LICENSE AGREEMENT
Exhibit
10.8
AGREEMENT, dated as of February 1, 2005 (the
“Effective Date”), between THE TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF
NEW YORK, a New York corporation located at 000xx Xxxxxx xxx Xxxxxxxx, Xxx Xxxx,
Xxx Xxxx 00000 (“Columbia”), and OMNIMMUNE CORP., a Texas corporation located at
0000 Xxxx Xxx Xxxxx, Xxxxx 000, Xxxxxxx, Xxxxx 00000 (“Company”). The
parties therefore agree as follows:
1. Definitions.
a “Affiliate”
shall mean any corporation or other business entity that directly or indirectly
controls, is controlled by, or is under common control with the
Company. Control means ownership or other beneficial interest in 50%
or more of the voting stock or other voting interest of a corporation or other
business entity.
b. “Claim”
shall mean a claim (a) of any issued, unexpired patent that has not been
revoked or held unenforceable or invalid by a decision of a court or
governmental agency of competent jurisdiction from which no appeal can be taken,
or with respect to which an appeal is not taken within the time allowed for
appeal, or (b)
of any patent application that has not been cancelled, withdrawn or permanently
abandoned nor been pending for more than (i) seven (7) years, if such patent
application is pending in any country other than Japan or (ii) ten (10) years,
if such patent application is pending in Japan.
c. “Confidential
Information” As used in this Agreement, the term “Confidential Information”
shall mean all confidential or proprietary materials or information designated
as such in writing by the party disclosing such information (the “Disclosing
Party”), whether by letter or by the use of an appropriate proprietary stamp or
legend, prior to or at the time any confidential or proprietary materials or
information is disclosed by the Disclosing Party to the receiving party (the
“Recipient”). Notwithstanding the foregoing, information or materials
which are orally or visually disclosed to the Recipient by the Disclosing Party,
or are disclosed in writing or other tangible form without an appropriate
letter, proprietary stamp or legend, shall constitute Confidential Information
if the Disclosing Party, within thirty (30) days after such disclosure, delivers
to the Recipient a written document or documents describing such information or
materials and referencing the place and date of such oral, visual or written or
other tangible disclosure, and the names of the employees or officers of the
Recipient to whom such disclosure was made.
d. “Effective
Date” shall mean February 1, 2005
e. “Fair
Market Value” shall mean the cash consideration which the Company, its affiliate
or sublicensee would realize from an unaffiliated, unrelated buyer in an arms’
length sale of an identical item sold in the same quantity and at the same time
and place of the transaction.
f “FDA”
shall mean the United States Food and Drug Administration, or any successor
agency thereof or foreign counterpart thereof.
g “Field”
shall be subdivided into the following “Subfields:” (i) The “Therapeutic
Subfield” shall mean cancer therapy (active and passive
immunotherapy) in humans and non-humans and
fertility control in non-humans . (ii) The
“Animal Subfield” shall include all therapeutic treatment in
non-humans. (iii) The “Diagnostic Subfield” shall include all
diagnostics in humans and non-humans.
h “First
Sale” shall mean, with respect to a Licensed Product in a country, the first
commercial sale of the Licensed Product by Licensee, its Affiliates or
sublicensees in such country. Sales for test marketing, clinical
trial purposes or compassionate or similar use shall not be considered to
constitute a First Sale.
i. “Know-How
shall mean any information, inventions, discoveries, copyrights, trade secrets,
data or materials, whether proprietary or not, including without limitation data
generated in pre-clinical and clinical studies.
j. “Licensed
Information” shall mean research and development information, records and data,
unpatented inventions, Know-How relating to Licensed Products in the Field that
are (i) developed by Columbia through or under the direction of Drs. Xxxxxx
Xxxxxxxx, Xxxxx Xxxxxx, Xxxxxxxxx Xxxxxxxxxx and others under their direction at
Columbia prior to
the Effective Date
of this Agreement and
(ii) which is provided by Columbia to Company or is provided by a third
party to Company at Columbia’s authorization.
k. “Licensed
Material” shall mean the tangible physical material that (i) are listed
in Attachment A hereto or (ii) any Company developed progeny or derivatives
thereof including those antibodies listed in Attachment A, and any MAb and/or
cell lines that Company, its Affiliates, successors or Sublicensees acquire that
are derived from amino acid, peptide, or DNA sequences of the antibodies listed
in Attachment A. MAb’s shall also be deemed to include the use of
respective cell lines used to produce MAb’s.
l. “Licensed
Patents” shall mean:
(i) the
United States and foreign patents and patent applications listed in Attachment A
hereto, and any patents issuing therefrom that are owned or controlled, in whole
or in part, by Columbia as at the date hereof, including. provisional patent
applications and PCT patent applications, all divisions and continuations of
these applications, all patents issuing from such applications, divisions, and
continuations, and any reissues, reexaminations, and extensions of all such
patents;.
