Exhibt 10.4
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
THE JOHNS HOPKINS UNIVERSITY
&
SIGN PATH PHARMA
JHU Agreement #A11537
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the
“Agreement”) is entered into by and between THE JOHNS
HOPKINS UNIVERSITY, a Maryland corporation having an address at
3400 N. Charles Street, Baltimore, Maryland, 21218-2695
(“JHU”) and Sign Path Pharma, Inc., a Delaware
corporation having an address at 45 Broadway, New York, New York
10006 (“Company”), with respect to the
following:
RECITALS
WHEREAS, as a center for research and education,
JHU is interested in licensing PATENT RIGHTS (hereinafter defined)
in a manner that will benefit the public by facilitating the
distribution of useful products and the utilization of new
processes, but is without capacity to commercially develop,
manufacture, and distribute any such products or processes;
and
WHEREAS, a valuable invention(s) entitled
“Biocompatible “smart” nanogels as carriers for
hydrophobic drugs” (JHU Ref: 5024) was developed during the
course of research conducted by Drs. Anirban Maitra, Georg Feldman
& Savita Bisht (all hereinafter, "Inventors"); and
WHEREAS, JHU has acquired through assignment all
rights, title and interest, with the exception of certain retained
rights by the United States Government, in its interest in said
valuable inventions; and
WHEREAS, Company desires obtain certain rights
in such inventions as herein provided, and to commercially develop,
manufacture, use and distribute products and processes based upon
or embodying said valuable inventions throughout the
world;
NOW THEREFORE, in consideration of the premises
and the mutual promises and covenants contained in this Agreement,
and for other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the parties hereto
agree as follows:
ARTICLE 1
DEFINITIONS
All references to particular Exhibits, Articles
or Paragraphs shall mean the Exhibits to, and Paragraphs and
Articles of, this Agreement, unless otherwise
specified. For the purposes of this Agreement and the
Exhibits hereto, the following words and phrases shall have the
following meanings:
1.1 "AFFILIATED COMPANY"
as used herein in either singular or
plural shall mean any corporation, company,
partnership, joint venture or other entity, which controls, is
controlled by or is under common control with
Company. For purposes of this Paragraph 1.1, control
shall mean the direct or indirect ownership of at least fifty-
percent (50%).
1.2 “EFFECTIVE DATE"
of this License Agreement shall mean
the date the last party hereto has executed this
Agreement.
1.3 "EXCLUSIVE LICENSE"
shall mean a grant by JHU to Company
of its entire right and interest in the PATENT RIGHTS subject to
rights retained by the United States Government, if any, in
accordance with the Bayh-Dole Act of 1980 (established by P.L.
96-517 and amended by P.L. 98-620, codified at 35 USC § 200
et. seq. and implemented according to 37 CFR Part 401), and subject
to the retained right of JHU to make, have made, provide and use
for its and The Johns Hopkins Health Systems' purposes LICENSED
PRODUCT(S) and LICENSED SERVICE(S), including the ability to
distribute any biological material disclosed and/or claimed in
PATENT RIGHTS for nonprofit academic research use to non-commercial
entities as is customary in the scientific
community. Any biological material supplied by the
Company to JHU shall be for the sole use of
Inventors. Neither the Inventors, nor JHU may provide
any Company Biological Materials to any third party (including
non-profits and universities), without the express written consent
of the Company. If Company approves the use of
Biological Materials and they are used in studies, the credit for
the origin of the material shall include the Company’s
name.
1.4 "LICENSED FIELD"
shall mean use of licensed polymeric
formulation incorporating curcumin and curcuminoids for treating
cancer and all other medical indications.
1.5 "LICENSED PRODUCT(S)"
as used herein in either singular or
plural shall mean any process or method, material, compositions,
drug, or other product, the manufacture, use or sale of which would
constitute, but for the license granted to Company pursuant to this
Agreement, an infringement of a claim of PATENT RIGHTS
(infringement shall include, but is not limited to, direct,
contributory, or inducement to infringe).
