Nevada
|
000-53127
|
75-3254381
|
||
(State or other jurisdiction
|
(Commission File No.)
|
(I.R.S. Employer
|
||
of incorporation)
|
Identification No.)
|
¨
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
¨
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
¨
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
¨
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
|
(d) | Exhibits . The following exhibit is included as part of this report. |
10.1
|
Patent License Agreement, effective October 5, 2011, by and between Genesis Biopharma, Inc. and the National Institutes of Health.
†
|
GENESIS BIOPHARMA, INC. | |||
Date: December 13, 2011
|
By:
|
/s/ ANTHONY CATALDO | |
Anthony Cataldo, Chief Executive Officer | |||
|
1.
|
United States Patent No. 5,399,346 issued March 21, 1995 [
HHS
Ref. No. E-189-1989/3-US-02]
|
|
2.
|
United States Patent No. RE39788 issued August 21, 2007 [
HHS
Ref. No. E-189-1989/3-US-04]
|
|
3.
|
United States Patent No. 5,830,755 issued November 3, 1998 [
HHS
Ref. No. E-093-1995/0-US-01]
|
|
4.
|
Australian Patent No. 709122 issued December 2, 1999 [
HHS
Ref. No. E-093-1995/0-AU-03]
|
|
5.
|
United States Patent No. 6,734,014 issued May 11, 2004 [
HHS
Ref. No. E-040-1996/0-US-07]
|
|
6.
|
United States Patent No. 7,378,277 issued May 27, 2008 [
HHS
Ref. No. E-040-1996/0-US-08]
|
|
7.
|
United States Patent No. 7,723,111 issued May 25, 2010 [
HHS
Ref. No. E-323-2000/0-US-01]
|
|
8.
|
European Patent No. 1379670 issued August 6, 2008 [
HHS
Ref. No. E-323-2000/0-EP-03]
|
|
9.
|
United States Patent Application No. 12/715,829 filed March 2, 2010 [
HHS
Ref. No. E-323-2000/0-US-09]
|
|
10.
|
United States Patent Application No. 10/526,697 filed May 5, 2005 [
HHS
Ref. No. E-275-2002/1-US-02]
|
|
11.
|
European Patent Application No. 3794636.5 filed April 4, 2005 [
HHS
Ref. No. E-275-2002/1-EP-03]
|
|
12.
|
Canadian Patent Application No. 2,497,552 filed March 2, 2005 [
HHS
Ref. No. E-275-2002/1-CA-04]
|
|
13.
|
Australian Patent Application No. 2003265948 filed September 5, 2003 [
HHS
Ref. No. E-275-2002/1-AU-05]
|
|
14.
|
United States Patent Application No. 13/178,644 filed July 8, 2011 [
HHS
Ref. No. E-275-2002/1-US-06]
|
|
15.
|
United States Patent No. 7,381,405 issued June 3, 2008 [
HHS
Ref. No. E-297-2002/0-US-02]
|
|
16.
|
Canadian Patent Application No. 2,501,087 filed April 1, 2005 [
HHS
Ref. No. E-297-2002/0-CA-03]
|
|
17.
|
Australian Patent No. 2002353822 issued February 23, 2009 [
HHS
Ref. No. E-297-2002/0-AU-04]
|
|
18.
|
United States Patent No. 7,915,036 issued March 29, 2011 [
HHS
Ref. No. E-106-2004/0-US-02]
|
|
19.
|
United States Patent Application No. 11/576,621 filed April 4, 2007 [
HHS
Ref. No. E-340-2004/2-US-02]
|
|
20.
|
Canadian Patent Application No. 2,590,401 filed April 4, 2007 [
HHS
Ref. No. E-340-2004/2-CA-03]
|
|
21.
|
Australian Patent No. 2005336093 issued June 9, 2011 [
HHS
Ref. No. E-340-2004/2-AU-04]
|
|
22.
|
European Patent Application No. 05858553.0 filed April 5, 2007 [
HHS
Ref. No. E-340-2004/2-EP-05]
|
|
23.
|
Australian Patent Application No. 2007248019 filed May 3, 2007 [
HHS
Ref. No. E-086-2006/0-AU-03]
|
|
24.
|
Canadian Patent Application No. 2,651,174 filed November 3, 2008 [
HHS
Ref. No. E-086-2006/0-CA-04]
|
|
25.
|
European Patent Application No. 07797329 filed May 3, 2007 [
HHS
Ref. No. E-086-2006/0-EP-05]
|
|
26.
|
United States Patent Application No. 12/298,927 filed May 3, 2007 [
HHS
Ref. No. E-086-2006/0-US-06]
|
|
27.
