Exhibit
10.10


 


CERTAIN
IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM
TO THE REGISTRANT IF PUBLICLY DISCLOSED. THE OMISSIONS HAVE BEEN INDICATED BY “[***].”


 





 


THERAPEUTIC
DEVELOPMENT AWARD AGREEMENT


 


November
17, 2020


 


	Development
    Program:	MAT2501
    for the Treatment of NTM Infections in Cystic Fibrosis Patients
	Awardee:	Matinas
    BioPharma Nanotechnologies, Inc. (the “Awardee”)
	Award
    Number:	MATINAS20W0
	Award
    Amount:	$4,234,249,
    consisting of $484,249 previously advanced and up to an additional $3,750,000 in accordance with the Payment Schedule attached
    hereto as Exhibit B


 


1.
Award. The Cystic Fibrosis Foundation, a Delaware corporation (“CFF”), is issuing this award (this “Award”)
to the Awardee for the Development Program named above and described in Exhibit A. CFF will fund the Development Program
up to the New Award Amount (as defined below), and Awardee will pay all of the remaining costs in excess of the Award required
to complete the Development Program and to further develop and commercialize the Product (as described below). $359,249 of the
Award Amount was previously disbursed to the Awardee pursuant to the Letter Agreement, dated as of November 16, 2016, by and between
CFF and the Awardee, and $125,000 of the Award Amount was previously disbursed to the Awardee pursuant to the Letter Agreement,
dated as of February 12, 2020, by and between CFF and the Awardee, which amounts are included in the Award Amount hereunder pursuant
to Section 2 of each such Letter Agreement. CFF will advance up to an additional $3,750,000 (the “New Award Amount”)
to fund the Development Program. Each party’s rights and obligations hereunder will commence as of the date written above
(the “Effective Date”). This Award is in furtherance of CFF’s charitable mission to cure and mitigate
the effects of cystic fibrosis. CFF has determined that without the Award, the Development Program may not occur or may be substantially
delayed. The Award is subject to the terms, conditions and policies of this Agreement (“Agreement”).


 


2.
Disbursement of Award; Use of Award; Return of Award. The New Award Amount will be disbursed to the Awardee in accordance
with the Payment Schedule set forth in Exhibit B. The Awardee hereby covenants and agrees to use the New Award Amount solely
to fund the Development Program. Any portion of the New Award Amount paid to the Awardee and not expended on the Development Program
must be returned to CFF promptly upon the Awardee’s determination that such funds will not be expended on the Development
Program, and in any event within thirty (30) days following completion or termination of the Development Program. Upon such return,
the amounts of such returned funds will not be included as part of the Actual Award for purposes of calculating any royalties
or other amounts owed by the Awardee to CFF pursuant to Section 3.


 




    	 



     


    

 


3.
Royalties. In consideration of the Award and CFF’s license of CFF Know-How (as defined below), the Awardee agrees to
pay royalties to CFF as follows:


 


(a)
The Awardee shall pay a one-time royalty (the “Royalty”) to CFF in an amount equal to the Royalty Cap if a Product
(as defined below) resulting from the Development Program is approved for commercial sale for human therapeutic use, payable in
three (3) equal installments: the first within ninety (90) days after the first commercial sale of the Product for human therapeutic
use in the Field (the “First Sale”); the second within ninety (90) days of the first (1st) anniversary of the First
Sale; and the third within ninety (90) days of the second (2nd) anniversary of the First Sale; provided however in no event shall
the Royalty payable for any particular installment be greater than 25% of Net Sales of the Product (the “Royalty Payment
Cap’) during the twelve (12) month period ending on the date of such payment. If the amount of the Royalty due for any applicable
period is greater than the Royalty Payment Cap, then in such instance the difference between the Royalty due and the Royalty Payment
Cap shall be carried over to next payment date until such time that the Royalty is paid in full. If the Royalty is not paid in
full by ninety (90) days following the second anniversary of the First Sale, the term of the Royalty repayment shall be automatically
extended for additional twelve-month periods until the Royalty has been paid in full. In addition to the extent CFF receives any
payments pursuant to 3(b) below, each Royalty installment payment shall be reduced pro-rata after crediting of the amounts paid
pursuant to Section 3(b).


 


(b)
In the event of a License (as defined below) or a Change of Control Transaction (as defined below), subject to Section 3(d), the
Awardee shall pay to CFF an amount equal to [***] percent ([***]%) of all License Revenue (as defined below) or [***] percent
([***]%) of all COC Consideration (as defined below), respectively. Such amount shall be payable within ninety (90) days after
the Awardee’s (or, if applicable, the Awardee’s Affiliates’ or equity holders’) receipt of any such amount.


 


(c)
If Net Sales exceed $[***] million, the Awardee shall pay a one-time royalty to CFF in an amount equal to one (1) times the Actual
Award within ninety (90) days of the end of the first calendar year in which such total Net Sales were achieved. If Net Sales
exceed $[***] million, the Awardee shall pay a one-time royalty to CFF in an amount equal to one (1) times the Actual Award within
ninety (90) days of the end of the first calendar year in which such total Net Sales were achieved.


 


(d)
Notwithstanding anything to the contrary, the total, aggregate, combined amount payable to CFF under Sections 3(a) and 3(b) shall
not in any event exceed the Royalty Cap.


