AMENDED AND RESTATED LICENSE AGREEMENT
Exhibit
10.4
AMENDED
AND RESTATED LICENSE AGREEMENT
THIS AMENDED AND RESTATED LICENSE AGREEMENT
(the “Agreement”), dated as
of February 1, 2005, is between ALLEGHENY-SINGER RESEARCH INSTITUTE, a
Pennsylvania nonprofit corporation with an address at 000 Xxxx Xxxxx Xxxxxx,
Xxxxxxxxxx, Xxxxxxxxxxxx 00000 ("ASRI") and Omnimmune
Corp., a Texas corporation located at 0000 Xxxx Xxx Xxxxx, Xxxxx 000, Xxxxxxx,
Xxxxx 00000 (the "Company").
WHEREAS, the parties hereto (each, a “Party,” and together,
the “Parties”)
entered into a License Agreement, dated as of February 3, 1999 (the “Original Agreement”),
and desire to amend and restate the Original Agreement in its entirety as set
forth below;
NOW,
THEREFORE, in consideration of the mutual promises contained herein and
other valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, and with the intent to be legally bound hereby, the parties hereto
amend and restate the Original Agreement in its entirety 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claim (a) of any issued, unexpired patent that has not been revoked or held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patent application that has not been cancelled, withdrawn or permanently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” 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. “Cost of Goods Sold”
shall mean, with respect to a Licensed Product, the Company’s or any of its
Affiliates’ actual cost to acquire the Licensed Product from a non-Affiliate
third party or the Company’s or such Affiliates’ direct variable costs for
materials and labor to make the Licensed Product, excluding all allocations of
indirect costs and all overhead, including without limitation rent, real estate
depreciation, utilities, insurance, equipment lease payments, equipment
depreciation, and selling, general and administrative or similar
expenses.
e.
“Effective Date” shall
mean February 1, 2005.
f. "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.
g. “FDA” shall mean the
United States Food and Drug Administration, or any successor agency thereof or
foreign counterpart thereof.
h.
"Field" shall mean i)
Cancer diagnosis and therapy (active and passive immunotherapy) in animals and
humans, and ii) fertility control in animals and humans.
i.
“First Sale” shall mean,
with respect to a Licensed Product in a country, the first commercial sale of
such 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.
j. “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.
k. "Licensed Information"
shall mean research and development information, records and data, unpatented
inventions, and Know-How, relating to Licensed Products in the Field, which were
(i) developed by ASRI through or under the direction of Drs. Xxxxxx Xxxxxxx or
Xxxxxxx Xxxxxxxxxx and others under their direction at ASRI prior to the Effective
Date of the Original Agreement and (ii) provided by ASRI to Company or provided
by a third party to Company at ASRI's authorization.
l.
"Licensed Material"
shall mean the tangible physical material listed in Attachment A hereto and any
Company developed progeny or derivatives thereof including those antibodies
listed in Attachment A, and any monoclonal antibody (MAb) and/or cell lines that
Company, its Affiliates or Sublicensees acquire that are derived from amino acid
or DNA sequences of the antibodies listed in Attachment A. MAb's
shall also be deemed to include the use of cell lines used to produce
MAb's.
m. "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 ASRI as of the date of the Original Agreement, including.
provisional patent applications and Patent Cooperation Treaty (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 that
described in subsection (i) immediately 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 that
described in subsection (i) immediately above: all counterpart foreign
applications and patents related to that described in subsections (i) and (ii)
above, including those listed in Appendix A.
n.
"Licensed
Product" or "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.
o . "Milestones" shall
mean those objectives set forth in Section 6.a below.
p.
