Agreement for Delivery and Licensed Use of Data Generated from OT-101 U.S.
Expanded Access
(Data License 1 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 for 25 or more patients in pancreatic cancer and other cancers known
to overexpress TGF-B2 (“USEAPOT101”, “The Expanded Access Program”, “The EAP”),
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 endeavors to capture information and clinical data relating to
patients treated in the Expanded Access Program (“USEAPOT101 Dataset” plus
Safety Addendums, collectively for this Agreement known as the “Data”) and to
format and store the Data in Licensor’s proprietary database, and

 

WHEREAS, Licensee desires to receive access to the Data from Licensor and
receive license to use the Data in support of its commercial activities, 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, with
respect to the United States, 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”), and the Health Insurance
Portability and Accountability Act (“HIPAA”).         1.2 “Course of Treatment”
means patients treatment with OT-101 consisting of 1-8 cycles, as described in
the Protocol.         1.3 “Data Tier” means the level of granularity in which
the referenced Dataset is to be transferred or disclosed, as defined in Sections
1.3 – 1.7 and summarized in Exhibit 1

 

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  1.4 “Data Tier 1” shall be defined as Discrete Observation-Level Data, which
includes all information captured from the Expanded Access Program, including
Protected Health Information (PHI) and treatment outcomes of individual
patients.         1.5 “Data Tier 2” shall be defined as Patient-Level Aggregated
Statistics, which are clinical statistics calculated and disclosed at the
line-item level of each participating patient, including rates of progression,
tumor size change, change of lab-calculated measures, number and frequency of
AEs, and baseline and ending clinical scores.         1.6 “Data Tier 3” shall be
defined as Trial-Specific Aggregate Statistics, calculated from data sets for
which more than 50% of human subjects are from USEAPOT101 or more than 50% of
total raw data volume is generated from USEAPOT101.         1.7 “Data Tier 4”
shall be defined as Pooled Aggregate Statistics, which are calculated solely
from data sets for which no more than 50% of human subjects are represented by
USEAPOT101 and no more than 50% of total raw data volume is generated from
USEAPOT101.         1.8 “Data Tier 5” shall be defined as Meta Data to include
measures such as number of patients enrolled, number of sites, ranges of health
conditions presented, and overall enrollment rate.         1.9 “Expanded Access
Program” or “EAP” generally 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.
For purposes of this Agreement, “The Expanded Access Program” or “The EAP” means
the particular Expanded Access Program contemplated by this Agreement for the
treatment use of OT-101 in patients with pancreatic cancer and other cancers
characterized by overexpression of TGF-B2.         1.10 “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.         1.11 “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.         1.12 “IND Authorization” means the passage
of 30 days after submission of properly assembled EAP IND to the appropriate FDA
review division with no response from FDA review division, OR an affirmative
statement of authorization from the FDA review division.

 

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  1.13 “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.         1.14 “Protected Health Information” or “PHI” is
individually identifiable health information created by health care providers,
as defined in the HIPAA Privacy Rule.         1.15 “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.         1.16
“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).         1.17
“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.         1.18 “Release Date” is 12 months after the
first market approval for OT-101.

 

2 License.

 

  2.1 License Grant. Subject to Licensee’s compliance with all other terms of
this Agreement and conditioned on Licensee’s payment of Fees, Licensor hereby
grants Licensee a perpetual, transferable license to the full USEAPOT101 Dataset
with partial exclusivity as defined in Section 2.2         2.2 Exclusivity.
Licensee’s right to disclose or transfer The Data shall be exclusive to Licensee
for periods of time according to the levels of data disclosure or transfer
contemplated, as defined below:

 

  2.2.1 Data Tier 1: the right to disclose or transfer Discrete
Observation-Level Data shall remain exclusively with the Licensee until the
Release Date, as defined in Section 1.18. This right of Licensee to transfer
Tier 1 Data to third parties is subject to and may be limited by HIPAA Privacy
Rule.         2.2.2 Data Tier 2: the right to disclose or transfer Patient-Level
Aggregate Statistics shall remain exclusively with the Licensee until the
Release Date, as defined in Section 1.18.

 

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  2.2.3 Data Tier 3: the right to disclose or transfer Trial-Specific Aggregated
Statistics, including inventions or derivations based primarily on the Data,
shall remain exclusively with the Licensee until the Release Date, as defined in
Section 1.18.         2.2.4 Data Tier 3: Notwithstanding the exclusivity
provided generally in 2.2.3, certain Trial-Specific Aggregated Statistics that
are publicly released by the Licensee may subsequently be released by the
Licensor upon the Publication Date, as defined in section 1.17.

