Exhibit
10.3
THE OHIO
STATE
UNIVERSITY RESEARCH
FOUNDATION
EXCLUSIVE LICENSE
AGREEMENT
THIS EXCLUSIVE LICENSE AGREEMENT
is made effective as of the
18 th
day of April 2008 (the
"Effective Date"), by and between THE OHIO STATE UNIVERSITY
RESEARCH FOUNDATION, located at 1960 Kenny Road, Columbus,
Ohio (“OSU”) and Omnimmune Corp., a Texas corporation
located at 4600 Post Oak Place, Suite 352, Houston,
TX 77027 (“LICENSEE”).
BACKGROUND
OSU owns certain PATENT RIGHTS (as later
defined) relating to OSU Case No. 99003, “Polypeptides
and Polynucleotides for Enhancing Immune Reactivity to HER-2
Protein”, and has the right to grant licenses under PATENT
RIGHTS (subject to only to a royalty-free nonexclusive license
previously granted to the United States Government);
OSU desires to have the PATENT RIGHTS developed
and commercialized to benefit the public and is willing to grant a
license for this purpose;
LICENSEE has represented to OSU, to induce OSU
to enter into this Agreement, that LICENSEE is experienced in
developing, producing, manufacturing, marketing, and selling
products similar to the LICENSED PRODUCT(s) (as later defined)
and/or using the LICENSED PROCESS(es) (as later defined) and that
it shall commit itself to a thorough, vigorous, and diligent
program of exploiting the PATENT RIGHTS so that the public shall
benefit; and
LICENSEE desires to obtain a license under the
PATENT RIGHTS upon the terms and conditions set forth
below.
The parties therefore agree as
follows:
ARTICLE I -
DEFINITIONS
For purposes of this Agreement, the following
words and phrases have the following meanings:
1.1
“COMBINATION PRODUCT” shall mean that product
that would result from combination of the HER-2 vaccine as and to
the extent licensed under this Agreement by LICENSEE with either
HER-2 peptodomimetics and/or VEGF peptidomimetics which, in either
such case, (a) act as antagonists by blocking receptor activation,
(b) is owned by OSU and (c) has not otherwise been licensed under
any other agreement to LICENSEE for such purpose.
1.2
“CONFIDENTIAL INFORMATION” means all
confidential or proprietary information designated as such in
writing by the party disclosing such information (the
“Disclosing Party”) to the receiving party (the
“Recipient”). Notwithstanding the foregoing,
information that is orally or visually disclosed to Recipient by
Disclosing Party or is disclosed in writing or other tangible form
without an appropriate letter, proprietary stamp or legend shall
constitute Confidential Information if Disclosing Party, within
thirty (30) days after such disclosure, delivers to Recipient
a written document or documents describing such information as
confidential. CONFIDENTIAL INFORMATION may be in written, graphic,
oral or physical form and may include scientific knowledge,
know-how, processes, inventions, techniques, formulae, products,
business operations, customer requirements, designs, sketches,
photographs, drawings, specifications, reports, studies, findings,
data, plans or other records, biological materials, and/or
software. CONFIDENTIAL INFORMATION shall not
include:
(a) information
which is, or later becomes, generally available to the public
through no fault of the recipient;
(b) information
which is provided to the recipient by an independent third party
having no obligation to keep the information secret;
(c) information
which the recipient can establish was previously known to it or was
independently developed by it without reference to the CONFIDENTIAL
INFORMATION.
Notwithstanding
the foregoing, if and to the extent the Recipient is required
pursuant to applicable law or court order, including Ohio Revised
Code Section 149.43, to disclose the Disclosing Party’s
Confidential Information, then it shall first notify the Disclosing
Party of any such requirement or attempt to require disclosure with
reasonable advance notice so as to permit the Disclosing Party to
petition a court of competent jurisdiction or to seek a protective
order such that the confidentiality of the Confidential Information
shall be maintained.
1.3
“FIELD OF USE” means active immunization with
chimeric HER-2 B-cell epitopes containing a “promiscuous T
cell epitope” emulsified in adjuvant for the treatment and
prevention of cancer by induction of HER-2 specific
antibodies.
1.4
“IMPROVEMENTS” shall mean any improvement,
addition, enhancement, modification, development, alteration,
technical advance or other discovery, whether patentable or not, of
an invention described in the PATENT RIGHTS, which, if unlicensed,
would infringe one or more claims, assuming the issuance thereof,
under the PATENT RIGHTS or other invention that falls under the
scope of the PATENT RIGHTS to the extent any such IMPROVEMENT is
owned or controlled by OSU and developed by an INVENTOR while
employed by OSU or any other individual who has an obligation to
assign his or her rights to inventions to OSU and who is under such
INVENTOR’S direct supervision or working in his or her
respective laboratory or collaborating with any of the foregoing;
provided, however, that in no event shall the term IMPROVEMENTS
include any right to the COMBINATION PRODUCT.
