THE OHIO STATE UNIVERSITY RESEARCH FOUNDATION EXCLUSIVE LICENSE AGREEMENT
Exhibit 10.3
THE OHIO
STATE
UNIVERSITY RESEARCH
FOUNDATION
THIS EXCLUSIVE LICENSE
AGREEMENT is made effective as of the 18th day
of April 2008 (the "Effective Date"), by and between THE OHIO STATE
UNIVERSITY RESEARCH FOUNDATION, located at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇
(“OSU”) and Omnimmune Corp., a Texas corporation located at ▇▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (“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
(45th) 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)
Where:
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 business day of the
applicable calendar quarter in the eastern edition of The Wall Street
Journal.
3.5 Royalty
payments shall be made on a quarterly basis with submission of the reports
required by Article 6, except the minimum annual royalty payment, which
shall be due as provided in Article 3.1. Such royalty payments
and reports shall be due within forty five (45) days of March 31,
June 30, September 30, and December 31 of each calendar
year. Undisputed late payments, including payments due for patent
cost reimbursement, shall be subject to a charge of one and one-half
percent (1.5%) per month or $100, whichever is greater. The
payment of such late charge shall not foreclose OSU from exercising any other
rights it may have resulting from any late payment.
ARTICLE IV -
SUBLICENSES
4.1 LICENSEE
has the right to enter into sublicensing agreements; provided, however, that all
such sublicensing agreements shall be subject to all applicable terms and
conditions of this Agreement, including but not limited to Articles 2, 6, 8, 9,
10, 11 and 14. LICENSEE further agrees to either provide a copy of this
Agreement to any such sublicensee or attach it to such sublicense
agreements.
4.2 LICENSEE
shall forward to OSU a copy of all sublicense agreements as soon as reasonably
practicable upon execution by the parties; provided, however, that all such
agreements shall constitute LICENSEE Confidential Information.
ARTICLE V - DUE
DILIGENCE
5.1 LICENSEE
shall use its best commercially reasonable efforts to bring one or more LICENSED
PRODUCTS or LICENSED PROCESSES to market through a thorough, vigorous and
diligent program for exploiting the PATENT RIGHTS and to continue active,
diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED
PROCESSES throughout the life of this Agreement.
5.2 As
part of this due diligence, LICENSEE agrees to reach the following
commercialization and research and development milestones for the LICENSED
PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following
dates:
|
Complete
transfer of Investigational New Drug Application (“IND”) from OSU to
LICENSEE (the “Transfer Date”)
|
Six
(6) months from the Effective Date
|
|
Initiate
Phase II clinical trials in the United States.
|
Twelve
(12) months from the Transfer Date.
|
|
Complete
Phase II clinical trials in the United States
|
Thirty-six
(36) months from initiation of a Phase II clinical trial or equivalent
thereof on a LICENSED PRODUCT
|
|
Complete
Phase III clinical trials in the United States
|
Forty-eight
(48) months from the completion of a Phase II clinical trial or equivalent
thereof on a LICENSED PRODUCT
|
Satisfaction
of a later-in-time Milestone shall be deemed to constitute satisfaction of any
prior-in- time Milestone. It is also agreed that OSU is to be a
selected site for the multi-center Phase II clinical trial unless otherwise
agreed to by both OSU and LICENSEE or otherwise deemed impracticable in the
reasonable good faith judgment of the LICENSEE. For the purposes of
this Agreement, "initiation of a clinical trial" shall mean that date upon which
the first patient or subject is treated with a LICENSED PRODUCT under a protocol
approved by an appropriate drug regulatory agency with a therapeutic agent or
process that has been manufactured according to Good Manufacturing Practices
(GMP) guidelines provided by the relevant regulatory agency.
5.3 The
MILESTONES are established to ensure that the LICENSED TECHNOLOGY is assiduously
developed and will toll from the successful completion of the previous
milestone. Nevertheless, it is acknowledged by the parties that
development can be delayed by unforeseen, unusual or other scientific, clinical
or regulatory problems, not including lack of capital for
development. Should such delays cause LICENSEE to fail to initiate or
complete any development activity or milestone within the allotted time, the
periods allotted shall be extended by mutual written agreement, not to be
unreasonably withheld or delayed, it being the responsibility of LICENSEE to
document and report any such delays. LICENSEE will provide an
estimate of the resources to be committed to such plans.
