EXCLUSIVE LICENSE AGREEMENT
THIS EXCLUSIVE LICENSE AGREEMENT
(the "Agreement"), is entered into as of the first day of November 2007
(the "Effective Date"), by and among Institut Xxxxxxx Xxxxxx, a private cancer
research and treatment non-profit making center incorporated in the Republic of
France ("IGR"),
IGR&D, S.A., a company incorporated in the Republic of France, Creteil
(societe anonyme au capital de 200 200 euro, immatriculee au Registre du
Commerce et des Societes de Creteil sous le numero B 432 439 776) and whose
registered office is 00, xxx Xxxxxxx Xxxxxxxxxx – 94805 VILLEJUIF Cedex
("IGR&D"), represented by Xxxxxxxx Xxxxxxxxx Bressac, managing director
(hereafter "IGR&D"), and Omnimmune Corp., a Texas corporation located at
0000 Xxxx Xxx Xxxxx, Xxxxx 000, Xxxxxxx, Xxxxx 00000, X.X.X. (hereinafter
"Omnimmune"). IGR&D and Omnimmune may also be hereinafter jointly
referred to as the "Parties" and individually referred to as the
"Party."
WHEREAS, IGR is the sole and
exclusive owner of the Inventions (as defined below);
WHEREAS, Omnimmune is
interested in exploiting and commercializing the Inventions, which relate to
monoclonal antibodies, cell lines, genetic sequences and gene-based products
that target and are related to a hormone called human chorionic
gonadotropin (hCG);
WHEREAS, IGR has granted all
of its right, title and interest to the Invention to IGR&D, its technology
transfer Affiliate, meaning that IGR&D is duly authorized to negotiate and
to license the rights under the Licensed Patents; and
WHEREAS, Omnimmune desires,
and IGR&D has agreed to license the rights under the Licensed Patents
pursuant to the terms of this Agreement.
NOW, THEREFORE, in
consideration of the mutual promises contained herein and other good and
valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, and with the intent to be legally bound hereby, the Parties hereto
agree as follows:
1. Definitions.
a.
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Affiliate shall
mean, with respect to a particular Party, a person, corporation,
partnership, or other entity that controls, is controlled by or is under
common control with such Party. For the purposes of the definition, the
word "control" (including, with correlative meaning, the terms "controlled
by" or "under the common control with") means the actual power, either
directly or indirectly through one or more intermediaries, to direct or
cause the direction of the management and policies of such entity, whether
by the ownership of at least fifty percent (50%) of the voting stock of
such entity, or by contract or
otherwise.
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b.
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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 Disclosing Party to the receiving party (the
"Recipient"). Notwithstanding the foregoing, information or
materials which are orally or visually disclosed to Recipient by
Disclosing Party, or are disclosed in writing or other tangible form
without an appropriate letter, proprietary stamp or legend, shall
constitute Confidential Information if Disclosing Party, within
thirty (30) days after such disclosure, delivers to Recipient a
written document or documents describing such information 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
Recipient to whom such disclosure was
made.
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c.
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Designative
Representatives shall mean employees, consultants and advisors of
the Parties or any Affiliate thereof to whom Confidential Information is
disclosed only on a “need-to-know” basis and who are directed and required
to both maintain the disclosed Confidential Information in strict
confidence and exclusively use such Confidential Information solely for
the purposes expressly permitted under this
Agreement.
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d.
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Field shall
mean all fields of use.
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e.
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First Commercial
Sale shall mean the first sale of a Licensed Product by Omnimmune
or an Affiliate or sublicensee of Omnimmune to a Third Party in a country
following regulatory approval of such Licensed Product in that country or,
if no such regulatory approval or similar marketing approval is required,
the date upon which such Licensed Product is first commercially launched
in such country.
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f.
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IND shall mean
an application submitted to a regulatory authority to initiate human
clinical trials, including (1) an Investigational New Drug application or
any successor application or procedure filed with the FDA or any foreign
equivalent thereof, and (2) all supplements and amendments that may be
filed with respect to the
foregoing.
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g.
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In
Vitro
Diagnostic 510(k) shall mean a premarket notification submission to
the United States ("US") Food and Drug Administration (FDA) or similar
governmental agency in jurisdictions other than the US. The
submission must provide evidence that the device is accurate, safe,
effective and substantially equivalent to a device legally marketed in the
United States.
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h.