(ii) to
the extent that the following contain one or more claims directed to the
invention or inventions disclosed in (i) above: a) continuations-in-part of (i)
above; b) all divisions and continuations of these continuations-in-part; c) all
patents issuing from such continuations-in-part, divisions, and continuations;
and d) any reissues, reexaminations, and extensions of all such
patents;
(iii) to the extent that the following
contain one or more claims directed to the invention or inventions disclosed in
a) above: all counterpart foreign applications and patents to (i) and (ii)
above, including those listed in Appendix A.
m. “Licensed
Products” shall mean any product or service, the development, manufacture, use,
sale, rental or lease of which (i) is covered by a claim of a Licensed Patent or
(ii) involves the use of Licensed Material and/or Licensed
Information.
n. “Net
Sales” shall mean the total of all cash consideration or, if none, the Fair
Market Value attributable to the Sale of Licensed Products by the Company and
its Affiliates and Sublicensees, less returns and customary trade discounts
actually taken, outbound freight, transportation insurance, value added, sales
or use taxes, and custom duties, and reasonable reserve for bad debts accrued in
accordance with the Company’s standard accounting practices applied consistently
across the Company’s and its Affiliates business. In the case of
transfers of Licensed Products to an Affiliate by the Company for sale, rental,
or lease of such Products to third parties by such Affiliate, Net Sales shall be
based upon the greater of the total fees and other consideration charged by the
Affiliate to third parties or the total fees and consideration charged by the
Company to the Affiliate. Net sales for Licensed Products sold by
Company or its affiliate(s) or Sublicensee(s) 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.
o. “Sale”
shall mean any bona fide transaction for which consideration is received or
expected for the sale, use, lease, transfer or other disposition of Licensed
Product(s). A Sale of Licensed Product(s) shall be deemed to be
completed at the time Company, its Affiliate or Sublicensee invoices for, ships,
or receives payment for such Licensed Product(s), whichever occurs
first.
p. “Sublicensee”
shall mean any third party to whom the Company has granted a sublicense pursuant
to this Agreement.
q. “Sublicense
Revenue” shall mean all amounts (except royalties on Net Sales by Sublicensees)
actually received by the Company and/or its Affiliates from third parties in
connection with or related to the licensing or sublicensing to such third
parties of rights with respect to Licensed Products, including without
limitation (a) all fees and milestone payments, (b) investment in securities and
(c) research and development funding, subject, however, to subsections (i) and
(ii) below:
(i) At
the Company’s sole discretion and on prior written notice to Columbia,
Sublicense Revenue shall not include any amounts constituting (1) bona fide research and
development funding directly relating to potential Licensed Products, as
reflected in the Company’s books and records in accordance with generally
accepted accounting principles, and are actually used for such purpose within
the Company, and (2) amounts reimbursed by a third party for Company payments
for bona fide research and
development activities directly relating to potential Licensed Products, as
reflected in the Company’s books and records in accordance with generally
accepted accounting principles. The parties acknowledge and agree
that (x) the two exceptions to Sublicense Revenue described above in this
subsection (i) shall apply only to direct expenses actually paid by the Company
for bona fide research and development activities, including salaries of full
and part-time employees, consultants and advisors, and shall only apply to
research and development activities undertaken after the Effective Date of this
Agreement and after execution of the relevant sublicense agreement; and (y) the
Company may not include in amounts excluded from Sublicense Revenue its own
internal costs other than those reasonably allocated to the R&D project
related to Columbia’s Licensed Products.
(ii) If
and to the extent that a Sublicensee makes a bona fide equity
investment in capital stock of Company, or a security convertible into or
exchangeable for capital stock of the Company (a “Convertible Security”), then
only such portion, if any, of the consideration paid for such capital stock or
Convertible Security that is in excess of the aggregate Fair Market Value1 of the shares of such capital stock
issued or issuable by Company to Sublicensee shall be deemed to be
Sublicense Revenue.
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1 As
used herein, the “Fair Market Value” per share of capital stock shall mean (A)
if such class of capital stock is then traded on a national securities exchange
or the Nasdaq National Market (or a similar national quotation system), an
amount equal to the average of the closing prices per share of shares of such
class of capital stock on such exchange or system for the twenty (20)
trading-day period ending three (3) days prior to the date of issuance of such
capital stock or Convertible Security to Sublicensee; (B) if such
class of capital stock is then traded over-the-counter, an amount equal to the
average of the closing bid prices per share of shares of such class of capital
stock over the twenty (20) trading day period ending three (3) days prior to the
date of issuance of such capital stock to Sublicensee; and (C) if such class of
capital stock is not then traded on a national securities exchange, any such
national quotation system or over-the-counter, an amount per share equal to the
lowest amount of consideration per share paid in consideration for the bona fide issuance of any
shares of such class of capital stock (other than to Sublicensee or to
employees, consultants, directors or advisors (collectively “Optionees”)
pursuant to the Company’s employee stock option plan) during the period
beginning twelve (12) months prior to the date of issuance of such shares of
capital stock to Sublicensee; provided that such amount shall be reduced from
time to time to an amount equal to the lowest amount of consideration per share
paid in consideration for the bona fide issuance of any
shares of such class of capital stock (other than to Sublicensee (or
Optionees) during the period ending twelve (12) months after the date of
such issuance to Sublicensee, if the amount of any such consideration is less
than the lowest amount of such consideration paid during the period beginning
twelve (12) months prior to the date of such issuance to Sublicensee; provided,
further, that if there has not been any bona fide issuance of
shares of such class of capital stock (other than to Sublicensee or
Optionees) during the twelve (12) months prior to the date of any such
issuance to Sublicensee or if the consideration for such shares of capital stock
issued by Company to Sublicense or to any other person or entity in an issuance
within the twelve (12) months prior to or following the date of any such
issuance to Sublicense consists of any consideration other than cash, then the
Board of Directors of Company shall, within thirty (30) days following the date
of such issuance to Sublicense (or the date of any issuance within 12 months
following the date of issuance to Sublicense) make a good faith determination as
to the Fair Market Value of the shares issued to Sublicense and furnish to
Columbia a written report setting forth in reasonable detail the basis for such
determination, and shall promptly furnish to Columbia all such additional
information as Columbia may request in connection with its review of such
determination. If Columbia and Company fail to agree on such
determination within (30) days following the date Columbia receives such report,
then the Fair Market Value of such shares shall be determined by an independent
accounting firm, investment bank or valuation firm which has not had any
relationship with Columbia or the Company, an Affiliate or Sublicensee for a
period of three years prior to such determination (the “Appraiser”); the
parties, acting reasonably and in good faith, shall mutually agree upon the
Appraiser. Company shall promptly furnish to the Appraiser all such
information as the Appraiser may request in connection with such
determination. The fees and expenses of the Appraiser shall be
shared equally by the Company and Columbia; provided that if the Fair Market
Value determined by the Appraiser is less than ninety-five (95%) of the Fair
Market Value as determined by Company’s Board of Directors, then all such fees
and expenses shall be borne by Company.