ARTICLE VI - REPORTS AND
RECORDS
6.1 LICENSEE
shall keep full, true and accurate books of account containing all particulars
necessary to show the amounts payable to OSU. The books of account
shall be kept at LICENSEE’s principal place of business or the principal place
of business of the appropriate division of LICENSEE to which this Agreement
relates. The books and supporting data shall be open at all reasonable times for
five (5) years following the end of the calendar year to which they
pertain, for inspection by OSU or its agents to verify not more than once during
any such calendar year LICENSEE’s royalty statement or compliance in other
respects with this Agreement. Should such inspection lead to the
discovery of discrepancy in reporting which is greater than five
percent (5%) to OSU’s detriment, LICENSEE agrees to pay the full reasonably
and actually incurred cost of such inspection (subject to its right to contest
the same).
6.2 LICENSEE
shall provide to OSU a written annual report on or before January 31 of each
calendar year. The annual report shall include: reports of progress
on research and development, regulatory approvals, manufacturing, sublicensing,
marketing and sales during the preceding twelve (12) months, and plans for
the coming year.
6.3 After
the first commercial sale of a LICENSED PRODUCT or LICENSED PROCESS, LICENSEE
shall provide quarterly reports to OSU. The quarterly reports shall
be delivered within forty-five (45) days after March 31, June 30,
September 30, and December 31 of each year. The quarterly
reports shall give particulars of the business conducted by LICENSEE and its
sublicensees during the preceding quarter that are pertinent to a royalty
accounting, including:
(a) number
of LICENSED PRODUCTS manufactured and sold by LICENSEE and all
sublicensees;
(b) total
▇▇▇▇▇▇▇▇ for LICENSED PRODUCTS sold by LICENSEE and all
sublicensees;
(c) accounting
for all LICENSED PROCESSES used or sold by LICENSEE and all
sublicensees:
(d) deductions
applicable as provided in Article 1.11;
(e) payments
due on SUBLICENSE REVENUE from sublicensees under
Article 3.1(d);
(f) any
minimum annual royalty payment credits applicable against running
royalties;
(g) total
royalties due; and
(h) names
and addresses of all sublicensees.
ARTICLE VII - PATENT
PROSECUTION
7.1 OSU
shall, in its sole discretion, using either its regularly engaged patent counsel
or other patent counsel reasonably acceptable to LICENSEE, be responsible for
the preparation, filing, prosecution and maintenance of any and all applications
and patents included in the PATENT RIGHTS. OSU shall consult with
LICENSEE as to the preparation, filing, prosecution and maintenance of such
applications and patents and shall furnish to LICENSEE copies of documents
relevant to any such preparation, filing, prosecution or maintenance, with all
such consultation and copies being made reasonably in advance of any filing or
other action to permit LICENSEE to review and offer comments
thereto. In the event that OSU shall elect to either forgo the
preparation, filing, prosecution or maintenance or otherwise abandon any PATENT
RIGHTS, OSU shall as soon as reasonably practicable, but in no event less than
sixty (60) prior to the date on which any such action would be timely
required, give written notice thereof to LICENSEE. Upon receipt of
any such notice or to the extent any such determination becomes actually known
to LICENSEE, LICENSEE shall have the option, but not obligation to prepare,
file, prosecute or maintain, as the case may be, the PATENT
RIGHTS. OSU and LICENSEE shall cooperate fully in determining, in a
timely manner, the countries in which patent protection shall be pursued and
maintained. Each party shall provide to the other prompt notice as to
all matters that come to its attention and which may affect the preparation,
filing, prosecution or maintenance of any such patent applications or
patents. In particular, LICENSEE will immediately notify OSU if
LICENSEE or a sublicensee (or optionee) does not qualify as a “small entity” as
provided by the United States Patent and Trademark Office.