 


4.
Commercially Reasonable Efforts. The Awardee shall use Commercially Reasonable Efforts (as defined below) to conduct the Development
Program during the term of this Agreement. After the Development Program is completed, the Awardee (or any licensee, sublicensee,
assignee or successor, as applicable) shall exercise Commercially Reasonable Efforts to continue to develop the Product in the
Field.


 


5.
Reports and Notices.


 


(a)
During the Development Program, the Awardee shall provide CFF and the PAG (as defined below) with a reasonably detailed, written
report within forty five (45) days after the close of each calendar quarter during the Development Program summarizing progress
toward achieving the goals of the Development Program.


 


(b)
The Awardee shall provide a Milestone Report within thirty (30) days following the completion of each milestone, as set forth
in Exhibit B.


 


(c)
The Awardee shall prepare and deliver to CFF a closing report within thirty (30) days after the completion of the Development
Program and receipt by Awardee of the final clinical study report related to the Development Program.


 




    	-2-



     


    

 


(d)
After the completion of the Development Program, the Awardee shall prepare and deliver a report to CFF annually, on or before
each anniversary of the Effective Date, detailing the progress of its research and development activities regarding the Product
in the Field, until the earlier of (i) the First Sale, (ii) all research efforts related to the Product in the Field are abandoned
by the Awardee, and (iii) the Interruption License Effective Date (as defined below).


 


(e)
The Awardee shall annually provide CFF a copy of its auditor’s most recent management letter within thirty (30) days of
issuance of such letter.


 


(f)
The Awardee shall provide CFF with prompt notice of the closing of a Change of Control Transaction, and of any material adverse
event which would reasonably be expected to adversely impact the Development Program.


 


(g)
Commencing upon the First Sale and ending upon payment of all amounts due under Section 3(c), within forty five (45) days after
the end of each year, the Awardee shall furnish to CFF a written sales report covering the prior year setting forth the Net Sales
during such year.


 


6.
Program Advisory Group.


 


(a)
The Awardee and CFF shall form a Program Advisory Group (“PAG”). The purpose of the PAG is to ensure that the
Award is used solely in furtherance of CFF’s tax-exempt mission, to facilitate communications between the Parties and to
make recommendations with respect to the Development Plan. The PAG shall review progress of the Development Program; determine,
discuss and propose amendments to the Development Program or the Budget; determine whether payment milestones have been achieved;
and consider and provide non-binding recommendations on other issues raised by either party relating to the Development Program;
provided, however, that no change to the Development Program shall be made without the written agreement of both parties. All
decisions of the PAG shall be made within thirty (30) days after the date on which a party first presents a particular matter
for consideration by the PAG. In the event that the PAG cannot make a decision with respect to any matter, such matter shall be
escalated to the CEO of Awardee and the CEO of CFF, or their respective designees, (collectively, the “Senior Executives”)
to determine such matter within thirty (30) days after the date on which such matter has been referred to such Senior Executives,
which determination shall be binding on the parties. In the event the Senior Executives are unable to reach agreement, then the
CEO of Awardee shall have the right to make the final decision on such matter.


 


(b)
The PAG shall consist of two (2) individuals appointed by the Awardee and two (2) individuals appointed by CFF. One of such individuals
from the Awardee and CFF, respectively, shall be the principal liaison to the Development Program. A party may replace any PAG
member appointed by it and designate a new individual to serve on the PAG upon written notice to the other party. The PAG shall
meet at least on a quarterly basis.


 


(c)
The PAG shall terminate and cease to exist on the earlier of the completion of the Development Program or termination or expiration
of this Agreement.


 


(d)
Each party shall be responsible for its own expenses in connection with attending meetings of and participating in the PAG.


 




    	-3-



     


    

 


7.
Interruption License.


 


(a)
Grant of License. Subject to the terms and conditions of this Agreement, and effective as of the Interruption License Effective
Date (as defined below), the Awardee hereby grants to CFF (i) an exclusive (even as to the Awardee), worldwide, perpetual, sublicensable
license under the Development Program Technology (as defined below) solely to the extent necessary to manufacture, have manufactured,
license, use, sell, offer to sell, and support the Product in the Field and (ii) a non-exclusive worldwide License under the Awardee
Background IP to the extent necessary or beneficial to manufacture, have manufactured, license, use, sell, offer to sell, and
support the Product in the Field. For the avoidance of doubt. Awardee shall retain all rights to Development Program Technology
for use outside the Field and any other intellectual property owned or controlled by Awardee including the Awardee Background
IP both inside and outside the Field.


