Document:

Blueprint

Exhibit 10.1

 

Confidential Treatment Requested by Cellular Biomedicine Group,
Inc.

IRS Employer Identification No. 86-1032927

Confidential treatment requested with respect to certain portions
hereof denoted with “[***]”

 

PUBLIC HEALTH SERVICE

 

PATENT LICENSE AGREEMENT NONEXCLUSIVE - SUBLICENSABLE

 

This
Agreement is based on the
model Patent License Non-Exclusive Sublicensable Agreement adopted
by the U.S. Public Health Service (“PHS”) Technology Transfer Policy
Board for use by components of the National Institutes of Health
(“NIH”), the
Centers for Disease Control and Prevention (“CDC”), and the Food and Drug
Administration (“FDA”), which are agencies of the
PHS within the Department of
Health and Human Services (“HHS”).

 

 

 

This
Cover Page identifies the Parties to this Agreement:

 

 

 

The
U.S. Department of Health and Human Services, as represented
by

 

National
Cancer Institute (“NCI”)

 

an
Institute or Center (hereinafter referred to as the
“IC”) of
the

 

NIH

 

 

 

and

 

 

 

Cellular
Biomedicine Group, Inc.,

 

hereinafter
referred to as the “Licensee”,

 

having
offices at 19925 Stevens Creek Blvd., Suite 100, Cupertino, CA
95014,

 

created
and operating under the laws of Delaware.

 

Tax ID
No.: 86-1032927

 

 

 

 

 

 

 

 

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Confidential Treatment Requested by Cellular Biomedicine Group,
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IRS Employer Identification No. 86-1032927

Confidential treatment requested with respect to certain portions
hereof denoted with “[***]”

 

 

For the
IC internal use
only:

 

License
Number:

 

License
Application Number: A-491-2018

 

Serial
Number(s) of Licensed Patent(s) or Patent
Application(s):

 

[***]

 

 

Licensee: Cellular
Biomedicine Group, Inc.

 

Cooperative
Research and Development Agreement (CRADA) Number (if a subject
invention): N/A

 

Additional Remarks:
None

 

Public
Benefit(s): New therapeutic options for the treatment of
cancer.

 

This
Patent License Agreement, hereinafter referred to as the
“Agreement”,
consists of this Cover Page, an attached Agreement, a Signature Page, Appendix A
(List of Patent(s) or Patent Application(s)), Appendix B (Fields of
Use and Territory), Appendix C (Royalties), Appendix D ((Benchmarks
and Performance), Appendix E (Commercial Development Plan),
Appendix F (Example Royalty Report), and Appendix G (Royalty
Payment Options.

 

 

 

 

 

 

 

 

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IRS Employer Identification No. 86-1032927

Confidential treatment requested with respect to certain portions
hereof denoted with “[***]”

 

 

The
IC and the Licensee agree as follows:

 

1.

BACKGROUND

 

1.1 

In the course of
conducting biomedical and behavioral research, the IC investigators made inventions that
may have commercial applicability.

 

1.2

By assignment of
rights from the IC employees
and other inventors, HHS, on
behalf of the Government,
owns intellectual property rights claimed in any United States or
foreign patent applications or patents corresponding to the
assigned inventions. HHS
also owns any tangible embodiments of these inventions actually
reduced to practice by the IC.

 

1.3

The Secretary of
HHS has delegated to the
IC the authority to enter
into this Agreement for the
licensing of rights to these inventions under 35 U.S.C. §§200-212,
the Federal Technology
Transfer Act of 1986, 15 U.S.C. §3710(a), and
the regulations governing the licensing of Government-owned
inventions, 37 C.F.R.
Part 404.

 

1.4

The IC desires to transfer these inventions
to the private sector through commercialization licenses to
facilitate the commercial development of products and processes for
public use and benefit.

 

1.5

The Licensee desires to acquire
commercialization rights to certain of these inventions in order to
develop processes, methods, or marketable products for public use
and benefit.

 

2.

DEFINITIONS

 

2.1 

“Affiliate(s)” means a corporation
or other business entity, which directly or indirectly is
controlled by or controls, or is under common control with the
Licensee. For this purpose,
the term "control" shall mean (a) ownership of more than fifty
percent (50%) of the voting stock or other ownership interest of
the corporation or other business entity, (b) the power to elect or
appoint more than fifty percent (50%) of the members of the
governing body of the corporation or other business entity, or (c)
the powers to direct or cause the direction of the management or
policies of the corporation or other business entity by contract,
agreement or otherwise.

 

2.2

“Benchmarks” mean the performance
milestones that are set forth in Appendix D.

 

2.3

“Commercial Development Plan” means
the written commercialization plan attached as Appendix
E.

 

2.4

“First Commercial Sale” means the
initial transfer by or on behalf of the Licensee or its sublicensees of the
Licensed Products or the
initial practice of a Licensed
Process by or on behalf of the Licensee or its sublicensees in exchange
for cash or some equivalent to which value can be assigned for the
purpose of determining Net
Sales.

 

2.5

“Government” means the Government
of the United States of America.

 

2.6

“Licensed Fields of Use” means the
fields of use identified in Appendix B.

 

 

 

 

 

 

 

 

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2.7

“Licensed Patent Rights” shall
mean:

 

(a)

Patent applications
(including provisional patent applications and PCT patent
applications) or patents listed in Appendix A, all divisions and
continuations of these applications, all patents issuing from these
applications, divisions, and continuations, and any reissues,
reexaminations, and extensions of all these patents;

 

(b)

to the extent that
the following contain one or more claims directed to the invention
or inventions disclosed in 2.7(a):

 

(i)

continuations-in-part
of 2.7(a);

 

(ii)

all divisions and
continuations of these continuations-in-part;

 

(iii)

all patents issuing
from these continuations-in-part, divisions, and
continuations;

 

(iv)

priority patent
application(s) of 2.7(a); and

 

(v)

any reissues,
reexaminations, and extensions of all these patents;

 

(c)

to the extent that
the following contain one or more claims directed to the invention
or inventions disclosed in 2.7(a): all counterpart foreign and U.S.
patent applications and patents to 2.7(a) and 2.7(b), including
those listed in Appendix A; and

 

(d)

Licensed Patent Rights shall
not include 2.7(b) or
2.7(c) to the extent that they contain one or more claims directed
to new matter which is not the subject matter disclosed in
2.7(a).

 

2.8

“Licensed Processes” means
processes, which in the course of being practiced, would be within
the scope of one or more Valid
Claims of one or more patents or pending patent applications
contained within the Licensed
Patent Rights.

 

2.9

“Licensed Products” means tangible
materials, which in the course of manufacture, use, sale, or
importation, would be within the scope of one or more Valid Claims of one or more patents or
pending patent applications contained within the Licensed Patent Rights.

 

2.10

“Licensed Territory” means the
geographical area identified in Appendix B.

