Exhibit 10.1

 

LICENSE AGREEMENT

 

 

 

 

BETWEEN

 

 

RELMADA THERAPEUTICS, INC.

 

 

 

AND

 

 

 

DR. PAOLO MANFREDI AND DR. CHARLES E. INTURRISI

 

 

  

 

 

 

LICENSE AGREEMENT

 

This agreement (“Agreement”) is entered into as of January 16, 2018 (the
“Effective Date”), by and between Dr. Charles E. Inturrisi, an individual, and
Dr. Paolo Manfredi, an individual, jointly and severally (collectively,
“Licensor”) and Relmada Therapeutics, Inc., a Nevada corporation (“Licensee”).

 

RECITALS

 

WHEREAS, Dr. Charles E. Inturrisi is an employee of Cornell University
(“Cornell”) and in that capacity developed certain inventions regarding
d-Methadone in the context of analgesic use (the “Cornell Invention”);

WHEREAS, Medeor, Inc. (“Medeor”), a corporation organized under the laws of
Delaware, and Cornell have entered into an Amended and Restated License
Agreement, dated April 17, 2012 and further amended on December 31, 2013,
pursuant to which Cornell licensed all its rights, title, and interest in and to
the Cornell Invention to Medeor (the “Cornell License Agreement”);

WHEREAS, pursuant to an Agreement and Plan of Merger dated December 31, 2013,
Licensee was merged into Medeor and Licensee became a party to Cornell License
Agreement as successor by merger to Medeor;

WHEREAS, pursuant to a letter dated August 17, 2012 from Cornell to Dr. Charles
E. Inturrisi (the “Carve-Out Letter”), a copy of which is attached as Exhibit 1
hereto, Cornell relinquished and released to Dr. Charles E. Inturrisi any
intellectual property rights that may arise from Dr. Charles E. Inturrisi’s
right, title, and interest with respect to any of Dr. Charles E. Inturrisi’s
work related to d-Methadone after that date, including the testing and research
on its formulations, its use as a therapeutic, or its effects on patients and
animals, including without limitation the subject matter of the Cornell License
Agreement, provided that such work is not performed as part of Dr. Inturrisi’s
employment responsibilities at Cornell and on such other terms and conditions as
further provided in the Carve-Out Letter;

WHEREAS, Licensor jointly and collectively developed certain inventions
regarding d-Methadone in the context of psychiatric use (the “Existing
Invention”);

WHEREAS, on October 29, 2013, Licensor and Medeor entered into an Intellectual
Property Assignment Agreement (“Original Assignment Agreement”) pursuant to
which Licensor assigned and transferred all of Licensor’s right, title, and
interest in the Existing Invention to Medeor, which was assigned to Licensee by
merger;

WHEREAS, Licensor jointly and collectively developed certain further inventions
regarding d-Methadone in the context of neurological and other uses (the “New
Invention”);

WHEREAS, immediately prior to the execution of this Agreement, Licensor and
Licensee entered into an Intellectual Property Assignment Agreement (the “New
Assignment Agreement”), providing for the assignment and transfer of all of
Licensee’s right, title, and interest in the Existing Invention and other rights
granted to Licensee pursuant to the Original Assignment Agreement to Licensor;

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WHEREAS, subject to the terms and conditions of this Agreement, Licensor and
Licensee desire to enter into this Agreement for Licensor to license the use of
certain inventions relating to d-Methadone, including without limitation, the
Existing Invention and the New Invention, to Licensee;

WHEREAS, Licensee acknowledges Licensor’s expertise relating to the development
of d-Methadone; the critical role of Licensor in any development of d-Methadone
and related products; and the importance of Licensor in any future development
of d-Methadone and related inventions and products by Licensee;

WHEREAS, Licensor and Licensee acknowledge the expertise, role, and value of
Sergio Traversa, Pharm.D. (“Mr. Traversa”), the Chief Executive Officer of
Licensee, in the development of d-Methadone and related products and
commercialization of the intellectual property that is the subject of this
Agreement;

NOW THEREFORE, in consideration of the mutual covenants set forth herein,
including among other things, Licensee entering into the New Assignment
Agreement, the receipt and sufficiency of which are hereby acknowledged,
Licensor and Licensee further agree as follows:

 

ARTICLE 1. DEFINITIONS

 

The terms, as defined herein, shall have the same meanings in both their
singular and plural forms.

 

1.1“Affiliate” shall mean any corporation or other entity in which Licensee owns
or controls, directly or indirectly, at least fifty percent (50%) of the
outstanding stock, membership units, or other voting rights, or in which
Licensee is owned or controlled by, or is under common control with Licensee,
directly or indirectly, by at least fifty percent (50%) of the outstanding
stock, membership units, or other voting rights; but in any country where the
local law does not permit foreign equity participation of at least fifty percent
(50%), then an Affiliate includes any entity in which Licensee owns or controls,
is under common control with, or is owned or controlled by, directly or
indirectly, the maximum percentage of outstanding stock, membership units, or
voting rights permitted by local law.

 

1.2“Bankruptcy Code” shall mean title 11 of the United States Code, as amended
from time to time.

 

1.3“Cause” shall mean: (a) Mr. Traversa’s conviction of (i) any felony or (ii)
any crime involving fraud by Mr. Traversa that results in material harm to
Licensee; or (b) Mr. Traversa’s unauthorized use or disclosure of any material
confidential information of Licensee that results in material harm to Licensee,
provided that evidence of any such material harm shall have been presented to
Mr. Traversa in writing by Licensee’s Board of Directors (“Board”) within thirty
(30) days of the Board becoming aware of the occurrence of such material harm,
and provided further that Mr. Traversa shall have subsequently failed to remedy
such breach within thirty (30) days of such notice.

 

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1.4“Enabled Patents” shall mean any new Patents relating to d-Methadone in any
way that Licensee’s use of the Technology enables Licensee, its Affiliates,
and/or Sublicensees to develop, file, or have issued that do not relate to
Future Inventions and are filed prior to the expiration or invalidation of the
last to expire or be invalidated of the Patent Rights.

 

1.5“Future Inventions” shall mean any invention, modification, idea, concept,
information, material, discovery, design, development, improvement, processes,
data, programs, improvements, artwork, formulae, other copyrightable works, and
techniques process, software program, work of authorship, documentation,
formula, data, technique, know-how, trade secret or intellectual property right
whatsoever (including without limitation, all trade secrets, patent rights,
copyrights, trademarks, and other intellectual property rights recognized by the
laws of any jurisdiction or country) or any interest therein whether or not
patentable or registrable under any copyright, trademark or similar statutes)
that Licensor either alone or jointly with others makes, conceives, creates,
discovers, invents, or reduces to practice in any way and that relates to
d-Methadone in any way and in any and all contexts. For the avoidance of doubt,
all contexts shall include, without limitation, the contexts of psychiatric use,
neurological use, the Existing Invention, the New Invention, the Licensed IP,
and/or the Related Licensed IP.

1.6“Licensed Intangible Assets” shall mean all of Licensor’s right, title, and
interest in and to the goodwill and all other intangible assets used exclusively
in connection with any of the Licensed IP and/or the Related Licensed IP,
including, without limitation, if and to the extent in existence, any and all
trade secrets, inventions, designs, copyrights, non-registered trademarks, and
other intellectual property, know-how, manufacturing methods, and processes.

 

1.7“Licensed Inventions” shall mean the Existing Invention and the New
Invention, collectively.

 

1.8“Licensed IP” shall mean Licensor’s right, title, and interest in and to (a)
the Licensed Inventions (including, without limitation, all existing work
relating to the Licensed Inventions) and (b) any and all Future Inventions.

 

1.9“Related Licensed IP” shall mean all of Licensor’s intellectual property
related to the Licensed IP. For the avoidance of doubt, the Licensed IP and the
Related Licensed IP collectively include, but are not limited to, Licensor’s
right, title and interest in and to the Patent Rights, Technology, and Licensed
Intangible Assets.

 

1.10“Licensed Method” shall mean any method (a) that uses Technology; or (b)
that is claimed in Patent Rights; or (c) the use of which would constitute, but
for the license granted to Licensee under this Agreement, an infringement, an
inducement to infringe or contributory infringement, of any pending or issued
claim within the Patent Rights.

 

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1.11“Licensed Product” shall mean any service, composition, or product (a) that
uses Technology; or (b) that is claimed in Patent Rights; or (c) that is
produced or enabled by a Licensed Method; or (d) the manufacture, use, sale,
offer for sale, or importation of which would constitute, but for the license
granted to Licensee under this Agreement, an infringement, an inducement to
infringe or contributory infringement, of any pending or issued claim within the
Patent Rights.