"Milestone Payments"
shall mean those payments due to ASRI under Section 6.a below.
q. "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
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) 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.
r. “Patent Rights” shall
mean all patents and patent applications (including any continuations of any
such patent applications, claims in continuations-in-part to the extent such
claims are entirely supported by the specifications of any such patent
applications, and any divisionals, provisionals or substitute applications
with respect to any such patent applications), any patent issued with respect to
any such patent applications,any reissue,reexamination, renewal or
extension (including any supplemental patent certificate) of any such
patent, and any confirmation patent or registration patent or patent
of addition based on any such patent, and all counterparts of any of the
foregoing.
s. "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 or any of its Affiliates invoices for, ships, or
receives payment for such Licensed Product(s),whichever occurs
first.
t. "Sublicense Agreement"
shall mean a sublicense agreement executed by the Company and a Sublicenseee
pursuant to this Agreement.
u. "Sublicensee" shall
mean any third party to whom the Company has granted a sublicense pursuant to
this Agreement.
v. “Sublicense Revenue” shall mean
all amounts 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 sublicense fees, royalties paid to Company by
Sublicensees and Milestone Payments, (b) transfer pricing (as defined
below) amounts paid in respect of Licensed Products supplied to such third
parties, (c) investments in securities and (d) research and development funding
received by the Company, excluding from Sublicense Revenue, however, that
described in subsections (i), (ii) and (iii) below and subject to subsections
(iv) and (v) below:
(i)
transfer pricing amounts equal to the Company's and/or
its Affiliates' Cost of Goods Sold in respect of Licensed Products supplied to
such third parties (where “transfer pricing” is
the price that is assumed to have been charged by one part of the Company for
products and services it provides to another part of the Company, in order to
calculate each division's profit and loss separately);
(ii)
amounts received by the Company and/or its Affiliates
from such third parties as the purchase price for the Company’s and/or its
Affiliates' debt or equity securities at prices not in excess of the
then-current market price of such securities or, if such securities are not
publicly traded, the then-current fair market value of such securities;
and
(iii) amounts
received by the Company and/or its Affiliates for (including as
reimbursement) research and development activities undertaken after the
execution date of the relevant third party license or sublicense agreement, for,
or in collaboration with, such third parties at rates not to exceed the fair
market value of such services.
(iv) At
the Company’s sole discretion and on prior written notice to ASRI, 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, to the extent that such funding is actually used
for such purpose within the Company, and (2) amounts reimbursed by a third party
for Company payments to any third party 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 (iv) 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, with respect to such Sublicense Revenue, after execution by the
Company and a Sublicensee of the relevant Sublicense Agreement related
thereto; and (y) the Company may not include in amounts excluded from
Sublicense Revenue its own internal costs other than those reasonably allocated
to the research and development project related to ASRI’s Licensed
Products.
(v) 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 Value (as defined below) of the shares of such capital stock
issued or issuable by Company to Sublicensee shall be deemed to be Sublicense
Revenue.
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 ASRI a written report setting forth in reasonable detail the basis
for such determination, and shall promptly furnish to ASRI all such additional
information as ASRI may request in connection with its review of such
determination. If ASRI and Company fail to agree on such
determination within (30) days following the date ASRI 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 ASRI 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 ASRI; 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. ASRI
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 ASRI may have in the Licensed Patents,
and/or Licensed Material, an exclusive worldwide license to use 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
Field; and
(ii) with
respect to any right title or interest ASRI may have in the Licensed
Information, a nonexclusive, worldwide license to use the Licensed Information
to develop, manufacture, use, sell, have sold, rent or lease Licensed Products
in the Field. The Company will treat as confidential any and all
Licensed Information furnished hereunder, and will not disclose the same to any
third party without ASRI's written permission.
b. ASRI
represents and warrants that except as for the Licensed Information and as set
forth on Attachment A attached hereto (i) it has not transferred by license or
otherwise any rights in the Licensed Patents or Licensed Materials to any person
or party, and (ii) it has not knowingly taken any action or omitted to take any
action that would result in the invalidity, reduction in scope, or abandonment
of any of the Licensed Patents. ASRI further covenants that it will not
knowingly and intentionally take or omit to take any of the actions described in
the immediately preceding sentence, and will require any other licensee of the
Licensed Patents or Licensed Material directly under contract with ASRI not to
take or omit to take any of the actions described in the immediately preceding
sentence, unless the prior written consent of the Company is
obtained.
