Agreement
for Delivery and Licensed Use of WideTrial Bonus Dataset

(Data License 2 Agreement)


 


between
WideTrial and Oncotelic


 


This
Agreement is made and entered into on September 5, 2019 (the “Effective Date”), by and between WideTrial Inc., a corporation
headquartered at 8 The Green, Suite 8298, Dover, DE 19901 (“WideTrial) (the “Licensor”), and Oncotelic Inc.,
headquartered at 29397 Agoura Rd. Ste 107, Agoura Hills, CA 91301 (“Oncotelic”) (the “Licensee”) (each
a “Party”, collectively “Parties” to this bilateral Agreement).


 


WHEREAS,
Licensor and Licensee intend to collaborate as Sponsor and Manufacturer, respectively, in a U.S. Expanded Access Program for
treatment use of OT-101 in 25 or more cancer patients (“USEAPOT101”), as defined and agreed to under the Parties’
Investigational Product Supply and Use Authorization Agreement for OT-101 U.S. Expanded Access (“IPSUA”), and


 


WHEREAS,
Licensor, in its ongoing activities, expects to generate clinical data from multiple sponsored Expanded Access programs in
the future and will retain control over this data, subject to various specific agreements and Release Dates as negotiated between
Licensor and the particular manufacturers, and


 


WHEREAS,
Licensor intends to maintain a Bonus Dataset that comprises all captured clinical data from its sponsored Expanded Access
Programs and is available for Licensor’s commercial use, including transfer, and


 


WHEREAS,
Licensee desires to have access and license to Bonus Dataset from Licensor, subject to the terms and conditions of this Agreement,
and


 


NOW,
THEREFORE, in consideration of the mutual covenants, terms, and conditions set forth herein, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:


 


	1.	Definitions


 


	 	1.1	“Applicable Law”
    means all laws, statutes, ordinances, codes, rules, and regulations that have been enacted by a Regulatory Authority in
    any jurisdiction relevant to the collection and management of clinical trial data and which are in force as of the Effective
    Date or come into force during the Term, in each case to the extent that the same are applicable to the performance by the
    Parties of their respective obligations under this Agreement, including the Prescription Drug Marketing Act, the Federal Food,
    Drug and Cosmetics Act of 1938, as amended, The Federal Policy for the Protection of Human Subjects (“Common Rule”),
    the Health Insurance Portability and Accountability Act (“HIPAA”).
	 	 	 
	 	1.2	“Data License 1 Agreement”
    is the Agreement for Delivery and Licensed Use of Data Generated from OT-101 U.S. Expanded Access



 






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	 	1.3	“Expanded Access Program” or
    “EAP” means an FDA-authorized clinical trial for the treatment use of an Investigational Product
    in patients who are not candidates to participate in any research trial for the particular Investigational Product.
	 	 	 
	 	1.4	“EAP Dataset” shall mean
    the dataset generated from any particular Expanded Access Program sponsored by WideTrial and whose availability and transferability
    is determined through negotiated agreement and release dates with the particular manufacturer.
	 	 	 
	 	1.5	“Health Insurance Portability and Accountability
    Act of 1996” or “HIPAA” is the U.S. regulation of healthcare-related data privacy described in
    the Code of Federal Regulations Title 45, Parts 160 and 164.
	 	 	 
	 	1.6	“Investigational New Drug Filing”,
    or “IND” is a required written claim of exemption from the Food, Drug, and Cosmetic Act prohibition on
    interstate delivery of investigational therapeutics for pre-market use in humans, for authorized research programs or treatment-use
    programs. For this Agreement, “The IND” or “The INDs” shall refer to the specific filing(s) submitted
    by the Sponsor to FDA for 30-day authorization of The Expanded Access Program.
	 	 	 
	 	1.7	“IPSUA” is the Investigational
    Product Supply and Use Authorization Agreement for OT-101 U.S. Expanded Access, the definitive Agreement of terms and
    conditions for Licensee’s -in the capacity of Manufacturer- provision of Investigational Drug supply for USEAPOT101.
	 	 	 
