Exhibit 10.18


 


[*Confidential Treatment has been requested
as to certain portions of this document. Each such portion, which has been omitted herein and replaced with an asterisk [*], has
been filed separately with the Securities and Exchange Commission.]


 


AMENDED AND RESTATED


 


EXCLUSIVE LICENSE AGREEMENT


 


BETWEEN


 


RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY


 


AND


 


AQUARIUS BIOTECHNOLOGIES INC.


 


EFFECTIVE JANUARY 29, 2015


 




    	 



    	 



    

 


TABLE OF CONTENTS


 


RECITALS


 


ARTICLE 1 - DEFINITIONS


 


ARTICLE 2 - LICENSE GRANT


 


ARTICLE 3 - SUBLICENSES


 


ARTICLE 4 - FEES, ROYALTIES, MILESTONE
AND OTHER PAYMENTS


 


ARTICLE 5 – ROYALTY, PROGRESS AND
PAYMENT REPORTS


 


ARTICLE 6 - DILIGENCE


 


ARTICLE 7 - CONFIDENTIALITY


 


ARTICLE 8 - TERM AND TERMINATION


 


ARTICLE 9 - PATENT MAINTENANCE AND REIMBURSEMENT


 


ARTICLE 10 - INFRINGEMENT AND LITIGATION


 


ARTICLE 11 - DISCLAIMER OF WARRANTY, INDEMNIFICATION
AND INSURANCE


 


ARTICLE 12 - USE OF LICENSOR’S NAME;
INDEPENDENT CONTRACTOR


 


ARTICLE 13 - MISCELLANEOUS PROVISIONS


 




    	 



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This Amended and Restated
Exclusive License Agreement (hereinafter the "AGREEMENT") is made and is effective as of the 29th day of January,
2015, (hereinafter the “RESTATEMENT DATE”) by and between Rutgers, The State University of New Jersey, having its statewide
Office of Technology Commercialization at ASB Annex III, 3 Rutgers Plaza, New Brunswick, New Jersey 08901-8559, (hereinafter the
“LICENSOR”) and Aquarius Biotechnologies Inc., a corporation organized and existing under the laws of Delaware (hereinafter
the "LICENSEE") having a place of business at 2037 W. Carroll Avenue, Chicago, IL 60612. Each of LICENSOR and LICENSEE
shall be referred to herein as a “PARTY” and collectively, as the “PARTIES.”


 


RECITALS


 


WHEREAS, certain PATENT
RIGHTS were acquired in the course of research at LICENSOR by the inventors of the applications and patents listed in Appendix
A (hereinafter the INVENTOR(S)) and are owned by LICENSOR; and,


 


WHEREAS, LICENSOR owns
the PATENT RIGHTS described in Section 1.12 below and owns or controls related TECHNICAL INFORMATION defined in Section 1.13 below;
and,


 


WHEREAS, LICENSEE desires
to secure licenses to use, develop, manufacture, market and commercially exploit the PATENT RIGHTS and TECHNICAL INFORMATION; and,


 


WHEREAS, LICENSOR desires
that the PATENT RIGHTS and TECHNICAL INFORMATION be developed and utilized to the fullest extent possible so that the benefits
can be enjoyed by the general public;


 


WHEREAS, the University
of Medicine and Dentistry of New Jersey, as licensor, and Aquarius Biotechnologies had previously entered into that certain Exclusive
License Agreement, effective as of March 25, 2013 (the “Original License Agreement”); and


 


WHEREAS, on or about
July 1, 2013 the University of Medicine and Dentistry merged with and into Rutgers, The State University of New Jersey; and


 


WHEREAS, the PARTIES
wish to replace the Original License Agreement in its entirety with this AGREEMENT as of the RESTATEMENT DATE;


 


NOW THEREFORE, in consideration
of the premises and of the promises and covenants contained herein and intending to be legally bound hereby, the parties agree
as follows:


 




    	 



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ARTICLE 1 – DEFINITIONS


 


1.1           AFFILIATE
means, when used with reference to LICENSEE, any ENTITY directly or indirectly controlling, controlled by or under common control
with LICENSEE. For purposes of this AGREEMENT, "control" means the direct or indirect ownership of over fifty percent
(50%) of the outstanding voting securities of an ENTITY or the right to receive over fifty percent (50%) of the profits or earnings
of an ENTITY, directly or indirectly.


 


1.2           BANKRUPTCY
EVENT means that the ENTITY in question becomes insolvent, or voluntary or involuntary proceedings by or against such ENTITY are
instituted in bankruptcy or under any insolvency law, or a receiver or custodian is appointed for such ENTITY, or proceedings are
instituted by or against such ENTITY for corporate reorganization or the dissolution of such ENTITY, which proceedings, if voluntary,
shall not have been dismissed within sixty (60) days after the date of filing, or such ENTITY makes an assignment for the benefit
of creditors, or substantially all of the assets of such ENTITY are seized or attached and not released within sixty (60) days
thereafter.


 


1.3           CALENDAR
QUARTER means each three (3) month period, or any portion thereof, beginning on January 1, April 1, July 1 and October 1.


 


1.4           CALENDAR
YEAR means a period of twelve (12) months beginning on January 1 and ending on December 31.


 


1.5           CHANGE
OF CONTROL means the sale of all or substantially all the assets of a Party; any merger, consolidation or acquisition of a Party
with, by or into another corporation, entity or person; or any change in the ownership of more than fifty percent (50%) of the
voting capital stock of a Party in one or more related transactions.


 


1.6           CONFIDENTIAL
INFORMATION means and includes (i) all TECHNICAL INFORMATION (as defined below) and (ii) all other information including reports
that relate to a PARTY in the course of this AGREEMENT, including without limitation, management reports, financial statements,
internal memoranda, marketing plans, financial, development or marketing reports and other materials of a proprietary nature, owned
or controlled by a PARTY and identified as confidential or proprietary at the time delivered or communicated to the other PARTY
within thirty (30) days thereafter.


 


1.7           ENTITY
means a corporation or other business entity.


 


1.8           FEDERAL
GOVERNMENT INTEREST means the rights of the United States Government under Public Laws 96-517, 97-256 and 98-620, codified at 35
U.S.C. 200-212, and any regulations issued there under; as such statutes and regulations may be amended from time to time during
the term of this Agreement.


 




    	 



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1.9           FAIR
MARKET VALUE means (i) in the case of a SALE, the cash consideration that LICENSEE, its AFFILIATE or sublicensee, as the case may
be, would realize from an unaffiliated, unrelated buyer in an arm's length SALE of an identical LICENSED PRODUCT sold in the same
quantity and at the same time and place of the transaction, or (ii) in the case of a transaction other than a sale, the current
value to LICENSEE or its AFFILIATES of consideration they receive in such transaction, as determined by the parties, or by a neutral
third party appraiser selected by LICENSOR if the parties are unable to agree within thirty (30) days of commencing discussions.


 


1.10         FIELD
OR FIELD OF USE means all fields.


 


1.11         NET
SALES means, with respect to any SALE of a Licensed Product, the greater of (i)
the gross consideration charged for the Licensed Product by Licensee,
its Affiliates or their sublicensees (regardless of tier), in an arm’s-length
transaction or (ii) the gross consideration received or agreed to be received by Licensee,
its Affiliates or their sublicensees (regardless of tier) on account of the SALE
in any arm’s-length transaction to an unrelated third party, in each case (i) and (ii) less documented qualifying costs borne
by the seller that were directly attributable to the SALE and identified on the invoice. For clarity, in the case of any SALE of
a Licensed Product between or among Licensee,
its Affiliates or their sublicensees (regardless of tier) which are intended for
resale to an unaffiliated third party, no Net Sales shall apply; in such circumstance,
Net Sales shall be calculated as above only on the consideration charged to or received
from the unaffiliated third party.


 


1.11.1         Qualifying
costs under Section 1.11 shall include the following:


		(i)	Cash, trade or quantity discounts customary in the trade;



		(ii)	Reasonable credits or refunds for claims or returns, not
exceeding the original invoice amount less all qualifying costs;



		(iii)	Prepaid outbound transportation insurance premiums;



		(iv)	Prepaid outbound transportation expenses; and



		(v)	Sales and use taxes imposed by a governmental agency.



 


1.12         LICENSED
PRODUCT(S) means any product, material, kit, service, process or procedure whose discovery, development, registration, manufacture,
use or sale would be covered in whole or in part by at least one VALID CLAIM of the PATENT RIGHTS and/or has utilized or would
utilize TECHNICAL INFORMATION.


 




    	 



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1.13         PATENT
RIGHTS means the following, to the extent that they are owned by LICENSOR and included in this Agreement at LICENSEE's election:
(a) the patents and patent applications listed in Appendix A (hereafter referred to as “Patent Applications”), (b)
any patents issuing on any such Patent Applications, (c) all foreign patents and patent applications corresponding to all of the
foregoing (including PCT filings) and (d) all reissues, extensions (including governmental equivalents thereto), substitutions,
continuations, continuations-in-part (but only to the extent their claims have the same priority date, subject matter and inventors
as their parent application) and divisionals thereof.