 

2.11

“Net Sales” means the total gross
receipts for sales of Licensed
Products or practice of Licensed Processes by or on behalf of
the Licensee or its
sublicensees, and from leasing, renting, or otherwise making
Licensed Products available
to others without sale or other dispositions, whether invoiced or
not, less:

 

(a)

trade, cash and
quantity discounts, including charge backs, rebates, premiums,
allowances and any other deduction actually granted (not to exceed
the original billing);

 

 

 

 

 

 

 

 

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Confidential treatment requested with respect to certain portions
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(b)

sales and excise
taxes and duties and other governmental charges imposed upon the
importation, use or sale of the Licensed Products or Licensed Processes actually
charged;

 

(c)

freight, insurance
and other transportation charges actually charged; and

 

(d)

amounts repaid or
credited (not to exceed the original billing) by reason of
rejections, defects, outdating, price differences, recalls,
returns, or because of retroactive price reductions or due to
governmental laws or regulations required requiring rebates
actually granted; calculated, in all cases, in accordance with US
Generally Accepted Accounting Principles (GAAP).

 

No
deductions shall be made for commissions paid to individuals,
whether they are with independent sales agencies or regularly
employed by the Licensee, or
its sublicensees, and on its payroll, or for the cost of
collections.

 

For
clarity, only sales of Licensed
Products or practice of Licensed Processes to persons and
entities other than a) Licensee, b) Affiliates and c) sublicensees are to be
included in Net Sales. Sales
of Licensed Products or
practice of Licensed
Processes between Affiliates, Licensee and/or sublicensees are not to
be included within Net
Sales, unless such Affiliate or sublicensee are the end
user(s) of Licensed Products
or Licensed Processes, and
further provided that subsequent sales from such Affiliates or sublicensees to third
parties shall be included within Net Sales.

 

2.12

“Phase 1 Clinical Study” shall mean
the initial introduction of an investigational new drug into
humans, the principal purpose of which is to determine the
metabolism and pharmacologic actions of the drug in humans, the
side effects associated with increasing doses, and, if possible, to
gain early evidence on effectiveness, in compliance with 21 C.F.R.
§312(a) or foreign equivalent.

 

2.13

“Phase 2 Clinical Study” shall mean
controlled human clinical studies conducted to evaluate the
effectiveness of a drug for a particular indication or indications
in patients with the disease or condition under study and to
determine the common short-term side effects and risks associated
with the drug in compliance with 21 C.F.R. §312(b) or foreign
equivalent, and shall include any clinical study that leads to a
conditional regulatory approval, that is followed by a confirmatory
Phase 3 Clinical Study.

 

2.14

“Practical Application” means to
manufacture in the case of a composition or product, to practice in
the case of a process or method, or to operate in the case of a
machine or system; and in each case, under these conditions as to
establish that the invention is being utilized and that its
benefits are to the extent permitted by law or Government regulations available to the
public on reasonable terms.

 

 

 

 

 

 

 

 

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Confidential Treatment Requested by Cellular Biomedicine Group,
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IRS Employer Identification No. 86-1032927

Confidential treatment requested with respect to certain portions
hereof denoted with “[***]”

 

  

 

2.15

“Valid Claims” means the later of
(a) a claim of any issued and unexpired patent within the
Licensed Patent Rights; or
(b) a claim of a pending patent application within the Licensed Patent Rights that has been
pending for no more than five (5) years after the first official
office action on its merits and, in each case has not been (i)
permanently revoked or held unpatentable, invalid or unenforceable
by a final decision of a court or governmental agency of competent
jurisdiction, which decision can no longer be appealed or was not
appealed within the time allowed, (ii) rendered unenforceable
through disclaimer or otherwise, (iii) abandoned or (iv)
permanently lost through an interference or opposition proceeding
without any right of appeal or review.

 

3.

GRANT OF RIGHTS

 

3.1 

The IC hereby grants and the Licensee accepts, subject to the terms
and conditions of this Agreement, a nonexclusive sublicensable
license under Licensed Patent
Rights in the Licensed
Territory to make and have made, to use and have used, to
sell and have sold, to offer to sell, and to import any
Licensed Products in the
Licensed Fields of Use and
to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

 

3.2

This Agreement confers no license or rights
by implication, estoppel, or otherwise under any patent
applications or patents of the IC other than the Licensed Patent Rights regardless of
whether these patents are dominant or subordinate to the
Licensed Patent
Rights.

 

4.

SUBLICENSING

 

4.1 

Upon written
approval, which shall include prior review of any sublicense
agreement by the IC and
which shall not be unreasonably withheld, the Licensee may enter into sublicensing
agreements under the Licensed
Patent Rights only when it concurrently licenses proprietary
or in-licensed intellectual property rights. For the avoidance of
doubt, the Licensee does not
have the right to solely sublicense the Licensed Patent Rights.

 

4.2

The Licensee agrees that any sublicenses
granted by it shall provide that the obligations to the
IC of Paragraphs 5.1, 5.2,
8.1, 10.1, 10.2, 12.6, and 13.7-13.9 of this Agreement shall be binding upon the
sublicensee as if it were a party to this Agreement. The Licensee further agrees to attach copies
of these Paragraphs to all sublicense agreements.

 

4.3

Any sublicenses
granted by the Licensee
shall provide for the termination of the sublicense, or the
conversion to a license directly between the sublicensees and the
IC, at the option of the
sublicensee, upon termination of this Agreement under Article 13. This
conversion is subject to the IC approval and contingent upon
acceptance by the sublicensee of the remaining provisions of this
Agreement.

 

4.4

The Licensee agrees to forward to the
IC a complete copy of each
fully executed sublicense agreement postmarked within thirty (30)
days of the execution of the agreement. To the extent permitted by
law, the IC agrees to
maintain each sublicense agreement in confidence.

 

4.5

The Licensee may enter into sublicensing
agreements under the Licensed
Patent Rights with Affiliates of Licensee, and Paragraph 4.1 and the
sublicense royalty obligation specified in Paragraph V of Appendix
C of this Agreement shall not apply to such
Affiliate
sublicense(s).

 

 

 

 

 

 

 

 

 

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Confidential Treatment Requested by Cellular Biomedicine Group,
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IRS Employer Identification No. 86-1032927

Confidential treatment requested with respect to certain portions
hereof denoted with “[***]”

 

  

 

5.

STATUTORY AND NIH REQUIREMENTS AND RESERVED GOVERNMENT
RIGHTS

 

5.1 

Prior to the
First Commercial Sale, the
Licensee agrees to provide
the IC with reasonable
quantities of Licensed
Products or materials made through the Licensed Processes for the IC’s research use.

 

5.2

The Licensee agrees that products used or
sold in the United States embodying Licensed Products or produced through
use of Licensed Processes
shall be manufactured substantially in the United States, unless a
written waiver is obtained in advance from the IC.

 

6.

ROYALTIES AND REIMBURSEMENT

 

6.1 

The Licensee agrees to pay the IC a non-creditable, non-refundable
license issue royalty as set forth in Appendix C.

 

6.2

The Licensee agrees to pay the IC a minimum annual royalty as set forth
in Appendix C.