 

1.12“Net Sales” shall mean the total of the gross invoice prices of Licensed
Products sold, leased, or transferred by or on behalf of Licensee, a
Sublicensee, or any of their respective Affiliates, or any combination thereof,
less the sum of the following actual and customary deductions where applicable
and separately listed: cash, trade, or quantity discounts; sales, use, tariff,
import/export duties or other excise taxes imposed on particular sales (except
for value-added and income taxes imposed on the sales of Licensed Product in
foreign countries); transportation charges; and credits to customers because of
rejections or returns. For purposes of calculating Net Sales, transfers to a
Sublicensee or an Affiliate of Licensee of Licensed Products under this
Agreement for (a) end use (but not resale) by the Sublicensee or Affiliate shall
be treated as sales by Licensee at the list price of Licensee in an arm’s-length
transaction in the ordinary course of business, or (b) resale by a Sublicensee
or an Affiliate shall be treated as sales at the list price of the Sublicensee
or Affiliate. In the event that Licensee, a Sublicensee, or an Affiliate of
Licensee or Sublicensee receives non-cash consideration for any Licensed
Products, or in the case of non-arm’s length transaction with a non-Affiliate
third party, Net Sales shall be calculated based on the fair market value of
such Licensed Product, assuming an arm’s length transaction made in the ordinary
course of business.

 

1.13“Patent” shall mean any and all patents, pending patents, patent
applications (whether registered or unregistered) (and equivalents of any of the
foregoing including certificates of invention, and any and all divisions,
continuations, provisional applications, continuations-in-part, continued
prosecution applications, requests for continued examinations, additions,
renewals, extension, re-examinations, reissues, supplementary protection
certificates, and all United States and foreign counterparts of any the
foregoing.

 

1.14“Patent Costs” shall mean all out-of-pocket expenses for the preparation,
filing, prosecution, and maintenance of all United States and foreign patents
included in Patent Rights. Patent Costs shall also include reasonable
out-of-pocket expenses for patentability opinions, inventorship review and
determination, preparation and prosecution of patent applications,
re-examination, re-issue, interference, and opposition activities related to
Patents in the Patent Rights.

 

1.15“Patent Rights” shall mean all of Licensor’s right, title, and interest in
and to the Patents set forth in Appendix A hereto (which may be updated from
time to time to reflect new Patents including without limitation from Future
Inventions) and any other Patent related to any of the Licensed IP and/or the
Related Licensed IP, including its development manufacture, packaging, use,
marketing, promotion, distribution, licensing, offer for sale, or importation.
For the avoidance of doubt, the Patent Rights shall include any Patent relating
to any of the Licensed IP and/or the Related Licensed IP licensed to Licensee
herein, including, without limitation, Patents relating to any and all of
Licensor’s right, title and interest in and to Future Inventions (including the
development manufacture, packaging, use, marketing, promotion, distribution,
licensing, offer for sale, or importation of any of the Licensed IP and/or the
Related Licensed IP), filed, requested, and/or issued after the Effective Date
regardless of whether Appendix A is updated to reflect such Patent.

 

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1.16“Person” shall mean any natural person or any legal entity, including,
without limitation, corporations, partnerships, associations, commissions,
boards, agencies, and any other business or governmental entity or associations.

 

1.17“Sublicense” shall mean an agreement into which Licensee enters with a third
party that is not an Affiliate for the purpose of (a) granting certain rights;
(b) granting an option to certain rights; or (c) forbearing the exercise of any
rights, granted to Licensee under this Agreement after the Effective Date.

 

1.18“Sublicensee” shall mean a third party that is not an Affiliate with whom
Licensee enters into a Sublicense.

 

1.19“Technology” shall mean all right, title, and interest of Licensor in and to
the Technical Information related to any of the Licensed Products, Licensed
Inventions, Licensed IP, and/or the Related Licensed IP, including any of their
development, manufacture, packaging, use, marketing, promotion, distribution,
licensing, offer for sale, or importation.

 

1.20“Technical Information” shall mean any and all technical information and
other technical subject matter (including, medical, toxicological,
pharmacological, and clinical), trade secrets, know-how, ideas, concepts,
discoveries, disclosure, claims, formulas, formulations, processes, methods,
procedures, designs, compositions of matter, specifications, drawings,
techniques, results, technologies, compounds, research, data, inventions, and
discoveries, whether or not patentable.

  

ARTICLE 2. GRANTS/COLLABORATION

2.1 License.

 

(a)       Subject to Section 5.1 and to the limitations set forth in this
Agreement, Licensor hereby grants to Licensee, and Licensee hereby accepts, a
perpetual (unless terminated pursuant to Article 7), worldwide, exclusive
license, exclusive even as to Licensor, under the Licensed IP and Related
Licensed IP to make and have made, to use and have used, to sell and have sold,
to offer for sale and have offered for sale, and to import and have imported
Licensed Products, to practice and have practiced Licensed Methods, and to
otherwise use and have used the Licensed IP and Related Licensed IP (including,
but not limited to, the Patent Rights and the Technology), in any and all ways
and respects in any and all fields (the “License”). To the extent that aspects
of the Technology not covered by Patent Rights may be used outside of the
context of d-Methadone, Licensor reserves the right to use and to license or
assign to third parties such aspects of the Technology outside of the context of
d-Methadone.

 

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(b)       Licensee may extend the rights granted above to an Affiliate pursuant
to a written agreement provided that (i) such agreement shall include, to the
extent applicable, an obligation of the Affiliate to comply with all rights and
obligations due to Licensor pursuant to this Agreement; (ii) such agreement
shall contain a provision prohibiting the Affiliate from directly or indirectly
licensing, sublicensing, further extending its rights to another Affiliate or
otherwise granting its rights thereunder to any Affiliate and/or Sublicensee
without first obtaining Licensor’s written consent, which shall not be
unreasonably withheld or delayed and shall be limited to the terms relating to
compliance of such Affiliate and/or Sublicensee with rights and obligations due
to Licensor pursuant to this Agreement (it being understood that Licensor’s
consent right shall not extend to specific business and financial terms of
Licensee’s or its Affiliates’ extension of rights to an Affiliate and/or
Sublicensee, and that Licensee and/or its Affiliates shall have the right in
their sole discretion to consent to such business and financial terms); (iii)
Licensee and/or its Affiliate shall provide Licensor with a copy of such
agreement and any amendment thereto within thirty (30) days of such agreement or
amendment; and (iv) Licensee and any such Affiliate shall be jointly and
severally liable to Licensor for any material violation of an Affiliate’s
aforementioned obligation to comply with rights and obligations due to Licensor
pursuant to this Agreement. In the event that in a transaction with an Affiliate
as contemplated in this Section 2.1(b), Licensee and/or an Affiliate directly or
indirectly receive an equity investment from a third party that is in
consideration or partial consideration for Licensee’s and/or Affiliate’s direct
or indirect extension or grant of any rights under this Agreement, the Licensed
IP, Related Licensed IP, and/or Enabled Patents, such transaction shall be
treated as a Sublicense for purposes of Section 3.1(c) taking into account such
consideration received and Licensor shall receive compensation in accordance
therewith.

 

2.2 Sublicense.

 

(a)       The License granted in Section 2.1 includes the right of Licensee to
grant Sublicenses to third parties other than Affiliates, provided and on the
express condition that (i) such Sublicenses shall include, to the extent
applicable, an obligation of Sublicensee to comply with all rights and
obligations due to Licensor pursuant to this Agreement (Licensor to be an
intended beneficiary of such Sublicense); (ii) such Sublicenses shall contain a
provision prohibiting the Sublicensee from sublicensing its rights thereunder
without first obtaining Licensor’s written consent, which shall not be
unreasonably withheld or delayed and shall be limited to the terms relating to
the compliance of the further Sublicensee with rights and obligations due to
Licensor pursuant to this Agreement (it being understood that Licensor’s consent
right shall not extend to specific business and financial terms of any
Sublicense, and that that Licensee and/or its Sublicensees shall have the right
in their sole discretion to consent to such business and financial terms); (iii)
Licensee shall provide Licensor with a copy of each Sublicense issued and any
amendment thereto within thirty (30) days of such Sublicense or amendment; and
(iv) Licensee shall collect and guarantee payment of all payments due, directly
or indirectly, to Licensor from Sublicensees and summarize and deliver all
reports due, directly or indirectly, to Licensor from Sublicensees.