|
United States Patent No. 7,820,174 issued October 26, 2010 [
HHS
Ref. No. E-106-2006/3-US-01]
|
|
28.
|
United States Patent Application No. 12/870,941 filed August 30, 2010 [
HHS
Ref. No. E-106-2006/3-US-03]
|
|
29.
|
Australian Patent Application No. 2009282886 filed August 20, 2009 [
HHS
Ref. No. E-106-2006/3-AU-04]
|
|
30.
|
Canadian Patent Application No. 2,734,838 filed August 20, 2009 [
HHS
Ref. No. E-106-2006/3-CA-05]
|
|
31.
|
European Patent Application No. 09791694.4 filed August 20, 2009 [
HHS
Ref. No. E-106-2006/3-EP-06]
|
|
32.
|
Australian Patent Application No. 2008206442 filed January 11, 2008 [
HHS
Ref. No. E-059-2007/2-AU-02]
|
|
33.
|
Canadian Patent Application No. 2,674,445 filed July 3, 2009 [
HHS
Ref. No. E-059-2007/2-CA-03]
|
|
34.
|
European Patent Application No. 08727582.2 filed January 11, 2008 [
HHS
Ref. No. E-059-2007/2-EP-04]
|
|
35.
|
United States Patent Application No. 12/522,321 filed July 7, 2009 [
HHS
Ref. No. E-059-2007/2-US-05]
|
|
36.
|
PCT Patent Application No. PCT/US2010/021909 filed January 25, 2010 [
HHS
Ref. No. E-043-2009/0-PCT-02]
|
|
37.
|
PCT Patent Application No. PCT/US2010/031988 filed April 22, 2010 [
HHS
Ref. No. E-170-2009/0-PCT-02]
|
|
38.
|
PCT Patent Application No. PCT/US2010/048701 filed September 14, 2010 [
HHS
Ref. No. E-205-2009/0-PCT-02]
|
|
39.
|
United States Patent Application No. 12/869,390 filed August 26, 2010 [
HHS
Ref. No. E-273-2009/0-US-02]
|
|
40.
|
United States Provisional Patent Application No. 61/405,668 filed October 22, 2010 [
HHS
Ref. No. E-236-2010/0-US-01]
|
|
41.
|
United States Provisional Patent Application No. 61/384,931 filed September 21, 2010 [
HHS
Ref. No. E-269-2010/0-US-01]
|
|
42.
|
United States Provisional Patent Application No. 61/466,200 filed March 22, 2011 [
HHS
Ref. No. E-114-2011/0-US-01]
|
|
43.
|
United States Provisional Patent Application No. 61/473,409 filed April 8, 2011 [
HHS
Ref. No. E-148-2011/0-US-01]
|
|
1)
|
The National Institutes of Health (“
NIH
”) or the Food and Drug Administration (“
FDA
”), hereinafter singly or collectively referred to as “
PHS
”, agencies of the United States Public Health Service within the Department of Health and Human Services (“
HHS
”); and
|
|
2)
|
The person, corporation, or institution identified above and on the Signature Page, having offices at the address indicated on the Signature Page, hereinafter referred to as “
Licensee
.”
|
1.
|
BACKGROUND
|
|
1.1
|
In the course of conducting biomedical and behavioral research,
PHS
investigators made inventions that may have commercial applicability.
|
|
1.2
|
By assignment of rights from
PHS
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
PHS
.
|
|
1.3
|
The Secretary of
HHS
has delegated to
PHS
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
|
PHS
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
|
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
Licensee
. For this purpose, the term "control" shall mean ownership of more than fifty percent (50%) of the voting stock or other ownership interest of the corporation or other business entity, or 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.
|
|
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
Licensee
or its sublicensees of
Licensed Products
or the initial practice of a
Licensed Process
by or on behalf of
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.
|
|
2.7
|
“
Licensed Patent Rights
” shall mean:
|
|
(a)
|
Patent applications (including provisional patent applications and PCT patent applications) and 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 claims of the
Licensed Patent Rights
that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
|
|
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 claims of the
Licensed Patent Rights
that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
|
|
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
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 returns and allowances, packing costs, insurance costs, freight out, taxes or excise duties imposed on the transaction (if separately invoiced), and wholesaler and cash discounts in amounts customary in the trade to the extent actually granted. No deductions shall be made for commissions paid to individuals, whether they are with independent sales agencies or regularly employed by
Licensee
or sublicensees, and on its payroll, or for the cost of collections.
|
|
2.12
|
“
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.
|
3.
|
GRANT OF RIGHTS
|
|
3.1
|
PHS
hereby grants and
Licensee
accepts, subject to the terms and conditions of this
Agreement
, a nonexclusive license under the
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 or have imported 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
PHS
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
PHS
and which shall not be unreasonably withheld,
Licensee
may enter into sublicensing agreements under the
Licensed Patent Rights
prior to
FDA
approval or foreign equivalent for a
Licensed Product
within each
Licensed Field of Use
from Appendix B only when it concurrently licenses proprietary or in-licensed intellectual property rights. For the avoidance of doubt,
Licensee
does not have the right to solely sublicense the
Licensed Patent Rights
prior to
FDA
approval or foreign equivalent for a
Licensed Product
within each
Licensed Field of Use
from Appendix B.
