Exhibit 10.1

 

Confidential Treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as “****”. A complete version of this exhibit has been
filed separately with the Securities and Exchange Commission.

 

Confidential

 

AMENDED AND RESTATED

 

MATERIAL TRANSFER, OPTION AND RESEARCH LICENSE AGREEMENT

between

OPIANT PHARMACEUTICALS, INC.

 

and

AEGIS THERAPEUTICS, LLC

 

Execution Date                      April 26, 2016

Original Effective Date         December 1, 2014

 

**** = REDACTED

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

MATERIAL TRANSFER, OPTION AND RESEARCH LICENSE AGREEMENT

 

This Amended and Restated Material Transfer, Option and Research License
Agreement (the “Agreement”) as executed on April 26, 2016 and effective as of
December 1st, 2014 (the “Effective Date”), is entered into between Aegis
Therapeutics, LLC (“Aegis”), having a place of business at 11770 Bernardo Plaza
Court, Suite 353, San Diego, CA 92128, and Opiant Pharmaceuticals, Inc. (f/k/a
Lightlake Therapeutics Inc.) (“Opiant”), having a place of business at 401
Wilshire Blvd., 12th Floor, Santa Monica, CA 90401.

 

WHEREAS, the Parties entered into a Material Transfer, Option and Research
License Agreement effective as of December 1, 2014 as amended on December 16,
2014 and May 19, 2015 (the “Original Agreement”); and

 

WHEREAS, the Parties wish to amend and restate in its entirety the Original
Agreement as set forth herein as of October 27, 2015 (the “Amendment Date”).

 

NOW THEREFORE, for this and other valuable consideration, the receipt of which
is hereby acknowledged, and intending to be legally bound, the Parties agree as
follows:

 

Recitals

 

WHEREAS, Aegis is the owner of certain Technology; and

 

WHEREAS, Opiant has requested that Aegis transfer and Aegis wishes to transfer
to Opiant the Technology for the purpose of enabling Opiant to conduct a
feasibility study of the Compound and, potentially, the Additional Compounds,
used with the Technology.

 

Now, therefore, in consideration of the mutual benefits in furthering the
interests of the parties, it is hereby agreed as follows:

 

A.DEFINITIONS

 

“Additional Compounds” mean naltrexone and nalmephene/ nalmefene.

 

“Compound” means naloxone or Additional Compounds and any metabolite, salt,
ester, hydrate, anhydride, solvate, isomer, enantiomer, free acid form, free
base form, crystalline form, co-crystalline form, complexes, amorphous form,
pro-drug (including ester pro-drug) form, racemate, polymorph, chelate, isomer,
tautomer, or optically active form of the foregoing.

 

“Field” means treatment, diagnosis, prediction, detection or prevention of any
disease, disorder, state, condition or malady in humans.

 

“Intellectual Property” means all discoveries, inventions, improvements,
developments, procedures, processes, formulations, know-how, trade secrets,
formulae, trademarks, service marks, trade dress, designs, logos, packaging,
proprietary information, technical information, techniques, works of authorship,
drawings, models, manuals and systems, whether or not patentable or
copyrightable or otherwise registerable, and all rights and applications or
registrations derived or derivable therefrom.

 

“****” means ****.

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

“Representatives” means, for a party, its directors, officers, employees,
advisors or agents.

 

“Study” means (a) the feasibility study to be performed by Opiant as described
in Attachment A and (b) the ****.