1.6 "LICENSED SERVICE(S)"
as used herein in either singular or
plural shall mean the performance on behalf of a third party of any
method or the manufacture of any product or the use of any product
or composition which would constitute, but for the license granted
to Company pursuant to this Agreement, an infringement of a claim
of the PATENT RIGHTS, (infringement shall include, but not be
limited to, direct, contributory or inducement to
infringe).
1.7 "NET SALES"
shall mean gross sales revenues and
fees billed by Company, AFFILIATED COMPANY and SUBLICENSEE(S) from
the sale of LICENSED PRODUCT(S) less trade discounts allowed,
refunds, returns and recalls, and sales taxes. In the
event that Company, AFFILIATED COMPANY and SUBLICENSEE(S) sells a
LICENSED PRODUCT(S) in combination with other ingredients or
substances or as part of a kit, the NET SALES for purposes of
royalty payments shall be based on the sales revenues and fees
received in proportion to the contribution of the JHU
PATENT RIGHTS to the kit or the combined product
1.8 "NET SERVICE REVENUES"
shall mean gross service revenues
and fees billed by Company, AFFILIATED COMPANY and SUBLICENSEE(S)
for the performance of LICENSED SERVICE(S) less sales and/or use
taxes imposed upon and with specific reference to the LICENSED
SERVICE(S). In the event that Company, AFFILIATED
COMPANY or SUBLICENSEE(S) sells a LICENSED SERVICE(S) in
combination with other services or substances or as part of a kit,
the NET SERVICE REVENUES for purposes of royalty payments shall be
based on the sales revenues and fees received in proportion to that
received from the licensed product.
1.9 "PATENT RIGHTS"
shall mean the U.S. patent
application Serial No. 60,866/516, filed on November 20
th , 2006, and assigned to JHU entitled
“Biocompatible "smart" nanogels as carriers for hydrophobic
drugs” and the invention disclosed and claimed therein, and
all continuations, divisions, and reissues based thereof, and any
corresponding foreign patent applications, and any patents, or
other equivalent foreign PATENT RIGHTS issuing, granted or
registered thereon.
1.10 “SUBLICENSEE(S)”
as used herein in either singular or
plural shall mean any person or entity other than an AFFILIATED
COMPANY to which Company has granted a sublicense under this
Agreement.
ARTICLE 2
LICENSE GRANT
2.1 Grant. Subject
to the terms and conditions of this Agreement, JHU hereby grants to
Company an EXCLUSIVE LICENSE to make, have made, use, import, offer
for sale and sell the LICENSED PRODUCT(S) and to provide the
LICENSED SERVICE(S) in the United States and worldwide under the
PATENT RIGHTS in the LICENSED FIELD. This Grant shall
apply to the Company and any AFFILIATED COMPANY, except that any
AFFILIATED COMPANY shall not have the right to sublicense others as
set forth in Paragraph 2.2 below. If any AFFILIATED
COMPANY exercises rights under this Agreement, such AFFILIATED
COMPANY shall be bound by all terms and conditions of this
Agreement, including but not limited to indemnity and insurance
provisions and royalty payments, which shall apply to the exercise
of the rights, to the same extent as would apply had this Agreement
been directly between JHU and the AFFILIATED COMPANY. In
addition, Company shall remain fully liable to JHU for all acts and
obligations of AFFILIATED COMPANY such that acts of the AFFILIATED
COMPANY shall be considered acts of the Company.