 

6.3

The Licensee agrees to pay the IC earned royalties as set forth in
Appendix C.

 

6.4

The Licensee agrees to pay the IC benchmark royalties as set forth in
Appendix C.

 

6.5

The Licensee agrees to pay the IC sublicense royalties as set forth in
Appendix C.

 

6.6

A patent or patent
application licensed under this Agreement shall cease to fall within the
Licensed Patent Rights for
the purpose of computing earned royalty payments in any given
country on the earliest date that a Valid Claim no longer exists. For the
avoidance of doubt, if a patent application pending for more than
five (5) years from the first official office action on its merits
later issues as a patent, Licensee shall pay any earned royalties
that would have been owed if such pending application had been
included within the Licensed Patent
Rights for the entire duration of its pendency.

 

6.7

No multiple
royalties shall be payable because any Licensed Products or Licensed Processes are covered by more
than one of the Licensed Patent
Rights.

 

6.8

On sales of
Licensed Products by the
Licensee to sublicensees or
on sales made in other than an arms-length transaction, the value
of the Net Sales attributed
under this Article 6 to this transaction shall be that which would
have been received in an arms-length transaction, based on sales of
like quantity and quality products on or about the time of this
transaction.

 

6.9

Reserved

 

 

 

 

 

 

 

 

 

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Confidential treatment requested with respect to certain portions
hereof denoted with “[***]”

 

  

 

6.10

With regard to
unreimbursed expenses associated with the preparation, filing,
prosecution, and maintenance of all patent applications and patents
included within the Licensed Patent
Rights and paid by the IC on or after the effective date of
this Agreement, the
IC, at its sole option, may
require the Licensee:

 

(a)

to pay the
IC on an annual basis,
within [*** ]of the
IC's submission of a
statement and request for payment, a royalty amount equivalent to
the lesser of (i) [***] of
these unreimbursed expenses paid during the previous calendar
year(s) or (ii) a pro-rated portion of such unreimbursed expenses
calculated by dividing the total patent costs paid during the
previous calendar year(s) by the number of commercialization
licensees of record whose licenses have a Licensed Field of Use which includes the
development of therapeutic or diagnostic products and falls within
the scope of the Licensed Patent
Rights as of the date of this statement;

 

(b)

to pay these
unreimbursed expenses directly to the law firm employed by the
IC to handle these
functions. However, in this event, the IC and not the Licensee shall be the client of the law
firm; or

 

(c)

under exceptional
circumstances, the Licensee
may be given the right to assume responsibility for the
preparation, filing, prosecution, or maintenance of any patent
application or patent included with the Licensed Patent Rights. In that event,
the Licensee shall directly
pay the attorneys or agents engaged to prepare, file, prosecute, or
maintain these patent applications or patents and shall provide the
IC with copies of each
invoice associated with these services as well as documentation
that these invoices have been paid.

 

6.11

The IC agrees, upon written request, to
provide the Licensee with
summaries of patent prosecution invoices for which the IC has requested payment from the
Licensee under Paragraph
6.10. The Licensee agrees
that all information provided by the IC related to patent prosecution costs
shall be treated as confidential commercial information and shall
not be released to a third party except as required by law or a
court of competent jurisdiction.

 

6.12

The Licensee may elect to surrender its
rights in any country of the Licensed Territory under any of the
Licensed Patent Rights upon
[***] written notice to the
IC and owe no payment
obligation under Paragraph 6.10 for patent-related expenses paid in
that country after the effective date of the written
notice.

 

7.

PATENT FILING, PROSECUTION, AND MAINTENANCE

 

7.1 

The IC agrees to take responsibility for the
preparation, filing, prosecution, and maintenance of any and all
patent applications or patents included in the Licensed Patent Rights.

 

 

 

 

 

 

 

 

 

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IRS Employer Identification No. 86-1032927

Confidential treatment requested with respect to certain portions
hereof denoted with “[***]”

 

  

 

8.

RECORD KEEPING

 

8.1 

The Licensee agrees to keep accurate and
correct records of Licensed
Products made, used, sold, or imported and Licensed Processes practiced under this
Agreement appropriate to
determine the amount of royalties due the IC. These records shall be retained for
at least five (5) years following a given reporting period and
shall be available during normal business hours for inspection, at
the expense of the IC, by an
accountant or other designated auditor selected by the IC for the sole purpose of verifying
reports and royalty payments hereunder. Such inspections shall be
limited to once per calendar year. The accountant or auditor shall
only disclose to the IC
information relating to the accuracy of reports and royalty
payments made under this Agreement. If an inspection shows an
underreporting or underpayment in excess of [***] for any [***] period, then the Licensee shall reimburse the
IC [***] at the time the Licensee pays the unreported royalties,
including any additional royalties as required by Paragraph 9.8.
All royalty payments required under this Paragraph shall be due
within [***] of the date the
IC provides the Licensee notice of the payment
due.

 

9.

REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS

 

9.1 

Prior to signing
this Agreement, the
Licensee has provided the
IC with the Commercial Development Plan in Appendix
E, under which the Licensee
intends to bring the subject matter of the Licensed Patent Rights to the point of
Practical Application. This
Commercial Development Plan
is hereby incorporated by reference into this Agreement. Based on this plan,
performance Benchmarks are
determined as specified in Appendix D.

 

9.2

The Licensee shall provide written annual
reports on its product development progress or efforts to
commercialize under the Commercial
Development Plan for each of the Licensed Fields of Use within
[***] after December 31 of
each calendar year. These progress reports shall include, but not
be limited to: progress on research and development, status of
applications for regulatory approvals, manufacture and status of
sublicensing, marketing, importing, and sales during the preceding
calendar year, as well as, plans for the present calendar year. The
IC also encourages these
reports to include information on any of the Licensee’s public service
activities that relate to the Licensed Patent Rights. If reported
progress differs from that projected in the Commercial Development Plan and
Benchmarks, the Licensee shall explain the reasons for
such differences. In any annual report, the Licensee may propose amendments to the
Commercial Development Plan,
acceptance of which by the IC may not be denied unreasonably. The
Licensee agrees to provide
any additional information reasonably required by the IC to evaluate the Licensee’s performance under this
Agreement. The Licensee may amend the Benchmarks at any time upon written
approval by the IC. The
IC shall not unreasonably
withhold approval of any request of the Licensee to extend the time periods of
this schedule if the request is supported by a reasonable showing
by the Licensee of diligence
in its performance under the Commercial Development Plan and toward
bringing the Licensed
Products to the point of Practical Application.

 

9.3

The Licensee shall report to the
IC the dates for achieving
Benchmarks specified in
Appendix D and the First Commercial
Sale in each country in the Licensed Territory within [***] of such occurrences.

