UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
Current
Report
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported)
September
5, 2019
MATEON
THERAPEUTICS, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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000-21990
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13-3679168
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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29397
Agoura Road, Suite 107
Agoura
Hills, CA 91301
(Address
of principal executive offices and Zip Code)
Registrant’s
telephone number, including area code
(650)
635-7000
Not
applicable.
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2. below):
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[ ]
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Written communications pursuant to Rule 425
under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12
under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to
Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement communications pursuant to
Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities
registered pursuant to Section 12(b) of the Act:
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Title
of class
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Trading
Symbols
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Name
of each exchange on which registered
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N/A
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Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company [ ]
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item
1.01 Entry into a Material Definitive Agreement.
On
September 5, 2019, Mateon Therapeutics, Inc. (the “Company”) through its wholly-owned subsidiary Oncotelic Inc., a
Delaware corporation (“Oncotelic”) entered into three related agreements with WideTrial, Inc., a Delaware corporation
(“WideTrial”) for an Expanded Access Program to evaluated Oncotelic’s therapeutic product candidate OT-101 for
the treatment of pancreatic cancer, as well as data access through license agreements. Each of the agreements is summarized below:
Investigational
Product Supply and Use Authorization Agreement for OT-101 U.S. Expanded Access (IPSUA) dated September 5, 2019 between WideTrial
and Oncotelic
Under
the IPSUA, WideTrial and Oncotelic will collaborate in a U.S. Expanded Access Program for evaluation of Oncotelic’s investigational
therapeutic product, OT-101, in pancreatic cancer and other cancers known to overexpress TGF-B2 (the “EAP”). Oncotelic
will provide WideTrial with supplies of OT-101 at designated treatment sites, for the sole purpose of supplying the EAP. In consideration
of the supply of OT-101, WideTrial will pay Oncotelic a fixed price of $5,000 per patient, per course of treatment (which may
include up to eight (8) cycles of treatment at prescribed dosage rates). WideTrial will then conduct the EAP in accordance with
the terms and conditions of the IPUSA, and will provide the data relating to the EPA under Data License 1 Agreement and Data License
2 Agreement (described below).
Agreement
for Delivery and Licensed Use of Data Generated from OT-101 U.S. Expanded Access (Data License 1 Agreement) dated September 5,
2019 between WideTrial and Oncotelic
Under
Data License 1 Agreement, WideTrial has agreed to license certain clinical data relating to patients treated in the EAP plus some
additional safety addendums to Oncotelic (the “Dataset”). Data License 1 Agreement provides Oncotelic with a perpetual
and transferable license, with certain partial exclusivities to the Dataset. The license grants Oncotelic the ability to use the
Dataset for commercial purposes, subject to applicable law including HIPAA and applicable data privacy laws. In consideration
for the license, Oncotelic has agreed to pay WideTrial $2,500 per patient enrolled in the EAP for the first 150 patients and $1,500
per patient for all patients enrolled in excess of the first 150 patients. Data License 1 Agreement requires an initial payment
to WideTrial of $30,000 for the first 12 patients upon FDA IND Authorization of the first IND submitted for OT-101; a second payment
of $32,500 upon start of treatment of the sixth patient under the EAP; and subsequent payments if the number of patients exceeds
25, the fee shall be paid for each additional patient within 30 days of start of treatment.
Agreement
for Delivery and Licensed Use of WideTrial Bonus Dataset (Data License 2 Agreement) dated September 5, 2019 between WideTrial
and Oncotelic
Under
Data License 2 Agreement, WideTrial has agreed to license certain clinical data relating to other Early Access Programs conducted
for third parties to Oncotelic. As part of its ongoing business, WideTrial 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 may be negotiated between WideTrial and the particular manufacturers from time to time. WideTrial intends to maintain
a “Bonus Dataset” that comprises all captured clinical data from its sponsored Expanded Access Programs. Data License
2 Agreement provides for a license of that Bonus Dataset to Oncotelic for its internal research and development purposes, including
development of quantitative analysis systems for disease modeling, covariate analysis and biomarker discovery. The license is
non-exclusive and is non-transferrable without WideTrial’s consent. Data License 2 Agreement can be terminated by WideTrial
if Oncotelic suspends the EPA or breaches Data License 1 Agreement or Data License 2 Agreement, including a failure to pay the
required license fees under the Data License 1 Agreement.