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In
Vitro
Diagnostic Clinical Study shall mean in order to demonstrate
clinical use as an aid in cancer detection, evaluations of hCG antibodies,
hCG genes or gene products to demonstrate that hCG as a tumor marker is a
significant indicator of the presence of cancerous
cells.
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i.
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In
Vitro
Diagnostic Compilation and Submission of a 510(k)
shall mean a premarket notification or application submitted to the FDA or
similar governmental agency in jurisdictions other than the US, the
purpose of which is to demonstrate that the medical device to be marketed
is substantially equivalent (SE) to a legally marketed device that was or
is currently on the U.S. market. The manufacturer may not place
their device into U.S. commerce until they receive a marketing
clearance/SE letter from the FDA.
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j.
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Improvements
shall mean any improvement, addition, enhancement, modification,
development, invention, alteration and/or technical advance or other
discovery, whether patentable or not, the exploitation of which is
dependent on or would infringe (but for a license thereto by IGR or
IGR&D (as the case may be)) at least one Valid Claim contained in the
Licensed Patents.
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k.
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Licensed
Information shall mean know-how, research and development,
analyses, notes and other such records, procedures, assay and other
methods, formulae, indices, techniques, drawings, improvements, software
code, algorithms, data management or interpretive systems, processes,
protocols, genetic or other libraries, designs, concepts, models,
inventions, discoveries, copyrights, trade secrets and other intellectual
property, whether proprietary or not, including, without limitation, data
generated in pre-clinical and clinical studies, relating to the Licensed
Technology, along with any and all documents and other records (electronic
or otherwise) relating thereto, including, without limitation, any and all
results of experiments,
clinical trials and studies relating to the claims made in the Licensed
Patents, and owned by IGR or any Affiliate thereof or to which IGR or any
Affiliate thereof may have any rights of
use.
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l.
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Licensed
Material shall mean the tangible or physical materials necessary
for the effective exercise of the Licensed Patents or any other uses and
such other materials as are routinely produced through use of the original
materials, including, without limitation, the materials listed on
Attachment A hereto and any and all other cell lines, samples, primers,
monoclonal antibodies, reagents, DNA or RNA replicated from isolated DNA
or RNA, recombinant proteins produced through use of isolated DNA or RNA,
substances routinely purified from a source material included in the
original materials (such as recombinant proteins isolated from a cell
extract or supernatant by non-proprietary affinity purification methods)
and any other materials relating to the Licensed Patents, together with
any progeny, mutants and unmodified derivatives thereof, and owned by
IGR&D or any Affiliate thereof or to which IGR&D or any Affiliate
thereof may have any rights of use.
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m.
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Licensed
Patents shall mean the following United States
patents: US 6194154 entitled “Malignant human cell
transformation detection method” claiming the priority date March 4, 1996,
from the French patent application FR9602683, and US 6514708 entitled
“Process for detecting the malignant transformation of human cells”
claiming the priority date March 4, 1996, from the French patent
application FR9602683 (the “Original Licensed Patents”), and any and all
patent applications and patents issued thereon in connection with any and
all Improvements, and
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(1) all
continuations, divisions, continuations-in-part, reissues, re-examinations, and
extensions thereof, and any patents issuing therefrom that are owned or
controlled, in whole or in part, by IGR, including, without limitation, any and
all provisional patent applications and Patent Cooperation Treaty (PCT) patent
applications, all divisions and continuations of these applications, all patents
issuing from such applications, divisions, and continuations, and any reissues,
reexaminations, and extensions of all such patents;
(2) to
the extent that the following contain one or more claims directed to that
described in subsection (1) immediately
above: (i) continuations-in-part of (1) above;
(ii) all divisions and continuations of these continuations-in-part;
(iii) all patents issuing from such continuations-in-part, divisions, and
continuations; and (iv) any reissues, reexaminations, and extensions of all
such patents; and
(3) to
the extent that the following contain one or more claims directed to that
described in subsection (1) immediately above: all counterpart foreign
applications and patents related to that described in subsections (1) and
(2) above, including those listed in Appendix A.
n.
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Licensed
Process shall mean any process, service, formulae, algorithm, data
management or other systems, methodology or similar capability that is
covered in whole or in part by an issued, unexpired claim or a pending
claim contained in the Licensed Patents, including, without limitation,
the process or methodology for detecting malignant transformation of human
cells and its applications for diagnosing and monitoring cancer patients
and for developing cancer
prognosis.