Licensee
may also enter into sublicensing agreements under the
Licensed Patent Rights
following
FDA
approval or foreign equivalent for a
Licensed Product
within each
Licensed Field of Use
from Appendix B.
|
|
4.2
|
Licensee
agrees that any sublicenses granted by it shall provide that the obligations to
PHS
of Paragraphs 5.1, 5.2, 8.1, 10.1, 10.2, 12.5, and 13.7-13.9 of this
Agreement
shall be binding upon the sublicensee as if it were a party to this
Agreement
.
Licensee
further agrees to attach copies of these Paragraphs to all sublicense agreements.
|
|
4.3
|
Any sublicenses granted by
Licensee
shall provide for the termination of the sublicense, or the conversion to a license directly between the sublicensees and
PHS
, at the option of the sublicensee, upon termination of this
Agreement
under Article 13. This conversion is subject to
PHS
approval and contingent upon acceptance by the sublicensee of the remaining provisions of this
Agreement
.
|
|
4.4
|
Licensee
agrees to forward to
PHS
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,
PHS
agrees to maintain each sublicense agreement in confidence.
|
5.
|
STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
|
|
5.1
|
Prior to the
First Commercial Sale
,
Licensee
agrees to provide
PHS
with reasonable quantities of
Licensed Products
or materials made through the
Licensed Processes
for
PHS
research use.
|
|
5.2
|
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
PHS
.
|
6.
|
ROYALTIES AND REIMBURSEMENT
|
|
6.1
|
Licensee
agrees to pay
PHS
a noncreditable, nonrefundable license issue royalty as set forth in Appendix C.
|
|
6.2
|
Licensee
agrees to pay
PHS
a minimum annual royalty as set forth in Appendix C.
|
|
6.3
|
Licensee
agrees to pay
PHS
earned royalties as set forth in Appendix C.
|
|
6.4
|
Licensee
agrees to pay
PHS
benchmark royalties as set forth in Appendix C.
|
|
6.5
|
Licensee
agrees to pay
PHS
sublicensing 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 of the dates that:
|
|
(a)
|
the application has been abandoned and not continued;
|
|
(b)
|
the patent expires or irrevocably lapses; or
|
|
(c)
|
the patent has been held to be invalid or unenforceable by an unappealed or unappealable decision of a court of competent jurisdiction or administrative agency.
|
|
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
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
|
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
PHS
prior to the effective date of this
Agreement
,
Licensee
shall pay
PHS
, as an additional royalty, within sixty (60) days of
PHS’
submission of a statement and request for payment to
Licensee
, an amount equivalent to fifty percent (50%) of the unreimbursed patent expenses previously paid by
PHS
.
|
|
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
PHS
on or after the effective date of this
Agreement
,
PHS
, at its sole option, may require
Licensee
:
|
|
(a)
|
to pay
PHS
on an annual basis, within sixty (60) days of
PHS
' submission of a statement and request for payment, a royalty amount equivalent to these unreimbursed expenses paid during the previous calendar year(s);
|
|
(b)
|
to pay these unreimbursed expenses directly to the law firm employed by
PHS
to handle these functions. However, in this event,
PHS
and not
Licensee
shall be the client of the law firm; or
|
|
(c)
|
under exceptional circumstances,
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,
Licensee
shall directly pay the attorneys or agents engaged to prepare, file, prosecute, or maintain these patent applications or patents and shall provide
PHS
with copies of each invoice associated with these services as well as documentation that these invoices have been paid.
|
|
6.11
|
PHS
agrees, upon written request, to provide
Licensee
with summaries of patent prosecution invoices for which
PHS
has requested payment from the
Licensee
under Paragraphs 6.9 and 6.10.
