Document:

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, 12th Floor, Oakland, California 94607-5200, 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.	Definitions.

 

		(a)	Capitalized terms used herein and not otherwise defined shall have the meaning ascribed in the License Agreement.

 

		(b)	Article 1 of the License Agreement is hereby amended to add the following definitions:

 

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.

 

		(c)	The Parties hereby agree that Article 1 of the License Agreement is hereby amended as follows:

 

		(i)	In Section 1.2 (“Licensed Product”) and Section 1.3 (“Licensed Method”), all references to “The
Regents’ Patent Rights” are replaced by the phrase “The Regents’ Patent Rights and/or the Additional Patent
Rights”.

 

		(ii)	Section 1.4 is replaced in its entirety with the following:

 

“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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		(iii)	Section 1.5 is replaced in its entirety with the following:

 

“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.

 

		(iv)	Section 1.10 is replaced in its entirety with the following:

 

“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.	Amendment to License Rights; Additional Licenses; Access to Know-How 

 

		(a)	Section 2.1 of the License Agreement is hereby amended to replace the Section in its entirety with the following:

 

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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		(b)	Section 3.1 of the License Agreement is hereby amended to replace the Section in its entirety with the following:

 

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.

 

		(c)	The Regents hereby grant to Licensee a non-exclusive (to the extent permitted by law) license, including the right to sublicense
through multiple tiers in accordance with Section 3.1 of License Agreement, as amended hereby, under the Licensed Know-How to research,
develop, make, have made, use, sell, offer for sale, import and export Licensed Products worldwide in the Field of Use.

 

		(d)	Sections 2.2 and 2.3 of the License Agreement shall apply to the licenses granted in subsections (b) and (c) above in the same
manner as to the License.

 

		(e)	Promptly after the Sixth Amendment Effective Date, The Regents shall use reasonable efforts to disclose and provide to Licensee
all Licensed Know-How. Promptly after new Licensed Know-How is identified, The Regents shall disclose and provide to Licensee such
new Licensed Know-How.

 

		3.	Right of First Negotiation to Expand the Field of Use. The Regents shall negotiate reasonably and in good faith
                                                                  with Licensee for up to 12 months from the Sixth Amendment Effective Date on the terms for the expansion of the Field of Use
                                                                  to include uses of Licensed Products to treat, palliate or prevent diseases, conditions or indications outside the existing
                                                                  Field of Use. If Licensee has signed a term sheet with a Development Partner for a Sublicense during this period, then The
                                                                  Regents also agrees to negotiate reasonably and in good faith with such potential Development Partner for such an expansion
                                                                  of the Field of Use for an additional period of negotiation extending until the date 90 days after the execution of a
                                                                  definitive Sublicense agreement with the Development Partner. The Regents agrees that the terms of any such expansion of the
                                                                  Field of Use will be commercially reasonable.

 

		4.	Terms Regarding Commitment To Find A Development Partner

 

		(a)	The diligence obligations in Sections 6 of the License Agreement shall remain in full effect and force, except as otherwise
expressly stated in this Sixth Amendment. Notwithstanding the foregoing, The Regents hereby agree that the obligations in subsection
6.3a and 6.3b of the License Agreement have been met or that The Regents waive compliance with such obligations.

 

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		(b)	The Parties, subject to the other provisions of this Article 4, agree that the mutual goal is for Licensee either (i) to obtain
a Sublicense agreement with a Development Partner within twelve (12) months of the Sixth Amendment Effective Date, which Sublicense
would include a commitment by the Development Partner to sponsor an appropriate phase clinical trial of an Estriol Product in the
Field of Use (assuming prior clinical data supports initiation of such trial and there is no regulatory or clinical guidance or
other delay outside of the control of Licensee and its Development Partner); or (ii) to continue the clinical development of a
Licensed Product, using commercially reasonable, diligent efforts (which may include sublicensing Licensed Product to a third party
at some later stage of development).

 

		(c)	Licensee shall use commercially reasonable efforts to seek and enter into a Sublicense agreement with a Development Partner
in the Field of Use, within twelve (12) months of the Sixth Amendment Effective Date and on commercially reasonable terms. Such
sublicensing activities will be conducted in consultation with The Regents, as follows: Licensee shall provide regular updates
on such partnering efforts to The Regents and use reasonable efforts to permit The Regents to attend (via a mutually-agreeable
designee) one or more material meetings with a prospective partner where the Parties agree such participation would be helpful
to the partnering process. The Regents agree to provide reasonable technical and other cooperation in connection with such partnering
efforts, at its expense, to the extent The Regents agrees to participate in a meeting.

 

		(d)	Prior to signing any Sublicense agreement for Estriol with a Development Partner, Licensee shall confer with The Regents regarding
the main provisions of such arrangement and shall consider The Regents’ reasonable comments and suggestions in good faith.
If The Regents reasonably disputes that a proposed partnering arrangement is appropriate, then if requested in writing by The Regents,
each party shall designate a senior representative and such representatives shall meet within ten (10) business days of such request
to discuss reasonably and seek to resolve the issue. Notwithstanding the foregoing, following such meeting, Licensee shall have
the right in its reasonable discretion to determine whether to enter into such agreement with such Development Partner.

 

		(e)	If Licensee does not enter into a Sublicense agreement with a Development Partner within the 12 month period contemplated in
subsection (b) and (c) above, then Licensee nonetheless will continue to retain its exclusive License rights with respect to the
Licensed Products in the Field of Use (and the rights subsequently to enter into Sublicense agreements, including with Development
Partners). Licensee will remain subject to its obligations under the License, and its diligence obligations as described above
in subsection (b), in Section 5 below, and in Section 6 of the License Agreement.