7.2 LICENSEE
shall reimburse OSU the amount of One Hundred One Thousand Nine Hundred Seven
Dollars and Twenty Cents ($101,907.20), which amount is the sum of all
documented expenses OSU has actually incurred through January 2008 for the
preparation, filing, prosecution and maintenance of the PATENT RIGHTS, which
shall be paid in eight (8) quarterly installments of Twelve Thousand Seven
Hundred and Thirty-Eight Dollars and Forty Cents ($21,738.40), with the first
installment due and payable October 1, 2009, and each subsequent payment due and
payable January 1, April 1, July 1 and October 1,
respectively. Thereafter, LICENSEE shall reimburse OSU for all such
unreimbursed or future expenses actually incurred for the preparation, filing,
prosecution or maintenance of the PATENT RIGHTS upon receipt of invoices from
OSU. Such reimbursement shall be made within thirty (30) days of
receipt of OSU’s invoice and shall, if overdue and not otherwise disputed, be
subject to late charges as specified in Article 3.5 above. OSU
reserves the right, in its sole discretion, to require the pre-payment by
LICENSEE of some or all of the anticipated filing costs for any foreign patent
application as a precondition for the filing of such application.
ARTICLE VIII -
INFRINGEMENT
8.1 LICENSEE
or its sublicensee(s) (subject to any applicable sublicensing agreement) has the
right to prosecute in their own name and at their own expense any infringement
of the PATENT RIGHTS, so long as the license is exclusive when the legal action
is commenced. OSU agrees to notify LICENSEE promptly of each
infringement of the PATENT RIGHTS of which OSU becomes aware. Before
LICENSEE or its sublicensees commences an action for infringement, LICENSEE or
sublicensee shall notify OSU and carefully consider the views of OSU and the
public interest.
8.2 Where
joinder is a matter of discretion, OSU agrees to join, subject to the approval
of the Ohio Attorney General, as a party plaintiff in any lawsuit initiated by
LICENSEE, if requested by LICENSEE. If required by law to obtain
standing, OSU shall join or otherwise permit any action or proceeding
to be brought on OSU’s behalf and in its name and cooperate with LICENSEE in all
aspects of any such action or proceeding brought under this Article, with all
costs, attorney fees and expenses reasonably and actually incurred to be paid by
LICENSEE.
8.3 If
LICENSEE undertakes to enforce and/or defend the PATENT RIGHTS by litigation,
LICENSEE may withhold up to fifty percent (50%) of the payments otherwise
thereafter due during the course of such litigation to OSU under
Article 3. LICENSEE may apply the amounts withheld to reimburse
up to half of LICENSEE’s litigation expenses, including reasonable attorneys’
fees. Any recovery under this Section of damages for
infringement by a third party shall be distributed as
follows: (a) each of OSU and LICENSEE shall be reimbursed for
any otherwise unreimbursed legal fees and other out-of pocket expenses incurred
in the action; (b) OSU shall be reimbursed for any payments under
Article 3 that are past due or were withheld pursuant to this
Article; and (c) the remaining balance being divided between OSU
and LICENSEE by, in the case where the recovery is based on LICENSEE’s lost
profits, determining the amount of NET SALES that were relied upon for purposes
of calculating such lost profits and calculating the amounts that would have
otherwise been paid to OSU under this Agreement had such NET SALES been earned
by LICENSEE (after taking into account the amounts allocated under
clauses (a) and (b) above, provided, however, that in no
event shall the amount payable from any such recovery exceed fifty
percent (50%) of any such lost profits, with all amounts remaining from any
such recovery being paid to or otherwise retained by LICENSEE. LICENSEE shall
during the term of this Agreement have the sole right subject to the terms and
conditions hereof to sublicense any alleged infringer for future use of the
PATENT RIGHTS to the extent licensed by this Agreement. Any upfront
fees paid to LICENSEE as part of such a sublicense, after reimbursement of any
legal expenses incurred by LICENSEE and OSU, shall be treated as SUBLICENSE
REVENUES for purposes of this Agreement.
8.4 No
settlement, consent judgment or other voluntary final disposition of the suit
may be entered into without OSU’s consent, which shall not be unreasonably
withheld, unless and to the extent that such settlement is in the form of a
sublicense pursuant to the terms and conditions of this Agreement.
8.5 If
LICENSEE and its sublicensee(s) elect not to exercise their right to prosecute
or defend an infringement of the PATENT RIGHTS, OSU may do so at its own
expense, controlling such action and retaining all recoveries; in the case where
any such action is undertaken by OSU due to LICENSEE being unable to do so
(e.g., in the case where LICENSEE is unable to obtain standing), then any
recoveries shall be allocated in accordance with Section 8.3 above.
8.6 If
a declaratory judgment action alleging invalidity of any of the PATENT RIGHTS is
brought against LICENSEE or OSU, then OSU, at its sole option, has the right to
intervene and take over the defense of the action at its own
expense.