 


(b)
Interruption Notice; Awardee Election. Awardee shall notify CFF if an Interruption (as defined below) has occurred. If
Awardee provides such notice, or if CFF otherwise believes that an Interruption has occurred, CFF will provide notice (the “Interruption
Notice”) to Awardee. The Awardee shall elect, within thirty (30) days of the Interruption Notice, one of the following
options by notice to CFF:


 


(i)
The Awardee shall reasonably demonstrate, in the form of a written progress report, that an Interruption has not occurred, or
that the Awardee, an Affiliate thereof, or a licensee or sublicensee of either of the foregoing is exercising Commercially Reasonable
Efforts to develop or commercialize a Product in the Field;


 


(ii)
The Awardee shall provide CFF with notice within such thirty (30) day period that the Awardee, an Affiliate thereof, or a licensee
or sublicensee of either of the foregoing, has plans to initiate or resume Commercially Reasonable Efforts to develop or commercialize
a Product in the Field and initiates or resumes such Commercially Reasonable Efforts within the sixty (60) day period following
such notice; provided that Awardee may select this option only once; or


 


(iii)
The Interruption License shall become effective, as set forth below.; or


 


If
the Awardee has not elected (i) or (ii) above within thirty (30) days of the Interruption Notice, or if it has elected (i) or
(ii) above but has not satisfied the requirements thereof within the time period required, the Awardee shall be deemed to have
made the election specified in (iii) above. The failure of the Product due to safety issues or lack of efficacy in the Field or
regulatory restrictions shall not constitute an Interruption. In addition, the Interruption License shall automatically terminate
and be of no further force or effect following payment in full by Awardee or any of its sublicensees or assigns of the Royalty
under Section 3(a).


 


(c)
Effectiveness of License. If the Awardee has made or is deemed to have made the election specified in (iii) above, the
Interruption License shall be effective upon such election (or deemed election) (such date, the “Interruption License
Effective Date”).


 


(d)
Materials and Data. The Awardee shall deliver to CFF, within thirty (30) days of the Interruption License Effective Date,
a copy of all materials and data in its possession or control generated in the performance of the Development Program and/or constituting
the Development Program Technology to the extent required by CFF to make, use or sell the Product in the Field.


 


(e)
Assignment of Rights. In the event that the Awardee assigns all of or certain of its rights and obligations to develop
and commercialize a Product at any time to a third party, such third party shall be subject to the obligations of the Interruption
License.


 


(f)
License as Intellectual Property. The Interruption License shall be deemed to constitute intellectual property as defined
in Section 365(n) of the U.S. Bankruptcy Code. the Awardee agrees that CFF, as a licensee of such rights, shall retain and may
exercise all of its rights and elections under the U.S. Bankruptcy Code; provided, however, that nothing in this Agreement shall
be deemed to constitute a present exercise of such rights and elections.


 




    	-4-



     


    

 


(g)
Third-Party Technology. To the extent Development Program Technology or applicable Awardee Background IP includes any intellectual
property in-licensed from a third party, the Awardee will inform CFF in writing, and CFF will elect by written notice to the Awardee
either to (i) obtain a sublicense to such intellectual property from the Awardee, in which case CFF shall assume the Awardee’s
obligations to such third party under the in-license, or (ii) exclude such intellectual property from the Interruption License.


 


8.
Indemnification.


 


(a)
The Awardee shall indemnify, defend and hold harmless CFF, its Affiliates, and their respective directors, officers, employees,
consultants, committee members, volunteers, agents and representatives and their respective successors, heirs and assigns (each,
an “CFF Indemnitee”) from and against any and all claims, suits and demands of third parties and losses, liabilities,
damages for personal injury, property damage or otherwise, costs, penalties, fines and expenses (including court costs and the
reasonable fees of attorneys and other professionals) (“Liabilities”) payable to such third parties arising
out of, resulting therefrom and relating to any such third party claims, suits and/or demands (“Third Party Claims”)
resulting from:


 


(i)
the conduct of the Development Program by the Awardee or its Affiliates or their respective directors, officers, employees, consultants,
agents, representatives, licensees, sublicensees, subcontractors and/or investigators (each, an “Awardee Party”)
under this Agreement and/or pursuant to one or more agreements between the Awardee and any the Awardee Party, or any actual or
alleged violation of law resulting therefrom;


 


(ii)
the Awardee’s or its Affiliates’ development, manufacture, or commercialization of any Product;


 


(iii)
any claim of infringement or misappropriation with respect to the conduct of the Development Program by or on behalf of the Awardee,
its Affiliates, or the Awardee or its Affiliate’s third party licensees or sublicenses, or with respect to the manufacture,
use, sale, or import of any Product by any such parties other than any such claim to the extent deriving from the use of CFF Know
How; and


 


(iv)
any tort claims of personal injury (including death) relating to or arising out of any such injury sustained as the result of,
or in connection with, the conduct of the Development Program by or on behalf of the Awardee, its Affiliates, or the Awardee or
its Affiliate’s third party licensees or sublicenses, or with respect to the manufacture, use, sale, or import of any Product
by any such parties;


 


(v)
in each case except to the extent the claim, suit, demand, liability, damage, or loss results from the gross negligence or willful
misconduct of a CFF Indemnitee.


 


(b)
CFF shall indemnify, defend and hold harmless the Awardee, its Affiliates and their respective directors, officers, employees,
consultants, agents and representatives and their respective successors, heirs and assigns (the “Awardee Indemnitees”)
from and against any and all Liabilities payable to such third parties arising out of, resulting from, or relating to any Third
Party Claims resulting from: (i) exercise of any rights under the Interruption License by or on behalf of CFF, any successor in
interest thereto, or any licensee or sublicensee of any of the foregoing (which shall in any event include any claim of patent
infringement or trade secret misappropriation resulting from the manufacture, use, sale, development, commercialization, or import
of any Product or practice of any the Development Program Technology) or (ii) CFF’s gross negligence, intentional misconduct,
or failure to comply with any applicable law, rule, or regulation with respect thereto, in each case except to the extent the
claim, suit, demand, liability, damage or loss results from the gross negligence or willful misconduct of an Awardee Indemnitee.


