Exhibit 10.10


 


Certain identified information has been
excluded because it is both not material and would





likely cause competitive harm if publicly
disclosed.



 


PATIENT RECORDS





LICENSE AGREEMENT


 


This Patient Records License Agreement
(“Agreement”) is dated as of this 9th day of November, 2018 (“Effective Date”) by and between
Purinix Pharmaceuticals LLC, 1266 E Main Street, Suite 700R, Stamford, Connecticut, USA, 06902 (“Purinix”)
and Lwala Hospital, with an address located at P.O Box 650, Soroti, Uganda (“Records Provider”). Purinix
and Records Provider may individually be referred to hereinafter as a “Party” or collectively as the “Parties.”


 


WHEREAS, Purinix holds the rights
to and is in the process of developing Suramin or a variant thereof (the “Product”) and intends to seek and
obtain regulatory approval of the Product in jurisdictions throughout the world for the pharmaceutical treatment of human African
trypanosomiasis (“HAT”);


 


WHEREAS, Records Provider maintains
medical data and information (in the form of patient medical files) related to patients who have been diagnosed with and/or treated
for HAT (“Patient Records”) and has the right under the laws of the jurisdiction in which it operates to grant
the rights and licenses with respect to the Patient Records as contemplated under this Agreement; and


 


WHEREAS, Purinix wishes to use the
Patient Records to conduct [***] from which it shall develop documentation to support its filings for regulatory approval of the
Product in jurisdictions throughout the world, and including as otherwise set forth in Section 1 of this Agreement (the “Purpose”),
and Records Provider wishes to license and transfer such Patient Records to Purinix in accordance with the terms hereof;


 


NOW, THEREFORE, in consideration
of the mutual promises set forth in this Agreement, and for other good and valuable consideration, Purinix and Records Provider
intend to be legally bound as follows:


 


		1.	License, Ownership and Use.



 


		1.1.	Exclusive License to Patient Records. Records Provider hereby grants to Purinix a perpetual,
exclusive, irrevocable, fully transferable, worldwide, [***] license (including, but not limited to, the right to grant sublicenses)
to use, display, embed, reproduce, aggregate, modify, transmit, distribute, publish, and create derivative works in or otherwise
related to the Patient Records in connection with the Purpose described herein. Purinix understands that the exclusivity of its
license is connected to the Purpose and that Records Provider does not otherwise maintain exclusive rights to the patients’
medical records.



 


		1.2.	Exclusive Ownership of Derivative Works. Records Provider hereby disclaims, waives, and
releases any right or title it has or might have in the future in and to any and all derivative works (or their equivalent) of
the Patient Records created or developed by Purinix and/or its licensees including, without limitation,[***]; the exclusive right
and title to which shall rest with Purinix and/or its licensees. In the event the foregoing is deemed unenforceable by a court
of competent jurisdiction, Records Provider hereby grants to Purinix a perpetual, exclusive, irrevocable, fully transferable, worldwide,
[***] license (including, but not limited to, the right to grant sublicenses) in and to any and all derivative works (or their
equivalent) of the Patient Records created or developed by Purinix and/or its licensees.



 






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Certain identified information has been
excluded because it is both not material and would


likely cause competitive
harm if publicly disclosed.





 


		1.3.	Restrictions. For the avoidance of doubt, Records Provider understands and agrees that it
may not (i) use, license, disseminate, distribute, or otherwise share the Patient Records with a third party for any purpose
in contravention of the Purpose described herein; or (ii) use, license, disseminate, distribute, or otherwise share any derivative
works of the Patient Records created by Purinix or its licensees for any reason whatsoever.



 


		1.4.	Patient Privacy. Records Provider shall ensure that the Patient Records are transferred
to Purinix in an irreversibly anonymous manner. If and to the extent Records Provider discovers that any transferred Patient Records
include any identifiable “Patient Health Information,” as such term is defined under the U.S. Health Insurance Portability
and Accountability Act of 1996 (“HIPAA”), the Parties shall cooperate in an effort to de-identify the Patient
Records consistent with the Safe Harbor approach required by §164.514 of HIPAA. Purinix shall only be entitled to take copies
of the Patient Records and, for the avoidance of doubt, nothing in this Agreement shall oblige Records Provider to deliver to Purinix
any original documents containing Patient Records.