 

  2.3 Licensor Regulatory Compliance. Notwithstanding the above exclusivity of
Licensee’s data transfer rights for commercial purposes, Licensor reserves the
right to disclose any part of the USEAPOT101 Dataset to participating
Investigators, IRBs, FDA, or any other authority as needed for safety reporting
and any other purpose required by Applicable Law.         2.4 Reservation of
Rights. Licensor reserves all rights not expressly granted to Licensee in this
Agreement.

 

3 Delivery and Content of Data

 

  3.1 Delivery. Licensee shall have full view and full download access to the
USEAPOT101 Dataset within Licensor’s clinical trial management system, beginning
with first patient enrolled.         3.2 Content. USEAPOT101 Dataset shall
include the following, as defined by the Protocol:

 

  3.2.1 Meta Data relating to overall enrollment and conduct of the program    
    3.2.2 Clinical Trial Data including patient screening information,
concomitant medications, co-morbidities, baseline clinical assessment, interim
and ending clinical assessment, adverse event log, and -as available- imagery
and lab tests captured throughout treatment period under patient’s standard of
care         3.2.3 Patient-specific identification code mapped to key held by
health care provider

 

  3.3 Safety Addendums. All event-specific safety information shall be made
available to Licensee for the purpose of enabling Licensee’s compliance with
regulatory reporting requirements. These addendums shall comprise safety event
processing forms and relevant correspondence, SAE narratives, SUSAR reports,
regulatory correspondence with IRB(s) and FDA, and transcripts of MedWatch
filings. These addendums shall be considered separate from the USEAPOT101
Dataset.

 

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  3.4 Compliance with Privacy Rule. Licensee warrants that it understands HIPAA
definition for Protected Health Information (PHI) and that permissible transfer
of PHI to other parties for research purposes is legally permissible only under
certain conditions as defined in Section 4 of this Agreement and subject to Code
of Federal Regulations Title 45 Sections 160 and 164.         3.5 Covenant to
Secure Data. Licensee covenants to maintain all parts of the USEAPOT101 Dataset
in a secure manner.

 

4 HIPAA Compliance and Data Use Agreement under Privacy Rule

 

  4.1 PHI in Data Tier 1. The USEAPOT101 Dataset shall not include personally
identifiable information (PII). But it shall include specific dates of treatment
and safety events, and therefore Tier 1 may not qualify as de-identified data
under the HIPAA Privacy Rule and therefore must be treated as Protected Health
Information (PHI).         4.2 Permissible Use of PHI that excludes PII. Use and
disclosure of Protected Health Information (PHI) is permissible without written
authorization from the patient, provided there is no Personally Identifiable
Information (PII) in the dataset and provided the resulting “Limited Data Set”
is transferred under a “Data Use Agreement” as composed in Section 4.3.        
4.3 Data Use Agreement. As required by HIPAA Privacy Rule, Licensee hereby
agrees to the following covenants of data privacy:

 

  4.3.1 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.         4.3.2 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.         4.3.3 Licensee will
hold any agent or subcontractor to the standards, restrictions, and conditions
stated in this Data Use Agreement with respect to the information.         4.3.4
Licensee will not use the Data to support attempts to identify or contact any of
the patients involved in the EAP.

 

  4.4 Use of Safety Addendum Information. The Licensee may also receive safety
event documentation, defined in 3.3, that reveals Personally Identifiable
Information (PII) and therefore constitutes Protected Health Information (PHI).
Licensor agrees to not use or disclose this information for research purposes
without (a) redacting all PII and (b) implementing a Data Use Agreement with any
subsequent recipient of the information.

 

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  4.5 Other Uses or Disclosures. Under Safe Harbor provision of the Privacy
Rule, Data Tier 2 is considered de-identified data because it does not include
PII and does not include specific dates of treatment or safety events. Data
Tiers 2-5 do not meet the definition of PHI and therefore are not restricted by
HIPAA Privacy Rule in their use or disclosure.         4.6 Liability. The
Licensor shall not be responsible for any Privacy Rule violations made by the
Licensee in its use or disclosure of USEAPOT101 Dataset or related Safety
Addendums.

 

5 Intellectual Property Ownership.

 

  5.1 Licensee acknowledges that, as between Licensee and Licensor, Licensor
owns all right, title, and interest in and to the Data. Licensee further
acknowledges that: (a) the Data is an original compilation protected by United
States copyright laws and (b) Licensor has dedicated substantial resources to
collect, manage, and compile the Data. 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 Data,
including without limitation, in a judicial proceeding anywhere throughout the
world.         5.2 Notwithstanding Licensor’s Data ownership, as defined in 5.1
of this Agreement, any derivation of the Data created by the Licensee, including
analyses, discoveries, and inventions shall be regarded as the intellectual
property of the Licensee.