c. ASRI
grants to the Company the right to grant non-exclusive sublicenses of the
Licensed Patents, the Licensed Materials and the Licensed Information to third
parties in the Field, 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 Sublicensees’ obligations hereunder;
(iii) the Company notifies ASRI of any grant of any such sublicense and provides
to ASRI upon ASRI's request a copy of any sublicense agreement; and (iv) no such
sublicense shall relieve the Company of its obligations under Section 6
hereof.
d. Except as
expressly provided in this Section 2, ASRI 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.
e. All
rights granted by ASRI 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 with regard thereto.
f. Except as
expressly set forth in this agreement, and notwithstanding anything to the
contrary in this agreement, the original agreement, or any other agreement
between the parties hereto, the company acknowledges and agrees that ASRI makes
no warranties, representations or guarantees of any kind, express or implied,
regarding any right, title or interest ASRI may have in and to the subject of
any license granted under this section and this agreement, including without
limitation, licensed patents, licensed information and licensed materials, and
any technology or other information embodied therein.
3. Royalties
and Payments.
a. In
consideration of the license granted under Section 2a of this Agreement, the
Company shall pay to ASRI:
(i) Patent
Prosecution Expenses - Company shall reimburse ASRI $25,000 after Sales of
Licensed Products by Company, its Affiliates, or Company's successors or any
combination thereof, an amount aggregating at least one million dollars
($1,000,000);
(ii) 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 period of ten (10) years from the date of the First Sale of each
such Licensed Product;
(iii) a royalty
of 1% of Net Sales of all Licensed Products that involve use of Licensed
Material or Licensed Information but are covered by a Claim of a Licensed Patent
pursuant to a non-exclusive license hereunder, for a term of ten (10) years from
the date of the First Sale of each such Licensed Product; and
(iv) 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 (i) the First Sale of each such Licensed Product or (ii) the last to
expire Licensed Patent, whichever is longer.
If more
than one Licensed Patent covers a Licensed Product, no additional royalties will
be paid by Company than if such Licensed Product were covered by only one
Licensed Patent.
If, after
review at any stage of prosecution, all Claims in pending patent applications
covering a Licensed Product covered by a Claim of a Licensed Patent are deemed
unpatentable by Company's and ASRI's patent counsel, then the royalty to ASRI
under Section 2a(vi) 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 ASRI shall
return to the original two percent (2%) of Net Sales on such Licensed Product,
beginning on the date of such issue.
b. In
consideration of the right to sublicense to third parties granted under Section
2b, the Company shall pay to ASRI in lieu of royalties or Milestone Payments as
set forth herein, a percentage of Sublicense Revenue received by the Company
and/or its Affiliates from its Sublicensees based upon the following
schedule:
From
therapeutic royalty included in Sublicense Revenue:
20% with
respect to a Sublicense entered into before first animal efficacy study of the
Licensed Products;
15% with
respect to a Sublicense entered into after first animal efficacy study of the
Licensed Products but before the commencement of the first human clinical trial
of the Licensed Products; and
10% with
respect to a Sublicense entered into after the commencement of the first human
clinical trial of the Licensed Products.
From all
other therapeutic Sublicense Revenue other than royalty income included in
Sublicense Revenue:
10% with
respect to a Sublicense entered into before first animal efficacy study of the
Licensed Products;
7.5% with
respect to a Sublicense entered into after first animal efficacy study of the
Licensed Products but before the commencement of the first human clinical trial
of the Licensed Products; and
5% with
respect to a Sublicense entered into after the commencement of the first human
clinical trial of the Licensed Products.
From
diagnostic royalty included in Sublicense Revenue:
15% with
respect to a Sublicense entered into before the commencement of the first human
diagnostic clinical trial of the Licensed Products; and
10% with
respect to a Sublicense entered into after the commencement of the first human
diagnostic clinical trial of the Licensed Products.