 

 

 

 

 

 

 

 

 

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9.4

The Licensee shall submit to the
IC, within [***] after each [***], beginning with the First Commercial Sale, a royalty report,
as described in the example in Appendix F, setting forth for the
preceding the amount of the Licensed Products sold or Licensed Processes practiced by or on
behalf of the Licensee in
each country within the Licensed
Territory, the Net
Sales, and the amount of royalty accordingly due. With each
royalty report, the Licensee
shall submit payment of earned royalties due. If no earned
royalties are due to the IC
for any reporting period, the written report shall so state. The
royalty report shall be certified as correct by an authorized
officer of the Licensee and
shall include a detailed listing of all deductions made under
Paragraph 2.11 to determine Net
Sales made under Article 6 to determine royalties
due.

 

9.5

The Licensee agrees to forward [***] to the IC a copy of these reports received by
the Licensee from its
sublicensees during the preceding [***] as shall be pertinent to a royalty
accounting to the IC by the
Licensee for activities
under the sublicense.

 

9.6

Royalties due under
Article 6 shall be paid in U.S. dollars and payment options are
listed in Appendix G. For conversion of foreign currency to U.S.
dollars, the conversion rate shall be the New York foreign exchange
rate quoted in The Wall Street
Journal on the day that the payment is due, and any loss of
exchange, value, taxes, or other expenses incurred in the transfer
or conversion to U.S. dollars shall be paid entirely by the
Licensee. The royalty report
required by Paragraph 9.4 shall be mailed to the IC at its address for Agreement Notices indicated on the
Signature Page.

 

9.7

The Licensee shall be solely responsible for
determining if any tax on royalty income is owed outside the United
States and shall pay this tax and be responsible for all filings
with appropriate agencies of foreign governments.

 

9.8

Additional
royalties may be assessed by the IC on any payment that is more than
[***] overdue at the rate of
[***]. This [***] rate may be applied retroactively
from the original due date until the date of receipt by the
IC of the overdue payment
and additional royalties. The payment of any additional royalties
shall not prevent the IC
from exercising any other rights it may have as a consequence of
the lateness of any payment.

 

9.9

All plans and
reports required by this Article 9 and marked
“confidential” by the Licensee shall, to the extent permitted
by law, be treated by the IC
as commercial and financial information obtained from a person and
as privileged and confidential, and any proposed disclosure of
these records by the IC
under the Freedom of Information Act (FOIA), 5 U.S.C. §552 shall be
subject to the predisclosure notification requirements of
45 C.F.R.
§5.65(d).

 

10.

PERFORMANCE

 

10.1 

The Licensee shall use its reasonable
commercial efforts to bring the Licensed Products and Licensed Processes to Practical Application. “Reasonable
commercial efforts” for the purposes of this provision shall
include substantial adherence to the Commercial Development Plan in Appendix
E and performance of the Benchmarks in Appendix D. The efforts of
a sublicensee shall be considered the efforts of the Licensee.

 

 

 

 

 

 

 

 

 

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IRS Employer Identification No. 86-1032927

Confidential treatment requested with respect to certain portions
hereof denoted with “[***]”

 

  

 

10.2

Upon the
First Commercial Sale, until
the expiration or termination of this Agreement, the Licensee shall use its reasonable
commercial efforts to make Licensed
Products and Licensed
Processes reasonably accessible to the United States
public.

 

 

10.3

The Licensee agrees, after its First Commercial Sale, to make
reasonable quantities of Licensed
Products or materials produced through the use of
Licensed Processes available
to patient assistance programs.

 

10.4

The Licensee agrees, after its First Commercial Sale and as part of its
marketing and product promotion, to develop educational materials
(e.g., brochures, website, etc.) directed to patients and
physicians detailing the Licensed
Products or medical aspects of the prophylactic and
therapeutic uses of the Licensed
Products.

 

10.5

The Licensee agrees to supply, to the
Mailing Address for Agreement Notices indicated on the
Signature Page, the Office of Technology Transfer, NIH with inert samples of the
Licensed Products or
Licensed Processes or their
packaging for educational and display purposes only.

 

11.

INFRINGEMENT AND PATENT ENFORCEMENT

 

11.1 

The IC and the Licensee agree to notify each other
promptly of each infringement or possible infringement of the
Licensed Patent Rights, as
well as, any facts which may affect the validity, scope, or
enforceability of the Licensed
Patent Rights of which either Party becomes
aware.

 

11.2

Pursuant to this
Agreement and the provisions
of 35 U.S.C. Part
29 the Licensee
may:

 

(a)

bring suit in its
own name, at its own expense, and on its own behalf for
infringement of presumably valid claims in the Licensed Patent Rights;

 

(b)

in any suit, enjoin
infringement and collect for its use, damages, profits, and awards
of whatever nature recoverable for the infringement;
or

 

(c)

settle any claim or
suit for infringement of the Licensed Patent Rights provided,
however, that the IC and
appropriate Government
authorities shall have the first right to take such actions;
and

 

(d)

if the Licensee desires to initiate a suit for
patent infringement, the Licensee shall notify the IC in writing. If the IC does not notify the Licensee of its intent to pursue legal
action within [***], the
Licensee shall be free to
initiate suit. The IC shall
have a continuing right to intervene in the suit. The Licensee shall take no action to compel
the Government either to
initiate or to join in any suit for patent infringement. The
Licensee may request the
Government to initiate or
join in any suit if necessary to avoid dismissal of the suit.
Should the Government be
made a party to any suit, the Licensee shall reimburse the
Government for any costs,
expenses, or fees which the Government incurs as a result of the
motion or other action. In all cases, the Licensee agrees to keep the IC reasonably apprised of the status and
progress of any litigation. Before the Licensee commences an infringement
action, the Licensee shall
notify the IC and give
careful consideration to the views of the IC and to any potential effects of the
litigation on the public health in deciding whether to bring
suit.

 

 

 

 

 

 

 

 

 

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IRS Employer Identification No. 86-1032927

Confidential treatment requested with respect to certain portions
hereof denoted with “[***]”

 

  

 

11.3

Any recovery,
whether by way of settlement or judgment, from a third party
pursuant to a legal proceeding initiated hereunder shall first be
used to reimburse the actual fees, costs and expenses incurred by
the parties in connection with such proceeding. The balance of such
recovery shall be treated as Net
Sales and subject to earned royalties pursuant to Appendix C
of this Agreement.

 

11.4

In the event
IC or Licensee initiates or defends a legal
proceeding concerning any Licensed
Patent Rights, the other party shall supply all reasonable
assistance reasonably requested by the party initiating such
proceeding.

 

11.5

In the event that a
declaratory judgment action alleging invalidity of any of the
Licensed Patent Rights shall
be brought against the IC,
the IC agrees to notify the
Licensee that an action
alleging invalidity has been brought. The IC does not represent that it shall
commence legal action to defend against a declaratory action
alleging invalidity. If the IC elects not to defend against such an
action, the Licensee (a) may
defend the suit in its own name, at its own expense, and on its own
behalf for presumably Valid
Claims in the Licensed
Patent Rights hereunder; (b) in any such suit, ultimately
may enjoin infringement and collect damages, profits and awards of
whatever nature recoverable for such infringement; and (c) settle
any claim or suit for declaratory infringement involving the
Licensed Patent Rights;
provided, however, that the IC and appropriate Government authorities shall have a
continuing right to intervene in such suit. The Licensee shall take no action to compel
the Government either to
initiate or to join in any declaratory judgment action. Should the
Government be made a party
to any suit by motion or any other action of the Licensee, the Licensee shall reimburse the
Government for any costs,
expenses, or fees, which the Government incurs as a result of the
motion or other action. Upon the Licensee's payment of all costs incurred
by the Government as a
result of the Licensee's
joinder motion or other action, these actions by the Licensee shall not be considered a
default in the performance of any material obligation under this
Agreement.

