeutic Candidate for Hepatocellular Carcinoma,” presented at the November, 2011 AACR-NCI-EORTC International
C-1 |
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Conference on Molecular Targets and Cancer Therapeutics in San Francisco, CA, Xxxxx scientists showed that mimics of five tumor suppressor miRNAs, including miR-34 and let-7, all significantly inhibited the growth of liver tumors compared to animals treated with formulated negative control miRNAs. The five xxXXX mimics were complexed with Marina Biotech’s SMARTICLES delivery formulation and injected into NOD/SCID mice with orthotopically grown Hep3B human liver cancer xenografts.
The companies will present their respective science and technologies at the upcoming Biotech Showcase™ 2012, January 9-11, 2012 at the Parc 55 Wyndham San Francisco – Union Square at 00 Xxxxx Xxxxxx Xxxxxx, Xxx Xxxxxxxxx, XX. Xxxxx Therapeutics will present on Monday, 9 January at 3:00 pm and Marina Biotech will present on Tuesday, 10 January at 2:30 pm.
About Marina Biotech, Inc.
Marina Biotech is a biotechnology company focused on the development and commercialization of oligonucleotide-based therapeutics utilizing multiple mechanisms of action including RNA interference (RNAi) and messenger RNA translational blocking. The Marina Biotech pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome) and two preclinical programs — in bladder cancer and malignant ascites. Marina Biotech entered into an exclusive agreement with The Debiopharm Group for the development and commercialization of the bladder cancer program. Marina Biotech’s goal is to improve human health through the development of RNAi- and oligonucleotide-based compounds and drug delivery technologies that together provide superior therapeutic options for patients. Additional information about Marina Biotech is available at xxxx://xxx.xxxxxxxxx.xxx.
About Xxxxx Therapeutics, Inc.
Xxxxx Therapeutics is a biotechnology company focused on the development and commercialization of microRNA (xxXXX) therapeutics. The Company has a substantial intellectual property portfolio on the therapeutic use of miRNAs developed by its own scientists as well as in-licensed from other institutions. Mirna’s IP portfolio contains >300 miRNAs with applications in oncology and other diseases. Oncology-directed miRNAs include those that are key tumor suppressors in cancer, such as miR-34 and let-7 that have proven to block tumor growth in a number of different pre-clinical animal studies. The Company, founded in 2007, is located in Austin, Texas, and has received significant funding from the State of Texas, both through the State’s Emerging Technology Fund and from the Cancer Prevention and Research Institute of Texas (CPRIT). Xxxxx Therapeutics is the recipient of a $10.3 million commercialization award from CPRIT. For more information, visit xxx.xxxxxxx.xxx
Forward-Looking Statements
Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that
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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.]
may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Marina Biotech to obtain additional funding; (ii) the ability of Marina Biotech to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of Marina Biotech and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of Marina Biotech and/or a partner to obtain required governmental approvals; and (v) the ability of Marina Biotech and/or a partner to develop and commercialize products prior to, and that can compete favorably with those of, competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Marina Biotech’s most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. Marina Biotech assumes no obligation to update and supplement forward-looking statements because of subsequent events.
Marina Biotech, Inc.
Xxxxxx Xxxxxx
Interim Chief Financial Officer
(000) 000-0000
xxxxxxx@xxxxxxxxx.xxx
Xxxxx Therapeutics, Inc.
Xxxx Xxxxxxx, M.D., X.Xx.
President and Chief Executive Officer
(000) 000-0000
xxxxxxxx@xxxxxxx.xxx
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