 


1.14         TECHNICAL
INFORMATION means any unpublished research and development information, unpatented inventions, know-how, trade secrets, and technical
information, technical data and other information and materials related to inventions listed in Appendix A, and which information
is not otherwise publicly known, that are (a) necessary or useful to discover, develop, make, have made, use or sell a LICENSED
PRODUCT(S), (b) owned or controlled by LICENSOR and came into LICENSOR’s possession prior to the RESTATEMENT DATE, (c) developed
by or under the supervision of one or more of the INVENTOR(S) of the PATENT RIGHTS prior to the RESTATEMENT DATE, and (d) can be
freely licensed to others by LICENSOR without incurring third party obligations (except for certain possible royalty obligations
by LICENSOR to BDSI if BDSI know-how is licensed), Examples of such TECHNICAL INFORMATION include, but are not limited to the following
(i) research and development information as described in laboratory notebooks of Dr. Raphael Mannino and Ruying Lu, to the extent
such laboratory notebooks were created while each was an employee of LICENSOR; (ii) CONFIDENTIAL INFORMATION, except such CONFIDENTIAL
INFORMATION which falls under any exception described in Sections 7.1.1 through 7.1.3; (iv) research and development information
formerly of BDSI, transferred to LICENSOR and presently owned by LICENSOR, and referred to as BDSI KNOW-HOW and BDSI CONFIDENTIAL
INFORMATION in that certain UMDNJ/BDSI Agreement, dated June 30, 2012; (v) know-how and trade secrets that are in Dr. Mannino’s
possession as of the RESTATEMENT DATE and under the LICENSOR’S patent policy are considered to be the property of LICENSOR;
(vi) know-how and trade secrets that were in Ruying Lu’s possession as of the last date of her employment by LICENSOR and
under the LICENSOR’S patent policy are considered to be the property of LICENSOR; and (vii) all information assigned by BDSI
to LICENSOR, both written and electronic, pertaining to the development, submission and performance of an IND application, PIND
[*], Product Name: [*] Cochleate Amphotericin B (CAMB), including but not limited to all manufacturing and batch
records related to the manufacturing of the GMP [*] Cochleate Amphotericin B product by [*] and all clinical trial
information and data relating to the Phase 1a, single escalating dose, human clinical trial, performed by [*], only to the
extent such information was actually provided by LICENSOR to LICENSEE.


 




    	 



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1.15         SALE
means any bona fide, arm’s-length transaction for which consideration is received or expected for the sale, use, lease, transfer
or other disposition of LICENSED PRODUCT(S). A SALE of LICENSED PRODUCT(S) shall be deemed completed at the time LICENSEE, its
AFFILIATE or a sublicensee, as the case may be, contracts for, invoices, ships, or receives payment for such LICENSED PRODUCT(S)
from a third party unaffiliated with LICENSEE, its AFFILIATES and the applicable sublicensee, whichever occurs first. If a particular
individual item of LICENSED PRODUCT is sold by more than one of LICENSEE, an AFFILIATE, or a sublicensee, the sale at highest price
(after deducting qualifying costs) shall be the sale considered for purposes of determining NET SALES.


 


1.16         TERRITORY
means worldwide.


 


1.17         VALID
CLAIM means (i) an issued and unexpired claim within the PATENT RIGHTS or (ii) for pending patent applications within the PATENT
RIGHTS a claim of such pending patent application that was filed in good faith, has not been pending for more than seven (7) years,
and which has not been abandoned or finally disallowed without the possibility of appeal or refilling of such application.


 


1.18         BDSI
means BioDelivery Sciences International, Inc., a former licensee of LICENSOR.


 


ARTICLE 2 - LICENSE GRANT


 


2.1           LICENSOR
grants to LICENSEE for the term of this AGREEMENT a royalty-bearing right and exclusive license under Table I of the Appendix A
(i) of the PATENT RIGHTS, a royalty-bearing right and exclusive license under Table II of the Appendix A (i) of the PATENT RIGHTS
to the extent LICENSOR is a co-owner of the identified PATENT RIGHTS, a non-exclusive license under the Appendix A (ii) of the
PATENT RIGHTS and non-exclusive license to use the TECHNICAL INFORMATION, with the right to grant sublicenses, to make, have made,
use, import, have sold, offer to sell and sell LICENSED PRODUCT(S) in TERRITORY and in the FIELD OF USE. Except for the rights
granted in Section 2.1, no other rights or licenses are granted hereunder either expressly or by implication or estoppel. LICENSOR
agrees not to grant a commercial license to anyone other than LICENSEE under the Appendix A (ii) of the PATENT RIGHTS, or grant
a commercial license to anyone other than LICENSEE to said TECHNICAL INFORMATION, subject to any limitations stated herein, for
the duration of this AGREEMENT. LICENSEE may delegate performance of duties and obligations under this AGREEMENT to its AFFILIATE(S),
but LICENSEE shall at all times have primary responsibility and liability for the performance of all LICENSEE duties and obligations
arising under this AGREEMENT, whether or not so delegated. To the extent that TECHNICAL INFORMATION includes an IND for Amphotericin
B developed prior to the RESTATEMENT DATE, LICENSOR shall not license such TECHNICAL INFORMATION to third parties for commercial
use except (i) in the event of early termination of this AGREEMENT, or (ii) in [*] LICENSEE’S rights in PATENT
RIGHTS relating to such TECHNICAL INFORMATION [*], or (iii) in [*] LICENSEE is not meeting its [*]
obligations under this AGREEMENT.


 




    	 



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2.2           LICENSEE
acknowledges that all rights reserved by the U.S. government and/or other sponsors of the research on which the rights licensed
hereunder are based, may limit the scope of the license. For example, the United States government retains certain rights in intellectual
property funded in whole or part under any contract, grant or similar agreement with a Federal agency. The license grants of Section
2.1 above are expressly subject to all such rights. LICENSOR represents to LICENSEE that, as of the RESTATEMENT DATE and after
reasonable inquiry, the Director of the Office of Research Commercialization of LICENSOR does not know of (i) any agreements between
LICENSOR and any third parties that conflict with the terms of this AGREEMENT, including but not limited to the grant of rights
provided under this Article 2 and (ii) any agreement to which LICENSOR is a party or by which it is bound that restricts the exercise
by LICENSEE of the rights granted under this AGREEMENT, including but not limited to the grant of rights provided under this Article
2.


 


2.3           LICENSOR
expressly reserves the right to have the PATENT RIGHTS and TECHNICAL INFORMATION rights licensed hereunder used for educational,
non-commercial research and other non-business purposes and to publish the results thereof. Notwithstanding the foregoing, LICENSOR
shall provide LICENSEE with the right of review and inspection of any article of writing relating to the PATENT RIGHTS and originating
from, under the direction or supervision of Dr. Mannino, and intended for publication not less than sixty (60) days in advance
of submission of such article so that LICENSEE may seek appropriate patent protection. LICENSOR may conduct commercial research
for LICENSEE pursuant to a mutually acceptable research agreement.


 


2.4           Some
TECHNICAL INFORMATION may have been made available to the public without restriction prior to the EFFECTIVE DATE of the Original
Agreement. LICENSOR agrees to use reasonable effort to the extent it has not already done so to deliver to LICENSEE the TECHNICAL
INFORMATION upon reasonable request by LICENSEE.


 


ARTICLE 3- SUBLICENSES


 


3.1           The
right to grant sublicenses conferred upon LICENSEE under this AGREEMENT is subject to the conditions of this Article 3. Copies
of all sublicenses shall be provided by LICENSEE to LICENSOR within thirty (30) days after execution.


 




    	 



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3.2           Sublicensees
may, at LICENSEE’s discretion, further sublicense the rights granted to them, subject to the applicable terms and conditions
of the license granted to LICENSEE under this AGREEMENT, and subject to the following further conditions: (i) the further sublicensee
may not grant further sublicenses without LICENSOR’S consent, which consent will not be unreasonably withheld; (ii) NET SALES
and SALES shall include, without limitation, SALES by further sublicensees; (iii) milestones referred to in Section 4.4 reached
by further sublicensees shall trigger payment obligations by LICENSEE to LICENSOR; and (iv) consideration received by LICENSEE
resulting from further sublicensing shall be included in the calculations under Section 4.5 and 4.5.1. Copies of all sublicenses
and further sublicenses by sublicensees shall be provided by LICENSEE to LICENSOR within sixty (60) days after execution.


 


3.3           The
legally controlling language of any sublicense shall be English. LICENSOR'S receipt of any sublicense shall not constitute an approval
of such sublicense or a waiver of any of LICENSOR'S rights or LICENSEE'S obligations hereunder.


