Document:

Exhibit 10.36

 

***Certain identified information has been omitted
from this exhibit because it is both (i) not material and (ii) information that the Registrant treats as private or confidential.
Such omitted information is indicated by brackets (“[...***...]”) in this exhibit. ***

 

SECOND AMENDMENT

 

TO

 

PRODUCT DEVELOPMENT AGREEMENT

 

THIS
SECOND AMENDMENT (this “Amendment”) is dated as of February 20, 2017 (the “Amendment Effective
Date”), by and between (1) Scilex Pharmaceuticals, Inc., a company formed in accordance with and by virtue
of the laws of the State of Delaware, having a principal place of business at 301 Lindenwood Drive, Suite 300, Malvern, Pennsylvania
19355, USA (“Scilex”), (2) Oishi Koseido Co., Ltd., a company formed in accordance with and by virtue
of the laws of Japan, having a principal place of business at 1-933, Honmachi, Tosu, Saga, 841-0037 Japan (“Oishi”),
and (3) ITOCHU CHEMICAL FRONTIER Corporation, a company formed in accordance with and by virtue of the laws of Japan, having
a principal place of business at 5-1, Kita-Aoyama 2-Chome, Minato-Ku, Tokyo 107-0061, Japan (“Itochu”). Oishi and Itochu
are collectively the “Developers”.

 

WHEREAS,
Stason Pharmaceuticals, Inc. (“Stason”) and Developers are Parties to that certain Product Development Agreement,
dated May 11, 2011, under which the Developers agreed to develop for Stason a lidocaine tape product and granted to Stason exclusive
license and distribution rights for such lidocaine tape product for the United States and Canada, including without limitation, their
respective territories and possessions (the “Development Agreement”);

 

WHEREAS,
Stason assigned to Scilex all of Stason’s rights and obligations under the Development Agreement pursuant to that certain Assignment
and Assumption Agreement, dated February 19, 2013 by and between Scilex, Stason, Oishi and Itochu;

 

WHEREAS,
Scilex and the Developers are Parties to that certain First Amendment to Product Development Agreement, dated April 2, 2013, under
which the Territory for the Development Agreement was expanded in also include Latin America and its respective territories and possessions
(the “First Amendment”);

 

WHEREAS,
Scilex and the Developers are Parties to that certain Memorandum of Understanding, dated November 5, 2014, under which the Developers
granted to Scilex exclusive license and distribution rights for the lidocaine tape product developed under the Development Agreement for
Israel, Russia, South Africa, Australia, and all countries in the European Union, including without limitation, each of their respective
territories and possessions (the “Expanded Territory MOU”);

 

WHEREAS,
Scilex and the Developers are Parties to that certain Memorandum of Understanding, dated November 5, 2014, under which the Developers
granted to Scilex exclusive, worldwide license and distribution rights for two new lidocaine tape products referred to as the 2X Product
and 3X Product thereunder (the “New Products MOU”);

 

WHEREAS,
The Parties acknowledge, above-mentioned agreements are the latest contracts among the Parties and now desire to amend certain terms of
the Development Agreement, as set forth herein in order to consolidate the Development Agreement, the First Amendment Agreement, the Expanded
Territory MOU and New Products MOU.

 

    1

     

    

 

NOW,
THEREFORE, in exchange for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the
Parties agree as follows:

 

1.              DEFINITIONS.
Capitalized terms herein used which are not herein defined shall have the respective meanings ascribed to them in the Development Agreement.
All references to the term “Agreement” in the Development Agreement shall be deemed to include all of the terms and conditions
of this Amendment. For the avoidance of doubt, Scilex may be referred to in the Development Agreement, as amended by this Amendment, as
either “Scilex” or “Stason.”

 

2.              AGREEMENT
CONSOLIDATION. The Parties agree that the First Amendment, the Expanded Territory MOU and the New Products MOU are, as of the
Amendment Effective Date, void and replaced and superseded by the Development Agreement, as amended by this Amendment

 

3.              PRODUCTS.
The Parties desire to expand the definition of “Product” under the Development Agreement to include alternative formulations
of a lidocaine tape product. Accordingly, Section 1.41 of the Development Agreement is hereby deleted in its entirety and replaced
with the following:

 

“1.41 “Product”
means each of the following (a) a lidocaine tape product intended to be a Bioequivalent pharmaceutical alternative to the brand product
Lidoderm® (the “Initial Product”); (b) a lidocaine tape product intended to be a pharmaceutical alternative to two
(2) Initial Product patches (the “2X Product”); (c) a lidocaine tape product intended to be a pharmaceutical alternative
to three (3) Initial Product patches (the “3X Product”); and (d) each Additional Product (as defined below) that
is added to this Agreement in accordance with Section 2.11.”