If
non-monetary consideration is received from third parties by the Company and/or
its Affiliates, then a commercially reasonable monetary value will be assigned
for purposes of calculating Sublicense Revenue.
2. License
Grant:
a. Columbia
grants to the Company, upon and subject to all the terms and conditions of this
Agreement
(i) with
respect to any right, title or interest Columbia may have in the Licensed
Patents, and/or Licensed Material, a worldwide exclusive license under the
Licensed Patents, and Licensed Material as specified in Attachment A, to
develop, manufacture, use, sell, have sold, rent, or lease Licensed Products in
the Therapeutic Subfield and the Animal Subfield; and
(ii) with
respect to any right, title or interest Columbia may have in the Licensed
Patents, and/or Licensed Material, a worldwide non-exclusive license under the
Licensed Patents, and Licensed Material as specified in Attachment A, to
develop, manufacture, use, sell, have sold, rent, or lease Licensed Products in
the Diagnostic Subfield, except that no license is granted in the Licensed
Patents and/or Licensed Materials with respect to B152 as listed on Attachment A
in the Diagnostic Subfield.
(iii) with
respect to any right, title or interest Columbia may have in the Licensed
Information, a nonexclusive, worldwide license to use Licensed Information to
develop, manufacture, use, sell, have sold, rent or lease Licensed Products in
the Field as specified in Attachment A. The Company will treat as
confidential any and all Licensed Information furnished hereunder, and will not
disclose the same to any third party without Columbia’s written
permission.
b. Columbia
grants to the Company the right to grant sublicenses to third parties in the
Field as specified in Attachment A, provided that (i) the Sublicensee agrees to
abide by all the terms and provisions of this Agreement; (ii) the Company
remains fully liable for the performance of its and its Sublicensee’s
obligations hereunder; (iii) the Company notifies Columbia of any grant of a
sublicense and provides to Columbia upon Columbia’s request a copy of any
sublicense agreement; and (iv) no such sublicense shall relieve the Company of
its obligations under Section 6 hereof.
c. Except
as expressly provided in this Agreement, Columbia is not granting the Company
any rights or license to any patents, patent applications, copyrights, trade
secrets, know how, trademarks or any other intellectual property
right.
d. All
rights granted by Columbia to the Company under this Agreement are subject to
the requirements of 35 U.S.C. '' 200 et seq., as amended, and
implementing regulations and policies.
e. THE COMPANY ACKNOWLEDGES AND AGREES THAT COLUMBIA
MAKES NO WARRANTIES, REPRESENTATIONS OR GUARANTEES OF ANY KIND, EXPRESS OR
IMPLIED, REGARDING ANY RIGHT, TITLE OR INTEREST COLUMBIA MAY HAVE IN AND TO THE
SUBJECT OF ANY LICENSE GRANT UNDER THIS SECTION AND THIS AGREEMENT, INCLUDING
WITHOUT LIMITATION, LICENSED PATENTS, LICENSED INFORMATION AND LICENSED
MATERIALS, AND ANY TECHNOLOGY EMBODIED THEREIN.
3. Royalties and
Payments.
a. In
consideration of the license granted under Section 2a of this Agreement, the
Company shall pay to Columbia:
(i) a
nonrefundable and non-creditable license fee of $30,000 which shall be payable
in accordance with the following schedule:
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(a)
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$15,000
sixty (60) days from the Effective Date of this
Agreement
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(b)
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$15,000
one year from the Effective Date of this
Agreement
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(ii)
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Company
shall reimburse Columbia $50,000 for all past expenses in accordance with
the following schedule:
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(a)
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$25,000
two (2) years from the Effective Date of this Agreement;
and
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(b)
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$25,000
after the sales by Company, its affiliates or Company’s successors or
sublicensees, or any combination thereof, for the first $1,000,000 in
sales of Licensed Products, as final payment for past patent
expenses;
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(c)
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however,
notwithstanding any of the above, Company will pay all past expenses
estimated to be $4,300 upon 30 days from invoice with respect to U.S.
Serial No. 10,164,914 .
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(iii)
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Five
percent equity in Company as per the Stockholders Agreement attached
hereto as Attachment B;
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(iv)
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a
royalty of 1% of Net Sales of all Licensed Products that involve use of
Licensed Material or Licensed Information but are not covered by a Claim
of a Licensed Patent for a term of ten (10) years from the date of the
first sale of each product.
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(v)
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a
royalty of 2% of Net Sales of all Licensed Products covered by a Claim of
a Licensed Patent exclusively licensed to the Company hereunder, for a
period of ten (10) years from the date of First Sale of each new Licensed
Product in a territory or the last to expire Licensed Patent in such
territory, whichever is longer.
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(a)
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If
more than one Licensed Patent covers a Licensed Product, no additional
royalties will be paid by Company than if the Licensed Product is covered
by one Licensed Patent.