 

(b)       Sublicenses granted by Licensee shall survive termination of this
Agreement under Section 7.1 and Licensor’s rights to the Licensed IP and Related
Licensed IP shall be subject to any such Sublicenses if Licensor consents to the
survival of such Sublicenses in writing before or after said Sublicenses are
issued. In the absence of such written consent of Licensor, Sublicenses granted
by Licensee shall survive termination of this Agreement under Section 7.1 and
Licensor’s rights to the Licensed IP and Related Licensed IP shall be subject to
any such Sublicenses, provided that the Sublicensee agrees in said Sublicenses
that:

 

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(i) In the event of termination of this Agreement, the Sublicensee shall
recognize Licensor as the beneficiary of the Licensee’s rights and obligations
under the Sublicense and shall make all payments otherwise due to Licensee
thereunder to Licensor; and

 

(ii)       The Sublicensee’s rights under the Sublicense will only survive
termination of this Agreement if, within thirty (30) days after termination of
this Agreement, the Sublicensee enters into a written license agreement with
Licensor, replacing its Sublicense with Licensee, substituting Licensor for
Licensee and otherwise on substantially the same terms and conditions as its
Sublicense.

 

Licensor shall enter into a license agreement with a Sublicensee as set forth in
Section 2.2(b)(ii) within the time period specified therein. Sublicenses granted
by Licensee shall automatically terminate if Licensee terminates this Agreement
pursuant to Section 7.2.

 

2.3 Collaboration.

 

(a)       Licensor and Licensee agree that they will, subject to their mutual
availability, collaborate and cooperate in good faith in any further
intellectual property development, including, but not limited to, filing of
applications for patent protection, patent prosecution, seeking any other type
of intellectual property registration or protection, and any decisions or
proceedings relating thereto with respect to the Licensed Inventions and any and
all Future Inventions (if any). Licensee shall share with Licensor all data and
research in connection with d-Methadone that is in Licensee’s possession or
control and Licensor shall keep such information confidential in accordance with
the terms of Section 4.3 hereof. Licensor shall notify Licensee within a
reasonable time after its invention or development of any Future Invention that
is reasonably sufficient for the submission of a patent application to the
United States Patent and Trademark Office.

 

(b)       To the extent that Licensee and/or any of its Affiliates or
Sublicensees develops any new inventions or Patents relating to d-Methadone,
Licensee (and/or any of its Affiliates or Sublicensees) shall do so in
collaboration with Licensor (it being understood that Licensor agrees to
collaborate with Licensee with respect to the same), and, as applicable, include
Licensor as inventor, in which case, for the avoidance of doubt, any such
inventions would constitute Future Inventions and any such Patents would
constitute Patent Rights, respectively. For the avoidance of doubt, such
inventions or Patents developed by Licensee (and/or its any of its Affiliates or
Sublicensees) including Licensor as inventor shall be jointly owned by Licensee
(and/or any of its Affiliates or Sublicensees) and Licensor, and Licensor’s
interest in such inventions or Patents would be hereby licensed to Licensee as
Future Inventions and Patent Rights respectively. If Licensee and/or any of its
Affiliates or Sublicensees develops any Enabled Patent, Licensee shall notify
Licensor of the same within thirty (30) days thereof. Licensee shall keep
Licensor informed as to the status of any prosecution of such Enabled Patents,
if any. For the avoidance of doubt, as between Licensor and Licensee (and/or any
of its Affiliates or Sublicensees), Enabled Patents shall be owned by Licensee
(and/or any of its Affiliates or Sublicensees) subject to Licensor’s rights set
forth herein.

 

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(c)        Licensee covenants to use commercially reasonable efforts to
prosecute and pursue development of the Licensed Inventions and Future
Inventions, if any, and market Licensed Products, if any.

 

(d)       Licensor agrees to cooperate with Licensee such that Licensee may
enjoy to the fullest extent the rights conveyed under this Agreement (including,
without limitation, all rights relating to Future Inventions). Following the
Effective Date, Licensor shall deliver to Licensee such further information and
documents and shall execute and deliver to Licensee such further instruments and
agreements as Licensee shall reasonably request to consummate or confirm the
transactions provided for in this Agreement, to accomplish the purpose of this
Agreement, or to confer on Licensee the benefits of this Agreement. Licensee
shall reimburse or pay Licensor for all actual and reasonable third party
out-of-pocket expenses incurred by Licensor in the course of complying with this
Section 2.3(d), within thirty (30) days of Licensor’s request.

 

(e)       The obligations of Licensor with respect to collaboration set forth in
this Section 2.3 and with respect to the invention, discovery and/or development
of any Future Inventions are applicable only to the extent that exercise and/or
performance of them is not rendered impossible, unfeasible, or impracticable by
the death, illness, disability, or incapacitation of Dr. Charles E. Inturrisi
and/or Dr. Paolo Manfredi and the occurrence of any of the foregoing shall not
in any way reduce, eliminate, terminate or affect the rights of Licensor and/or
obligations of Licensee hereunder.

 

(f)       To the extent that the Licensed IP and/or Related Licensed IP includes
or comes to include trademarks, Licensor and Licensee agree to negotiate in good
faith an amendment to this Agreement with respect to quality control concerning
any such marks, as applicable. Such quality control provisions shall meet the
applicable legal standard in order to ensure that naked trademark licensing is
avoided and Licensee shall be able to enjoy full use of any trademarks.  

ARTICLE 3. CONSIDERATION 

3.1 License Fees and Royalties.

(a)       In addition to consideration already delivered to Licensor pursuant to
the Original Assignment Agreement, including 3,000 Warrants of Licensee issued
by Licensee to Licensor and the New Assignment Agreement, in consideration for
the License and other rights granted herein to Licensee, as well as other
promises and agreements herein, Licensee shall pay Licensor within five (5) days
following the Effective Date, a nonrefundable payment of One Hundred and Eighty
Thousand Dollars (USD $180,000).

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(b)       In further consideration for the License and other rights granted
herein to Licensee, as well as other promises and agreements herein, beginning
the day that is three (3) months after the Effective Date and each three-month
period thereafter, Licensee shall pay Licensor Forty Five Thousand Dollars (USD
$45,000) on or before the expiration of each three-month period (for the
avoidance of doubt, Licensee shall pay Licensor such Forty Five Thousand Dollar
(USD $45,000) payment four times in each twelve (12) month period following the
Effective Date) until the earliest to occur of the following events: (A) the
first commercial sale of a Licensed Product anywhere in the world, (B) the
expiration or invalidation of the last to expire or be invalidated of the
Patents Rights anywhere in the world, or (C) the termination of this Agreement
pursuant to Section 7.1 or 7.2 herein.

(c)       In further consideration for the License and other rights granted
herein to Licensee, as well as the other promises and agreements herein,
Licensee shall pay Licensor for as long as Licensee shall continue to receive
any income from the Licensed IP, Related Licensed IP, and/or Enabled Patents, if
any, subject to the following terms, conditions, and limitations:

(A)       for each country in which Patent Rights have issued and are in force,
continuing until the expiration or invalidation of the last to expire or be
invalidated of the Patent Rights in such country, including any adjustments
and/or extensions of the term of any such Patent Rights, (1) (i) an earned
royalty of two percent (2%) on Net Sales of Licensed Products derived from the
Licensed IP, Related Licensed IP, and/or Enabled Patents that are not sold by a
Sublicensee, and (ii) on each and every Sublicense earned royalty payment
received by Licensee from its Sublicensees on sales of Licensed Products derived
from the Licensed IP, Related Licensed IP, and/or Enabled Patents by a
Sublicensee, the higher of (x) twenty percent (20%) of the royalties received by
Licensee from the Licensed IP, Related Licensed IP, and/or Enabled Patents; or
(y) two percent (2%) on Net Sales of Sublicensee derived from the Licensed IP,
Related Licensed IP, and/or Enabled Patents; and (2) twenty percent (20%) of all
consideration received by Licensee and/or its Affiliates for Sublicenses,
including but not limited to, Sublicense fees, consideration in the form of
investments in equity in Licensee, and non-monetary consideration derived from
the Licensed IP, Related Licensed IP, and/or Enabled Patents received by
Licensee from Sublicensees that are not earned royalties;