 

		(f)	Licensee shall use reasonable efforts to provide that Investigator shall have the first right to be a “co-Principal Investigator”
on any future Estriol clinical trial sponsored by Licensee or its Development Partner.

 

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		5.	Diligence.

 

		(a)	The License Agreement is hereby amended to replace Section 6.3(c) of the License Agreement in its entirety with the following:

 

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.

 

		(b)	If Licensee sublicenses all or substantially all of its rights in the Licensed Products to a Development Partner at least in
the United States and/or Europe within twelve (12) months of the Sixth Amendment Effective Date, then the diligence obligations
in Section 6.3 of the Licensee Agreement shall be automatically amended and adjusted as follows:

 

		(i)	Section 6.3(c) of the License Agreement shall be replaced with the following:

 

(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;

 

		(ii)	The time frames set forth in Section 6.3(c) will be subject to reasonable extensions for any delays caused by regulatory issues
outside of the Development Partner’s control. To the extent a first Phase III trial of a Licensed Product within the Field
of Use commences later than 40 months from Effective Date of this Sixth Amendment, the Development Partner must pay $100,000 to
The Regents for every 6 months of additional delay beyond such date.

 

		(c)	Subsections (a) and (b) do not in any way alter the diligence obligations of Section 6.3(d) of the License Agreement.

 

		6.	Royalties. Section 5.1 of the License Agreement is hereby amended in its entirety to read:

 

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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		7.	Milestone Payments. Section 4.2 of the License Agreement is hereby amended in its entirety to read as follows:

 

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:

 

		(a)	Two million dollars ($2,000,000) upon the dosing of the first patient in the first Phase III clinical trial of a Licensed Product.

 

		(b)	Three million dollars ($3,000,000) upon the filing of an NDA with the U.S. Food and Drug Administration for a Licensed Product
which is covered by a validly issued U.S. patent.

 

		(c)	One million five hundred thousand dollars ($1,500,000) upon the approval by the U.S. Food and Drug Administration of an NDA
for a Licensed Product which is covered by a validly issued U.S. patent.

 

		(d)	One million five hundred thousand dollars ($1,500,000) upon the achievement of fifty million dollars ($50,000,000) in annual
Net Sales for a Licensed Product which is covered by a validly issued U.S. patent.

 

		(e)	Three million dollars ($3,000,000) upon the achievement of one hundred million dollars ($100,000,000) in annual Net Sales for
a Licensed Product which is covered by a validly issued U.S. patent.

 

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.

 

		8.	Sublicensing Income. Sections 3.2 and 3.3 of the License Agreement are hereby deleted and replaced in their entirety
with the following:

 

3.2. Sublicensing Income.

 

		(a)	Licensee shall pay The Regents the Sublicense Percentage of all Sublicensing Income received by Licensee or an Affiliate, provided
that, once a Sublicensee begins selling Licensed Products or Licensed Methods, The Regents shall not in any event receive under
this Section 3.2(a) less than an amount equal to five percent (5%) of Net Sales of such Licensed Products or Licensed Methods sold
or disposed of by such Sublicensee, its Affiliate, Joint Venture or Sublicensee, in the Field of Use in accordance with Article
5 (Royalties) as if these were Licensee’s Net Sales (the “Net Sales Floor”).

 

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		(b)	The “Sublicense Percentage” is 40% commencing as of the Sixth Amendment Effective Date, and such percentage
may be adjusted as provided below. Licensee represents and warrants that it has not previously granted any Sublicenses that includes
the rights to offer for sale and sell Licensed Products and Licensed Method. If Licensee, together with its Affiliates, incur Development
Costs in aggregate of fourteen million dollars ($14,000,000) on developing Licensed Products in the Field of Use following the
Sixth Amendment Effective Date (the “Development Cost Threshold”), then thereafter the Sublicense Percentage
will be reduced as provided in subsection (c) below if Licensee, together with its Affiliates, incur additional Development Costs
prior to granting a Sublicense to a Development Partner, which Development Costs may include costs expended in connection with
any of the following: (i) clinical trials and other studies and development work on Licensed Products (including manufacturing
and regulatory activities); and (ii) the analysis of the clinical trial and grey matter data described in Section 3.2 of the CTA
Amendment. Licensee will provide The Regents with written notice if and when the Development Cost Threshold has been met, accompanied
by such supporting documentation for such costs as The Regents may reasonably request.

 

		(c)	Once the Development Cost Threshold has been met, any Development Costs incurred by Licensee or its Affiliates shall decrease
the Sublicense Percentage by one percentage point for every four million dollars ($4,000,000), or by the corresponding fraction
thereof, of additional Development Costs incurred by Licensee or its Affiliates, provided that the Sublicense Percentage shall
never decrease below twenty-five percent (25%) (provided that the Net Sales Floor shall still apply). For example, if the Development
Cost Threshold has been met, and Licensee then incurs Development Costs of twenty million dollars ($20,000,000) in conducting a
Phase II study, the Sublicense Percentage will automatically decrease to thirty-five percent (35%), (provided that the Net Sales
Floor shall still apply). Licenseee shall provide supporting documentation that The Regents may reasonably request to establish
the amount of Development Costs.

 

		(d)	To the extent Licensee’s assets associated with the use of Compound in the Field are transferred to a third party through
an asset sale or other similar procedure other than a Sublicense (an “Asset Transaction”, which expressly excludes
an acquisition of Licensee or its Affiliates), The Regents will receive the Sublicense Percentage of the compensation Licensee
receives in consideration of the Asset Transaction. To the extent more assets than those related to the Compound in the Field of
Use are transferred in connection with an Asset Transaction, the Sublicense Percentage shall only apply to consideration received
for the Estriol assets (that is, a reasonable allocation of the total consideration paid shall be made between the amount of consideration
appropriately allocable to the value of the Estriol assets and the value of the other assets in the transaction), with any dispute
as to such allocation to be settled by binding arbitration under the complex commercial arbitration rules of the AAA, with both
parties bearing their own costs.