 

12.

NEGATION OF WARRANTIES AND INDEMNIFICATION

 

12.1 

The IC offers no warranties other than those
specified in Article 1.

 

12.2

The IC represents that it owns the
Licensed Patent Rights in
the Licensed Fields of Use
and is duly authorized to enter into this Agreement on the terms and conditions
herein set forth.

 

12.3

The IC does not warrant the validity of the
Licensed Patent Rights and
makes no representations whatsoever with regard to the scope of the
Licensed Patent Rights, or
that the Licensed Patent
Rights may be exploited without infringing other patents or
other intellectual property rights of third parties.

 

12.4

THE IC MAKES NO WARRANTIES, EXPRESSED OR
IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF
ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THE LICENSED PATENT RIGHTS OR TANGIBLE
MATERIALS RELATED THERETO.

 

12.5

The IC does not represent that it shall
commence legal actions against third parties infringing the
Licensed Patent
Rights.

 

 

 

 

 

 

 

 

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12.6

The Licensee shall indemnify and hold the
IC, its employees, students,
fellows, agents, and consultants harmless from and against all
liability, demands, damages, expenses, and losses, including but
not limited to death, personal injury, illness, or property damage
in connection with or arising out of:

 

(a)

the use by or on
behalf of the Licensee, its
sublicensees, its directors, employees, or third parties of any
Licensed Patent Rights;
or

 

(b)

the design,
manufacture, distribution, or use of any Licensed Products, Licensed Processes or materials by the
Licensee, or other products
or processes developed in connection with or arising out of the
Licensed Patent
Rights.

 

12.7

The Licensee agrees to maintain a liability
insurance program consistent with sound business
practice.

 

13.

TERM, TERMINATION, AND MODIFICATION OF RIGHTS

 

13.1 

This Agreement is effective when signed by
all parties, unless the provisions of Paragraph 14.15 are not
fulfilled, and shall extend to the expiration of the last to expire
of the Licensed Patent
Rights unless sooner terminated as provided in this Article
13.

 

13.2

In the event that
the Licensee is in default
in the performance of any material obligations under this
Agreement, including but not
limited to the obligations listed in Paragraph 13.5, and if the
default has not been remedied within [***] after the date of notice in
writing of the default, the IC may terminate this Agreement by written notice and pursue
outstanding royalties owed through procedures provided by the
Federal Debt Collection
Act.

 

13.3

In the event that
the Licensee becomes
insolvent, files a petition in bankruptcy, has such a petition
filed against it, determines to file a petition in bankruptcy, or
receives notice of a third party’s intention to file an
involuntary petition in bankruptcy, the Licensee shall immediately notify the
IC in writing.

 

13.4

The Licensee shall have a unilateral right
to terminate this Agreement
in any country or territory by giving the IC [***] written notice to that
effect.

 

13.5

The IC shall specifically have the right to
terminate or modify, at its option, this Agreement, if the IC determines that the Licensee:

 

(a)

is not using
reasonable commercial efforts, as defined in Paragraph 10.1, in
executing the Commercial
Development Plan submitted with its request for a license
and the Licensee cannot
otherwise demonstrate to the IC’s satisfaction that the
Licensee has taken, or can
be expected to take within a reasonable time, effective steps to
achieve Practical
Application of the Licensed
Products or Licensed
Processes;

 

(b)

has not achieved
the Benchmarks as may be
modified under Paragraph 9.2;

 

(c)

has willfully made
a false statement of, or willfully omitted, a material fact in the
license application or in any report required by this Agreement;

 

 

 

 

 

 

 

 

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(d)

has committed a
material breach of a covenant or agreement contained in this
Agreement;

 

(e)

is not keeping
Licensed Products or
Licensed Processes
reasonably available to the public after commercial use
commences;

 

(f)

cannot reasonably
satisfy unmet health and safety needs; or

 

(g)

cannot reasonably
justify a failure to comply with the domestic production
requirement of Paragraph 5.2, unless waived.

 

13.6

In making the
determination referenced in Paragraph 13.5, the IC shall take into account the normal
course of such commercial development programs conducted with sound
and reasonable business practices and judgment and the annual
reports submitted by the Licensee under Paragraph 9.2. Prior to
invoking termination or modification of this Agreement under Paragraph 13.5, the
IC shall give written notice
to the Licensee providing
the Licensee specific notice
of, and a [***] opportunity
to respond to, the IC’s concerns as to the items
referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the
IC’s concerns as to
the items referenced in 13.5(a)-13.5(g) or fails to initiate
corrective action to the IC’s satisfaction, the
IC may terminate this
Agreement.

 

13.7

 The
IC reserves the right
according to 35 U.S.C.
§209(d)(3) to terminate or modify this Agreement if it is determined that the
action is necessary to meet the requirements for public use
specified by federal regulations issued after the date of the
license and these requirements are not reasonably satisfied by the
Licensee.

 

13.8

Within [***] of receipt of written notice of
the IC’s unilateral
decision to modify or terminate this Agreement, the Licensee may, consistent with the
provisions of 37 C.F.R.
§404.11, appeal the decision by written submission to
the designated the IC
official. The decision of the designated IC official shall be the final agency
decision. The Licensee may
thereafter exercise any and all administrative or judicial remedies
that may be available.

 

13.9

Within [***] of expiration or termination of
this Agreement under this
Article 13, a final report shall be submitted by the Licensee. Any royalty payments,
including those incurred but not yet paid (such as the full minimum
annual royalty), and those related to patent expense, due to the
IC shall become immediately
due and payable upon termination or expiration. If terminated under
this Article 13, sublicensees may elect to convert their
sublicenses to direct licenses with the IC pursuant to Paragraph 4.3. For a
period of [***] following
termination or expiration of this Agreement, the Licensee shall have the right to offer
for sale and sell any existing inventory of Licensed Products, subject to the
royalty obligations as set forth in Appendix C. After this
[***] period, the
Licensee shall return all
remaining Licensed Products
or other materials included within the Licensed Patent Rights to the
IC or provide the
IC with certification of the
destruction thereof. The Licensee may not be granted additional
IC licenses if the final
reporting requirement is not fulfilled.

 

 

 

 

 

 

 

 

 

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14.

GENERAL PROVISIONS

 

14.1 

Neither party may
waive or release any of its rights or interests in this
Agreement except in writing.
The failure of the Government to assert a right hereunder
or to insist upon compliance with any term or condition of this
Agreement shall not
constitute a waiver of that right by the Government or excuse a similar
subsequent failure to perform any of these terms or conditions by
the Licensee.

