Exhibit 10.1


 


[*] Certain information in this document
has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly
disclosed.


 


SPONSORED RESEARCH AGREEMENT


 


This
Sponsored Research Agreement (“Agreement”) is effective as of the last date of signature on the signature page
below (“Effective Date”) by and between the University of Maryland, Baltimore (“UMB”),
a public university of the State of Maryland, having offices at 620 West Lexington Street, 4th floor, Baltimore, Maryland
21201, and Silo Pharma, Inc., a Delaware corporation with its principal place of business at 560 Sylvan Ave, Suite 3160, Englewood
Cliffs, New Jersey 078632 (“Sponsor”).


 


ARTICLE 1 - BACKGROUND


 


1.1 Sponsor
desires the research assistance of persons employed by UMB who have access to UMB facilities and equipment. Accordingly, Sponsor
agrees to fund research entitled “A novel peptide-guided drug delivery approach for the treatment of multiple sclerosis”
and described in the protocol attached as Exhibit A, to be performed by UMB Personnel (defined below).


 


1.2 UMB
and Sponsor entered into a Commercial Evaluation License and Option Agreement as of July 15, 2020 (“CELA)”, regarding
UMB’s inventions generally known as “Central nervous system-homing peptides in vivo and their use for the investigation
and treatment of multiple sclerosis and other neuroinflammatory pathology” made by Kamal Moudgil, MD, PhD, and Bodhraj
Acharya, PhD, both employees of UMB.


 


1.3 UMB
has determined that the research is consistent with its education, research, and public service missions, and is willing to furnish
the research services of UMB Personnel as described in Exhibit A upon the terms and conditions of this Agreement.


 


ARTICLE 2 - DEFINITIONS


 


In this Agreement, the following terms are
defined as stated:


 


2.1 “Arising
IP”: Any invention, discovery, or improvement (whether or not patentable) and any copyrightable work which is made, conceived,
developed, invented, or discovered during and directly in the course of performing the Project Work.


 


2.2 “Confidential
Information”: Information (including without limitation, documents, notes, drawings, models, designs, data, results,
memoranda, tapes, records, hardware, software, formulae, algorithms, standard operating procedures, strategic business plans, product
forecasts, communications with government entities, financial information, pricing information, personnel information, and other
commercially sensitive or proprietary information or materials (in hard copy form or in electronic form), which is disclosed by
a party to the other party in connection with this Agreement.


 






    1  


     


    

  


2.3 “Project
Work”: The scope of work as described in Exhibit A to be undertaken by UMB, or by UMB and Sponsor, under this
Agreement, and any amendments to Exhibit A made in accordance with Section 17.3.


 


2.4 “Results”:
Data and results which are generated during and directly in the course of performing the Project Work.


 


2.5 “Sponsor
Affiliate”: Any person or entity that controls, is controlled by, or is under common control with Sponsor. For the purposes
of this definition, the term “control” (including, with correlative meanings, the terms “controlled by”
and “under common control with”) means the ownership, directly or indirectly, whether through one or more intermediaries,
of fifty percent (50%) or more of the equity securities entitled to vote in the election of directors (or, in the case of an entity
that is not a corporation, for the election of the corresponding managing authority).


 


2.6 “UMB
Personnel”: The following individuals to the extent that they use UMB resources and are subject to UMB intellectual
property policies (including any prior or future policy): The PI; UMB faculty members; research fellows; students; technicians;
scientists; trainees; and/or other individuals working under the supervision or direction of the PI on the Project Work. “UMB
Personnel” will also include independent contractors, consultants, agents, and representatives of UMB, when those individuals
are acting in those capacities. 


 


2.7 “UMB
Related Organization”: University System of Maryland, any constituent institution of University System of Maryland, University
of Maryland Medical System, the faculty practice organizations of UMB, and the Baltimore Veterans Administration Medical Center.


 


ARTICLE 3 - PROJECT WORK


 


3.1 UMB
agrees to commence performance of the Project Work promptly after the Effective Date of this Agreement, and will undertake to perform
the Project Work substantially in accordance with the terms and conditions of this Agreement. Sponsor and UMB may amend the Project
Work at any time in accordance with Section 17.3. Each party will work diligently and in good faith to accomplish the goals
and objectives of this Agreement. Any modification to the Project Work will be executed in writing by the duly authorized representative
of each Party and will thereafter, as amended or modified, be incorporated into this Agreement by reference.


 


3.2 The
Principal Investigator (“PI”) for the Project Work is Kamal Moudgil, MD, PhD, an employee of UMB. The Project
Work will be supervised by the PI. If for any reason the PI is unwilling or unable to continue to serve, UMB will notify Sponsor
promptly, and UMB will endeavor to find an acceptable replacement. If a substitute PI acceptable to both UMB and Sponsor is not
appointed within sixty (60) days, this Agreement may be terminated by either party in accordance with Section 8.2 below.


 


ARTICLE 4 - REPORTS AND CONFERENCES


 


4.1 Written
progress reports will be provided by UMB to Sponsor as specific phases of work are completed. A final report will be submitted
by UMB within ninety (90) days after the expiration or termination of this Agreement.


 






    2  


     


    

  


4.2 If
necessary during the Term, UMB Personnel may meet with representatives of Sponsor at times and places mutually agreed upon to discuss
the progress and results of the Project Work, as well as ongoing plans, or any changes in the Project Work. To the extent consistent
with UMB policy, Sponsor shall reimburse UMB for travel costs associated with these meetings for the PI and other UMB Personnel
invited to the meetings with Sponsor’s approval if such costs have not been included in the approved budget.


 


ARTICLE 5 - COST, BILLINGS, AND OTHER
SUPPORT


 


5.1 Subject
to modifications in the Project Work, the total costs to Sponsor under this Agreement shall not exceed the sum of $[*]. These costs
will be allocated by UMB generally in accordance with the budget incorporated in Exhibit B.


 


5.2 Sponsor
shall make payments to UMB in U.S. Dollars within thirty (30) days upon Sponsor’s receipt of an invoice, as set forth on
Exhibit C.


 


5.3 Sponsor
agrees that it will not make any incentive payments to UMB Personnel or otherwise compensate individual UMB Personnel for their
involvement in performing the Study.