 

3.3.  [Reserved]

 

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		9.	Effects of Merger/Acquisition. To the extent there is a merger or acquisition (including by a “change of control”
transaction) of Licensee or an Affiliate that holds the rights to the Licensed Products, then the surviving entity (which may remain
the Licensee, or may be the acquirer) shall pay the amounts set forth above in Sections 6 and 7 for its development and sale of
Licensed Products, unless and until such rights are sublicensed by a Sublicense, in which case the sharing of Sublicense Income
set forth in Section 8 above shall apply.

 

		10.	Representations, Warranties and Covenants.

 

		(a)	Reciprocal Representations and Warranties. Each Party represents and warrants to the other Party that: (i) the License
Agreement, as amended hereby, is a legal and valid obligation binding upon the execution of this Sixth Amendment and enforceable
against it in accordance with its terms and conditions; and (ii) the execution, delivery and performance of this Sixth Amendment
by such Party has been duly authorized by all necessary corporate action, and the person executing this Sixth Amendment on behalf
of such Party has been duly authorized to do so by all requisite corporate actions.

 

		(b)	The Regents’ Representations and Warranties. The Regents represent and warrant that:

 

		(i)	The Regents have the right to license the rights to The Regents’ Patent Rights, the Additional Patent Rights and the
Licensed Know-How as provided herein;

 

		(ii)	Except as set forth in 2.2 of the License Agreement, and to the extent of the knowledge of the UCLA Office of Intellectual
Property Administration as of the Effective Date, The Regents have not granted to any Third Party any license or other right with
respect to any portion of The Regents’ Patent Rights, or the Additional Patent Rights.

 

		(iii)	Exhibit A contains a true and complete list of the Additional Patent Rights existing on the Sixth Amendment Effective Date;
and

 

		(iv)	The Regents have obtained a full assignment of ownership from all known inventors and/or creators of The Regents’ Patent
Rights, to the extent of the knowledge of the UCLA Office of Intellectual Property Administration, and will make best efforts to
do so for the Additional Patent Rights.

 

		11.	Updates. Within 30-days of the Effective Date of this Sixth Amendment, The Regents shall provide the following information:

 

		(i)	Whether The Regents or Institution have been served with or received any notice of any (A) threatened interference actions
or oppositions to any Patent Rights within The Regents’ Patent Rights or the Additional Patent Rights or (B) other litigation
before any patent office, court, or any other governmental entity in any jurisdiction in regard to the Regents’ Patent Rights
or the Additional Patent Rights; and

 

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		(ii)	Whether The Regents or Institution have not been served with any complaint alleging infringement of a third party’s Patent
Rights arising from the practice of the claims in any of The Regents’ Patent Rights or the Additional Patent Rights.

 

		12.	Replacement of Regents’ Patent Rights. 

 

		(a)	Every reference to "Regents’ Patent Rights" in the License Agreement shall be amended to read as provided in
the following: (i) "Regents’ Patent Rights and Additional Patent Rights" for Recitals, Sections 1.2, 1.3, 2.1 (first
instance), 2.3, 5.2, 7.2, 17.4d, 17.4e, (ii) "Regents' Patent Rights or Additional Patent Rights" for Sections 1.8, 2.1
(second instance), 5.8, 7.1, 7.6, 13.1, 17.4a, 18.1, 29.5.

 

		(b)	Section 5.3 of the License Agreement is hereby amended to read as follows: "5.3 Paragraphs 1.1, 1.2, 1.3, 1.4 and 1.12
define Regents' Patent Rights, Licensed Products, Licensed Methods, the Field of Use and Additional Patent Rights so that royalties
are payable on products covered by pending patent applications and issued patents. Royalties accrue for the duration of this Agreement".

 

		13.	Life of the Agreement. Section 11.1 of the License Agreement is hereby amended in its entirety to read:

 

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.

 

		14.	Effectiveness Conditioned. This Sixth Amendment is effective only if (a) it is fully executed by both Parties and (b)
both Parties fully execute the CTA Amendment and the Release Agreement of equal date with this Sixth Amendment.

 

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		15.	General. Except as expressly set forth in this Sixth Amendment, all terms and conditions of the License Agreement remain
in full force and effect. This Sixth Amendment sets forth and constitutes the entire agreement and understanding between the Parties
with respect to the subject matter hereof and all prior agreements, understanding, promises and representations, whether written
or oral, with respect thereto. Each Party confirms that it is not relying on any representations or warranties of the other Party
except as specifically set forth herein. No amendment or modification of this Sixth Amendment will be binding upon the Parties
unless in writing and duly executed by an authorized representatives of each Party. Any term or condition of this Sixth Amendment
may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver will be effective unless set
forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party
hereto of any right hereunder or of claims based on the failure to perform or a breach by the other Party will not be deemed a
waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise.
Each Party acknowledges that it has been represented by legal counsel with respect to the negotiation and preparation of this Sixth
Amendment and agrees that no provision hereof shall be strictly construed against either Party, irrespective of which Party is
deemed to have drafted such provision. The captions of this Sixth Amendment are for convenience of reference only and in no way
define, describe, extend or limit the scope or intent of this Sixth Amendment or the intent of any provision contained in this
Sixth Amendment. The term “including” as used herein means including, without limiting the generality of any description
preceding such term. This Sixth Amendment may be executed in two or more counterparts, each of which will be deemed an original,
but all of which together will constitute one and the same instrument. In addition, this Sixth Amendment may be executed by facsimile
or “PDF” and such facsimile or “PDF” signature shall be deemed to be an original.

 

REMAINDER OF PAGE INTENTIONALLY BLANK.