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(b)
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If,
after review at any stage of prosecution, Company and Columbia amend this
agreement in writing that all claims issued or pending either do not cover
a Licensed Product, or are deemed unpatentable, then the royalty to
Columbia under Section 3a(v) hereof shall be reduced to one percent (1%)
of Net Sales on such Licensed Product. Notwithstanding the
foregoing, if a patent subsequently issues from such applications, then
the royalty due to Columbia shall return to the original two percent (2%)
of Net Sales on such Licensed Product, beginning on the date of such
issue.
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b. For
the avoidance of doubt, Licensee owes the same royalty to Columbia on Net Sales
by a Sublicensee as the royalty Licensee would pay if the sales were made by
Licensee itself. In addition, on all other gross revenues to the
extent included in sublicense income as defined above in Section1q (other than
royalties on Net Sales), fees, payments and consideration, or any part thereof,
received by Company from Sublicensee as full or partial consideration for the
grant of any sublicense by Company pursuant to Section 2B., the Company shall
pay to Columbia a percentage of Sublicensed Revenue received by the Company
and/or its Affiliates from its Sublicensees according to the following
schedule:
From Sublicensed
Therapeutics:
20% with
respect to a sublicense entered into before the first animal efficacy study of
the Licensed Products,
15% after
first animal efficacy study of the Licensed Products
10% after
first human clinical trial of the Licensed Products
From Sublicensed
Diagnostics:
15%
before diagnostic clinical trial of the Licensed Products
10% after
diagnostic clinical trial of the Licensed Products;
c. Minimum
Annual Royalties - Company shall pay to Columbia minimum royalties
for sales of Licensed Products according to the following schedule,
all of which payments shall be credited towards and offset against royalties and
payments due with respect to Sublicense Revenue before any such
payments are due to Columbia:
(i) $25,000
on each anniversary after the First Sale of the first Licensed Product based on
diagnostic purpose; and
(ii) $75,000
on each anniversary after the First Sale of the first Licensed Product based on
therapeutic purpose
(iii) For
the avoidance of doubt, in the event a product is sold for both diagnostic
purposes and therapeutic purposes, then both the payments under Sections 3c(i)
and 3c(ii) are due.
d. Licensed
Product(s) Derived From More Than One Licensed Patent - If a Licensed Product is
derived from more than one Licensed Patent and/or uses more than one Licensed
Material, Company is obligated to pay only one royalty to Columbia, the highest
royalty applicable.
e. License
Maintenance Fees - Company shall pay annual license maintenance fees according
to the schedule below:
$10,000
on or before February 1, 2007;
$20,000 on
or before February 1, 2008
$35,000 on or before February 1,
2009
$50,000
on or before February 1, 2010 and $40,000 each first of February thereafter.
The
foregoing maintenance fees shall be due and payable until the Company pays
Columbia the minimum royalties under Section 3(c)(i) and 3(c)(ii) hereof on an
annual basis.
4. Reports and
Payments.
a. On
or before the last business day of January, April, July, and October of each
year of this Agreement, the Company shall submit to Columbia a written report
with respect to the preceding calendar quarter (the “Payment Report”)
stating:
(i) Net
Sales made by the Company and any Sublicensee and/or Affiliate during such
quarter;
(ii) In
the case of transfers of Products to an Affiliate or Sublicensee by the
Company for sale, rental, or lease of such Products by the Affiliate or
Sublicensee to third parties, Net Sales by the Company to the Affiliate, or
Sublicensee and Net Sales by the Affiliate, or Sublicensee to third parties
during such quarter;
(iii) Amounts
accruing to, and received by, the Company from its Sublicensees during such
quarter; and/or
(iv) For
the avoidance of doubt, in the event a product is sold for both diagnostic
purposes and therapeutic purposes, then both the payments under Sections 3c(i)
and 3(c)(ii) are due.
(v) A
calculation under Section 3 of the amounts due to Columbia, if any, making
reference to the application subsection thereof.
b. Simultaneously
with the submission of each Payment Report, the Company shall make payments to
Columbia of the amounts due for the calendar quarter covered by the Payment
Report.
c. The
Company shall maintain at its principal office usual books of account and
records showing its actions under this Agreement. Upon reasonable
notice, such books and records shall be open to inspection and copying, during
usual business hours, by an independent certified public accountant to whom the
Company has no reasonable objection, for two years after the calendar quarter to
which they pertain, for purposes of verifying the accuracy of the amounts paid
by the Company under this Agreement. If such independent accountant
determines that Company has underpaid royalties by five percent (5%) or more
with respect to any calendar quarter, Company will pay the costs and expenses
incurred by Columbia in connection with such inspection and
copying.
5. Reservation of Rights for
Research Purposes.
With
respect to any exclusive license grants to the Company in the Field, Columbia
reserves the right to use the exclusively Licensed Patents, and exclusively
Licensed Materials for noncommercial research purposes and to permit other
entities or individuals to use such Licensed Patents, and Licensed Materials for
noncommercial research purposes. Columbia shall obtain from all such
entities or individuals an agreement in writing not to use Licensed Patents, and
Licensed Materials for commercial purposes and shall inform the Company of the
identity of all such entities and individuals.
6. Best
Efforts.
a. The
Company shall achieve the following objectives within specified time periods
following the date of this Agreement in accordance with the following
schedule:
(i)
Before February 1, 2007, Company, and/or its Sublicensees or Affiliates shall
have spent at least Four Hundred Thousand Dollars ($400,000) on
the direct research and development of Licensed Product(s) in the
Field.
(ii) Before
February 1, 2007, Company shall raise procure, or arrange commitments in the
form of equity or debt capital from individuals, corporations, foundations,
governments, partnerships, and any other means of financing for funding the
Company or its collaborators in the amount of One Million Dollars
($1,000,000). Such obligation will be maintained if Company becomes a
public company, or if Company will have merged with another company; then such
obligation will be transferred to such company, provided, however, that if the
Company acquires or is merged into another company that has, at the time of such
transaction, at least One Million Dollars ($1,000,000) of capital or net
tangible assets, the obligation of this paragraph will be deemed to have been
satisfied.