1.5
“INVENTOR(S)” shall mean the PERSON so named on
any PATENT RIGHTS (including, without limitation, with respect to
any IMPROVEMENT) who has an obligation to assign his or her rights
to inventions to OSU.
1.6
“KNOW-HOW” means know-how, research and
development, analyses, notes and other such records, procedures,
assay and other methods, formulae, indices, techniques, drawings,
software code, algorithms, processes, protocols, libraries,
designs, models, copyrights, trade secrets and other intellectual
property, whether proprietary or not, including, without
limitation, data generated in pre-clinical and clinical studies,
relating to the PATENT RIGHTS and IMPROVEMENTS (other than
IMPROVEMENTS otherwise constituting MATERIALS or PATENT RIGHTS),
along with any and all documents and other records (electronic or
otherwise) relating thereto, including, without limitation, any and
all results of experiments, clinical trials and studies directly
related to the claims made in the PATENT RIGHTS and owned by OSU or
any affiliate thereof or to which OSU or any affiliate thereof may
have any rights of use and which OSU has the right to grant rights
thereto, including, without limitation, that know how that is
described on Appendix C.
1.7
“LICENSED PROCESS” means any process that (a) is
covered in whole or in part by a VALID CLAIM contained in the
PATENT RIGHTS or (b) is developed, made or manufactured from KNOW
HOW or MATERIALS, which, as the case may be, has not been made the
subject of a public disclosure or otherwise becomes available to
the public other than pursuant to the issuance of a PATENT
RIGHT.
1.8
“LICENSED PRODUCT” means any product or product
part which:
(a) is
covered in whole or in part by a VALID CLAIM contained in the
PATENT RIGHTS in the country in which any such product or product
part is made, used or sold;
(b) is
manufactured by using a process or is employed to practice a
process which is covered in whole or in part by a VALID CLAIM
contained in the PATENT RIGHTS in the country in which any LICENSED
PROCESS is used or in which such product or product part is used or
sold; or
(c)
is developed, made or manufactured from KNOW HOW or MATERIALS,
which, as the case may be, has not been made the subject of a
public disclosure or otherwise becomes available to the public
other than pursuant to the issuance of a PATENT RIGHT.
1.9
“LICENSED TECHNOLOGY” means the PATENT RIGHTS,
KNOW HOW and MATERIALS.
1.10
“LICENSEE” means Omnimmune Corp. and any other
entity that directly or indirectly Controls, is Controlled by, or
is under common Control with Omnimmune
Corp. “Control” means ownership or other
beneficial interest in more than fifty percent (50%) of the voting
stock or other voting interest of a person.
1.11
“MATERIALS” means the tangible or physical
materials necessary for the effective exercise of the PATENT RIGHTS
and KNOW HOW and such other materials as are routinely produced
through use of the original materials, including without
limitation, theoriginal materials are listed in Appendix B, and any
and all IMPROVEMENTS thereof (other than any IMPROVEMENTS that
otherwise constitute KNOW HOW or PATENT RIGHTS) relating to the
FIELD OF USE.
1.12
“NET SALES” means the gross amount invoiced by
LICENSEE thereof from the sales of LICENSED PRODUCTS and LICENSED
PROCESSES by LICENSEE or any affiliate thereof to any customer
less:
(a) discounts
allowed in amounts customary in the trade;
(b) sales,
tariff duties and/or use taxes directly imposed and with reference
to particular sales;
(c) freight
and insurance, if separately itemized on the invoice and paid by
the customer;
(d) amounts
allowed or credited on returns; and
(e) and
reasonable reserve for bad debts accrued in accordance with the
LICENSEE’s standard accounting practices applied consistently
across the LICENSEE’s business, provided ,
however , that until such time as LICENSEE shall have
retained independent certified public accountants for the purpose,
inter alia, to determine its reserves for bad debts, the reserve
for bad debts employed in determining its NET SALES shall in no
event exceed two percent (2%) of NET SALES as otherwise determined
without regard to this Subsection 1.10(e).
No deductions
shall be made for cost of collections or for commissions paid to
individuals whether they are with independent sales agencies or
regularly employed by LICENSEE and on its
payroll. Inter-company transfers under this Agreement
between LICENSEE and any affiliate thereof shall not constitute a
sale or lease for purposes of this Paragraph. NET SALES
for LICENSED PRODUCTS sold by LICENSEE as a unit in conjunction
with other services or products will be determined pro-rata in
accordance with the respective stand-alone price or value of such
products and/or services. For the avoidance of doubt,
NET SALES shall not include SUBLICENSING REVENUE.