(B)       after the expiration or invalidation of the last to expire or be
invalidated of the Patents Rights in a country or if no Patent Rights have
issued or are in force in a country but Enabled Patents have issued and are in
force in the country, continuing until the expiration or invalidation of the
last to expire or be invalidated of the Enabled Patents in such country, (1) (i)
an earned royalty of one-and-three-quarters percent (1.75%) on Net Sales of
Licensed Products derived from the Licensed IP, Related Licensed IP, and/or
Enabled Patents that are not sold by a Sublicensee, and (ii) on each and every
Sublicense earned royalty payment received by Licensee from its Sublicensees on
sales of Licensed Product derived from the Licensed IP, Related Licensed IP,
and/or Enabled Patents by a Sublicensee, the higher of (x)
seventeen-and-one-half percent (17.5%) of the royalties received by Licensee
from the Licensed IP, Related Licensed IP, and/or Enabled Patents; or (y)
one-and-three-quarters percent (1.75%) on Net Sales of Sublicensee derived from
the Licensed IP, Related Licensed IP, and/or Enabled Patents; and (2)
seventeen-and-one-half percent (17.5%) of all consideration received by Licensee
and/or its Affiliates for Sublicenses, including but not limited to, Sublicense
fees, consideration in the form of investments in equity in Licensee, and
non-monetary consideration derived from the Licensed IP, Related Licensed IP,
and/or Enabled Patents received by Licensee from Sublicensees that are not
earned royalties; and

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 (C)       after the expiration or invalidation of the last to expire or be
invalidated of the Patent Rights and Enabled Patents in a country or if no
Patent Rights or Enabled Patents have issued or are in force in a country, (1)
(i) an earned royalty of one-and-one-half percent (1.5%) on Net Sales of
Licensed Products derived from the Licensed IP, Related Licensed IP, and/or
Enabled Patents that are not sold by a Sublicensee, and (ii) on each and every
Sublicense earned royalty payment received by Licensee from its Sublicensees on
sales of Licensed Product derived from the Licensed IP, Related Licensed IP,
and/or Enabled Patents by a Sublicensee, the higher of (x) fifteen percent (15%)
of the royalties received by Licensee from the Licensed IP, Related Licensed IP,
and/or Enabled Patents; or (y) one-and-one-half percent (1.5%) on Net Sales of
Sublicensee derived from the Licensed IP, Related Licensed IP, and/or Enabled
Patents; and (2) fifteen percent (15%) of all consideration received by Licensee
and/or its Affiliates for Sublicenses, including but not limited to, Sublicense
fees, consideration in the form of investments in equity in Licensee, and
non-monetary consideration derived from the Licensed IP, Related Licensed IP,
and/or Enabled Patents received by Licensee from Sublicensees that are not
earned royalties.

(d)       Beginning the calendar year after cessation of payments under Section
3.1(b) pursuant to Section 3.1(b)(A) and continuing until the earlier to occur
of the events specified in Section 3.1(b)(B) or 3.1(b)(C), if the total amounts
paid by Licensee under Section 3.1(c) to Licensor in any such year cumulatively
are less than USD $180,000, Licensee shall pay to Licensor on or before February
28 following the last quarter of such year the difference between USD $180,000
and the total amount paid by Licensee for such year under Section 3.1(c);
provided, however, that for the year of commercial sales of the first Licensed
Product, the amount payable under this Section 3.1(d) shall be prorated for the
number of months remaining in that calendar year.

3.2. Payments.

(a)       Consideration in the form of royalties payable to Licensor pursuant to
Section 3.1(c) hereunder (whether direct or indirect from a Sublicensee or an
Affiliate) shall be paid by Licensee quarterly on or before March 31, June 30,
September 30, and December 31 of each calendar year. Each such payment shall be
for royalties under Section 3.1(c) accrued within Licensee’s most recently
completed calendar quarter (which, for the avoidance of doubt, is the quarter
preceding the one in which the payment is due). For the avoidance of doubt,
royalties shall accrue when payments on which such royalties are due are
received by Licensee.

(b)       Royalties earned on Net Sales occurring or under Sublicenses granted
pursuant to this Agreement in any country outside the United States shall not be
additionally reduced by Licensee for any taxes, fees, or other charges imposed
by the government of such country on the payment of royalty income, except that
all payments made by Licensee in fulfillment of Licensor’s tax liability in any
particular country may be credited against earned royalties or fees due Licensor
for that country provided that Licensee provides Licensor with a receipt
evidencing such payment (which would be acceptable to the United States Internal
Revenue Service). Licensee shall pay all bank charges resulting from the
transfer of such royalty payments. Licensor may opt to receive the earned
royalties or fees in the foreign currency of the country outside the United
States and provide Licensee written notice thereof. If royalties in the foreign
currency are to be paid in U.S. dollars, the amount owed will be calculated
according to the currency exchange rate against U.S. dollars of the day the
royalties are being paid.

 11 

 

(c)       In the event that any patent or patent claim within Patent Rights is
held invalid in a final decision by a patent office in any country from which no
appeal or additional patent prosecution has been or can be taken, or by a court
of competent jurisdiction and last resort and from which no appeal has or can be
taken, all obligation to pay royalties based solely on that patent or claim or
any claim patentably indistinct therefrom in such country shall cease as of the
date such final decision takes effect. For the avoidance of doubt, the
aforementioned cessation of the obligation to pay royalties only applies with
respect to the jurisdiction or jurisdictions in which such final decision was
made or otherwise has force and effect. Licensee shall not, however, be relieved
from paying any royalties that accrued before the date such final decision takes
effect or are based on another patent or claim not involved in such final
decision. For the avoidance of doubt, this Section 3.2(c) has no effect on the
operation of Section 3.1(c)(B) and 3.1(c)(C), which are and remain applicable in
a jurisdiction after the relevant patents have expired or are held invalid.

(d)       All consideration due Licensor under this Agreement shall be paid in
United States dollars or, if requested by Licensor, in foreign currency if
originating from a foreign country as provided in Section 3.2(b), and be divided
equally between Dr. Charles Inturrisi and Dr. Paolo Manfredi. The portion of the
consideration payable to Dr. Charles Inturrisi shall be paid by check or money
transfer payable to him and the portion of the consideration payable to Dr.
Paolo Manfredi shall be paid by check or money transfer payable to him and each
sent to the addresses set forth in this Agreement.

3.3.            Transaction Costs. Licensee shall pay Licensor’s reasonable
attorney fees for the preparation and negotiation of this Agreement.

3.4.            Patent Costs. Licensee shall reimburse Licensor (or pay for) all
Patent Costs within thirty (30) days following the date an itemized invoice is
sent from Licensor to Licensee.

3.5.            Late Payments. In the event royalty, reimbursement, and/or fee
payments are not received by Licensor when due, Licensee shall pay to Licensor
interest charges at a rate of ten percent (10%) per year. Such interest shall be
calculated from the date payment was due until actually received by Licensor. 

ARTICLE 4. REPORTS AND RECORDS

4.1 Reports.

 

(a) Copies of Agreements/Documentation. In addition to the disclosure of
agreements with Affiliates pursuant to Section 2.1(b) and Sublicenses pursuant
to Section 2.2(a), Licensee shall provide Licensor with copies of any agreements
and any amendments thereto relating to the rights granted herein within thirty
(30) days of such agreements or amendments.

 

 12 

 

  

(b) Commercialization Reports. After the first commercial sale of a Licensed
Product anywhere in the world, Licensee shall submit to Licensor quarterly
reports on or before each February 28, May 31, August 31 and November 30 of each
year. Each report shall cover Licensee’s (and each Affiliate’s and
Sublicensee’s) most recently completed calendar quarter (which, for the
avoidance of doubt, is the quarter preceding the one in which the report is due)
and shall show:

 

(i) the gross sales and Net Sales during the most recently completed calendar
quarter and the royalties, in US dollars or foreign currency where applicable,
payable with respect thereto;

 

(ii) the number of each type of Licensed Product sold;

 

(iii) Sublicense fees and royalties received during the most recently completed
calendar quarter in US dollars, payable with respect thereto;

 

(iv) the method used to calculate the royalties;

 

(v) the exchange rates used, if any; and

 

(vi) relevant business and corporate development efforts relating to the rights
granted in this Agreement.

 

Licensee shall provide the above information using the form as shown in Appendix
B and include information on the date of the first commercial sale of each
additional Licensed Product or in each additional country. If no sales of
Licensed Products have been made and no Sublicense revenue has been received by
Licensee during any reporting period, Licensee shall so report.

 

4.2 Records and Audits.

 

(a) Licensee shall keep, and shall require its Affiliates and Sublicensees to
keep, accurate and correct records of all Licensed Products manufactured, used,
and sold, and Sublicense fees received under this Agreement. Such records shall
be retained by Licensee and its Affiliates and Sublicensees for at least five
(5) years following a given reporting period.