References
to Agreements.
The
descriptions of the IPUSA, the Data 1 License Agreement, and the Data 2 License Agreement do not purport to be complete and are
qualified in their entirety by reference to the complete copies of the IPUSA, the Data 1 License Agreement and the Data 2 License
Agreement, which are attached as exhibits to this Current Report on Form 8-K, and each of which is incorporated herein by reference.
The
agreements have been included to provide investors and stockholders with information regarding their respective terms. Those agreements
are not intended to provide any other factual information about the Company. The representations, warranties and covenants contained
in those agreements were made only for purposes of those agreements and as of specific dates, were solely for the benefit of the
parties to those agreements, may be subject to limitations agreed upon by the contracting parties, and may be subject to standards
of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party
beneficiaries under any of the agreements and should not rely on the representations, warranties or covenants or any descriptions
thereof as characterizations of the actual state of facts or condition of the Company. Moreover, information concerning the subject
matter of the representations and warranties may change after the date of the agreements, which subsequent information may or
may not be fully reflected in our public disclosures.
Item
8.01 Other Events.
On
September 9, 2019, the Company and WideTrial issued a joint press release announcing the execution of the foregoing agreements,
a copy of which is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Forward-Looking
Statements
This
document contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical
facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives
of management are forward-looking statements. In addition, when or if used in this communication, the words “will,”
“may,” “would,” “approximate,” “expect,” “intend,” and similar expressions
and their variants may identify forward-looking statements. Examples of forward-looking statements include, but are not limited
to, statements relating to the anticipated timing, parameters or results of the EAP, the quantity or quality of any data information
to be derived under the licenses with WideTrial; the Company’s ability to effectively use any data from the EAP or the data
licenses to further the development of OT-101 or any product candidate, or the Company’s ability to monetize value from
the data it expects to receive under the data license agreements. Actual results could differ materially from those contained
in any forward-looking statement as a result of various factors that could cause actual events to differ from expectations, including
the risk factors included in the Company’s most recent Annual Report on Form 10-K and other periodic reports filed with
the Securities and Exchange Commission. Except as required by applicable law, the Company undertakes no obligation to revise or
update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information,
future events or otherwise.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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Mateon Therapeutics, Inc.
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Date: September
10, 2019
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/s/
Vuong Trieu
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By:
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Vuong Trieu
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Chief Executive Officer
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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:
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1.1
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“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.
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1.2
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“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.
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1.3
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“CRO”
means a Contract Research Organization company who provides clinical research services
for the EAP to the Sponsor.
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1.4
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“Designated
Site” means the specific location for Investigational Product delivery to be
indicated by Sponsor to Manufacturer in accordance with section 3.2
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1.5
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“DSUR”
means Development Safety Update Report that is a required annual filing for FDA authorized
clinical program involving Investigational Products.
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1.6
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“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.
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1.7
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“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
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1.8
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“Instructions
for Use” or “IFU” means the Manufacturer instructions on
how to use the Investigational Product to be attached hereto in within forthcoming Exhibits.
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1.9
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“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.
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1.10
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“IRB”
means Institutional Review Board.
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1.11
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“IRB
Application” means any documents and action required by the IRB to obtain IRB
approval.
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1.12
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“IRB
Approval” means the written approval by the IRB of the Protocol and the EAP
in the corresponding Site.
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1.13
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“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.
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1.14
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“Protocol
1” shall be the clinical protocol used for OT-101 treatment of patients with
unresectable, gemcitabine refractory, adenocarcinoma of the pancreas (“Indication”).
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1.15
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“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”)
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1.16
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“Purpose”
shall have the meaning set forth in Section 2.1.