 


5.4 Any
dispute of an invoice must be made to UMB in writing and within thirty (30) days of receipt of said invoice.


 


5.5 Any
balance outstanding forty five (45) days after the date payment was due shall bear interest at the rate of one and a half percent
(1.5%) monthly on the unpaid amount. Such interest to begin accruing on the thirty first (31st) day after the date the payment
was due. Further, any payment which is uncontested and not paid in full within 180 days after the date payment was due shall be
turned over to the State Central Collection Unit (SCCU), which shall result in an additional seventeen percent (17%) collection
fee, plus any legal fees required, to be added to the amount due and becoming immediately due and payable.


 


ARTICLE 6 - RESULTS AND PUBLICATIONS


 


6.1 All
Results will be owned by UMB. Until UMB publishes the Results pursuant to this Article 6 (but not later than twenty four
(24) months after the completion of the Project Work): (a) Sponsor shall treat the unpublished Results as UMB’s Confidential
Information; and (b) Sponsor may use the unpublished Results only for internal research purposes. Following publication of any
Results, Sponsor may use any such published Results for any purpose (but the restrictions of the preceding sentence shall continue
to apply to any unpublished Results until the expiration of the twenty four month period).


 


6.2 
Sponsor acknowledges that UMB and UMB Personnel have an interest in publishing the Results. Notwithstanding anything herein to
the contrary, but subject to the provisions of this Article 6, UMB and UMB Personnel may present the Results at symposia
and other professional meetings, and publish the Results in journals, theses, dissertations, or other publications or presentations
of their own choosing.


 


6.3 UMB
shall forward a copy of the proposed publication to Sponsor thirty (30) days in advance of the planned publication date. Sponsor
will treat the copy of the proposed publication as UMB’s Confidential Information. Sponsor’s review of the proposed
publication and its rights regarding the proposed publication will be limited to the following:


 






    3  


     


    




 


(a) If Sponsor
determines reasonably and in good faith that the proposed publication contains Sponsor’s Confidential Information, Sponsor
will promptly identify such information to UMB. UMB Personnel will delete such information from the publication as reasonably requested
by Sponsor, and publication may be delayed for a maximum of thirty (30) days for that purpose.


 


(b) If Sponsor
determines reasonably and in good faith that there is patentable subject matter contained in the proposed publication, Sponsor
will promptly identify such subject matter to UMB. If Sponsor reasonably requests a delay in order to file patent applications
or otherwise to protect its intellectual property, the publication may be delayed for a maximum of ninety (90) days for that purpose.


 


6.4 Following
publication by UMB Personnel or UMB, Sponsor may freely publish, reproduce, and use any such publication to the extent that any
such use is consistent with 17 U.S.C. §107.


 


ARTICLE 7 - INTELLECTUAL PROPERTY


 


7.1 Each
party owns and will continue to own its intellectual property that: (a) exists prior to the Effective Date of this Agreement; or
(b) that is made, conceived, developed, invented, or discovered after the Effective Date of this Agreement but not during and directly
in the course of performing the Project Work (“Background IP”). Neither party has or will have any right, title,
or interest in the other party’s Background IP; provided however, that each party shall have certain rights in the
other party’s Background IP as provided in the CELA. Sponsor’s Background IP is listed in Exhibit D. UMB’s Background
IP is listed in Exhibit E. However, Sponsor hereby grants to UMB a royalty-free, non-exclusive, non-assignable, and non-transferrable
license to use Sponsor’s Background IP during the term of this Agreement for the sole purpose of performing the Project Work,
or as otherwise permitted by this Agreement. Each of the parties will hold in confidence any Background IP of the other party which
is included in any Results.


 


7.2  
If UMB and Sponsor execute a master license agreement to UMB Background IP prior to the expiration or termination of the Agreement,
the terms of the master license agreement will supersede.


 


7.3  Sponsor
will own all right, title and interest in and to any Arising IP that is invented, discovered, or made solely by employees or agents
of Sponsor and does not incorporate any UMB Background IP (“Sponsor Arising IP”). UMB will own all right, title
and interest in and to any Arising IP that is invented, discovered, or made solely by UMB Personnel, or by persons otherwise under
an obligation to assign to UMB (“UMB Arising IP”). UMB and Sponsor will jointly own any Arising IP which is
invented, discovered, or made by one or more UMB Personnel (or by persons otherwise under an obligation to assign to UMB) and one
or more employees or agents of Sponsor (“Joint Arising IP”).


 






    4  


     


    

 





7.4 UMB
will report promptly to Sponsor in writing all UMB Arising IP or Joint Arising IP that is disclosed to UMB’s Office of Technology
Transfer or its successor during the term of this Agreement. Sponsor will hold in confidence these reports from UMB.


 


7.5 UMB
hereby grants to Sponsor an option to negotiate and obtain an exclusive license to any UMB Arising IP and UMB’s rights in
any Joint Arising IP (the “Option”), provided that there are no uncured defaults or material breaches by Sponsor
of this Agreement. The Option (and the license to be granted upon exercise of the Option) is subject to the provisions of 35 U.S.C.
§§ 201 et seq. and all implementing regulations,
if applicable (“Federal IP Policy”), and UMB’s agreements with third parties. 


 


7.6 Sponsor
may exercise the Option by giving written notice to UMB within sixty (60) days after Sponsor receives notice from UMB of the relevant
UMB Arising IP or Joint Arising IP. Before receiving such a license, Sponsor must outline its capability and plans to develop and
commercialize products that use the relevant Arising IP, which must be acceptable to UMB in its reasonable discretion. Promptly
following UMB’s receipt of Sponsor’s notice of exercise, the parties will negotiate in good faith for a period of ninety
(90) days (the “Negotiation Period”) the terms of a master license agreement.


 


7.7 The
master license agreement will contain terms and conditions customary to technology licenses normally granted by UMB, including
without limitation terms consistent with the provisions of Federal IP Policy, if applicable; a reservation of the rights of UMB
to practice and to grant other not-for-profit organizations the right to practice the relevant Arising IP for research, teaching
and other educational purposes, and to publish; license fees; royalty payments; milestone payments; reimbursement of patent expenses;
commercially reasonable due diligence obligations; liability limitations; and indemnity and insurance provisions for the benefit
of UMB and UMB Related Organizations.


