Investigational
Product Supply and Use Authorization Agreement for OT-101 U.S. Expanded Access (IPSUA)


 


between
WideTrial and Oncotelic


 


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


 


WHEREAS,
Manufacturer, among its other activities, is engaged in the business of developing and manufacturing its investigational therapeutic
product, OT-101 (“Investigational Product”), and


 


WHEREAS,
Sponsor and Manufacturer intend to collaborate in a U.S. Expanded Access Program for treatment use of OT-101 for 25 or more
patients in pancreatic cancer and other cancers known to overexpress TGF-B2 (“USEAPOT101”, “The Expanded Access
Program”, “The EAP”), and


 


WHEREAS,
Manufacturer wishes to provide delivery of the finished Investigational Product (as defined below) to the Sponsor, at the Sponsor’s
designated treatment sites, for the sole purpose of supplying the EAP, according to the terms and conditions set forth herein,
and


 


WHEREAS,
Sponsor wishes to provide data to Manufacturer relating to the Investigational Product and the EAP according to the terms
and conditions set forth in two Data License Agreements.


 


NOW,
THEREFORE, for good and valuable consideration as set forth herein, the Parties agree as follows:


 





	1.	Definitions:



 


	 	1.1	“Adverse
                                         Event” or “AE” shall mean any undesirable medical occurrence
                                         in a Subject under the treatment and which is not necessarily caused by the treatment.

                                         

		1.2	“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 performance
                                         of the EAP 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, with
                                         respect to the United States, the Prescription Drug Marketing Act, the Federal Food,
                                         Drug and Cosmetics Act of 1938, as amended, the Health Insurance Portability and Accountability
                                         Act, the Federal Anti-Kickback Statute, and any applicable regulations relating to sampling
                                         practices.
	 	 	 
		1.3	“CRO”
                                         means a Contract Research Organization company who provides clinical research services
                                         for the EAP to the Sponsor.
	 	 	 
		1.4	“Designated
                                         Site” means the specific location for Investigational Product delivery to be
                                         indicated by Sponsor to Manufacturer in accordance with section 3.2



 




    	 	Page
                                         1
                                         of 13	 



    	 	 	 



    

 


		1.5	“DSUR”
                                         means Development Safety Update Report that is a required annual filing for FDA authorized
                                         clinical program involving Investigational Products.
	 	 	 
		1.6	“Expanded
                                         Access Program”, or “EAP” means an FDA-authorized clinical
                                         trial for the treatment use of the Investigational Product in patients who are
                                         not candidates to participate in any research trials for the particular Investigational
                                         Product.
	 	 	 
		1.7	“The
                                         Indication” for this Agreement shall generally refer to the indication specified
                                         in either of the two Protocols defined in 1.14 and 1.15
	 	 	 
		1.8	“Instructions
                                         for Use” or “IFU” means the Manufacturer instructions on
                                         how to use the Investigational Product to be attached hereto in within forthcoming Exhibits.
	 	 	 
		1.9	“Investigational
                                         Product” means a regulated pharmaceutical or device that is not yet approved
                                         for marketing in any population by the governing Agency of the particular country or
                                         territory of use and, for this Agreement, shall mean OT-101, a TGFB2-inhibiting antisense
                                         oligonucleotide, which is in active clinical development for use in pancreatic cancer.
	 	 	 
		1.10	“IRB”
                                         means Institutional Review Board.
	 	 	 
		1.11	“IRB
                                         Application” means any documents and action required by the IRB to obtain IRB
                                         approval.
	 	 	 
		1.12	“IRB
                                         Approval” means the written approval by the IRB of the Protocol and the EAP
                                         in the corresponding Site.
	 	 	 
		1.13	“Protocol”
                                         means either of two clinical protocols for conduct of the EAP, to be drafted and
                                         signed by the Sponsor, to be submitted to FDA and IRBs for authorizations, to be attached
                                         hereto within forthcoming Exhibits.
	 	 	 
		1.14	“Protocol
                                         1” shall be the clinical protocol used for OT-101 treatment of patients with
                                         unresectable, gemcitabine refractory, adenocarcinoma of the pancreas (“Indication”).
	 	 	 