	 	1.8	“Personally Identifiable Information”
    or “PII” means data that directly or indirectly could be used to identity individuals in association
    with sensitive personal information. e.g. Name, social security number, address, medical record number.
	 	 	 
	 	1.9	“Protected Health Information”
    or “PHI” is individually identifiable health information created by health care providers, as defined
    in the HIPAA Privacy Rule.
	 	 	 
	 	1.10	“Privacy Rule” is the set
    of requirements under HIPAA defining the permitted capture and electronic transfer of Protected Health Information in clinical
    programs including Expanded Access Programs, codified in 45CFR160 and 45CFR164 Subparts A and E.
	 	 	 
	 	1.11	“Protocol” is the clinical
    plan for Expanded Access, including eligibility criteria, treatment regimen, and data capture, included in The IND(s) for
    the particular study population and authorized by FDA and IRB(s).



 






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	 	1.12	“Publication Date” is the
    earlier of (a) the date of Licensee’s first publication of clinical results of the EAP or (b) 12 months following the
    completion of the program.
	 	 	 
	 	1.13	“Release Date” is the date
    a particular EAP dataset becomes available for WideTrial’s commercial use and disclosure; it is also the date upon which
    the data from a particular EAP dataset shall be added to the Bonus Dataset.
	 	 	 
	 	1.14	“The Bonus Dataset” means
    the deliverable dataset contemplated by this Agreement, consisting of all clinical data that is available for release, subject
    to limitations described in Section 3.2.
	 	 	 
	 	1.15	“USEAPOT101” shall mean the
    U.S. Expanded Access Program contemplated in the Investigational Product Supply and Use Authorization Agreement for OT-101
    U.S. Expanded Access (IPSUA)”


 


	2	Intellectual Property
    Ownership. Licensee acknowledges that, as between Licensee and Licensor, Licensor owns all right, title, and interest,
    including all intellectual property rights, in the Bonus Dataset. Licensee further acknowledges that: (a) the Bonus Dataset
    is an original compilation protected by United States copyright laws, (b) the Bonus Dataset is trade secret, and (c) Licensor
    has dedicated substantial resources to collect, manage, and compile the Bonus Dataset. Licensee agrees that it will be considered
    a material breach by Licensee under this Agreement if Licensee contests any of Licensor’s right, title, or interest
    in or to the Bonus Dataset, including without limitation, in a judicial proceeding anywhere throughout the world. Subject
    to the above and the Permitted Use as defined in Section 4.3 of this Agreement, Parties agree that derivative work products
    created by licensee through use of the Bonus Dataset, i.e. statistical analysis/ AI modeling tools, shall belong to Licensee.
	 	 
	3	Delivery and Content of Data


 


	 	3.1	Delivery. Licensee
    shall be provided a password-permissioned link which allows download of a prepared export file of the most up-to-date version
    of the Bonus Dataset, subject to limitations described in Section 3.2. Export file will be updated, with notification sent
    to Licensee within 30 days of every Release Date of additional data in the Bonus Dataset.
	 	 	 
	 	3.2	Scope of Bonus Dataset. Bonus Dataset
    shall consist of all captured, legally transferable clinical trial data from WideTrial-sponsored EAPs until the Dataset includes
    data from at least 1000 total patients, of which at least 500 are in EAPs for cancer treatment.



 






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	 	3.3	Content. Bonus Dataset shall include
    the following:


 


	 	3.3.1	All captured clinical trial
    data to include, as available from each EAP and as permissibly transferred under Applicable Law and EAP-specific data licenses,
    including baseline clinical assessment and score, interim and ending clinical assessment and score, adverse event log, and
    -as available- imagery, biomarkers, and lab tests captured throughout treatment period under patient’s standard of care
    and according to the particular EAP protocol.
	 	 	 