 

SIGNATURE PAGE FOLLOWS

 

    	13

    	 

    

 

Execution Version

Confidential 

 

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

 

	The Regents Of The University Of California
	 	 	 
	By:	/s/ Emily W Loughran	 
	Name: 	Emily W Loughran	 
	Title:	Sr. Director of Licensing	 
	 	 	 
	 	 	 
	Putney Drug Corp.
	 	 	 
	By:	/s/ Jeffrey Riley	 
	Name:	Jeffrey Riley	 
	Title:	CEO, President and Director

	 

 

    	14

    	 

    

 

Execution Version

Confidential 

 

Exhibit A

 

Additional Patent Rights 

as of the Sixth Amendment Effective Date

 

		1)	UCLA CASE NO. 2015-280: “Using
Estrogens as Treatment to Improve Fatigue in Multiple Sclerosis and Other Neurodegenerative Diseases”

 

			Provisional Patent Application No. 62/067,264 entitled, “Compositions and Methods
for Treating Fatigue”, filed October 22, 2014 (UCLA Case No. 2015-280-1) by Dr. Rhonda R. Voskuhl, and assigned to The
Regents.

 

		2)	UCLA CASE NO. 2015-282: “Using Estrogens as Treatments to Improve Depression Mood
in Multiple Sclerosis and Other Neurodegenerative Diseases”

 

			Provisional Patent Application No. 62/068,162 entitled, “Compositions and Methods
for Treating Depression”, filed October 24, 2014 (UCLA Case No. 2015-282-1) by Dr. Rhonda R. Voskuhl, and assigned to
The Regents.

 

		3)	UCLA CASE NO. 2015-605: “Estriol Blood
Level for Maximizing Treatment in MS”

 

			Provisional Patent Application No. 62/140,239 entitled, “Methods of Monitoring
Estriol Therapy”, filed October 30, 2014 (UCLA Case No. 2015-605-1) by Dr. Rhonda R. Voskuhl, and assigned to The Regents.

 

		4)	UCLA CASE NO. 2015-606-1: “Sparing Gray Matter Atrophy In Ms Patients That
Are Enhancing Lesion Negative”

 

			Provisional Patent Application No. 62/140,245 entitled, “Methods of Providing Neuroprotective
Therapy”, filed March 30, 2015 (UCLA Case No. 2015-606-1) by Dr. Rhonda R. Voskuhl, and assigned to The Regents.

 

    	15

    	 

    

 

Execution Version

Confidential 

 

Exhibit B

 

Estriol

 

 

    	16Exhibit 10.3

 

CLINICAL TRIAL AGREEMENT

 

This Clinical Trial
Agreement (“Agreement”) is made as of the 29th day of April, 2010 (“Effective Date”) between
Putney Drug Corp., a Nevada corporation, having a principal place of business at 3930 Varsity Drive, Ann Arbor, MI 48109 (“Company”),
and The Regents of the University of California, a constitutional California corporation, on behalf of its Los Angeles campus,
with an address at David Geffen School of Medicine UCLA Clinical Trials Contracts Unit, 10911 Weyburn Avenue, 3rd Floor,
Los Angeles, CA 90095-7170 (“Institution”), each referred to herein individually as a “Party” and collectively
as the “Parties.”

 

Whereas, Company and
Institution are parties to a License Agreement, effective as of November 17, 2005 (“the License”), under which Company
has agreed to develop products based on an invention by Rhonda Voskuhl, M.D., for the use of estriol, which invention is the subject
of estriol for the treatment of autoimmune disease and the use of estriol and other estranges, estrogens and estrogen receptor
active compositions in the treatment of psoriasis and other autoimmune diseases (UCLA case No. 1998-531 & UCLA case No. 2004-101),
assigned by Rhonda Voskuhl, M.D., to Institution.

 

Whereas, the Company is a wholly-owned subsidiary
of Adeona Pharmaceuticals, Inc.

 

Whereas, Rhonda Voskuhl,
M.D., an employee of Institution, (“Principal Investigator”) is the Principal Investigator for a clinical research
study (“the Study”) entitled “A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Scleroses”
(“the Protocol”), and has received funding for the Study from the National Institutes of Health (“NIH”)
and the National Multiple Sclerosis Society (“NMSS”).

 

Whereas, Principal Investigator is the author
of the Protocol and holds the IND.

 

Whereas, the Study
is being conducted at Institution and Institution is subcontracting with other sites to conduct the Study.

 

Whereas, Company has been providing estriol
(“Study Drug”) and placebo to Institution.

 

Whereas Company and Institution desire to
memorialize this arrangement in writing.

 

Whereas, Company has
agreed to continue to provide Study Drug and placebo gratis to Institution for the conduct of the Study.

 

Accordingly, for good
and valuable consideration, the sufficiency of which is hereby acknowledged, the Parties agree as follows:

 

    	 

    	 

    

 

Section 1: Study Performance

 

1.1           Conduct
of Study in Accordance with Protocol; Priority of Terms. Subject to the initial and continuing approvals described in Section
1.2 below, Institution, through Principal Investigator, agrees to conduct the Study in accordance with the Protocol, which is attached
to this Agreement as Exhibit A and herein incorporated by reference. In the event of any conflict between the Protocol and
the provisions of this Agreement, the Protocol shall govern with respect to scientific issues, and the provisions of this Agreement
shall govern with respect to all other issues. The Study shall be conducted in accordance with all applicable federal, state and
local laws relating to the conduct of clinical studies, including Food and Drug Administration (“FDA”) Good Clinical
Practice (“GCP”), the Health Insurance Portability and Accountability Act of 1996 (together with any regulations promulgated
thereunder, “HIPAA”), and the California Confidentiality of Medical Information Act (“CMIA”) (collectively
“Applicable Laws”).