From all
other diagnostic Sublicense Revenue other than royalty income included in
Sublicense Revenue
7.5% with
respect to a Sublicense entered into before the commencement of the first human
diagnostic clinical trial of the Licensed Products; and
5% with
respect to a Sublicense entered into after the commencement of the first
human diagnostic clinical trial of the Licensed Products.
c. Minimum Annual
Royalties. Company shall pay to ASRI minimum royalties for
sales of Licensed Products (on a product by product basis) according to the
following schedule, all of which payments shall be credited towards and offset
against royalties and payments due to ASRI with respect to Sublicense
Revenue during the year with respect to which such minimum royalties are
due, as follows:
(i) $25,000
annually on the first anniversary after the First Sale of the first Licensed
Product based on diagnostic technology in the Field; and
(ii) $75,000
annually on the first anniversary after the First Sale of the first Licensed
Product based on therapeutic technology in the Field.
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 ASRI, which shall be
the highest royalty applicable with regard to such License Patent or Licensed
Material.
e. License Maintenance
Fees. Company shall pay annual license maintenance fees
according to the schedule below:
$50,000
on or before February 1, 2007;
$50,000 on
or before February 1, 2008
$50,000
on or before February 1, 2009
$50,000
on or before February 1, 2010
The
foregoing maintenance fees shall be due and payable until the Company begins and
continues to pay ASRI the minimum royalties under Section 3c(i) and 3c(ii)
hereof on an annual basis. Company shall be given a dollar-for-dollar credit
against the foregoing maintenance fees for any funding it and/or its
Sublicensee(s) or Affiliate(s) provide (provides) in support of research at ASRI
as described in Section 8 below.
f. The
royalty amounts and percentages of Sublicense Revenue payable by the Company
pursuant to this Section 3 (“Percentage
Payments”), shall be reduced, but not below 50% of the Percentage
Payments due prior to such reduction, by fifty percent (50%) of royalty
amounts, sublicense percentage payments, or like payments payable by the Company
to third parties in respect of Patent Rights, Know How or other proprietary
rights or information licensed after the Effective Date from such third parties
by the Company that are necessary to make, use, offer for sale, sell or import
the Licensed Product in such country.
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 ASRI a written report with
respect to the preceding calendar quarter (the "Payment Report")
stating:
(i) Net Sales
made by the Company and Affiliate during such quarter;
(ii) In the
case of transfers of Products to an Affiliate by the Company for sale, rental,
or lease of such Products by the Affiliate to third parties, Net Sales by the
Company to the Affiliate, 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
(iv) A
calculation under Section 3 of the amounts due to ASRI, making reference to the
application subsection thereof.
b. Simultaneously
with the submission of each Payment Report, the Company shall make payments to
ASRI 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
ASRI 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, ASRI
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. ASRI shall obtain from all such
entities or individuals an agreement in writing not to use such Licensed Patents
and Licensed Materials for commercial purposes and shall inform the Company in
writing of the identity of all such entities and individuals. If,
during the course of this Agreement, the use by ASRI or any other entity or
individual allowed by ASRI to use the exclusively Licensed Patents or Licensed
Materials results in an invention or discovery that falls under the scope of the
claims made in the Licensed Patents (“Follow-on
Technology”), ASRI shall promptly disclose such Follow-on Technology to
Company and the Follow-on Technology shall be automatically deemed included in
the license grant of exclusive rights hereunder without any further act on the
part of ASRI or Company, without any further payment and without duplication of
payment upon achievement of milestones or commercialization, except that all
products utilizing the Follow-on Technology shall be deemed to be Licensed
Products hereunder and shall subject to the royalty provisions set forth herein
for Licensed Products. Each agreement by ASRI to allow another entity or
individual to use the exclusively Licensed Patents or Licensed Materials for
noncommercial research purposes shall contain provisions requiring prompt
disclosure to ASRI of inventions and discoveries, providing for each such
invention and discovery to be covered by appropriate patent filings and/or
confidentiality (unless otherwise agreed by the Company), and assigning rights
to Follow-on Technology to Company in accordance with this
provision.