	 	3.3.2	Relative time intervals (or actual calendar
    dates) for baseline date, treatment date and recorded event dates, as available under Privacy Rule and program-specific Data
    Use Agreements
	 	 	 
	 	3.3.3	Patient-specific unique identification code
    mapped to each patient-level line item.


 


	 	3.4	Limitations


 


	 	3.4.1	No PII. Safety event
    processing forms -including medical narratives – which are considered “Safety Addendums” in Data License
    1 may be excluded from the Bonus Dataset due to the non-transferability of Personally Identifiable health Information (PII)
    without study-specific patient authorization.
	 	 	 
	 	3.4.2	Limited PHI. The transferability of Protected
    Health Information (PHI) will be subject to determinations of de-identification and EAP-specific Data Use Agreements,
    as required under HIPAA Privacy Rule and IRB authorizations, and therefore may impact the volume and timing of data provided
    at the Tier 1 level of data granularity.


 


	 	3.5	Compliance with Privacy
    Rule. Licensee warrants that it understands HIPAA definition for Protected Health Information (PHI) and that receipt of
    datasets that may include PHI requires, at minimum, a “Data Use Agreement” as composed in Section 3.4.1.


 


	 	3.5.1	Data Use Agreement.
    As required by 45 CFR 164, Licensee hereby agrees to the following covenants of data privacy regarding the Bonus Dataset:


 


	 	3.5.1.1	Licensee is not permitted
    to use or further disclose the Limited Data Set in a way that, if done by the Health Care Provider, would violate the Privacy
    Rule.
	 	 	 
	 	3.5.1.2	Licensee will use appropriate safeguards to
    prevent the use or disclosure of the information, except as provided for in the Agreement, and report to the Licensor any
    uses or disclosures in violation of the Agreement of which the Licensee becomes aware.
	 	 	 
	 	3.5.1.3	Licensee will hold any agent or subcontractor
    to the standards, restrictions, and conditions stated in this Data Use Agreement with respect to the information.
	 	 	 
	 	3.5.1.4	Licensee will not use the Dataset for attempts
    to identify or contact any of the patients involved in the EAP.


 






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	4	License


 


	 	4.1	License Grant. Subject
    to the conditions set forth in Section 4.2 of this Agreement and Licensee’s compliance with all other terms of this
    Agreement, Licensor hereby grants Licensee a perpetual, non-transferable, non-exclusive license to use the Bonus Dataset for
    Licensee’s Permitted Use as defined in Section 4.3 of this Agreement.
	 	 	 
	 	4.2	Conditions. The License is subject to
    the following conditions:


 


	 	4.2.1	Data License 1 has not been
    terminated due to Licensee’s non-payment of fees, and
	 	 	 
	 	4.2.2	Licensee, in its capacity as Manufacturer for
    USEAPOT101, has neither stopped nor suspended supply, nor -for any other reason- unilaterally terminated USEAPOT101 prior
    to the enrollment of 25 patients, and
	 	 	 
	 	4.2.3	USEAPOT101 has not been terminated due to safety-related
    issues prior to enrollment of 25 patients.


 


	 	4.3	Permitted Use. The
    Permitted Use of the Bonus Dataset is the internal research, development, and training of Licensee’s quantitative analysis
    systems which may include -without limitation- disease models, covariate analysis, and biomarker discovery and may serve to
    inform internal decision making. Permitted Use does not include further disclosure of any portion of the Bonus Dataset
    at any level of granularity. Intellectual property obtained from Permitted Use shall belong to Licensee.
	 	 	 