1.13
“PATENT RIGHTS” means all of the following OSU
intellectual property:
(a) the
United States and foreign patents and/or patent applications listed
in Appendix A and IMPROVEMENTS;
(b) all
continuations, divisions, continuations-in-part, to the extent the
subject matter is entitled to the priority date of the applications
for the respective VALID CLAIMS, including, without limitation, any
and all IMPROVEMENTS, reissues, re-examinations, and
extensions thereof, and any and all United States and foreign
patents directly issued therefrom, in whole or in part, including,
without limitation, any and all provisional patent applications and
Patent Cooperation Treaty (PCT) patent applications, all divisions
and continuations of these applications, all patents issuing from
such applications, divisions, continuations and
continuations-in-part; and
(c) any
reissues, reexaminations and extensions of patents described in (a)
or (b) above; provided, however, that in no event shall the term
“PATENT RIGHTS” include any right to the COMBINATION
PRODUCT.
1.14
“PERSON” shall mean any individual, partnership,
limited partnership, limited liability partnership, limited
liability company, corporation, trust, association, non-profit or
charitable organization or other entity, or an unincorporated
organization, a governmental entity or any department or agency
thereof.
1.15
“SUBLICENSE REVENUE” shall mean, except as
otherwise provided herein, all amounts actually received from a
sublicensee on account of the sublicensing of all or any part of
the LICENSED TECHNOLOGY, provided , however , that
SUBLICENSE REVENUE shall not include any amounts constituting
(a) bona fide research and development funding directly
relating to potential LICENSED PRODUCTS or LICENSED PROCESSES and
can be demonstrated by written evidence to be directed exclusively
to such activity, and (b) amounts reimbursed by a third party
for payments for bona fide research and development activities
directly relating to potential LICENSED PRODUCTS or LICENSED
PROCESSES and (c) a bona fide equity or capital investment in
capital stock or loan or other evidence of indebtedness made in
favor of LICENSEE.
1.16
“VALID CLAIM” shall mean a claim of any pending,
or issued and unexpired PATENT RIGHT that shall not have been
withdrawn, canceled, or disclaimed, nor held invalid by a court of
competent jurisdiction in any unappealed or unappealable decision
(after all such statutes of limitation for such appeal have run) in
the country where the product or process was made, used or sold by
LICENSEE or any sublicensee thereof.
ARTICLE II -
GRANT
2.1 OSU
grants to LICENSEE and LICENSEE accepts, subject to the terms and
conditions of this Agreement, a worldwide exclusive license in the
FIELD OF USE under the PATENT RIGHTS and a worldwide non-exclusive
license to the KNOW HOW and MATERIALS in the FIELD OF USE to make,
have made, use, lease, sell, and import LICENSED PRODUCTS and to
practice or permit the practice of the LICENSED PROCESSES, with
rights of sublicensing as provided in this Agreement.
2.2 This
Agreement is effective when signed by all parties and shall extend
until the later of either the expiration of the last to expire of a
VALID CLAIM under any PATENT RIGHT or, so long as a LICENSED
PRODUCT OR LICENSED PROCESS is available for sale based on or
derived from KNOW HOW or MATERIALS that has not otherwise been made
the subject of a public disclosure or otherwise becomes available
to the public other than pursuant to the issuance of a PATENT
RIGHT, ten (10) years following the date on which the first
commercial sale is made of a LICENSED PRODUCT or LICENSED PROCESS,
unless sooner terminated as provided in Article 11.
2.3 LICENSEE
agrees that LICENSED PRODUCTS leased or sold in the United States
shall be manufactured substantially in the United
States.
2.4 OSU
reserves the right to practice under the PATENT RIGHTS for
noncommercial research and educational purposes with respect to any
exclusive license granted to the LICENSEE.
2.5 The
license granted under this Article is subject to all rights the
United States Government may have under 35 U.S.C. 200-212 and
applicable governmental regulations, notwithstanding anything is
this Agreement to the contrary.
2.6 OSU
shall, as soon as reasonably practicable, but in no event later
than thirty (30) business days following the Effective Date,
and thereafter during the Term of this Agreement provide LICENSEE
with all KNOW HOW and MATERIALS, and reasonable opportunity to
confer with OSU’s research personnel regarding the inventions
claimed in the PATENT RIGHTS. OSU shall have a
continuing obligation during the term of this Agreement to promptly
disclose to LICENSEE any and all IMPROVEMENTS and coordinate
therewith the filing of any patent applications as
appropriate.