Licensee
agrees that all information provided by
PHS
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
|
Licensee
may elect to surrender its rights in any country of the
Licensed Territory
under any of the
Licensed Patent Rights
upon sixty (60) days written notice to
PHS
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
|
PHS
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
.
|
|
7.2
|
PHS
shall notify
Licensee
in writing upon receipt of all communications from global patent authorities relating the preparation, filing, prosecution, maintenance, allowance, rejection, claim restrictions or amendments for any and all patent applications or patents included in the
Licensed Patent Rights
. Such written notification by
PHS
to
Licensee
shall be done to allow
Licensee
the opportunity to decide whether
Licensee
desires to surrender rights pursuant to Section 6.11 herein.
|
8.
|
RECORD KEEPING
|
|
8.1
|
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
PHS
. 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
PHS
, by an accountant or other designated auditor selected by
PHS
for the sole purpose of verifying reports and royalty payments hereunder. The accountant or auditor shall only disclose to
PHS
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 five percent (5%) for any twelve (12) month period, then
Licensee
shall reimburse
PHS
for the cost of the inspection at the time
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 sixty (60) days of the date
PHS
provides
Licensee
notice of the payment due.
|
|
8.2
|
Licensee
agrees to have an audit of sales and royalties conducted by an independent auditor at least every two (2) years if annual sales of the
Licensed Products
or
Licensed Processes
are over two (2) million dollars. The audit shall address, at a minimum, the amount of gross sales by or on behalf of
Licensee
during the audit period, terms of the license as to percentage or fixed royalty to be remitted to the
Government
, the amount of royalties owed to the
Government
under this
Agreement
, and whether the royalties owed have been paid to the
Government
and is reflected in the records of the
Licensee
. The audit shall also indicate the
PHS
license number, product, and the time period being audited. A report certified by the auditor shall be submitted promptly by the auditor directly to
PHS
on completion.
Licensee
shall pay for the entire cost of the audit.
|
9.
|
REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS
|
|
9.1
|
Prior to signing this
Agreement
,
Licensee
has provided
PHS
with the
Commercial Development Plan
in Appendix E, under which
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
|
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 sixty (60) days 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, manufacturing, marketing, importing, and sales during the preceding calendar year, as well as, plans for the present calendar year.
PHS
also encourages these reports to include information on any of
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
,
Licensee
shall explain the reasons for such differences. In any annual report,
Licensee
may propose amendments to the
Commercial Development Plan
, acceptance of which by
PHS
may not be denied unreasonably.
Licensee
agrees to provide any additional information reasonably required by
PHS
to evaluate
Licensee’s
performance under this
Agreement
.
Licensee
may amend the
Benchmarks
at any time upon written approval by
PHS
.
PHS
shall not unreasonably withhold approval of any request of
Licensee
to extend the time periods of this schedule if the request is supported by a reasonable showing by
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
|
Licensee
shall report to
PHS
the dates for achieving
Benchmarks
specified in Appendix D and the
First Commercial Sale
in each country in the
Licensed Territory
within thirty (30) days of such occurrences.
|
|
9.4
|
Licensee
shall submit to
PHS
, within sixty (60) days after each calendar half-year ending June 30 and December 31, a royalty report, as described in the example in Appendix F, setting forth for the preceding half-year period the amount of the
Licensed Products
sold or
Licensed Processes
practiced by or on behalf of
Licensee
in each country within the
Licensed Territory
, the
Net Sales
, and the amount of royalty accordingly due. With each royalty report,
Licensee
shall submit payment of earned royalties due. If no earned royalties are due to
PHS
for any reporting period, the written report shall so state. The royalty report shall be certified as correct by an authorized officer of
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
|
Licensee
agrees to forward semi-annually to
PHS
a copy of these reports received by
Licensee
from its sublicensees during the preceding half-year period as shall be pertinent to a royalty accounting to
PHS
by
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
Licensee
. The royalty report required by Paragraph 9.4 shall be mailed to
PHS
at its address for
Agreement
Notices indicated on the Signature Page.
|
|
9.7
|
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
PHS
on any payment that is more than ninety (90) days overdue at the rate of one percent (1%) per month. This one percent (1%) per month rate may be applied retroactively from the original due date until the date of receipt by
PHS
of the overdue payment and additional royalties. The payment of any additional royalties shall not prevent
PHS
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
Licensee
shall, to the extent permitted by law, be treated by
PHS
as commercial and financial information obtained from a person and as privileged and confidential, and any proposed disclosure of these records by the
PHS
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
|
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 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
Licensee
.
|
|
10.2
|
Upon the
First Commercial Sale
, until the expiration or termination of this
Agreement
,
Licensee
shall use its reasonable commercial efforts to make
Licensed Products
and
Licensed Processes
reasonably accessible to the United States public.
|
|
10.3
|
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
|
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
|
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
|
PHS
and
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
|
In the event that a declaratory judgment action alleging invalidity of any of the
Licensed Patent Rights
shall be brought against
PHS
,
PHS
agrees to notify
Licensee
that an action alleging invalidity has been brought.