(iii) Before
February 1, 2009, Company and/or its Sublicensees or Affiliates shall have spent
at least $2,500,000 on the direct research and development of Licensed
Product(s) in the Field.
(iv) Diagnosis
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(a)
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Company
and/or its Sublicensees or Affiliates shall file an application with the
FDA for at least one (1) Licensed Product for diagnosis of a human disease
before February 1,
2007.
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(b)
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Company
and/or its Sublicensees or Affiliates shall have received FDA approval for
at least one Licensed Product for diagnosis of a human disease before
February
1, 2009.
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(c)
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Company
and/or its Sublicensees or Affiliates shall develop and market at least
one (1) Licensed Product for diagnosis of a human disease somewhere in the
world before February1, 2010.
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(v). Therapy
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(a)
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Company
and/or its Sublicensees or Affiliates shall begin the first animal
efficacy study of a murine or humanized MAb or fragment or any other
variation thereof leading to a Licensed Product for therapy of a human
disease before February 1, 2007, and shall complete said animal study
before February 1, 2009.
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(b)
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Company
and/or its Sublicensees or Affiliates shall begin the first human clinical
trial of at least one (1) Licensed Product for therapy of a human disease
before February 1,
2009.
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(c)
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Company
and/or its Sublicensees or Affiliates shall begin the first phase II human
clinical trial of at least one (1) Licensed Product for therapy of a human
disease before February 1, 2010.
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(d)
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Company
and/or its Sublicensees or Affiliates shall have filed an NDA with the FDA
for at least one (1) Licensed Product for therapy for a human disease by
February
1, 2012.
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b. Failure
to achieve the objectives in Sections 6a(i)-6a(iii) above shall result in
Columbia having the option to terminate all of the licenses granted hereunder or
convert the exclusive licenses to non-exclusive licenses.
c. Failure
to achieve the objectives in Section 6a(iv) above shall result in Columbia
having the option to terminate the license as it pertains to cancer diagnosis
granted hereunder or convert the exclusive licenses to nonexclusive
licenses.
d. Failure
to achieve the objectives in Section 6a(v) above shall result in Columbia having
the option to terminate the license as it pertains to cancer therapy granted
hereunder or convert the exclusive licenses to nonexclusive
licenses.
e. No less
often than every twelve months after the execution of the Agreement the Company
shall report in writing to Columbia on progress made toward the objectives set
forth above.
7. Patent Prosecution and
Maintenance.
At the
Company’s expense, Columbia by counsel it selects to whom Company has
no reasonable objection, in consultation with counsel appointed by the Company,
will prepare, prosecute and maintain all Licensed Patent
Rights. Company shall promptly cooperate in transferring prosecution
control to Columbia and its counsel with respect to any licensed patents,
including but not limited to European Patent No. 0636171 issued June
7, 2000 (known as the “Lysis Case.” Company will promptly provide
Columbia or its designated counsel copies of all correspondence in its
possession related to preparation, prosecution and maintenance of the Lysis
case. Within sixty days of receipt of itemized invoices, the Company
will pay reasonable expenses incurred by Columbia for its role in prosecuting
and maintaining all Licensed Patents, including attorneys' fees, the costs of
any interference proceedings, reexaminations, or any other ex parte or inter partes administrative
proceeding before patent offices, taxes, annuities, issue fees, working fees,
maintenance fees and renewal charges. The Company, at Columbia’s
option, either will reimburse Columbia for such expenses or will pay Columbia’s
counsel directly upon receipt of invoices therefrom.
8. Infringement.
a. Columbia
will protect its Licensed Patents from infringement and prosecute infringers at
its own expense when in its sole judgment such action may be reasonably
necessary, proper, and justified.
b. For
rights for which Company has exclusive rights, if the Company shall have
supplied Columbia with written evidence demonstrating to Columbia’s satisfaction
prima facie infringement of
a claim of a Licensed Patent by a third party making, using or selling
products in the Therapeutic Subfield and Animal Subfield in competition with the
Company or any of its Affiliates or Sublicensees, the Company may by notice
request that Columbia take steps to assert the Licensed
Patent. Unless Columbia shall within three months of the receipt of
such notice either (i) cause such infringement to terminate or (ii) initiate
legal proceedings against the infringer, the Company, may upon notice to
Columbia, initiate legal proceedings against the infringer at the Company’s
expense and Columbia agrees to allow Company to name Columbia co-plaintiff in
such an action. In such event, the Company may deduct from payments
due hereunder to Columbia fifty percent of reasonable costs and legal fees
(for which no third party is obligated to reimburse Company) incurred to conduct
such proceedings, but in no event shall any payment due in any calendar quarter
be reduced by more than 25% of the amount otherwise due to Columbia
hereunder. Any recovery by the Company in such proceedings shall
first be used to reimburse the Company for its reasonable costs and legal fees
incurred to conduct such proceedings and next to pay to Columbia an amount equal
to all amounts withheld from Columbia by the Company under this
Section 8 during the pendency of the proceedings. The
balance shall be divided 60% to the Company and 40% to Columbia.
c. In the
event one party shall initiate or carry on legal proceedings under 8b to enforce
any Licensed Patent against an alleged infringer, the other party shall use, at
its own expense, its best efforts to cooperate fully with and shall supply all
assistance reasonably requested by the party initiating or carrying on such
proceedings. The party that institutes any proceeding to protect or
enforce a Licensed Patent shall have sole control of that proceeding and shall
be responsible for the reasonable expenses incurred by said other party in
providing such assistance and cooperation as is requested pursuant to this
Section.8, provided, however, that the Party retaining control of any such
action, or a declaratory judgment brought by a third party alleging
non-infringement, may not, without the prior written consent of the other Party,
not to be unreasonably withheld, settle any such action on terms which would
involve a monetary payment by the other Party, provide for an admission of
liability or wrongdoing by the other Party or its Affiliates or employees, or
obligate the other Party to take or refrain from taking any action in the
future. For the sake of clarity, this Section 8c shall not apply to
any Licensed Patent licensed non-exclusively under this Agreement or to any
legal proceedings that are not initiated under Section 8b.