ARTICLE IX - PRODUCT
LIABILITY
9.1 LICENSEE
shall at all times during the term of this Agreement and thereafter, indemnify,
defend and hold OSU, its trustees, directors, officers, employees and
affiliates, (collectively, the “Indemnitees”) harmless against all claims,
proceedings, demands and liabilities of any kind whatsoever, including legal
expenses and reasonable attorneys’ fees, arising out of the death of or injury
to any person or persons or out of any damage to property, or resulting from the
production, manufacture, sale, use, lease, consumption or advertisement of the
LICENSED PRODUCT(s) and/or LICENSED PROCESS(es) or arising from any obligation
of LICENSEE under this Agreement, provided, however, that this indemnification
shall not extend to any claims arising out of any act or
omission: (a) constituting (i) a material breach of this
Agreement by OSU; (ii) a material violation by OSU, its directors,
officers, employees or agents, of applicable law or other governmental
requirement; (iii) intentional or willful misconduct by OSU, its directors,
officers, employees, contractors, agents or representatives; or (iv) PATENT
RIGHTS infringing third party intellectual property; or (b) occurring prior to
the Effective Date of this Agreement.
9.2 LICENSEE
shall, at all times after the Effective Date of this Agreement and prior to the
occurrence of an event described in Article 9.2(a), maintain commercial
general liability insurance in amounts adequate to cover its reasonably
anticipated obligations to OSU under Section 9.1 of this
Agreement.
(a) Beginning
at the time any product, process or service relating to, or developed pursuant
to, this Agreement is being commercially distributed or sold (other than for the
purpose of obtaining regulatory approvals) by LICENSEE or by a sublicensee or
agent of LICENSEE, LICENSEE shall, at its own expense, procure and maintain
commercial general liability insurance in amounts of not less than two million
dollars ($2,000,000) per incident and ten million
dollars ($10,000,000) annual aggregate and naming Indemnitees as additional
insureds. During clinical trials of any such product, process or
service, LICENSEE shall, at its sole expense, procure and maintain commercial
general liability insurance in such equal or lesser amounts as OSU may
reasonably require. The general commercial liability insurance
required under this paragraph shall provide (i) product liability coverage
and (ii) broad form contractual coverage for LICENSEE’s indemnification
under this Agreement.
(b) LICENSEE
shall provide (not more than once per twelve (12) consecutive calendar month
period) OSU with written evidence of such insurance upon request of
OSU. LICENSEE shall provide OSU with written notice at least
thirty (30) days prior to the cancellation, non-renewal or material change
of such insurance; if LICENSEE does not obtain replacement insurance providing
comparable coverage within such thirty (30) day period and provide written
evidence to OSU of such replacement insurance, OSU shall have the right to
terminate this Agreement effective at the at the end of such thirty (30)
day period without notice or any additional waiting periods.
(c) LICENSEE
shall maintain such commercial general liability insurance beyond the expiration
or termination of this Agreement during (i) the period that any product,
process, or service relating to, or developed pursuant to, this Agreement is
being commercially distributed or sold by LICENSEE or a sublicensee or agent of
LICENSEE and (ii) a reasonable period after the period referred to
Article 9.2(a) above, which in no event shall be less than
fifteen (15) years.
9.3 EXCEPT
AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, OSU, ITS TRUSTEES,
DIRECTORS, OFFICERS, EMPLOYEES, AND AFFILIATES MAKE NO REPRESENTATIONS AND
EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT
LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
VALIDITY OF PATENT RIGHTS CLAIMS ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR
OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE. NOTHING IN THIS AGREEMENT SHALL BE
CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY OSU THAT THE PRACTICE BY
LICENSEE OF THE LICENSE GRANTED SHALL NOT INFRINGE THE PATENT RIGHTS OF ANY
THIRD PARTY. OSU, ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND
AFFILIATES SHALL NOT BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY
KIND, INCLUDING ECONOMIC DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS,
REGARDLESS OF WHETHER OSU IS ADVISED, HAS OTHER REASON TO KNOW, OR IN FACT DOES
KNOW OF THE POSSIBILITY.
