SIXTH AMENDMENT TO THE LICENSE AGREEMENT UC Control No. 2006-04-0026

Exhibit 10.2

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SIXTH AMENDMENT TO THE LICENSE AGREEMENT
UC Control No. 2006-04-0026

THIS SIXTH AMENDMENT (the “Sixth Amendment”), dated July 8, 2015, (the “Sixth Amendment Effective Date”), is made by and between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA (“The Regents”), a California corporation having its statewide administrative offices at 1111 Franklin Street, 12^th Floor, Oakland, California ###-###-####, acting through the offices of The University of California, Los Angeles, located at 11000 Kinross Avenue, Suite #200, Los Angeles, CA 90095-1406 (the “Institution”), and PUTNEY DRUG CORP. (“Licensee”), having a principal place of business at 617 Detroit Street, Suite 100, Ann Arbor, MI 48104, and amends the Exclusive License Agreement, dated June 11, 2005, between Licensee and The Regents with UC Agreement Control No. 2006-04-0026 (the “Original License Agreement”) and subsequent amendments thereto (collectively, the “License Agreement”) in accordance with the terms and conditions of this Sixth Amendment. The Regents and Licensee may be referred to herein individually as a “Party”, and collectively as the “Parties”.

RECITALS

WHEREAS, Institution’s employee Rhonda Voskhul, M.D. (“Investigator”) and her laboratory have conducted and are conducting other research and development relating to Estriol, and The Regents and Licensee are parties to that certain Clinical Trial Agreement dated April 29, 2010 relating to the conduct of certain clinical trials of Estriol by Investigator (the “CTA”), and certain additional intellectual property relating to the subject matter of the License Agreement has been created at Institution;

WHEREAS, issues have arisen concerning certain of the Parties’ respective rights and obligations under the License Agreement and the CTA and the Parties wish to expand their relationship to cover such additional intellectual property and to resolve such issues, including by amending the License Agreement to provide for, inter alia, expanded intellectual property rights to Licensee and enhanced economic consideration to The Regents as provided in the terms and conditions set forth below, and by amending certain terms of the CTA; and

WHEREAS, in connection therewith, the Parties have entered into an amendment to the CTA (the “CTA Amendment”) and a Release Agreement, each of even date herewith;

NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises, terms and conditions contained in this Agreement, the sufficiency of which is hereby acknowledged, the Parties agree as follows:

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1.12             “Additional Patent Rights” means all Patent Rights, other than the Regents’ Patent Rights, that are Controlled by The Regents during the term of the License Agreement that satisfy all of the following criteria: (a) the practice, manufacture, use or sale of the invention in such Patent Right is covered or claimed by a claim in The Regents Patent Rights; (b) the invention arose from Investigator’s Laboratory Work; (c) the invention was conceived of and reduced to practice (solely or jointly with others) prior to the Effective Date or on or after the Effective Date but prior to the 24-month anniversary of the Sixth Amendment Effective Date; (d) covers the use of Compounds in the Field of Use.

1.13             “Compound” means Estriol, and shall specifically exclude any other E3-receptor targeted molecules.

1.14             “Control” means, with respect to any intellectual property right (including, without limitation, know-how), that a Party owns or has a license to such intellectual property right and has the ability to grant to the other Party access, a license, or a sublicense (as applicable) to the foregoing on the terms and conditions set forth in this Agreement without violating the terms of any then-existing agreement with a third party, without violating any law or regulation, and without incurring any additional financial obligation.

1.15             “Development Costs” means fully-burdened costs and expenses incurred by or on account of Licensee and its Affiliates in conducting development activities that are directed to or useful for obtaining or maintaining marketing approval(s) of a Licensed Product, including: all non-clinical, preclinical and clinical activities, testing and studies of such Licensed Product (including IND-enabling Studies and translational research); manufacturing development, process and formulation development; toxicology, pharmacokinetic, pharmacodynamic, drug-drug interaction, safety, tolerability and pharmacological studies; distribution of such Licensed Product for use in clinical trials (including placebos and comparators); data and statistical analyses; assay development; instrument design and development; protocol design and development; quality assurance and control; report writing; and the preparation, filing and prosecution of any regulatory filings and applications for marketing approval for Licensed Product; development activities directed to label expansion (including prescribing information) and/or obtaining marketing approval for one or more additional indications or patient populations following initial marketing approval; development activities conducted after receipt of marketing approval which were a condition for the receipt of such marketing approval (including Phase IV studies); and all regulatory activities related to any of the foregoing.