 


7.8 If
the parties are not able to resolve any differences regarding the master license agreement within the Negotiation Period, the parties
will utilize the dispute resolution process set forth in Article 16 to resolve, to the extent reasonably possible, such
differences. Subject to any such dispute resolution, if the parties have not executed a master license agreement before the end
of the Negotiation Period, Sponsor will thereafter have no rights with respect to the relevant Arising IP, and UMB may license
all or a portion of such relevant Arising IP to one or more third parties.


 


7.9 For
purposes of this Agreement, inventorship or authorship of any Arising IP shall be determined solely in accordance with U.S. intellectual
property law, notwithstanding that the laws of other countries where patent, trademark, or copyright applications are filed may
differ from U.S. intellectual property law.


 


ARTICLE 8 - TERM AND TERMINATION


 


8.1 The
term of this Agreement commences as of the Effective Date and the Project Work shall commence on March 1, 2021 and will continue
until the substantial completion of the Project Work (the “Term”), subject to renewal upon mutual written consent
of the parties.


 






    5  


     


    

  


8.2 Either
party may terminate this Agreement upon thirty (30) days’ prior written notice to the other party, subject to Section
8.4 below.


 


8.3 In
addition, if either party commits any material breach of or default in any of the terms or conditions of this Agreement, and fails
to remedy that default or breach within ten (10) business days after receipt of written notice from the other party, the party
giving notice may, in its sole but reasonable discretion and in addition to any other remedies which it may have at law or in equity,
terminate this Agreement by sending written notice of termination to the other party to that effect, and such termination will
be effective as of the date of the receipt of that notice.


 


8.4 If
Sponsor terminates this Agreement for any reason other than an uncured material breach by UMB, Sponsor shall relinquish any and
all rights it may have in the Results to UMB.


 


8.5 If
this Agreement is terminated early, Sponsor will pay all costs accrued by UMB as of the effective date of termination and any costs
incurred by UMB as a result of termination. In addition, Sponsor will reimburse UMB for non-cancellable obligations called for
by the Project Work and incurred prior to the effective date of termination.


 


8.6 Expiration
or termination of this Agreement does not relieve either party of any obligation for payment or reporting which arises before expiration
or termination including obligations under Articles 4, 5, and 7. Any provision of this Agreement which contemplates
performance or observance subsequent to any termination or expiration of this Agreement shall survive any termination or expiration
of this Agreement and continue in full force and effect, including without limitation Articles
6, 7, 9, 10, 13, 14, and 17


 


ARTICLE 9 - INDEMNIFICATION AND INSURANCE


 


9.1 UMB
and its officers and employees acting within the scope of their employment by UMB are subject to the Maryland Tort Claims Act,
Title 12, Subtitle 1, State Government Article, Annotated Code of Maryland, which permits, under certain circumstances and subject
to limitations provided by law, claims in tort against the State of Maryland related to negligence of UMB employees. In order to
file a claim under the Act, a claimant must submit a written claim to the Treasurer of the State of Maryland or a designee of that
office within one year after the injury to the person or property that is the basis of the claim.


 


9.2 Sponsor
warrants that it maintains a policy or program of insurance or self-insurance at levels sufficient to support the indemnification
obligations assumed herein. A certificate evidencing such coverage will be delivered to UMB upon request.


 


9.3 Sponsor
shall defend, indemnify, and hold harmless UMB, UMB Personnel, UMB Related Organizations, and the State of Maryland, and their
respective regents, officers, employees, students, subcontractors, and agents (each individually a “UMB Party”)
against any claim, liability, cost, damage, deficiency, loss, expense or obligation of any kind or nature (including without limitation
reasonable attorneys’ fees, expert witness fees, court costs and other costs and expenses of litigation at trial and appellate
levels) incurred by or imposed upon any UMB Party in connection with any claims, suits, actions, demands or judgments arising directly
or indirectly from (a) Sponsor’s use or reporting of the Results; (b) use of any material or equipment provided by Sponsor
resulting in a claim of patent infringement or violation of proprietary rights against a UMB Party; and/or (c) Sponsor’s
negligence, intentional misconduct, or breach of this Agreement, or that by any Sponsor employee or agent.


 






    6  


     


    

  


9.4 The
agreement to defend, indemnify, and hold harmless a UMB Party is conditioned upon: (a) the UMB Party or UMB promptly notifying
Sponsor in writing after the UMB Party receives notice of any claim; provided, however, the failure to so notify
Sponsor will not relieve Sponsor of any obligation which it may have to a UMB Party under this Agreement or otherwise, to the extent
that such failure or delay does not actually and materially prejudice Sponsor;
and (b) the UMB Party cooperating with Sponsor in the defense of the claim (but at Sponsor’s expense). The agreement to defend,
indemnify, and hold harmless a UMB Party will not apply to the extent that the claim, cost, or liability was solely caused by the
negligence or intentional misconduct of that UMB Party. Notwithstanding the foregoing, each UMB Party will have the right to participate
at its own expense in the defense of any claims through counsel of its own choosing. Sponsor will not settle any claim in any manner
that affects a UMB Party’s rights without that UMB Party’s prior written consent, which will not be unreasonably withheld,
conditioned, or delayed.


 


9.5 UMB
and Sponsor further agree that nothing in this Agreement will be interpreted as: (a) a denial to either party of any remedy or
defense available to it under the laws of the State of Maryland; (b) the consent of the State of Maryland or its agents, agencies,
or instrumentalities to be sued; or (c) a waiver of sovereign immunity or any other governmental immunity of the State of Maryland
and UMB beyond the extent of any waiver provided by law.


 


ARTICLE 10 – CONFIDENTIALITY


 


Any Confidential Information
shall be subject to the terms of Exhibit F.


 


ARTICLE 11 - PUBLICITY


 


11.1 Neither
Sponsor nor UMB will use the name, seal, logo, trademark, or service mark of the other or the name of any employee, student, or
Affiliate (or in the case of UMB, UMB Related Organization) of the other, or any adaptation thereof, in any advertising, promotional,
or sales literature without obtaining the prior written consent from the other party (and such consent will not be unreasonably
withheld), individual, affiliate or organization, as the case may be, except that consent will not be required where a disclosure
is required by applicable law or regulation. 