9. No
Warranty.
a. COLUMBIA
MAKES NO WARRANTIES EXPRESSED OR IMPLIED OF ANY KIND, AND HEREBY EXPRESSLY
DISCLAIMS ANY WARRANTIES, REPRESENTATIONS OR GUARANTIES OF ANY KIND AS TO
LICENSED PATENTS, LICENSED INFORMATION OR LICENSED MATERIALS OR ANYTHING
DEVELOPED, MANUFACTURED, USED, SOLD, RENTED, LEASED OR OTHERWISE DISPOSED OF
UNDER ANY LICENSE GRANTED UNDER THIS AGREEMENT, INCLUDING BUT NOT LIMITED
TO: ANY WARRANTIES OF MERCHANTABILITY, TITLE OR FITNESS FOR A
PARTICULAR PURPOSE, RESULT OF USE; ANY WARRANTIES OR REPRESENTATIONS AS TO THE
VALIDITY OF ANY LICENSED PATENT; AND ANY WARRANTIES OF FREEDOM OF INFRINGEMENT
OF DOMESTIC OR FOREIGN PATENTS, COPYRIGHTS, TRADE SECRETS, TRADEMARKS, KNOW HOW
OR ANY OTHER INTELLECTUAL OR PROPRIETARY RIGHTS OF THIRD PARTIES. IN
PARTICULAR, COLUMBIA DOES NOT WARRANT THAT THE RIGHTS OF XXXXXXXXX XXXXXXXXXX
HAVE VESTED IN COLUMBIA.
b. Columbia,
its trustees, officers, employees and agents, shall not have any liability to
Company its Affiliates, Sublicensees, or its (their) trustees, directors,
officers, employees, agents, distributors, students, users of Licensed Patents,
Licensed Information, Licensed Material or Licensed Products, or any other party
arising out of the use, storage, handling, transportation, or other disposal of
Licensed Patents, Licensed Information, Licensed Material or Licensed Products
by the Company or any other party, including for any destructions to any
property or from any loss of use, revenue or profit, good will, or any other
direct, indirect, special, incidental or consequential damages (whether or not
arising from strict or absolute liability or from the negligence of Columbia)
caused by or in connection with Licensed Patents, Licensed Information, Licensed
Material or Licensed Products.
c. In
no event shall any liability of Columbia to the Company exceed the payments made
by the Company pursuant to this Agreement.
10. Prohibition Against Use of
Columbia’s Name.
The
Company will not use the name, insignia, or symbols of Columbia, its faculties
or departments, or any variation or combination thereof, or the name of any
trustee, faculty member, other employee, or student of Columbia for any purpose
whatsoever without Columbia’s prior written consent, which consent shall not be
unreasonably withheld, or as required by law.
11. Compliance with Governmental
Obligations.
a. Notwithstanding
any provision in this Agreement, Columbia disclaims any obligation or liability
arising under the license provisions of this Agreement if the Company is charged
in a governmental action for not complying with or fails to comply with
governmental regulations in the course of taking steps to bring any Licensed
Product to a point of practical application.
b. The
Company shall comply upon reasonable notice from Columbia with all governmental
requests pertaining to the license hereunder of any Licensed Products that are
directed to either Columbia or the Company and provide all information and
assistance necessary to comply with legitimate governmental requests pertaining
to the license hereunder or any Licensed Products.
c. The
Company shall insure that research, development, and marketing under this
Agreement complies with all government regulations in force and effect
including, but not limited to, Federal, state, and municipal
legislation.
12. Indemnity and
Insurance.
a. The
Company will indemnify, defend and hold Columbia harmless from and against any
and all actions, suits, claims, demands, prosecutions, liabilities, costs, and
expenses (including actual attorneys’ fees) based on, arising out of, or
relating to, directly or indirectly, this Agreement, including, without
limitation, (a) the development, manufacture, packaging, use, sale, rental, or
lease of Licensed Products, even if altered for use for a purpose not intended,
(b) use of Licensed Patents, Licensed Information or Licensed Materials by the
Company, its Affiliates, its Sublicensees or its (or their) customers, (c) any
representation made or warranty given by the Company, its Affiliates or
Sublicensees with respect to Licensed Products, Licensed Patents, Licensed
Information or Licensed Materials, and (d) any infringement claims relating to
Licensed Products, Licensed Patents, Licensed Information or Licensed
Materials. The Company shall reimburse Columbia for all of its costs
and expenses (including actual attorneys' fees) in enforcing this
Section.
b. The
Company shall maintain, during the term of this Agreement, comprehensive general
liability insurance, provided that such insurance shall be obtained when Company
laboratory operations begin or when Licensed Material is received by Company
from Columbia--including products liability and contractual liability
(applicable to the indemnity obligations in Section 12a insurance -- with
reputable and financially secure insurance carriers reasonably acceptable to
Columbia to cover the activities of the Company, its Affiliates and its
Sublicensees, for minimum limits of $2,000,000 combined single limit for bodily
injury and property damage. However, prior to the start of any
clinical trials related to this License Agreement, Company’s minimum of
$2,000,000 shall only be $1,000,000 until such clinical trials
begin. Such insurance shall include Columbia, its trustees,
directors, officers, employees, and agents as additional
insureds. The Company shall furnish a certificate of insurance
evidencing such coverage, with thirty days’ written notice to Columbia of
cancellation or material change. The minimum amounts of insurance
coverage required herein shall not be construed as creating any limitation on
Company’s indemnity obligations under Section 12a.