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1.17
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“QC”
and “QA” shall mean Quality Control and Quality Assurance, respectively
and refer to the testing and release specifications of the Investigational Product.
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1.18
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“Safety
Plan” shall have the meaning set forth in Section 6.
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1.19
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“Serious
Adverse Event” or “SAE” shall have the meaning set forth
in Section 6.
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1.20
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“Subject”
means an individual who consents to participate in the EAP.
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1.21
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“Territory”
means the United States of America (USA or US).
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1.22
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“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
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1.23
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“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.
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2.1
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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.
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2.2
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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.
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2.3
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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.
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3.1
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Sponsor
shall issue a purchase order (“PO”) to Manufacturer for each Subject prior
to subject’s beginning of Course of Treatment.
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3.2
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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.
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3.3
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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.
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3.4
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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.
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3.5
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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.
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4
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Manufacturer Obligations
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4.1
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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.
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4.2
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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.
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4.3
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Regulatory
documents.
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4.3.1
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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:
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4.3.1.1
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Investigator’s
brochure for OT-101
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4.3.1.2
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Letter
of Authorization for WideTrial to cross-refer to the U.S. Manufacturer’s commercial
IND for OT-101
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4.3.1.3
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Current
drafts of Protocols for any planned or authorized research trials involving OT-101
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4.3.1.4
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Suggested
wording for the EAP informed consent form
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4.3.2
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Manufacturer
shall provide Sponsor with all product documentation and clinical data required to support
the EAP’s regulatory, clinical and IRB authorizations.
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4.3.3
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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.
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5
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Covenant of Non-Competition
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5.1
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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.
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5.2
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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.
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6.1
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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.
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6.2
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Regulatory
Requirements.
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6.2.1
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Sponsor
shall be responsible for compliance with regulatory requirements pertaining to the following:
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6.2.1.1
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Filing
of Intermediate-Population IND (EAP IND) and all components;
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6.2.1.2
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Annual
FDA Reporting
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6.2.1.3
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Investigator
and site-level agreements
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6.2.1.4
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IRB
submissions and follow-up
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6.2.1.5
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NIH
submission for ClinicalTrials.Gov
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6.2.1.6
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Site
coordination and monitoring
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6.2.1.7
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Adverse
events monitoring and reporting
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6.2.1.8
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Any
misconducts / misuse of the investigational product
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6.2.1.9
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Return
and/or destruction of unused investigational product
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6.2.2
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Sponsor
shall notify Manufacturer of any clinical hold letter from the FDA on the Investigational
Product notifications of audits/inspections and audits/inspections reports.
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6.3
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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.
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6.4
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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.
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6.5
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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.
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6.6
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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.
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7.1
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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.
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7.2
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Sponsor
shall appoint a medical monitor and arrange additional resources as necessary to meet
all requirements for safety event reporting and escalation.
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7.3
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Sponsor
shall be responsible for the surveillance, receipt, evaluation, and reporting of Adverse
Events in the EAP.
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7.4
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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.
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7.5
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Manufacturer
shall provide Sponsor an exact copy of its submitted DSUR, which Sponsor shall submit
under its own IND.
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7.6
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Sponsor
to provide Manufacturer an exact copy of its submitted DSUR
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7.7
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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.
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7.8
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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.
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7.9
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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.
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7.10
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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.
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8.1
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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.
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8.2
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EAP
Steering Committee.
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8.2.1
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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.
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|
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|
|
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;
|
|
|
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.
|
|
|
10.1
|
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.
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|
|
|
|
|
|
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.
|
|
|
11.1
|
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.
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|
|
|
|
|
|
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.
|
|
|
12.1
|
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.
|
|
|
13.1
|
The
Sponsor shall be liable for the communication, coordination and reporting among all parties
involved in the conduct of the EAP.
|
|
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|
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|
13.2
|
Sponsor
is required to maintain adequate clinical trial insurance for the clinical trials
|
|
|
|
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|
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.
|
|
|
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|
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.
|
|
|
|
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|
|
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.
|
|
|
14.1
|
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.