PHS
does not represent that it shall commence legal action to defend against a declaratory action alleging invalidity.
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
Licensee
,
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
Licensee's
payment of all costs incurred by the
Government
as a result of
Licensee's
joinder motion or other action, these actions by
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
|
PHS
offers no warranties other than those specified in Article 1.
|
|
12.2
|
PHS
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.
|
|
12.3
|
PHS
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.
|
|
12.4
|
PHS
does not represent that it shall commence legal actions against third parties infringing the
Licensed Patent Rights
.
|
|
12.5
|
Licensee
shall indemnify and hold
PHS
, 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
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
Licensee
, or other products or processes developed in connection with or arising out of the
Licensed Patent Rights
.
|
|
12.6
|
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
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 ninety (90) days after the date of notice in writing of the default,
PHS
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
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,
Licensee
shall immediately notify
PHS
in writing. Furthermore,
PHS
shall have the right to terminate this
Agreement
immediately upon
Licensee’s
receipt of written notice.
|
|
13.4
|
Licensee
shall have a unilateral right to terminate this
Agreement
in any country or territory by giving
PHS
sixty (60) days written notice to that effect.
|
|
13.5
|
PHS
shall specifically have the right to terminate or modify, at its option, this
Agreement
, if
PHS
determines that the
Licensee
:
|
|
(a)
|
is not executing the
Commercial Development Plan
submitted with its request for a license and the
Licensee
cannot otherwise demonstrate to
PHS’
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
;
|
|
(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,
PHS
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
Licensee
under Paragraph 9.2. Prior to invoking termination or modification of this
Agreement
under Paragraph 13.5,
PHS
shall give written notice to
Licensee
providing
Licensee
specific notice of, and a ninety (90) day opportunity to respond to,
PHS’
concerns as to the items referenced in 13.5(a)-13.5(g). If
Licensee
fails to alleviate
PHS’
concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to
PHS’
satisfaction,
PHS
may terminate this
Agreement
.
|
|
13.7
|
PHS
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
Licensee
.
|
|
13.8
|
Within thirty (30) days of receipt of written notice of
PHS’
unilateral decision to modify or terminate this
Agreement
,
Licensee
may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated
PHS
official. The decision of the designated
PHS
official shall be the final agency decision.
Licensee
may thereafter exercise any and all administrative or judicial remedies that may be available.
|
|
13.9
|
Within ninety (90) days of expiration or termination of this
Agreement
under this Article 13, a final report shall be submitted by
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
PHS
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
PHS
pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this
Agreement
, upon termination or expiration of this
Agreement
,
Licensee
shall return all
Licensed Products
or other materials included within the
Licensed Patent Rights
to
PHS
or provide
PHS
with written certification of the destruction thereof.
Licensee
may not be granted additional
PHS
licenses if the final reporting requirement is not fulfilled.
|
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
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
Licensee’s
Affiliate(s)
without the prior written consent of
PHS
. 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
PHS
approves a proposed assignment,
Licensee
shall pay
PHS
, as an additional royalty, one percent (1%) of the fair market value of any consideration received for any assignment of this
Agreement
within sixty (60) days of the assignment
|
|
14.8
|
Licensee
agrees in its use of any
PHS
-supplied materials to comply with all applicable statutes, regulations, and guidelines, including
PHS
and
HHS
regulations and guidelines.
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.
Licensee
agrees not to use the materials for research involving human subjects or clinical trials outside of the United States without notifying
PHS
, in writing, of the research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to
PHS
of research involving human subjects or clinical trials outside of the United States shall be given no later than sixty (60) days prior to commencement of the research or trials.
|
|
14.9
|
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
Licensee
that it shall not export these items to certain foreign countries without prior approval of the agency.
PHS
neither represents that a license is or is not required or that, if required, it shall be issued.
|
|
14.10
|
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
PHS
patent rights in those countries.
|
|
14.11
|
By entering into this
Agreement
,
PHS
does not directly or indirectly endorse any product or service provided, or to be provided, by
Licensee
whether directly or indirectly related to this
Agreement
.
Licensee
shall not state or imply that this
Agreement
is an endorsement by the
Government
,
PHS
, any other
Government
organizational unit, or any
Government
employee. Additionally,
Licensee
shall not use the names of
NIH
,
PHS
,
FDA
or
HHS
or the
Government
or their employees in any advertising, promotional, or sales literature without the prior written approval of
PHS
.
|
|
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.