 


11.2 Each
party may publicize the fact that the parties have entered into this Agreement in its business development documentation and/or
its website. However, press releases or other public releases of information will be approved in writing by the parties prior to
release, except where that disclosure is required by applicable law or regulation.


 


11.3 UMB
does not directly or indirectly endorse any product or service provided or to be provided by Sponsor, its successors, assigns,
or sublicensees by entering into this Agreement or otherwise. Sponsor shall not in any way advertise, publicize, or imply that
UMB endorses any of those products or services.


 






    7  


     


    

 





ARTICLE 12 - NOTICES


 


All notices, consents
and other communications required or allowed under this Agreement must be in writing and are effective upon receipt: (a) when delivered
by hand with proof of delivery; or (b) when received by the addressee after being mailed by registered or certified mail (air mail
if mailed overseas), return receipt requested; or (c) when received by the addressee by express delivery service (return receipt
requested), in each case addressed to the party at its address set forth below (or to another address that a party may later designate
by notice to the other party):


 


	 	If to UMB:	Associate Vice President, CCT
	 	 	Office of Research and Development
	 	 	University of Maryland, Baltimore
	 	 	620 West Lexington Street, 4th floor
	 	 	Baltimore, Maryland 21201-1508
	 	 	 
	 	Copy to:	University Counsel
	 	 	University of Maryland, Baltimore
	 	 	220 Arch Street, Room 03-111
	 	 	Baltimore, Maryland 21201-1531
	 	 	 
	 	If to Sponsor:	Eric Weisblum, CEO
	 	 	Silo Pharma, Inc.
	 	 	560 Sylvan Avenue, Suite 3160
	 	 	Englewood Cliffs, NJ  07632 
	 	 	 
	 	Copy to:	Richard A Friedman, Esq.
	 	 	Sheppard Mullin
	 	 	30 Rockefeller Plaza
	 	 	New York, NY  10112-0015





 


ARTICLE 13 - FEDERAL REQUIREMENTS


 


13.1 The
use and disclosure of technical information acquired pursuant to this Agreement and the use of patent rights under any licenses
granted under the terms of this Agreement are subject to the export, assets, and financial control regulations of the United States
of America, including, but not limited to, restrictions under regulations of the United States that may be applicable to direct
or indirect re-exportation of such technical information or of equipment, products, or services directly produced by use of such
technical information. Sponsor is responsible for taking any steps necessary to comply with such regulations.


 


13.2 If Arising
IP is made with equipment or facilities funded in whole or in part by agencies of the United States government or embody or are
dependent upon background intellectual property funded in whole or in part by agencies of the United States government, products
of Sponsor for use or sale in the United States that embody Arising IP or are produced through the use of Arising IP shall be manufactured
substantially in the United States. 


 






    8  


     


    

 





ARTICLE 14 - STATE REQUIREMENTS


 


14.1 Sponsor
will not knowingly employ or compensate, directly or indirectly, any UMB Personnel working on matters related to the Project Work
or involved in negotiating this Agreement on behalf of UMB, during employment by UMB or for two (2) years thereafter, unless consented
in writing by UMB’s President (or his/her designee); provided, however, that nothing in this Section 14.1 will prohibit
Sponsor from hiring any UMB Personnel who respond to general employment solicitation not targeted at UMB Personnel, including general
advertisement. “Compensation” includes without limitation: stock option or stock purchase agreements, consulting agreements,
any other form of agreement, and cash payments. “Employment” includes both uncompensated and compensated service. The
Maryland Public Ethics Law (Title 5, General Provisions Article, Annotated Code of Maryland) may apply to a decision by the UMB
President in regard to the matter.


 


14.2 This
Article 14 is not intended to prevent UMB Personnel from (a) serving on Sponsor’s scientific advisory board; (b) conducting
the Project Work or performing research pursuant to a sponsored research agreement between Sponsor and UMB; or (c) serving as a
consultant to or performing any work for Sponsor for a fee. However, all of those cases are subject to and contingent upon compliance
with the conflict of interest and other provisions of the Maryland Public Ethics Law, and with applicable policies and procedures
of University System of Maryland and UMB, including without limitation those regarding consulting arrangements.


 


14.3 During
the Term, UMB will not knowingly employ or compensate, directly or indirectly, any officers, directors, and employees of Sponsor
working on matters related to the Project Work or involved in negotiating this Agreement on behalf of Sponsor, during employment
by Sponsor or for two (2) years thereafter, unless consented in writing by Sponsor; provided, however, that nothing in this Article
14 will prohibit UMB from hiring any officer, director, or employee of Sponsor who responds to general employment solicitation
not targeted at him or her, including general advertisement.


 


ARTICLE 15 - INTEGRATION AND SEVERABILITY


 


15.1 This
Agreement, together with any Exhibits specifically referenced and attached, embodies the entire understanding between Sponsor and
UMB. There are no contracts, understandings, conditions, warranties or representations, oral or written, express or implied, with
reference to the subject matter of this Agreement that are not merged in this Agreement.


 


15.2 If
any condition or provision in this Agreement is held to be unenforceable by a court of competent jurisdiction, then that condition
or provision will be modified to the minimum extent necessary to make it enforceable, unless that modification is not permitted
by law, in which case the condition or provision will be disregarded. If an unenforceable condition or provision is modified or
disregarded in accordance with this Section, then the rest of the Agreement will remain in effect as written.


 


ARTICLE 16 - DISPUTE RESOLUTION


 


16.1 If
a dispute between the parties related to this Agreement arises, either party, by notice to the other party, may have the dispute
referred to the parties’ respective officers designated below, or their successors, for attempted resolution by good faith
negotiations within thirty (30) days after the notice is received. The designated officers are as follows:


 


For Sponsor: CEO


For UMB: Chief Enterprise
and Economic Development Officer and Vice President


 






    9  


     


    

 





16.2 If
the designated officers are not able to resolve the dispute within this thirty (30) day period, or any agreed extension, they will
confer in good faith with respect to the possibility of resolving the matter through mediation with a mutually acceptable third
party or a national mediation organization. If the parties agree to attempt to resolve the matter through mediation, they will
participate in any mediation sessions in good faith in an effort to resolve the dispute in an informal and inexpensive manner.
All expenses of the mediator will be shared equally by the parties.