6. Best
Efforts.
a. The
Company shall use its best efforts, consistent with commercial practices
standard in the industry and taking into account prudent scientific and business
judgment consistent with the efforts of Company or its Sublicensees devoted to
products of similar market potential, to 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 or other
collaborators shall have spent at least Four Hundred Thousand Dollars ($400,000)
on research and development with regard to Licensed Product(s) in the
Field.
(ii) Before
February 1, 2007, Company shall raise or 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 deemed to have been
satisfied if Company becomes a public company, but if Company
will have merged with another company and such other company is the surviving
entity, then such obligation will be transferred to such surviving 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 or other
collaborators shall have spent at least $2,500,000 on research and
development of Licensed Product(s) in the Field or otherwise achieved the
stated Milestones.
(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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|
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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 ASRI
having the option at any time thereafter, but prior to subsequent achievement of
the Milestones, to terminate all of the licenses granted under this
Agreement or convert the exclusive licenses granted under this
Agreement to non-exclusive licenses, in its sole and absolute
discretion.
c. Failure
to achieve the objectives in Section 6a(iv) above shall result in ASRI having
the option to terminate, but prior to subsequent achievement of the Milestones,
all the licenses granted under this Agreement, to the extent they
pertain to cancer diagnosis, or convert the exclusive licenses
granted under this Agreement to nonexclusive licenses, in its sole and
absolute discretion.
d. Failure
to achieve the objectives in Section 6a(v) above shall result in ASRI having the
option to terminate, but prior to subsequent achievement of the Milestones, all
the licenses granted under this Agreement, to the extent they pertain to cancer
therapy, or convert the exclusive licenses granted under this Agreement to
nonexclusive licenses, in its sole and absolute discretion.
e. No less
often than every twelve months after the execution of the Agreement the Company
shall report in writing to ASRI on progress made toward the objectives set forth
in this Section 6 above.
f. Notwithstanding
subparagraphs 6 (b), (c) and (d) above, ASRI shall not unreasonably withhold its
consent to any revision of the objective(s) set forth in Paragraph 6(a) (the
“Development
Plan”) when requested in writing in advance by Company if (i) the request is reasonably supported by credible evidence of technical difficulties
or delays, if any, in the clinical studies
or regulatory process, that are outside of the control of Company; (ii) Company
is proposing and agrees to implement reasonably satisfactory and effective means of
addressing such difficulties or delays, including utilizing its available commercially reasonable
financial and technical resources; and (iii) Company, its Affiliates and/or
Sublicensees have in good faith made commercially reasonable efforts to meet
said objective(s) and continue to do so. In the event of any dispute between the Parties
regarding whether revision of the
objective(s) set forth in the Development Plan is warranted under the
above criteria, the Parties shall discuss such dispute in good faith and
reach a mutually agreeable resolution or,
failing that, submit the dispute to arbitration. ASRI’s right
to terminate this license or portions of it, or convert this license to a
non-exclusive license, shall be suspended during any period (i) with respect to
which the Parties are attempting to resolve differences regarding the
Development Plan, (ii) when a dispute has been submitted to
arbitration. If Company does not abide by the decision of the Parties
or a ruling of the arbitrator within sixty (60) days after such decision or
ruling, ASRI may thereafter terminate or convert the license as provided above
in subparagraphs 6 (a), (b) or (c), as applicable.
g. In the
event Company fails to meet the objective(s) set forth in the Development Plan
within sixty (60) days of the timetables
established in Section 6(a) above, as the
same may be changed from time to time pursuant to this Agreement, ASRI
shall notify Company thereof in writing, and Company shall have thirty (30) days
following such notification to establish that (i) it has met such objective(s);
or (ii) a revision to the Development Plan is necessary and appropriate as
contemplated above.