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o.
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Licensed
Product shall mean any product or part thereof that (1) is covered
in whole or in part by an issued, unexpired claim or a pending claim
contained in the Licensed Patents in the country in which any such product
or part thereof is made, used or sold; (2) is manufactured by using a
process that is covered in whole or in part by an issued, unexpired claim
or a pending claim contained in the Licensed Patents, in any country in
which any such process is used or in which any such product is used or
sold or (3) is developed or manufactured from the Licensed Material or
Licensed Information, but which is not covered under clauses (1) and (2)
above.
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p.
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Licensed
Technology shall mean the Licensed Patents, Licensed
Information and Licensed Materials, along with the Licensed Products and
Licensed Processes, and any and all Improvements
thereon.
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q.
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NDA shall mean
an application submitted to a regulatory authority for marketing approval
of a product, including (1) a New Drug Application, Product License
Application or Biologics License Application filed with the FDA or any
successor applications or procedures, or any foreign equivalent thereof,
and (2) all supplements and amendments that may be filed with respect to
the foregoing.
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r. |
Net Sales shall mean with
respect to the Licensed Technology, the gross revenue received by
Omnimmune or its Affiliates (in the case where any such Affiliate is not a
sublicensee) for the sale of the Licensed Products or
Licensed Processes during the term of this Agreement to a Third
Party, less allowances for the following
items:
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(1)
trade, quantity and cash discounts actually allowed;
(2)
discounts, refunds, rebates, charge backs, retroactive price adjustments, and
any other allowances actually granted which effectively reduce the net selling
price;
(3)
product returns and allowances actually granted;
(4) any
tax, tariff or duty imposed on the production, sale, transportation, delivery or
use of the product (excluding federal, state or local taxes based on
income);
(5)
freight, postage, shipping, transportation, customs duties, excises and
insurance charges actually allowed or paid for delivery of Licensed Products, to
the extent billed; and
(6) a
reasonable reserve for bad debts accrued in accordance with Omnimmune's standard
accounting practices applied consistently across its business.
For the
avoidance of doubt, Net Sales (or performance, as the case may be) of Licensed
Technology shall not include Transfer Pricing Amounts. Net Sales for Licensed
Products and Licensed Processes sold by Omnimmune or its Affiliate(s) as a unit
in conjunction with other licensed processes or
licensed products will be determined pro rata in accordance with the respective
stand-alone price or value of such licensed products and/or licensed
processes.
s.
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Phase I Study
shall mean a study of a product in human volunteers or patients, the
purpose of which is the preliminary determination of safety and
tolerability of a dosing regime and for which there are no primary
endpoints (as recognized by FDA) in the protocol relating to
efficacy.
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t.
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Phase II Study
shall mean (1) a dose exploration, dose response, duration of effect,
kinetics, dynamic relationship or preliminary efficacy and safety study of
a product in the target patient population, or (2) a controlled dose
ranging clinical trial to evaluate further the efficacy and safety of a
product in the target patient population and to define the optimal dosing
regimen.
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u.
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Phase III Study
shall mean a controlled pivotal clinical study of a product that is
prospectively designed to demonstrate statistically whether such product
is effective and safe for use in a particular indication in a manner
sufficient to obtain regulatory approval to market such
product.
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v.
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Sublicense
Revenue shall mean, except as otherwise provided herein, all
amounts actually received by Omnimmune or any Affiliate thereof (if such
Affiliate is the sublicensor under a sublicense) from a sublicensee on
account of the sublicensing of all or any part of the Licensed Technology,
including, without limitation, all sublicense fees, royalties, milestone
payments and other fees or payments; provided, however, that
Sublicense Revenue shall not include any amounts constituting
(1) bona fide research and development funding, such as NIH or other
grants, directly relating to potential Licensed Products or Licensed
Processes, as reflected in the recipient's books and records in accordance
with generally accepted accounting principles, including allocations for
overhead and general and administrative costs, and (2) amounts
reimbursed by a Third Party for payments for bona fide research and
development activities directly relating to potential Licensed Products or
Licensed Processes, as reflected in the recipient's books and records in
accordance with generally accepted accounting principles including
allocations for overhead and general and administrative
costs.
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w.
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Territory shall
mean worldwide.
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x.
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Third
Party shall mean any
entity other than the Parties to this Agreement and their respective
Affiliates.