 


3.4           Upon
termination of this AGREEMENT for any reason, LICENSOR in its sole discretion shall determine whether any or all sublicenses shall
be cancelled or assigned to LICENSOR. LICENSOR agrees to negotiate in good faith with sublicensees for a period of no less than
90 days regarding a license of LICENSOR’s rights similar to those rights held by such sublicensee prior to such termination.


 


3.5           Notwithstanding
any such sublicense, LICENSEE shall remain primarily liable to LICENSOR for all of the LICENSEE'S duties and obligations contained
in this AGREEMENT.


 


3.6.          Except
as required by law, LICENSOR agrees to use reasonable efforts, and in no case less effort than LICENSOR uses with respect to its
own confidential information, (i) to receive and maintain all information provided by LICENSEE under this Article 3, including
but not limited to copies sublicenses and further sublicenses, in strict confidence, except such information which falls under
any exception described in Sections 7.1.1 through 7.1.3, and (ii) to not distribute, disclose or disseminate any of the information
described in (i) above including but not limited to copies of sublicenses and further sublicenses, to anyone except employees of
LICENSOR and others who are bound by obligations of confidentiality to LICENSOR who have a reasonable need to have access to such
information, at LICENSOR’S sole discretion.


 


ARTICLE 4 – FEES, ROYALTIES, ANNUAL
AND MILESTONE PAYMENTS, OTHER PAYMENTS AND EQUITY


 


4.1           As
partial consideration, LICENSEE shall pay to LICENSOR a License Issue Fee of twenty-five thousand dollars ($25,000) upon
execution of this AGREEMENT.


 


4.2           LICENSEE
shall pay to LICENSOR a royalty as provided in the subsections of this Section 4.2, except under the circumstances described hereafter
in Section 4.5.1.


 




    	 



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4.2.1           For
LICENSED PRODUCTS [*], LICENSEE shall pay to LICENSOR:


 


(i)               for NET SALES in countries
where such LICENSED PRODUCT(S) are covered by a VALID CLAIM:


 


[*]% of NET SALES between
$[*] to $[*] in NET SALES,


[*]% of NET SALES between
$[*] and up to $[*] in NET SALES,


[*]% of NET SALES beyond
$[*]


 


(ii)              for NET SALES during
a period of [*] after first commercial sale of such LICENSED PRODUCT(S) in each country where such LICENSED PRODUCT(S) utilize
TECHNICAL INFORMATION and are not covered by a VALID CLAIM:


 


[*]% of NET
SALES for $[*] to $[*] in NET SALES,


[*]% of NET
SALES above $[*] and up to $[*] in NET SALES,


[*]% of NET
SALES for $[*] in NET SALES and beyond


 


(iii)            the above royalties
in this Section 4.2.1 shall be [*] in the event LICENSEE must (a) substantially [*] which has been described in the
definition of TECHNICAL INFORMATION (Section 1.13) and (b) substantially [*].


 


(iv)            notwithstanding those
royalties provided in subsections (i)-(iii) of this Section 4.2.1, if LICENSEE receives royalty revenue based on net sales
of LICENSED PRODUCTS [*] from a sublicensee, the amounts due LICENSOR under this Section shall not [*] of such royalty
revenue received by LICENSEE from such sublicensee.


 


4.2.2           
For LICENSED PRODUCTS [*], LICENSEE shall pay to LICENSOR,


 


(i)               for
NET SALES in countries where such LICENSED PRODUCT(S) are covered by a VALID CLAIM:


 


[*]% of NET
SALES between $[*] and up to $[*] in NET SALES,


[*]% of NET
SALES beyond $[*] and up to $[*] in NET SALES,


[*]% of NET
SALES beyond $[*]


 


(ii)              for
NET SALES during a period of [*] after first commercial sale of such LICENSED PRODUCT(S) in each country where such LICENSED
PRODUCTS utilize TECHNICAL INFORMATION and are not covered by the scope of a VALID CLAIM:


 


[*]% of NET
SALES between $[*] and up to $[*] in NET SALES,


 




    	 



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[*]% of NET
SALES beyond $[*] and up to $[*] in NET SALES,


[*]% of NET
SALES beyond $[*]


 


4.2.3           In
the event it becomes necessary, as determined by LICENSEE in its reasonable discretion, for LICENSEE to obtain a license under
patent rights of a third party which are necessary in order for LICENSEE to make, have made, use, or sell the LICENSED PRODUCT(S)
and LICENSEE must pay such third party a royalty on net sales of LICENSED PRODUCT(S) for such license, upon LICENSEE’S provision
of a copy of such license and all related agreements to LICENSOR, notice of such license to LICENSOR, , the royalty rates provided
in this Article 4 for any LICENSED PRODUCT(S) will be [*] to third parties on such LICENSED PRODUCT(S), provided that in
no event shall the royalty rates under any provision of this Article 4 be [*] of (i) [*] the original royalty
rates set forth in Sections 4.2.1 and 4.2.2 above, or (ii) [*] percent of Net Sales.


 


4.2.4 Notwithstanding
any other provision of this AGREEMENT, the [*] royalty rates will be [*] to in this Section 4 shall be the following:
(a) for 4.2.1 (i) [*]%; (b) for 4.2.1 (ii) [*]%; (c) for 4.2.2 (i) [*]%; (d) for 4.2.2 (ii) [*]%.


 


4.3           LICENSEE
shall pay to LICENSOR on each anniversary of the RESTATEMENT DATE a non-refundable annual license fee as follows. Each of such
fees will be creditable against royalties due during the 12 months following the due date for the payment of the annual fee.


 


	PERIOD	 	 	 
	 	 	 	 
	First and second anniversaries:	 	$	10,000	 
	 	 	 	 	 
	Third anniversary:	 	$	20,000	 
	 	 	 	 	 
	Fourth anniversary:	 	$	25,000	 
	 	 	 	 	 
	Fifth anniversary and each Anniversary thereafter	 	$	50,000	 



 


4.4           For
each LICENSED PRODUCT reaching a milestone listed below, LICENSEE shall pay either (y) that amount due under Sections 4.5 or 4.5.1
for that milestone, or (z) the following milestone payments, whichever is [*], within [*] after the reaching of each
milestone by LICENSEE, its AFFILIATES or its sublicensees, and shall report the reaching of each milestone within sixty (60) days
after it is reached.


 




    	 



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(i) for each LICENSED
PRODUCT(S) [*]:


(a)          [*];


(b)          [*];


(c)          [*];


(d)          [*].


 


(ii) for
each LICENSED PRODUCT(S) [*]:


(a)          [*];


(b)         [*];


(c)          [*];


(d)         [*];


(e)          [*].


 


(iii) Sales Milestone fee
of one hundred thousand dollars ($100,000) shall be paid by LICENSEE to LICENSOR upon reaching sales of [*].


 


4.4.1 Notwithstanding
anything to the contrary set forth in this AGREEMENT, it shall be understood that the [*] contemplated by the LICENSEE as
of the RESTATEMENT DATE and to be supported by the [*] will not trigger the milestone payment of 4.4(i)(a) or 4.4(ii)(b).
This contemplated [*] shall be the only exemption allowed by this AGREEMENT, and that all future [*] initiated after
the execution date of this AGREEMENT shall be subject to the payment terms of this section 4.4. For purposes of this section 4.4
only, it shall be understood that a [*] shall mean a [*]; while a [*] shall mean a [*].


 


4.5           Except
under the circumstances described hereafter in this Section 4.5 and in Section 4.5.1, LICENSEE shall pay to LICENSOR [*] of
all non-royalty consideration (other than (i) cash received for direct costs of research and development personnel working on LICENSED
PRODUCTS and spent for such purposes within two years of receipt, (ii) the FAIR MARKET VALUE of machinery and equipment to the
extent non-cash consideration used to support research and development activities for LICENSED PRODUCTS within two years of receipt,
and (iii) reimbursement of costs incurred by LICENSEE for PATENT RIGHTS) received by LICENSEE from sublicensing or transferring
any of the rights licensed to LICENSEE hereunder. All non-cash consideration received by LICENSEE from such sublicensees shall
be valued at the FAIR MARKET VALUE as of the date of receipt, and shall be paid to LICENSOR either in cash (U.S. dollars) or in
equity in LICENSEE or in another mutually agreeable method, within ninety (90) days after the date of receipt; the parties agree
to negotiate in good faith to determine a mutually acceptable and equitable method of resolving this situation should it occur.
Beginning on the first anniversary of the Original Agreement EFFECTIVE DATE after LICENSEE has spent at least [*] on the
direct costs of research and development personnel working on LICENSED PRODUCTS and not reimbursed or paid for by one or more sublicensees,
the amount of non-royalty consideration payable to LICENSOR shall be [*]. Beginning on the first anniversary of the Original
Agreement EFFECTIVE DATE after LICENSEE has spent at least [*] on the direct costs of research and development personnel
working on LICENSED PRODUCTS and not reimbursed or paid for by one or more sublicensees, the amount of non-royalty consideration
payable to LICENSOR shall be [*].