2.2 Sublicense.
Company may sublicense to others
under this Agreement, subject to the terms and conditions of this
Paragraph. As a condition to its validity and enforceability, each
sublicense agreement shall: (a) incorporate by reference the terms
and conditions of this Agreement, (b) be consistent with the terms,
conditions and limitations of this Agreement, (c) prohibit
SUBLICENSEE’s further sublicense of the rights delivered
hereunder, (d) name JHU as an intended third party beneficiary of
the obligations of SUBLICENSEE without imposition of obligation or
liability on the part of JHU or its Inventors to the SUBLICENSEE,
(e) specifically incorporate Paragraphs 6.2 “Representations
by JHU”, 7.1
“Indemnification”, 10.1 “Use of
Name”, 10.4 “Product Liability” into the body of
the sublicense agreement, and cause the terms used in therein to
have the same meaning as in this Agreement, and, (f) bear signature
from JHU indicating JHU’s review and approval of the
sublicense agreement. Company shall provide to JHU each
proposed sublicense agreement, executed by both Company and
proposed SUBLICENSEE, for review, approval and signature by
JHU. To the extent that any terms, conditions or
limitations of any sublicense agreement are inconsistent with this
Agreement, those terms, conditions and limitations are null and
void against JHU, even though JHU has approved the sublicense in
writing.
2.3 Government
Rights. The
United States Government may have acquired a nonexclusive,
nontransferable, irrevocable, paid-up license to practice or have
practiced for or on behalf of the United States the inventions
described in PATENT RIGHTS throughout the world. The
rights granted herein are additionally subject to: (i) the
requirement that any LICENSED PRODUCT(S) produced for use or sale
within the United States shall be substantially manufactured in the
United States (unless a waiver under 35 U.S.C. § 204 or
equivalent is granted by the appropriate United States government
agency), (ii) the right of the United States government to require
JHU, or its licensees, including Company, to grant sublicenses to
responsible applicants on reasonable terms when necessary to
fulfill health or safety needs, and, (iii) other rights acquired by
the United States government under the laws and regulations
applicable to the grant/contract award under which the inventions
were made. JHU shall use reasonable efforts to address
the status of the extent to which the United States government has
rights, if any, with regard to support for the inventions described
in PATENT RIGHTS prior to signing this Agreement. The
Company intends to synthesize the product and formulate it in the
United States, however, economic realities may require a foreign
provider of pure substance and formulation, in which event JHU
shall support the Company in obtaining a waiver or equivalency from
the United States Government.
ARTICLE 3
FEES, ROYALTIES, &
PAYMENTS
3.1 License
Fee. Company
shall pay to JHU within thirty (30) days of the EFFECTIVE DATE of
this Agreement a license fee as set forth in Exhibit A ,
which is nonrefundable and shall not be credited against royalties
or other fees. JHU will not submit an invoice for the
license fee.
3.2 Minimum Annual
Royalties. Company shall pay to JHU minimum annual
royalties as set forth in Exhibit A . These
minimum annual royalties shall be due, without invoice from JHU,
within thirty (30) days of each anniversary of the EFFECTIVE DATE
beginning with the first anniversary. Running royalties
accrued under Paragraph 3.3 and paid to JHU during the one year
period preceding an anniversary of the EFFECTIVE DATE shall be
credited against the minimum annual royalties due on that
anniversary date.
3.3 Running
Royalties. Company shall pay to JHU a running royalty as
set forth in Exhibit A , for each LICENSED PRODUCT(S) sold,
and for each LICENSED SERVICE(S) provided, by Company, AFFILIATED
COMPANIES and SUBLICENSEE(S), based on NET SALES and NET SERVICE
REVENUES for the term of this Agreement. Such payments
shall be made quarterly. All non-US taxes related to
LICENSED PRODUCT(S) or LICENSED SERVICE(S) sold under this
Agreement shall be paid by Company and shall not be deducted from
royalty or other payments due to JHU.
In order to insure JHU the full royalty payments
contemplated hereunder, Company agrees that in the event any
LICENSED PRODUCT(S) shall be sold to an AFFILIATED COMPANY or
SUBLICENSEE(S) or to a corporation, firm or association with which
Company shall have any agreement, understanding or arrangement with
respect to consideration (such as, among other things, an option to
purchase stock or actual stock ownership, or an arrangement
involving division of profits or special rebates or allowances) the
royalties to be paid hereunder for such LICENSED PRODUCT(S) shall
be based upon the greater of: 1) the net selling price (per NET
SALES) at which the purchaser of LICENSED PRODUCT(S) resells such
product to the end user, 2) the NET SERVICE REVENUES received from
using the LICENSED PRODUCT(S) in providing a service, 3) the fair
market value of the LICENSED PRODUCT(S) or 4) the net selling price
(per NET SALES) of LICENSED PRODUCT(S) paid by the
purchaser.