		1.15	“Protocol
                                         2” shall be the clinical protocol used for OT-101 treatment of patients within
                                         a range of unresectable, refractory solid tumor cancers known to overexpress TGF-B2 –
                                         excluding gliomas (AA and GBM and other brain cancers) (“Indication, “Indications”)
	 	 	 
		1.16	“Purpose”
                                         shall have the meaning set forth in Section 2.1.
	 	 	 
		1.17	“QC”
                                         and “QA” shall mean Quality Control and Quality Assurance, respectively
                                         and refer to the testing and release specifications of the Investigational Product.



 




    	 	Page
                                         2
                                         of 13	 



    	 	 	 



    

 


		1.18	“Safety
                                         Plan” shall have the meaning set forth in Section 6.
	 	 	 
		1.19	“Serious
                                         Adverse Event” or “SAE” shall have the meaning set forth
                                         in Section 6.
	 	 	 
		1.20	“Subject”
                                         means an individual who consents to participate in the EAP.
	 	 	 
		1.21	“Territory”
                                         means the United States of America (USA or US).
	 	 	 
		1.22	“Treatment
                                         Course” or “Course of Treatment” means the full duration
                                         of treatment, up to eight (8) cycles of 96-hour infusion, as delivered according to the
                                         Protocols
	 	 	 
		1.23	“Treatment
                                         Cycle” means a single administration of the Investigational Treatment as part
                                         of a periodic round of drug administration, subject to the Protocol and the patient’s
                                         care plan, up to eight (8) cycles.



 


	2	Subject
                                         Matter



 


		2.1	Purpose.
                                         The Purpose of this agreement is to allow Sponsor to provide treatment with the Investigational
                                         Product for Subjects suffering from the Indication in the framework of EAP and subject
                                         to the Protocol in the Territory.
	 	 	 
		2.2	Use
                                         of Investigational Product. Manufacturer grants Sponsor a non-exclusive, non-transferable,
                                         and non-sublicensable right to use the Investigational Product in the U.S. during the
                                         Term of this Agreement for the Purpose of conducting the EAP subject to the terms of
                                         this Agreement.
	 	 	 
		2.3	No
                                         Implied License. Except for the right granted to Sponsor herein, all right, title
                                         and interest in and to the Investigational Product shall remain with Manufacturer, whether
                                         developed or conceived prior, during or after the Term of this Agreement. Except as expressly
                                         provided in this Agreement, neither Party will be deemed by this Agreement to have been
                                         granted any license or other rights to the other Party’s intellectual property
                                         rights, either expressly or by implication, estoppel or otherwise.



 


	3	Order and Delivery




 


		3.1	Sponsor
                                         shall issue a purchase order (“PO”) to Manufacturer for each Subject prior
                                         to subject’s beginning of Course of Treatment.
	 	 	 
		3.2	The
                                         PO shall include specific details for shipping, including address and contact person,
                                         and proposed date of treatment which shall be mutually agreed by the Parties.



 




    	 	Page
                                         3
                                         of 13	 



    	 	 	 



    

 


		3.3	Manufacturer
                                         will use its reasonable efforts to provide the Investigational Product to the Designated
                                         Site within 2 weeks from the date of the PO and before the agreed date of treatment.
                                         As early as possible, Manufacture will advise Sponsor of shipping date and expected arrival
                                         and will provide Sponsor with tracking details.
	 	 	 
		3.4	It
                                         is hereby agreed that the POs shall be submitted electronically in a format to be mutually
                                         agreed upon by both parties. Example of format is to be included within forthcoming Exhibits.
	 	 	 
		3.5	It
                                         is the responsibility of the Manufacturer to deliver the Investigational Product to the
                                         Designated Site undamaged, and all delivery costs including delivery insurance and -if
                                         necessary- import customs shall be borne by Manufacturer. Title and risk in the Investigational
                                         Product shall pass to Sponsor after acceptance by the Designated Site.



 


	4	Manufacturer Obligations




 


		4.1	Quality
                                         of Investigational Product. Manufacturer undertakes to supply the Investigational
                                         Product in compliance with the quality requirements and in accordance with GMP standards
                                         and Applicable Law relating to the supply, delivery manufacturing of the Investigational
                                         Product or similar products.
	 	 	 
		4.2	Training.
                                         Manufacturer shall be responsible to provide Sponsor with educational material regarding
                                         the Investigational Product, including Instructions for Use (IFU) document, as well as
                                         training to Sponsor personnel.
	 	 	 