7. Patent Prosecution and
Maintenance.
The
Company, by counsel it selects to whom ASRI has no reasonable objection will
prepare, file, prosecute and maintain all Licensed Patents in ASRI's name and in
countries designated by the Company. Company will timely provide ASRI
copies of all correspondence related to reasonable Licensed Patent prosecution
and maintenance. The Company will reimburse ASRI for reasonable
expenses it has incurred in accordance with Section 3a(iii) above, and will pay
expenses incurred in the future directly in filing, prosecuting and maintaining
such 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.
8. Sponsored
Research.
As
additional consideration to ASRI, Company, its Affiliates or Sublicensees shall
sponsor research in the amount no less than $100,000 per year for two years
beginning on the date the Company obtains funding as set out in Section 6a(ii)
above. ASRI may agree to allow Company to sponsor research at another
institution mutually agreeable to the parties, if no interested researcher at
ASRI can be identified within sixty (60) days of Company's written
request.
9. Infringement.
a. ASRI 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. If the
Company shall have supplied ASRI with written evidence demonstrating to ASRI's
satisfaction prima facie infringement of
a claim of a Licensed Patent, by a third party making, using or selling products
in competition with the Company or any of its Affiliates or Sublicensees, the
Company may by notice request that ASRI take steps to assert the Licensed
Patent. Unless ASRI 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 ASRI,
initiate legal proceedings against the infringer at the Company's expense and
ASRI agrees to allow Company to name ASRI co-plaintiff in such an action. In
such event, the Company may deduct from payments due hereunder to ASRI
reasonable costs and legal fees incurred to conduct such proceedings, but in no
event shall any payment due in any calendar quarter be reduced by more than 50%
of the amount otherwise due to ASRI 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 ASRI an amount equal to all amounts withheld from ASRI by the Company
under this Section 9 during the pendency of the proceedings. The
balance shall be treated as Net Sales.
In the event one party shall initiate
or carry on legal proceedings to enforce any Licensed Patent against an alleged
infringer, the other party shall use 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 9, 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 9.c shall not apply to any
Licensed Patent licensed non-exclusively under this Agreement or to any legal
proceedings that are not initiated under Section 9.b.
c. Company
shall during the exclusive period 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 Company as part of such a
sublicense, after reimbursement of any legal
expenses incurred by Company, shall be treated as Sublicense Revenues for purposes of
this Agreement.
10. No
Warranty.
a. Except as
set forth below, ASRI 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. ASRI represents
that, to its knowledge, the licensed patents are owned by or have been
irrevocably assigned to ASRI and, in the case of the licensed patents licensed
as exclusive licenses hereunder, have not been transferred, assigned or licensed
to any third party.
ASRI, 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 ASRI) caused
by or in connection with Licensed Patents, Licensed Information, Licensed
Material or Licensed Products.
In no
event shall any liability of ASRI to the Company exceed the payments made by the
Company to ASRI pursuant to this Agreement.
11. Prohibition Against Use of
ASRI's Name.
The
Company will not use the name, insignia, or symbols of ASRI, its faculties or
departments, or any variation or combination thereof, or the name of any
trustee, faculty member, other employee, or student of ASRI for any purpose
whatsoever without ASRI's prior written consent, which consent shall not be
unreasonably withheld, or except when such use is required by law.
12. Compliance with Governmental
Obligations.
a. Notwithstanding
any provision in this Agreement, ASRI 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 ASRI with all governmental
requests pertaining to the license hereunder or any Licensed Products that are
directed to either ASRI 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.
13. Indemnity and
Insurance.
a. The
Company will indemnify, defend and hold ASRI 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 ASRI 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 on or
before the earlier to occur of when Company’s laboratory operations begin or
when Licensed Material is received at the Company’s laboratory
facilities from ASRI, including products liability and contractual
liability (applicable to the indemnity obligations in Section 13a insurance with
reputable and financially secure insurance carriers reasonably acceptable
to ASRI 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 ASRI, 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 ASRI 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
13a.