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1.16             “Development Partner” means an entity to which Licensee (or its Affiliate) has granted, as contemplated in the provisions of Section 7 of this Sixth Amendment, a Sublicense to develop and commercialize Licensed Products in at least the United States or Europe, provided that such entity (together with its affiliates) has, at the time such Sublicense is granted, at least one hundred million dollars ($100,000,000) in annual sales in the pharmaceutical industry. A Development Partner must be an independent Third Party that is not an Affiliate of Licensee or its Affiliates and enters into an arms-length Sublicense.

1.17             “Estriol” means the compound having the structure set forth in Exhibit B.

1.20             “Estriol Product” means any Compound and any pharmaceutical composition or preparation (in any and all formulations and dosage forms) containing a Compound.

1.21             “IND” means an investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority, including any such application filed with the FDA pursuant to 21 CFR Part 312.

1.22             “Investigator’s Laboratory Work” means any work performed by or on behalf of Investigator or by a person working in Investigator’s laboratories or research facilities or under Investigator’s direction, in each case, to the extent relating or applicable to the Field of Use. Investigator’s Laboratory Work shall expressly exclude any human clinical trial work or patient work.

1.23             “Joint Venture” shall mean a contractual relationship between a third party and Licensee or its Affiliate or Sublicensee, under which the third party and such party markets and commercializes the Licensed Product or Licensed Method in collaboration with Licensee, or its Affiliate or such Sublicensee, as applicable.

1.24             “Know-How” means any and all data, results, technology and other information of any type, in any tangible form, that is located by the University of California Office of Intellectual Property after a reasonable investigation.

1.25             “Licensed Know-How” means all non-privileged Know-How that meets all of the following criteria: (a) is Controlled by The Regents, (b) was generated or developed as part of the Investigator’s Laboratory Work prior to the Effective Date or after the Effective Date but prior to the date 24 months after the Sixth Amendment Effective Date; and (c) is reasonably necessary for development, use, manufacture or sale of any Licensed Product or Licensed Method in the Field of Use, or, in the case of Licensed Know-How created after the Effective Date, “in the Field of Use” shall be replaced with “ in the Compound in the Field of Use. “

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1.26             “Patent Rights” means (a) patents and patent applications (which for the purposes of the License Agreement shall be deemed to include certificates of invention and applications for certificates of invention), (b) any and all divisionals, continuations, continuations-in-part but only to the extent of claims entirely supported in the specification and entitled to the priority date of the parent application to such CIP, reissues, renewals, substitutions, registrations, re-examinations, revalidations, extensions, supplementary protection certificates and the like of any such patents and patent applications, and (c) any and all foreign equivalents of any of the foregoing.

1.27             “Sales-Based Payments” means all payments received by Licensee from a Sublicensee based on sales of Licensed Product or Licensed Methods, which expressly includes royalties, sales-based milestone payments, and profit-sharing payments.

1.28             “Sixth Amendment” means that certain Sixth Amendment to the License Agreement, dated as of July 7, 2015.

1.29             “Sublicense” means the grant by Licensee of sublicense rights under the License to a Sublicensee between Licensee and such Sublicensee, and the applicable terms of the agreement between Licensee and such Sublicensee relating so such sublicensing.

“Field of Use” means the use of Licensed Products for the treatment, prevention or palliation of any autoimmune disease, condition or indication, including, without limitation, multiple sclerosis.

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“Affiliate” means, with respect to Licensee, any entity that directly or indirectly controls, is controlled by or is under common control with Licensee. An entity shall be deemed to control another entity if such entity possesses the power to direct or cause the direction of the management, business and policies of such entity, whether through the ownership of 50% or more of the voting securities of such entity, by contract or otherwise.