 


		1.5.	Use of Data. The rights and licenses provided for in this Agreement (a) are coupled
with an interest, (b) are subject to any and all data privacy laws applicable to the Patient Records, and (c) include,
without limitation, the right on the part of Purinix to use any or all of the data included in the Patient Records (i) [***]
(ii) in filings or other submissions to the U.S. Food and Drug Administration and/or any other similar governmental and regulatory
authorities throughout the world (collectively, for the purposes of this Agreement, the “FDA”) regarding the
Product including, but not limited to, filings or other submissions to obtain or maintain FDA approval of an NDA (as defined hereunder)
for the Product in the United States market. For the purposes of this Agreement, “NDA” means a United States
New Drug Application (as defined in the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et. seq.) (the “Act”)
and the regulations promulgated thereunder) pursuant to Section 505 of the Act (21 U.S.C. Section 355) and the regulations
promulgated thereunder submitted to the FDA for approval to market a pharmaceutical drug or product in the United States or, for
registrations sought outside of the United States, any similar regulatory requirements in such jurisdictions. As the sponsor of
the Product NDA, Purinix shall ensure that the results of its study are supported by source documentation, shall include reports
on serious adverse events (SAE), and, where required, filings to the FDA at a pre-IND meeting, pre-NDA meeting, and/or in the NDA
submission with respect to the Product shall include relevant Patient Records data.



 


		1.6.	Support. From time to time, at Purinix’s request [***], the Records Provider shall
use commercially reasonable efforts to cooperate with Purinix in order to effectuate the foregoing, which cooperation may include,
but not be limited to, confirming and/or effectuating the Patient Records by executing and delivering any such certifications,
consents or other written documents or instruments as Purinix may reasonably request. Records Provider shall also use commercially
reasonable efforts to cooperate with Purinix with respect to any FDA queries regarding the nature of the Patient Records and shall
permit Purinix and FDA personnel to audit such Patient Records, as required.



 






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Certain identified information has been
excluded because it is both not material and would


likely cause competitive
harm if publicly disclosed.


 


		2.	Term and Termination






 


		2.1.	Term. The term of this Agreement shall be perpetual (the “Term”), provided,
however, either Party shall have the right to terminate the Agreement if the other Party breaches, in any material respect, any
material term or condition of this Agreement and fails to remedy such breach within thirty (30) days after being given written
notice of such breach by the non-breaching Party.



 


		2.2.	Survival. Notwithstanding anything in this Agreement to the contrary, the following Sections
of this Agreement shall survive any termination of this Agreement: 1.2, 2, 4.2, and 5 – 13.



 


		3.	Administrative Fees and Attribution



 


		3.1.	Fees. Purinix shall, within [***], reimburse Records Provider, at the Record Provider’s
standard rates, as set forth in Exhibit A, for time actually spent by one or more clinical study coordinators or other staff
currently employed by the Records Provider, [***].



 


		3.2.	Attribution. Purinix shall acknowledge the contributions of the Records Provider including,
if appropriate, at Purinix’s sole and reasonable discretion or as mutually agreed in writing, the names of any individual
Records Provider staff as authors, to the extent they contributed meaningfully to the Purpose.



 


		4.	Representations and Warranties.



 


		4.1.	Mutual Warranties. Each Party represents and warrants to the other that (a) the Agreement
has been duly executed and delivered and constitutes a valid and binding agreement enforceable against such Party in accordance
with its terms; (b) no authorization or approval from any third party is required in connection with such Party’s execution,
delivery, or performance of the Agreement; and (c) the execution, delivery, and performance of the Agreement does not violate
the laws of any jurisdiction or the terms or conditions of any other agreement to which it is a party or by which it is otherwise
bound.



 


		4.2.	Additional Records Provider Warranties. Records Provider further represents and warrants
that (a) it has and will have all requisite ownership, rights, and licenses necessary to grant to Purinix the rights and licenses
granted under this Agreement, (b) the license grant does not violate any applicable law, regulation, or statute, (c) it
has not and will not enter into any agreement with a third party the execution or performance of which would violate or conflict
with any of the rights or licenses set forth in Section 1 of this Agreement, and (d) to Records Provider’s best
knowledge and belief (having made no specific enquiry), the Patient Records are an accurate and complete record in all material
respects.