The
Company's insurance shall be primary coverage; any insurance ASRI 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.
14. 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.
15. Export Control
Laws.
This
Agreement is made subject to any restrictions concerning the export of products
or technical information from the United States of America which may be imposed
from time to time by the government of the United States of America.
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.
16. Arbitration.
Any and
all claims, disputes or controversies arising under, out of, or in connection
with this Agreement, which have not been resolved by good faith negotiations
between the Parties shall be resolved by final and binding arbitration in
Pittsburgh, PA, in accordance with the rules then obtaining applicable to the
appointment of a single arbitrator of the American Health Lawyers Association or
in the event such arbitration is not then available under those rules, the rules
of the American Arbitration Association. All expenses and costs of
the arbitrators and the arbitration in connection therewith will be shared
equally between the Parties, except that each Party will bear the costs of its
prosecution and defense, including without limitation attorneys fees and the
production of witnesses and other evidence. Any award rendered in
such arbitration shall be final and may be enforced by either
Party.
17. 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
Section 17, 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 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 ASRI
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 this Section 17.
c. All
obligations of confidentiality imposed under this Section 17 shall expire upon
the later of (a) the date when no further royalties are payable to ASRI
under this Agreement, and (b) five (5) years after the date the applicable
Confidential Information is disclosed.
18. 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 ASRI or the
Company pursuant to Section 12b; or (iii) a material breach of the Stock
Purchase Agreement or the Stockholder’s 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 for any monetary breach and sixty days for any other non-monetary
breach after notice given by the non-breaching party, provided, however, that in
the case of such other non-monetary breach that cannot be cured with the sixty
day period, ASRI’s right to terminate shall be suspended during any period
during which the Company is attempting to cure and diligently pursues curing the
breach in question.
19. 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 19.
b. Unless
terminated earlier under any provision of this Agreement, the term of the
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 First Sale of the Licensed Products produced from such Licensed Patents,
whichever is later.
(c)
The
license granted under this Agreement may be terminated by ASRI (i) upon thirty
days written notice to the Company if ASRI elects to terminate in accordance
with Section 6b, 6c or 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 18b, 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
provided, however, that in the event of a dispute between the Parties submitted
to arbitration in accordance with Section 16, no such right to terminate or
take any other action shall arise unless a final determination has been made in
favor of ASRI and Company has failed to make payment or to take other required
action within the appropriate cure period immediately following the rendering of
the decision.
(d) The
license granted under this Agreement may be terminated by the Company (i) upon
thirty days' written notice to ASRI for ASRI's material breach of the Agreement
and ASRI's failure to cure such material breach in accordance with Section 18b,
or (ii) should ASRI commit any act of bankruptcy, become insolvent, file a
petition under any bankruptcy or insolvency act or have any such petition filed
against it, provided, however, that in the event of a dispute between the
Parties submitted to arbitration in accordance with Section 16, no such right to
terminate or take any other action shall arise unless a final determination has
been made in favor of Company and ASRI has failed to make payment or to take
other required action within the appropriate cure period immediately following
the rendering of the decision, or (iii) at any time upon one hundred eight (180)
days prior written notice, provided that upon termination, the Company (a) pays
ASRI $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.
d. Upon any
termination of this Agreement pursuant to Section 19c or 19d, all sublicenses
granted by the Company hereunder shall be assigned to ASRI.
e. Sections
4c, 8, 10, 11, 12b, 13, and 15 shall survive the termination or expiration of
this Agreement.
f. 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 ASRI,
to:
President and CEO
Allegheny Singer Research
Institute
000 Xxxx Xxxxx Xxxxxx
Xxxxxxxxxx,
XX 00000-0000
copy
to:
General Counsel
Allegheny Singer Research
Institute
000 Xxxx Xxxxx Xxxxxx
Xxxxxxxxxx,
XX 00000-0000
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 by Company without the written consent of
ASRI. ASRI may assign ASRI's rights to receive royalties payable
pursuant to this Agreement without the consent of Company. ASRI shall not
otherwise assign this Agreement except to an affiliate without the written
consent of Company, which consent shall not be unreasonably
withheld.