 

14.2

This Agreement constitutes the entire
agreement between the Parties relating to the subject matter of the
Licensed Patent Rights,
Licensed Products and
Licensed Processes, and all
prior negotiations, representations, agreements, and understandings
are merged into, extinguished by, and completely expressed by this
Agreement.

 

14.3

The provisions of
this Agreement are
severable, and in the event that any provision of this Agreement shall be determined to be
invalid or unenforceable under any controlling body of law, this
determination shall not in any way affect the validity or
enforceability of the remaining provisions of this Agreement.

 

14.4

If either party
desires a modification to this Agreement, the parties shall, upon
reasonable notice of the proposed modification by the party
desiring the change, confer in good faith to determine the
desirability of the modification. No modification shall be
effective until a written amendment is signed by the signatories to
this Agreement or their
designees.

 

14.5

The construction,
validity, performance, and effect of this Agreement shall be governed by Federal
law as applied by the Federal courts in the District of
Columbia.

 

14.6

All Agreement notices required or permitted
by this Agreement shall be
given by prepaid, first class, registered or certified mail or by
an express/overnight delivery service provided by a commercial
carrier, properly addressed to the other party at the address
designated on the Signature Page, or to any other address as may be
designated in writing by such other party. Agreement notices shall be considered
timely if such notices are received on or before the established
deadline date or sent on or before the deadline date as verifiable
by U.S. Postal Service postmark or dated receipt from a commercial
carrier. Parties should request a legibly dated U.S. Postal Service
postmark or obtain a dated receipt from a commercial carrier or the
U.S. Postal Service. Private metered postmarks shall not be
acceptable as proof of timely mailing.

 

14.7

This Agreement shall not be assigned or
otherwise transferred (including any transfer by legal process or
by operation of law, and any transfer in bankruptcy or insolvency,
or in any other compulsory procedure or order of court) except to
the Licensee’s
Affiliate(s) without the
prior written consent of the IC, which shall not be unreasonably
withheld. The parties agree that the identity of the parties is
material to the formation of this Agreement and that the obligations under
this Agreement are
nondelegable. In the event that the IC approves a proposed assignment, the
Licensee shall pay the
IC, as an additional
royalty, [***] of the fair
market value of any consideration received for any assignment of
this Agreement within
[***] of the
assignment.

 

 

 

 

 

 

 

 

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14.8

The Licensee agrees in its use of any
IC-supplied materials to
comply with all applicable statutes, regulations, and guidelines,
including NIH and
HHS regulations and
guidelines. The Licensee
agrees not to use the materials for research involving human
subjects or clinical trials in the United States without complying
with 21 C.F.R. Part
50 and 45 C.F.R.
Part 46. The Licensee
agrees not to use the materials for research involving human
subjects or clinical trials outside of the United States without
notifying the IC, in
writing, of the research or trials and complying with the
applicable regulations of the appropriate national control
authorities. Written notification to the IC of research involving human subjects
or clinical trials outside of the United States shall be given no
later than [***] prior to
commencement of the research or trials.

 

14.9

The Licensee acknowledges that it is subject
to and agrees to abide by the United States laws and regulations
(including the Export
Administration Act of 1979 and Arms Export Control Act)
controlling the export of technical data, computer software,
laboratory prototypes, biological materials, and other commodities.
The transfer of these items may require a license from the
appropriate agency of the Government or written assurances by the
Licensee that it shall not
export these items to certain foreign countries without prior
approval of the agency. The IC neither represents that a license is
or is not required or that, if required, it shall be
issued.

 

14.10

The Licensee agrees to mark the Licensed Products or their packaging
sold in the United States with all applicable U.S. patent numbers
and similarly to indicate “Patent Pending” status. All
Licensed Products
manufactured in, shipped to, or sold in other countries shall be
marked in a manner to preserve the IC patent rights in those
countries.

 

14.11

By entering into
this Agreement, the
IC does not directly or
indirectly endorse any product or service provided, or to be
provided, by the Licensee
whether directly or indirectly related to this Agreement. The Licensee shall not state or imply that
this Agreement is an
endorsement by the Government, the IC, any other Government organizational unit, or any
Government employee.
Additionally, the Licensee
shall not use the names of the IC, NIH, FDA, HHS, or the Government or their employees in any
advertising, promotional, or sales literature without the prior
written approval of the IC.

 

14.12

The Parties agree
to attempt to settle amicably any controversy or claim arising
under this Agreement or a
breach of this Agreement,
except for appeals of modifications or termination decisions
provided for in Article 13. The Licensee agrees first to appeal any
unsettled claims or controversies to the designated IC official, or designee, whose decision
shall be considered the final agency decision. Thereafter, the
Licensee may exercise any
administrative or judicial remedies that may be
available.

 

14.13

Nothing relating to
the grant of a license, nor the grant itself, shall be construed to
confer upon any person any immunity from or defenses under the
antitrust laws or from a charge of patent misuse, and the
acquisition and use of rights pursuant to 37 C.F.R. Part 404 shall not
be immunized from the operation of state or Federal law by reason
of the source of the grant.

 

14.14

Paragraphs 8.1,
9.7-9.9, 12.1, 12.3-12.6, 13.8, 13.9, 14.12 and 14.14 of this
Agreement shall survive
termination of this Agreement.

 

 

 

 

 

 

 

 

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14.15

The terms and
conditions of this Agreement
shall, at the IC’s
sole option, be considered by the IC to be withdrawn from the Licensee’s consideration and the
terms and conditions of this Agreement, and the Agreement itself to be null and
void, unless this
Agreement is
executed by the
Licensee and a fully
executed original is received by the IC within sixty (60) days from the date
of the IC signature found at
the Signature Page.

 

 

SIGNATURES BEGIN ON NEXT PAGE

 

 

 

 

 

 

 

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NIH PATENT LICENSE AGREEMENT
NONEXCLUSIVE - SUBLICENSABLE

 

SIGNATURE PAGE

 

For the
IC:

 

/s/ Richard U.
Rodriguez                                                                                      

September 21, 2018

Richard U.
Rodriguez,
MBA                                                                                      

Date

Associate
Director

Technology
Transfer Center, National Cancer Institute

National
Institutes of Health

 

Mailing
Address or E-mail Address for Agreement notices and
reports:

 

License
Compliance and Administration

Monitoring
& Enforcement

Office
of Technology Transfer

National
Institutes of Health

6011
Executive Boulevard, Suite 325

Rockville,
Maryland  20852-3804 U.S.A.

 

E-mail:
LicenseNotices_Reports@mail.nih.gov

 

For the
Licensee (Upon, information
and belief, the undersigned expressly certifies or affirms that the
contents of any statements of the Licensee made or referred to in this
document are truthful and accurate.):

 

by:

 

/s/ Bizuo (Tony)
Liu                                                                                      

October 2, 2018

Signature of
Authorized
Official                                                                                      

Date

 

Bizuo (Tony ) Liu

Printed
Name

 

Chief Executive Officer

Title

 

I.