 


		5.	Indemnification.



 


		5.1.	Mutual Indemnification. Each Party shall defend, indemnify, and hold harmless the other
Party for a breach of its respective representations and warranties in Section 4.1



 


		5.2.	Records Provider’s Indemnification. Records Provider shall indemnify, defend, and
hold Purinix, and its officers, directors, employees, agents and licensees, harmless from and against all claims, demands, liabilities,
causes of action, costs and expenses (including reasonable out-of-pocket attorneys’ fees) arising out of a breach of the
representations and warranties contained in Section 4.2 or arising out of or based on Purinix’s use of the Patient Records
as permitted by, and subject to, the terms of this Agreement.



 






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likely cause competitive harm if publicly
disclosed.





 


		5.3.	Indemnification Procedure. If any Party entitled to indemnification under this section (an
 “Indemnified Party”) makes an indemnification request to the other, the Indemnified Party shall permit the other
party (the “Indemnifying Party”) to control the defense, disposition or settlement of the matter at its own
expense; provided that the Indemnifying Party shall not, without the consent of the Indemnified Party enter into any settlement
or agree to any disposition that imposes an obligation on the Indemnified Party that is not wholly discharged or dischargeable
by the Indemnifying Party. The Indemnified Party shall notify the Indemnifying Party promptly of any claim for which the Indemnifying
Party is responsible and shall cooperate with the Indemnifying Party as commercially reasonable to facilitate defense of any such
claim; provided that the Indemnified Party’s failure to notify Indemnifying Party shall not diminish the Indemnifying Party's
obligations under this Section except to the extent that the Indemnifying Party is materially prejudiced as a result of such
failure. An Indemnified Party shall at all times have the option to participate in any matter or litigation through counsel of
its own selection at its own expense.



 


		6.	Confidential Information. Each Party acknowledges that it may have access to certain confidential
information of the other Party concerning the other Party’s business, plans, customers, technology, and products (“Confidential
Information”) as a result of its obligations under this Agreement. The Parties agree: (a) the Party receiving the information
(the “Receiving Party”) shall use, and cause their employees to use, reasonable efforts to safeguard the Confidential
Information of the other Party (“Disclosing Party”); (b) the Receiving Party shall not disclose Confidential Information
to any third party (other than contractors who have agreed to maintain its confidentiality); and (c) the Receiving Party shall
not use Confidential Information for any purpose other than as authorized by this Agreement. Information shall not be subject to
the foregoing confidentiality obligations if it is: (i) in the public domain through no fault of the Receiving Party; (ii) known
to the Receiving Party prior to the time of disclosure; (iii) disclosed to the Receiving Party by a third party that doesn’t
have a duty of confidentiality to the Disclosing Party; (iv) developed by the Receiving Party without reference to the Confidential
Information; or (v) required to be disclosed by law, provided that the Receiving Party promptly provides notice to the Disclosing
Party of any such request or requirement so that the Disclosing Party can seek appropriate protective orders.



 


		7.	WARRANTY DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN SECTION 4, NEITHER PARTY MAKES
ANY REPRESENTATION, WARRANTY, OR GUARANTY WHATSOEVER AND ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY
OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE,
ARE HEREBY DISCLAIMED BY BOTH PARTIES TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW.



 


		8.	LIMITATION OF LIABILITY. EXCEPT FOR ANY LIABILITY OF A PARTY ARISING UNDER OR RELATED TO
ITS INDEMNIFICATION OBLIGATIONS IN SECTION 5 OR A BREACH OF ITS CONFIDENTIALITY OBLIGATION IN SECTION 6; IN NO EVENT
SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, PUNITIVE, SPECIAL, EXEMPLARY, INCIDENTAL, CONSEQUENTIAL
OR OTHER DAMAGES OF ANY TYPE OR KIND ARISING UNDER OR IN RESPECT OF THIS AGREEMENT.



 






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Certain identified information has been
excluded because it is both not material and would





likely cause competitive harm if publicly
disclosed.