 


16.3 Any
applicable statute of limitations will be tolled during the pendency of a dispute resolution procedure initiated under this Agreement.
Evidence of anything said or any admission made in the course of any dispute resolution procedure will not be admissible in evidence
in any civil action between the parties. In addition, no document prepared for the purpose of, or in the course of, or pursuant
to, the dispute resolution procedure, or copy thereof, will be admissible in evidence in any civil action between the parties.
However, the admissibility of evidence will not be limited if all parties who participated in the dispute resolution procedure
consent to disclosure of the evidence.


 


16.4 With
respect to any dispute that is not resolved pursuant to other provisions of this Article 16, each party consents to the
jurisdiction of the Circuit Court of Baltimore City or Anne Arundel County, Maryland for any suit against the other party relating
to this Agreement, and agrees to file any such suit in one of those courts. THE PARTIES WAIVE THEIR RIGHTS TO TRIAL BY JURY IN
ANY LITIGATION BETWEEN THEM RELATING TO THIS AGREEMENT.


 


16.5 No
provision of this Agreement will constitute or be construed as a limitation, abrogation, or waiver of any defense or limitation
of liability available to the State of Maryland or its units (including without limitation USM and UMB), officials, or employees
under Maryland or Federal law, including without limitation the defense of sovereign immunity or any other governmental immunity.


 


16.6 LIMITATION
OF LIABILITY. NO PARTY WILL BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE OR INCIDENTAL DAMAGES
(INCLUDING LOST OR ANTICIPATED REVENUES OR PROFITS RELATING TO THE SAME), ARISING FROM ANY CLAIM RELATING TO THIS AGREEMENT, WHETHER
SUCH CLAIM IS BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EVEN IF A DULY AUTHORIZED REPRESENTATIVE OF SUCH PARTY
IS ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME.


 






    10  


     


    

 


ARTICLE 17 - MISCELLANEOUS


 


17.1 This
Agreement is made and will be construed in accordance with the laws of the State of Maryland without regard to the principles of
conflicts of laws.


 


17.2 Neither
party may assign this Agreement in whole or in part without the prior written consent of the other party, which consent shall not
be unreasonably withheld. Any assignment in violation of this Agreement shall be null and void.


 


17.3 This
Agreement, including Exhibits, may not be amended, nor may any right or remedy of either party be waived, unless the amendment
or waiver is in writing and signed by a duly authorized representative of each party.


 


17.4 Neither
party is liable for failure or delay in performing any of its obligations under this Agreement if the failure or delay is required
in order to comply with any governmental regulation, request or order, or necessitated by other circumstances beyond the reasonable
control of the party so failing or delaying, including but not limited to Acts of God, war (declared or undeclared), insurrection,
fire, flood, accident, labor strikes, work stoppage or slowdown (whether or not such labor event is within the reasonable control
of the parties), or inability to obtain raw materials, supplies, power or equipment necessary to enable a party to perform its
obligations. Each party shall: (a) promptly notify the other party in writing of an event of force majeure, the expected duration
of the event and its anticipated effect on the ability of the party to perform its obligations; and (b) make reasonable efforts
to remedy the event of force majeure.


 


17.5 UMB
and Sponsor are not (and nothing in this Agreement may be construed to constitute them as) partners, joint venturers, agents, representatives,
or employees of the other, nor is there any status or relationship between them other than that of independent contractors. Neither
party has any responsibility nor liability for the actions of the other party except as specifically provided in this Agreement.
Neither party has any right or authority to bind or obligate the other party in any manner or make any representation or warranty
on behalf of the other party.


 


17.6 This
Agreement is not intended to create, and does not create, enforceable legal rights as a third party beneficiary or through any
other legal theory on the part of any UMB Personnel or any other person except as expressly provided within this Agreement.


 


17.7 This
Agreement may be signed in duplicate originals. The headings used in this Agreement are for convenience of reference only and do
not affect the meaning or construction of this Agreement.


 


17.8 Each
party has participated in the negotiations and drafting for the Agreement. Therefore, in the event of any ambiguity in the wording
of this Agreement, the ambiguity shall not be construed against any particular party as the drafter of the ambiguous provision.


 


17.9  The
parties will execute and deliver and cause to be executed and delivered further agreements, instruments, and document and will
take further actions as may reasonably be required or appropriate to carry out the terms and conditions of this Agreement.


 


[Signature page follows]


 



    11  


     


    


 


SIGNATURE PAGE TO SPONSORED RESEARCH AGREEMENT


 








IN
WITNESS WHEREOF, each party has caused this Agreement to be executed
by its duly authorized representatives on the dates indicated below.


 


SILO
PHARMA, Inc. 


 





	By: 	/s/ Eric Weisblum	 
	Name: 	Eric Weisblum	 
	Title:  	Chief Executive Officer	 
	 	 	 
	Date:	_________	 
	 	 	 
	UNIVERSITY OF MARYLAND, BALTIMORE
	 	 	 
	By: 	/s/ Michael A. Rollor, Ph.D.	 
	 	Michael A. Rollor, Ph.D.	 
	 	Associate Vice President	 
	 	Center for Clinical Trials and Corporate Contracts	 
	 	 	 
	Date: 	_________	 
	 	 	 



 


I have reviewed the Agreement and Exhibits
and I understand and acknowledge the responsibilities of the Principal Investigator.