 

4.              TERRITORY.
The Parties desire to expand the definition of “Territory” under the Development Agreement. Accordingly, Section 1.48
of the Development Agreement is hereby deleted in its entirety and replaced with the following:

 

“1.48 “Territory”
means worldwide except for Japan.”

 

5.              DEVELOPMENT
ACTIVITIES. The Parties acknowledge that each Product shall be developed independently and have its own development schedule,
and that some of the development activities currently set forth in the Development Agreement apply to the Initial Product only. Accordingly,
the Parties agree to the following:

 

The introductory paragraph of Section 2.1
of the Development Agreement is hereby deleted in its entirety and replaced with the following:

 

“2.1 General
Development Obligations. Developers shall develop each Product in accordance with this Agreement, including the decisions of the Development
Committee as described below. Unless otherwise decided by the Development Committee or expressly set forth in an applicable Additional
Product Addendum as described below, Developer’s development responsibilities shall include, the following;”

 

Section 2.1.1 of the Development Agreement
is hereby deleted in its entirety and replaced with the following:

 

“2.1.1 Developers
shall develop a stable final dosage form of the Product suitable for submission of an application for Regulatory Approval for approval
to market such Product in the Territory as expeditiously as reasonably practicable.”

 

    2

     

    

 

The introductory paragraph of Section 2.4
of the Development Agreement is hereby deleted in its entirety and replaced with the following:

 

“2.4 Developers
shall be responsible, at its expense, for carrying out all applicable in vitro and in vivo studies required for Regulatory Approval of
(a) the Initial Product for United States, and (b) unless otherwise decided by the Development Committee or expressly set forth
herein or in an applicable Additional Product Addendum, all other Products in the Territory and the Initial Product in the Territory except
the United States. It is currently expected that such studies shall include the following:”

 

Section 2.8 of the Development Agreement
is hereby deleted in its entirety and replaced with the following:

 

“2.8 Scilex
agrees to cooperate fully with Developers in connection with Developers carrying out their development responsibilities for the Territory
and development for Japan (“Development Activities”) and will promptly provide Developers, as requested and at no additional
charge, such technical and regulatory assistance, that is reasonably necessary or useful for Developers to carry out their Development
Activities. For purposes of Japan, Scilex shall use commercially reasonable efforts to provide such cooperation and assistance.

 

A new Section 2.11 is hereby inserted into
the Development Agreement as follows:

 

“2.11 Additional
Products. The Parties may, from time to time, agree to add additional lidocaine tape products (each an “Additional Product”)
to this Agreement by entering into a written addendum to this Agreement (“Additional Product Addendum”). Each Additional Product
Addendum will include (a) a description of the Additional Product that will be added to this Agreement, (b) a mutually agreed
upon development plan for the development (including obtaining Regulatory Approval) of such Additional Product (or a reference to the
development plan being drafted and agreed upon by the Development Committee) and (c) any other terms and conditions applicable to
the Additional Product that may be in addition to, or a replacement of, the terms and conditions set forth in this Agreement.”

 

A new Section 2.12 is hereby inserted into
the Development Agreement as follows:

 

“2.12
The Parties acknowledge that this Agreement is a “master” agreement to cover the development of various Products and agree
that the terms and conditions of this Agreement shall be applied to each Product individually on a Product-by-Product basis.”

 

6.            REGULATORY

 

Section 4.1 of the Development Agreement
is hereby deleted in its entirety and replaced with the following:

 

“4.1 Ownership
and Maintenance. The Regulatory Approvals, and associated applications, for each Product in the Territory shall be owned exclusively
by Scilex and Scilex shall maintain such Regulatory Approvals during the term of this Agreement at its own expense.

 

    3

     

    

 

A new Section 4.2.5 is hereby inserted into
the Development Agreement as follows:

 

“4.2.5 Developers
including their licensee may submit applications for Regulatory Approval for each Product in Japan and in pursuing Regulatory Approval
for each Product in Japan. Scilex shall use commercially reasonable efforts to provide Developers such technical and other assistance,
including all available Product Information and data in its control, reasonably necessary or useful for Developers to apply for, obtain,
and maintain Regulatory Approvals in Japan and to market, sell or otherwise commercialize in Japan. As may be requested by Developers,
Scilex shall, if reasonable, provide any necessary documents in CTD format.