3.4 Development
Milestones. Company shall pay to JHU upon reaching
certain development milestones as set forth in Exhibit A
regardless of whether the milestone is achieved by licensee, a
sublicensee or affiliate.
3.5 Sublicense
Consideration. In addition to the running royalty
as set forth under Paragraph 3.3, Company shall pay to JHU a
percentage of consideration received for sublicenses under this
Agreement as set forth in Exhibit A . This
sublicense consideration shall be due, without the need for invoice
from JHU, within forty-five (45) days of the effective date of each
sublicense agreement. Such consideration shall mean
consideration of any kind received by the Company or AFFILIATED
COMPANIES from a SUBLICENSEE(S) for the grant of a sublicense under
this Agreement, such as upfront fees or milestone fees and
including any premium paid by the SUBLICENSEE(S) over Fair Market
Value for stock of the Company or an AFFILIATED COMPANY in
consideration for such sublicense. However, not included in such
sublicense consideration are amounts paid to the Company or an
AFFILIATED COMPANY by the SUBLICENSEE(S) for running royalties on
LICENSED PRODUCT(S) and LICENSED SERVICE(S), product development,
research work, clinical studies and regulatory approvals performed
by or for the Company or AFFILIATED COMPANIES (including third
parties on their behalf), each pursuant to a specific agreement
including a performance plan and commensurate
budget. The term "Fair Market Value" shall mean the
average price that the stock in question is publicly trading at for
twenty (20) days prior to the announcement of its purchase by the
SUBLICENSEE(S) or if the stock is not publicly traded, the value of
such stock as determined by the most recent private financing
through a financial investor (an entity whose sole interest in the
Company or AFFILIATED COMPANY is financial) of the Company or
AFFILIATED COMPANY that issued the shares. If the company receives
stock as part of payment in sublicense the company can pay JHU the
sublicense consideration in stock.
3.6 Patent
Reimbursement. Company will reimburse JHU, within thirty (30)
days of the receipt of an invoice from JHU, for all reasonable
costs associated with the preparation, filing, maintenance, and
prosecution of PATENT RIGHTS incurred by JHU on or before the
EFFECTIVE DATE of this Agreement. In accordance with Paragraph 4.1
below, Company will reimburse JHU, within thirty (30) days of the
receipt of an invoice from JHU, for all costs associated with the
preparation, filing, maintenance, and prosecution of PATENT RIGHTS
incurred by JHU subsequent to the EFFECTIVE DATE of this
Agreement.
3.7 Sponsored Research
. Company shall provide sponsored
research funding for the completion of preclinical studies
necessary to file an IND on the licensed product containing nano
curcumin as set forth in Exhibit A.
3.8 Form of
Payment. All
payments under this Agreement shall be made in U.S.
Dollars. Checks are to be made payable to “The
Johns Hopkins University". Wire transfers may be made
through:
100 N. Charles Street, 5
th Floor
Attn: JHU Agr ID # A11537
Wire transfers may be made through:
Johns Hopkins University Central
Lockbox
Transit/Routing/ABA number:
026009593
Account number: 003936830516
Type of account: Depository
Reference: JHU Technology Transfer JHU
Agrmt# A11537
COMPANY shall
be responsible for any and all costs associated with wire
transfers.
3.8 Late Payments.
In the event that any
payment due hereunder is not made when due, the payment shall
accrue interest beginning on the tenth day following the due date
thereof, calculated at the annual rate of the sum of (a) two
percent (2%) plus (b) the prime interest rate quoted by The Wall
Street Journal on the date said payment is due, the interest being
compounded on the last day of each calendar quarter, provided
however, that in no event shall said annual interest rate exceed
the maximum legal interest rate for corporations. Each
such payment when made shall be accompanied by all interest so
accrued. Said interest and the payment and acceptance
thereof shall not negate or waive the right of JHU to seek any
other remedy, legal or equitable, to which it may be entitled
because of the delinquency of any payment including, but not
limited to termination of this Agreement as set forth in Paragraph
9.2.