		4.3	Regulatory
                                         documents.



 


		4.3.1	Initial
                                         Documents Required for the Filing of Investigational New Drug (IND) Application: Manufacturer
                                         shall provide Sponsor with the following documents, in order to allow it to facilitate
                                         the successful submission of IND for EAP:



 


		4.3.1.1	Investigator’s
                                         brochure for OT-101
	 	 	 
		4.3.1.2	Letter
                                         of Authorization for WideTrial to cross-refer to the U.S. Manufacturer’s commercial
                                         IND for OT-101
	 	 	 
		4.3.1.3	Current
                                         drafts of Protocols for any planned or authorized research trials involving OT-101
	 	 	 
		4.3.1.4	Suggested
                                         wording for the EAP informed consent form



 


		4.3.2	Manufacturer
                                         shall provide Sponsor with all product documentation and clinical data required to support
                                         the EAP’s regulatory, clinical and IRB authorizations.
	 	 	 
		4.3.3	Manufacturer
                                         Regulatory Commitments. Manufacturer shall provide Sponsor with new versions of the
                                         Investigator’s Brochure, once they are issued by Manufacturer. Manufacturer shall
                                         notify Sponsor of any Investigational Product withdrawals, recalls or clinical hold letters
                                         from the FDA.



 




    	 	Page
                                         4
                                         of 13	 



    	 	 	 



    

 


	5	Covenant of Non-Competition







 


		5.1	Manufacturer
                                         covenants that during the duration of this Agreement, neither Manufacturer nor any of
                                         its subsidiaries or assignees will engage (either directly or indirectly) any Activated
                                         Designated Sites in relation to any OT-101 Expanded Access Program sponsored by any party
                                         other than WideTrial, as contemplated by this Agreement. Manufacturer is free to conduct
                                         its clinical trials across any sites it so desired so long as it is not engaging these
                                         sites for the sole purpose of Expanded Access Program.
	 	 	 
		5.2	For
                                         purposes of above, an Activated Designated Site shall mean a health care provider who
                                         has signed WideTrial’s EAP Site Agreement for the conduct of WideTrial’s
                                         US Expanded Access Program for OT-101.



 


	6	Sponsor Obligations




 


		6.1	Sponsor
                                         shall be the official sponsor of record of the EAP and will assume all sponsor responsibilities
                                         defined in section 21 of the U.S. Code of Federal Regulations and ICH-GCP.
	 	 	 
		6.2	Regulatory
                                         Requirements.



 


		6.2.1	Sponsor
                                         shall be responsible for compliance with regulatory requirements pertaining to the following:



 


		6.2.1.1	Filing
                                         of Intermediate-Population IND (EAP IND) and all components;
	 	 	 
		6.2.1.2	Annual
                                         FDA Reporting
	 	 	 
		6.2.1.3	Investigator
                                         and site-level agreements
	 	 	 
		6.2.1.4	IRB
                                         submissions and follow-up
	 	 	 
		6.2.1.5	NIH
                                         submission for ClinicalTrials.Gov
	 	 	 
		6.2.1.6	Site
                                         coordination and monitoring
	 	 	 
		6.2.1.7	Adverse
                                         events monitoring and reporting
	 	 	 
		6.2.1.8	Any
                                         misconducts / misuse of the investigational product
	 	 	 
		6.2.1.9	Return
                                         and/or destruction of unused investigational product



 


		6.2.2	Sponsor
                                         shall notify Manufacturer of any clinical hold letter from the FDA on the Investigational
                                         Product notifications of audits/inspections and audits/inspections reports.



 


		6.3	Use
                                         of Investigational Product. The Sponsor undertakes to use the Investigational Product
                                         and to cause any third parties acting on its behalf including but not limited to CRO,
                                         institution and investigators who will conduct the EAP to use the Investigational Product
                                         (i) solely for the Purpose; (ii) in accordance with the terms of the EAP Protocols; (iii)
                                         in accordance with the IFU (iv) in accordance with the terms of this Agreement; (v) in
                                         strict compliance with Applicable Law. Sponsor is not responsible for any acts of non-compliance
                                         on the part of the Manufacturer or its affiliates or agents.