 

1.2           Study
Review and Approvals. The Study shall be conducted by Institution under the direction of the Principal Investigator at Institution.
Institution, through Principal Investigator, shall provide Company with written evidence of review and approval of this Study by
Institution’s Institutional Review Board (“IRB”) prior to receipt of the Study Drug provided by Company and shall
inform Company of the IRB’s continuing reviews of the Study promptly after each such review takes place, which shall be at
least once per year. Initiation of the Study protocol shall not begin until IRB approval is obtained.

 

1.3           Completion
of the Study. For purposes of this Agreement, Company and Institution shall consider the Study to be complete and concluded
at such time as the occurrence of final data lock or earlier termination by a Data Safety Monitoring Board (“Study Conclusion”).

 

1.4           Provision
and Use of Study Drug. Company shall be responsible for providing and will ship directly to each of the Institution and the
Study subsites, at no charge, sufficient quantities of the Study Drug and placebo as may be required for the Study in accordance
with the Study schedule. Company understands that Institution is relying on timely delivery of the Study Drug in order for Institution
and the subsites to conduct the Protocol. Institution, through Principal Investigator, will safeguard such Study Drug in accordance
with all Applicable Laws and shall return or otherwise dispose of any remaining Study Drug at the Study Conclusion in accordance
with Company’s instructions and at Company’s expense. Institution shall not use any Study Drug for any purpose other
than the conduct of the Study. Company represents and warrants that it is in compliance with federal, state, and local laws and
regulations relating to the manufacture and formulation of any investigational drug and to other materials supplied, and with other
applicable legal requirements. Company shall ensure that the supplies of the Study Drug and placebo shall be from the same vendor
in order to ensure consistency throughout the term of the Study and that the method of overencapsulation will also remain constant
throughout the Study. Company is not providing funding for the Study or other support other than the Study Drug and placebo.

 

Section 2: Material Subject Information

 

2.1           Company
agrees to notify Institution in writing promptly but no later than fifteen (15) days upon knowledge of information that could affect
the safety or medical care of current or former subjects, affect current subjects’ willingness to continue participation,
influence the conduct of the Study, or alter the IRB’s approval. Company and Institution shall comply with their respective
reporting requirements to regulatory authorities, including, for example, the FDA, the Office for Human Research Protections, and
other authorities as required. Institution, through the Principal Investigator and/or IRB as appropriate, shall be responsible
for informing subjects of the above information they learn from Company in accordance with the IRB-approved informed consent form
and Company shall not contact them. No other provision of this Agreement shall be construed to override the provisions of this
Section 2.1.

 

    	Putney UCLA Clinical Trial Agreement	Page 2 of 12

    	 

    

 

Section 3: Study Data/Deliverables

 

3.1           Institution
shall own the data resulting from the Study. Following completion of the Study Institution shall provide to Company, (a) at the
Company’s expense and subject to a confidentiality agreement in favor of Institution, HIPAA and CMIA-compliant redacted copies
of patient case report forms (such redactions removing any patient identifying information) in order to facilitate Company’s
further clinical testing, regulatory approval and commercialization of estriol (b) a report setting forth the accomplishments and
significant findings of the Study upon completion of the Study (c) “open” reports on accrual and safety (together, the
“Deliverables”). The Company will not receive data on efficacy until the trial is completed and the blind is broken.

 

3.2           The
Deliverables provided, to Company will be held in confidence until publication of the results of the Study is made by Institution
pursuant to Article 4, or the Deliverables become publicly available, or written permission to disclose the Deliverables is granted
by Institution authorized representative. Thereafter, Company may freely use the Deliverables in compliance with all applicable
laws and consent forms. It is agreed, however, that under no circumstances will Company state or imply in any publication or other
published announcement that Institution has or approved any product.

 

Section 4: Publication

 

4.1           Company
agrees that Institution and/or Principal Investigator shall have the first right to publish the results of the Study; provided,
however, that none of the following actions shall be considered to be a publication of the results of the Study in violation of
the publication rights of the Institution and/ or the Principal Investigator: (i) issuance of a press release disclosing the results
of the Study (ii) the disclosure of results of the Study to investors, prospective investors of potential corporate partners or
(iii) the disclosure of the results of the study to the Securities and Exchange Commission or any other regulatory authority or
in any filing with therewith. Institution and/or Principal Investigator shall be free to publish the results of the Study subject
only to the provisions of Section 7 regarding Company’s Proprietary Information. Company shall be provided with a copy of
any proposed publication thirty (30) days prior to submission for publication. Company shall be entitled to review such proposed
publications solely for the purpose of identifying Company Proprietary Information, which shall be removed from the publication
upon Company’s request; and to identify any patentable Inventions, which shall be addressed as described below; and to provide
any other comments Company desires to provide, provided that Institution and/or Principal Investigator shall have no obligation
to address any such additional comments. At the expiration of such thirty (30) day period, Institution and/or Principal Investigator
may proceed with submission for publication provided that any identified Company Proprietary Information has been removed; and
provided further that upon notice by Company that Company reasonably believes a patent application claiming an Invention (as defined
in Section 5) should be filed prior to such publication, in Institution’s discretion such submission shall be delayed for
up to an additional thirty (30) days or until any patent application or applications have been filed, whichever shall first occur.
In no event shall the submission of such publication of results be delayed for more than sixty (60) days for manuscripts and for
more than thirty-seven (37) days for abstracts from the date such proposed publication was provided to Company; at the end of said
sixty (60) or thirty-seven (37) days, the Principal Investigator shall be free to publish such results as proposed.