Official and
Mailing Address for Agreement notices:

 

Andy
Chan                                                                       

 

Name

 

Secretary                                                                       

 

Title

 

 

 

 

 

 

 

 

 

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Mailing
Address

 

19925 Stevens Creek Blvd., Suite
100                                                                       

Cupertino, CA
95014                                                                       

 

Email
Address:                                                                                         

andy.chan@cellbiomedgroup.com

 

Phone:                       

(949)
212-9772                                                                    

 

Fax:                      

 

 

 

II.

Official and
Mailing Address for Financial notices (the Licensee’s contact person for
royalty payments)

 

Yun
Ji                                                                    

Name

 

R&D Site
Director                                                                    

Title

 

Mailing
Address:

 

209 Perry Parkway, Suite
13                                                                    

 

Gaithersburg, MD
20877                                                                    

 

 

 

 

 

Email
Address:                                                                                         

yun.ji@cellbiomedgroup.com

 

Phone:                       

(240)
505-8670                                                                    

 

Fax:                      

 

Any
false or misleading statements made, presented, or submitted to the
Government, including any
relevant omissions, under this Agreement and during the course of
negotiation of this Agreement are subject to all applicable
civil and criminal statutes including Federal statutes 31 U.S.C.
§§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal
liability including fine(s) and/or imprisonment).

 

 

 

 

 

 

 

 

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APPENDIX A – PATENT(S) OR PATENT APPLICATION(S)

 

Patent(s) or Patent Application(s):

 

[***]

 

 

 

 

 

 

 

 

 

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APPENDIX B – LICENSED FIELDS OF USE AND
TERRITORY

 

I. 

Licensed
Fields of Use:

 

(a)

Development,
manufacture and commercialization of autologous, tumor-reactive
lymphocyte adoptive cell therapy products, isolated from tumor
infiltrating lymphocytes as claimed in the Licensed Patent Rights, for the
treatment of non-small cell lung, stomach, esophagus, colorectal,
and head and neck cancer(s) in humans.

 

 

 

II.

Licensed
Territory:

 

(a)

Worldwide

 

 

 

 

 

 

 

 

 

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APPENDIX C – ROYALTIES

 

Royalties:

 

I.

The Licensee agrees to pay to the
IC a non-creditable,
non-refundable license issue royalty in the amount of [***] from the effective date of this
Agreement.

 

II.

The Licensee agrees to pay to the
IC a non-refundable minimum
annual royalty in the amount of [***] as follows:

 

(a)

The first minimum
annual royalty is due within [***] of the effective date of this
Agreement and may be
prorated according to the fraction of the calendar year remaining
between the effective date of this Agreement and the next subsequent
January 1; and

 

(b)

Subsequent minimum
annual royalty payments are due and payable on January 1 of each
calendar year and may be credited against any earned royalties due
for sales made in that year.

 

III.

The Licensee agrees to pay the IC earned royalties of [***] on Net Sales by or on behalf of the
Licensee or its
sublicensee(s), subject to the following adjustment:

 

(a)

[***]

 

IV.

The Licensee agrees to pay the IC Benchmark royalties within [***] of achieving each Benchmark:

 

[***]

 

 

 

V.

The Licensee agrees to pay the IC additional sublicense royalties of
[***] on the fair market
value of any consideration received for granting each sublicense
within [***] of the
execution of each sublicense.

 

 

 

 

 

 

 

 

 

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APPENDIX D – BENCHMARKS AND PERFORMANCE

 

The
Licensee agrees to use
commercially reasonable efforts to meet the following Benchmarks for its performance under
this Agreement and, within
[***] of achieving a
Benchmark, shall notify the
IC that the Benchmark has been
achieved.

 

 

 

 

 

 

 

 

 

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[***]

 

 

 

 

 

 

 

 

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APPENDIX E – COMMERCIAL DEVELOPMENT PLAN

 

The
Licensee is developing
autologous, tumor infiltrating lymphocyte (TIL)-based adoptive cell
therapy products reactive to neoantigens for the treatment of
cancer. The Licensee has an
existing GMP manufacturing facility with sufficient capacity to
produce a variety of cell therapy products for approximately 20,000
patients per year. Plans and funding are available to reconfigure
part of the facility for TIL isolation, characterization and
expansion. Product development activities will follow three
principal aims. In the first aim, the Licensee will identify biomarkers which
are predictive of positive patient response to TIL therapy.
[***]

 

 

 

 

 

 

 

 

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APPENDIX F – EXAMPLE ROYALTY REPORT

 

Required royalty report information includes:

 

● 

License reference
number (L-XXX-200X/0)

● 

Reporting
period

● 

Catalog number and
units sold of each Licensed Product (domestic and
foreign)

● 

Gross Sales per
catalog number per country

● 

Total Gross
Sales

● 

Itemized deductions
from Gross Sales

● 

Total Net
Sales

● 

Earned Royalty Rate
and associated calculations

● 

Gross Earned
Royalty

● 

Adjustments for
Minimum Annual Royalty (MAR) and other creditable payments
made

● 

Net Earned Royalty
due

 

Example

	

Catalog Number

	

Product Name

	

Country

	

Units Sold

	

Gross Sales (US$)

	

1

	

A

	

US

	

250

	

62,500

	

1

	

A

	

UK

	

32

	

16,500

	

1

	

A

	

France

	

25

	

15,625

	

2

	

B

	

US

	

0

	

0

	

3

	

C

	

US

	

57

	

57,125

	

4

	

D

	

US

	

12

	

1,500

Total
Gross Sales153,250

Less
Deductions:

Freight  3,000

Returns  7,000

Total
Net Sales  143,250

 

Royalty
Rate  8%

Royalty
Due11,460

Less
Creditable Payments10,000

Net
Royalty Due  1,460

 

 

 

 

 

 

 

 

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APPENDIX G – ROYALTY PAYMENT OPTIONS

New
Payment Options Effective March 2018

 

The License Number MUST appear on payments, reports and
correspondence.

 

Credit and Debit Card Payments: Credit and debit card
payments can be submitted for amounts up to $24,999. Submit your
payment through the U.S. Treasury web site located at: https://www.pay.gov/public/form/start/28680443.

 

Automated Clearing House (ACH) for payments through U.S. banks
only

 

The
IC encourages its licensees
to submit electronic funds transfer payments through the Automated
Clearing House (ACH). Submit your ACH payment through the U.S.
Treasury web site located at: https://www.pay.gov/public/form/startJ28680443.
Please note that the IC "only" accepts ACH payments through this
U.S. Treasury web site.

 

Electronic Funds
Wire Transfers: The following account information
is provided for wire payments. In order to process payment via
Electronic Funds Wire Transfer sender MUST supply the following
information within the transmission:

 

Drawn
on a U.S. bank account via
FEDWIRE:

 

Please
provide the following instructions to your Financial Institution
for the remittance of Fedwire payments to the NIH ROYALTY
FUND.