 

(b) Upon reasonable notice from Licensor to Licensee, Licensee shall make (and
shall cause its Affiliates and/or Sublicensees to make) all records set forth in
Section 4.2(a) available at Licensee’s offices during normal business hours for
inspection at Licensor’s expense (except as otherwise provided in this Section
4.2(b)) by a an accountant selected by Licensor for the sole purpose of
verifying reports and payments or other compliance issues. Such accountant shall
keep any information learned during or related to the audit confidential as
provided in Section 4.3 and shall not disclose to Licensor any information other
than information relating to the accuracy of payments and disclosures made under
this Agreement or other compliance issues. In the event that any such inspection
shows an underreporting and underpayment in excess of five percent (5%) for any
six-month (6-month) period, then Licensee shall pay the cost of the inspection
and/or audit as well as any additional sum that would have been payable to
Licensor had Licensee reported correctly, plus an interest charge at a rate of
ten percent (10%) per year. Such interest shall be calculated from the date the
correct payment was due to Licensor up to the date when such payment is actually
made by Licensee. For underpayment not in excess of five percent (5%) for any
six-month (6-month) period, Licensee shall pay the difference within thirty (30)
days without interest charge or inspection/audit cost.

 13 

 

 

4.3 Confidentiality. Licensor and/or its accountants conducting any audit or
inspection shall keep any copies of Sublicenses, other agreements, amendments,
financial statements, reports, data, research, information or other materials
provided pursuant to Sections 2.1, 2.2, 2.3, 4.1, or 4.2 and any information
learned during or related to an audit or inspection pursuant to Section 4.2
confidential, except if (a) such information is or becomes publicly known and
available through no fault of Licensor and/or its accountants, (b) such
information becomes known to Licensor and/or its accountants by a third party
that has a lawful right to disclose the same, (c) Licensee consents to
Licensor’s and/or its accountants’ disclosure of such information, (d) if such
information is independently developed by Licensor and/or its accountants prior
to acquiring such information from Licensee, and (e) if Licensor and/or its
accountants are compelled by applicable law, a court, governmental authority, or
regulatory authority to disclose such information.

ARTICLE 5. PATENT MATTERS

5.1 Patent Prosecution and Maintenance.

 

(a)       Provided that Licensee has reimbursed Licensor for Patent Costs in
accordance with this Agreement, Licensor shall diligently file, prosecute, and
maintain the United States and, if available, foreign, Patents in Patent Rights
using counsel of Licensor’s choice. Licensor shall provide Licensee with copies
of all relevant documentation relating to such prosecution, and Licensee shall
keep this documentation confidential.

 

(b)       Licensor shall amend any patent application in the Patent Rights to
include or file a new application relating to the Licensed Inventions or Future
Inventions, if any, (which for the avoidance of doubt, would be part of the
Patent Rights), containing, as appropriate, claims reasonably requested by
Licensee to protect the products contemplated to be sold as Licensed Products by
Licensee under this Agreement.

 

(c)        Licensee may elect to terminate its reimbursement obligations with
respect to any Patent in the Patent Rights upon three (3) months’ written notice
to Licensor. Licensor shall use reasonable efforts to curtail further Patent
Costs for such Patent when such notice of termination is received from Licensee.
Licensor, in its sole discretion and at its sole expense, may continue
prosecution and maintenance of said Patent. However, Licensee shall have no
further license with respect thereto, Licensor shall be the sole owner all
right, title, and interest in such Patent, and any rights thereto granted by
Licensee to any Affiliate or Sublicensee of Licensee shall cease unless said
Affiliate or Sublicensee agrees in writing to assume Licensee’s reimbursement
obligations to Licensor with respect to such Patent prior to the expiration of
the three (3) month period of Licensee’s notice. If Licensee does not cure any
material non-payment of any portion of Patent Costs with respect to any Patent
within sixty (60) days after receiving written notice of the non-payment from
Licensor, said non-payment may be deemed by Licensor as an election by Licensee
to terminate its reimbursement obligations with respect to such Patent and its
license with respect thereto. Licensor is not obligated to, but may, file,
prosecute, or maintain Patent Rights outside of countries where they exist or to
file, prosecute, or maintain Patent Rights to which Licensee has terminated its
license hereunder, with the exception that Licensor shall file, prosecute, and
maintain Patent Rights in additional countries in which they do not already
exist at the reasonable request of Licensee, at Licensee’s cost.

 

 14 

 

  

(d)       With the exception of Future Inventions subject to Section 5.1(e),
Licensor may file United States and, if available, foreign, Patents for Future
Inventions. If Licensor files any such applications, it shall provide notice of
the same to Licensee within thirty (30) days. At Licensee’s reasonable request,
Licensor shall file such United States and, if available, foreign, Patents for
Future Inventions. For the avoidance of doubt, all Patents for Future Inventions
filed pursuant to this subsection shall be subject to the terms and conditions
set forth in Sections 5.1(a)-(c).

 

(e)       Any Patents in Patent Rights developed by Licensee (and/or any of its
Affiliates or Sublicensees) including Licensor as an inventor pursuant to
Section 2.3(b) shall only be filed with the agreement of both Licensor and
Licensee, such agreement not to be unreasonably withheld or delayed by Licensor
or Licensee if said filing is requested by the other of Licensor or Licensee. If
Licensor and Licensee come to such agreement, Licensor shall be responsible for
the diligent filing, prosecution, and maintenance of such Patents in Patent
Rights using counsel of Licensor’s choice and Licensee shall be responsible for
all Patent Costs relating to such Patents in Patent Rights. Licensor and
Licensee agree to cooperate with each other in any such patent prosecution and
proceedings, including, but not limited to, deliver to each other such further
information and documents and to execute and deliver to each other such further
instruments and documents as Licensor or Licensee shall reasonably request for
the purpose of furthering such patent prosecution efforts.

 

5.2       Patent Infringement.

 

(a)       In the event that Licensor or Licensee learns of infringement of
potential commercial significance of any Patent licensed under this Agreement,
the knowledgeable party will provide the other (i) with written notice of such
infringement and (ii) with any evidence of such infringement available to it
(the “Infringement Notice”). Except as provided in this Section 5.2, neither
Licensor nor Licensee will notify a third party (including the infringer) of
infringement or put such third party on notice of the existence of any Patent
Rights without first obtaining consent of the other. Both Licensor and Licensee
will use their diligent efforts to cooperate with each other to terminate such
infringement without litigation.

 

 15 

 

  

(b)       If infringing activity of potential commercial significance by the
infringer has not been abated within thirty (30) days following the date the
Infringement Notice takes effect (or earlier if Licensor is in agreement),
Licensee may, upon written notice to Licensor and at its sole cost and expense,
institute suit for patent infringement against the infringer. Licensor may
voluntarily join such suit (at Licensee’s expense for costs and any reasonable
legal fees of counsel selected by Licensor) but may not thereafter commence suit
against the infringer for the acts of infringement that are the subject of
Licensee’s suit or any judgment rendered in that suit. Licensee may not join
Licensor in a suit initiated by Licensee without Licensor’s prior written
consent. However, notwithstanding the foregoing, even if Licensor withholds such
consent, if a court requires Licensee to join Licensor in a suit or states that
it will dismiss Licensee’s suit unless Licensor is joined, Licensor agrees that
Licensee may join Licensor in the suit upon five (5) days’ written notice to
Licensor. If Licensor is so joined in the suit without its prior written consent
pursuant to the preceding sentence or is involuntarily joined in the suit,
Licensee shall pay any costs incurred by Licensor arising out of such suit,
including but not limited to, any reasonable legal fees of counsel that Licensor
selects and retains to represent it in the suit.

 

(c)       If, within sixty (60) days following the date the Infringement Notice
takes effect, infringing activity of potential commercial significance by the
infringer has not been abated and if Licensee has not brought suit against the
infringer, Licensor may, upon written notice to Licensee, institute suit for
patent infringement against the infringer. If Licensor institutes such suit,
Licensee may not join such suit unless Licensor consents to the same and may not
thereafter commence suit against the infringer for the acts of infringement that
are the subject of Licensor’s suit or any judgment rendered in that suit.

 

(d)       Subject to Section 5.2(e), recoveries from actions brought pursuant to
Section 5.2(b) or (c) shall belong to the party bringing suit. Legal actions
brought jointly by Licensor and Licensee shall be at Licensee’s expense and all
recoveries shall be shared equally by Licensor on one hand and Licensee on the
other hand, after Licensee deducts and recuperates its expenses, including,
without limitation, attorney fees, as evidenced by third party invoices.