 

“Technology” means all drug delivery and stabilization technologies and
associated Intellectual Property owned or controlled by Aegis, including without
limitation (a) Aegis’ drug delivery technology known as Intravail® delivery
enhancement agents (alkylsaccharide surfactants and formulations thereof as
described in US Patent No. 5,661,130) and ProTek® stabilization technologies
(alkylsaccharide surfactants and formulations thereof as described in US Patent
8,226,949 and US Patent Application numbers 11/474,055, 11/937,966, 12/050,038
and US06/024577); (b) any substances or formulations, which constitute an
unmodified form or functional sub-unit of the technology set forth in sub-clause
(a) above, for example but not by way of limitation, formulations at
concentrations not specifically disclosed in US Patent No. 5,661,130 or mixtures
of different alkylglycosides; or (c) any substances or formulations which
constitute a modified form of the technology set forth in sub-clause (a) above
but still contains/incorporates alkylglycosides having chemical compositions or
concentrations that may differ from those disclosed in US Patent No. 5,661,130
and 8,226,949 or US Patent Application numbers 11/474,055, 11/937,966,
12/050,038 and US06/024577 or which may be used individually or in combination,
or in combination with other materials not specified in US Patent No. 5,661,130
and 8,226,949 or US Patent Application numbers 11/474,055, 11/937,966,
12/050,038 and US06/024577.

 

B.GENERAL TERMS, TECHNOLOGY TRANSFER and RESEARCH LICENSE

 

B.1In partial consideration for Aegis entering into this Agreement, Opiant has
paid Aegis a one-time upfront, noncreditable fee of $150,000 (the “Study Fee”).
Opiant may elect to pay up to 50% of the Study Fee, or Extension Fee, by issuing
to Aegis shares of Opiant’s common stock subject to the following:

 

a.There must be a public market for Opiant's shares and Opiant must be current
with all statutory filings

 

b.The shares shall be issued pursuant to Rule 144 of the Securities Act of 1933;

 

c.The number of shares to be issued shall be calculated to 75% of the average
closing price for the previous 20 trading days;

 

d.After the statutory holding period has been satisfied, Opiant’s legal counsel
shall provide a legal opinion so that the shares can be sold in accordance with
Rule 144 of the Securities Act of 1933.

 

All cash payments shall be wired to the following Aegis bank account within 15
days of execution of this Agreement:

 

  Bank Name: ****   Account Name: Aegis Therapeutics, LLC   Routing Number: ****
  Account Number: ****

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

B.2In partial consideration for the fee specified in Section B.1 above, Aegis
agrees to:

 

a.provide Intravail® and/or ProTek® excipients (individually and collectively
“Aegis Material”) to Opiant to conduct the Study on the Compound and Additional
Compounds in accordance with Attachment A;

 

b.provide Opiant with technical support in accordance with Attachment A in
connection with the Study on the Compound and Additional Compounds; and

 

c.perform the other activities delegated to it in Attachment A.

 

B.3In partial consideration for the fee specified in Section B.1 above:

 

a.Aegis hereby grants to Opiant an exclusive royalty-free research license to
the Technology for a period beginning on the Effective Date and ending August
17, 2015 (the “Compound Research Period”) for the sole purpose of (i) conducting
the Study with the Compound and such other activities as described herein and
(ii) evaluating Opiant’s interest in licensing the Technology in the Field for
the Compound (the “Compound Purpose”). The Technology may not be used in
clinical trials involving human subjects without the written permission of
Aegis. During the Compound Research Term, Opiant may provide the Technology to
contract research or service organizations to perform the Studies or activities
contemplated in Attachment A, provided that such organizations have
confidentiality obligations at least as protective as those set forth in this
Agreement. As of the date hereof, Opiant has extended the Compound Research
Period through making a first extension non-refundable payment of $150,000 (the
“First Extension Fee”) prior to October 13, 2015, and through exercising a
second extension of the Contract Research Period through December 31, 2016 (the
“Second Extension”) through making another non-refundable payment of $150,000
(the “Second Extension Fee”) prior to February 13, 2016. Opiant may elect to pay
up to 50% of both Study Fee extensions by issuing to Aegis shares of Opiant’s
common stock subject to the provisions of Section B.1 of this Agreement with the
measurement date for determining the number of shares to be issued set as August
17, 2015 for the First Extension. In the event that Opiant exercises the Opiant
Option prior to the Second Extension, then First Extension Fee shall be fully
creditable against the Upfront License Fee provided that the definitive License
Agreement has been executed during the 120 day period following exercise of the
Opiant Option. In the event that Opiant exercises the Opiant Option subsequent
to the Second Extension, then only the Second Extension Fee shall be fully
creditable against the Upfront License Fee provided that the definitive License
Agreement has been executed during the 120 day period following exercise of the
Opiant Option.