 


		9.	Basis of the Bargain; Failure of Essential Purpose. The Parties acknowledge that each Party
has entered into this Agreement in reliance upon the limitations of liability and the disclaimers of warranties and damages set
forth herein, and that the same form an essential basis of the bargain between the Parties. The Parties agree that the limitations
and exclusions of liability and disclaimers specified in this Agreement will survive and apply even if found to have failed of
their essential purpose.



 


		10.	Notices. Any notice or other communication under this Agreement shall be sufficiently given
if given in writing and delivered by hand delivery, or in lieu of such personal service, twenty-four (24) hours after delivery
to a national, overnight courier service, to the addresses listed at the end of this Agreement. Either Party may designate a different
address by giving notice of change of address in the manner provided above.



 


		11.	Choice of Law, Jurisdiction and Venue. This Agreement will be governed by and construed
in accordance with the laws of the State of New York in the United States, without reference to its conflicts of law provisions.
The Parties agree that the exclusive jurisdiction and venue of any action to enforce or interpret this Agreement will be the state
and federal courts located in the State of New York in the United States. Each Party hereto hereby irrevocably and unconditionally
waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying
of venue of any suit, action or proceeding arising out of or relating to this Agreement in any state or federal court in the State
of New York. Each of the Parties hereto hereby irrevocably waives, to the fullest extent permitted by law, the defense of an inconvenient
forum to the maintenance of such action or proceeding in any such court.



 


		12.	Injunctive Relief. The Parties agree that any breach of Sections 1, 4, or 6 of the Agreement
could cause the non-breaching Party substantial and irrevocable damage and, therefore, in the event of any such breach, in addition
to such other remedies which may be available, the non-breaching Party shall have the right to specific performance and injunctive
relief.



 


		13.	General Provisions. Neither Party may assign this Agreement to a third party without the
prior written consent of the non-assigning Party, provided, however, Purinix may assign this Agreement to any affiliate, subsidiary,
or parent entity, or in connection with a merger, acquisition, reorganization or other business combination or change of control
event. Any assignment in derogation of the foregoing shall be deemed null and void. The Parties hereto are independent contractors
and nothing contained herein or done in pursuance of this Agreement shall constitute either Party as the agent of the other Party
for any purpose or in any sense whatsoever, or constitute the Parties as partners, joint venturers or franchisor and franchisee.
No alteration, amendment, waiver, cancellation or any other change in any term or condition of this Agreement shall be valid or
binding on either Party unless mutually assented to in writing by both Parties. Without limiting the foregoing, the failure of
either Party to enforce at any time any of the provisions of this Agreement, or the failure to require at any time performance
by the other party of any of the provisions of this Agreement, shall in no way be construed to be a present or future waiver of
such provisions, nor in any way affect the ability of either party to enforce each and every such provision thereafter. The express
waiver by either Party of any provision, condition or requirement of this Agreement shall not constitute a waiver of any future
obligation to comply with such provision, condition or requirement. If for any reason a court of competent jurisdiction finds any
provision of this Agreement, or portion thereof, to be unenforceable, that provision will be enforced to the maximum extent permissible
so as to affect the intent of the parties, and the remainder of this Agreement will continue in full force and effect. This Agreement
is the entire agreement between the Parties with respect to the subject matter hereof. This Agreement may be executed in counterparts,
each of which shall constitute an original but all of which, when taken together, shall constitute one agreement.



 






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Certain identified information has been
excluded because it is both not material and would


likely cause competitive
harm if publicly disclosed.





 


IN WITNESS WHEREOF, the parties have executed
this Agreement to be effective as of the Effective Date written above.


 


	Purinix Pharmaceuticals LLC	 	Lwala Hospital
	 	 	 
	 	 	 
	By:  	             	 	By:  	 
	 	 	 
	Name:  	 	 	Name:  	 
	 	 	 
	Title:  	 	 	Title:  	 
	 	 	 
	Date:  	 	 	Date:  	 
	 	 	 
	Notice Address:	 	Notice Address:
	 	 	 
	Purinix Pharmaceuticals LLC	 	Lwala Hospital
	1266 E Main Street	 	P.O. Box 650
	Suite 700R	 	Soroti, Uganda
	Stamford, Connecticut 06902	 	[***]
	United States	 	 
	[***]	 	 



 






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Certain identified information has been
excluded because it is both not material and would





likely cause competitive harm if publicly
disclosed.


 


Exhibit A








 


[***]


 






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