 




    	 



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4.5.1           In
the event where LICENSEE grants a sublicense of the rights granted hereunder to an unaffiliated third party which [*], then,
in lieu of the royalty and non-royalty consideration described in Sections 4.2 and 4.6, LICENSEE shall pay LICENSOR [*] received
by LICENSEE from sublicensing or transferring any of the rights licensed to LICENSEE hereunder to a third party sublicensee, without
the step down described in the last two sentences of Section 4.5.


 


4.6           Royalties
payable pursuant to Section 4.2 hereof and received during a CALENDAR QUARTER and other payments due hereunder pursuant to Sections
4.5 or 10.2 hereof based on recoveries or consideration received during a CALENDAR QUARTER by LICENSEE or its AFFLITIATE(S) shall
be paid within forty-five (45) days following the last day of the applicable CALENDAR QUARTER.


 


4.7           NET
SALES of any LICENSED PRODUCT(S) shall not be subject to more than one assessment of the scheduled royalty, and such assessment
shall be that which yields the highest royalty payment to LICENSOR.


 


4.8           All
dollar amounts referred to in this AGREEMENT are expressed in United States dollars. All payments to LICENSOR under this AGREEMENT
shall be made in United States dollars by check payable to LICESOR.


 


4.9           If
LICENSEE receives revenues from SALES of LICENSED PRODUCT(S) and or sublicense payments pursuant to Section 4.5 in currency other
than United States dollars, such revenues shall be converted into United States dollars prior to payment to LICENSOR at the conversion
rate for the foreign currency as published in the eastern edition of The Wall Street Journal as of the last business day of the
applicable CALENDAR QUARTER. If legal restrictions in a country prevent the acquisition or prompt remittance of United States dollars
to LICENSOR with respect to SALES of LICENSED PRODUCTS in such country, LICENSEE shall make timely payment to LICENSOR from LICENSEE’s
other sources of U.S. dollars.


 


4.10         LICENSEE
shall be responsible for any and all taxes, fees, or other charges imposed by the government of any country outside the United
States on the remittance of royalty income for sales of LICENSED PRODUCT occurring in any such country. LICENSEE shall also be
responsible for all bank transfer charges.


 


4.11         In
the event that any patent or any claim thereof included within the PATENT RIGHTS shall be held invalid in a final decision by a
court of competent jurisdiction and last resort in any country and from which no appeal has or can be taken, all obligation to
pay royalties based on such patent or claim or any claim patentably indistinct there from shall cease as of the date of such final
decision with respect to such country. LICENSEE shall not, however, be relieved from paying any royalties that accrued before such
decision or that are based on (i) another patent or claim not involved in such decision or (ii) TECHNICAL INFORMATION.


 




    	 



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4.12         Amounts
due LICENSOR under this AGREEMENT that are not paid when due shall accrue interest from the due date until paid, at a rate equal
to one and one-half percent (1.5%) per month (or the maximum allowed by law, if less).


 


4.13         As
of the RESTATEMENT DATE, as partial consideration for the license granted under this Agreement, LICENSEE has issued to LICENSOR
[*] common stock of LICENSEE, which represented five percent (5%) of LICENSEE’s equity on a fully diluted basis outstanding
on the EFFECTIVE DATE of the Original Agreement. LICENSEE shall [*] at such time or times as may be necessary to assure
that LICENSOR’s [*] five percent (5%) [*] until one of the following happens: LICENSEE has [*] OR the
[*]. Notwithstanding the foregoing, in the event of a CHANGE OF CONTROL of LICENSEE, immediately in advance of the consummation
of such CHANGE OF CONTROL, LICENSEE shall issue to LICENSOR such additional amount of common stock of LICENSEE as may be necessary
to bring LICENSOR’s total holdings of common stock of LICENSEE to an amount equal to seven and a half percent (7.5%) of the
equity of LICENSEE on a fully diluted basis immediately prior to the consummation of such CHANGE OF CONTROL, at which point the
anti-dilution provisions of this Section 4.13 shall be considered fully satisfied and of no further force or effect.


 


4.14         If
LICENSEE proposes to [*], then LICENSOR and/or its Assignee (defined below) will have the right to [*]. The term
“Assignee” means (a) [*], or its assignee, (b) Rutgers University, or its assignee or (c) any entity that is
controlled by LICENSOR.


 


4.15         LICENSOR
shall have the right to have an observer seat on the Board of Directors of LICENSEE as long as LICENSOR’s common stock in
LICENSEE represents more than one percent (1%) of LICENSEE’s equity issued and outstanding on a fully-diluted basis; provided,
however, notwithstanding LICENSOR’s interest in LICENSEE, the right to an observer seat under this Section 4.16 shall cease
no later than the listing of LICENSEE’s common stock on any public securities exchange in the United States of America. LICENSOR’s
observer shall be the Executive Director of LICENSOR’s Office of Technology Transfer and Business Development, or another
designee of LICENSOR, its successors or assigns. LICENSEE shall provide to LICENSOR all notices and information that it provides
to its full members of the Board of Directors at the same time it provides it to them. For the avoidance of doubt, LICENSOR’s
rights under this Section 4.15 shall become null and void should LICENSEE undergo a CHANGE OF CONTROL.


 




    	 



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ARTICLE 5- ROYALTY, PROGRESS AND PAYMENT
REPORTS


 


5.1           LICENSOR
shall deliver to LICENSEE with each payment made pursuant to Section 4.7 herein a report, certified by the chief financial officer
of LICENSEE, setting forth in reasonable detail the calculation of the royalties, as well as all other payments due to LICENSOR
during such CALENDAR QUARTER pursuant to the terms of Article 4 of this AGREEMENT. Each report shall include, without limitation:


 


		5.1.1	Number of LICENSED PRODUCT(S) involved in SALES, listed
by country;



		5.1.2	Gross SALES of LICENSED PRODUCT(S);



		5.1.3	Qualifying costs, as defined in Section 1.11, listed by
category of cost;



		5.1.4	NET SALES of LICENSED PRODUCT(S) listed by country;



		5.15	Royalties owed to LICENSOR;



		5.1.6	Deductions from royalties owed because of annual fees paid
under Section 4.3;



		5.1.7	Calculation of LICENSOR’S share of any infringement
litigation recoveries subject to payment under Section 4.5 and any sublicense consideration received and subject to payment under
Section 4.6.



		5.1.8	Listing and accounting for any other payments due to LICENSOR
pursuant to Article 4 hereof during the CALENDAR QUARTER;



 


5.2           LICENSEE
shall maintain and cause its AFFILIATES and sublicensees to maintain, complete and accurate books and records in accordance with
generally accepted accounting principles consistently applied that enable the royalties and other payments due hereunder to be
verified. The records for each CALENDAR QUARTER shall be maintained for seven (7) years after the submission of each report under
Section 5.1 hereof. Upon reasonable prior notice to LICENSEE, LICENSOR and its accountants shall have access to all books and records
relating to the reports due under Section 5.1 and the payments due under Article 4, as well as the diligence requirements and reports
under Article 6 sufficient to conduct a review and audit thereof. Such access shall be available not more than once each CALENDAR
YEAR, during normal business hours, and for each of three (3) years after the expiration or termination of this AGREEMENT. If LICENSOR
determines that LICENSEE has underpaid undisputed royalties or other undisputed payments due by five percent (5%) or more, LICENSEE
will pay the costs and expenses of LICENSOR and its accountants in connection with their review and/or audit. LICENSEE will pay
any undisputed overdue amounts as well as late interest charges within fourteen (14) days of notification to it of underpayment
with supporting documentation.


 


5.3           Beginning
six (6) months after the RESTATEMENT DATE, and semi-annually thereafter until the later of five years after the RESTATEMENT DATE
or one year after this AGREEMENT has been terminated or expires, LICENSEE shall submit to LICENSOR a progress report covering LICENSEE’S
activities related to the research, development and testing of all LICENSED PRODUCTS and the obtaining of applicable governmental
approvals necessary for marketing. These progress reports shall be made for each LICENSED PRODUCT in each country of the TERRITORY.
Beginning on the sixth anniversary of the RESTATEMENT DATE, such progress reports shall be submitted annually instead of semiannually,
with the last report due one year after this AGREEMENT has been terminated or expires.


 




    	 



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5.4           The
progress reports submitted under Section 5.3 shall include sufficient information to enable LICENSOR to determine LICENSEE’S
progress in fulfilling its obligations under Article 6, and shall follow the format of the document attached as Appendix C.