	 	4.4	Restricted Use. Licensee shall only use
    the Bonus Dataset for the Permitted Use and shall not disclose, release, distribute, or deliver the Bonus Dataset, or any
    portion thereof, or any derivation thereof to any third party without Licensor’s prior written consent. Any purpose
    or use not specifically authorized herein is prohibited unless otherwise agreed to in writing by Licensor. Without limiting
    the foregoing and except as otherwise expressly set forth in this Agreement, Licensee shall not at any time, directly or indirectly:
    (i) rent, lease, lend, sell, sublicense, assign, distribute, publish, transfer, or otherwise make available the Bonus Dataset;
    (iii) publish, enhance, or display any compilation or directory based upon information derived from the Bonus Dataset; or
    (vi) use the Bonus Dataset in any manner or for any purpose that infringes, misappropriates, or otherwise violates any intellectual
    property right or other right of any person, or that violates any applicable law.
	 	 	 
	 	4.5	Reservation of Rights. Licensor reserves
    all rights not expressly granted to Licensee in this Agreement.


 






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	5	Disclaimer of Warranties.
    The Bonus Dataset is provided “As Is” and Licensor hereby disclaims all warranties, whether express, implied,
    statutory, or otherwise. Licensor specifically disclaims all implied warranties of merchantability, fitness for a particular
    purpose, title, and non-infringement, and all warranties arising from course of dealing, usage or trade practice, Licensor
    makes no warranty of any kind that the Bonus Dataset, or any products or results of its use, will meet Licensee’s or
    any other person’s requirements, operate without interruption, achieve any intended result, be compatible or work with
    any software, system, or other services, or be free of harmful code or errors.
	 	 
	6	Exclusion of Liability. Subject
    to the indemnification obligations set forth in Section 7, in no event shall either Party be liable (including without limitation,
    contract, and tort liability) for any indirect, incidental, punitive, exemplary, special or consequential damages, loss of
    profit, or costs of substitute services suffered by the other Party or any third party, however caused, regardless of the
    theory of liability, whether in contract, tort, product liability or otherwise.
	 	 
	7	Indemnification


 


	 	7.1	Licensee Indemnification:
    Licensee shall hold harmless, indemnify, and defend Licensor from and against any claim, liability, loss, damage or expense,
    including, without limitation, reasonable attorneys’ fees (collectively, “Loss”), arising out of any third
    party claim resulting from the use of the misuse of Bonus Dataset provided that Licensee’s obligation to hold harmless,
    indemnify and defend as aforesaid shall be proportionately reduced and shall not apply to the extent that such Loss is the
    result of Licensor’s act of fraud, negligence or willful misconduct or breach of Applicable Law, and further provided
    that Licensee is notified in writing as soon as practicable under the circumstances of any complaint or claim potentially
    subject to indemnification and has full control of any disposition or settlement of such claim, and Licensor and everyone
    on its behalf has fully cooperated with Licensee regarding such disposition or settlement; provided however that Licensee
    shall not dispose or settle any claim admitting liability on the part of Licensor without its prior consent, which consent
    shall not be unreasonably withheld.
	 	 	 
	 	7.2	Licensor Indemnification. The Licensor
    shall hold harmless, indemnify, and defend Licensee for any Loss arising out of: (i) Licensor’s own or any of its representatives’
    or agents’ act of fraud, negligence or willful misconduct (ii) breach of this Agreement (iii) failure to manage the
    data according to HIPAA Privacy Rule; (iv) breach of Applicable Law or regulation, provided that Licensor’s obligation
    to hold harmless, indemnify and defend as aforesaid shall be proportionately reduced and shall not apply to the extent that
    such Loss is the result of Licensee’s act of fraud, negligence or willful misconduct or breach of Applicable Law, and
    further provided that the Licensor is notified in writing as soon as practicable under the circumstances of any complaint
    or claim and has full control of any disposition or settlement of such claim, and Licensee and everyone on its behalf has
    fully cooperated with the Licensor regarding such disposition or settlement; provided however that the Licensor shall not
    dispose or settle any claim admitting liability on the part of Licensee without its prior consent, which consent shall not
    be unreasonably withheld.