 




    	-5-



     


    

 


(c)
A party entitled to indemnification under this Section 8 (the “Indemnified Party”) will promptly notify the
other Party (the “Indemnifying Party”) of any claims, suits, demands, losses, liabilities, damages costs, penalties,
fines, or expenses subject to indemnification under this Section 8 of which it is made aware. The Indemnified Party will cooperate,
and exert efforts to cause other Indemnified Parties to cooperate, in assisting the Indemnifying Party in presenting a defense,
if requested to do so. The Indemnifying Party shall have sole control to select defense counsel, direct the defense of any such
complaint or claim, and the right to settle claims at the Indemnifying Party’s sole expense, provided that any such settlement
does not incur non-indemnified liability for or admit fault by any Indemnified Party. In the event a claim or action is or may
be asserted, the Indemnified Party shall have the right to select and to obtain representation by separate legal counsel. If the
Indemnified Party exercises such right, all costs and expenses incurred for such separate counsel shall be borne by the Indemnified
Party. No Indemnified Party shall settle or enter into any voluntary disposition of any matter subject to indemnification under
this Section 8 without the prior written consent of the Indemnifying Party, such consent not to be unreasonably withheld.


 


9.
Insurance. The Awardee shall maintain at its own expense, with a reputable insurance carrier, coverage for the Awardee, its
Affiliates, and their respective employees written on a per occurrence basis commensurate with a reasonable assessment of the
risks associated with the research and development efforts being conducted by the Awardee, the following policies: commercial
general liability insurance, including contractual liability as respects this Agreement for bodily injury and property damage
and, no later than the first administration of a Product to a human subject, products liability and clinical trials liability.


 


Maintenance
of such insurance coverage will not relieve the Awardee of any responsibility under this Agreement for damage in excess of insurance
limits or otherwise. On or prior to the Effective Date of this Agreement, the Awardee shall provide CFF with an insurance certificate
from the insurer(s), broker(s) or agent(s) evidencing the applicable insurance coverage. At CFF’s request, CFF may review
the Awardee’s insurance coverage with relevant Awardee personnel no more than one time per year.


 


10.
Intellectual Property Rights.


 


(a)
All inventions, data, know-how, information, results, analyses, and other intellectual property rights resulting from the Development
Program shall, as between the parties, be owned by the Awardee and the preparation, filing and maintenance of all patents resulting
from the Development Program shall, as between the parties, be the sole responsibility, and under the sole control, of the Awardee.
CFF hereby assigns and transfers to the Awardee all of CFF’s right, title, and interest in and to all inventions and other
intellectual property resulting from the Development Program, CFF’s access to, or knowledge or use of, any Development Program
Technology, Product, or confidential or proprietary information of the Awardee, and all intellectual property rights related to
any of the foregoing, free and clear of all liens, claims, and encumbrances. CFF agrees to take, and cause all of its employees,
agents, and other representatives to take, any and all actions, and execute any and all documents, reasonably requested by the
Awardee as necessary to effect the foregoing.


 


(b)
To the extent CFF provides or makes available any information, expertise, know-how or other intellectual property related to cystic
fibrosis or the treatment, prevention, or cure thereof (“CFF Know-How”) to the Awardee, CFF hereby grants to
the Awardee a non-exclusive, perpetual, transferable, sublicensable (through multiple tiers), worldwide right and license under
all of CFF’s rights in such CFF Know-How to research, develop, commercialize, make, use, sell, offer for sale, import and
otherwise exploit the Product in the Field.


 




    	-6-



     


    

 


11.
Confidentiality. All information made available hereunder will be governed by that certain Nondisclosure Agreement, dated
as of August 22, 2019, by and between the Parties.


 


12.
Audits. At the request of CFF, from time to time, the Awardee shall permit CFF, upon reasonable notice, to audit and examine
such books and records of the Awardee as may be necessary for verifying the Awardee’s expenditures of the Award Amount and
the payment of royalties, if any, but no more frequently than once every calendar year.


 


13.
Term and Termination. The term of this Agreement shall commence on the Effective Date and expire on the earlier of the date
on which the Awardee has paid CFF the Royalty and all of the royalty payments set forth in Section 3, or the Interruption License
Effective Date. Either party may terminate this Agreement for cause, without prejudice to any other remedies available, by providing
the other party with written notice of such cause and intent to terminate; provided, however, that the other party shall have
thirty (30) days following the receipt of written notice to cure such cause and, in the event of such cure, such termination shall
not be effective. For this Section 11, “cause” shall mean (i) a party’s material breach of its covenants or
obligations under this Agreement, (ii) a bankruptcy or similar filing by a party or a proceeding under the applicable bankruptcy
laws or under any dissolution or liquidation law or statute now or hereafter in effect and filed against such party or all of
substantially all of its assets if such filing is not dismissed within sixty (60) days after the date of its filing, or (iii)
the Awardee’s material failure to achieve any milestone described in Exhibit A or B within ninety (90) days after its anticipated
achievement date; provided however that in the event there is a regulatory, scientific or other technical delay in achieving such
milestone that is beyond the reasonable control of Awardee (a “Tolling Event”), Awardee provides CFF with notice of
any such anticipated delay as soon as reasonably practicable after becoming aware that such a delay is likely, and Awardee uses
its Commercially Reasonable Efforts to overcome such delay during its pendency, Awardee shall not be deemed to have failed to
meet a required milestone during the pendency of a Tolling Event. The following provisions shall survive the termination of this
Agreement: Sections 3, 7, 8, 9, 10, 11, 12, 13 and 14.