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|
|
|
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|
|
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.
|
|
|
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.
|
|
|
15.1
|
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.
|
|
17.1
|
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
|
|
|
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.
|
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
|
|
|
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.
|
|
21.1
|
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.
|
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
|
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:
|
|
1.1
|
“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
|
|
|
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.
|
|
|
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.
|
|
|
2.1
|
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.
|
|
|
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.
|
|
|
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.
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3.5
|
Covenant to Secure
Data. Licensee covenants to maintain all parts of the USEAPOT101 Dataset in a secure manner.
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4
|
HIPAA Compliance and Data Use Agreement under
Privacy Rule
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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).
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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.
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4.3
|
Data Use Agreement. As required by HIPAA Privacy Rule, Licensee hereby agrees to the following covenants of data privacy:
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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.
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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.
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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.
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4.3.4
|
Licensee will not
use the Data to support attempts to identify or contact any of the patients involved in the EAP.
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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
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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.
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4.6
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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.
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5
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Intellectual Property Ownership.
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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.
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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.
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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.
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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.
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6.3
|
Timing of Payments.
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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.
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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.
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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.
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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.
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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
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9
|
Indemnification
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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.
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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)”
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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.
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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:
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|
|
10.3.1
|
Non-Sponsor-caused
early termination of The Expanded Access Program due to causes cited in Section 16.2 of the IPSUA
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10.3.2
|
In the capacity
of Manufacturer, Licensee’s material breach of the IPSUA
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10.3.3
|
Licensee’s
material breach of this Agreement
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10.3.4
|
Licensee’s
material breach of Data License 2 Agreement
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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:
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|
|
10.4.1
|
Licensor’s
material breach of this Agreement
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10.4.2
|
Licensor’s
material breach of Data License 2 Agreement
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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.
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10.6
|
The Parties may
terminate this Agreement by Mutual Consent.
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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”):
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|
|
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.
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|
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10.8
|
Survival.
Sections 1, 2, 4, 5, 7, 8, 9, 12, and 13 shall survive the termination of this Agreement howsoever caused.
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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.
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11.2
|
Each Party will
notify the other Party of any Force Majeure without undue delay.
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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.
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|
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.
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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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|
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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.
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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.
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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.
|
The
undersigned have executed this Agreement as of the day and year noted below.
|
Oncotelic Inc.
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|
WideTrial Inc.
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|
|
Signature:
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/s/ Vuong Trieu
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|
Signature:
|
/s/ Jess Rabourn
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|
|
|
|
Name:
|
Vuong Trieu
|
|
Name:
|
Jess Rabourn
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|
|
Title:
|
CEO
|
|
Title:
|
CEO
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|
|
Date:
|
9/5/2019
|
|
Date:
|
9/5/2019
|
EXHIBIT
1
SUMMARY
OF USEAPOT101 DATA TIERS
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:
|
|
1.1
|
“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”).
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|
|
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|
|
1.2
|
“Data License 1 Agreement”
is the Agreement for Delivery and Licensed Use of Data Generated from OT-101 U.S. Expanded Access
|
|
|
|
|
|
|
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.
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|
|
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|
|
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.
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|
|
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|
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.
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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.
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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.
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|
|
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|
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.
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|
|
|
|
|
|
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).
|
|
|
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.
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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.
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|
|
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.
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|
|
|
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|
|
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.
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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.
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|
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.
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|
|
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
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|
|
|
3.3.3
|
Patient-specific unique identification code
mapped to each patient-level line item.
|
|
|
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.
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|
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|
|
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.
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|
|
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.
|
|
|
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
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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.
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4.4
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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.
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4.5
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Reservation of Rights. Licensor reserves
all rights not expressly granted to Licensee in this Agreement.
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5
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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.
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6
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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.
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7
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Indemnification
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7.1
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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.
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7.2
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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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8.1
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The Term of this Agreement
shall commence on the Effective Date of this Agreement.