Licensee
agrees first to appeal any unsettled claims or controversies to the designated
PHS
official, or designee, whose decision shall be considered the final agency decision. Thereafter,
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, 12.1-12.5, 13.8, 13.9, 14.12 and 14.14 of this
Agreement
shall survive termination of this
Agreement
.
|
|
14.15
|
The terms and conditions of this
Agreement
shall, at
PHS’
sole option, be considered by
PHS
to be withdrawn
from
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
PHS
within sixty (60) days from the date of
PHS
signature found at the Signature Page.
|
/s/ RICHARD U. RODRIGUEZ
|
September 29, 2011
|
Richard U. Rodriguez
|
Date
|
/s/ ANTHONY J. CATALDO
|
October 5, 2011
|
Signature of Authorized Official
|
Date
|
|
I.
|
Official and Mailing Address for
Agreement
notices:
|
Genesis Biopharma, Inc.
|
10880 Wilshire Boulevard, Suite 950
|
Los Angeles, California 90024
|
Email Address:
|
mhandelman@genesis-biopharma.com
|
Phone:
|
866-963-2220
|
Fax:
|
310-500-2151
|
Martin Schroeder
|
|
Name
|
Executive Vice President and Managing Director
|
|
Title
|
Emmes Group, Inc.
|
92 Natoma Street, Suite 200
|
San Francisco, California 94105
|
Email Address:
|
martin_schroeder@emmesgroup.com
|
Phone:
|
415-495-7111
|
Fax:
|
415-495-3777
|
II.
|
Official and Mailing Address for Financial notices (
Licensee’s
contact person for royalty payments)
|
Genesis Biopharma, Inc.
|
10880 Wilshire Boulevard, Suite 950
|
Los Angeles, California 90024
|
Email Address:
|
mhandelman@genesis-biopharma.com
|
Phone:
|
866-963-2220
|
Fax:
|
310-500-2151
|
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|
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|
21.
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HHS
Ref. No. E-340-2004/2-AU-04]
|
22.
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HHS
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|
23.
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|
24.
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|
25.
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HHS
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|
26.
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HHS
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|
27.
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HHS
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|
28.
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HHS
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|
29.
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HHS
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|
30.
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Canadian Patent Application No. 2,734,838 filed August 20, 2009 [
HHS
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|
31.
|
European Patent Application No. 09791694.4 filed August 20, 2009 [
HHS
Ref. No. E-106-2006/3-EP-06]
|
32.
|
Australian Patent Application No. 2008206442 filed January 11, 2008 [
HHS
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|
33.
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Canadian Patent Application No. 2,674,445 filed July 3, 2009 [
HHS
Ref. No. E-059-2007/2-CA-03]
|
34.
|
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HHS
Ref. No. E-059-2007/2-EP-04]
|
35.
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|
36.
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|
37.
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|
38.
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|
39.
|
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|
40.
|
United States Provisional Patent Application No. 61/405,668 filed October 22, 2010 [
HHS
Ref. No. E-236-2010/0-US-01]
|
41.
|
United States Provisional Patent Application No. 61/384,931 filed September 21, 2010 [
HHS
Ref. No. E-269-2010/0-US-01]
|
42.
|
United States Provisional Patent Application No. 61/466,200 filed March 22, 2011 [
HHS
Ref. No. E-114-2011/0-US-01]
|
43.
|
United States Provisional Patent Application No. 61/473,409 filed April 8, 2011 [
HHS
Ref. No. E-148-2011/0-US-01]
|
I.
|
Licensed Fields of Use:
|
|
(a)
|
The use of the
Licensed Patent Rights
to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic melanoma.
|
|
(b)
|
The use of the
Licensed Patent Rights
to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of ovarian cancer.
|
|
(c)
|
The use of the
Licensed Patent Rights
to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of breast cancer.
|
|
(d)
|
The use of the
Licensed Patent Rights
to develop and manufacture autologous tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of colorectal cancer.
|
II.
|
Licensed Territory:
|
|
(a)
|
Worldwide
|
I.
|
Licensee
agrees to pay to
PHS
a noncreditable, nonrefundable license issue royalty in the amount of six hundred fifty thousand dollars ($650,000.00) within sixty (60) days from the effective date of this
Agreement.
|
II.
|
Licensee
agrees to pay to
PHS
a nonrefundable minimum annual royalty in the amount of twenty thousand dollars ($20,000.00) as follows:
|
|
(a)
|
The first minimum annual royalty is due within sixty (60) days 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.
|
Licensee
agrees to pay
PHS
earned royalties of six percent (6%) on
Net Sales
by or on behalf of
Licensee
or its sublicensees.