ARTICLE X -
CONFIDENTIALITY
10.1 Except
as may otherwise be agreed to in any subsequent agreement, each Party to this
Agreement agrees that all CONFIDENTIAL INFORMATION disclosed by Disclosing Party
to Recipient or its Designated Representatives (i) shall not be used for
any purpose whatsoever by Recipient or its Designated Representatives, except in
fulfillment of Recipient’s rights or obligations under this Agreement,
(ii) shall be maintained in confidence by Recipient and its Designated
Representative for the period described below, and (iii) shall not be
otherwise disclosed by Recipient or its Designated Representative to any other
third party to this Agreement without Disclosing Party’s prior written
consent. Notwithstanding the foregoing, Recipient may disclose
Disclosing Party’s CONFIDENTIAL INFORMATION if Recipient is required to make
such disclosure by applicable law, regulation or legal process, including,
without limitation, by the rules or regulations of the United States Securities
and Exchange Commission or similar regulatory agency in a country other than the
United States or of any stock exchange or NASDAQ, in which event Recipient shall
provide prior notice of such intended disclosure to Disclosing Party if possible
under the circumstances and shall disclose only such CONFIDENTIAL INFORMATION of
such Disclosing Party as is required to be disclosed.
10.2 Recipient
agrees that it shall provide Disclosing Party’s CONFIDENTIAL INFORMATION only to
the employees, consultants and advisors of the Recipient or any affiliate
thereof (collectively, the “Designated Representatives”) who have a need to know
such CONFIDENTIAL INFORMATION to assist the Recipient in fulfilling its
obligations under this Agreement and have agreed to provisions similar to those
contained in this Agreement restricting the use and disclosure thereof, provided, however, that
Recipient shall remain responsible for any failure by any such Designated
Representative to treat such CONFIDENTIAL INFORMATION as required under this
Section.
10.3 The
obligations of confidentiality in this Agreement are binding for the term and a
period of three (3) years from the date of termination of this Agreement;
provided, however, that in the
case of CONFIDENTIAL INFORMATION that constitutes a trade secret, such period of
limitation shall run for the term of this Agreement and for such period
thereafter, if longer, during which any such information continues to constitute
a trade secret as defined under applicable law. This Section shall be construed
as an agreement ancillary to the other provisions of this Agreement, and the
existence of any claim or cause of action of one party against the other,
whether predicated on this Agreement or otherwise, shall not constitute a
defense to the enforcement of this Section. All written documents containing
CONFIDENTIAL INFORMATION, together with copies of excerpts thereof, shall
promptly be returned to Disclosing Party by Recipient upon request following
termination of this Agreement. Notwithstanding anything to the
contrary herein, any information, including information that may be considered
to be part of the LICENSED TECHNOLOGY, that is or becomes generally known to the
public through no wrongful acts of Recipient shall not be deemed to be
CONFIDENTIAL INFORMATION and shall not be subject to the confidentiality
restrictions imposed under this Agreement.
ARTICLE XI -
TERMINATION
11.1 If
LICENSEE becomes bankrupt, or files a petition in bankruptcy, or if the business
of LICENSEE is placed in the hands of a receiver, assignee or trustee for the
benefit of creditors, whether by the voluntary act of LICENSEE or otherwise, the
exclusive license granted under Article 2 herein will automatically convert
to a nonexclusive license that may not be assumed or assigned without the
consent of OSU.
11.2 If
LICENSEE fails to make any payment due to OSU, OSU has the right to terminate
this Agreement effective on thirty (30) days’ written notice, unless
LICENSEE makes all such payments within the thirty (30) day period. If
LICENSEE has not made all such payments to OSU by the time the thirty (30)
day period expires, this Agreement shall automatically terminate.
11.3 If
LICENSEE fails to obtain or maintain the insurance coverage as described in
Article 9.2, OSU shall have the right to terminate this Agreement without
further notice as provided under Article 9.2(b).
11.4 Upon
any material breach or default of this Agreement by LICENSEE other than those
occurrences listed in Articles 5.3, 11.1, 11.2 and 11.3 (the terms of which
shall take precedence over the handling of any other material breach or default
under this Paragraph), OSU has the right to terminate this Agreement effective
on ninety (90) days’ written notice to LICENSEE. Such termination shall
become automatically effective upon expiration of the ninety (90) day
period unless LICENSEE cures the material breach or default before the period
expires.