 

(e)       Any agreement made by Licensee for purposes of settling litigation or
other dispute shall comply with the requirements for Sublicenses in this
Agreement.

 

(f)       Each party will cooperate with the other in litigation proceedings
instituted hereunder but at the expense of the party who initiated the suit
(unless such suit is being jointly prosecuted by the parties, in which case
expenses shall be paid by Licensee).

 

(g)       Any litigation proceedings will be controlled by the party bringing
the suit, except that Licensor may be represented by counsel of its choice in
any suit brought by Licensee (and Licensor’s reasonable legal expenses shall be
paid by Licensee).

 

5.3 Patent Marking. Licensee shall mark all Licensed Products made, used, or
sold under the terms of this Agreement, or their containers, in accordance with
the applicable patent marking laws, if any.

 

 16 

 

 

ARTICLE 6. GOVERNMENTAL MATTERS

 

6.1 Governmental Approval or Registration. If this Agreement or any associated
transaction is required by the law of any nation to be either approved or
registered with any governmental agency, Licensee shall assume all legal
obligations to do so. Licensee shall notify Licensor if it becomes aware that
this Agreement is subject to a United States or foreign government reporting or
approval requirement. Licensee shall make all necessary filings and pay all
costs including fees, penalties, and all other out-of-pocket costs associated
with such reporting or approval process.

 

6.2 Export Control Laws. Licensee shall observe all applicable United States and
foreign laws with respect to the transfer of Licensed Products and related
technical data to foreign countries, including, without limitation, the
International Traffic in Arms Regulations and the Export Administration
Regulations.

ARTICLE 7. TERMINATION

7.1 Termination by Licensor.

 

(a)       Except as expressly set forth herein, this Agreement, including the
License and other rights granted herein, shall terminate and be of no further
force or effect in the event that:

 

(i) Licensee (or any of its successors and assigns) fails to make any payment
required by this Agreement (including payments pursuant to Article 3) in excess
of $12,500, and does not cure said failure before all of the following have
occurred: (A) Licensee receives a first written notice of said failure from
Licensor, (B) Licensee receives a second written notice of said failure from
Licensor, said second written notice given no sooner than sixty (60) days after
the first written notice, (C) Licensee receives a written notice that this
Agreement shall terminate in fifteen (15) days in the absence of cure, said
written notice given no sooner than sixty (60) days after the second written
notice, and (D) fifteen (15) days pass after Licensee receives said written
notice of termination (without cure of said failure by Licensee);

 

(ii)       Any payment failure described in Section 7.1(a)(i) beyond the second
such failure occurs (and is not cured promptly) within any twenty-four (24)
month period, and Licensee does not cure such subsequent failure before all of
the following have occurred: (A) Licensee receives a first written notice of
said failure from Licensor, (B) Licensee receives a written notice that this
Agreement shall terminate in sixty (60) days in the absence of cure, said
written notice given no sooner than forty (40) days after the first written
notice, and (C) sixty (60) days pass after Licensee receives said written notice
of termination (without cure of said failure by Licensee);

 

(iii)       Licensee (for the avoidance of doubt, inclusive of any successors or
assigns of Licensee) terminates Mr. Traversa’s employment for any reason other
than for Cause prior to the later of the date five (5) years from the Effective
Date or December 31, 2022;

 17 

 

 

(iv)       Licensee (for the avoidance of doubt, inclusive of any successors or
assigns of Licensee) prior to the later of the date five (5) years from the
Effective Date or December 31, 2022: (A) removes Mr. Traversa from the position
of Chief Executive Officer of Licensee without his written consent for any
reason other than for Cause except in connection with or following any
transaction of a type permitting Licensee to assign this Agreement to a third
party without the consent of Licensor pursuant to Section 9.2(b); (B) changes
Mr. Traversa’s job responsibilities such that he is no longer the executive
responsible for decision-making relating to development and marketing of
d-Methadone without his written consent, (C) decreases Mr. Traversa’s
compensation without his written consent, or (D) assigns or sells its rights to
the Licensed IP and/or Related Licensed IP to another Person pursuant to Section
9.2(b) without the written consent of Mr. Traversa;

(v)       Licensee or an Affiliate that is (or has been during any relevant
bankruptcy look-back period) a party to an agreement pursuant to Section 2.1(b)
hereof (or any if their respective successors and assigns) shall file or
acquiesce to a petition in any court in any bankruptcy, reorganization, or
insolvency proceedings, or any such petition shall be filed against Licensee or
its successors and/or assigns, or a receiver or trustee shall be appointed for
Licensee or its successors and/or assigns for all or any portion of its assets,
and any such proceedings shall not be dismissed discontinued, or vacated within
thirty (30) days;

(vi)       Licensee (or any of its successors and assigns) materially fails to
perform or otherwise materially violates any provision of Sections 2.1(b), 2.2,
4.1, 4.2, or 9.2, and does not cure said failure or violation before all of the
following have occurred: (A) Licensee receives a first written notice of said
failure or violation from Licensor, (B) Licensee receives a second written
notice of said failure or violation from Licensor, said second written notice
given no sooner than sixty (60) days after the first written notice, (C)
Licensee receives a written notice that this Agreement shall terminate in thirty
(30) days in the absence of cure, said written notice given no sooner than sixty
(60) days after the second written notice, and (D) thirty (30) days pass after
Licensee receives said written notice of termination (without cure of said
failure or violation by Licensee); or

(vii)       Licensee or any Affiliate files a claim including in any way the
assertion that any portion of Licensor’s Patent Rights is invalid or
unenforceable where the filing is by the Licensee, an Affiliate, a third party
on behalf of the Licensee or an Affiliate, or a third party at the written
urging of the Licensee or an Affiliate.

(b)       Except as expressly set forth herein, if Licensee (or any of its
successors and assigns) materially fails to perform or materially violates any
term of this Agreement other than those requiring a payment to be made covered
by Section 7.1(a)(i) or those set forth in Section 7.1(a)(vi), Licensor may give
Licensee written notice of the breach providing a thirty (30) day period to cure
such breach. If Licensee fails to cure such breach within such thirty (30) day
period, Licensor shall have the right to bring suit against Licensee seeking any
remedies at law (including without limitation, monetary damages) or in equity
(including without limitation, specific performance, injunctions, and in the
case of a threatened breach of any covenant or obligation, injunctions to
prevent such breaches or enforce specific performance). In the event that
Licensor pursues remedies in equity in such action, Licensee hereby waives (i)
any defense in any action for specific performance that a remedy at law would be
adequate, and (ii) any requirement under any law that Licensor obtain, furnish,
or post any security or bond or similar instrument in connection with such
equitable remedy. For the avoidance of doubt, if Licensor prevails in such suit,
Licensor shall be entitled to recover its reasonable legal costs and expenses
(including without limitation, reasonable attorney fees and expenses) pursuant
to Section 9.4. Likewise, if Licensor prevails in obtaining preliminary or
interlocutory relief in such suit, Licensor shall be entitled to recover its
reasonable legal costs and expenses (including without limitation, reasonable
attorney fees and expenses) pursuant to Section 9.4, except that Licensor shall
have the right to seek such reasonable legal costs and expenses at any time
after prevailing with respect to said preliminary or interlocutory relief and
need not wait until a final judgment to do so. This Agreement, including the
License and other rights granted herein, shall terminate and be of no further
force or effect in the event that Licensee fails to comply with any court
decision awarding Licensor the aforementioned equitable and/or legal remedies
(inclusive of any such court decision awarding preliminary or interlocutory
relief) and/or pay an award of Licensor’s reasonable legal fees as required by
this Section 7.1(b), within thirty (30) days of any such court decision or award
and does not cure such a failure within thirty (30) days of receiving written
notice of the failure from Licensor (it being understood that Licensee’s taking
of any appeal of any such court decision does not constitute a failure to comply
with said court decision). For the avoidance of doubt, nothing in this Section
7.1(b) limits the ability of Licensor or Licensee to otherwise bring a legal
action or seek any remedy (including, without limitation, injunctive relief or
specific performance) for breach of this Agreement.

 18 

 

 

(c)       For the avoidance of doubt, Licensor may not terminate this Agreement
except as expressly provided in this Section 7.1.

7.2 Termination by Licensee.

(a) Notwithstanding Section 2.3(c), Licensee shall have the right at any time
and for any reason to terminate this Agreement upon ninety (90) days’ written
notice to Licensor stating that Licensee will cease development of the Licensed
Inventions or any other Licensed IP or Related Licensed IP, and marketing, sale,
and export of Licensed Products.