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8.2
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The Licensor may terminate this Agreement, with
revocation of License, in the event of either of the following:
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8.2.1
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Licensee’s material
breach of Data License 1 Agreement
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8.2.2
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Licensee’s material breach of this Agreement
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8.3
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The Parties may terminate
this Agreement by Mutual Consent.
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8.4
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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”):
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8.5
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Survival. Sections 1, 2, 5, 6, 7, 8,
10, and 11 shall survive the termination of this Agreement howsoever caused.
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9.1
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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.
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9.2
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Each Party will notify the other Party of any
Force Majeure without undue delay.
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10
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Governing Law and Venue
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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.
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11.1
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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.
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11.2
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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
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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.
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11.4
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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.
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11.5
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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.
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Oncotelic Inc.
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WideTrial Inc.
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Signature:
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/s/Vuong
Trieu
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Signature:
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/s/Jess
Rabourn
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Name:
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Vuong Trieu
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Name:
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Jess Rabourn
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Title:
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CEO
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Title:
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CEO
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Date:
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9/5/2019
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Date:
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9/5/2019
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Mateon
Partners with WideTrial for Data-Generating Expanded Access Programs in Cancer
AGOURA
HILLS, California and SAN FRANCISCO, California, September 9th, 2019 -- Mateon Therapeutics Inc. (OTCQB:MATN),
announced today that it has executed agreements with WideTrial Inc. for an Expanded Access program (EAP) in pancreatic cancer.
Using WideTrial’s novel platform, the investigational therapeutic OT-101 will be made available for elective treatment-use
to patients who do not meet the inclusion criteria of OT-101 research trials. The partnership may also support Expanded Access
for OT-101 in additional patients with advanced solid tumors, excluding brain cancers (AA, GBM, and other gliomas). Separately,
the companies executed data access agreements to support the development of Mateon’s AI/Blockchain technologies with WideTrial’s
data assets in cancer and other therapeutic areas.
OT-101
is a first-in-class RNA therapeutic targeting TGF beta and is the lead immune-oncology drug candidate of Oncotelic, a wholly owned
subsidiary of Mateon Therapeutics Inc.. The investigational drug exhibited single-agent activity in relapsed/refractory cancer
patients during multiple Phase 2 clinical trials.
Like
research trials, cohort Expanded Access programs (EAPs) are centrally monitored trials that enroll patients at designated sites
under a single protocol. They differ from research trials in that their primary objective is to provide the option of treatment-use
to patients who cannot take part in the product’s research trials.
“This
Expanded Access program will allow us to meet the spirit of clinical trial inclusivity, as described in the 2017 FDA Reauthorization
Act. We are pleased to have found a viable way to accommodate greater numbers of patients in need and the doctors who seek to
treat them,” said Dr. Vuong Trieu, Chairman and CEO of Mateon Therapeutics Inc.. “Though the primary objective is
treatment, we intend to utilize generated data to improve the power and targeting of future research trials.”
“The
PointR platform applies cutting edge algorithms to clinical datasets and could be used to quickly and cost-effectively identify
the best therapy tailored fit to a single individual. The ability to access EAP data is helpful to the development of this platform”
said Saran Saund, CEO of PointR Data, which is becoming a wholly owned subsidiary of Mateon Therapeutics Inc.. “We are thrilled
at the opportunity of vertically integrating artificial intelligence and drug development capabilities under one roof to quickly
identify promising new therapeutic opportunities for various diseases and to deliver compelling business value.”
“We
built WideTrial to solve the economic and operational barriers that drug developers face with Expanded Access,” said Jess
Rabourn, CEO of WideTrial. “The new platform enables larger numbers of gravely ill patients to choose to try investigational
medicines under a properly designed protocol. Although treatment is the primary objective, EAP sponsors can learn a lot from patients’
experiences in these programs.”
About
Mateon Therapeutics
Mateon
was created by the recent reverse merger with Oncotelic which became a wholly owned subsidiary of Mateon Therapeutics Inc.