11.5 Notwithstanding
any provision in this Agreement to the contrary, if in the event the LICENSEE
disputes an alleged default or other breach of its obligations under this
Agreement, then the period during which LICENSEE is permitted to cure any such
default or breach under this Section shall be tolled for the period during which
any such dispute remains pending and this Agreement shall remain in full force
and effect; provided, however, that LICENSEE elects to cause the cure period to
toll under this Section, then any such tolling thereof shall be conditioned upon
LICENSEE posting a bond and paying any and all of OSU’s legal fees and courts
costs should OSU prevail in any dispute over the matter that is the subject of
the alleged breach. Should it be finally determined that LICENSEE was
in default under this Agreement, then such Defaulting Party shall have the
remainder of the cure period to cure the same. Any such notice of
default or breach shall state the nature of the defaults claimed by the
non-breaching party.
11.6 LICENSEE
has the right to terminate this Agreement at any time on three (3) months’
written notice to OSU if LICENSEE:
(a) pays
all amounts due OSU through the effective date of the termination;
(b) submits
a final report of the type described in Article 6.3;
(c) returns
any confidential or trade-secret materials provided to LICENSEE by OSU in
connection with this Agreement;
(d) suspends
its use of the LICENSED PROCESS(ES) AND LICENSED PRODUCT(S) (subject to
Article 11.8 below);
11.7 Within
ten (10) days following any termination hereof by OSU, OSU shall have the right
to elect whether to license from LICENSEE any and all patent applications or
obtained patents to any modification or improvement (the practice of which would
constitute an infringement of the PATENT RIGHTS) to LICENSED PRODUCTS or
LICENSED PROCESSES and other data and know how developed by LICENSEE in the
course of LICENSEE’S efforts to develop LICENSED PRODUCTS and LICENSED
PROCESSES, including access any regulatory information filed with any US or
foreign government agency with respect to LICENSED PRODUCTS and
PROCESSES. Upon any exercise thereof, such right of first refusal
shall have a term of ninety (90) days thereafter during which each of the
parties agrees to negotiate for a period of ninety (90) days in good faith for
the purpose of agreeing upon the terms and conditions of any such license,
pursuant to which OSU shall have the right to use such data and know-how for any
purpose whatsoever, including the right to transfer same to future
licensees.
11.8 Termination
of this Agreement shall not release OSU and LICENSEE from any obligation that
matured prior to the effective date of such
termination. Articles 1, 9, 10, 11 and 14 shall survive
termination. LICENSEE and any sublicensee may, however, after the effective date
of such termination, complete and sell LICENSED PRODUCTS in the process of
manufacture and sell all LICENSED PRODUCTS already in existence at the time of
termination, if LICENSEE pays OSU as required by Article 3 and submits the
reports required by Article 6 of this Agreement. Sublicenses
granted hereunder relating to the LICENSED TECHNOLOGY shall be assigned to OSU
to the extent, and only to the extent necessary for any such sublicensee to
continue its use thereunder, with OSU assuming LICENSEE's rights and obligations
thereunder; provided, however, that:
(a) any
such assignment and assumption shall be conditioned upon and subject to the
sublicensee not otherwise being in material default thereunder; and
(b) either
the sublicense agreement expressly provides for or the sublicensee agrees under
a separate agreement that any such sublicense is subject to the terms and
conditions of this Agreement and that in the event of a conflict between the
terms and conditions of any such sublicense and this Agreement, this Agreement
shall control, but not operate to expand or increase the rights granted under
the sublicense to the sublicensee.
ARTICLE XII - PAYMENTS,
NOTICES,
AND OTHER
COMMUNICATIONS
12.1 Any
payment, notice or other communication required by this Agreement shall be
sufficiently made or given on the date of mailing if sent by recognized express
carrier or certified first class mail, postage prepaid, addressed to OSU or
LICENSEE at its address below or as it designates by written notice to the
other.
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For
OSU:
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Technology
Licensing & Commercialization
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The
Ohio State University
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▇▇▇-▇▇▇▇; FAX (▇▇▇) ▇▇▇-▇▇▇▇
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For
LICENSEE:
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▇▇▇▇▇▇
▇. ▇▇▇▇▇▇▇▇▇▇▇▇, Ph.D.
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President &
CEO
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Omnimmune
Corp.