 





	/s/ Kamal Moudgil, MD, PhD	 
	Kamal Moudgil, MD, PhD	 
	Principal Investigator	 
	 	 	 
	Date: 	_________	 


 









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EXHIBIT A


PROJECT WORK 


 


 


Summary of proposed research Silo Pharma, Inc. , Attn: Eric
Weisblum, CEO


(prepared by Kamal Moudgil)


 


Title


 


A novel peptide-guided drug delivery approach for the treatment
of multiple sclerosis


 


Institution


 


University of Maryland, Baltimore


 


Principal Investigator


 


Kamal Moudgil, MD, PhD


Professor, Microbiology and Immunology


School of Medicine


University of Maryland, Baltimore


Baltimore, MD


 


Background


 


Multiple sclerosis (MS) is an autoimmune
disease affecting the central nervous system (CNS). Inflammation and demyelination of neurons resulting from a self-directed immune
attack leads to muscle weakness and paralysis. Approximately 2.3 million people globally are affected with MS, of which about 1
million reside in the U.S. 1-3. Many patients manifest a relapsing-remitting pattern of clinical signs and symptoms.
Uncontrolled disease can result in severe disability. Despite the availability of several drugs, many MS patients do not respond
well to them. In addition, these drugs have many side effects 3-5. Thus, there is an urgent need to develop more efficient
drug delivery approaches with the purpose of increasing efficacy but reducing adverse effects of these drugs. The currently used
drugs are taken orally or given by injection. Therefore, several organs become unintended targets of those drugs that are primarily
intended to target the diseased tissue in the CNS. In that context, targeted drug delivery to the CNS might overcome many of the
limitations of current therapies 6,7. In a previous study, we reported the identification of a novel phage-encoded peptide
(denoted as MS-1) following phage peptide-display library screening of mice with experimental autoimmune encephalomyelitis (EAE),
a model of human MS8. When injected intravenously (iv) in mice with EAE, peptide MS-1 preferentially homed to inflamed
CNS. We believe that peptide MS-1 can serve as a guide to direct drugs into the CNS and thereby minimize or eliminate off-target
side effects. This will fill in an unmet need in MS therapy. There is a large global and local market for liposomal therapy of
MS.


 


Global market for MS/liposomal drugs


 


The global market for drugs for MS was
valued at USD 20 billion in 2019, and is projected to reach USD 31.5 billion by 2027 9. The liposome drug delivery market
is expected to reach US$ 6,992.95 million by 2027 from US$ 3,594.41 million in 2019, and the market is estimated to grow at a CAGR
of 8.8% from 2020 to 2027 10.


 



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Drug delivery vehicle


 


For targeted drug delivery, a drug for MS will be incorporated
within a nanoparticle, which displays a CNS-homing peptide (MS-1) on its surface. In addition, this nanoparticle will have polyethylene
glycol (PEG) on its surface to minimize the otherwise rapid clearance of the particles by the reticuloendothelial system. We propose
to use liposomes because this category of nanoparticles has already been approved by the Food and Drug Administration (FDA) for
use in cancer.


 


The disease model for human MS, EAE 


 


There are different models of EAE available for pre-clinical
studies on MS. We plan to use the relapsing-remitting disease model in SJL (H-2s) mice, which closely mimics the relapsing
nature of MS in humans. In this model, proteolipid protein (PLP), a neuronal antigen, is used for disease induction. PLP emulsified
in complete Freund’s adjuvant (CFA) is injected subcutaneously (s.c.). The onset of signs of EAE and disease progression,
including relapses and remissions, are graded on a standardized disease severity scale. Changes in clinical disease are then confirmed
by histopathological signs of demyelination in the brain and spinal cord.


 


Drugs to be tested


 


The main objective of our study is to critically assess whether
peptide MS-1 guided drug delivery is superior to plain liposomal drug delivery or free drug. As a proof-of-concept, we will consider
two different drugs, one that is commonly used in MS (e.g., dexamethasone)5 and the other that has potential (e.g.,
TGFβ2; transforming growth factor beta 2, a biologic) but its use was halted in the past because of poor bioavailability and
toxicity11,12. This approach will permit us to improve the therapeutic index of an otherwise widely used drug (dexamethasone),
as well as challenge our drug delivery system to improve the utility of a disadvantaged drug (TGFβ2).


 


Objective of the study


 


Using the EAE model, our goal is to evaluate whether MS-1-displaying
liposomes can effectively deliver dexamethasone to the CNS, and if it is superior to plain liposomes or free drug in inhibiting
the relapses and progression of EAE. Additionally, we aim to identify specific cell types within the CNS that are targeted by MS-1
peptide and MS-1-displaying liposomes.


 


Specific Aims


 


Aim 1- To test the peptide (MS-1)-guided drug delivery
system for its relative efficacy against relapsing disease in SJL mice compared with that of drug delivery via plain liposomes
or as unpackaged (free) drug. In addition, to monitor various pparameters of systemic toxicity (e.g., toxicity to the liver, kidney,
heart, and muscle) in experimental and control groups, and compare the efficacy versus safety profiles of the drug administered
via 3 different modalities.


 






    14  


     


    

  


Aim 2- To define the cell types within CNS (e.g., neurons,
astrocytes, glial cells, endothelial cells) that are targeted by peptide MS-1 and MS-1-displaying liposomes. This is important
for knowing how and where drug-carrying liposomes interact with the CNS tissue cells.


 


Experimental Plan


 


Aim 1. 


 


Expt. 1. Pre-clinical efficacy testing in EAE mice.
A cohort of SJL mice will be injected s.c. with PLP for EAE induction, which appears about d 10 after PLP injection. At the time
of onset of EAE, mice will be randomized into 3 sets of two groups each for treatment with dexamethasone administered in three
different formulations. A group of untreated EAE mice will serve as another control. The liposomes will be prepared as in our previous
study in arthritis 7.


 


(a) Set 1: MS-1-guided liposomal
dexamethasone delivery. Dexamethasone (Group 1) will be entrapped in liposomes. Liposomes containing vehicle only (Group 2)
will serve as a control. All these liposomes will display on their cell surface a CNS-homing peptide MS-1 as well as polyethylene
glycol (PEG); the latter to reduce their clearance by the reticuloendothelial system.


 


(b) Set 2: liposomes lacking
MS-1. Plain liposomes containing dexamethasone (Group 3) or vehicle (Group 4) will be prepared.


 


(c) Set 3: plain dexamethasone
(Group 5) or vehicle (Group 6). Set-3 will serve as controls for the other two sets.


 


The liposomes or free drug/vehicle will be injected intravenously
(iv) into EAE mice. One injection will be given at the time of EAE onset, with a second injection after 3 days, and a third injection
after another 3 days, coinciding with the peak phase of disease (about d16 after PLP injection). Throughout this period, the EAE
severity of mice will be graded in a blinded fashion.


 


Expt. 2. Histopathological and serological confirmation
of disease severity and/or toxicity. After 7-10 days of the third injection, all mice will be sacrificed, and various tissues
and sera collected will be tested as follows:


 


(i) Efficacy: the CNS tissue
(brain and spinal cord) will be histologically analyzed for signs of perivascular inflammation and demyelination for confirmation
of clinical observations.