ARTICLE 4
PATENT PROSECUTION, MAINTENANCE,
& INFRINGEMENT
4.1 Prosecution &
Maintenance. JHU, at Company's expense, shall
file, prosecute and maintain all patents and patent applications
specified under PATENT RIGHTS and, subject to the terms and
conditions of this Agreement, Company shall be licensed
thereunder. Title to all such patents and patent
applications shall reside in JHU. JHU shall have full
and complete control over all patent matters in connection
therewith under the PATENT RIGHTS, provided however, that JHU shall
(a) cause its patent counsel to timely copy Company on all official
actions and written correspondence with any patent office, and (b)
allow Company an opportunity to comment and advise
JHU. JHU shall consider and reasonably incorporate all
comments and advice. By concurrent written notification
to JHU and its patent counsel at least thirty (30) days in advance
(or later at JHU’s discretion) of any filing or response
deadline, or fee due date, Company may elect not to have a patent
application filed in any particular country or not to pay expenses
associated with prosecuting or maintaining any patent application
or patent, provided that Company pays for all costs incurred up to
JHU’s receipt of such notification. Failure to
provide such notification can be considered by JHU to be
Company’s authorization to proceed at Company’s
expense. Upon such notification, JHU may file,
prosecute, and/or maintain such patent applications or patent at
its own expense and for its own benefit, and any rights or license
granted hereunder held by Company, AFFILIATED COMPANIES or
SUBLICENSEE(S) relating to the PATENT RIGHTS which comprise the
subject of such patent applications or patent and/or apply to the
particular country, shall terminate.
4.2 Notification.
Each party will notify the other promptly in writing when any
infringement of a claim in any of the patent applications or
patents by another is uncovered or suspected.
4.3 Infringement.
Company shall have the
first right to enforce any patent within PATENT RIGHTS against any
infringement or alleged infringement thereof, and shall at all
times keep JHU informed as to the status thereof. Before Company
commences an action with respect to any infringement of such
patents, Company shall give careful consideration to the views of
JHU and to potential effects on the public interest in making its
decision whether or not to sue. Thereafter, Company may,
at its own expense, institute suit against any such infringer or
alleged infringer and control and defend such suit in a manner
consistent with the terms and provisions hereof and recover any
damages, awards or settlements resulting therefrom, subject to
Paragraph 4.5. However, no settlement, consent judgment
or other voluntary final disposition of the suit may be entered
into without the prior written consent of JHU, which consent shall
not be unreasonably withheld. This right to sue for
infringement shall not be used in an arbitrary or capricious
manner. JHU shall reasonably cooperate in any such
litigation at Company's expense.
If Company
elects not to enforce any patent within the PATENT RIGHTS, then it
shall so notify JHU in writing within ninety (90) days of receiving
a legal opinion that an infringement exists, and JHU may, in its
sole judgment and at its own expense, take steps to enforce any
patent and control, settle, and defend such suit in a manner
consistent with the terms and provisions hereof, and recover, for
its own account, any damages, awards or settlements resulting
therefrom.
4.4 Patent Invalidity
Suit. If a
declaratory judgment action is brought naming Company as a
defendant and alleging invalidity of any of the PATENT RIGHTS, JHU
may elect to take over the sole defense of the action at its own
expense. Company shall cooperate fully with JHU in connection with
any such action.
4.5 Recovery. Any
recovery by Company under Paragraph 4.3 shall be deemed to reflect
loss of commercial sales, and Company shall pay to JHU fifteen
percent (15%) of the recovery net of all reasonable costs and
expenses associated with each suit or settlement. If the
cost and expenses exceed the recovery, then one-half (1/2) of the
excess shall be credited against royalties payable by Company to
JHU hereunder in connection with sales of LICENSED PRODUCT covered
in the PATENT RIGHTS which are the subject of the infringement
suit, in
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