 






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	8	Term & Termination


 


	 	8.1	The Term of this Agreement
    shall commence on the Effective Date of this Agreement.
	 	 	 
	 	8.2	The Licensor may terminate this Agreement, with
    revocation of License, in the event of either of the following:


 


	 	8.2.1	Licensee’s material
    breach of Data License 1 Agreement
	 	 	 
	 	8.2.2	Licensee’s material breach of this Agreement


 


	 	8.3	The Parties may terminate
    this Agreement by Mutual Consent.
	 	 	 
	 	8.4	Obligations after Termination and Wind-Down
    Activities. Upon notification of termination, the Parties agree to cooperate with each other to ensure an orderly wind-down
    of the Services and discharge of their respective obligations under this Agreement and applicable Law (“Wind-Down Activities”):
	 	 	 
	 	8.5	Survival. Sections 1, 2, 5, 6, 7, 8,
    10, and 11 shall survive the termination of this Agreement howsoever caused.


 


	9	Force Majeure


 


	 	9.1	No Party shall be considered
    to be in breach of this Agreement if it is prevented from fulfilling its obligations under this Agreement by Force Majeure,
    if instructed by regulatory or by law, or as a matter of safety.
	 	 	 
	 	9.2	Each Party will notify the other Party of any
    Force Majeure without undue delay.


 


	10	Governing Law and Venue
	 	 
	 	This Agreement shall be governed by and construed
    in accordance with the laws of the State of Delaware, U.S.A without regard for conflict of laws principles. The Parties consent
    to the exclusive jurisdiction and venue of the competent courts in Delaware, U.S.A.


 


	11	Miscellaneous


 


	 	11.1	Assignment. Neither
    party may assign, delegate or otherwise transfer any of its rights or obligations under this Agreement without the prior written
    consent of the other party. Any attempt to assign without compliance with this provision shall be void. 
	 	 	 
	 	 	 
	 	11.2	Entire Agreement. This Agreement, with
    all forthcoming Exhibits, in conjunction with the IPSUA and Data License 1 Agreement, constitute the entire scope of Agreement
    and understanding between the parties. It supersedes all prior discussions (whether oral or written) between the parties with
    regards to the subject matter, and neither party will be bound by conditions, definitions, warranties, understandings, or
    representations concerning such subject matter except as provided in this Agreement. This Agreement can only be modified by
    written Agreement duly signed by persons authorized to sign Agreements on behalf of both Manufacturer and Sponsor. In the
    event of any inconsistency between the terms of this Agreement and any attached Exhibits, the terms of this Agreement will
    prevail.



 






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	 	11.3	Waiver. The failure of a party in any
    instance to insist upon the strict performance of the terms of this Agreement will not be construed to be a waiver or relinquishment
    of any of the terms of this Agreement, either at the time of the party’s failure to insist upon strict performance or
    at any time in the future, and such terms will continue in full force and effect. All waivers of the terms of this Agreement
    shall be in writing.
	 	 	 
	 	 	 
	 	11.4	Severability. Each clause of this Agreement
    is a distinct and severable clause and if any clause is deemed illegal, void or unenforceable, the validity, legality or enforceability
    of any other clause or portion of this Agreement will not be affected thereby.
	 	 	 
	 	11.5	Titles. All titles and articles headings
    contained in this Agreement are inserted only as a matter of convenience and reference. They do not define, limit, extend
    or describe the scope of this Agreement or the intent of any of its provisions.


 


The
undersigned have executed this Agreement as of the day and year noted below.


 


	Oncotelic Inc.	 	WideTrial Inc.
	 	 	 
	Signature:	/s/Vuong
    Trieu	 	Signature:	/s/Jess
    Rabourn
	 	 	 	 	 
	Name:	Vuong Trieu	 	Name:	Jess Rabourn
	 	 	 	 	 
	Title:	CEO	 	Title:	CEO
	 	 	 	 	 
	Date:	9/5/2019	 	Date:	9/5/2019


 




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