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y.
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Transfer Pricing
Amounts shall mean prices used in the transfer of materials between
units or Affiliates or Sublicensees of the same company, at cost or cost
plus transportation costs and only if this transfer does not result in a
consumption, destruction or loss of activity of the Licensed
Product.
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z.
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Valid Claim
shall mean a claim of any pending, or issued and unexpired Licensed Patent
which shall not have been withdrawn, canceled, or disclaimed, nor held
invalid by a court of competent jurisdiction in any unappealed or
unappealable decision (after all such statutes of limitation for such
appeal have run) in the country where the product or process was made,
used or sold by Licensee or its
Affiliates.
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2.
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License
Grant
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a.
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Exclusive
License. Subject to the terms and conditions of this
Agreement, IGR&D grants to Omnimmune and any Affiliate thereof, an
exclusive license in the Territory for the term of this Agreement to use
the Licensed Patents, Licensed Material and Licensed Information (along
with Improvements thereon), directly and indirectly, to invent,
characterize, select, discover, make, develop, manufacture, use, sell,
rent, lease, distribute, import, export or otherwise use the Licensed
Products, and to practice and permit the practice of the Licensed
Processes in the Field, with rights to sublicense to Third
Parties.
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b.
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Representations and
Warranties. Each of IGR and IGR&D represents and
warrants that, except as otherwise provided in this Agreement, (1) it
has not transferred by license or otherwise any rights in the Licensed
Technology to any Person, (2) that each has the power and authority to
enter into, deliver and perform its obligations under this Agreement, and
(3) 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. Each of IGR and
IGR&D further covenants that it will not knowingly or intentionally
take or omit to take any of the actions described in the immediately
preceding sentence.
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c.
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Access to Licensed
Information and Licensed Material. During the term of
this Agreement, each of IGR and IGR&D, as applicable, shall provide as
soon as reasonably practicable, but in no event later than ten (10)
business days following the Effective Date, Omnimmune with (1) all
Licensed Information and Licensed Materials, and (2) a reasonable
opportunity to discuss the Invention with IGR's research
personnel. Each of IGR and IGR&D shall have a continuing
obligation during the term of this Agreement to supplement such
disclosures to Omnimmune with current information and materials relating
directly to the Licensed Patents, including any Improvements to Licensed
Patents. Omnimmune shall provide each of IGR and IGR&D with
a Federal Express account number or an account number for another courier
service, so that IGR or IGR&D, as applicable, may ship the Licensed
Material to Omnimmune.
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d.
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Sublicensing
Rights. For the term of this Agreement, IGR&D grants
to Omnimmune the right to grant sublicenses of the Licensed Technology to
Third Parties in the Field and throughout the Territory; provided, however, that
(1) the sublicensee shall have agreed that any right granted thereto
pursuant to this Subsection shall be subject to the terms and conditions
of this Agreement, including, without limitation, Section 16(d) below; (2)
Omnimmune will provide promptly IGR&D with information of any grant of
any such sublicense and will provide to IGR&D, upon IGR&D’s
request, a copy of any sublicense agreement; provided, that Omnimmune's
obligation to provide a copy of any such sublicense shall be subject to
applicable confidentiality obligations of Omnimmune, and any sublicense
provided to IGR&D shall constitute Omnimmune Confidential Information;
and (3) no such sublicense shall relieve Omnimmune of its obligations
under this Agreement.
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3.
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Royalties and Other
Payments.
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a.
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License Fee Upfront
Payment. A one-time nonrefundable and non-creditable
license fee of one hundred twenty-five thousand euro (125,000€) as
follows:
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(1) Twenty-five
thousand euro (25,000€) shall be paid upon and coincident with the Effective
Date;
(2) Fifty
thousand euro (50,000€) shall be paid upon the first anniversary following the
Effective Date; and
The
balance of fifty thousand euro (50,000€) shall be paid upon the second
anniversary of the Effective Date.
b.
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License Maintenance
Fees. An annual license maintenance fees according to
the schedule below:
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(1) Ten
thousand euro (10,000€) one (1) year from the execution of this
Agreement;
(2) Twenty
thousand euro (20,000€) two (2) years from the execution of this
Agreement;
(3) Thirty-five
thousand euro (35,000€) three (3) years from the execution of this
Agreement;
(4) Fifty
thousand euro (50,000€) four (4) years and thereafter from the execution of this
Agreement.
