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.

 

Exhibit 10.3

 

Execution Version

 

AMENDMENT NO. 1 TO LICENSE AGREEMENT

 

This Amendment No. 1 to License Agreement (this “Amendment”) is made as of
December 13, 2016, by and among Opiant Pharmaceuticals, Inc. (formerly known as
Lightlake Therapeutics Inc.), a Nevada corporation (“Opiant”), and Adapt Pharma
Operations Limited, an Irish limited company (“Adapt”). Opiant and Adapt are
sometimes referred to herein individually as a “Party” and collectively as the
“Parties”. Capitalized terms used but not defined herein have the meanings given
to them in the License Agreement (as defined below).

 

RECITALS

 

WHEREAS, the Parties entered into a License Agreement, dated as of December 15,
2014 (including the exhibits and schedules thereto, the “License Agreement”),
pursuant to which Opiant licenses to Adapt certain intellectual property rights
to develop and commercialize Products in accordance with the terms and
conditions set forth therein;

 

WHEREAS, Section 11.9 of the License Agreement provides that no amendment or
modification to the License Agreement shall be binding upon the Parties unless
in writing and duly executed by authorized representations of both Parties; and

 

WHEREAS, the Parties desire to amend, modify and supplement the License
Agreement in the manner specified in this Amendment.

 

NOW, THEREFORE, for other good and valuable consideration, the receipt and
adequacy of which are hereby acknowledged, the Parties hereby agree as follows:

 

1.           Amendment to Lightlake References.  Each instance of “Lightlake”
appearing in the Agreement, including where such word is used as part of other
defined terms, but excluding instances where such word is used as part of
“Lightlake Therapeutics Inc.”, is hereby replaced with “Opiant”.

 

2.           Amendment to Section 1.11 of the License Agreement. Section 1.11 of
the License Agreement is hereby deleted in its entirety and replaced with the
following:

 

“1.11         “Commercial Sublicensee” means a Sublicensee to whom Adapt has
granted a right to offer for sale, have sold or sell one or more Products in all
or a portion of the Territory including exclusive distributors, but excluding
(i) Persons who Manufacture Product(s) or any element thereof and sell such
Product(s) only to or at the direction of Adapt, Sublicensees or any of their
respective Affiliates, (ii) wholesalers, (iii) pharmacies, (iv) Persons
comprising the First Responder Market, (v) any Person performing third party
logistics or warehousing services on behalf of Adapt or its Affiliates or
Sublicensees, and (vi) any other Person who does not have any obligation to make
an upfront, milestone, royalty or similar payment with respect to the applicable
Products.”

 

 

 

 

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.

 

3.           Amendment to Section 1.30 of the License Agreement.  Section 1.30
of the License Agreement is hereby amended by deleting clause (i) thereof and
replacing such clause (i) with the following:

 

“(i) is sold by a Third Party (or any of such Third Party’s direct or indirect
licensees or sublicensees) that is not a licensee or a Commercial Sublicensee of
Adapt or its Affiliates (A) in the United States, under an Abbreviated New Drug
Application (ANDA), (B) in the European Union, pursuant to a provision of
Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as
amended (including an application under Article 6.1 of Parliament and Council
Regulation (EC) No 726/2004 that relies for its content on any such provision),
or (C) in any other country or jurisdiction, pursuant to all equivalents of such
provisions”.

 

4.           Amendment to Section 3.3.1(b) of the License Agreement. Section
3.3.1(b) of the License Agreement is hereby amended by (a) deleting the phrase
“recall,” from the first sentence thereof and (b) deleting the word “such” from
the second sentence thereof.

 

5.           Amendment to Section 3.5.2 of the License Agreement. Section 3.5.2
of the License Agreement is hereby amended by deleting the first sentence
thereof and replacing such sentence with the following:

 

“Once a Product receives all requisite Regulatory Approvals in the United States
necessary to Commercialize such Product therein, Adapt shall use Commercially
Reasonable Efforts to Commercialize such Product in the United States.”

 

6.           Amendment to Section 3.6.2 of the License Agreement. Section 3.6.2
of the License Agreement is hereby amended by deleting the words “and Commercial
Sublicensees” from the first sentence thereof.