 

7.              FINANCIAL
PROVISIONS. The Parties desire to change the portion of Royalty and Sublicense Fees for Oishi and Itochu under the Development
Agreement. Accordingly, Section 7.2 and 7.3 of the Development Agreement is hereby deleted in its entirety and replaced with the
following:

 

“7.2 Royalty.
Scilex shall pay a royalty of [...***...] of Net Profits to Oishi and [...***...] of Net Profits to Itochu. Scilex
shall pay Oishi and Itochu their respective royalties quarterly within forty-five (45) days of the end of each applicable quarter in which
Product is sold. Each quarterly payment to Oishi and Itochu shall include data and information on the amount of Marketing Expenses, Net
Profits and Net Sales, with materials supporting such data and information (which materials are not required to be prepared by accountants
but may be materials prepared for Scilex’s internal use), In the event that the Net Profit for any of the first four calendar
quarters after Commercial Launch equals a negative amount (“Net Loss”), then Scilex shall be permitted to carry over
such Net Loss to apply against future calendar quarters until such Net Losses are recovered all calculated in accordance with United States
GAAP.

 

“7.3 Sublicense
Fees. Scilex shall pay a royalty on any licensing fees received by Scilex from a sublicensee of [...***...] of such licensing
fee to Oishi and [...***...] of such licensing fee to Itochu. Scilex shall pay Oishi and Itochu their respective royalties within
forty-five (45) days of receipt of such licensing fee by Scilex.

 

8.              TERM
AND TERMINATION. As the Parties desire for the Term of the Development Agreement to be applied on a Product-by-Product basis
and to eliminate certain termination rights under the Development Agreement, the Parties agree to the following:

 

Section 15.1 of the Development Agreement
is hereby deleted in its entirety and replaced with the following:

 

“15.1 Term.
Unless earlier terminated pursuant to this Article 15, the term of this Agreement for each Product shall continue in force from the
Effective Date until the date that is ten (10) years following such Product first being added to this Agreement (the “Initial
Period”), except that if a Commercial Launch of such Product occurs within the Initial Period, the Agreement shall remain in full
force and effect with respect to such Product until the date that is ten (10) years following the Commercial Launch of such Product
(the “Term”). This Agreement shall automatically renew with respect to such Product for subsequent successive one (1) year
renewal terms thereafter, unless prior written notice of at least six (6) months is given by Scilex to Developers or by Developers
to Scilex indicating that the notifying Party wishes this Agreement to terminate for the applicable Product at the end of the then-current
term — in which case this Agreement shall not renew for the applicable Product, it shall be deemed to have been expired without fault, and the
termination provisions relating thereto shall apply with respect to such Product. For the avoidance of doubt, the Parties acknowledge
and agree that (a) the Initial Product was first added to this Agreement on the Effective Date and (b) the 2X Product and 3X
Product were first added to this Agreement on November 5, 2014.”

 

    4

     

    

 

9.              NO
OTHER AMENDMENT. Except as expressly provided in this Amendment, all other terms, conditions and provisions of the Development
Agreement shall apply and remain in full force and effect To the extent there are any conflicts, inconsistencies or ambiguities between
the terms of this Amendment and the Development Agreement, the terms of this Amendment shall supersede and prevail.

 

10.           COUNTERPARTS.
This Amendment may be executed in three counterparts each of which shall be deemed an original but all of which taken together shall constitute
one and the same instrument. Signatures to this Amendment transmitted by email, portable document format (.pdf) or by any other electronic
means intended to preserve the original graphic and pictorial appearance of this Amendment shall have the same effect as the physical
delivery of the paper document bearing the original signatures.

 

[Signature Page Follows]

 

    5

     

    

 

IN
WITNESS WHEREOF, this Amendment has been executed by the Parties through their duly authorized representatives as of the Amendment
Effective Date.