 




    	 	Page
                                         5
                                         of 13	 



    	 	 	 



    

 


		6.4	Investigational
                                         Product Handling. Sponsor shall be responsible for compliance with Manufacturer’s
                                         procedures for the storage, handling, delivery methods, and disposition, of the Investigational
                                         Product from the time of transfer from Manufacturer to the Designated Site until completion
                                         of use of such Investigational Product.
	 	 	 
		6.5	Training.
                                         Sponsor undertakes to train the CRO, institution, investigators and any other relevant
                                         third party that will use and/or otherwise administrate the Investigational Product and
                                         the EAP in accordance with the training given to it by Manufacturer in accordance to
                                         section 4.2.
	 	 	 
		6.6	Medical
                                         Oversight. Sponsor shall be responsible for medical data review for the purpose of
                                         monitoring Subjects’ safety and ensuring medical data consistency and integrity.
                                         Sponsor shall be responsible for the conduct of the clinical trial per ICH guideline
                                         including insuring that investigator is trained in GCP and full complied with GCP guideline.



 


	7	Safety







 


		7.1	Each
                                         Party agrees to immediately inform the other Party of all new known and suspected Serious
                                         Adverse Events (SAEs) and suspected, unexpected serious adverse reactions (SUSARs) arising
                                         in its ongoing clinical programs for OT-101 human use, in a timeframe and breadth that
                                         allows compliant regulatory reporting by each Party under its own IND, as detailed in
                                         the forthcoming Safety Plan.
	 	 	 
		7.2	Sponsor
                                         shall appoint a medical monitor and arrange additional resources as necessary to meet
                                         all requirements for safety event reporting and escalation.
	 	 	 
		7.3	Sponsor
                                         shall be responsible for the surveillance, receipt, evaluation, and reporting of Adverse
                                         Events in the EAP.
	 	 	 
		7.4	Sponsor
                                         shall provide Manufacturer with regular transcripts of its AE log, to be included in
                                         Manufacturer’s end-of-year compilation and filing of DSUR.
	 	 	 
		7.5	Manufacturer
                                         shall provide Sponsor an exact copy of its submitted DSUR, which Sponsor shall submit
                                         under its own IND.
	 	 	 
		7.6	Sponsor
                                         to provide Manufacturer an exact copy of its submitted DSUR
	 	 	 
		7.7	Sponsor
                                         and Manufacturer shall mutually establish and agree upon a Safety Plan, setting forth
                                         a process of compliance with Applicable Law and both Parties’ obligations related
                                         to Adverse Event responsibilities for the Investigational Product as well procedures
                                         for sharing information between the Parties regarding Adverse Events. Safety Plan documentation
                                         shall be included in forthcoming Exhibits.
	 	 	 
		7.8	Manufacturer
                                         shall be responsible for reporting to Sponsor of all safety expedited reports and changes
                                         to the benefit-risk analysis arising in other clinical programs of the Investigational
                                         Product for the Indication, per timeline agreed in the Safety Plan.
	 	 	 
		7.9	Parties
                                         shall (a) notify each other of any safety-related regulatory inquiries, request of information
                                         or regulatory communication from FDA relating to the safety of OT-101 and (b) provide
                                         copies of the regulatory correspondence within two (2) business days of receipt.



 




    	 	Page
                                         6
                                         of 13	 



    	 	 	 



    

 


		7.10	Each
                                         Party agrees to provide support with respect to any actual or potential regulatory action,
                                         and will supply all necessary information as is reasonable to resolve the issue.



 


	8	Control







 


		8.1	All
                                         key documentation and regulatory filings will be subject to Manufacturer review approval,
                                         which approval shall not be unreasonably withheld, unless otherwise subject to legal
                                         reporting requirements, in which case such approval is not required.
	 	 	 
		8.2	EAP
                                         Steering Committee.



 


		8.2.1	The
                                         Parties desire to establish a joint steering committee (the “EAP Steering Committee”)
                                         which shall oversee the Parties’ activities under this Agreement and facilitate
                                         communications between the Parties.
	 	 	 
		8.2.2	The
                                         EAP Steering Committee shall consist of at least one appointee from Sponsor, the rest
                                         will be appointees of Manufacturer and may include people who are unaffiliated with the
                                         Parties (e.g. investigator, bioethicists), at Manufacturer’s sole discretion.
	 	 	 