 


5.5           LICENSOR
agrees to receive and maintain all information provided by LICENSEE under this Article 5, including but not limited to royalty
reports, in confidence to the same extent described in Section 3.6, except such information which falls under any exception described
in Sections 7.1.1 through 7.1.3.


 


ARTICLE 6- DILIGENCE


 


6.1           LICENSEE
shall use commercially reasonable efforts, and require its sublicensees and further sublicensees to use commercially reasonable
efforts, to develop and make commercially available LICENSED PRODUCT(S) for commercial sales and distribution in a timely manner
and create and fulfill market demand for such LICENSED PRODUCTS in at least the United States, Europe and Japan.


 


6.2           Prior
to signing this Agreement, LICENSEE has provided to LICENSOR the Commercial Development Plan attached hereto as Appendix B, under
which LICENSEE intends to bring LICENSED PRODUCTS to market. LICENSOR shall have full opportunity to review, comment on, and approve
the final, mutually agreed Plan prior to execution of this Agreement. PERFORMANCE BENCHMARKS means those diligence goals and dates
defined in the Commercial Development Plan.


 


6.3           As
provided in Article 5, LICENSEE shall provide written reports on its product development progress or efforts to commercialize under
the Commercial Development Plan. If reported progress differs from that projected in the Commercial Development Plan, LICENSEE
shall explain the reasons for such differences. In the event that a substantial change in laws or regulations or feedback following
interactions with the FDA affects the approval process in a material way or the Commercial Development Plan for any LICENSE PRODUCT(s)
hereunder, and prevents LICENSEE from meeting any of the PERFORMANCE BENCHMARKS or milestone dates set forth in the Commercial
Development Plan, LICENSOR and LICENSEE agree to negotiate in good faith a reasonable change in the dates so affected.


 




    	 



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6.4           Subject
to Section 6.3, LICENSEE may amend the PERFORMANCE BENCHMARKS at any time upon written consent by LICENSOR. LICENSOR shall not
unreasonably withhold approval of any request of LICENSEE to extend the time periods associated with the PERFORMANCE BENCHMARKS
if such request is supported by a reasonable showing by LICENSEE of diligence in its performance under the Commercial Development
Plan.


 


6.5           On
or about the anniversary date of this Agreement, LICENSOR shall have the right to call for a half-day, detailed review meeting
during which LICENSEE and representatives of sublicensees, if any, and LICENSOR shall discuss the progress reports submitted by
LICENSEE pursuant to Article 5 hereof. These meetings shall be held at LICENSEE’s facility under appropriate confidentiality
and LICENSEE will encourage its scientists and staff to provide full and detailed information to enable LICENSOR to evaluate the
progress reports submitted by LICENSEE and to evaluate proposed amendments to the Commercial Development Plan as described in this
Section 6.


 


6.6           LICENSOR
agrees to receive and maintain all information provided by LICENSEE under this Article 6, including but not limited to the Commercial
Development Plan and modifications thereto, in confidence, to the same extent described in Section 3.6, except such information
which falls under any exception described in Sections 7.1.1 through 7.1.3.


 


ARTICLE 7 – CONFIDENTIALITY


 


7.1           Each
PARTY shall maintain in confidence, and hereby agrees not to disclose to any third party, and use only to perform its obligations
under this AGREEMENT all CONFIDENTIAL INFORMATION received pursuant to this AGREEMENT. Each PARTY agrees to ensure that its employees
and sublicensees have access to CONFIDENTIAL INFORMATION only on a need-to-know basis and shall treat the CONFIDENTIAL INFORMATION
with the same level of confidentiality with which each PARTY treats its own CONFIDENTIAL INFORMATION, but no less than reasonable
care. The foregoing obligations shall not apply to:


 


7.1.1           information
that is known to LICENSEE or independently developed by LICENSEE prior to the time of disclosure, in each case, to the extent evidenced
by written records promptly disclosed to LICENSOR after receipt of the CONFIDENTIAL INFORMATION; or


7.1.2           information
disclosed to LICENSEE by a third party that has a right to make such disclosure without restriction; or


7.1.3           information
that is or becomes patented, published or otherwise part of the public domain as a result of acts by LICENSOR or a third person
obtaining such information as a matter of right, including the right to publish; or


 




    	 



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7.1.4           information
that is required to be disclosed by order of governmental authority or a court of competent jurisdiction; provided that LICENSEE
shall use its best efforts to obtain confidential treatment of such information by the agency or court; or


7.1.5           TECHNICAL
INFORMATION that is necessary or helpful to be disclosed in order for LICENSED PRODUCT(S) to be developed and commercialized as
intended herein by the parties, including any disclosure required or helpful to obtain or expedite regulatory approval, provided
LICENSEE uses reasonable efforts to disclose such information under obligations of confidentiality and limited use comparable to
those contained in this Section 7.1.


 


7.2           The
confidentiality and use obligations set forth in Section 7.1 herein shall apply during the term of this AGREEMENT and for three
(3) years after termination or expiration of this AGREEMENT.


 


ARTICLE 8 - TERM AND TERMINATION


 


8.1           Unless
otherwise terminated by operation of law or by acts of the parties in accordance with the provisions of this AGREEMENT, this AGREEMENT
shall commence on the RESTATEMENT DATE and shall remain in effect in each country until the expiration of the last-to-expire PATENT
RIGHTS licensed under this AGREEMENT or seven and one-half (7.5) years from the date of first commercial sale of a LICENSED PRODUCT
in such country, whichever is later.


 


8.2           LICENSEE
may, at its option, terminate this AGREEMENT at any time by doing all of the following:


 


8.2.1           by
ceasing to develop, register, make, have made, use and sell all LICENSED PRODUCT(S);


8.2.2           by
terminating all sublicenses, and causing all sublicensees to cease developing, registering, making, having made, using and selling
all LICENSED PRODUCT(S);


8.2.3           by
giving one hundred eighty (180) days written notice to LICENSOR of such cessation and of LICENSEE'S intent to terminate;


8.2.4           by
tendering payment of all accrued royalties and amounts due under this AGREEMENT as of the last day of the 180 day period referred
to in Section 8.2.3.


 


8.3           LICENSOR
may terminate this AGREEMENT if any of the following occur:


 


8.3.1           LICENSEE
becomes more than sixty (60) days in arrears of any payments due to LICENSOR pursuant to this AGREEMENT, and LICENSEE does not
provide full payment within thirty (30 ) business days after written demand therefor by LICENSOR; or


8.3.2           LICENSEE
becomes subject to a BANKRUPTCY EVENT; or


 




    	 



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8.3.3           LICENSEE
otherwise breaches this AGREEMENT and does not cure such breach within sixty (60) days written notice thereof. Breaches shall include,
without limitation, failure to make any royalty or progress report when due under this AGREEMENT and failure to exercise required
diligence efforts under Article 6, including failure to successfully complete any diligence requirement described in Article 6;
provided, however, than any such termination pursuant to Article 6 shall be limited to only those fields for which LICENSEE has
failed to complete such diligence requirements and no termination shall be possible in the event there has been a change in law
or regulation, or in the event an action, omission or other feedback, recommendation, decision or guidance from the FDA is determined
to materially affect the ability of LICENSEE to meet its obligations under Article 6.


8.3.4           Nine
(9) years have elapsed from the RESTATEMENT DATE, LICENSEE, an AFFILIATE or a sublicensee has not commenced commercial sales of
at least one LICENSED PRODUCT, and LICENSOR has given LICENSEE ninety (90) days’ notice of intent to terminate.


 


8.4           If
LICENSEE becomes subject to a BANKRUPTCY EVENT, all duties of LICENSOR and all rights (but not duties) of LICENSEE under this AGREEMENT
shall immediately terminate without the necessity of any action being taken either by LICENSOR or by LICENSEE 


 


8.5           LICENSEE'S
accrued obligations under all provisions of this Agreement shall survive early termination or expiration of this AGREEMENT. In
addition, the provisions of Sections 3.4, 3.5, 8.5, 8.6, 8.7, 9.7, 10.6 and Articles 5, 7, 11, 12 and 13 shall survive such early
termination or expiration.


 


8.6           Any
termination or expiration of this AGREEMENT shall not relieve LICENSEE of any obligation or liability accrued hereunder prior thereto
or rescind anything done by LICENSEE or any payments made to LICENSOR prior thereto, and such termination or expiration shall not
affect in any manner any rights of LICENSOR arising under this AGREEMENT prior to such termination or expiration.


 


8.7           Upon early termination or expiration
of this AGREEMENT, LICENSEE shall within sixty (60) days return to LICENSOR all TECHNICAL INFORMATION and CONFIDENTIAL INFORMATION.
The parties shall negotiate in good faith regarding LICENSOR’S right to receive and use data generated by or for LICENSEE
that may facilitate the development or commercialization of the technology licensed hereunder.