Licensee
shall be entitled to a credit of one-half percent (0.5%) against the earned royalty rate for each percent point in excess of four percent (4%) that
Licensee
must pay to an unaffiliated licensor for the manufacture and sale of
Licensed Product(s)
and
Licensed Process(es)
. Said credit, however, shall not reduce the earned royalty due to
PHS
for
Licensed Product(s)
and
Licensed Process(es)
below three percent (3%).
|
IV.
|
Licensee
agrees to pay
PHS
Benchmark
royalties within sixty (60) days of achieving each
Benchmark
:
|
|
(a)
|
Three hundred thousand dollars ($300,000.00) for completion of the first Phase 2
clinical study in each of
Licensed Field of Use
(a) and (b) from Appendix B.
|
|
(b)
|
Six hundred thousand dollars ($600,000.00) for completion of the first Phase 2
clinical study in each of
Licensed Field of Use
(c) and (d) from Appendix B.
|
|
(c)
|
Five hundred thousand dollars ($500,000.00) for completion of the first Phase 3
clinical study in each of
Licensed Field of Use
(a) and (b) from Appendix B.
|
|
(d)
|
One million dollars ($1,000,000.00) for completion of the first Phase 3
clinical study in each of
Licensed Field of Use
(c) and (d) from Appendix B.
|
|
(e)
|
Seven hundred fifty thousand dollars ($750,000.00) upon the first
FDA
approval or foreign equivalent for a
Licensed Product
or
Licensed Process
in each of
Licensed Field of Use
(a) and (b) from Appendix B.
|
|
(f)
|
One million five hundred thousand dollars ($1,500,000.00) upon the first
FDA
approval or foreign equivalent for a
Licensed Product
or
Licensed Process
in each of
Licensed Field of Use
(c) and (d) from Appendix B.
|
|
(g)
|
Three million dollars ($3,000,000.00) for the
First Commercial Sale
of a
Licensed Product
or
Licensed Process
in the United States for either of
Licensed Field of Use
(a) or (b) from Appendix B.
|
|
(h)
|
Six million dollars ($6,000,000.00) for the
First Commercial Sale
of a
Licensed Product
or
Licensed Process
in the United States for either of
Licensed Field of Use
(c) or (d) from Appendix B.
|
|
(i)
|
One million five hundred thousand dollars ($1,500,000.00) for the
First Commercial Sale
of a
Licensed Product
or
Licensed Process
in any foreign country for either of
Licensed Field of Use
(a) or (b) from Appendix B.
|
|
(j)
|
Three million dollars ($3,000,000.00) for the
First Commercial Sale
of a
Licensed Product
or
Licensed Process
in any foreign country for either of
Licensed Field of Use
(c) or (d) from Appendix B.
|
V.
|
Licensee
agrees to pay
PHS
:
|
|
(a)
|
additional sublicensing royalties of fifteen percent (15%) on the fair market value of any consideration received for granting each sublicense within sixty (60) days of the execution of each sublicense if any such sublicense is executed prior to
FDA
approval or foreign equivalent for a
Licensed Product
or
Licensed Process
within each
Licensed Field of Use
from Appendix B; and
|
|
(b)
|
additional sublicensing royalties of six percent (6%) on the fair market value of any consideration received for granting each sublicense within sixty (60) days of the execution of each sublicense if any such sublicense is executed following
FDA
approval or foreign equivalent for a
Licensed Product
or
Licensed Process
within each
Licensed Field of Use
from Appendix B.
|
I.
|
Completion of the standard operation procedures (SOPs) for current Good Manufacturing Practices (cGMP) of autologous tumor infiltrating lymphocyte adoptive cell therapy products
|
|
within 18 months
|
||
II.
|
Completion of the first Phase 1/Phase 2 clinical trial for the treatment of metastatic Melanoma
|
|
within 36 months
|
||
III.
|
Completion of the first randomized Phase 3 clinical trial for the treatment of metastatic Melanoma
|
|
within 60 months
|
||
|
||
IV.
|
Regulatory Approval by the
FDA
(or foreign equivalent) of a
Licensed Product
or
Licensed Process
for the treatment of metastatic melanoma
|
|
within 72 months
|
||
V.
|
First Commercial Sale
of a
Licensed Product
or
Licensed Process
for the treatment of metastatic melanoma
|
|
within 84 months
|
||
VI.
|
Completion of the first Phase 1/Phase 2 clinical trial for the treatment of ovarian cancer
|
|
within 36 months
|
||
VII.
|
Completion of the first randomized Phase 3 clinical trial for the treatment of ovarian Cancer
|
|
within 60 months
|
||
VIII.
|
Regulatory Approval by the
FDA
(or foreign equivalent) of a
Licensed Product
or
Licensed Process
for the treatment of ovarian cancer
|
|
within 72 months
|
||
IX.