		8.2.3	The
                                         EAP Steering Committee shall meet (including by teleconference) on a monthly basis, or
                                         as agreed by its members.
	 	 	 
		8.2.4	Day
                                         to day operations will be run by Sponsor staff members and agents. Sponsor shall consult
                                         with the EAP Steering Committee on key decisions and developments.



 





	9	Representation and Warranties




 


		9.1	Mutual
                                         Representations. Each of the Parties represents, warrants and covenants to the other
                                         that: (a) it is a corporation duly incorporated, validly existing and in good standing;
                                         (b) it has taken all necessary actions on its part to authorize the execution, delivery
                                         and performance of the obligations undertaken in this Agreement, and no other corporate
                                         actions are necessary with respect thereto; (c) it is not a party to any agreement or
                                         understanding and knows of no law or regulation that would prohibit it from entering
                                         into and performing this Agreement; (d) when executed and delivered by it, this Agreement
                                         will constitute a legal, valid and binding obligation of it, enforceable against it in
                                         accordance with this Agreement’s terms;



 




    	 	Page
                                         7
                                         of 13	 



    	 	 	 



    

 


		9.2	Mutual
                                         Warranties. Each Party represents and warrants to each other that (a) it will perform
                                         its obligations hereunder and will, to the best of its abilities, cause any other third
                                         party working on its to perform their obligations in accordance with the terms of this
                                         Agreement and the Protocol (b) it complies with and will comply and perform its obligations
                                         hereunder in accordance with Applicable Law, industry standards, guidance or industry
                                         code of practice, and recognized applicable international and ethical principles including
                                         ICH GCP in force from time to time; (c) to the best of its knowledge performance of its
                                         obligations hereunder will not infringe or violate the rights of any third party including
                                         but not limited to property, contractual, employment, trademark, trade secrets, copyright,
                                         patent, proprietary information and non-disclosure rights; (d) it will not enter into
                                         any other agreements which would interfere or prevent performance of the obligations
                                         described herein. and (e) it is not debarred or, to the best of its knowledge, proposed
                                         for debarment under 21 U.S.C. § 335(a), or otherwise subject to any restrictions
                                         or sanctions by the United States Food and Drug Administration (a “Debarred Person”)
                                         Sponsor undertakes to immediately inform Manufacturer on any Debarred Person according
                                         to this section.



 


	10	Confidentiality



 


		10.1	All
                                         Confidential Information (as hereinafter defined) of the Sponsor, Manufacturer (or other
                                         parties whose Confidential Information that either Party has in its possession under
                                         obligations of confidentiality) shall be held in trust and strict confidence and, except
                                         as may be authorized in writing, shall not be used for any purpose other than for the
                                         Purpose of this Agreement and shall not be disclosed to any person, association, company,
                                         entity or other organization.
	 	 	 
		10.2	For
                                         purposes of this Agreement, “Confidential Information” shall include, without
                                         limitation, information of either Party (including information of any affiliate of either
                                         Party) that is treated by the Party as confidential or is subject to an obligation of
                                         the Party to treat such information as confidential, whether such obligation is contractual
                                         or arises by operation of law, including without limitation, this Agreement, the Protocol,
                                         Clinical Data and Reports, and deliverables made in connection with this Agreement.



 


	11	Consideration







 


		11.1	In
                                         consideration for the provision of the Investigational Product, Sponsor shall pay to
                                         Manufacturer a fixed price of USD 5000 per patient per Course of Treatment which
                                         will include Supply for up to eight (8) cycles of treatment at dosage prescribed in the
                                         applicable Protocol.
	 	 	 
		11.2	The
                                         payment shall be due within 30 days from the receipt of the Investigational Product at
                                         the Designated Site for the patient’s first Treatment Cycle within the Course of
                                         Treatment.



 


	12	Market
                                         Entrance



 


		12.1	In
                                         the case of State level market approval of OT-101, either Party has the right to suspend
                                         enrollment of new patients in the Expanded Access program in the particular State. In
                                         such event, existing EAP participants in the State may complete their Course of Treatment
                                         in the EAP, but may -at the discretion of either Party to this Agreement- be denied subsequent
                                         Courses of Treatment within the EAP. No provision of this Agreement shall impede the
                                         Manufacturer from recovering reimbursement from payers at full market price.