 




    	 



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ARTICLE 9 - PATENT MAINTENANCE AND REIMBURSEMENT


 


9.1           LICENSEE
shall, at its expense, manage, direct and shall have sole responsibility and discretion in decisions respecting the preparation,
filing, prosecution, maintenance, defense, and abandonment of the PATENT RIGHTS licensed hereunder, using counsel of its choice
(chosen with the consent of LICENSOR, which consent will not be unreasonably withheld). LICENSOR consents to the use of McCarter
& English, MH2 Technology Law Group, and any other counsel the parties may mutually agree upon in the future. LICENSEE shall
instruct counsel to copy LICENSOR on all communications related to prosecution of the PATENT RIGHTS. LICENSEE’S counsel shall
take instructions only from LICENSEE. LICENSEE shall keep LICENSOR informed and apprised of actions and decisions relating to the
PATENT RIGHTS, including but not limited to providing copies of patent filings, office actions and communications from and to any
patent offices and providing at least 60 days written notice to LICENSOR prior to (i) abandoning any of the PATENT RIGHTS or (ii)
failing to defend any of the PATENT RIGHTS.


 


9.1.1           LICENSEE
shall be free to abandon PATENT RIGHTS at its discretion provided that it accords LICENSOR adequate notice of any such decision
as specified in Section 9.1. In the event LICENSOR wishes to take over management of any PATENT RIGHTS which LICENSEE chooses to
abandon, pursuant to the 60 day notice provided in Section 9.1, LICENSOR may do so upon written notice to LICENSEE.


 


9.1.2.          LICENSEE
shall be free to file or not file applications related to the PATENT RIGHTS in any country at its discretion. Should LICENSEE elect
not to file a patent application in a country or countries, LICENSOR may file such application(s) using counsel of its choice upon
written notice to LICENSEE.


 


9.1.3.          After
LICENSOR provides notice to LICENSEE pursuant to Section 9.1.1 or 9.1.2, LICENSOR shall be solely responsible, at its expense,
for all aspects of management of such patent or patent application. LICENSEE shall remain responsible providing the information
required under Section 9.1, and for paying for all costs incurred prior to the date that LICENSOR has taken responsibility. Thereafter,
LICENSEE shall have not further rights in such PATENT RIGHTS, and LICENSOR shall have full discretion in how it wishes to manage
them, including but not limited to licensing them to third parties.


 


9.2           Each
party shall cooperate reasonably with the other’s activities under Section 9.1, including but not limited to applying for
an extension of the term of any patent included within PATENT RIGHTS if appropriate under the Drug Price Competition and Patent
Term Restoration Act of 1984 as amended. Each party agrees to execute all documents and to take any additional action as the other
may reasonably request in connection with activities under Section 9.1.


 




    	 



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9.3           All
unreimbursed past, present and future costs associated with preparing, filing, prosecuting, defending, and maintaining and management
of the licensed PATENT RIGHTS shall be borne and promptly paid by LICENSEE; provided, however, any costs incurred by LICENSEE in
recording that certain assignment of PATENT RIGHTS by BDSI to LICENSOR before the USPTO or any foreign patent office shall be credited
against any payment owed to LICENSOR by LICENSEE under this Agreement.


 


9.4           After
the RESTATEMENT DATE, upon periodic request by LICENSEE, LICENSOR shall advise LICENSEE of discoveries or inventions made by, under
the direction or supervision of Dr. Mannino and owned by LICENSOR that have been formally disclosed to LICENSOR’s technology
transfer office and which LICENSOR considers may be of interest to LICENSEE and which are available for licensing to LICENSEE.
If not covered by the PATENT RIGHTS, and should LICENSEE wish to license the intellectual property relating to such discoveries
or inventions, the PARTIES will enter into good faith negotiations for the possible licensing of them to LICENSEE.


 


9.6           LICENSEE,
its AFFILIATES and its sublicensees and their further sublicensees shall comply with all United States and foreign laws with respect
to patent marking of LICENSED PRODUCT(S).


 


9.7           Upon expiration or early termination
of this AGREEMENT, or the removal of any PATENT RIGHTS or claims thereof from this AGREEMENT, LICENSOR shall become responsible
for such PATENT RIGHTS and/or claims, except for non-cancellable commitments made by and liabilities incurred by LICENSEE during
the term of this AGREEMENT.


 


ARTICLE 10 - INFRINGEMENT AND LITIGATION


 


10.1         LICENSOR
and LICENSEE are responsible for notifying each other promptly of any infringement of PATENT RIGHTS that may come to their attention.
The parties shall consult with one another in a timely manner concerning any appropriate response thereto.


 


10.2         LICENSEE
shall have the right, but not the obligation to prosecute such infringement at its own expense. At LICENSEE’S request and
expense, LICENSOR will reasonably cooperate by joining as a party plaintiff if required to do so by law to maintain such action
or proceeding and by executing and making available such documents as LICENSEE may reasonably request. LICENSEE shall have the
right to settle any claim or suit for infringement of the PATENT RIGHTS with prior approval of LICENSOR, including by granting
the infringing party a sublicense to the PATENT RIGHTS pursuant to Article 3 of this AGREEMENT. LICENSEE shall not settle or compromise
any such suit in a manner that imposes any obligations or restrictions on LICENSOR without LICENSOR'S written permission, such
permission not to be unreasonably withheld. Any excess financial recovery, after all litigation costs and expenses have been paid,
shall be apportioned between LICENSEE and LICENSOR with [*] to LICENSEE and [*] to LICENSOR.




    	 



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10.3         LICENSEE’S
rights in Section 10.2 shall be subject to the continuing right of LICENSOR to intervene at LICENSOR's own expense and join LICENSEE
in any claim or suit for infringement of the PATENT RIGHTS. Any consideration received by LICENSEE in settlement of any claim or
suit shall be shared between LICENSOR and LICENSEE in proportion with their share of the litigation expenses in such infringement
action, but LICENSOR shall in no event receive less than the percentage share it is entitled to under Section 10.2.


 


10.4         If
LICENSEE fails to prosecute such infringement, LICENSOR shall have the right, but not the obligation, to prosecute such infringement
at its own expense. In such event, financial recoveries will be entirely retained by LICENSOR.


 


10.5         In
any action to enforce any of the PATENT RIGHTS, either party, at the request and expense of the other party, shall cooperate to
the fullest extent reasonably possible. This provision shall not be construed to require either party to undertake any activities,
including legal discovery, at the request of any third party except as may be required by lawful process of a court of competent
jurisdiction.


 


10.6      This Article
10 shall survive expiration or termination of this AGREEMENT to the extent any litigation has been commenced hereunder prior to
expiration or termination.


 


ARTICLE 11 - DISCLAIMER OF WARRANTY,
INDEMNIFICATION AND INSURANCE


 


11.1         THE
PATENT RIGHTS AND TECHNICAL INFORMATION ARE PROVIDED ON AN "AS IS" BASIS, AND NO REPRESENTATIONS OR WARRANTIES, EXPRESS
OR IMPLIED, ARE MADE WITH RESPECT THERETO. BY WAY OF EXAMPLE BUT NOT OF LIMITATION, NO REPRESENTATIONS OR WARRANTIES ARE MADE (i)
OF COMMERCIAL UTILITY; (ii) OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE; OR (iii) THAT THE USE OF THE PATENT RIGHTS,
TECHNICAL INFORMATION, OR THAT MAKING, USING OR SELLING LICENSED PRODUCT(S) WILL NOT INFRINGE ANY PATENT, COPYRIGHT OR TRADEMARK
OR OTHER PROPRIETARY OR PROPERTY RIGHTS OF OTHERS. LICENSOR AND BDSI SHALL NOT BE LIABLE TO LICENSEE, ITS AFFILIATES, OR
THEIR RESPECTIVE SUCCESSORS OR ASSIGNS OR ANY THIRD PARTY WITH RESPECT TO: ANY CLAIM ARISING FROM THE USE OF THE PATENT RIGHTS
OR TECHNICAL INFORMATION, OR FROM THE MANUFACTURE, USE OR SALE OF LICENSED PRODUCT(S); OR ANY CLAIM FOR LOSS OF PROFITS, LOSS OR
INTERRUPTION OF BUSINESS, OR FOR, DIRECT, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND.