 

    	Putney UCLA Clinical Trial Agreement	Page 3 of 12

    	 

    

 

Section 5: Inventions/Intellectual Property

 

5.1           The
Parties acknowledge and agree that because the Study is supported by the NIH and the NMSS, any Inventions (as defined below) are
subject to the pre-existing rights and limitations of the policies of those entities. Any license to an Invention shall be subject
to such rights. Further, Company acknowledges and understands that, under Institution’s agreements with NIH and NMSS, NIH
and NMSS each obtain certain rights to Inventions. Additionally Company acknowledges that Federal regulations such as the Bayh-Dole
Act and the Tax Reform Act of 1986 may also affect the range and scope of rights that may be granted to Company. The Parties mutually
acknowledge that the United State government, as a matter of statutory right under 35 U.S.C 200-212, may hold a nonexclusive license
and certain other rights under patents or inventions made as a consequence of research whose funding includes funds supplied by
the United States government. In the event the United States government has such rights or in the future is found to have such
rights with respect to all or any Inventions, any license contemplated under this Agreement, even if termed an “exclusive”
license shall be understood to be subject to the rights of the United States government, without any effect on the Parties’
remaining obligations as set forth in the license or in this Agreement.

 

5.2           The
term “Invention” shall mean any new discovery or invention that is first conceived and actually reduced to practice
in the conduct of the Study under this Agreement.

 

5.3           Inventorship
of Inventions shall be determined in accordance with U.S. patent Law. All rights to Inventions made solely by employees of Institution
shall be the sole property of Institution. All rights to Inventions made solely by employees of Company shall be the sole property
of Company. All rights to Inventions made jointly by employees of Company and Institution shall belong jointly to Company and Institution.

 

5.4           To
the extent that Institution is legally able, Company will be granted a time-limited first right to negotiate an option or license
under Institution’s rights in any Invention that belongs either solely to Institution or jointly to Institution and Company.
If the Institution receives a bona fide written offer from an independent third party to enter into a license with respect to any
Invention, it will offer the Company a right of first refusal to enter into a license with respect to such Invention upon the same
terms as those offered by the independent third party in the bona fide written offer.

 

    	Putney UCLA Clinical Trial Agreement	Page 4 of 12

    	 

    

 

5.5           Institution
will promptly disclose to Company any Inventions. Company will hold such disclosure on a confidential basis and will not disclose
the information to any third party without consent of Institution. Company will advise Institution in writing within sixty (60)
days of such disclosure whether or not it wishes to secure an option or commercial license (“Election Period”). Company
will have ninety (90) days from the date of election to conclude an option or license agreement with Institution (“Negotiation
Period”). Said license will contain reasonable terms, will require diligent performance by Company for the timely commercial
development and early marketing of the Invention, and include Company’s obligation to reimburse Institution’s patent
costs for all Inventions subject to the license. In the event it is necessary in the opinion of Institution to file any patent
applications to protect an Invention during the Election or Negotiation Periods, Company will reimburse patent costs incurred by
Institution during such period. If such option or license is not concluded within the Negotiation Period, neither party will have
any further obligations to the other with respect to such Invention. If Company does not elect to secure such option or license,
rights to such Invention will be disposed of in accordance with Institution’s policies, with no further obligation to Company
with respect to such Invention.

 

5.6           Except
as set forth in this Agreement, neither Party shall be deemed to grant either directly or by implication, estoppel, or otherwise,
any rights under any patents, patent applications or other proprietary interests, whether dominant or subordinate, or any other
invention, discovery or improvement of either Party, other than the specific rights covering Inventions under this Agreement.

 

Section 6: Use of Name

 

6.1           Except
for disclosure by Institution of Company’s support for the Study in publications, for purposes of recruitment/consent of
Study subjects, and for purposes of meeting any applicable requirements for the registration of the Study or of Study results with
a publicly accessible or other clinical trial registry, neither Party to this Agreement shall use the name of the other Party or
of any staff member, employee, student, or agent of the other Party or any adaptation, acronym or name by which the other Party
is commonly known, in any advertising, promotional or sales literature or in any publicity without the prior written approval of
the Party or individual whose name is to be used. Company understands that California Education 92000 prohibits the use of Institution’s
names to suggest that Institution endorses a product or service.

 

Section 7: Proprietary Information

 

It is anticipated
that in the performance of this Agreement, Company and Institution may need to disclose to each other information, which is considered
confidential. The rights and obligations of the parties with respect to such information are as follows:

 

7.1           “Disclosing
Party” shall mean a party that discloses Proprietary Information (as defined in paragraph 8.2 below) under this Agreement.
“Receiving Party” shall mean a party that receives Proprietary Information under this Agreement.

 

    	Putney UCLA Clinical Trial Agreement	Page 5 of 12

    	 

    

 

7.2           “Proprietary
Information” refers to information necessary to conduct the Study, other than data from or results of the Study, which is
obtained by Receiving Party from Disclosing Party, which, by appropriate marking, is identified as confidential and proprietary
at the time of disclosure. In the event that Proprietary Information must be provided visually or orally, obligations of confidence
shall attach only to that information which is confirmed by Disclosing Party in writing within thirty (30) working days as being
confidential. Both Parties acknowledge that the Protocol is the Proprietary Information of Institution.

 

7.3           Period
of Restriction. For a period of five (5) years after the expiration or early termination of this Agreement, Receiving Party
agrees to use reasonable efforts, no less than the protection given its own confidential information, to use Proprietary Information
received from Disclosing Party and accepted by Receiving Party only in accordance with this Section 8.

 

7.4           Use
of Proprietary Information. Receiving Party agrees to use Disclosing Party’s Proprietary Information solely for the purposes
of conducting the Study, obtaining any required review of the Study or its conduct, or ensuring proper medical treatment of any
subject. Receiving Party agrees to make Proprietary Information available only to those personnel and agents at Receiving Party
and to inform them of the confidential nature of such information.

 

7.5           Release
of Proprietary Information. Except as provided herein, Receiving Party agrees to keep all Proprietary Information confidential
unless Disclosing Party gives specific written consent for release.