 

6 Fees and Payment

 

  6.1 Data Fee. In consideration for delivery and license of the USEAPOT101
Dataset and Safety Addendums, Licensee shall pay Licensor USD 2500 per patient
treated, for up to 150 patients. After 150 patients have been registered, the
Data Fee shall be USD 1500 per patient.         6.2 Count of Patients. For its
use in this section of the Agreement, a “Patient” shall mean a patient’s single
Course of Treatment, which comprises 1-8 individual cycles. If the same patient
returns for a second Course of Treatment, 6 or more months after completing the
first Course of Treatment, he or she shall be considered a new additional
patient and shall be counted a second time.         6.3 Timing of Payments.

 

  6.3.1 First Payment. Upon FDA IND Authorization of the first IND submitted for
UAEAPOT101, Licensee shall complete its payment to the Licensor for the first 12
patients, equaling a fixed sum of USD 30,000.         6.3.2 Second Payment. Upon
start of treatment of the 6th patient, Licensee shall complete its payment to
the Licensor for the 13th through 25th patients, equaling a fixed sum of USD
32,500.

 

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  6.3.3 Subsequent Payment. If the number of patients exceeds 25, Data Fee shall
be paid for each additional patient within 30 days of start of treatment.

 

  6.4 Investigator Allowance. On behalf of Licensee, Licensor may pay certain
health care providers (HCPs) up to $1500 per treated patient to cover clinical
coordination and data entry costs at the particular site. These costs will be
passed through to Licensee on the same billing cycle under which the Licensor
agrees to pay the HCP. Licensee hereby agrees to reimburse Licensor for these
payments within the billing cycle presented.

 

7 Disclaimer of Warranties. The Data 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 data, 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.     8
Exclusion of Liability. Subject to the indemnification obligations set forth in
Section 9, 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     9 Indemnification

 

  9.1 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 the Data, 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.

 

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  9.2 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.

 

10 Term & Termination

 

  10.1 Term. The Term of this Agreement shall commence on the Effective Date of
this Agreement and shall continue through the completion of The Expanded Access
Program as defined in Section 16.1 of the “Investigational Product Supply and
Use Authorization Agreement for OT-101 U.S. Expanded Access (IPSUA)”        
10.2 Privacy Breach by Licensee. Notwithstanding provision of Section 10.1,
Licensor may terminate this Agreement, with possible revocation of License -if
required by law- in the event of Licensee’s material breach of the data privacy
provisions herein, including Sections 3.4, 4.3, and 4.4.         10.3 Early
Termination of EAP. Notwithstanding provision of Section 10.1, Licensor may
terminate this Agreement, without refund of any paid data fees as described in
Sections 6.3.1 and 6.3.2, in the event of any of the following:

 

  10.3.1 Non-Sponsor-caused early termination of The Expanded Access Program due
to causes cited in Section 16.2 of the IPSUA         10.3.2 In the capacity of
Manufacturer, Licensee’s material breach of the IPSUA         10.3.3 Licensee’s
material breach of this Agreement         10.3.4 Licensee’s material breach of
Data License 2 Agreement

 

  10.4 Material Breach by Licensor. Notwithstanding the provision of Section
10.1, the Licensee may terminate this Agreement in the event of any of the
following:

 

  10.4.1 Licensor’s material breach of this Agreement         10.4.2 Licensor’s
material breach of Data License 2 Agreement         10.4.3 In the capacity of
Sponsor, Licensor’s material breach of the IPSUA

 

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  10.5 Survival of License. With the exception of any legally required
revocation of License, as described in Section 10.2, termination of this
Agreement shall not invalidate the perpetual License to full use of the data
that has already been delivered as described Sections 2 and 3.         10.6 The
Parties may terminate this Agreement by Mutual Consent.         10.7 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”):

 

  10.7.1 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.

 

  10.8 Survival. Sections 1, 2, 4, 5, 7, 8, 9, 12, and 13 shall survive the
termination of this Agreement howsoever caused.

 

11 Force Majeure

 

  11.1 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.         11.2
Each Party will notify the other Party of any Force Majeure without undue delay.

 

12 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.

 

13 Miscellaneous

 

  13.1 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.         13.2 Entire Agreement. This Agreement, with all
forthcoming Exhibits, in conjunction with the IPSUA and Data License 2,
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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  13.3 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.         13.4 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.  
      13.5 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.

 

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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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EXHIBIT 1

 

SUMMARY OF USEAPOT101 DATA TIERS

 

[ex10-2_001.jpg]

 

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