 


14.
Miscellaneous.


 


(a)
Governing Law. This Agreement shall be governed by and construed in accordance with the internal laws of the State of Maryland.


 


(b)
Dispute Resolution.


 


(i)
In the event of any dispute, claim or controversy arising out of, relating to or in any way connected to the interpretation of
any provision of this Agreement, the performance of either party under this Agreement or any other matter under this Agreement,
including any action in tort, contract or otherwise, at equity or law (a “Dispute”), either party may at any
time provide the other party written notice specifying the terms of such Dispute in reasonable detail. As soon as practicable
after receipt of such notice, an officer of each party shall meet at a mutually agreed upon time and location to engage in good
faith discussions for the purpose of resolving such Dispute. If the Dispute is not resolved within thirty (30) days of such notice,
either party may institute arbitration in accordance with (ii) below.


 




    	-7-



     


    

 


(ii)
In the event any Dispute is not resolved in accordance with Section 12(b)(i), such Dispute shall be resolved by final and binding
arbitration. Whenever a party decides to institute arbitration proceedings, it shall give written notice to that effect to the
other party. Arbitration shall be held in New York, New York, according to the then-current commercial arbitration rules of the
Center for Public Resources (“CPR”), except to the extent such rules are inconsistent with this subparagraph. The
arbitration will be conducted by one (1) independent, neutral arbitrator who shall be mutually acceptable to both parties, such
acceptance not to be unreasonably withheld, and who shall be appointed in accordance with CPR rules. If the parties are unable
to mutually agree on such an arbitrator, then the arbitrator shall be appointed in accordance with CPR rules. Any arbitrator chosen
hereunder shall have educational training and industry experience sufficient to demonstrate a reasonable level of relevant scientific,
financial, medical and industry knowledge. Within twenty (20) days of the selection of the arbitrator, each party shall submit
to the arbitrator a proposed resolution of the Dispute that is the subject of the arbitration (the “Proposals”). The
arbitrator shall thereafter select one of the Proposals so submitted as the resolution of the Dispute, but may not alter the terms
of either Proposal and may not resolve the Dispute in a manner other than by selection of one of the submitted Proposals. If a
party fails to submit a Proposal, the arbitrator shall select the Proposal of the other party as the resolution of the Dispute.
The arbitrator shall agree to render its opinion within thirty (30) days of the final arbitration hearing. No arbitrator shall
have the power to award punitive damages regardless of whether any such damages are contained in a Proposal, and such award is
expressly prohibited. The proceedings and decisions of the arbitrator shall be confidential, final and binding on all of the parties.
Judgment on the award so rendered may be entered in any court having jurisdiction thereof. The parties shall share the costs of
arbitration according to the decision of the arbitrator. Nothing in this subparagraph will preclude either party from seeking
equitable or injunctive relief, or interim or provisional relief, from a court of competent jurisdiction, including a temporary
restraining order, preliminary injunction, or any other form of permanent or interim equitable or injunctive relief, concerning
a dispute either prior to or during any arbitration.


 


(c)
Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed to be an original,
but all of which together shall constitute one and the same Agreement. Facsimile and other electronically scanned signatures shall
have the same effect as their originals.


 


(d)
Notices. All communications between the parties with respect to any of the provisions of this Agreement will be sent to
the addresses set out below, or to such other addresses as may be designated by one party to the other by notice pursuant hereto,
by prepaid, certified air mail (which shall be deemed received by the other party on the seventh (7th) business day
following deposit in the mails) or nationally recognized overnight courier (which shall be deemed received upon verification of
receipt), or by email (which shall be deemed received when transmitted, if during normal business hours, or on the recipient’s
next business day, if not sent during normal business hours):


 


if
to CFF, at:


 


Cystic
Fibrosis Foundation


6931
Arlington Rd., Suite 200


Bethesda,
MD 20814


Attn:
Michael Boyle, President and CEO


Phone:
240-200-3743


Email:
mboyle@cff.org


 


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


 


Cystic
Fibrosis Foundation


6931
Arlington Rd., Suite 200


Bethesda,
MD 20814


Attn:
Stephanie Singer, Senior Counsel


Phone:
240-200-3707


Email:
ssinger@cff.org


 




    	-8-



     


    

 


if
to the Awardee, at:


 


Matinas
Biopharma NanoTechnologies, Inc


1545
Route 206 S


Suite
302


Bedminster,
NJ 07921


Attn:
Jerome Jabbour, CEO


Phone
908-505-0959


Email
jjabbour@matinasbiopharma.com


 


(e)
Headings. The paragraph headings are for convenience only and will not be deemed to affect in any way the language of the
provisions to which they refer.


 


(f)
No Avoidance. The Awardee will not, by amendment of its organizational or governing documents, or through reorganization,
recapitalization, consolidation, merger, dissolution, sale, transfer or assignment of assets, issuance of securities, or any other
voluntary action, avoid or seek to avoid the observance or performance of any of the terms, provisions, covenants or agreements
of this Agreement.