 

b.During the Term of this Agreement Aegis hereby grants to Opiant a right of
first refusal and option to add any, or all, of the compounds included under
Additional Compounds to the Agreement (the “Additional Compound Option”). Except
as permitted by this section, Aegis shall not sell, license, offer for sale,
offer for license or agree to sell or license any Aegis Technology relating to
the Additional Compound to any third party during the Term of this Agreement.
The following sets forth the procedure whereby Opiant may exercise the
Additional Compound Option.

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

i.In the event that Aegis is approached by a third party interested in licensing
the Additional Compound(s), Aegis shall provide a written notice to Opiant
specifying the specific compound(s) (the “Aegis Notice”).

 

ii.Opiant shall as soon as possible, but in no event longer than twenty (20)
business days of receipt of the Aegis Notice, provide a written notice to Aegis
whether Opiant intends to exercise the Additional Compound Option. In the event
that Opiant does not does exercise the Additional Compound Option or fails to
deliver to Aegis its intent to exercise such option within the twenty (20)
business day period, then Aegis shall be free to grant such licenses to any
other third party covering such Additional Compound(s) and such compound(s)
shall be removed for the definition of Additional Compound.

 

iii.In the event Opiant exercises the Additional Compound Option, then Opiant
must pursue Commercially Reasonable Efforts within sixty (60) business days to
pursue development of such Additional Compound(s) as contemplated in Attachment
A. “Commercially Reasonable Efforts” shall mean that level of effort that a
biotechnology or pharmaceutical company of comparable size and capabilities
would normally apply in the United States and the EU, as applicable, in pursuing
the development of a pharmaceutical product with a similar efficacy and safety
profile to the Product (taking into account at all times the relevant patent,
medical/scientific, technical, regulatory, development cost, market potential,
or commercial profile of same), subject to intervening Regulatory Authority
actions or requests, new legislation, any breach of the Aegis’ obligations under
this Agreement or any other third-party action not within the reasonable control
of Opiant.

 

iv.Without limiting the foregoing right of first refusal, Opiant may in its sole
discretion elect to affirmatively exercise the Additional Compound Option with
respect to any available Additional Compound at any time by written notice to
Aegis.

 

c.Aegis hereby grants Opiant the right and license to use, and to grant **** the
right and license to use, the Technology in a ****, provided that:

 

i. ****; and

 

ii. ****.

 

B.4In consideration of Aegis providing the Technology to Opiant under the terms
described under B.2 above, Opiant shall provide copies of the test results from
the Study to Aegis in accordance with Attachment A. Such results shall be deemed
Opiant Confidential Information and Opiant hereby grants to Aegis a co-exclusive
license with Opiant, to use such data for the purposes of this Agreement.
Notwithstanding the foregoing, nothing in this Agreement requires Opiant to
complete the Study.

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

B.5Notwithstanding Section B.4 or any other provision in this Agreement, the
grant of rights and licenses to Aegis and disclosure of information resulting
from the **** shall be subject to the terms set forth in the agreement by and
between Opiant and ****, as set forth in Attachment B.

 

C.NON-DISCLOSURE RESTRICTIONS

 

C.1All non-public information belonging to Aegis or Opiant disclosed during the
course of the Study or arising out of the Study will be deemed Confidential
Information subject to the Mutual Confidentiality Agreement dated November 13,
2013 between Aegis and Opiant (the “NDA”); provided however, that (a) in
addition to the right to use the Confidential Information as permitted under the
NDA, the party receiving the Confidential Information shall have the right to
use same for the purposes of performing its obligations under this Agreement,
and (b) the term of the NDA therein shall be deemed amended and extended to
coincide with the term of this Agreement (Section F.1, Term and Termination)
plus ten (10) years.