 




    	 



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11.2         To
the maximum extent permitted by applicable law, LICENSEE shall defend, indemnify and hold harmless LICENSOR, BDSI, and their respective
trustees, officers, agents and employees (individually, an "Indemnified Party", and collectively, the "Indemnified
Parties"), from and against any and all liability, loss, damage, action, claim or expense suffered or incurred by the Indemnified
Parties (including attorney's fees) (individually, a "Liability", and collectively, the "Liabilities") that
results from or arises out of: (i) the development, use, manufacture, promotion, sale or other disposition, of any TECHNICAL INFORMATION,
PATENT RIGHTS or LICENSED PRODUCT(S) by LICENSEE, its AFFILIATES or their respective assignees, sublicensees and their further
sublicensees, vendors or other third parties; (ii) breach by LICENSEE or its AFFILIATE(S) of any covenant or agreement contained
in this AGREEMENT; and (iii) the enforcement by an Indemnified Party of its rights under this Section. Without limiting the foregoing,
LICENSEE will defend, indemnify and hold harmless the Indemnified Parties from and against any Liabilities resulting from:


 


11.2.1           any
product liability or other claim of any kind related to the use by a third party of a LICENSED PRODUCT(S) that was developed, manufactured,
used, sold or otherwise disposed of by LICENSEE, its AFFILIATES or their assignees, sublicensees and their further sublicensees,
vendors or other third parties; and/or


 


11.2.2           a
claim by a third party that the TECHNICAL INFORMATION or PATENT RIGHTS or the design, composition, manufacture, use, sale or other
disposition of any LICENSED PRODUCT(S) infringes or violates any patent, copyright, trademark or other intellectual property rights
of such third party other than claims that result solely from the actions of LICENSOR or its agents.


 


11.3         The
Indemnified Party shall notify LICENSEE of any claim or action giving rise to Liabilities subject to the provisions of the foregoing
Section. LICENSEE shall have the obligation to defend any such claim or action, at its cost and expense. LICENSEE shall not settle
or compromise any such claim or action in a manner that imposes any restrictions or obligations on LICENSOR without LICENSOR'S
prior written consent. If LICENSEE fails or declines to assume the defense of any such claim or action within thirty (30) days
after notice thereof, LICENSOR may assume the defense of such claim or action for the account of and risk of LICENSEE, and any
Liabilities related thereto shall be conclusively deemed a liability of LICENSEE. LICENSEE shall pay promptly to the Indemnified
Party any Liabilities to which the foregoing indemnity relates, as incurred. The indemnification rights of LICENSOR or other Indemnified
Party contained herein are in addition to all other rights which such Indemnified Party may have at law or in equity or otherwise.


 




    	 



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11.4         LICENSEE
shall procure and maintain a policy or policies of comprehensive general liability insurance, including broad form and contractual
liability, in a minimum amount of $1,000,000 combined single limit per occurrence and in the aggregate as respects personal injury,
bodily injury and property damage arising out of LICENSEE'S or its AFFILIATE(S) performance of this AGREEMENT. LICENSEE insurance
shall be primary coverage, and LICENSOR insurance or self-insurance shall be excess coverage and non-contributory.


 


11.5         The
policy or policies of insurance specified herein shall be issued by an insurance carrier with an A.M. Best rating of "A"
or better and shall name LICENSOR and BDSI as additional insureds with respect to LICENSEE'S performance of this AGREEMENT. LICENSEE
shall provide LICENSOR with certificates evidencing the insurance coverage required herein and all subsequent renewals thereof.
Such certificates shall provide that LICENSEE'S insurance carrier(s) notify LICENSOR in writing at least thirty (30) days prior
to cancellation or material change in coverage.


 


11.6         LICENSOR
shall periodically review the adequacy of the minimum limits of liability specified herein. Following such review and based upon
LICENSOR’s good faith determination that such minimum limits of liability specified herein are no longer adequate, LICENSOR
reserves the right to require LICENSEE to adjust such coverage limits accordingly; provided, however, LICENSEE’s inability
to comply with such request shall not be considered a breach of this AGREEMENT nor form the basis of termination under Article
8. The specified minimum insurance amounts shall not constitute a limitation on LICENSEE'S obligation to indemnify LICENSOR or
other Indemnified Parties under this AGREEMENT.


 


ARTICLE 12 - USE OF LICENSOR'S NAME;
INDEPENDENT CONTRACTOR


 


12.1         LICENSEE
and its employees and agents shall not use and LICENSEE shall not permit its AFFILIATES or sublicensees to use LICENSOR'S name,
any adaptation thereof, any LICENSOR logotype, trademark, service mark or slogan or the name mark or logotype of any LICENSOR representative
or organization in marketing or advertising materials, or in a manner that implies endorsement, without the prior written consent
of LICENSOR in each instance, which consent will not be unreasonably withheld.


 


12.2         Nothing
herein shall be deemed to establish a relationship of principal and agent between LICENSOR and LICENSEE, nor any of their agents
or employees for any purpose whatsoever. This AGREEMENT shall not be construed as constituting LICENSOR and LICENSEE as partners,
or as creating any other form of legal association or arrangement that would impose liability upon one party for the act or failure
to act of the other party.


 




    	 



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ARTICLE 13 - MISCELLANEOUS PROVISIONS


 


13.1         LICENSEE
shall comply with all prevailing laws, rules and regulations pertaining to the development, testing, manufacture, marketing, sale,
use, import or export of LICENSED PRODUCT(S). Without limiting the foregoing, it is understood that this AGREEMENT may be subject
to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other
commodities, articles and information, including the Arms Export Control Act as amended in the Export Administration Act of 1979,
and that the parties’ obligations hereunder are contingent upon compliance with applicable United States export laws and
regulations. The transfer of certain technical data and commodities may require a license from the cognizant agency of the United
States Government and/or written assurances by LICENSEE that LICENSEE shall not export data or commodities to certain foreign countries
without prior approval of such agency. LICENSOR neither represents that a license is not required nor that, if required, it will
issue.


 


13.2         This
AGREEMENT will be binding on the parties hereto and upon their respective successors and assigns. LICENSEE may at any time, upon
written notice to LICENSOR, assign this AGREEMENT to a purchaser of all of its business, provided such assignment does not adversely
affect LICENSOR’S rights hereunder. Except as provided above, LICENSEE will not assign this AGREEMENT, or delegate any right
or obligation hereunder without the prior written consent of LICENSOR, which consent may not be unreasonably withheld. LICENSOR
may assign this AGREEMENT at any time to Rutgers, the State University of New Jersey. Any attempted assignment or delegation in
violation of this Section 13.2 will be void.


 


13.3         Notices,
payments, statements, reports and other communications under this AGREEMENT shall be in writing and shall be deemed to have been
received (i) when personally delivered, or (ii) five (5) days after mailing if mailed by first-class certified mail, postage paid
and deposited in the United States mail, or (iii) as of the date dispatched if sent by public overnight courier (e.g., Federal
Express), or (iv) or as otherwise agreed upon in writing by the parties and addressed as follows:


 


If for LICENSOR:


 


Director, Biomedical
and Life Sciences Licensing


Office of Technology
Commercialization


Rutgers, The State
University of New Jersey


ASB Annex III, 3 Rutgers
Plaza


New Brunswick, New
Jersey 08901-8559


 




    	 



    	Amended and Restated License Agreement
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If for LICENSEE:


 


Dr. J Carl Craft, M.D.


CEO


Aquarius Biotechnologies,
Inc.


2037 W. Carroll Avenue


Chicago, IL 60612


 


Either party may change its official address
upon written notice to the other party.


 


13.4         This
AGREEMENT shall be construed and governed in accordance with the laws of the State of New Jersey, without giving effect to conflict
of law provisions, but the scope and validity of any patent or patent application shall be governed by the applicable laws of the
country of such patent or patent application.


 


13.5         This
AGREEMENT embodies the entire understanding of the parties and shall supersede all previous and contemporaneous communications,
representations or understandings, either oral or written, between the parties relating to the subject matter hereof. Any modification
of this AGREEMENT shall be in writing and signed by an authorized representative of each party.


 


13.6         In
the event that a party to this AGREEMENT perceives the existence of a dispute with the other party concerning any right or duty
provided for herein, the parties shall, as soon as practicable, confer in an attempt to resolve the dispute. If the parties are
unable to resolve such dispute amicably within ninety (90) days of initial notice of dispute by one party to the other party, then
the parties hereby submit to the exclusive jurisdiction of and venue in the courts located in the State of New Jersey with respect
to any and all disputes relating to this AGREEMENT.


 


13.7         A
waiver by either party of a breach or violation of any provision of this AGREEMENT will not constitute or be construed as a waiver
of any subsequent breach or violation of that provision or as a waiver of any breach or violation of any other provision of this
AGREEMENT or a subsequent breach of the same provision.


 


13.8         In
case any of the provisions contained in this AGREEMENT shall be held to be invalid, illegal or unenforceable in any respect in
any jurisdiction, (i) such invalidity, illegality or unenforceability shall not affect any other provisions hereof, (ii) the particular
provision, to the extent permitted by law, shall be reasonably construed and equitably reformed to be valid and enforceable and
if the provision at issue is a commercial term, it shall be equitably reformed so as to maintain the overall economic benefits
of the AGREEMENT as originally agreed upon by the parties, and (iii) this AGREEMENT shall be construed as if such invalid or illegal
or unenforceable provisions had never been contained herein.