 

	OISHI KOSEIDO CO., LTD.	 	SCILEX PHARMACEUTICALS, INC.
	By:	/s/ Ryoji Nonaka	​	By:	/s/ Anthony P. Mack
	Name:	Ryoji Nonaka	​	Name:	Anthony P. Mack
	Title:	President	​	Title:	President
	Date:	March 9, 2017	​	Date:	March 22, 2017

 

	ITOCHU CHEMICAL FRONTIER CORPORATION
	By:	/s/ Kenji Hakoda	​
	Name:	Kenji Hakoda	​
	Title:	Executive Officer

Chief Operating Officer

Pharmaceutical Division	​
	Date:	February 28, 2017	​

 

    6Exhibit 10.37

 

***Certain identified information has been omitted
from this exhibit because it is both (i) not material and (ii) information that the Registrant treats as private or confidential. Such
omitted information is indicated by brackets (“[...***...]”) in this exhibit. ***

 

THIRD AMENDMENT

TO

PRODUCT DEVELOPMENT AGREEMENT

 

THIS THIRD AMENDMENT (this “Amendment”) is
dated as of August 29th, 2018 (the “Amendment Effective Date”), by and between (1) Scilex Pharmaceuticals,
Inc., a company formed in accordance with and by virtue of the laws of the State of Delaware, having a principal place of business
at 4955 Directors Place, San Diego, California 92121, USA (“Scilex”), (2) Oishi Koseido Co., Ltd., a company
formed in accordance with and by virtue of the laws of Japan, having a principal place of business at 1-933, Honmachi, Tosu, Saga, 841-0037
Japan (“Oishi”), and (3) ITOCHU CHEMICAL FRONTIER Corporation, a company formed in accordance with and by virtue
of the laws of Japan, having a principal place of business at 5-1, Kita-Aoyama 2-Chome, Minato-Ku, Tokyo 107-0061, Japan (“Itochu”).
Oishi and Itochu are collectively the “Developers”.

 

WHEREAS, Scilex and
Developers are Parties to that certain Product Development Agreement, dated May 11, 2011, as amended, under which the Developers agreed
to develop for Scilex lidocaine tape products and granted to Scilex exclusive license and distribution rights for such lidocaine tape
products for certain territories in the world (the “Development Agreement”);

 

WHEREAS, Scilex and
the Developers are Parties to that certain Memorandum of Understanding, dated November 5, 2014, under which the Parties agreed on the
management and payment of prosecution and maintenance of patent and patent applications in the certain countries in the Territory (the
 “Intellectual Property MOU”);

 

WHEREAS, The Parties
agree that the Intellectual Property MOU is, as of the Amendment Effective Date, void and replaced and superseded by this Amendment; and

 

WHEREAS, The Parties
desire to enter into this Amendment to amend certain terms of the Development Agreement, as set forth herein.

 

NOW, THEREFORE, in
exchange for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

 

1.             DEFINITIONS.  Capitalized terms
herein used which are not herein defined shall have the respective meanings ascribed to them in the Development Agreement.  All references
to the term “Agreement” in the Development Agreement shall be deemed to include all of the terms and conditions of this Amendment.
  For the avoidance of doubt, Scilex may be referred to in the Development Agreement, as amended by this Amendment, as either “Scilex”
or “Stason.”

 

2.             PATENT PROSECUTION.  Article 11.2
of the Development Agreement is hereby deleted, in its entirety, and replaced with the following:

 

“11.2 Patent Prosecution.

 

11.2.1 The
Parties shall cooperate in good faith to determine whether to seek or continue to seek or to maintain patent protection in the
Territory with respect to the Product, the API, or any associated method of use, or method of manufacturing, or any other invention
that could reasonably be expected to affect the Commercialization or value of the Product in the Territory (collectively
 “Inventions”).  All such Inventions shall be considered as Intellectual Property related to the Product and/or the
API for the Product and shall be included under the license in Section 9.1.1.  Developers shall have the first right to pursue
patent protection for any Invention that is invented by Developers and the Parties shall jointly agree on the appointment of the
patent representatives in each country in the Territory.

 

    1

     

    

 

11.2.2 In connection
therewith, all Parties shall promptly provide each other with copies of all correspondence to and from each countries’ Patent Office
(including the U.S. Patent and Trademark Office), as well as any related demand, notice, and summons that relates to any Invention.

 

11.2.3 Each Party,
and its employees and agents, shall provide the other Parties and their legal representatives with reasonable assistance and cooperation
with respect to such Patent prosecution, including entering into any joint defense and/or joint privilege agreement that may be reasonably
requested by such Party and each Party shall consider in good faith all reasonable suggestions of the other Parties and their patent counsel
related thereto.