 




    	 	Page
                                         8
                                         of 13	 



    	 	 	 



    

 


	13	Liability







 


		13.1	The
                                         Sponsor shall be liable for the communication, coordination and reporting among all parties
                                         involved in the conduct of the EAP.
	 	 	 
		13.2	Sponsor
                                         is required to maintain adequate clinical trial insurance for the clinical trials
	 	 	 
		13.3	The
                                         Sponsor makes no claims to any party regarding the safety or effectiveness of the Investigational
                                         Product, and therefore, with respect to Manufacturer or other parties, assumes no liability
                                         for product design.
	 	 	 
		13.4	The
                                         Manufacturer shall be liable for the purity, quality, and stability of the Investigational
                                         Product that is delivered to the Designated Sites for use in the EAP.
	 	 	 
		13.5	Exclusion
                                         of Liability. Subject to the indemnification obligations set forth in Section 13
                                         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.



 


	14	Indemnification







 


		14.1	Manufacturer
                                         Indemnification: Manufacturer shall hold harmless, indemnify, and defend Sponsor
                                         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 Investigational Product, provided
                                         that Manufacturer’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 Sponsor act of fraud, negligence or willful misconduct or breach of Applicable
                                         Law, and further provided that Manufacturer 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 Sponsor and
                                         everyone on its behalf has fully cooperated with Manufacturer regarding such disposition
                                         or settlement; provided however that Manufacturer shall not dispose or settle any claim
                                         admitting liability on the part of Sponsor without its prior consent, which consent shall
                                         not be unreasonably withheld.
	 	 	 
		14.2	Sponsor
                                         Indemnification. The Sponsor shall hold harmless, indemnify, and defend Manufacturer
                                         for any Loss arising out of: (i) Sponsor’s own or any of its representatives’
                                         or agents’ act of fraud, negligence, or willful misconduct, (ii) breach of this
                                         Agreement; (iii) failure to conduct the EAP in accordance with the Protocol; (iv) breach
                                         of Applicable Law or regulation, provided that Sponsor’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 Manufacturer’s act of fraud, negligence
                                         or willful misconduct or breach of Applicable Law, and further provided that the Sponsor
                                         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 Manufacturer
                                         and everyone on its behalf has fully cooperated with the Sponsor regarding such disposition
                                         or settlement; provided however that the Sponsor shall not dispose or settle any claim
                                         admitting liability on the part of Manufacturer without its prior consent, which consent
                                         shall not be unreasonably withheld.



 



    	 	Page
                                         9
                                         of 13	 



    	 	 	 



    

 


		14.3	Patient
                                         Release of Liability Regarding Expected Safety and Efficacy. Patients and physicians
                                         participating in the Expanded Access program shall be required to acknowledge the investigational
                                         nature of the treatment provided. Patients will provide written acknowledgement that
                                         no claim of efficacy or safety is made by Sponsor or Manufacturer and that Sponsor and
                                         Manufacturer are released from liability relating to any such perceived claims.



 


	15	Insurance







 


		15.1	Manufacturer
                                         shall maintain commercially reasonable insurance with coverage appropriate for its respective
                                         obligations hereunder with limits of at least $3,000,000 per occurrence and $5,000,000
                                         in the aggregate.
	 	 	 
		15.2	The
                                         Sponsor shall maintain for the duration of the Study and thereafter for such period as
                                         is commercially reasonable clinical trial liability insurance, with limits of at least
                                         $3,000,000 per occurrence and $5,000,000 in the aggregate. Sponsor’s clinical trials
                                         insurance shall include Manufacturer as additional insured.



 


	16	Independent Contractor Relationship







 


The
Parties are independent contractors. Nothing in this Agreement shall be construed to create the relationship of partners, joint
ventures, or employer and employee between the Parties. Neither party, nor its employees, or independent contractors will have
authority to act on behalf of or bind the other party in any manner whatsoever unless otherwise authorized in this Agreement or
in a separate amendment signed by both Parties.


 


	17	Term & Termination







 


		17.1	The
                                         Term of this Agreement shall commence on the Effective Date of this Agreement and shall
                                         continue until the New Drug Application (NDA) for the study population is granted.
	 	 	 