(b) Any termination under Section 7.2(a) shall not relieve Licensee of any
obligation or liability accrued under this Agreement prior to termination, or
rescind any payment made to Licensor or action by Licensee prior to the time
termination becomes effective. Termination shall not affect in any manner any
rights of Licensor arising under this Agreement prior to termination.

 

7.3 Survival on Termination. The following Sections and Articles shall survive
the termination of this Agreement:

 

(a)       Section 2.2(b) (Survival of Sublicenses), provided a Sublicensee
complies with the terms thereof;

 

(b)       Article 4 (REPORTS AND RECORDS), for a period of one (1) year
following termination of this Agreement;

 

(b)       Section 7.5 (Disposition of Licensed Products on Hand);

 

(c)       Section 8.2 (Indemnification);

 

(d)       Section 9.4 (Failure to Perform); and

 

(e)       Section 9.5 (Governing Laws).

 

7.4 Transfer of Data to Licensor. Upon termination of this Agreement pursuant to
Section 7.1 or 7.2, any data relating to the Licensed Inventions, and Future
Inventions, if any, that Licensee may have shall be deemed to be owned by
Licensor and Licensee shall share with Licensor and transfer and assign to
Licensor any and all right, title, and interest therein. Licensee shall execute
and deliver to Licensor such further instruments and agreements as Licensor
shall reasonably request to consummate or confirm such transfers and
assignments.

 

7.5 Disposition of Licensed Products on Hand. Upon termination of this Agreement
pursuant to Section 7.1 or 7.2, Licensee (and any Affiliates and Sublicensees)
may dispose of all previously made or partially made Licensed Product within a
period of one hundred and twenty (120) days of the effective date of such
termination provided that the sale of such Licensed Product by Licensee, its
Sublicensees, or Affiliates shall be subject to the terms of this Agreement,
including but not limited to the rendering of reports and payment of royalties
required under this Agreement.

 

7.6 Grant Back to Licensor. Upon termination of this Agreement pursuant to
Section 7.1 or 7.2, Licensee (and/or its Affiliates or Sublicensees) shall grant
to Licensor a fully paid-up, irrevocable, non-exclusive license to the Enabled
Patents, if any, with the right to grant sublicenses to third parties.

ARTICLE 8. LIMITED WARRANTY AND INDEMNIFICATION

8.1 Limited Warranty.

 

(a)       Licensor warrants that it has the lawful right to grant this License.
Licensor further warrants and represents that it has not entered and will not
enter into any license, contract or understanding in conflict with the terms and
provisions of this Agreement whether in part or in their entirety, including,
without limitation, the exclusive rights and License to Licensee.

(b)       Licensor warrants and represents that it owns the New Invention and
that no other Person, including, but not limited to, Cornell and entities
related to Cornell, has an ownership right or interest therein. Licensor further
warrants that at the time it entered into the Original Assignment Agreement, it
owned the Existing Invention and that no other Person, including, but not
limited to, Cornell and entities related to Cornell, had an ownership right or
interest therein.

 

 19 

 

 

 

(c)        Except as expressly provided in Sections 8.1(a) and (b) above, the
license granted herein is provided “AS IS” and without WARRANTY OF
MERCHANTIBILITY or WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE or any other
warranty, express or implied. Licensor makes no representation or warranty that
the Licensed Products, Licensed Methods, or the use of Patent Rights or
Technology will not infringe any other patent or other proprietary rights.

 

       (d)       In no event shall Licensor be liable for any incidental,
special or consequential damages resulting from exercise of the License granted
herein or the use of the Licensed IP, Related Licensed IP, Licensed Product,
Licensed Method, or Technology.

 

(e)       Nothing in this Agreement shall be construed as:

 

(i)       a warranty or representation by Licensor as to the validity or scope
of any Patent Rights;

 

(ii)      a warranty or representation that anything made, used, sold, or
otherwise disposed of under any license granted in this Agreement is or shall be
free from infringement of patents of third parties;

 

(iii)     an obligation to bring or prosecute actions or suits against third
parties for patent infringement except as provided in Section 5.2 hereof; or

 

(iv)     conferring by implication, estoppel, or otherwise any license or rights
under any patents of Licensor other than Patent Rights as defined in this
Agreement.

 

 

8.2 Indemnification.

 

(a) Licensee shall indemnify, hold harmless, and defend Licensor and their
successors and assigns against any and all claims, suits, losses, damage, costs,
fees, and expenses resulting from or arising out of this Agreement or any
Sublicense. This indemnification shall include, but not be limited to, any
product liability. Licensee shall (and shall cause its Affiliates and/or
Sublicensees, as applicable, to) add each Licensor and their respective
successors and assigns, as “additional insured” under any product liability
policy of Licensee for the Licensed Inventions and Future Inventions (if any).

(b)       Licensee, at its sole cost and expense, shall insure its activities in
connection with the work under this Agreement and obtain, keep in force and
maintain insurance or an equivalent program of self-insurance as follows:

 

(i)       comprehensive or commercial general liability insurance (contractual
liability included) with limits of at least: (A) each occurrence, five million
dollars (US$5,000,000); (B) products/completed operations aggregate, ten million
dollars (US$10,000,000); (C) personal and advertising injury, five million
dollars (US$5,000,000); and (D) general aggregate (commercial form only), ten
million dollars (US$10,000,000); and

 

(ii)       the coverage and limits referred to above shall not in any way limit
the liability of Licensee.

 

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(c)       Licensee shall (and shall cause its Affiliates and/or Sublicensees, as
applicable, to), within ninety (90) days of the Effective Date (or the execution
date of any agreement with an Affiliate and/or a Sublicensee), furnish Licensor
with certificates of insurance showing compliance with all requirements. Such
certificates shall: (i) provide for thirty (30) day advance written notice to
Licensor of any modification; (ii) indicate that Licensor has been endorsed as
an additionally insured party under the coverage referred to above; and (iii)
include a provision that the coverage shall be primary.

 

(d)       Licensor shall notify Licensee in writing of any claim or suit brought
against Licensor in respect of which Licensor intends to invoke the provisions
of this Article. Licensee shall keep Licensor informed on a current basis of its
defense of any claims under this Section 8.2.

ARTICLE 9. MISCELLANEOUS PROVISIONS

 

9.1       Correspondence. Any notice, invoice or payment required to be given to
either party under this Agreement shall be deemed to have been properly given
and effective:

 

(a)       on the date of delivery if delivered in person;

 

(b)       one (1) day after delivery to the respective addresses given below, or
to such other address as is designated by written notice given to the other
party if sent via an overnight delivery service or express mail;

 

(c)       one (1) day after the successful transmission in pdf file format if
sent by electronic mail using the Internet; or

 

(d)       five (5) days after mailing if mailed by first-class or certified
mail, postage paid, to the respective addresses given below, or to such other
address as is designated by written notice given to the other party.

 

If sent to Licensee:           Relmada Therapeutics, Inc.     750 Third Avenue,
9th Floor     New York, NY 10016     Attention: Sergio Traversa, Pharm.D., Chief
Executive Officer           TEL: (646) 667-3854     FAX: (888)-228-5672    
EMAIL: st@relmada.com           And        

 

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  Thomas R. Slusarczyk, Esq.     The Matt Law Firm, PLLC     1701 Genesee Street
    Utica, NY 13501           TEL: (315) 235-2299     FAX: (315) 624-7359    
EMAIL: tslusarczyk@mattlawfirm.com         If sent to Licensor:           For
all correspondence except payments -           Dr. Paolo Manfredi     11
Bleecker Street     New York, NY 10012           Tel: (646) 284-3119     EMAIL:
paolomanfredi11@gmail.com           With copy to:     PMLRD LLC     11 Bleecker
Street     New York, NY 10012           And           Dr. Charles Inturrisi    
444 East 82 Street Apt 2 S     New York NY 10028           Tel: (860) 482-5117  
  EMAIL: ceintur@gmail.com           For all payments -         If sent by mail:
    Payments for Dr. Paolo Manfredi shall be made to PMLRD LLC and sent to the
address above.       Payments for Dr. Charles Inturrisi shall be made to him and
sent to the address above.

         

            

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Licensee is responsible for all bank charges of wire transfer of funds for
payments. Such bank charges shall not be deducted from total amount due to
Licensor.