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c.
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Milestones
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(1) In Vitro Diagnostic
Milestones. Milestone payments for each diagnostic Licensed
Product within thirty (30) days of the following events:
(i) In
the territory of the United States and so long as the Original Licensed Patents
have not been rendered invalid or held to infringe on any other patent right as
of the due date thereof, Omnimmune shall pay IGR&D the
following:
(A) At
the commencement of an In Vitro diagnostic Clinical Study: Five thousand euro
(5,000€);
(B) Upon
compilation and Submission of a 510(k) authorization or equivalent thereto : Ten
thousand euro (10,000€); and
(C) At
the First Commercial Sale following the 510(k) authorization or equivalent
thereto: Twenty-five thousand euro (25,000€) if the First Commercial
Sale is in the United States of America (“USA”).
(ii) If
milestones are reached in countries outside of the territory of the United
States or if the Original Licensed Patents have been rendered invalid or held to
infringe on any other patent right as of the due date thereof, Omnimmune shall
pay IGR&D the following:
(A)
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At
the commencement of an In Vitro diagnostic Clinical Study: Two thousand
five hundred euro (2,500€);
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(B)
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Upon
compilation and Submission of a 510(k) authorization or equivalent
thereto: Five thousand euro (5,000€);
and
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(C)
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At
the First Commercial Sale following the 510(k) authorization or equivalent
thereto: Twelve thousand euro five hundred euro (12,500€) if
the First Commercial Sale is in the United States of
America (“USA”).
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(2) Therapeutic
Milestones. Omnimmune agrees to make milestone payments to IGR&D for
each Licensed Product within thirty (30) days of the following
events:
(i)
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At
the first entrance in Phase II Clinical Trial: Twenty five
thousand euro (25,000€);
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(ii)
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At
the first entrance in Phase III Clinical Trial: Seventy five thousand euro
(75,000€);
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(iii)
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At
the first NDA submission: One hundred twenty five thousand euro
(125,000€); and
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(iv)
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At
the First Commercial Sale: one hundred seventy five thousand
euro (175,000€).
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d.
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Running
Royalty. In consideration of the license granted under
this Agreement, Omnimmune shall pay to IGR&D a royalty equal to
four percent (4%) of Net Sales in the USA and a royalty equal to two
percent (2%) of Net Sales in the Territory outside of the USA (the
"Running Royalty"). The Running Royalty shall be reduced, but
not below fifty percent (50%) of the amount due prior to such
reduction, by fifty percent (50%) of any royalty amounts, fees or
other like payments payable to Third Parties in respect of patent rights,
know how or other proprietary rights or information licensed from such
Third Parties that are necessary for use of the Licensed Patents as
contemplated in this Agreement or are incorporated into the License
Products or Licensed Processes; provided, however, that
said incorporation must be necessary for the commercialization of the
License Products or Licensed Processes (i.e., improves,
enhances or otherwise makes the commercialization thereof more
likely).
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e.
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Sublicensing
Royalty. In consideration of the right to sublicense to
Third Parties granted under this Agreement, Omnimmune shall pay to
IGR&D twenty percent (20%) of Sublicense Revenue received in the
Territory of the USA and ten percent (10%) of Sublicense Revenue received
elsewhere in the Territory. The Sublicense
Royalty shall be reduced, but not below fifty percent (50%) of the amount
due prior to such reduction, by fifty percent (50%) of any
royalty amounts, fees or other like payments payable to Third Parties in
respect of patent rights, know how or other proprietary rights or
information licensed from such Third Parties that are necessary for use of
the Licensed Technology as contemplated in this
Agreement.
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f.
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Additional Payment
Adjustments. If more than one Licensed Patent covers a
Licensed Product or Licensed Process, Omnimmune is not obligated to pay
multiple royalties based on the fact that such Licensed Product or
Licensed Process are covered by more than one Licensed
Patent. If and to the extent all claims in any pending
application under the Licensed Patents covering a product or process are
deemed unpatentable or either such claims or the Licensed Materials or
Licensed Information otherwise cannot be made the subject of a patent,
then the Running Royalty or Sublicense Royalty, as the case may be, shall
be reduced by fifty percent (50%). Milestone payments, except for first
commercial sale milestone payments, are non-refundable, non-creditable
against future royalties, and are payable only once the first time a
milestone is achieved. First commercial sales milestones for
diagnostic and, if any, therapeutics are fully creditable against future
Percentage Payments.