21. Governing
Law. This Agreement shall be governed by Pennsylvania Law
applicable to agreements made and to be fully performed in Pennsylvania, 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 Western District of Pennsylvania or in the courts of the Commonwealth of
Pennsylvania located in the City of Pittsburgh and County of Allegheny, 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, ASRI and the Company have
caused this Agreement to be executed by their duly authorized representatives as
of the day and year written below.
ALLEGHENY-SINGER
RESEARCH INSTITUTE
By: \s\ Xxxxxx
Xxxxx
Its: Director, Office of
Sponsored Research
OMNIMMUNE CORP.
By Xxxxxx X.
Xxxxxxxxxxxx
Xxxxxx X.
Xxxxxxxxxxxx, Ph.D., President & CEO
ATTACHMENT
A
*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
Serial
No. 07/856,455 filed 3/24/92 & related foreign
Serial
No. 08/219,805 Continuation filed 3/29/94
Serial
No. 08/262,739 Divisional filed 6/20/94
Serial
No. 08/482,490 Divisional filed 6/7/95
*2. Use of
Antibodies to hCG Related Determinants to Measure (detect) Malignant Cells via
Flow Cytometry. Amendment to Serial No. 07/856,455
*3. 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 continuationU.S.
Serial No. 10/164,914 and any continuation, or divisional
thereof.
Serial
No. 08/062,925 filed 5/13/93 & related foreign
Serial
No. 08/478,431 Continuation filed 6/7/95
*4. Methods
of Using Antibodies Against Hormone-Related Determinants.
U.S.
Patent number 6,339,143 issued January 15, 2002.
Serial
No. 08/255,482 filed 6/8/94
Serial
No. 08/487,949 Continuation
5.
Differential
Immunocytochemical Diagnosis of Cancer Using Antibodies or Antisera Against
hCGB. Serial No. 08/258,044 filed 6/13/94
6.
Methods
to Produce Primate Monoclonal Antibodies Directed to determinants of the
B-subunit of Human Chorionic Gonadotropin to Use for Cancer Treatment (AUHS File
#252), and Method(s) for Stabilizing Primate Hybridomas
7.
All
monoclonal antibodies and hybridomas raised against hCG and hLH including
primate monoclonal antibodies.
8.
Rights to
any future disclosures resulting from any and all information, technology,
methods, techniques and material related to the research conducted by Xxxxxx
Xxxxxxx, Ph.D. and Gavreel (Xxxx) Xxxxxxxxxx, Ph.D. under the Sponsored Research
Agreement and its Amendments between Allegheny-Singer Research Institute and
Omnimmune Corporation executed on April 1, 1996 and supporting investigation of
development, production and studies of monoclonal antibodies against antigens
including human chorionic gonadotropin including but not limited to a protocol
for the production of Cell Lines with improved fusion and stability
characteristics resulting from construction of the fusion partner according to
the detailed descriptions in Attachment A-1 to Amendment 1 of the Sponsored
Research Agreement.
9.
Direct
Cytotoxic Activity by Anti-hCG Monoclonal Antibodies
Serial
No. 60/065,464 Filed 11/19/97
10.
Method of
Treating Brain Neoplasm with Monoclonal Antibodies to hCGB-CTP and
Pharmaceutical and Composition Thereof
Serial
No. 08/258,860 filed 6/13/94 and related foreign;
Serial
No. 08/796,964 Continuation
Licensed
Materials:
Antibodies
and Cell Lines:
*CTP-101,
*CTP-102, *CTP-103
GK-1
* Jointly
owned with Columbia University