 

7.6           Notice
of Unauthorized Disclosure. Receiving Party shall notify, Disclosing Party of any disclosure not authorized hereunder of which
it becomes aware. In such situations, Receiving Party shall take and shall require each such unauthorized recipient to take reasonable
steps to prevent any further disclosure or unauthorized use.

 

7.7            Exclusions.
No Receiving Party shall be required to treat any information as Proprietary Information under this Agreement in the event:

 

(a)            it
is publicly available prior to the date of the Agreement or becomes publicly available thereafter through no wrongful act of Receiving
Party;

 

(b)            it
was known to Receiving Party prior to the date of disclosure or becomes known to Receiving Party thereafter from a third party
having an apparent bona fide right to disclose the information;

 

(c)            it
is disclosed by Receiving Party in accordance with the terms of Disclosing Party’s prior written approval;

 

(d)            it
is disclosed by Disclosing Party without restriction on further disclosure;

 

(e)            it
is independently developed by Receiving Party without reliance upon or access to Disclosing Party’s Proprietary Information;
or,

 

    	Putney UCLA Clinical Trial Agreement	Page 6 of 12

    	 

    

 

(f)          Receiving
Party is obligated to produce it pursuant to a requirement of applicable law, regulation or an order of a court of competent jurisdiction
or a facially valid administrative, Congressional or other subpoena, provided that the Receiving Party, subject to the requirement
or order or subpoena (A) promptly notifies Disclosing Party or the requirement for disclosure.

 

7.8         Each
Party reserves the right, in its sole discretion and without prior notice to the other Party, to disclose its own Proprietary Information
to any third party for any purpose.

 

Section 8: Term and Termination

 

8.1         Term.
The term of this Agreement shall be from the Effective Date until completion of the Parties’ substantive obligations under
the Agreement in the performance of the Study, unless earlier terminated in accordance with Section 10.2.

 

8.2          Termination.

 

(a)          Either
Party hereto shall have the right to terminate this Agreement at any time upon three (3) months prior written notice thereof to
the other Party, except that either Party may terminate this Agreement at any time upon thirty (30) days prior written notice thereof
to the other Party in the event of a material breach of the Agreement by the other Party, which breach is not cured within thirty
(30) days of initial notice thereof, and except that either Party may terminate this Agreement immediately upon written notice
to the other Party if necessary to protect the health, welfare or safety of any Study subject.

 

(b)          If
the Principal Investigator ceases to serve in such role during the term of the Agreement, Institution shall promptly notify Company.
Institution may name a substitute principal investigator (who shall thereafter be referred to as Principal Investigator for purposes
of this Agreement), subject to the approval of Company, which approval may be withheld in Company’s sole discretion. If the
Parties fail to reach agreement with respect to continuation of the Study and the Agreement within ninety (90) days following the
date on which Institution notifies Company that the original Principal Investigator became unavailable, Company shall have the
right to terminate the Study and this Agreement immediately upon written notice to Institution.

 

8.3          Continuation
of Enrolled Subjects. The Parties agree that if, at the time either Party receives notice of termination pursuant to this section,
Company shall continue to provide sufficient quantities of Study Drug necessary to allow such subjects to complete the Study, at
Company’s expense, if completion is in the best interest of said subjects.

 

8.4           Survival.
The obligations of the Parties under Sections 1.1 (Priority), 1.3, [1.4,] 2.1, 3.1, 3.2, 4.1, 5.1-5.6, 6.1, 7.1 − 7.8,
8.3, 9.1, 9.2 , 10.1, 11.2, and 11.4-13.7 shall survive any termination or expiration of this Agreement.

 

    	Putney UCLA Clinical Trial Agreement	Page 7 of 12

    	 

    

 

Section 9: Indemnification; Insurance;

 

9.1          Indemnification.

 

(a)          Company
shall indemnify, defend and hold harmless Institution, its trustees, officers, employees, including Principal Investigator, and
agents (the “Institution Indemnitees”), against any liability, damage, loss or expense (including reasonable attorney’s
fees and expenses of litigation) incurred by or imposed upon the Institution Indemnitees or any one of them in connection with
any claims, suits, actions, demands or judgments arising out of the performance of this Agreement, but only in proportion to and
to the extent such liability, damage loss or expense is caused by or results from the use of the Deliverables or from the negligent
or intentional acts or omissions of Company, its directors, officers, agents or employees.

 

(b)          Company’s
indemnification under (a) above shall not apply to any liability, damage, loss or expense in proportion to and to the extent that
it is directly attributable to: (i) the negligence or intentional misconduct of, or violation of Applicable Laws by, the Institution
Indemnitees; or (ii) failure of the Institution Indemnitees to adhere to the terms of the Protocol for the Study, provided, however,
that emergency medical care shall not be deemed a violation of the Protocol.

 

Institution shall
indemnify, defend and hold harmless Company, its directors, officers, employees, including Principal Investigator, and agents (the
“Company Indemnitees”), against any liability, damage, loss or expense (including reasonable attorney’s fees
and expenses of litigation) incurred by or imposed upon the Company Indemnitees or any one of them in connection with any claims,
suits, actions, demands or judgments arising out of the performance of this Agreement, but only in proportion to and to the extent
such liability, damage loss or expense is caused by or results from the negligent or intentional acts or omissions of Institution,
its trustees, officers, agents or employees.

 

(c)          In
the event of a claim against, the Party seeking indemnification agrees to notify the other Party promptly of such claim and to
cooperate fully with the other Party in the investigation and defense thereof. The indemnifying Party will have the right to assume
and control the defense and settlement of such claim (including negotiations related to the settlement thereof), and in such case
the indemnified Party may employ its own counsel if it wishes to do so, at its own expense. Notwithstanding anything herein, no
settlement shall be made by the indemnifying Party without the other Party’s prior written consent that would result in any
admission of liability by the other Party’s indemnitees, or that does not contain an unconditional release of all claims
against the other Party’s indemnitees.