The
Company’s insurance shall be primary coverage; any insurance Columbia may
purchase shall be excess and noncontributory. The Company's insurance
shall be written to cover claims incurred, discovered, manifested, or made
during or after the expiration of this Agreement.
The
Company shall at all times comply with all statutory workers’ compensation and
employers liability requirements covering its employees with respect to
activities performed under this Agreement.
13. Marking.
Prior to
the issuance of patents, the Company will xxxx Licensed Products made, sold, or
otherwise disposed of by it under the license granted in this Agreement with the
words “Patent Pending,” and following the issuance of one or more patents, with
the numbers of such patents.
14. Export
Laws
a. This
Agreement is made subject to any restrictions concerning the export and
re-export of products or technical information that the U.S. government may
impose from time to time (“Export Laws”). To this end, the Company
shall cooperate with Columbia as reasonably necessary to permit Columbia to
comply with the Export Laws. The Company hereby represents and
covenants that the Company: (a) is neither a national of nor Controlled by a
national of any country to which the United States prohibits the export or
re-export of goods, services, or technology; (b) is not a person specifically
designated as ineligible to export from the United States or deal in U.S.-origin
goods, services, or technologies; (c) will not export or re-export, directly or
indirectly, any goods, services, or technology, to any country or person
(including juridical persons) to which the United States prohibits the export of
goods, technology, or services; and (d) in the event that a U.S. government
license or authorization is required for an export or re-export of goods,
services, or technology (including technical information acquired from Columbia
under this Agreement and/or any products created by using such technical
information or any part thereof), the Company shall obtain any necessary U.S.
government license or other authorization prior to undertaking the export or
re-export.
b.
Furthermore, each party hereto agrees that it will not export, directly or
indirectly, any technical information acquired from the other under this
Agreement or any products using such technical information to any country for
which the United States government or any agency thereof at the time of export
requires an export license or other governmental approval, without first
obtaining the written consent to do so from the Department of Commerce or other
agency of the United States government when required by an applicable statute or
regulation.
15. Confidentiality.
a. Each
Party agrees that all Confidential Information disclosed to it or its Affiliates
by the other Party (a) shall not be used by the receiving Party or its
Affiliates except in connection with the activities contemplated by this
Agreement or in order to further the purposes of this Agreement, (b) shall
be maintained in confidence by the receiving Party and its Affiliates, and (c)
shall not be disclosed by the receiving Party or its Affiliates to any third
party who is not an Affiliate or consultant of, or an advisor to, the
receiving Party or its Affiliates without the prior written consent of the
disclosing Party. Notwithstanding the foregoing provisions of this
Paragraph 16, either Party may disclose Confidential Information of the other
Party if such Party 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 (the “SEC”)
or similar regulatory agency in a country other than the United States or of any
stock exchange or NASDAQ, in which event such Party shall provide prior notice
of such intended disclosure to such other Party if possible under the
circumstances and shall disclose only such Confidential Information of such
other Party as is required to be disclosed.
b. Each
Party agrees that it and its Affiliates shall provide Confidential Information
received from the other Party only to the receiving Party's respective
employees, consultants and advisors, and to the employees, consultants and
advisors of the receiving Party’s Affiliates, who have a need to know such
Confidential Information to assist the receiving Party in fulfilling its
obligations under this Agreement, provided that
Company and Columbia shall each remain responsible for any failure by
its and its Affiliates' respective employees, consultants and advisors to treat
such information and materials as required under Paragraph 16.
c. All
obligations of confidentiality imposed under this Paragraph 16 shall expire upon
the later of (a) the expiration of the royalty term, and (b) five (5) years
after the date the applicable Confidential Information is
disclosed.
16. Breach and
Cure.
a. In
addition to applicable legal standards, the Company shall be considered to be in
material breach of this Agreement for (i) failure to pay fully and promptly
amounts due pursuant to Section 3 and payable pursuant to Section 4 or Section
7; (ii) failure to comply with governmental requests directed to Columbia or the
Company pursuant to Section 11b; or (iii) a material breach of the Stock
Purchase Agreement or the Stockholder’s Agreement which is to be executed within
sixty days of the execution of this Agreement is a material breach of this
Agreement.
b. Either
party shall have the right to cure its material breach. The cure
shall be effected within a reasonable period of time but in no event later than
thirty days after notice of any other breach given by the non-breaching
party.