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ARTICLE XII -
REPRESENTATIONS AND WARRANTIES
13.1 OSU
represents and warrants that it has the right to enter into, deliver and perform
its obligations under this Agreement and, to the best of its knowledge and
belief upon reasonable investigation, it is not a party to any other agreement
the terms or conditions of which will be in conflict with this
Agreement.
13.2 LICENSEE
represents and warrants that it has the full corporate power and authority to
enter into this Agreement, that this Agreement constitutes the binding legal
obligation of LICENSEE, and that the execution and performance of this Agreement
by LICENSEE will not violate or conflict with any other agreement to which
LICENSEE is a party or by which it is bound or with any law, rule or regulation
applicable to LICENSEE.
ARTICLE XIV - MISCELLANEOUS
PROVISIONS
14.1 This
Agreement shall be construed, governed, interpreted and applied according to
Ohio law, except that questions affecting the construction and effect of any
patent shall be determined by the law of the country in which the patent was
granted.
14.2 OSU
and LICENSEE acknowledge that this Agreement sets forth their entire
understanding concerning the subject matter of this Agreement, and no
modification of the Agreement will be effective unless both OSU and LICENSEE
agree to it in writing.
14.3 The
provisions of this Agreement are severable. If any provisions of this
Agreement are determined invalid or unenforceable under any controlling body of
law, such invalidity or unenforceability shall not affect the validity or
enforceability of the remaining provisions.
14.4 LICENSEE
agrees to ▇▇▇▇ the LICENSED PRODUCTS sold in the United States with all
applicable United States patent numbers. All LICENSED PRODUCTS
shipped to or sold in other countries shall be marked to comply in all material
respects with applicable patent laws and practice of the country of manufacture
or sale.
14.5 The
failure of either OSU or LICENSEE to assert a right or insist upon compliance
with any term or condition of this Agreement shall not constitute a waiver of
that right or excuse a similar subsequent failure to perform any such term or
condition by the other.
14.6 Except
as otherwise provided in this Agreement, LICENSEE shall not use, either directly
or indirectly, the name of The Ohio State University Research Foundation, The
Ohio State University, or any of their officers, employees, students or board
members in any publicity or advertising unless a copy is submitted to and
approved in writing by OSU.
14.7 LICENSEE
agrees to comply in all material respects with all applicable laws and
regulations. In particular, LICENSEE understands and acknowledges that the
transfer of certain commodities and technical data is subject to United States
laws and regulations controlling the export of such commodities and technical
data, including all Export Administration Regulations of the United States
Department of Commerce. These laws and regulations prohibit or require a license
for the export of certain types of technical data to certain specified
countries. LICENSEE agrees to comply in all material respects with
all applicable United States laws and regulations controlling the export of
commodities and technical data, as between the parties to this Agreement, to be
solely responsible for any violation of such laws and regulations by LICENSEE or
its sublicensees, and to defend and hold OSU harmless if any legal action of any
nature results from the violation.
14.8 This
Agreement may not be assigned by either party without the written prior consent
of the other party, which consent shall not be unreasonably withheld, delayed,
denied or conditioned, except, however, that in no
event shall any such consent be required in connection with any assignment of
this Agreement on account of a Change in Control of LICENSEE or any Affiliate
thereof or successor in interest of either. For purposes of this
subsection, the phrase “Change In Control” means: (a) the acquisition
of ownership, directly or indirectly (in a single transaction or a series of
related transactions), beneficially or of record, by any Person or group (within
the meaning of Section 13(d) and Section 14(d)(2) of the Securities Exchange Act
of 1934 as in effect on the date hereof) of capital stock representing more than
fifty and one-tenth percent (50.1%) of the issued and outstanding capital stock
of LICENSEE entitled to vote for the members of the board of directors of
LICENSEE (other than by any PERSON or group in control of LICENSEE on the date
hereof), or (b) the acquisition of ownership, directly or indirectly (in a
single transaction or a series of related transactions), by any PERSON or group
(other than the group in control of LICENSEE on the date hereof) of over fifty
and one-tenth percent (50.1%) of the assets of LICENSEE; provided, however, that a
Change in Control shall not include any acquisitions described in clause (a) or
(b) above by any holder of LICENSEE's common stock, group of such stockholders
or their respective Affiliates or any change in control that occurs on account
of any initial public offering of LICENSEE's common stock registered under the
Securities Exchange Act of 1934. OSU may assign OSU rights to receive
royalties payable pursuant to this Agreement without the consent of
LICENSEE.