 

11.2.4 Any of Developer’s
Patent, patent prosecution and maintenance expenses associated with any Inventions that are related to Japan, shall be borne by Developers.
  Any of Developer’s Patent, patent prosecution and maintenance expenses associated with any Invention that are related to the
US, Europe, Canada, Brazil, Mexico, China and Korea, shall be borne by each Party [...***...]% (including but not limited to attorney’s
fees and filing fees).  To the extent such costs exceed US $[...***...]/country/each application the excess costs shall be paid solely
by Scilex.  Any of Developer’s Patent, patent prosecution and maintenance expenses associated with any Inventions that are
related to all countries other than Japan, US, Europe, Canada, Brazil, Mexico, China and Korea shall be borne by Scilex.  Each Party’s
patent counsel, as applicable, will timely apply for any applicable patent term extension in all countries.

 

11.2.5 Both Parties
agree to cooperate fully in the preparation, filing, prosecution and maintenance of any of Developer’s Patents in the Territory
under this Agreement, and in obtaining and maintenance of any patent extensions and the like with respect to such Patents.

 

11.2.6 If Developer
elects (i) to abandon the prosecution or maintenance of any Developer’s Patent under which Scilex has a license hereunder, or (ii)
elects not to file a patent application in the Territory for any Invention, then Developers shall promptly notify Scilex in writing at
least sixty (60) days before abandonment or applicable filing deadline therefore, and Scilex shall have the right, upon providing written
notice to Developers of Scilex’s election to do so, at Scilex’s expense subject to the terms of Section 11.2.4, to file, prosecute,
continue to prosecute and/or maintain, as applicable, such Developer’s Patent.  In such case, Scilex shall keep Developer reasonably
informed on matters regards such filing, prosecution and maintenance, including by providing Developers with a copy of any and
all correspondence between Scilex and the U.S. Patent and Trademark Office, providing Developers with sufficient time to review and comment
on such communications (excluding any non-substantive correspondence or communications) and Scilex shall consider in good faith the requests
and suggestions of the Developers with respect to such communications with the U.S. Patent and Trademark Office.  With respect to
the activities set forth in this Section 11.2.6 that are continued by Scilex, Developers shall provide a power of attorney and relevant
files and other information owned or controlled by Developers pertaining to such Developer’s Patents or Program Developments, as
soon as reasonably practical after receiving such written election by Scilex.”

 

    2

     

    

 

3.             NO OTHER AMENDMENT.  Except as expressly
provided in this Amendment, all other terms, conditions and provisions of the Development Agreement, as amended, shall apply and remain
in full force and effect.  To the extent there are any conflicts, inconsistencies or ambiguities between the terms of this Amendment
and the Development Agreement, the terms of this Amendment shall supersede and prevail.

 

4.             COUNTERPARTS.  This Amendment may
be executed in three counterparts each of which shall be deemed an original but all of which taken together shall constitute one and the
same instrument.  Signatures to this Amendment transmitted by email, portable document format (.pdf) or by any other electronic means
intended to preserve the original graphic and pictorial appearance of this Amendment shall have the same effect as the physical delivery
of the paper document bearing the original signatures.

 

[Signature Page Follows]

 

    3

     

    

 

IN WITNESS WHEREOF,
this Amendment has been executed by the Parties through their duly authorized representatives as of the Amendment Effective Date.

 

	OISHI KOSEIDO CO., LTD.	 	SCILEX PHARMACEUTICALS, INC.
	​	​	​
	By:	/s/ Ryoji Nonaka	​	By:	/s/ William Pedranti
	​	​	​	​	​
	Name:	Ryoji Nonaka	​	Name:	William Pedranti
	​	​	​	​	​
	Title:	President	​	Title:	President, Operations
	​	​	​	​	​
	Date:	September 3, 2018	​	Date:	September 3, 2018

 

	ITOCHU CHEMICAL FRONTIER CORPORATION	​
	​	​
	By:	/s/ Kenji Hakoda	​
	​	​	​
	Name:	Kenji Hakoda	​
	​	​	​
	Title:	Managing Executive Officer	​
	​	Chief Operating Officer	​
	​	Pharmaceutical Division	​
	​	​	​
	Date:	August 30, 2018	​

 

    4

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00346-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00346-of-00352.parquet"}]]