|
First Commercial Sale
of a
Licensed Product
or
Licensed Process
for the treatment of ovarian cancer
|
|
within 84 months
|
||
X.
|
Completion of the first Phase 1/Phase 2 clinical trial for the treatment of breast cancer
|
|
within 42 months
|
||
XI.
|
Completion of the first randomized Phase 3 clinical trial for the treatment of breast cancer
|
|
within 60 months
|
||
XII.
|
Regulatory Approval by the
FDA
(or foreign equivalent) of a
Licensed Product
or
Licensed Process
for the treatment of breast cancer
|
|
within 72 months
|
||
XIII.
|
First Commercial Sale
of a
Licensed Product
or
icensed Process
for the treatment of breast cancer
|
|
within 84 months
|
||
XIV.
|
Completion of the first Phase 1/Phase 2 clinical trial for the treatment of colorectal
cancer
|
|
within 48 months
|
||
XV.
|
Completion of the first randomized Phase 3 clinical trial for the treatment of colorectal
Cancer
|
|
within 60 months
|
XVI.
|
Regulatory Approval by the
FDA
(or foreign equivalent) of a
Licensed Product
or
Licensed Process
for the treatment of colorectal cancer
|
|
within 72 months
|
||
XVII.
|
First Commercial Sale
of a
Licensed Product
or
Licensed Process
for the treatment of colorectal cancer
|
A.
|
Development of SOPs relating to cGMP manufacturing, tumor tissue harvest/chain-of-custody/ship logistics, QA/QC, cell isolation/expansion, ready-to-infuse product formulation, etc.: 18 months
|
B.
|
Complete pilot Phase I/II clinical trial (30 patients; 3-5 sites):
|
C.
|
Manufacturing scale-up & complete randomized Phase III clinical trial (200 patients; 5-7 sites):
|
A.
|
Development of SOPs relating to cGMP manufacturing, chain-of-custody logistics, QA/QC, cell isolation and expansion, ready-to-infuse product
formulation, etc.:
|
B.
|
Complete pilot Phase I/II clinical trial (30 patients; 3-5 sites):
$15 million
|
C.
|
Manufacturing scale-up & complete randomized Phase III clinical trial (200 patients; 5-7 sites):
|
D.
|
Administrative, regulatory & other:
$25 million
|
1.
|
DEVELOPMENT PLAN: Application of Tumor Infiltrating Lymphocytes (TILs) for the Treatment of Ovarian Epithelial Cancer.
|
2.
|
Plan for Development of TIL Adoptive Cell Therapy Program for Metastatic Colorectal Cancer.
|
·
|
OTT license reference number (L-XXX-200X/0)
|
·
|
Reporting period
|
·
|
Catalog number and units sold of each Licensed Product (domestic and foreign)
|
·
|
Gross Sales per catalog number per country
|
·
|
Total Gross Sales
|
·
|
Itemized deductions from Gross Sales
|
·
|
Total Net Sales
|
·
|
Earned Royalty Rate and associated calculations
|
·
|
Gross Earned Royalty
|
·
|
Adjustments for Minimum Annual Royalty (MAR) and other creditable payments made
|
·
|
Net Earned Royalty due
|
Catalog Number
|
Product Name
|
Country
|
Units Sold
|
Gross Sales (US$)
|
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 Sales
|
153,250 | |||
Less Deductions: | ||||
Freight
|
3,000 | |||
Returns
|
7,000 | |||
Total Net Sales
|
143,250 | |||
Royalty Rate
|
8% | |||
Royalty Due
|
11,460 | |||
Less Creditable Payments | 10,000 | |||
Net Royalty Due
|
1,460 |
Beneficiary Account:
|
Federal Reserve Bank of New York or TREAS NYC
|
Bank:
|
Federal Reserve Bank of New York
|
ABA#
|
021030004
|
Account Number:
|
75080031
|
Bank Address:
|
33 Liberty Street,
New York, NY 10045
|
Payment Details:
|
License Number (L-XXX-XXXX)
|
Name of Licensee |
|
Drawn on a
foreign bank account
should be sent directly to the following account. Payment must be sent in
U.S. Dollars (USD)
using the following instructions:
|
Beneficiary Account:
|
Federal Reserve Bank of New York/ITS or FRBNY/ITS
|
Bank:
|
Citibank N.A. (New York)
|
SWIFT Code:
|
CITIUS33
|
Account Number:
|
36838868
|
Bank Address:
|
388 Greenwich Street, New York, NY 10013
|
Payment Details (Line 70):
|
NIH 75080031
|
License Number (L-XXX-XXXX)
|
|
Name of Licensee
|
|
Detail of Charges (line 71a):
|
Charge Our
|