 




    	 



    	Amended and Restated License Agreement
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13.9         The
headings and captions used in this AGREEMENT are for convenience of reference only and shall not affect its construction or interpretation.


 


13.10         Nothing
in this AGREEMENT, express or implied, is intended to confer on any person, other than the parties hereto or their permitted assigns,
any benefits, rights or remedies.


 


13.11         Neither
LICENSEE nor its AFFILIATES shall originate any publicity, news release or other public announcement, written or oral, relating
to this AGREEMENT or the existence of an arrangement between the parties, except as required by law or any applicable securities
exchange rules (including, without limitation, provisions regarding the disclosure requirements required by the U.S. Securities
and Exchange Commission for publicly quoted companies provided that such party required to file or disclose shall seek appropriate
confidential treatment and shall seek to minimize such disclosure), without the prior written approval of the LICENSOR, which approval
shall not be unreasonably withheld. Each party shall respond to a request for approval from the other party within thirty (30)
days after receipt of the request.


 


13.12         This
AGREEMENT may be executed in any number of counterparts, each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.


 


13.13         LICENSEE
shall not enter into any agreements relating to this AGREEMENT with any of the INVENTORS or other LICENSOR employees or students
in contravention of the legal rights or policies of LICENSOR or without the prior written consent of LICENSOR, which consent shall
not be unreasonably withheld.


 


13.14         In
the event of a failure of performance due under the terms of this AGREEMENT by either party, if the other party undertakes legal
action against the non-performing party on account thereof, then the party undertaking legal action shall be entitled to reasonable
attorneys’ fees in addition to costs and disbursements if it prevails in such legal action.


 


[End of Agreement – Signature Pages
To Follow]


 




    	 



    	Amended and Restated License Agreement
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IN WITNESS WHEREOF the parties, intending
to be legally bound, have caused this AGREEMENT to be executed by their duly authorized representatives on the date first set forth
above.


 


	FOR LICENSOR:   	/s/ David Kimball, Ph.D.	 
	By:	S. David Kimball, Ph.D.
	Title:	Associate Vice President, Research Commercialization Office of Research and Economic Development
	DATE:	January 29, 2015


 


	FOR LICENSEE:     	/s/ J Carl Craft	 
	By:	J Carl Craft
	Title:	Chief Executive Officer 
	Date:	January 29, 2015


 




    	 



    	Amended and Restated License Agreement
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APPENDIX A (i)


 


Table I.         Solely Owned by Rutgers


 


	Title	 	Country	 	Appln. No.	 	Patent No.
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	 
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	 
	[*]	 	[*]	 	[*]	 	 
	[*]	 	[*]	 	[*]	 	[*]
	[*]	 	[*]	 	[*]	 	 
	[*]	 	[*]	 	[*]	 	[*]


 




    	 



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Table I.        Solely Owned by Rutgers (cont’d)


 


	Title	 	Country	 	Appln. No.	 	Patent No.
	[*]	 	[*]	 	[*]	 	 
	[*]	 	[*]	 	[*]	 	 
	[*]	 	[*]	 	[*]	 	 
	[*]	 	[*]	 	[*]	 	 


 


Table II. Co-Owned by Rutgers


 


	Title	 	Country	 	Appln. No.	 	Patent No.
	[*]	 	[*]	 	[*]	 	 
	[*]	 	[*]	 	[*]	 	 
	[*]	 	[*]	 	[*]	 	 


 




    	 



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APPENDIX A (ii)


 


[*]


 




    	 



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APPENDIX B – Commercial Development
Plan


 


As the cochleate technology is a drug delivery platform with
broad potential applications, there are many potential development routes that would lead to a commercial product utilizing cochleates.
These development routes include pharmaceutical applications and non-pharmaceutical applications, such as food and cosmetics.


 


Diligence terms are listed below for both pharmaceutical and
non-pharmaceutical products. The PHARMACEUTICAL PRODUCT field shall mean the treatment of any disease or condition. The NON-PHARMACEUTICAL
PRODUCT field shall mean all fields except the treatment of any disease or condition.


 


PHARMACEUTICAL PRODUCT Diligence Terms


 


General


 


LICENSEE, an AFFILIATE or a sublicensee will ensure on-going
development of one or more LICENSED PRODUCTS by continued annual expenditure for direct costs of no less than [*] annually
during the first year after the Restatement Date and [*] annually thereafter.


 


For Pharmaceutical Products other than encochleated Amphotericin
B or Amikacin[*]:


 


LICENSEE, an AFFILIATE or a sublicensee will [*].


LICENSEE, an AFFILIATE or a sublicensee will [*].


LICENSEE, an AFFILIATE or a sublicensee will [*].


LICENSEE, an AFFILIATE or a sublicensee will [*].


LICENSEE, an AFFILIATE or a sublicensee will [*].


 


Development Plan Disclaimer


 


LICENSOR and LICENSEE acknowledge and agree that during the
course of normal pharmaceutical development certain key findings: (i) may provide opportunities for accelerated development, either
under fast track FDA review or under alternative regulatory pathways such 505(b)(2), and LICENSEE commits to exploit such opportunities
for rapid development as is commercially reasonable; (ii) may reveal issues related to safety/tolerability or lack of efficacy,
or may result in FDA advise/action adversely affecting the development plan for a certain pharmaceutical product; or (iii) significant
development progress or regulatory approval of competing products may affect clinical utility or commercial competitiveness, such
that items (ii) and (iii) may require assessment of any viable development pathways given such findings and potential adjustment
of the development or abandonment of the program if further development is no longer commercially reasonable.




    	 



    	Amended and Restated License Agreement
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For Pharmaceutical Products comprising encochlaeted Amphotericin
B:


 


		·	Amphotericin B is a fungicidal (as opposed to fungistatic) broad spectrum
antifungal. As of the Restatement Date, the program for encochleated Amphotericin B has completed a one dose escalating (200-800mg)
single dose oral administration PK study, with favorable tolerability. [*].



 


		·	In collaboration with NIH-NIADD, LICENSEE is developing a protocol
for an open label Phase 2a efficacy study of patients with refractory mucocutaneous Candidiasis, also incorporating single and
multiple dose PK in such patients. [*].



 


[*].


 


For Pharmaceutical Products comprising encochleated Amikacin:


 


		·	Amikacin is an aminoglycoside antibiotic with broad spectrum activity
against many gram-negative bacteria. [*].



 


		·	As of the RESTATEMENT DATE, the encochleated Amikacin has undergone
[*]



 


		·	[*]



 


		·	[*] 



 


NON-PHARMACEUTICAL PRODUCT diligence terms


 


LICENSEE, an AFFILIATE or a sublicensee will commence a [*]
of at least one LICENSED PRODUCT in the NON-PHARMACEUTICAL field within [*] of the RESTATEMENT DATE in the [*].


 




    	 



    	Amended and Restated License Agreement
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APPENDIX C – PROGRESS REPORT
TEMPLATE


 


Licensee:


Program:


Reporting Period:


 


		·	Upon the first anniversary of the Restatement Date of the License,
please modify/complete the attached schematic (Appendix B) or submit a similar schematic that provides an overview of the proposed
development program, including key milestones (regulatory and commercial). Submit a revised version of the plan when adjustments
to the timeline occur;



 


		·	For the reporting period, provide a summary of work completed, including
key scientific results and a brief interpretation of pre-clinical/clinical findings;



 


		·	For the upcoming reporting period, provide an overview of work in
progress or to be initiated related to drug candidate development and testing;



 


		·	Report on the estimated timings or status (e.g., meeting requested,
identify the date when a meeting occurred, preparation of filing in process) of the following regulatory milestones:



 


		o	Pre-IND discussions with FDA



		o	IND filing



		o	End of Ph2 meeting with FDA



		o	NDA filing



		o	NDA approval



 


		·	Upon initiation of Ph2 summarize the expected period of exclusivity/time
on the market for the launched LICENSED PRODUCT;



 


		·	Upon initiation of Ph2 please summarize: i) existing standard of care
for the anticipated lead indication; and ii) how the LICENSED PRODUCT will meet existing unmet needs/differentiate from launched
products; 



 




    	 



    	Amended and Restated License Agreement
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		·	Upon completion of Ph2 please summarize the selling and promotion
strategy for the launched LICENSED PRODUCT (e.g., use of existing sales force; establishment of sales force; or partner to access
established sales force);



 


		·	Describe activities relating to obtaining sublicenses and activities
of sublicensees;



 


		·	Report on IP milestones relating to the licensed IP, including costs
associated with filings, prosecution or maintenance;



 


		·	Provide a summary of resources (dollar value) spent in the reporting
period for research, development and marketing of LICENSED PRODUCTS;



 


		·	Provide uncertified and certified (audited/unaudited) financial statement
as of the end of the previous calendar quarter.