 

9.2       Assignability.

 

(a)       This Agreement, including without limitation the right to receive any
payments under Article 3 hereof, may be freely assigned in whole or in part by
Licensor (or either Dr. Charles Inturrisi or Dr. Paolo Manfredi) except that (i)
Licensor may not assign or delegate its obligations with respect to licensing
Future Inventions (if any) to Licensee pursuant to this Agreement and (ii) any
assignment by Licensor of any rights and/or obligations under this Agreement
shall have no effect on Licensor’s obligations or Licensee’s rights with respect
to Future Inventions developed after such assignment. This Agreement is binding
upon the successors and assigns of Licensor, other than with respect to
obligations in connection with Future Inventions, which remain personal to Dr.
Paolo Manfredi and Dr. Charles Inturrisi and subject to Section 2.3 (e ) hereof,
including, without limitation, any assignee of Licensor with respect to any of
its right, title, and interest in the Licensed IP and/or Related Licensed IP.
For the avoidance of doubt, any assignment of any of Licensor’s right, title, or
interest in the Licensed IP and/or Related Licensed IP shall be subject to the
License and rights of Licensee set forth herein.

 

(b)       This Agreement is not assignable in any way by Licensee without the
written consent of Licensor, except expressly as follows: Licensee may without
prior written consent of Licensor, but with two (2) business days prior written
notice thereof, assign this Agreement as a whole (but not in part) and the
rights and obligations and interests granted herein to any bona fide third party
purchaser of substantially all of Licensee’s assets or substantially all of
Licensee’s equity, or to any successor entity resulting from any merger, reverse
merger, or consolidation of Licensee with or into such entity; provided in each
case, that the assignee and/or surviving entity agrees in writing to be bound by
the terms of this Agreement for the benefit of Licensor. For the avoidance of
doubt, assignment of this Agreement by Licensee pursuant to this Section 9.2(b)
does not constitute extension of rights to an Affiliate under Section 2.1(b) or
a Sublicense and, without limitation, is not subject to the requirements of
Section 2.1(b) or Section 2.2 or the payment obligations with respect to
Sublicenses set forth in Section 3.1(c).

 

(c)       This Agreement is a license of the type described by Section 365(c)(1)
of the Bankruptcy Code.

 

(d)       Any assignment, agreement, or other transaction attempted or entered
into in violation of this Section 9.2 shall be deemed null and void and have no
legal effect.

 

9.3       No Waiver. No waiver by either party of any breach or default of any
covenant or agreement set forth in this Agreement shall be deemed a waiver as to
any subsequent and/or similar breach or default.

 

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9.4       Failure to Perform. In the event of a failure of performance due under
this Agreement and if it becomes necessary for either party to undertake legal
action against the other on account thereof, then the prevailing party shall be
entitled to reasonable attorneys fees in addition to costs and necessary
disbursements.

 

9.5        Governing Laws/Jurisdiction.

(a)       This Agreement shall be governed by, and construed in accordance with
(A) the laws of the United States, in respect to trademark and patent issues,
except that the scope and validity of any foreign Patent or trademark shall be
governed by the applicable laws of the country of the Patent or trademark, and
(B) in all other respects, including as to validity (except for patent and
trademark issues), interpretation and effect, by the laws of the State of New
York without giving effect to the conflict of laws rules thereof.

(b)       The parties hereby consent to the sole and exclusive jurisdiction of
the courts of the state of New York, in the county of New York, or the United
States Federal District Court for the Southern District of New York for purposes
of any action or proceeding brought by either of them on or in connection with
this Agreement on any alleged breach thereof and waive any right to assert any
rights or defenses within any other jurisdiction or to require that litigation
regarding this Agreement take place elsewhere. Notwithstanding the foregoing,
either party may apply to any court of competent jurisdiction for injunctive
relief or any other appropriate relief.

9.6       Force Majeure. Except for monetary obligations hereunder, a party to
this Agreement may be excused from any performance required herein if such
performance is rendered impossible or unfeasible due to any catastrophe or other
major event beyond its reasonable control, including, without limitation, war,
riot, and insurrection; laws, proclamations, edicts, ordinances, or regulations;
strikes, lockouts, or other serious labor disputes; and floods, fires,
explosions, or other natural disasters, provided that the nonperforming part
uses commercially reasonable efforts to avoid or remove such causes for
non-performance. When such events have abated, the non-performing party's
obligations herein shall resume.

 

9.7       Headings. The headings of the several sections are inserted for
convenience of reference only and are not intended to be a part of or to affect
the meaning or interpretation of this Agreement.

 

9.8       Entire Agreement. This Agreement sets forth the entire Agreement and
understanding between the parties, and incorporates and merges therein all prior
discussions, understandings and arrangements, expressed or implied, oral or
written, between the parties, and neither party should be bound by any
conditions, definitions, warranties or representations, with respect to the
subject matter of this Agreement, other than as expressly provided in this
Agreement, unless and other than expressly set forth in writing and executed by
Licensor and Licensee (or their successors or assigns).

9.9       Amendments. No amendment or modification of this Agreement shall be
valid or binding on the parties unless made in writing and signed on behalf of
each party.

 

9.10        Severability.

 24 

 

 

(a)       The invalidity of any portion of this Agreement will not and shall not
be deemed to affect the validity of any other provision. If any provision of
this Agreement is held to be invalid or and/or unenforceable, Licensor and
Licensee agree that the remaining provisions shall be deemed to be in full force
and effect as if they had been executed by both parties subsequent to the
expungement of the invalid provision.

 

(b)       In the event that this Agreement, or any part thereof, is held to be
invalid and/or unenforceable with respect to the License granted to Licensee, if
Licensee so elects in a writing delivered to Licensor, all right, title, and
interest of Licensor in the Existing Invention and other rights granted pursuant
to the Original Assignment Agreement assigned and transferred to Licensor
pursuant to the New Assignment Agreement shall revert to Licensee, subject to
the terms of the Original Assignment Agreement, with the exception that Section
3.1(C)(c) of this Agreement shall govern royalties after the expiration or
invalidation of any applicable patents. Upon such reversion to Licensee,
Licensor shall transfer and assign all such right, title, and interest back to
Licensee. Licensor shall execute and deliver to Licensee such further
instruments and agreements (including without limitation, patent and
intellectual property assignment agreements) as Licensee shall reasonably
request to consummate or confirm such transfers and assignments. The remainder
of this Agreement that is not held invalid and/or unenforceable shall remain in
full force and effect.

(signature page follows)

IN WITNESS WHEREOF, Licensor and Licensee caused this Agreement to be duly
executed as of the Effective Date. 

LICENSOR           Dr. Charles E. Inturrisi and Dr. Paolo Manfredi           By:
/s/ Charles E. Inturrisi   By: /s/ Paolo Manfredi Dr. Charles E. Inturrisi   Dr.
Paolo Manfredi             LICENSEE           RELMADA THERAPEUTICS, INC.        
  By: /s/ Sergio Traversa     Sergio Traversa     Chief Executive Officer      
   

 

 25 

 

 

Appendix A - Patents and Patent Applications

 

 26 

 

 

Appendix B - Commercialization Report

 

 

Company Name   Your Reference No

Reporting Period ( mm / dd / yyyy )

 

From _______ / _______ / _____________ Through _______ / _______ /
______________

EXPECTED or ACTUAL ( mm / dd / yyyy )

Date of first sale of

Licensed Product(s) ________ / ________ / _____________

Please list all trade names for product(s) incorporating licensed rights whether
or not you had sales during this reporting period.

 

 

 

Docket # Country Number of Units Sold Gross Sales by Country

Net Sales by Country*

( A )

Royalty Rate*

( B )

 

Total Royalties by Country

( A * B )

                                                                               
                                                                               
       

* Please refer to the license agreement for:

·         applicable royalty rate, please provide as decimal;

·         how Net Sales should be calculated;

·         applicable share of sublicense fees;

·         application of minimum royalty rate

·         If sales were in a currency other than United States Dollars, please
specify exchange rate used

Royalty Subtotal   Minimum Royalty Payment*   Total Royalty Owed  

Total Sublicense Fees*

(if applicable)

 

Total Payment

 

                 

 

 

 

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Sublicense Activity (if applicable) Number of sublicenses granted during the
reporting period     Number of sublicenses terminated or expired during the
reporting period   Granted Sub-Licensee Company Name(s) (please list below)  
Terminated Sub-Licensee Company Name(s) (please list below)                    
          Total Number of active sublicenses during reporting period            
   

 

 

Other Licensed Products in the pipeline Product Name   Developmental Stage  
Product Name   Developmental Stage   Product Name   Developmental Stage  
Product Name   Developmental Stage  

 

Report Prepared & Approved By Name  ( Please Print ) Title

Email

 

 

Signature

Date ( mm / dd / yyyy )

 

 

_________ / _________ / ______________

 

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