 

C.2For greater clarity, Opiant and Aegis Confidential Information shall include
information, trade secret, know how, formulations, methods and results generated
in its conduct of the Study The existence of, and the terms and conditions of,
this Agreement are Confidential Information of both parties.

 

C.3Either Party shall be free to disclose, without the other Party’s prior
written consent, any information that was publicly disclosed on or prior to the
Amendment Date, including without the requirement to seek a confidential
treatment request of any such information. To the extent practicable, the
disclosing Party shall be given advance notice of any legally required
disclosure of Confidential Information by the other Party, and the disclosing
Party shall provide any comments on the proposed disclosure within five (5)
business days. To the extent that either Party determines that it or the other
Party is required to file or register this Amendment or information arising from
the Agreement, including this Amendment, or a notification thereof to comply
with the requirements of an applicable stock exchange or NASDAQ regulation or
any governmental authority, including without limitation the U.S. Securities and
Exchange Commission, the Competition Directorate of the Commission of the
European Communities or the U.S. Federal Trade Commission, such Party shall
promptly inform the other Party thereof. Prior to making any such filing,
registration or notification, the Parties shall agree on the provisions of this
Amendment or the Agreement for which the Parties shall seek confidential
treatment, which provisions shall be reasonable and in accordance with
information that such agency would reasonably agree to redact under a
confidential treatment request, provided that a confidential treatment request
will not be required for information previously disclosed. The Parties shall
cooperate, each at its own expense, in such filing, registration or
notification, including without limitation such confidential treatment request,
and shall execute all documents reasonably required in connection therewith.
Notwithstanding the foregoing, in the event that the disclosing Party does not
provide comments within the five (5) business day period from notification by
the other Party, then the other Party shall be free to publicly disclose such
Confidential Information in accordance with the terms herewith.

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

C.4The Parties agree that neither they, nor any of their agents or attorneys,
shall disclose, divulge or furnish to any person or entity Confidential
Information of the other party, except to the extent required by law or rules
applicable to public financial filings as set forth in Section C.3; provided,
however, that the Parties may disclose, if necessary, information to their
accountants, attorneys, bankers, financial advisors, actual or potential
investors, actual or potential collaborators or business partners, and/or
business consultants (collectively “Permitted Recipients”), provided, however,
that any such Permitted Recipient shall also agree in writing to, and shall keep
such information confidential.

 

C.5Nothing contained herein shall prohibit the Parties from making known the
terms and conditions of the Agreement or this Amendment if the production of
same is required by a subpoena issued by a lawfully constituted judicial body
having jurisdiction over the Party; however, the Party receiving any such
subpoena agrees to provide prompt written notice to the other Parties prior to
producing the subpoenaed information to afford the other Parties the opportunity
to move to quash the subpoena.

 

D.INTELLECTUAL PROPERTY, LIMITED PERMITTED USE, OPTION

 

D.1Intellectual Property Related To Compound and Additional Compounds

 

D.1.a.As between Aegis and Opiant, the Compound and Additional Compounds, and
any Intellectual Property related thereto, is the property of Opiant and:

 

i.Aegis shall not (and shall not attempt or purport to) file or prosecute in any
country any patent application which claims or uses or purports to claim or use
solely the Compound or Additional Compounds, or any information or other
materials directly or indirectly derived therefrom, without the prior express
written consent of Opiant;

 

ii.if the Study results in an invention related solely to Compound, regardless
of whether it may be commercially useful, Aegis agrees to promptly disclose such
invention to Opiant. Inventorship of any such invention shall be determined in
accordance with the U.S. Patent Law. Aegis shall promptly supply Opiant with a
copy of the disclosure for Opiant evaluation purposes. Opiant shall have the
sole right to determine what, if any, patent applications should be filed.