ARTICLE III - LICENSE FEES,
ROYALTIES
AND
MILESTONE
PAYMENTS
3.1 LICENSEE
shall pay royalties to OSU for the term of this Agreement or until
this Agreement is terminated, if such termination occurs
beforehand. Royalties shall include:
(a) Upfront
License Fee. A license issue fee of Three Hundred
Thousand dollars ($300,000)(the “LICENSE
FEE”). Five Thousand Dollars of such LICENSEE fee
shall be deemed earned and due immediately upon execution of this
Agreement. One Hundred Forty-Five Thousand Dollars of
such LICENSEE FEE shall be nonrefundable and deemed earned as of
the forty-fifth (45 th )
day following the Effective Date, unless and except LICENSEE shall
notify OSU in writing of its intent to terminate this Agreement due
to its review of the Phase I data as outlined in Appendix D which
relates to the LICENSED TECHNOLOGY (the “PHASE I DATA REVIEW
PERIOD”), in which case this Agreement shall terminate
forthwith without any obligation whatsoever on the part of LICENSEE
to pay all but the initial Five Thousand Dollar ($5,000) portion of
the LICENSE FEE. Failing to exercise its right to
terminate this Agreement within the PHASE I DATA REVIEW PERIOD,
however, LICENSEE shall pay to OSU the LICENSE FEE in the following
installments: upon and coincident with the first
business day immediately following the PHASE I DATA REVIEW PERIOD
(the “FIRST INSTALLMENT”), Forty-Five Thousand Dollars
($45,000); three months thereafter, Fifty Thousand Dollars
($50,000). The remainder of the LICENSE FEE shall be due
and payable as follows: One Hundred Thousand Dollars ($100,000)
shall be due and payable on November 15, 2008, Fifty Thousand
Dollars shall be due and payable on June 30, 2009, and the
remaining Fifty Thousand Dollars ($50,000) shall be due and payable
on September 30, 2009.
(b) Minimum
Annual Royalty. A minimum annual royalty of One Hundred
Thousand Dollars ($100,000). Such minimum annual
royalty shall be deemed earned and accrued as of January 1
beginning in the first calendar year immediately following the
twelve-month period after the first commercial sale of a LICENSED
PRODUCT, escalating to Two Hundred Thousand dollars ($200,000)
per year beginning in the first calendar year immediately following
the thirty-six (36) month period after the first commercial
sale of a LICENSED PRODUCT. The minimum annual royalty
payment shall be credited against the LICENSEE's running royalty
obligation under Paragraph 3.1(c), below, for that calendar year;
and LICENSEE's quarterly reports under Article 6.3 shall
reflect such credit. The minimum annual royalty payments
shall not be creditable against milestone payments (if
any).
(c) Running
Royalties. Running royalties equal to:
(i) three
percent (3%) of annual NET SALES of up to five hundred million
dollars ($500,000,000);
(ii) four
percent (4%) of annual NET SALES in excess of five
hundred million dollars ($500,000,000) and up to
one billion dollars ($1,000,000,000); and
(iii) five
percent (5%) of annual NET SALES in excess of one billion
dollars ($1,000,000,000)(the “RUNNING
ROYALTIES”).
If, after
review at any stage of prosecution, all claims in pending patent
applications contained within PATENT RIGHTS covering LICENSED
PRODUCT(s) or LICENSED PROCESS(es) are deemed unpatentable by
LICENSEE and OSU patent counsel or are otherwise invalidated, then
the RUNNING ROYALTIES shall be reduced by fifty percent (50%);
provided, however, that in no event shall LICENSEE be obligated to
pay for amounts otherwise due and owing under this Agreement if and
to the extent the LICENSED PRODUCT(s) or LICENSED PROCESS(es) with
respect to which any such obligation would arise is not subject to
a protectable intellectual property right (e.g., a patent right or
trade secret). Notwithstanding the foregoing, if a
patent subsequently issues from such application contained within
PATENT RIGHTS or any such invalidation is overturned or rescinded,
then the RUNNING ROYALTIES shall return to the original percentage
described in this Article 3.1(c) beginning on the date of such
issue. Additionally, the parties to this Agreement agree
to negotiate in good faith a reduction to the RUNNING ROYALTIES due
and payable in connection with NET SALES attributable to LICENSED
PRODUCTS or LICENSED PROCESSES based on KNOW HOW or MATERIALS and
for which there does not exist a VALID CLAIM.