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g.
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VAT. All
payments pursuant to this Agreement by Omnimmune to IGR&D are
expressed exclusive of any Value Added Tax ("VAT"), which may be
chargeable thereon. The USA national VAT, if any, shall be paid by
Omnimmune directly to its competent USA tax
authority.
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h.
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Withholding
Taxes. Withholding taxes (if any) levied by the USA tax
authorities or a government of any country on payments made to IGR&D
by Omnimmune hereunder shall be deducted from the royalties due by
Omnimmune. Omnimmune shall lend its support to IGR&D to
avoid any double taxing and provide it upon request with any document
necessary for this purpose. Omnimmune shall use its commercially
reasonable efforts to help IGR&D claim exemption therefrom under any
double taxation or similar agreement in force and shall produce to
IGR&D proper evidence of payment of all withholding tax.
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4.
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Reports
and Payments.
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a.
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Payment
Report. On or before the sixtieth (60th) day following
each calendar quarterly period, Omnimmune shall submit to IGR&D a
written report with respect to the preceding calendar quarter (the
“Payment Report”) stating (i) Net Sales made by Omnimmune or any Affiliate
thereof (or both) during such quarter; (ii) in the case of transfers of
Licensed Technology by Omnimmune to an Affiliate thereof for use by any
such Affiliate, Net Sales by Omnimmune to such Affiliate, and Net Sales by
such Affiliate or sublicensee to Third Parties during such quarter; (iii)
amounts accruing to, and received by, Omnimmune or any Affiliate thereof
(or both) from any sublicensee thereof during such quarter; and (iv) a
calculation under this Agreement of the amounts due to
IGR&D.
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b.
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Timing of
Payment. Simultaneously with the submission of each
Payment Report, Omnimmune shall make payments to IGR&D of the amounts
due for the calendar quarter covered by the Payment
Report.
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c.
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Books and
Records. Omnimmune 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 IGR&D at its sole cost and expense, for inspection and
copying, during usual business hours, not more than once during any twelve
(12) consecutive calendar month period, by an independent certified public
accountant to whom Omnimmune has no reasonable objection. Such
books and records shall be open to IGR&D for two years after the
calendar quarter to which any such Payment Report relates, for purposes of
verifying the accuracy of the amounts paid by Omnimmune under this
Agreement. If such independent accountant reasonably determines
that Omnimmune has underpaid royalties by more than five percent (5%)
otherwise due and owing for any particular calendar quarter, Omnimmune
will pay (subject to its right to contest the same) the costs and expenses
reasonably and actually incurred by IGR&D in the inspection and
copying of such calendar quarter.
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5.
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Reservation
of Rights for Research Purposes. With
respect to the license granted to Omnimmune, IGR reserves the right to use
the Licensed Patents for its internal, noncommercial research
purposes. IGR shall obtain in advance from all of its
researchers and other personnel who it permits to use the Licensed Patents
for such purposes an agreement in writing (1) requiring that all
information defined under this Agreement as Confidential Information be
maintained in strict confidence in accordance with terms and conditions
substantially similar to the provisions of Section 14 of this Agreement;
(2) requiring prompt disclosure to IGR and Omnimmune of any and all
inventions and discoveries; (3) providing for each such invention and
discovery to be covered by appropriate patent filings; (4) requiring the
assignment of all Improvements to Omnimmune in accordance with this
Agreement; and (5) prohibiting the use of such Licensed Patents for
commercial purposes; and shall inform Omnimmune in writing of the identity
of all such Persons. Either of IGR or IGR&D (or both as the
case may be) shall promptly disclose such Improvements to Omnimmune and
such Improvements shall be deemed included in the license grant hereunder
without any further act on the part of IGR, IGR&D or Omnimmune,
without any further payment and without duplication of payment upon
achievement of milestones or commercialization, except that all products
utilizing the Improvements shall be deemed to be Licensed Products or
Licensed Process, as the case may be, and shall be subject to the royalty
provisions set forth herein for Licensed Products and Licensed
Process.
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6.