 

D.1.b.This Agreement shall not be construed to grant any license or other rights
to Aegis in any Intellectual Property or Confidential Information of Opiant. No
rights are provided to Aegis under any patents, patent applications, trade
secrets or other proprietary rights of Opiant. In particular, no rights are
provided to use the Compound and any patents or intellectual property of any
kind to Opiant for profit-making, commercial or research purposes, including but
not limited to sale of the Compound, use in manufacturing, provision of a
service to a third party in exchange for consideration, or use in research or
consulting by a commercial or not for-profit entity.

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

D.2Intellectual Property Related To Technology

 

D.2.a.As between Aegis and Opiant, the Technology is the property of Aegis and,
unless otherwise agreed to in writing by Aegis, is to be used by Opiant only as
authorized under this Agreement. Opiant shall use the Technology, and any
information and other materials directly or indirectly derived therefrom, solely
for the Purpose, and they shall not be used for any other purpose whatsoever.
Opiant shall not (and shall not attempt or purport to) file or prosecute in any
country any patent application which claims or uses or purports to claim or use
the Technology, or any information or other materials directly or indirectly
derived therefrom, without the prior express written consent of Aegis.

 

D.2.b.Except for contract research or service organizations performing work
under the direction of Opiant, provided such work is conducted under a
confidentiality agreement with the terms and conditions consistent with those
described under Section C of this Agreement, Opiant shall not transfer the
Technology to anyone who does not work under its direct supervision without the
prior written consent of Aegis, which shall not be unreasonably withheld.

 

D.2.c.Except for the Opiant Option under Section D.4, (i) this Agreement shall
not be construed to grant any license or other rights to Opiant in any
Intellectual Property or Confidential Information of Aegis other than the
license set forth above, (ii) no other rights are provided to Opiant under any
patents, patent applications, trade secrets or other proprietary rights of
Aegis, and (iii) in particular, no rights are provided, other than the right to
use same for the sole Purpose set forth above, to use the Technology and any
related patents or intellectual property of any kind of Aegis for profit-making,
commercial or research purposes, including but not limited to sale of the
Technology, use in manufacturing, provision of a service to a third party in
exchange for consideration, or use in research or consulting by a commercial or
not for-profit entity.

 

D.2.d.If the Study results in an invention related solely to Technology,
regardless of whether it may be commercially useful, Opiant agrees to promptly
disclose such invention to Aegis. Inventorship of any such invention shall be
determined in accordance with the U.S. Patent Law. Opiant shall promptly supply
Aegis with a copy of the disclosure for Aegis’ evaluation purposes. Aegis shall
have the right to determine what, if any, patent applications should be filed.
Aegis also retains full ownership of the Technology as defined above and sole
licensing rights.

 

D.2.e.The provision of the Technology to Opiant shall not alter any preexisting
right of Aegis in the Technology.

 

D.2.f.Opiant shall use the Technology in compliance with all applicable statutes
and regulations including, for example, those relating to research involving the
use of animals.

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

D.2.g.Notwithstanding the preceding limitations on Opiant’s use and ownership of
the Technology, nothing in this Agreement shall be construed as limiting
Opiant’s right to own and use technology related to delivery of the Compound
that is developed independently by Opiant and without reliance on any Aegis
Technology.

 

D.3Intellectual Property Created Under this Agreement

 

D.3.a.In the event that an invention arises from the conduct of the Study
hereunder, that embodies the Compound and Technology, including without
limitation any invention relating to the use of Technology for administering or
stabilizing the Compound (the “Joint Invention”), regardless of whether it may
be commercially useful, Opiant agrees to promptly disclose such invention to
Aegis. Inventorship of any such Joint Invention shall be determined in
accordance with the U.S. Patent Law. Ownership of any such Joint Invention shall
be deemed to be solely that of Aegis.

 

D.3.b.In the event that the Joint Inventions have applications for compounds
other than the Compound (“Dual Inventions”), regardless of whether it may be
commercially useful, Aegis shall have the sole right to determine what, if any,
patent applications should be filed. Inventorship for Dual Inventions shall be
determined in accordance with the patent laws of the United States (Title 35,
United States Code). Aegis retains full ownership of the Dual Invention as
defined above and sole licensing rights.