 


(g)
Assignment. This Agreement may not be assigned by any party without the consent of the other party which consent shall
not be unreasonably withheld, delayed or conditioned; provided, however, that the Awardee may assign this Agreement, without the
consent of CFF, to an Affiliate or to the acquiror of Awardee or its equity or assets pursuant to a Change of Control Transaction
of Awardee or in the sale or license to a third party of the assets to which this Agreement relates. Awardee shall give prompt
notice to CFF of any such assignment or transfer by operation of law.


 


(h)
No Relationship. Nothing herein contained shall be deemed to create an agency, joint venture, amalgamation, partnership
or similar relationship between CFF and the Awardee. Notwithstanding any of the provisions of this Agreement, neither party to
this Agreement shall at any time enter into, incur, or hold itself out to third parties as having authority to enter into or incur,
on behalf of the other party, any commitment, expense, or liability whatsoever, and all contracts, expenses and liabilities in
connection with or relating to the obligations of each party under this Agreement shall be made, paid, and undertaken exclusively
by such party on its own behalf and not as an agent or representative of the other.


 


(i)
Publicity. The Awardee shall submit any proposed press release or other public announcement, other than an academic, scholarly,
or scientific publication, concerning the terms of this Agreement or this Award prior to its public release, to the Public Affairs
Department of CFF for approval prior to its public release, with sufficient time prior to its public release to allow for review
and comment, except to the extent any such release or announcement is required by law, rule, or regulation or the rules of any
securities exchange. The parties agree that they intend to advance the body of general scientific knowledge of cystic fibrosis
and its potential therapies and cures and the parties acknowledge that the Awardee intends to, and CFF desires that the Awardee
does, as commercially and scientifically reasonable based on the results of the Development Program, publish the results of the
Development Program in a scientific peer-reviewed publication as soon as reasonably practicable. In furtherance of the foregoing,
but subject to the Awardee’s right to preserve and protect its confidential information and any information that if published
would have an adverse effect on any patent application which the Awardee (or any Affiliate thereof, licensee or sublicensee of
the Awardee or any Affiliate thereof, or contractor or collaborator of any of the foregoing) intends to file, the Awardee shall
use commercially reasonable efforts to make available to academic third parties for non-commercial research purposes such tangible
research materials or resources developed during the Development Program as the Awardee considers appropriate under the circumstances
and under reasonable terms and conditions. CFF’s support for the Development Program shall be acknowledged in any press
releases and publications relating to the Development Program.


 




    	-9-



     


    

 


(j)
Anti-Terrorism. In accordance with the U.S. Department of the Treasury Anti-Terrorist Financing Guidelines, the Awardee
shall take reasonable steps to ensure that the payments received from CFF are not distributed to terrorists or their support networks
or used for activities that support terrorism or terrorist organizations. The Awardee certifies that it is in compliance with
all laws, statutes and regulations restricting U.S. persons from dealing with any individuals, entities, or groups subject to
Office of Foreign Assets Control sanctions.


 


(k)
Amendments and Waiver. Any amendment or waiver of any provision of this Agreement shall be in writing and signed by a duly
authorized representative of each party. The delay or failure of a party at any time to require performance of any provision of
this Agreement shall in no way affect such party’s rights at a later time to enforce the same.


 


(l)
Entire Agreement. This Agreement (including the Exhibits attached here) constitutes the entire agreement between the parties
relating to the subject matter hereof and supersedes all prior or contemporaneous agreements, understandings or representations,
either oral or written, between the parties with respect to such subject matter.


 


(m)
Force Majeure. If the performance of any part of this Agreement by either party is prevented, restricted, interfered
with or delayed by any reason of force majeure (including fire, flood, embargo, power shortage, pandemic or failure, acts
of war, insurrection, riot, terrorism, strike, lockout or other labor disturbance or acts of God) (a “Force Majeure Event”),
the party so affected shall, upon giving written notice to the other party, be excused from such performance to the extent of
such prevention, restriction, interference or delay; provided, that the affected party shall use reasonable efforts to avoid or
remove such causes of non-performance.


 


15.
Definitions; Valuation Determination. Unless otherwise defined in this letter, the following shall apply:


 


(a)
“Actual Award” means the total amount of the Award Amount actually paid to the Awardee, to the extent not returned
by the Awardee to CFF pursuant to Section 2. For clarity, this includes the funds previously advanced to the Awardee pursuant
to the prior Letter Agreements as well as the New Award Amount.


 


(b)
“Affiliate” means, with respect to a party, any entity which directly or indirectly controls, is controlled
by, or is under common control with, such party. For these purposes, “control” shall refer to (i) the ownership, directly
or indirectly, of at least fifty percent (50%) of the voting securities or other ownership interest of an entity; or (ii) the
possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through the ownership
of voting securities, by contract or otherwise.


 


(c)
“Award” shall have the meaning set forth in Section 1 of the Agreement.


 


(d)
“Awardee Background IP” shall mean any intellectual property rights that are (a) owned or controlled by Awardee
prior to the Effective Date, (b) created, conceived or reduced to practice by Awardee independently from this Agreement or (c)
acquired by Awardee from a third party after the Effective Date.