 


(ii) Toxicity: the sera will
be tested for tissue enzymes/markers for toxicity to liver, kidney, pancreas, etc. 7.


 


(iii) Toxicity: the liver, spleen,
kidney, and heart will be examined by histology for necrosis or immune cell infiltrates.


 


Above plan is to assess the effect of dexamethasone treatment
on disease progression beginning from the onset phase. If needed, a similar plan will be followed for another group of mice in
which efficacy of drug delivery to suppress a relapse flare will be tested.


 


For TGFβ2, a similar plan will be followed as described
above for dexamethasone.


 


Milestone- Aim 1: We plan to have preliminary
data to assess the relative efficacy and toxicity of MS-1-guided drug delivery system compared with that of plain liposomes and
free drug.


 






    15  


     


    

 





Aim 2. 


 


The brain and spinal cord of EAE and control mice will be harvested
for two sets of experiments.


 


Expt 1. Cell-based study.
Isolation of different cell types (e.g., neurons, glial cells, endothelial cells), defining their identity by specific markers,
and testing the binding of fluorescence-labeled peptide MS-1 or control peptide using flow cytometry and confocal microscopy. A
similar approach will be used for testing the cellular binding specificity of MS-1-displaying liposomes.


 


Expt 2. Histological study. Examining the pattern
of binding of fluorescence-labeled MS-1 or control peptide to histological sections of the brain and spinal cord along with staining
for cell-type specific markers.


 


Milestone- Aim 2: We hope
to know the identity of specific cell types within the CNS that are preferentially targeted by MS-1 and MS-1-displaying liposomes.


 


TIMELINE (9 months)


 


Aim 1:


(i) Pre-clinical efficacy and toxicity of dexamethasone (0-6
months)


 


		-	Preparation and characterization of liposomes, and setting up EAE model (0-2 months)



		-	Testing the efficacy of dexamethasone using different modalities (2-6 months)



		-	Toxicity evaluation of dexamethasone using different modalities (5-6 months)



 


(ii) Testing TGFβ2 in EAE model using different modalities
(4-9 months)


 


Aim 2: (2-6 months)


 


(i) Cell-based study


(ii) Histological study


 


References


 


1. Evans C, Beland
SG, Kulaga S, et al. Incidence and prevalence of multiple sclerosis in the Americas: a systematic review. Neuroepidemiology 2013;40:195-210.


 


2. Rostami A, Ciric
B. Role of Th17 cells in the pathogenesis of CNS inflammatory demyelination. J Neurol Sci 2013;333:76-87.


 


3. Yadav SK, Mindur
JE, Ito K, Dhib-Jalbut S. Advances in the immunopathogenesis of multiple sclerosis. Curr Opin Neurol 2015;28:206-19.


 


4. Plavina T, Subramanyam
M, Bloomgren G, et al. Anti-JC virus antibody levels in serum or plasma further define risk of natalizumab-associated progressive
multifocal leukoencephalopathy. Ann Neurol 2014;76:802-12.


 


5. Matysiak M, Makosa
B, Walczak A, Selmaj K. Patients with multiple sclerosis resisted to glucocorticoid therapy: abnormal expression of heat-shock
protein 90 in glucocorticoid receptor complex. Multiple sclerosis 2008;14:919-26.


 


6. Ruoslahti E, Bhatia
SN, Sailor MJ. Targeting of drugs and nanoparticles to tumors. J Cell Biol 2010;188:759-68.


  


7. Meka RR, Venkatesha SH, Moudgil KD. Peptide-directed liposomal
delivery improves the therapeutic index of an immunomodulatory cytokine in controlling autoimmune arthritis. J Control Release
2018;286:279-88.


 


8. Acharya B, Meka RR, Venkatesha SH, Lees JR, Teesalu T, Moudgil
KD. A novel CNS-homing peptide for targeting neuroinflammatory lesions in experimental autoimmune encephalomyelitis. Mol Cell Probes
2020:101530.


 


9. Transparent Market Research NY. https://www.transparencymarketresearch.com/multiple-sclerosis-drugs.html.
2020.


10. ReportLinker NY.


 


https://www.globenewswire.com/news-release/2020/05/07/2029023/0/en/The-liposome-drug-delivery-market-is-expected-to-reach-US-6-992-95-million-by-2027-from-US-3-594-41-million-in-2019.html.
2020.


 


11. Calabresi PA, Fields NS, Maloni HW, et al. Phase 1 trial
of transforming growth factor beta 2 in chronic progressive MS. Neurology 1998;51:289-92.


 


12. Wiendl H, Hohlfeld R. Therapeutic approaches in multiple
sclerosis: lessons from failed and interrupted treatment trials. BioDrugs 2002;16:183-200.


 









    16  


     


    

 


EXHIBIT B


BUDGET


 


[*].Payment Schedule: 


 


$[*]. upon
execution of this Agreement. 


 


$[*].upon
completion of the Project work. 


 


EXHIBIT C


PAYMENT INFORMATION


 


		(1)	All payments must be made to University of Maryland, Baltimore (Federal I.D. #52-6002033).



 


		(2)	All payments must reference the name of the PI and the CCT number 2021-14640.



 


		(3)	Payments may be made in any of the following manners:



 


(a) By
check: Payable to “University of Maryland, Baltimore,” and sent to:


 


University of Maryland, Baltimore


 


Attention: Sponsored Programs Accounting & Compliance


 


P.O. Box 41428


 


Baltimore, Maryland 21203-6428


 


Fed. ID #52-6002033 


 


(b) ACH/Wire or International
Payments:



Wells Fargo Bank, N.A., 420 Montgomery Street, San Francisco, CA 94101

Account Name: State of Maryland – University of Maryland Baltimore

Account Number: [*].

Routing Number [*].

Required Reference: [*].


 


International SWIFT Code:
WFBIUS6S


 




    17  


     


    

 


EXHIBIT D


Sponsor Background Intellectual Property


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




    18  


     


    

 


EXHIBIT E


UMB Background Intellectual Property


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




    19  


     


    



 


EXHIBIT F


STANDARD CONFIDENTIALITY PROVISIONS




 



1. General
Restrictions on Use and Disclosure.


 


 1.1 A party
(“Provider”) may disclose Confidential Information to the other party (“Recipient”). For
a period of five (5) years following the Effective Date, Recipient shall hold the Confidential Information in confidence, and may
disclose or use the Confidential Information only as permitted by this Agreement. Recipient shall not use Provider’s Confidential
Information for any other purpose without the prior written consent of Provider.