 

D.4License Option

 

D.4.a.Aegis hereby grants to Opiant an exclusive option (the “Opiant Option”),
to obtain an exclusive (even as to Aegis), worldwide, royalty-bearing license
(with the right to grant sublicenses through multiple tiers) under Aegis’s
interests in the Technology and any Joint Invention (including under any
resulting patents) (the “Subject Invention”) to the Technology to research,
develop, make, have made, use, sell, offer for sale, and import products
containing the Compound or an Additional Compound in the Field (the “License
Agreement”). Opiant may exercise such Opiant Option with respect to the
Compounds by written notice to Aegis within 90 days of the completion of the
Study for the Compounds. Opiant may also separately exercise such Opiant Option
with respect to the Additional Compounds by written notice to Aegis within 90
days the completion of the Study for the Additional Compounds. The License
Agreement shall include terms and conditions to be negotiated in good faith by
the Parties and shall supersede any restrictions on use of the Technology
contained in this Agreement. The parties shall use commercially reasonable
efforts and shall work in good faith to negotiate and execute the definitive
License Agreement during the 120 day periods following exercise of the Opiant
Option with respect to the Compound and the Additional Compounds (the
“Negotiation Periods”). Such Negotiation Periods may be extended by mutual
agreement of the Parties.

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

D.4.b.If such option or license is not concluded within the Negotiation Period,
except as set forth below, neither party will have any further obligations to
the other with respect to such Subject Invention. In the event that the parties
are unable to finalize the License Agreement despite good faith negotiations in
accordance with Section D.4.a during the Term, then Aegis shall be free to offer
exclusive or non-exclusive licenses to the Joint Invention provided that for a
period of twelve (12) months after the termination of the negotiations, Aegis
shall not offer such a license to any third party under financial terms
materially different from those offered to Opiant without first offering those
same terms to Opiant.

 

E.WARRANTIES

 

E.1.aEach party represents and warrants to the other party that such party (i)
is duly organized, validly existing and in good standing under the laws of the
jurisdiction in which it is organized; (ii) has the requisite power and
authority and the legal right to enter into this Agreement and to perform its
obligations hereunder; and (iii) has obtained all necessary consents, approvals
and authorizations of all governmental authorities and other persons or entities
required to be obtained by such party in connection with this Agreement. Each
party represents that this Agreement does not conflict with any other right or
obligation provided under any other agreement or obligation that such party has
with any third party.

 

E.1.bAny Technology, Compound or Additional Compound delivered pursuant to this
Agreement is understood to be experimental in nature and may have hazardous
properties. EXCEPT AS SET FORTH IN SECTION E.1.a, NEITHER AEGIS NOR Opiant MAKES
ANY REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR
IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.

 

F.TERM AND TERMINATION

 

F.1This Agreement will begin on the Effective Date and terminate on the earliest
of the following dates: (a) expiration of the Opiant Negotiation Periods, or (b)
on 30 days written notice by Opiant (the “Term”).

 

F.2If a party has materially breached any of its obligations hereunder, and such
material breach shall continue for 30 days after written notice of such breach
was provided to the breaching party by the nonbreaching party, the nonbreaching
party shall have the right at its option to terminate this Agreement effective
at the end of such 30 day period.

 

F.3On termination of this Agreement, Opiant will discontinue its use of the
Technology as defined in this Agreement and will, upon direction of Aegis,
return or destroy any remaining Technology.

 

F.4The rights and obligations of the parties, which by intent or meaning have
validity beyond termination (including, but not limited to, rights with respect
to intellectual property, confidentiality, exclusivity, indemnification and
liability limitations) shall survive the termination of this Agreement.

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

G.MISCELLANEOUS.

