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
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 “[***]”
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.
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 “[***]”
The
IC
and the
Licensee
agree as follows:
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.
2.1
“
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.
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 “[***]”
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);
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 “[***]”
(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.
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 “[***]”
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.
3.1
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
.
4.1
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).
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 “[***]”
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.
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 “[***]”
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
.
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 “[***]”
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.
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 “[***]”
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).
10.1
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
.
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 “[***]”
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.
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 “[***]”
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
.
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 “[***]”
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
;
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 “[***]”
(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.
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 “[***]”
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.
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 “[***]”
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
.
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 “[***]”
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
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 “[***]”
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:
Name
Title
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 “[***]”
Mailing
Address
19925 Stevens Creek Blvd., Suite
100
Email
Address:
andy.chan@cellbiomedgroup.com
II.
Official and
Mailing Address for Financial notices (the
Licensee’s
contact person for
royalty payments)
Name
Title
Mailing
Address:
209 Perry Parkway, Suite
13
Email
Address:
yun.ji@cellbiomedgroup.com
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).
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 “[***]”
APPENDIX A – PATENT(S) OR PATENT APPLICATION(S)
Patent(s) or Patent Application(s):
[***]
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 “[***]”
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.
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 “[***]”
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:
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.
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 “[***]”
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.
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 “[***]”
[***]
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 “[***]”
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.
[***]
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 “[***]”
APPENDIX F – EXAMPLE ROYALTY REPORT
Required royalty report information includes:
●
License reference
number (L-XXX-200X/0)
●
Catalog number and
units sold of each Licensed Product (domestic and
foreign)
●
Gross Sales per
catalog number per country
●
Itemized deductions
from Gross Sales
●
Earned Royalty Rate
and associated calculations
●
Adjustments for
Minimum Annual Royalty (MAR) and other creditable payments
made
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
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 “[***]”
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
|
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
Cellular Biomedicine Group Obtained NCI Patent License for Next
Generation Neoantigen-Reactive Tumor Infiltrating Lymphocyte (TIL)
Technology to Treat Solid Tumors
SHANGHAI, China and CUPERTINO, Calif., Oct. 03, 2018 (GLOBE
NEWSWIRE) --
Cellular Biomedicine
Group Inc
.
(NASDAQ:
CBMG
) (“CBMG”
or the “Company”), a clinical-stage biopharmaceutical
firm engaged in the development of immunotherapies for cancer and
stem cell therapies for degenerative diseases, today announced it
has entered into a Patent License Agreement (the “License
Agreement”) with the National Cancer Institute
(“NCI”), an institute of the National Institutes of
Health, within the Department of Health and Human Services.
Pursuant to the License Agreement, NCI granted CBMG a
non-exclusive, sub-licensable worldwide license to develop,
manufacture and commercialize next generation neoantigen-reactive
tumor infiltrating lymphocyte (“TIL”) technology to
treat a variety of cancers.
“We are extremely pleased to finalize this License Agreement
as this next generation TIL technology will fortify our clinical
development pipelines for solid tumors. It is a significant
extension of our CAR/TCR-T pipelines against solid tumors in the
immuno-oncology platform,” stated Tony (Bizuo) Liu, Chief
Executive Officer of CBMG. “The medical oncology community is
very aware of the innovative work using T cell-based immunotherapy
and autologous TIL transfer for the treatment of various cancers.
We look forward to continuing to advance this
field.”
About Cellular Biomedicine Group
Cellular Biomedicine Group, Inc. (NASDAQ:
CBMG
)
develops proprietary cell therapies for the treatment of cancer and
degenerative diseases. We conduct immuno-oncology and stem cell
clinical trials in China using products from our integrated GMP
laboratory. Our GMP facilities in China, consisting of 12
independent cell production lines, are designed and managed
according to both China and U.S. GMP standards. Our Shanghai
facility includes a “Joint Laboratory of Cell Therapy”
with GE Healthcare and a “Joint Cell Therapy Technology
Innovation and Application Center” with Thermo Fisher
Scientific, whose partnerships focus on improving manufacturing
processes for cell therapies. The CBMG pipeline includes
preclinical compounds targeting CD20-, CD22- and B-cell maturation
antigen (BCMA)-specific CAR-T compounds, and T-cell receptor (TCR)
and tumor infiltrating lymphocyte (TIL) technologies. A Phase IIb
trial in China for Rejoin® autologous Human
Adipose-derived Mesenchymal Progenitor Cell (haMPC) for the
treatment of Knee Osteoarthritis (KOA) as well as a Phase I trial
in China for AlloJoin™ (CBMG's “Off-the-Shelf”
haMPC) for the treatment of KOA are ongoing. CBMG is included in
the broad-market Russell 3000® Index and the small-cap Russell
2000® Index, and the Loncar China BioPharma index. To learn
more about CBMG, please visit
www.cellbiomedgroup.com
.
Forward-Looking Statements
Statements in this press release relating to plans, strategies,
trends, specific activities or investments, and other statements
that are not descriptions of historical facts and may be
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Forward-looking
information is inherently subject to risks and uncertainties, and
actual results could differ materially from those currently
anticipated due to a number of factors, which include those
regarding our ability to implement our plans, strategies and
objectives for future operations, including regulatory approval of
our IND applications, our plan to configure part of our Shanghai
facility with GE Healthcare's FlexFactory platform, our ability to
execute on our obligations under the terms of our licensing and
collaboration arrangement with Novartis, our ability to execute on
proposed new products, services or development thereof, results of
our clinical research and development, regulatory infrastructure
governing cell therapy and cellular biopharmaceuticals, our ability
to enter into agreements with any necessary manufacturing,
marketing and/or distribution partners for purposes of
commercialization, our ability to seek intellectual property rights
for our product candidates, competition in the industry in which we
operate, overall market conditions, any statements or assumptions
underlying any of the foregoing and other risks detailed from time
to time in CBMG's reports filed with the Securities and Exchange
Commission, quarterly reports on form 10-Q, current reports on form
8-K and annual reports on form 10-K. Forward-looking statements may
be identified by terms such as “may,”
“will,” “expects,” “plans,”
“intends,” “estimates,”
“potential,” or “continue,” or similar
terms or the negative of these terms. Although CBMG believes the
expectations reflected in the forward-looking statements are
reasonable, they cannot guarantee that future results, levels of
activity, performance or achievements will be obtained. CBMG does
not have any obligation to update these forward-looking statements
other than as required by law.
Contacts:
Sarah Kelly
Director of Corporate Communications, CBMG
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com