 

7.           Amendment to Section 4.3.1 of the License Agreement. Section 4.3.1
of the License Agreement is hereby deleted in its entirety and replaced with the
following:

 

“4.3.1           Right to Grant Sublicenses.  Adapt shall have the right to
grant Sublicenses (through multiple tiers of Sublicensees).  Adapt shall cause
each Sublicensee to comply with the applicable terms and conditions of this
Agreement.  Adapt shall remain responsible for the performance of its Affiliates
and Sublicensees that are granted Sublicenses as permitted herein, and the grant
of any such Sublicense shall not relieve Adapt of its obligations under this
Agreement.  With respect to any such Sublicense, Adapt shall ensure that the
agreement pursuant to which it grants such Sublicense (i) does not conflict with
the terms and conditions of this Agreement and (ii) contains terms obligating
the Sublicensee to comply with confidentiality and non-use provisions consistent
with those set forth in this Agreement.  With respect to any such Sublicense to
a Commercial Sublicensee that grants such Commercial Sublicensee rights to
Commercialize a Product in the United States, Adapt shall use Commercially
Reasonable Efforts to ensure that the agreement pursuant to which it grants such
Sublicense contains (A) terms obligating such Commercial Sublicensee to permit
Opiant rights of inspection, access, and audit substantially similar to those
provided to Opiant in this Agreement and (B) terms relating to intellectual
property and data ownership consistent with those set forth in this Agreement. 
With respect to any such Sublicense to a Commercial Sublicensee that grants such
Commercial Sublicensee rights to Commercialize a Product in the United States,
Adapt shall ensure that the agreement pursuant to which it grants such
sublicense contains an exclusivity provision consistent with that contained in
Section 4.6.2.  A copy of any Sublicense agreement with a Commercial Sublicensee
executed by Adapt shall be provided to Opiant within fourteen (14) days after
its execution; provided that the financial terms of any such Sublicense
agreement may be redacted to the extent not pertinent to an understanding of a
Party’s obligations or benefits under this Agreement.”

 

 2 

 

 

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.

 

8.           Amendment to Section 4.3.2 of the License Agreement. Section 4.3.2
of the License Agreement is hereby amended by replacing the first instance of
the word “In” therein with the following:  “Subject to the provisions of Section
10.11, in”.

 

9.           Amendment to Section 4.6.2 of the License Agreement. Section 4.6.2
of the License Agreement is hereby deleted in its entirety and replaced with the
following:

 

“4.6.2           During the term of any agreement pursuant to which a Commercial
Sublicensee is granted a Sublicense to sell a Product in the United States or
have a Product sold in the United States, other than as contemplated by this
Agreement, each Party shall cause such Commercial Sublicensee not to (i)
directly or indirectly, develop, commercialize or manufacture any Competing
Product in the United States, or (ii) license, authorize, appoint, or otherwise
enable any Third Party to directly or indirectly, develop, commercialize or
manufacture any Competing Product in the United States.”

 

10.         Amendments to Article 6 of the License Agreement.

 

(a)          Section 6.3 of the License Agreement is hereby amended by adding a
new Section 6.3.4 thereto, immediately after Section 6.3.3, as follows:

 

“6.3.4           Commercial Sublicensees. Anything to the contrary herein
notwithstanding, Adapt shall have the right to assign its rights and delegate
its obligations under this Section 6.3 with respect to Patents in any country or
territory outside the United States to any Commercial Sublicensee to whom Adapt
has granted a right to sell the Product in such country or territory. In such
event, Adapt shall remain responsible for ensuring that such Commercial
Sublicensee performs any such delegated obligations in accordance with the terms
of this Section 6.3, as applicable.”

 

(b)          Section 6.4 of the License Agreement is hereby amended by adding a
new Section 6.4.5 thereto, immediately after Section 6.4.4, as follows:

 

 3 

 

 

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.

 

“6.4.5           Commercial Sublicensees. Anything to the contrary herein
notwithstanding, Adapt shall have the right to assign its rights and delegate
its obligations under Sections 6.4.2 and Section 6.4.3 with respect to actual or
suspected infringement or misappropriation in any country or territory outside
the United States to any Commercial Sublicensee to whom Adapt has granted a
right to sell the Product in such country or territory. In such event, Adapt
shall remain responsible for ensuring that such Commercial Sublicensee performs
any such delegated obligations in accordance with the terms of Section 6.4.2 and
6.4.3, as applicable.”