 


(e)
“CFF Know-How” shall have the meaning set forth in Section 10(b).


 




    	-10-



     


    

 


(f)
“Change of Control Transaction” means the consummation of a transaction, or a series of related transactions,
constituting (i) a merger, share exchange or other reorganization of Awardee, following which the stockholders of the Awardee
immediately prior to such transaction do not own a majority of the voting power of the acquiring, surviving or successor entity,
(ii) the sale by one or more stockholders of a majority of the voting power of the Awardee, or (iii) a sale of all or substantially
all of the assets of the Awardee (or that portion of its assets related to the subject matter of this Agreement). For purposes
of clarity, and notwithstanding anything to the contrary, a Change of Control Transaction shall not include any bona fide financing
transaction whose primary purpose is for the benefit of the Awardee (i.e. in which the Awardee raises capital for general working
capital or other business purposes) in which one or more persons or entities acquire shares of the Awardee capital stock from
the Awardee.


 


(g)
“COC Consideration” means the consideration received by the Awardee and/or its equityholders in connection
with the Change of Control, including up-front consideration and any payments due for any deferred or contingent consideration
(including, without limitation, any post-closing milestone payment, escrow or holdback of consideration). The valuation of any
securities or other property shall be determined by reference to the operative transaction agreement for the Merger, Stock Sale
or Asset Sale, provided that if no such valuation is readily determinable from such operative transaction agreement, (i) the valuation
of marketable securities shall be deemed to be the average of the closing prices of the securities on such exchange or market
over the thirty (30) day period ending three days prior to the closing of such transaction, and (ii) the valuation of non-marketable
securities shall be determined in good faith by the Board of Directors of the Awardee or, if such determination is objected to
by CFF in writing within twenty (20) business days after CFF receives written notice thereof from the Awardee, by an independent,
neutral third party appraiser agreed upon by the Awardee and CFF. The cost of such appraiser shall be borne by CFF or, if such
appraiser’s determination of such valuation is equal to or greater than one hundred ten percent (110%) of the valuation
determined by the Awardee’s Board of Directors, by the Awardee.


 


(h)
“Commercially Reasonable Efforts” shall mean the level of effort, expertise and resources that is substantially
and materially consistent with industry standards for companies of similar size and financial resources to research, develop and
commercialize a Product where such research, development and commercialization is technically feasible, devoting the same degree
of attention and diligence to such efforts that is substantially and materially consistent with industry standards for products
at a comparable stage in development (with similar market potential, and taking into account, without limitation, issues of safety
and efficacy, proprietary position, the competitive environment, the regulatory environment, and other relevant scientific, technical
and commercial factors) for companies of similar size and financial resources.


 


(i)
“Development Program Technology” means all technology first created or conceived in whole, or developed directly
or indirectly, as a result of the Development Program and owned or controlled by Awardee, excluding without limitation any Awardee
Background IP.


 


(j)
“Field” shall mean the treatment of pulmonary non-tubercular mycobacteria (NTM) infections and other pulmonary
disease.


 


(k)
“Interruption” means the cessation for more than one hundred eighty (180) consecutive days of Commercially
Reasonable Efforts to develop a Product at any time before the first commercial sale of a Product, or to commercialize a Product
following regulatory approval of a Product for sale for human therapeutic use. Notwithstanding the foregoing, delays resulting
from events outside of the Awardee’s reasonable control (e.g., technical difficulties, shortages of supplies or materials,
delays in preclinical or clinical studies or regulatory processes, etc.) or Force Majeure will not be deemed cessation of the
use of Commercially Reasonable Efforts.


 


(l)
“License” means (a) the grant of rights to a third party that includes a license to the Development Program
Technology in the Field, or (b) the grant of distribution or marketing rights to a third party with respect to a Product.


 




    	-11-



     


    

 


(m)
“License Revenue” means all revenues and other consideration paid to the Awardee or to an Affiliate in consideration
of a License. Without limiting the generality of the foregoing, License Revenue shall include, without limitation all upfront
fees, license fees, milestone payments, technology access fees, premiums above the fair market value on sales of debt or equity
securities of the Awardee or of an Affiliate, annual maintenance fees, and any other payments to the extent, in each case, received
as consideration for the Awardee’s or its Affiliate’s grant of such license, distribution or marketing rights. Notwithstanding
the foregoing, License Revenue shall exclude: (i) payments for debt or equity securities of the Awardee or an Affiliate thereof
to the extent equal to or less than the fair market value of such securities as of the date of receipt of such payments as determined
in good faith by the Awardee’s Board of Directors; (ii) reimbursements or advances for any actual costs of patent preparation,
filing, prosecution, maintenance, or defense incurred by the Awardee or its Affiliates with respect to the Development Program
Technology or any other patent rights to which rights are granted to the applicable licensee; and (iii) payments made by a licensee
as consideration for the Awardee’s or an Affiliate’s performance of services. The valuation of any securities or other
property shall be determined by reference to the operative transaction agreement, provided that if no such valuation is readily
determinable from such operative transaction agreement, (i) the valuation of marketable securities shall be deemed to be the average
of the closing prices of the securities on such exchange or market over the thirty (30) day period ending three days prior to
the closing of such transaction, and (ii) the valuation of non-marketable securities shall be determined in good faith by the
Board of Directors of the Awardee or, if such determination is objected to by CFF in writing within twenty (20) business days
after CFF receives written notice thereof from the Awardee, by an independent, neutral third party appraiser agreed upon by the
Awardee and CFF. The cost of such appraiser shall be borne by CFF or, if such appraiser’s determination of such valuation
is equal to or greater than one hundred ten percent (110%) of the valuation determined by the Awardee’s Board of Directors,
by the Awardee.