 

G.1In consideration of the covenants, promises and agreements set forth in this
Amendment, Aegis for itself and for each of its respective past, present and
future Aegis affiliate or subsidiary, predecessors, successors, assigns,
directors, officers, employees, contractors, and agents (each, an “Aegis
Releasing Party”) hereby fully releases, acquits, and forever discharges Opiant
and each of its respective past, present, and future parents, subsidiaries,
affiliates, predecessors, successors, assigns, directors, officers, employees,
contractors and agents (each, a “Opiant Released Party”) from any and all claims
or liability in connection with the disclosure of information, including Aegis
Confidential Information, by Opiant as of the Amendment Date, including any and
all actions, causes of action, claims, suits, debts, dues, losses, sums of
money, accounts, reckonings, bonds, bills, specialties, covenants, contracts,
controversies, agreements, promises, variances, trespasses, damages, injuries,
judgments, executions, demands, costs (including, without limitation, the cost
of investigation, the cost of litigation and attorney’s fees), obligations
and/or liabilities of any kind whatsoever, direct or consequential, whether in
law or equity, whether arising out of tort or agreement, or imposed by statute,
regulation, ordinance, common law, or otherwise, whether or not now known or
anticipated, unanticipated, suspected, or claimed, whether fixed or contingent,
whether or not yet accrued, and whether or not damage has yet resulted from
such, that any Aegis Releasing Party ever had, now has, or hereafter can, shall,
or may have against any Opiant Released Party for, based upon, or by reason of
any act, omission, matter, thing, or event occurring on or before the Effective
Date that relates in any way to the disclosure of information by a Opiant
Released Party. Explicitly excepted from the releases of this Section are claims
of Aegis arising out of the performance or breach of the Agreement after the
Amendment Date by Opiant. In consideration of the foregoing, Opiant agrees to
issue to Aegis as of the Amendment Date 50,000 shares of common stock of Opiant,
which shares shall be issued in accordance with the terms of Section B.1 of the
Agreement.

 

G.2Neither party may assign or otherwise transfer this Agreement, whether
voluntarily, by operation of law or otherwise, without the prior written consent
of the other party; provided, however, that a party may, without such consent,
assign this Agreement and its rights and obligations hereunder in connection
with the transfer or sale of all or substantially all of its business to which
this Agreement relates, or in the event of its merger or consolidation or change
in control or similar transaction. Any permitted assignee shall assume all
obligations of its assignor under this Agreement. Any purported assignment or
transfer of this Agreement in violation of this section shall be void.

 

G.3This Agreement represents the entire agreement between the parties regarding
the subject matter hereof and, with the exception of the NDA, shall supersede
all previous communications, representations, understandings and agreements,
whether oral or written, by or between the parties with respect to the subject
matter hereof.

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

G.4No change, modification, extension, termination or waiver of this Agreement,
or any of the provisions herein contained, shall be valid unless made in writing
and signed by duly authorized representatives of the parties.

 

G.5Opiant use of Technology shall be at its own risk. Opiant shall hold harmless
and indemnify Aegis against any and all losses, liabilities, damages and
expenses (including reasonable attorneys’ fees and costs) of every kind to the
extent resulting from claims or demands brought by third parties (“Claims”)
against Aegis arising from the use by Opiant of the Technology, except to the
extent due to the negligence, gross negligence, bad faith or intentional or
willful misconduct by Aegis or its Representatives.

 

G.6Aegis agrees to defend, indemnify and hold harmless Opiant and its
Representatives from and against any and Claims arising out of or resulting from
(a) the negligence, gross negligence, bad faith or intentional or willful
misconduct of Aegis or Representatives, (b) breach of any of Aegis’
representations, warranties, covenants or agreements contained herein, and (c)
the actual or alleged infringement, misappropriation or violation of a third
party’s Intellectual Property by Opiant’s use, practice or other exploitation of
the Technology.