 

(c)          Section 6.5 of the License Agreement is hereby amended by adding
the words “As between the parties,” immediately prior to the first occurrence of
“Adapt” therein.

 

11.         Amendment to Section 7.5 of the License Agreement. Section 7.5 of
the License Agreement is hereby amended by deleting the phrase “and Lightlake
shall be provided with a copy of any such Publication in advance of public
publication or presentation thereof and Adapt shall consider in good faith any
comments Lightlake may have with respect thereto” from the second sentence
thereof.

 

12.         Amendments to Article 10 of the License Agreement.

 

(a)          Section 10.3 of the License Agreement is hereby amended by adding
the following as a new final sentence thereof:  “Notwithstanding the foregoing,
in no event shall Opiant have the right to terminate this Agreement on the basis
of any breach of any term hereof by a Sublicensee or attributable to the action
or inaction of a Sublicensee.”

 

(b)          Section 10.4 of the License Agreement is hereby amended by deleting
the words “or Commercial Sublicensees” and “or Commercial Sublicensee” therein.

 

(c)          Section 10.6 of the License Agreement is hereby amended by
replacing the first instance of the word “In” therein with the following: 
“Subject to Section 10.11, in”.

 

(d)          Section 10.6.5 of the License Agreement is hereby deleted in its
entirety and replaced with the following:

 

“10.6.5         at Opiant’s request and subject to the terms of any applicable
third party agreement, assign to Opiant all right, title and interest of Adapt
in each Product Trademark at Adapt’s expense; and”.

 

(e)          Section 10.10 of the License Agreement is hereby amended by adding
“, Section 10.11” after “Section 10.10” in clause (i) thereof.

 

(f)          Article 10 of the License Agreement is hereby amended by adding the
following after Section 10.10 thereof:

 

 4 

 

 

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.

 

“10.11         Step-In Rights.  If this Agreement is properly terminated by
Opiant pursuant to Sections 10.3, 10.4 or 10.5, then, provided that such
Commercial Sublicensee is not then in material breach of the agreement pursuant
to which its Sublicense has been granted (the “Sublicense Agreement”), any
Commercial Sublicensee may (in its sole discretion), within thirty (30) days of
receiving notice of such termination, upon written notice to Opiant and Adapt,
elect to become a direct licensee of Opiant under rights and terms equivalent to
the rights and terms of such Sublicense Agreement, effective from and after the
effective date of such termination of this Agreement; provided that such
Commercial Sublicensee shall not have any rights greater than the rights granted
to Adapt under this Agreement and Opiant shall have no obligations under such
Sublicense Agreement to such Commercial Sublicensee in excess of its obligations
to Adapt. In the event that this Section 10.11 is invoked in respect of a
particular Commercial Sublicensee, the references to Sublicensees and Commercial
Sublicensees in Sections 10.6.3 and 10.6.4 shall thereupon be deemed not to
refer to such Commercial Sublicensee in respect of which this Section 10.11 is
invoked. If requested by Adapt, Opiant shall enter into a reasonable and
customary letter agreement with any Commercial Sublicensee and Adapt containing
terms consistent with this Section 10.11 and other terms reasonably acceptable
to Opiant, Adapt and such Commercial Sublicensee.”

 

13.         Amendment to Section 11.8.2 of the License Agreement. Section 11.8.2
of the License Agreement is hereby amended by replacing the address for notice
of Opiant set forth therein with the following:

 

If to Opiant, to:

 

Opiant Pharmaceuticals, Inc.

401 Wilshire Blvd., 12th Floor

Santa Monica, CA 90401

Attention: CEO

Facsimile: 1-917-322-2105

 

With a copy (which shall not constitute notice) to:

 

DLA Piper LLP (US)

1650 Market Street, Suite 4900

Philadelphia, PA 19103

Attention: Fahd M.T. Riaz

Facsimile: 1-215-606-2069

 

14.         Amendment to Section 11.12 of the License Agreement.  Section 11.12
of the License Agreement is hereby amended by replacing the word “Covenants”
therein with the following:  “Except as otherwise provided in Section 10.11
hereof, covenants”.