 

	

Fedwire
Field Tag

	

Fedwire
Field Name

	

Required
Information

	
 

	

{1510}

	

Type/Subtype

	

1000

	

{2000}

	

Amount

	

(enter payment amount)

	

{3400}

	

Receiver
ABA routing number*

	

02103004

	

{3400}

	

Receiver
ABA short name

	

TREAS NYC

	

{3600}

	

Business
Function Code

	

CTR (or
CTP)

	

{4200}

	

Beneficiary
Identifier (account number)

	

(enter 12 digit gateway account #)

875080031006

	

{4200}

	

Beneficiary
Name

	

(enter agency name associated with the Beneficiary
Identifier)

DHHS / NIH (75080031)

	

{5000}

	

Originator

	

(enter the name of the originator of the payment)

COMPANY NAME

	

{6000}

	

Originator
to Beneficiary Information – Line 1

	

(enter information to identify the purpose of the
payment)

ROYALTY

	

{6000}

	

Originator
to Beneficiary Information – Line 2

	

(enter information to identify the purpose of the
payment)

LICENSE NUMBER

	

{6000}

	

Originator
to Beneficiary Information – Line 3

	

(enter information to identify the purpose of the
payment)

INVOICE NUMBER

	

{6000}

	

Originator
to Beneficiary Information – Line 4

	

(enter information to identify the purpose of the
payment)

	

Notes:
*The financial institution address for Treasury’s routing
number is 33 Liberty Street, New York, NY 10045.

 

Agency Contacts: Office of Technology Transfer (OTT) (301)
496-7057 OTT-Royalties@mail.nih.gov

 

Drawn
on a foreign bank account
via FEDWIRE:

 

The
following instructions pertain to the Fedwire Network. Deposits
made in US Dollars
(USD).

 

Should
your remitter utilize a correspondent US domestic bank in
transferring electronic funds, the following Fedwire instructions
are applicable.

 

	

Fedwire
Field Tag

	

Fedwire
Field Name

	

Required
Information

	
 

	

{1510}

	

Type/Subtype

	

1000

	

{2000}

	

Amount

	

(enter payment amount)

	

{3100}

	

Sender
Bank ABA routing number

	

(enter the US correspondent bank’s ABA routing
number)

	

{3400}

	

Receiver
ABA routing number*

	

02103004

	

{3400}

	

Receiver
ABA short name

	

TREAS NYC

	

{3600}

	

Business
Function Code

	

CTR (or
CTP)

	

{4200}

	

Beneficiary
Identifier (account number)**

	

(enter 12 digit gateway account #)

875080031006

	

{4200}

	

Beneficiary
Name

	

(enter agency name associated with the Beneficiary
Identifier)

DHHS / NIH (75080031)

	

{5000}

	

Originator

	

(enter the name of the originator of the payment)

COMPANY’S NAME

	

{6000}

	

Originator
to Beneficiary Information – Line 1

	

(enter information to identify the purpose of the
payment)

ROYALTY

	

{6000}

	

Originator
to Beneficiary Information – Line 2

	

(enter information to identify the purpose of the
payment)

LICENSE NUMBER

	

{6000}

	

Originator
to Beneficiary Information – Line 3

	

(enter information to identify the purpose of the
payment)

INVOICE NUMBER

	

{6000}

	

Originator
to Beneficiary Information – Line 4

	

(enter information to identify the purpose of the
payment)

	

Notes:
*The financial institution address for Treasury’s routing
number is 33 Liberty Street, New York, NY 10045.

**Anything
other than the 12 digit gateway account # will cause the Fedwire to
be returned – SWIFT CODE:
FRNYUS33

 

 
27

Confidential Treatment Requested by Cellular Biomedicine Group,
Inc.

IRS Employer Identification No. 86-1032927

Confidential treatment requested with respect to certain portions
hereof denoted with “[***]”

 

 

Agency Contacts:

 

Office of
Technology Transfer
(OTT)                                                                                 

(301)
496-7057                                       

OTT-Royalties@mail.nih.gov

 

Checks

 

All
checks should be made payable to “NIH Patent
Licensing”

 

Checks
drawn on a U.S. bank
account and sent by US Postal Service should be sent
directly to the following address:

 

National Institutes
of Health

P.O.
Box 979071

St.
Louis, MO 63197-9000

 

Checks
drawn on a U.S. bank account and sent by overnight or
courier should be sent to the following
address:

 

US
Bank

Government Lockbox
SL-MO-C2GL

1005
Convention Plaza

St.
Louis, MO 63101

Phone:
314-418-4087

 

Checks
drawn on a foreign bank
account should be sent directly to the following
address:

 

National Institutes
of Health

Office
of Technology Transfer

License
Compliance and Administration

Royalty
Administration

6011
Executive Boulevard

Suite
325, MSC 7660

Rockville, Maryland
20852

 

 

 

 

 

 

 

28Exhibit 10.1

 

 

VIA ELECTRONIC MAIL

  

October 5, 2018

 

Stephen Thompson

 

 

Dear Steve:

 

Congratulations once again on your retirement. I want to thank
you for your years of service and many contributions. This letter of agreement outlines the terms of your separation from employment
with Abeona Therapeutics Inc. (the “Company”), which will be further agreed to in a definitive separation agreement
containing all the terms and conditions of your separation (“Separation Agreement”). You and the Company agree as follows:

 

		1.	Separation Date; Transition Period - Your effective date of separation from the Company will be December 31,
2018 (the “Separation Date”).

 

The period between the date you
execute the Separation Agreement with the Company and the Separation Date will be a transition period (the “Transition Period”),
during which time you agree to reasonably assist the Company with the transition of your job duties and to perform any other transition
duties as may be reasonably requested by the Company (collectively, the “Transition Duties”). The Company shall maintain,
at the Company’s cost and expense, your current level of benefits (health/medical and any other applicable benefits) and
salary at all times during the Transition Period.

 

		2.	Compensation/Severance Benefits

 

		(a)	The Company will pay your current annual base salary through the Separation Date in accordance with the Company’s usual
payroll guidelines and practices.

 

		(b)	Within sixty (60) days following the Separation Date, you will be paid an additional amount equal to your pro-rated target
bonus for the period ending the date of the Separation Agreement.

 

		(c)	You will further be paid for any accrued but unused vacation days, and will be reimbursed for previously submitted, but un-reimbursed,
business expenses in accordance with the Company’s usual guidelines and practices.

 

     

     

    

 

		3.	All stock options that have vested as of the Separation Date, if any, must be exercised by the earlier of 12 months of the
Separation Date or the expiration of the option.

 

Once again, congratulations and
best of luck in your retirement.

 

Very truly yours,

Abeona Therapeutics, Inc.

 

	 	By:	/s/ Carsten Thiel	 
	 	 	 	 
	 	 	F. Carsten Thiel, Ph.D.	 
	 	 	Chief Executive Officer	 

  

I hereby agree to the terms and conditions set forth
above.

 

 

	 	 	/s/ Stephen Thompson	 	Date     10/5/18      
	 	 	Stephen Thompson

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