 

G.7NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY IN ANY
MANNER, UNDER ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT (INCLUDING
WITHOUT LIMITATION NEGLIGENCE), INDEMNITY, BREACH OF WARRANTY OR OTHER THEORY,
FOR ANY INDIRECT, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY, PUNITIVE, STATUTORY OR
SPECIAL DAMAGES, INCLUDING LOST PROFITS AND LOSS OF DATA, REGARDLESS OF WHETHER
SUCH PARTY WAS ADVISED OF OR WAS AWARE OF THE POSSIBILITY OF SUCH DAMAGES.

 

G.8This Agreement shall be governed by and construed in accordance with the laws
of the State of New York, U.S.A., without regard to the conflicts of law
principles thereof.

 

G.9The waiver by any party hereto of a breach of any provision of this Agreement
shall not operate or be construed as a waiver of any subsequent breach. In the
event that individual provisions of this Agreement become wholly or partially
invalid as evidenced by a ruling of a court of competent jurisdiction, the
effectiveness of the remaining provisions shall not be affected, to the extent
severable. The parties undertake in good faith to replace an invalid provision
by a valid one which most closely corresponds with the economic intention of the
invalid provision.

 

G.10Nothing in this Agreement shall operate to or be construed or interpreted as
to render the parties as other than independent contractors, nor shall anything
in this Agreement operate or be construed or interpreted as to render any party,
or any of such party’s Representatives, to be employees, agents, associates,
joint ventures or partners of the other party.

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

G.11Any notice, requests, delivery, approval or consent required or permitted to
be given under this Agreement shall be in writing and shall be deemed to have
been sufficiently given if delivered in person or sent by overnight courier or
registered mail to the party to whom it is directed at its address shown below
or such other address as such party shall have last given by notice to the other
party. Any such notice, requests, delivery, approval or consent shall be deemed
received on the date of facsimile or hand delivery, two (2) business days after
deposit with an overnight courier or five (5) business days after the date of
the registration receipt provided by the applicable postal authority.

 

If to Aegis:

 

Aegis Therapeutics, LLC

11770 Bernardo Plaza Court, Suite 353

San Diego, CA 92128

Attn: Chief Executive Officer

 

If to Opiant:

 

Opiant Pharmaceuticals, Inc.,

401 Wilshire Blvd., 12th Floor

Santa Monica, CA 90401

Attn: Chief Executive Officer

 

G.12The headings contained in this Agreement do not form a substantive part of
this Agreement and shall not be construed to limit or otherwise modify its
provisions.

 

G.13This Agreement may be executed in counterparts, including via facsimile or
.PDF file, each of which shall be deemed an original and both of which together
shall constitute one and the same instrument.

 

[Signature Page Follows]

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

IN WITNESS WHEREOF, the parties have entered into this Agreement as of the
Effective Date.

 

AGREED:       Aegis Therapeutics, LLC         Name:  Ralph R. Barry          
Title:  Chief Business Officer           Signature: /s/ Ralph R. Barry      
Opiant Pharmaceuticals, Inc.         Authorized Official:  Kevin Pollack        
  Title:  CFO & Director           Signature: /s/ Kevin Pollack  

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Attachment A – The Study

 

One or more Intravail® delivery enhancement and/or ProTek® stabilization agents
will be used solely for testing of Compound or Additional Compounds, as the case
may be, as follows:

 

List of Aegis Activities

1.Aegis will supply sufficient quantities of Intravail® or ProTek® to Opiant in
order to conduct the Study for both the Compounds and the Additional Compounds
as reasonably requested by Opiant.

2.Aegis will provide such reasonable and necessary technical support including
formulation advice as may be requested by Opiant.

3.****

4.****

 

List of Opiant Activities

1.****

2.Opiant or Opiant designated contract research organization will formulate
Compound or Additional Compounds, as the case may be, with excipients comprising
but not limited to those defined as Technology.

3.****

4.****

 

Ø****

Ø****

Ø****

Ø****

Ø****

Ø****

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Initial Study Outline.

Further studies potentially to be added

 

Objective

****

 

Drug

****

 

Study Design

****

Subjects

****

 

Output Data

****

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY
FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS ARE DESIGNATED AS “****”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

Attachment B - ****