 

15.         Possible Future Amendments.  If requested by Adapt in connection
with the granting of a Sublicense to a Commercial Sublicensee in respect of
Europe and/or the United Kingdom, the Parties shall promptly negotiate in good
faith additional amendments to the License Agreement necessary to implement the
changes to the financial terms of the License Agreement that are contemplated on
Exhibit A to this Amendment, or such other terms as the Parties may mutually
agree upon in good faith.

 

 5 

 

 

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.

 

16.         References in the License Agreement. All references in the License
Agreement to “this Agreement” shall mean the License Agreement as amended by
this Amendment.

 

17.         Limitation of Amendment and Affirmation of License Agreement. Except
as expressly provided herein, this Amendment shall not be deemed to be a waiver
or modification of any term, condition or covenant of the License Agreement. Any
conflict between the terms herein and in the License Agreement shall be governed
by the terms of this Amendment. Except as expressly amended hereby, all terms
and conditions set forth in the License Agreement are hereby affirmed by the
Parties and shall remain in full force and effect.

 

18.         Incorporation by Reference. The provisions of Sections 11.3.1, 11.4,
11.5, 11.6, 11.7, 11.8, 11.10, 11.11, 11.12, 11.13, 11.14, 11.16 and 11.18 of
the License Agreement are hereby incorporated by this reference, mutatis
mutandis, as if the provisions were fully set forth herein.

 

[Signature Page Follows]

 

 6 

 

 

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, this Amendment is hereby executed by the authorized
representatives of the Parties as of the date first written above.

 

  OPIANT PHARMACEUTICALS, INC.

 

  By:   /s/ Roger Crystal     Name:  Roger Crystal    
Title:    Chief Executive Officer

 

  ADAPT PHARMA OPERATIONS LIMITED

 

  By:   /s/ David Brabazon     Name:   David Brabazon     Title:     Director

 

 

 

 

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.

 

EXHIBIT A

 

In the event that Adapt proposes to enter into an agreement with a Commercial
Sublicensee who would Exploit a Product in the European Union and/or the United
Kingdom (as applicable, “Europe”), at Adapt’s request, the Parties will
negotiate in good faith to amend the License Agreement as necessary to implement
the terms described below.

 

Term   Addition or Modification Revenue sharing  

Opiant (or its designee) would share in royalties, milestone payments and
payments for any supplied Product, less all costs incurred in generating such
European revenues (including, amongst others, development, regulatory,
licensing, safety, supply and distribution costs attributable to Europe)
received by Adapt from a Sublicensee in Europe (“Europe Net Revenues”) based on
the following:

 

·     ****% of all such amounts, up to $**** of cumulative revenue; and

 

·     ****% of all such amounts in excess of $**** million in cumulative
revenue.

 

In the event that Opiant (or its designee) does not receive the $**** milestone
contemplated by Section 5.2.4 of the License Agreement, then the $**** threshold
contemplated above shall be reduced to $****.

 

Amounts comprising Europe Net Revenues and revenues earned by any Sublicensee in
Europe would be excluded for purposes of determining Net Sales on which Opiant
(or its designee) would otherwise be entitled to royalties under the License
Agreement, subject to the provisions set forth below in Global Sales Milestones
and Royalty Tiers.

 

Adapt shall make the revenue share payments in respect of the Europe Net
Revenues to Opiant (or its designee) on a Calendar Quarter basis in accordance
with the terms of Section 5.6 of the License Agreement and any other written
instructions agreed to by Adapt.

      Global Sales Milestones and Royalty Tiers   Europe Net Revenues received
by Adapt from any Sublicensee in Europe would be included for purposes of
determining Net Sales giving rise to sales-based milestones pursuant to Section
5.3.1 of the License Agreement and for purposes of determining royalty tiers set
forth in Section 5.4.1 of the License Agreement.  Sublicensee revenues in Europe
would be excluded for purposes of such determinations.

 

 

 

 

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.

 

Term   Addition or Modification          

The $**** Annual Net Sales Milestone Threshold specified in Section 5.3.1 of the
License Agreement would be changed to $****.

 

The $**** Annual Net Sales Milestone Threshold specified in Section 5.3.1 of the
License Agreement would be changed to $****.