 


(n)
“Net Sales” means, for any period, the gross amount invoiced for sales of the Product by the Awardee or any
Affiliate, licensee, sublicensee or transferee, as applicable (a “Selling Person”), to a non-Affiliate of such
Selling Person, less the following deductions, in each case to the extent specifically related to the Product and taken by the
Selling Person or otherwise paid for or accrued by the Selling Person (“Permitted Deductions”): (a) normal
and customary trade, quantity, cash and/or other discounts, rebates, and sales returns and allowances, including (i) those granted
on account of price adjustments (including retroactive price adjustments), billing errors, rejected goods, damaged goods, returns
and rebates, (ii) administrative and other fees including inventory management fees and reimbursements and similar payments to
wholesalers and other distributors, buying groups, pharmacy benefit management organizations, health care insurance carriers and
other institutions, (iii) allowances, rebates and fees paid to distributors and (iv) chargebacks; (b) customs, excise, import,
or export duties, tariffs, or similar payments; (c) rebates, chargebacks, and similar payments made with respect to sales paid
for by any governmental or regulatory authority; (d) sales, value added, consumption, use, or similar taxes directly related to
the sale, transfer, purchase, or delivery of the Product (but not including taxes assessed against the income derived from such
sale, transfer, purchase, or delivery or similar taxes); (e) the cost of freight, postage, shipping, insurance, and special packaging;
and (f) bad debt or uncollectible amounts . Notwithstanding anything to the contrary, Net Sales shall not include, and shall be
deemed zero with respect to, (i) Products sold, supplied, or distributed for promotional use and (ii) Products sold, supplied,
or distributed for research, development, clinical trials, compassionate use, or charitable purposes.


 


In
the case of any sale or other disposal of a Product between or among the Selling Persons for resale, Net Sales shall be calculated
as above only on the value charged or invoiced on the first arm’s-length sale thereafter to a third party; provided that
any subsequent sale of the Product (or any product produced or manufactured using the Product) by a Selling Person to a non-Affiliate
of such Selling Person shall be included in Net Sales. In the case of any sale which is not invoiced or is delivered before invoice,
Net Sales shall be calculated at the time the Product is paid for. In the case of any sale or other disposal for value, such as
barter or counter-trade, of any Product, or part thereof, other than in an arm’s length transaction exclusively for money,
Net Sales shall be calculated as above on the fair market value of the consideration received.


 


(o)
“Product” means MAT2501 and its formulations and derivatives, and any other oral amikacin developed in whole
or in part as a result of the Development Program.


 


(p)
“Royalty Cap” means an amount equal to five (5) times the amount of the Actual Award.


 


[Remainder
of this page intentionally left blank.]


 




    	-12-



     


    

 


In
witness whereof, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the dates
set forth below.


 


Cystic
Fibrosis Foundation


 


	By:	                            	 	 
	Name:	 	 	 
	Title:	 	 	 
	Date:	 	 	 
	 	 	 	 
	Awardee	 	 
	Matinas
    BioPharma Nanotechnologies, Inc.	 	 
	 	 	 	 
	By:	 	 	 
	Name:	 	 	 
	Title:	 	 	 
	Date:	 	 	 


 




    	-13-



     


    

 


Exhibit
A


 


Development
Program Plan


 


[***]


 




    	Exhibit A-1



     


    

 


Exhibit
B


 


Payment
Schedule


 


Award
payments will be made based on the following schedule:


 


	Milestone Payment Number	 	Development Program Milestone	 	Milestone Payment	 	Estimated Milestone Completion Date
	1.	 	Agreement execution	 	$	650,000	 	 	The date hereof
	2.	 	[***]	 	$	[***]	 	 	[***]
	3.	 	[***]	 	$	[***]	 	 	[***]
	4.	 	[***]	 	$	[***]	 	 	[***]
	5.	 	[***]	 	$	[***]	 	 	[***]



 


Upon
the achievement of each Development Program Milestone, the Awardee shall prepare a report (each, a “Milestone Report”)
that includes: description of the work, summary data generated, interpretation of the data, and progress toward achieving the
goals of the Development Program.


 


The
Awardee shall submit an invoice and a corresponding Milestone Report within one month after achievement of each Development Program
Milestone. Milestone Reports will be reviewed by the CFF Program Officer responsible for this Agreement.


 


Milestone
payments will be made by CFF within forty-five (45) days of:


 


	 	1.	Receipt
    from the Awardee of a dated invoice, identifying Milestone Payment Number and corresponding Development Program Milestone;
	 	2.	Receipt
    from the Awardee of a written Milestone Report for the applicable Milestone Payment; and
	 	3.	Approval,
    by the responsible CFF Program Officer, of the Milestone Report.


 


All
reports and documents must be submitted electronically to: grants@CFF.org


 




    	Exhibit B-1