 

9.2          Insurance.

 

(a)          Company
shall, at its sole cost and expense, procure and maintain policies of professional and general liability insurance in amounts not
less than one million dollars ($1,000,000) per occurrence and five million dollars ($5,000,000) annual aggregate covering its obligations
under this Agreement, including contractual liability coverage for its indemnification obligations under this Section 9, if any.

 

    	Putney UCLA Clinical Trial Agreement	Page 8 of 12

    	 

    

 

(b)          Company
shall provide Institution at its request with written evidence of such insurance prior to the commencement of the shipment of the
Study Drug. Company shall provide Institution with written notice at least thirty (30) days prior to the cancellation, non-renewal
or material change, in such insurance; if Company does not obtain replacement insurance providing comparable coverage within such
thirty (30) day period, Institution shall have the right to terminate this Agreement effective at the end of such thirty (30) day
period without notice of any additional waiting periods.

 

Section 10: Notices

 

10.1       Any written
notices, reports, correspondences or other communications required under or pertaining to this Agreement shall be given
by prepaid, first class, registered or certified mail or by an express/overnight delivery service provided by a commercial carrier,
properly addressed as follows:

 

If to Institution:

 

David Geffen School of Medicine at UCLA

Clinical Trials Contract Unit

10911 Weyburn Avenue, 3rd Floor

Los Angeles, CA 90095-7170

Industry Contract Officer

 

Putney Drug Corp.

c/o Adeona Pharmaceuticals, Inc.

3930 Varsity Drive

Ann Arbor, MI 48108

Attn: Lara M. Guzman, VP of Administration

 

Section 11: Miscellaneous

 

11.1         Amendment.
The terms of this Agreement can be modified only by a writing, which is signed by authorized representatives of Institution and
Company.

 

11.2         Choice
of Law; Jurisdiction and Venue. This Agreement shall be governed by and construed and interpreted in accordance with the laws
of the State of California.

 

11.3         Assignment.
Neither Party to this Agreement may assign its obligations hereunder without the prior written consent of the other Party. Notwithstanding
the foregoing, the Company may assign this Agreement (i) to a purchaser, merging or consolidating corporation, or acquirer of substantially
all of the Company’s assets or business and/or pursuant to any reorganization qualifying under section 368 of the Internal
Revenue Code of 1986 as amended, as may be in effect at such time, or (ii) to an Affiliate of the Company without such prior written
consent. For the purpose of this Agreement, the term “Affiliate” shall mean any entity that directly or indirectly
owns, is owned by or is under common ownership with Company. A corporation shall be regarded as in control of another corporation
if it owns directly or indirectly at least fifty percent (50%) of the voting stock of the other company or in the absence of the
ownership of at least (50%) of the voting stock of a corporation, if it possesses, directly or indirectly, the power to direct
or cause the direction of the management and policies of such corporation.

 

    	Putney UCLA Clinical Trial Agreement	Page 9 of 12

    	 

    

 

11.4         Entire
Agreement. This Agreement, including any exhibits, attachments, and other documents that are incorporated by reference herein,
constitutes the entire understanding and agreement between the Parties, and supersedes and replaces all prior agreements, understandings,
writings and discussions between the Parties with respect to the subject matter of this Agreement.

 

11.5         Waiver.
The failure of a Party in any instance to insist upon the strict performance of the terms of this Agreement shall not be construed
to be a waiver or relinquishment of any of the terms of the Agreement, whether at the time of the Party’s failure to insist
upon strict performance or at any time in the future, and such term(s) shall continue in full force and effect.

 

11.6         Severability.
Each clause of this Agreement is a distinct and severable clause and if any clause is deemed illegal, void, or unenforceable, the
validity, legality, or enforceability of any other clause of this Agreement will not be affected thereby.

 

11.7         Titles.
All the titles and headings contained in the Agreement are inserted only as a matter of convenience and reference and do not define,
limit, extend, or describe the scope of this Agreement or the intent of any of its provisions.

 

11.8         Counterpart
Signatures. This Agreement may be executed in one or more counterparts, each of which counterpart shall be deemed an original
Agreement and all of which shall constitute but one Agreement. Further, the Parties to this document agree that a copy of the
original signature (including an electronic copy) may be used for any and all purposes for which the original signature may have
been used. The parties agree they will have not rights to challenge the use or authenticity of this document based solely on the
absence of an original signature.

 

11.9         Relationship
of Parties: The Parties hereto are independent contractors. Neither party shall act nor represent itself, directly or by implication,
as an agent of the other.

 

 

    	Putney UCLA Clinical Trial Agreement	Page 10 of 12

    	 

    

 

IN WITNESS WHEREOF, the Parties have caused
this Agreement to he duly executed as of the Effective Date above written.

 

	PUTNEY DRUG CORP.	The Regents of the University of California

 

	By:	/s/ James S. Kuo, M.D.	 	By:	/s/ Ann Ciminera
	Name:  	James S. Kuo, M.D.	 	Name:  	Ann Ciminera
	Title:	Chief Executive Officer	 	Title:	Industry Contract Officer
	Date:	4/30/10	 	Date:	May 5, 2010

 

Read and Acknowledged:

 

	/s/ Rhonda
    Voskuhl, M.D.	 
	By:   Rhonda Voskuhl, M.D.
	Date:     5/5/10

 

    	Putney UCLA Clinical Trial Agreement	Page 11 of 12

    	 

    

 

EXHIBIT A

 

PROTOCOL

 

    	Putney UCLA Clinical Trial Agreement	Page 12 of 12

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