(OTCQB: MATN) creating an immune-oncology company dedicated to the development of first in class RNA therapeutics as well as
small molecule drugs against cancer. OT-101, the lead immune-oncology drug candidate of Mateon, is a first-in-class RNA
therapeutic targeting TGF beta that exhibited single agent activity in some relapsed/refractory cancer patients in clinical
trial settings. The founding team of Oncotelic was responsible for the development of Abraxane as chemotherapeutic agents for
breast, lung, melanoma, and pancreatic cancer. Abraxane was approved in 2005 and has $1B in sales annually and Cynviloq, a
next generation Abraxane, was acquired by NantPharma for $1.3B. Mateon will leverage its deep expertise in oncology and RNA
therapeutic drug development to improve treatment outcomes and survival of cancer patients. For more information, please
visit www.oncotelic.com or www.mateon.com.
About
WideTrial Inc.
WideTrial
is clinical data company in Silicon Valley serving as a specialist, third-party sponsor of data-generating cohort Expanded Access
programs (EAPs). More information is available at www.widetrial.com.
About
PointR Data Inc.
PointR
is a revenue generating stage AI company with a revolutionary cluster-computer platform for AI that crunches machine learning
models at a fraction of the power and budget of mainstream computing. It provides for an AI computing platform for pharmaceutical
and healthcare verticals including blockchain support for clinical and manufacturing where data integrity and security are of
utmost importance. PointR is composed of a team of seasoned Silicon Valley executives. PointR CEO, Saran Saund has been founder,
CEO and GM at several startups and public companies. He has returned significant value to shareholders in his startups. Chief
technology officer, Burcak Beser has been founder and CTO of several successful private and public companies with over 144 patents
during his career. For additional information please visit www.pointr.ai
About
Mateon’s Lead Product Candidate, OT-101
High-grade
gliomas (HGG) are characterized by a T-cell exhaustion signature and pronounced T-cell hyporesponsiveness of their tumor microenvironment
(TME). Transforming growth factor beta 2 (TGFB2) has been implicated as a key contributor to the immunosuppressive landscape of
the TME in HGG. OT-101, a TGFB2-specific first-in-class RNA therapeutic designed to abrogate the immunosuppressive actions of
TGFB2. In a completed Phase 2 clinical study, OT-101 exhibited clinically meaningful single-agent activity and induces durable
complete and partial responses in recurrent and refractory adult HGG patients, including young adults with GBM or AA. Efficacy
was also demonstrated in treatment failure pancreatic cancer patients and melanoma patients, suggesting that OT-101 is effective
among all solid tumors overexpressing TGF-beta.
Mateon’s
Cautionary Note on Forward-Looking Statements
This
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
All statements, other than statements of historical facts, included in this communication regarding strategy, future operations,
future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as “may”,
“expect”, “anticipate” “hope”, “vision”, “optimism”, “design”,
“exciting”, “promising”, “will”, “conviction”, “estimate,” “intend,”
“believe” and similar expressions are intended to identify forward-looking statements. Forward-looking statements
contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical
development, scope and success of future clinical trials, the reporting of clinical data for the company’s product candidates
and the potential use of the company’s product candidates to treat various cancer indications. Statements concerning the
anticipated completion of the proposed merger, the anticipated success of the PointR technology, or the benefits expected to be
gained from the merger are all forward-looking statements. Each of these forward-looking statements involves risks and uncertainties
and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current
expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies,
clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition,
changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and
unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including
the risk factors described in the company’s annual report on Form 10-K filed with the SEC on April 10, 2019 and in the company’s
other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release.
Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to
reflect any change in expectations, whether as a result of new information future events, or otherwise.
Contact
Information:
Mateon
Amit
Shah
Email:
ashah@oncotelic.com
PointR
Data
Saran
Saund
Email:
saran@pointr.ai
WideTrial
Ian
Manger, Ph.D.
Email:
ian.manger@widetrial.com