 


 1.2 Recipient
shall use the level of care to prevent the unauthorized use or disclosure of Provider’s Confidential Information that Recipient
exercises in preventing the unauthorized use or disclosure of its own Confidential Information. Recipient may disclose Provider’s
Confidential Information only to its personnel who have a need to know the Confidential Information for the purposes permitted
by this Agreement.


 


1.3 Any Confidential
Information that would identify human research subjects or patients shall be maintained confidentially in accordance with applicable
law.


 


2. Permitted
Use and Disclosure.


 


 2.1 The confidentiality
obligations created by this Agreement shall not apply, and the Recipient may disclose or use Provider’s Confidential Information,
if and to the extent that: (a) the Confidential Information has already been released to the public (other than through Recipient’s
breach of this Agreement, any other agreement, or applicable law, or any unauthorized act by the Recipient); (b) the Confidential
Information was already in the possession of Recipient at the time of the disclosure (other than pursuant to a confidential disclosure
agreement or any unauthorized act by Recipient); (c) the Confidential Information is or was developed by Recipient independent
of and with no reliance upon Confidential Information of Provider or any other information furnished to Recipient by Provider under
obligation of confidentiality; (d) the disclosure or use is reasonably necessary to fulfill or comply with requirements of governmental
authorities having jurisdiction, including without limitation the U.S. Securities and Exchange Commission, National Institutes
of Health, Food and Drug Administration, and Patent and Trademark Office, and foreign equivalents of the foregoing; or (e) disclosure
is required by law.


 


 2.2 In the event
of disclosure pursuant to clauses (d) or (e) of Section 2.1, Recipient shall make a reasonable effort to give Provider prior
written notice of disclosure. Recipient, consistent with its counsel’s advice, shall take reasonable and lawful actions to
obtain confidential treatment for disclosed Confidential Information of the Provider and to minimize the extent of the disclosure,
or allow Provider the opportunity to take those actions. In the event of a dispute as to the applicability of this Section 2,
the burden of proof shall be upon the Recipient to demonstrate permissibility of disclosure or use.


 


3. Markings
and Legends. Provider shall use reasonable efforts to mark all Confidential Information disclosed to Recipient as “Confidential.”
If the Confidential Information is not in written or tangible form and marked “Confidential” when disclosed, Provider
shall use reasonable efforts to summarize the information in writing, marked as “Confidential,” and to provide the
summary to Recipient within thirty (30) days after disclosure of the Confidential Information to Recipient. To the extent Recipient
has actual knowledge that information is Confidential Information, failure to meet the marking requirements shall not affect Recipient’s
confidentiality obligations under this Agreement.


 


4. UMB
Practices. UMB is an educational institution with practices for protection of Confidential Information which may differ from
Sponsor’s 





standards and practices. UMB shall only be required to use reasonable efforts to protect the confidentiality of
Sponsor’s Confidential Information in a manner consistent with the efforts used by UMB to protect its own confidential information.
Provided that those efforts are made, UMB, UMB employees, students, and trainees, and other persons using UMB facilities, shall
not be liable in the event of disclosure or use of Sponsor’s Confidential Information.


 


5. Public
Information Act. This Agreement and Confidential Information provided to UMB under this Agreement is a public record when in
the possession of UMB, which may be subject to inspection pursuant to § 4-101 et seq., General Provisions Article,
Annotated Code of Maryland (the “Public Information Act”). If Sponsor asserts that any Confidential Information
provided to UMB under this Agreement is a trade secret, confidential financial information, or confidential commercial information
which is exempt from disclosure under § 4-335 of the Public Information Act, then UMB shall assert in response to any such
request that inspection should be denied, unless UMB determines on the advice of its counsel that Sponsor’s position is not
reasonable.


 


6.  Government
and Sponsor Rights. UMB’s Confidential Information may have been developed under a grant or contract or in collaboration
with the government of the United States, the government of the State of Maryland, or other entities or research sponsors. The
entities or sponsors may have rights in UMB’s Confidential Information and may have the right to license or use UMB’s
Confidential Information. UMB shall provide Sponsor with further information about any sponsor’s rights if Sponsor requests
this information in writing, subject to confidentiality obligations.


 


 7. Export
Control Laws. To the best of its knowledge, the Discloser shall notify the Recipient, prior to disclosing any Confidential
Information, whether the information being disclosed is subject to any restrictions or controls imposed by the Arms Export Control
Act; the Export Administration Act of 1979; the International Traffic in Arms Regulations; the Export Administration Regulations;
or any other rules or regulations pertaining to restrictions on use or disclosure of goods, information, or technology, of any
applicable governmental agency (collectively, the “Export Control Laws”). Recipient shall use reasonable efforts
to prevent Confidential Information and any direct product thereof from being used for any purpose prohibited by the Export Control
Laws, and to cause uses of that Confidential Information to comply with the Export Control Laws. In addition, Recipient shall obtain
the express written consent of Discloser prior to export of any technical data or products received. That written consent does
not constitute governmental license or authorization.


 


8. Return
or Destruction of Confidential Information. Upon expiration or termination of this Agreement for any reason, each party shall
either return or destroy the other party’s Confidential Information, together with all copies and other forms of reproduction,
and shall provide written notice of the same to the other party. However, each party may retain one copy of the other party’s
Confidential Information subsequent to its return in the event of any question or dispute concerning a party’s obligations
under this Agreement. Each party agrees that termination of this Agreement does not alter the five (5) year obligation of confidentiality
set forth in this Exhibit D.


 


9. Sponsor
Affiliates. In the event of any disclosure of Confidential Information to a Sponsor Affiliate, Sponsor and any such Sponsor
Affiliate shall be jointly and severally liable for all of Sponsor’s and Sponsor Affiliates’ obligations with respect
to this Agreement. Sponsor shall promptly identify to UMB by name and address all Sponsor Affiliates to whom Sponsor has disclosed
Confidential Information.