“Sublicensing Income” mean all consideration received by Licensee from a Development Partner or other Sublicensee based on the grant of Sublicense rights (including rights to any of The Regents data, including clinical data licensed under the CTA) to such Development Partner or other Sublicensee, including in kind consideration, development milestone payments, Sales-Based Payments, upfront license payment, and other license fee payments for such Sublicense grant, but expressly excluding the following: cash reimbursements or advances for actual future research or development costs, amounts received in connection with the sale or issuance of equity or convertible debt issued as part of an investment (to the extent at fair market value), bona fide loans and reimbursement of patent expenses.

2.1             Subject to the limitations in this Agreement, The Regents hereby grants to Licensee the exclusive license (the “License”) under the Regents’ Patent Rights and the Additional Patent Rights, in all jurisdictions where The Regents’ Patent Rights or Additional Patent Rights exist, to make, have made, use, sell, offer for sale and import Licensed Products and to practice Licensed Methods in the Field of Use to the extent permitted by law. Notwithstanding the foregoing, all rights granted in this Agreement as to Additional Patent Rights shall be limited solely to the use of Compound in the Field of Use.

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3.1         The Regents also grants to Licensee the rights to issue exclusive or nonexclusive sublicenses through multiple tiers (“Sublicenses”) to third parties under the License (including as amended in Section 2(a) of the Sixth Amendment) and under the rights granted to Licensee in Section 2(c) of the Sixth Amendment (which are themselves non-exclusive), to research, develop, make, have made, use, sell, offer for sale, import or export Licensed Products and to practice Licensed Methods. To the extent applicable, sublicenses must include all of the rights of and obligations to the Regents (and, if applicable, the U.S. Government under 35 U.S.C. ss 2012) contained in the License Agreement, except that the payment obligations of the Sublicensee may be different from Sections 4 and 5, and the diligence obligation may be different for a Development Partner pursuant to Section 5(b) of the Sixth Amendment.

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6.3(c)    Within 25 months of the Effective Date of Sixth Amendment, initiate Phase III clinical trials for a Licensed Product in the Field of Use.

(A) Within twenty-four (24) months of delivery to Licensee of all the patient name-redacted MRI image and electronic data created under the Study under the CTA, as required under Section 3.1 of the CTA, as amended by the CTA Amendment, complete all clinical trials requested by the FDA to be completed prior to initiating Phase III clinical trials of a Licensed Product within the Field of Use; and

(B) Within six (6) months of completing the trials covered in (A) above, initiate a phase III clinical trial of a Licensed Product within the Field of Use;

5.1         Licensee must pay to The Regents for sales by Licensee or its Affiliates the an earned royalty of 7% of Net Sales on Licensed Products or Licensed Methods

For clarity, the Licensee does not owe The Regents any royalty payments under this Section 5.1 for sales of Licensed Products or Licensed Methods by any Sublicensee (such sales are covered under the obligations in Sections 3.2 of the License Agreement, and Section 8 of this Sixth Amendment).

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4.2         Upon each of the following milestone events first being achieved by Licensee or its Affiliates, Licensee shall make the corresponding one-time payments to The Regents within thirty (30) days of such achievement:

If Licensee sublicenses all or substantially all of its rights in the Licensed Products in at least in the United States to a Development Partner, then the above milestones shall not be owed and need not be paid.

3.2. Sublicensing Income.

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3.3.  [Reserved]

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11.1      Unless otherwise terminated by operation of law or by acts of the Parties in accordance with the terms of this Agreement, this Agreement is in force from the Effective Date recited on page 1 of the License Agreement and remains in effect for the life payment obligations recited in this Agreement.

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REMAINDER OF PAGE INTENTIONALLY BLANK.

SIGNATURE PAGE FOLLOWS

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In Witness Whereof, the Parties have executed this Sixth Amendment by their respective authorized representatives as of the date first written above.

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Exhibit A

Additional Patent Rights
as of the Sixth Amendment Effective Date

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Exhibit B

Estriol