14.9 In
the event any Party hereto is prevented from or delayed in the performance of
any of its obligations hereunder (other than the payment of monies due and
owing) by reason of acts of God, war, terrorism, strikes, riots, storms, fires,
electrical or telecommunications outages or any other cause whatsoever beyond
the reasonable control of the Party, the Party so prevented or delayed shall be
excused from the performance of any such obligation to the extent and during the
period of such prevention or delay, provided that such Party takes all
reasonable steps to overcome such cause(es) as soon as is reasonably
possible.
14.10 Nothing
contained in this Agreement will be deemed to place the parties in a
partnership, joint venture or agency relationship and neither party will have
the right or authority to obligate or bind the other party in any
manner.
14.11 This
Agreement may be executed in two or more counterparts, each of which will be
deemed an original, but all of which taken together will constitute one and the
same instrument.
The
authorized signatures of OSU and LICENSEE below signify their acceptance of the
terms of this Agreement.
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THE
OHIO STATE UNIVERSITY RESEARCH FOUNDATION
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OMNIMMUNE
CORP.
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By: /s/ ▇▇▇▇ ▇.
▇▇▇▇▇▇▇▇▇
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By: /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇▇▇
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Name:
▇▇▇▇ ▇.
▇▇▇▇▇▇▇▇▇
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Name:
▇▇▇▇▇▇ ▇.
▇▇▇▇▇▇▇▇▇▇▇▇
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Title:
AVP,
Commercialization
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Title:
President &
CEO
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Date:
April 22,
2008
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Date:
April 22,
2008
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APPENDIX
A
PATENT
RIGHTS
US Patent
No. 7,060,284, entitled “Polypeptides and Polynucleotides for Enhancing Immune
Reactivity to HER-2 Protein” filed August 3, 2000, issued June
13,2006
US Patent
Application Serial No. 11/423,194, entitled “Polypeptides and Polynucleotides
for Enhancing Immune Reactivity to HER-2 Protein” filed June 9,
2006
European
Patent Application No. 00953823.2, entitled “Polypeptides and Polynucleotides
for Enhancing Immune Reactivity to HER-2 Protein”
Japanese
Patent Application No. 2001/513369, entitled “Polypeptides and Polynucleotides
for Enhancing Immune Reactivity to HER-2 Protein”
US Patent
Application Serial No. 11/424,526, entitled “HER-2 Peptides” filed June 15,
2006
PCT
Application No. US06/23672, entitled “HER-2 Peptides
APPENDIX
B
ORIGINAL
MATERIALS
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1.
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Toxicity
studies performed on Synthetic peptides: Endotoxin, Sterility,
Stability studies performed by GMP lab, Certificate of
Analysis.
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2.
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GMP
grade Adjuvant Specifications: Certificate of
Analysis.
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3.
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GMP
grade Vehicle specifications SEPPIC ISA 720: Certificate of
Analysis. (AIR LIQUID AND SEPPIC (France) WILL PROVIDE FREE TO Dr.
Kaumaya).
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4.
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Copy
of FDA applications and approval and IND
TRANSFER.
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5.
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IRB
Documents.
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6.
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Video
of Patients, Press Releases from OSU CCC for Vaccine and Power Point
Presentations.
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7.
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Review
of Phase I trial application for 2nd
generation vaccine.
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8.
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Toxicity
and Safety Results.
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9.
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Final
FDA report when completed.
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10.
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Manuscript
submission for Phase I results to be submitted to JCO when
finalized.
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APPENDIX
C
KNOW
HOW
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1.
|
GLP/GMP
Manufacture of Synthetic Peptides as per Kaumaya protocol (lab notes) and
company syntheses details: Chemistry, manufacturing and control
date, Certificate of Analysis.
|
|
2.
|
Vaccine
Mixing Instructions.
|
APPENDIX
D
PHASE
I REVIEW DATA*
|
1.
|
A
summary of the purpose of the trial to include the details of the regimen,
(agent, doses, routes, modalities of observation) number and type of
patients ( types and extent of tumor) and time of
observation.
|
|
2.
|
A
summary of the trial to include the clinical observations, laboratory
studies etc.
|
|
3.
|
A
summary of conclusions.
|
*The data
and information provided will not include any personal
identifiers.