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Best
Efforts. Omnimmune shall use, and shall cause its
Affiliates and its sublicensees to use, its or their best commercially
reasonable efforts, consistent with commercial practices standard in the
industry and taking into account prudent scientific and business judgment
consistent with the efforts of Omnimmune or its sublicensees devoted to
products, kits, gene probes or antibodies of similar market potential, to
effect introduction as soon as reasonably practicable of the Licensed
Products or Licensed Processes into the marketplace. No less
often than every twelve (12) months following the execution of this
Agreement, Omnimmune shall report in writing to IGR&D on progress made
toward the objectives set forth in this Agreement. In the event that
neither Omnimmune nor its Affliiates generate Net Sales or Sublicense
Revenue within three (3) years after the Effective Date, the Licensed
Patent rights granted by this Agreement will become non-exclusive;
provided that Omnimmune shall be entitled to an extension of such
exclusivity for two additional consecutive one year periods upon (1)
notice by Omnimmune to IGR&D that Omnimmune wishes to extend the
exclusivity period of the Licensed Patent rights, and (2) payment to
IGR&D of twenty-five thousand euro (25,000€) for each year such
exclusivity is extended pursuant to this Section. If during any
such periods of extension such sales or revenue are achieved, then the
exclusive license granted Omnimmune shall continue for the remainder of
the Term under this Agreement.
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7.
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Patent
Prosecution and Maintenance. Omnimmune shall, by counsel
it selects to whom IGR&D has no reasonable objection, prepare, file,
prosecute and maintain all Licensed Patents in IGR’s name and in countries
designated by Omnimmune. Omnimmune will timely provide
IGR&D copies of all correspondence related to reasonable Licensed
Patent prosecution and maintenance. IGR&D shall undertake
timely any and all actions deemed necessary by Omnimmune to enable it to
fulfill its obligations under this Section, including, without limitation,
making available to it any and all researchers and information relating
thereto. Omnimmune will reimburse and pay the expenses IGR or
IGR&D reasonably and actually incurs in supporting or otherwise
cooperating with Omnimmune 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; provided that
all such expenses are subject to the prior written approval of
Omnimmune.
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8.
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Infringement.
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a.
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Third Party
Infringement of Licensed Patent
Rights.
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(1) In
General. Omnimmune and IGR&D (or IGR, if applicable) shall
promptly provide written notice to the other Party of any alleged infringement
by a Third Party of the Licensed Patents and provide such other Party with any
available evidence of such infringement. In the event there is good
reason to believe infringement of any of the Licensed Patents is occurring,
Omnimmune will take prompt, commercially reasonable action to xxxxx or settle
such infringement. Omnimmune shall have the right to institute an
action in its own name, in so far as permitted by law, to xxxxx the infringement
of the Licensed Patent and may join IGR or IGR&D as a party plaintiff, only
if without cost to IGR or IGR&D. During the term of this
Agreement, Omnimmune shall have the right to prosecute, at its own expense and
utilizing counsel of its choice, any infringement of the Licensed
Patent. Omnimmune shall promptly provide IGR&D copies of
all litigation pleadings ands other documents submitted to the court regarding
the infringement of the Licensed Patents. No settlement, consent
judgment or other voluntary final disposition of any such claim of infringement
of the Licensed Patents may be entered into without the written consent of
IGR&D, which consent shall not unreasonably be withheld, delayed, denied or
conditioned.
(2) Third Party Enforcement
Costs and Recoveries. If Omnimmune undertakes to enforce
and/or defend the Licensed Patents by litigation, Omnimmune may deduct from
payments due hereunder to IGR&D 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 fifty percent (50%) of the amount otherwise due
to IGR&D hereunder. Any recovery by Omnimmune in such proceedings
shall first be used to reimburse Omnimmune for its reasonable costs and legal
fees incurred to conduct such proceedings and next to pay to IGR&D an amount
equal to all amounts withheld from IGR&D by Omnimmune under this Section
during the pendency of the proceedings. The remaining balance being
divided between IGR and Omnimmune by, in the case where the recovery is based on
Omnimmune’s lost profits, determining the amount of Net Sales that would have
been required for purposes of calculating such lost profits, and then
calculating the royalty that would have otherwise been paid to IGR under this
Agreement had such Net Sales been received by Omnimmune (after taking into
account the amounts allocated under clauses (1) and (2) above); provided, however, that in no
event shall the amount payable from any such recovery exceed fifty
percent (50%) of any such lost profits, with all amounts remaining from any
such recovery being paid to or otherwise retained by Omnimmune.