(d) Sublicensing
Fees. Twenty percent (20%) of any SUBLICENSE
REVENUE (the “SUBLICENSING FEES”) received by LICENSEE
under any sublicense agreements prior to two (2) years from the
Effective Date, fifteen percent (15%) of any SUBLICENSE REVENUE
received by LICENSEE under any sublicense agreements between two
(2) years and four (4) years of the Effective Date, and ten percent
(10%) of any SUBLICENSE REVENUE received by LICENSEE under any
sublicense agreements thereafter. If and to the extent LICENSEE
enters into a sublicense agreement that could result in the payment
of a SUBLICENSING FEE other than cash, LICENSEE shall notify OSU of
any such provision in the sublicense agreement at the time of its
delivery to OSU under Article 4.2 below, and with respect thereto,
if OSU is prohibited by applicable law from accepting the form of
consideration LICENSEE has agreed to accept under such sublicense
agreement, then LICENSEE shall be obligated to satisfy its
obligation under this Section 3.1(d) in such form of consideration
as OSU is permitted by applicable law to accept, provided ,
however , than in any such event the fair market value of
any such substituted consideration shall be equal to or greater
than the fair market value of the form of consideration OSU is
unable to so accept.
(e) If
LICENSEE is reasonably required to take a license under any third
party patents to use the PATENT RIGHTS or if LICENSEE in its
discretion determines that a license to any third party patents
would be useful for the LICENSED PRODUCT or LICENSED PROCESS and
LICENSEE’S total royalty burden for NET SALES of LICENSED
PRODUCTS and LICENSED PROCESSES exceeds five percent (5%) of NET
SALES under Section 3.1(c)(i), six percent (6%) of NET SALES under
Section 3.1(c)(ii), or seven percent (7%) of NET SALES under
Section 3.1(c)(iii), respectively (in sum, the “Royalty
Cap”), the royalty percentage payable hereunder shall be
reduced proportionally in accordance with the following
formula:
R2 = R1 x
(Royalty Cap/T)
R2 is the
adjusted reduced royalty rate due hereunder;
R1 is the
royalty due under Section 3.1(c); and
T is the total
royalty due to all licensors (the “ANTISTACKING
FORMULA”).
The
ANTISTACKING FORMULA shall be applied to NET SALES under Sections
3.1(c)(i-iii) independently with the corresponding Royalty Cap
defined in this Section. Notwithstanding the foregoing,
in no event will the royalty rate due in connection with RUNNING
ROYALTIES be reduced by more than fifty percent (50%).
(f) Milestone
Payments. For and with respect to LICENSED PRODUCTS or
LICENSED PROCESSES based on a VALID CLAIM, the following milestone
payments shall be due upon the first occurrence of the
following:
$50,000 upon
the first dosing of a subject in a Phase II clinical
trial;
$150,000 upon
the first dosing of a subject in a Phase III clinical
trial;
$250,000 upon
the first filing of an NDA for a product;
$350,000 upon
the first commercial sale of product in the United States;
and
$350,000 upon
the first commercial sale of product in first country outside of
the United States.
Milestone
payments, except for first commercial sale milestone payments, are
non-refundable, non-creditable against future royalties, and are
payable only once the first time a milestone is
achieved. First commercial sales milestones are fully
creditable against future royalties.
3.2 LICENSEE
shall be responsible for the payment of all taxes (other than
income and franchise taxes), duties, levies, and other charges,
including, but not limited to, sales, use, gross receipts, excise,
VAT, and any other taxes, any withholdings or deductions, import
and custom taxes, any duties, or any other charges, imposed by any
taxing authority with respect to the royalties payable to OSU under
this Agreement. Should LICENSEE be required under any
law or regulation of any government entity or authority, domestic
or foreign, to withhold or deduct any portion of the payments on
royalties due to OSU, then the sum payable to OSU shall be
increased by the amount necessary to yield to OSU an amount equal
to the sum it would have received had no withholdings or deductions
been made. OSU shall cooperate with LICENSEE in the
event LICENSEE elects to assert, or requires OSU to assert, at
LICENSEE’s expense, OSU’s exemption from any such tax
or deduction.
3.3 LICENSEE
is not obligated to pay multiple royalties based on the fact that
any LICENSED PRODUCT or LICENSED PROCESS or the manufacture, use,
lease or sale thereof is covered by more than one PATENT RIGHTS
patent application or PATENT RIGHTS patent licensed under this
Agreement.
3.4 Royalty
payments shall be paid in United States dollars in Columbus, Ohio,
or at such other place as OSU may reasonably designate consistent
with the laws and regulations controlling in any foreign country.
If any currency conversion is required in connection with the
payment of royalties, such conversion shall be made by using the
exchange rate as published as of the last busin