		17.2	Notwithstanding
                                         the provision of Section 17.1 above, either Party may terminate this Agreement early
                                         in the event of any of the following:



 


		17.2.1	Mutual
                                         consent
	 	 	 
		17.2.2	Safety
                                         or compliance issues expressed via:



 


		17.2.2.1	Regulatory
                                         hold
	 	 	 
		17.2.2.2	Internal
                                         determination of safety-related cause for termination or suspension of the EAP



 




    	 	Page
                                         10
                                         of 13	 



    	 	 	 



    

 


		17.2.3	Supply
                                         interruption, resulting in either:



 


		17.2.3.1	Order
                                         fulfillment delay of 3 months or greater, after enrollment has begun, or
	 	 	 
		17.2.3.2	A
                                         known supply holdup of 6 months or greater.



 


		17.2.4	Termination
                                         for material breach of IPSUA. Either Party may terminate this Agreement by written notice
                                         at a date set in the notice (allowing at least thirty (30) days for cure) in the event
                                         of a material breach of this Agreement by the other Party; provided that the breaching
                                         Party fails to cure such breach within thirty (30) days from the date of such notice.
	 	 	 
		17.2.5	Termination
                                         for material breach of Data License. Either Party may terminate this Agreement by written
                                         notice at a date sent in the notice (allowing at least thirty (30) days for cure) in
                                         the event of a material breach of Agreement for Delivery and Licensed Use of Data
                                         Generated from OT-101 U.S. Expanded Access (“Data License 1”) by the
                                         other Party; provided that the breaching Party fails to cure such breach within thirty
                                         (30) days from the date of such notice.
	 	 	 
		17.2.6	Insolvency.
                                         If either Party shall become insolvent or shall make or seek to make an arrangement with,
                                         or an assignment for the benefit of creditors, or if proceedings in voluntary or involuntary
                                         bankruptcy shall be instituted by, on behalf of or against such Party, or if a receiver
                                         or trustee of such Party’s assets shall be appointed, or bankruptcy proceedings
                                         begin, the other Party may terminate this Agreement, as may be permitted by the applicable
                                         laws, with immediate effect.



 


		17.3	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”):
	 	 	 
		17.4	Subject
                                         to Applicable Law, upon the termination of the Agreement as provided above, the Sponsor
                                         will discontinue its use of the Investigational Product and will, upon direction from
                                         Manufacturer, return or destroy any remaining Investigational Product.
	 	 	 
		17.5	Survival.
                                         Sections 7, 10, 11, 13, 14, 15, 16, 17, 19, and 20 shall survive the termination of this
                                         Agreement howsoever caused.



 


	18	Notices







 


Any
notice or other communication required or permitted under this Agreement will be in writing and will be deemed given as of the
date it is: (a) delivered by hand; (b) by electronic mail within on business day after such notice has been sent or (b) received,
after it was sent, shipping prepaid, return receipt requested, by national courier service, to the party at the address listed
below or subsequently specified in writing:


 


	As
                                         to Sponsor:

        WideTrial
        Inc.

        8
        The Green, Suite 8298

        Dover,
        DE. 19901

        Attn:
        Jess Rabourn

        Telephone:
        (415) 637-4774

        Email:
        jess.rabourn@widetrial.com
	As
                                         to Manufacturer:

        Oncotelic
        Inc.

        29397
        Agoura Road, Ste 107

        Agoura
        Hills, CA 91301

        Attn:
        Vuong Trieu

        Telephone:
        (818-575-9560

        Email:
        vtrieu@oncotelic.com



 



    	 	Page
                                         11
                                         of 13	 



    	 	 	 



    

 


	19	Force Majeure







 


		19.1	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.
	 	 	 
	 	19.2	Each
    Party will notify the other Party of any Force Majeure without undue delay.






 


	20	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.


 


	21	Miscellaneous







 


		21.1	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.
	 	 	 
		21.2	Entire
                                         Agreement. This Agreement, with all forthcoming Exhibits, in conjunction with the
                                         two Data License Agreements constitute the entire 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.
	 	 	 
		21.3	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.
	 	 	 
		21.4	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.
	 	 	 
		21.5	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.



 



    	 	Page
                                         12
                                         of 13	 



    	 	 	 



    

 


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


 




    	 	Page
                                         13
                                         of 13