17. Term of
Agreement.
a. This
Agreement shall be effective as of the date first recited above and shall
continue in full force and effect until its expiration or termination in
accordance with this Section 17; provided however that if the Stock Purchase
Agreement or the Stockholders Agreement with Columbia and Omnimmune are still
negotiating as of the execution of this Agreement is not executed within sixty
days of the effective date of this Agreement, then this Agreement is null an
void.
b. Unless
terminated earlier under any provision of this Agreement, the term of exclusive
license granted under the Licensed Patents shall extend until the expiration of
the last to expire of the Licensed Patents or ten years from the date of the
first sale, whichever is later, on a product by product basis.
c. The
license granted under this Agreement may be terminated by Columbia (i) upon
thirty days written notice to the Company if Columbia elects to terminate in
accordance with Sections 6b, 6c, and 6d (ii) upon thirty days’ written notice to
the Company for the Company’s material breach of the Agreement and the Company’s
failure to cure such material breach in accordance with Section 17b, or (iii)
should the Company commit any act of bankruptcy, become insolvent, file a
petition under any bankruptcy or insolvency act or have any such petition filed
against it.
d. The
license granted under this Agreement may be terminated by the Company (i) upon
thirty days written notice to Columbia for Columbia’s material breach of the
Agreement and Columbia’s failure to cure such material breach in accordance with
Section 17b, or (ii) should Columbia commit any act of bankruptcy, become
insolvent, file a petition under any bankruptcy or insolvency act or have any
such petition filed against it; or (iii) at any time upon one hundred eight
(180) days prior written notice, provided that upon termination, the Company (a)
pays Columbia $250,000 in addition to any other payments accrued through the
date of termination and (b) not have the rights to and cease use of, Licensed
Materials.
e. Upon
any termination of this Agreement pursuant to Section 17c(i), 17c(ii) or 17d(i)
all sublicenses granted by the Company hereunder shall be assigned to Columbia,
and Columbia shall accept the same, provided Columbia’s obligations and
liabilities are no greater than Columbia undertook in this
Agreement.
f. Upon
termination the parties shall remain liable for all obligations and liabilities
accrued through the date of termination, and sections 4c, 9, 10, 11b, 12, and 14
shall survive the termination or expiration of this Agreement.
18 Notices.
Any
notice required or permitted to be given under this Agreement shall be
sufficient if sent by certified mail (return receipt requested), postage
pre-paid, if to Columbia, to:
Executive
Director
Columbia
Innovation Enterprise
Columbia
University
Engineering
Terrace, Suite 363
500 West
120th St., Mail Code 2206
Xxx Xxxx,
XX 00000
copy
to:
General
Counsel
Columbia
University
000 Xxx
Xxxxxxxx Xxxxxxx
000 Xxxx
000xx Xx., Mail Code 4308
Xxx Xxxx,
XX 00000
if to the
Company, to:
Xxxxxx X.
Xxxxxxxxxxxx, Ph.D.
President
& CEO
Omnimmune
Corp.
0000 Xxxx
Xxx Xxxxx
Xxxxx
000
Xxxxxxx,
Xxxxx 00000
or to
such other address as a party may specify by notice hereunder.
20. Assignment. This
Agreement may not be assigned without the written consent of the other party,
which consent will not be unreasonably withheld or delayed and provided,
however, that the Company may assign this agreement as part of a merger with
and/or into another company or as part of a sale of all or substantially all of
its assets to which this license relates.
21. Governing
Law. This Agreement shall be governed by New York Law
applicable to agreements made and to be fully performed in New York, and without
reference to the conflict of laws principles of any jurisdiction. The
parties agree that any and all claims arising under this Agreement or relating
thereto shall be heard and determined either in the United States District Court
for the Southern District of New York or in the courts of the State of New York
located in the City and County of New York, and the parties agree to submit
themselves to the personal jurisdiction of those courts.
22. Preference for U.S.
Industry. The Company agrees that any Licensed Products used
or sold in the United States will be manufactured substantially in the United
States, in accordance with 35 U.S.C. ' 204.
IN WITNESS THEREOF, Columbia and the Company
have caused this Agreement to be executed by their duly authorized
representatives as of the day and year first written above.
THE
TRUSTEES OF COLUMBIA UNIVERSITY
IN
THE CITY OF NEW YORK
By /s/ Xxxxxxx X.
Cleare______________________
Executive
Director, Columbia Innovation Enterprise
Date:__________________________
OMNIMMUNE
CORP.
By /s/ Xxxxxx X.
Xxxxxxxxxxxx
Xxxxxx X.
Xxxxxxxxxxxx, Ph.D.,
President
& CEO
Date: 1/17/05
ATTACHMENT
A
Licensed
Patents:
|
|
1.
|
Methods
of Using Antibodies Against Human Chorionic Gonadotropin-Related
Determinants to Lyse, Quantitatively Measure and Enrich Human Malignant
Cells.
|
European
Patent No. 0636171 issued 6/7/00
|
|
|
2.
|
Methods
of Using Antibodies Against Human Luteinizing Hormone-Related Determinants
to Detect and Enrich Human Malignant Cells. Patent No.6,403,326
issued 6/11/02 and its continuation
|
U.S.
Serial No. 10/164,914 and any continuation, or divisional
thereof.
|
|
|
3.
|
Method
of Using Antibodies against Hormone-Related Determinants. U.S.
Patent number 6,339,143 issued January 15,
2002.
|
Licensed
Materials:
|
|
Antibodies
and Cell Lines:
|
|
|
A)
|
X000,
X000, X000, X000,
|
|
|
B)
|
B109,
B201, B204, B205, B151, B152, B405, B406,
B407, B408, B409, B411, B412, B413,
and
|
|
|
C)
|
XXX-000,
XXX-000, XXX-000, XXX 104, CTP 105.
|
Columbia
makes no guarantees that it has viable cell line cultures that it can provide to
Omnimmune. Columbia will make reasonable efforts to provide or find
providers of a portion of such cell lines to Omnimmune provided Omnimmune will
reimburse reasonable costs in growing up and providing any such cell line
cultures to Omnimmune. Omnimmune may have more than one source
from which to acquire Licensed Materials, but if Omnimmune acquires the Licensed
Materials directly from Columbia, Omnimmune and Columbia will make reasonable
efforts to document the transfer with a material transfer agreement referencing
this Agreement.
ATTACHMENT
B
STOCK
AGREEMENTS