(3)
IGR&D's Control of
Enforcement Actions. If within six (6) months after receiving
notice of any alleged infringement of the Licensed Patents by a Third Party,
Omnimmune shall have been unsuccessful in persuading the alleged infringer to
desist, and shall not have brought and shall not be diligently prosecuting an
infringement action, or if Omnimmune shall notify IGR&D, at any time prior
thereto, of its intention not to bring suit against the alleged infringer, then
IGR&D shall have the right, but not the obligation, to prosecute, at its own
expense and utilizing counsel of its choice, any infringement of the Licensed
Patents, and IGR&D may, for such purposes, join Omnimmune as a party
plaintiff at IGR&D's sole cost and expense. The total cost of any
such infringement action commenced solely by IGR&D shall be borne by
IGR&D and IGR&D shall allocate and distribute, in accordance with the
methodology referenced in Section 8(a)(ii) above, any recovery or damages for
past infringement derived therefrom that remains after reimbursement of any
costs of litigation (including negotiation and settlement proceedings) relating
thereto that has been incurred by IGR&D and Omnimmune.
b.
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Infringing Rights of
Third Parties. Each Party shall promptly notify the
other Party if any legal proceedings are commenced or threatened against
either Party or any purchaser of a Licensed Product or Licensed Process
sold by Omnimmune on the grounds that the manufacture, use, sale or
possession thereof is an infringement of a Third Party’s patent or other
intellectual property rights. Omnimmune shall, at its own
expense, defend all suits brought against it as a result of the exercise
of the rights granted hereunder, and IGR and IGR&D shall, at the
request and expense of and when requested by Omnimmune, give Omnimmune all
reasonable assistance in any such
proceedings.
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c.
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Sublicensing
Agreements with Infringer. Omnimmune shall, during the
exclusive period of this Agreement, have the sole right subject to the
terms and conditions hereof to sublicense to any alleged infringer for
future use of the Licensed Patents to the extent licensed by this
Agreement. Any upfront fees paid to Omnimmune as part of such a
sublicense, after reimbursement of any legal expenses incurred by
Omnimmune, shall be treated as Sublicense Revenues for purposes of this
Agreement.
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d.
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Cooperation. In
the event one Party shall initiate or carry on legal proceedings to
enforce or defend any Licensed Patent against a Third Party, the other
Party shall use its best commercially reasonable efforts to cooperate
fully with and shall supply all assistance reasonably requested by the
Party initiating or carrying on such
proceedings.
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9.
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No
Warranty. EXCEPT AS SET FORTH IN THIS AGREEMENT,
IGR&D MAKES NO WARRANTIES EXPRESSED OR IMPLIED OF ANY KIND, AND HEREBY
EXPRESSLY DISCLAIMS ANY WARRANTIES, REPRESENTATIONS OR GUARANTIES OF ANY
KIND AS TO LICENSED TECHNOLOGY 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 OR 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.
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10.
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No
Infringement. On the Effective Date, neither IGR nor
IGR&D has any knowledge that it is infringing upon any patent and
neither IGR nor IGR&D has received any notice of any such
infringement.
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11.
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Prohibition
Against Use of IGR&D’s Name. Except as may be
required by governmental authority or law, Omnimmune will not use the
name, insignia, or symbols of IGR or IGR&D, its faculties or
departments, or any variation or combination thereof, or the name of any
trustee, faculty member, other employee, or student of IGR or IGR&D
for any purpose whatsoever without IGR or IGR&D’s prior written
consent, which consent shall not be unreasonably
withheld.
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12.
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Compliance
with Governmental Obligations. Omnimmune shall comply in
all material respects upon reasonable notice from IGR&D with all
reasonable governmental requests pertaining to the license hereunder or
any Licensed Products or Licensed Processes that are directed to either
IGR&D or Omnimmune and shall provide all information and assistance
reasonably necessary to comply with reasonable governmental requests
pertaining to the license hereunder or any Licensed Products or Licensed
Processes. Omnimmune shall insure that research, development
and marketing under this Agreement complies in all material respects with
all applicable government regulations in force and effect, including, but
not limited to, federal, state, and municipal
legislation.
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13.
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Indemnity. Omnimmune
will indemnify, defend and hold each of IGR and IGR&D harmless from
and against any and all actions, suits, claims, demands, prosecutions,
liabilities, costs, and expenses (including reasonably and actually
incurred 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 or Licensed Process, even if altered for use
for a purpose not intended, (b) use of Licensed Technology by
Omnimmune, its Affiliates, its sublicensees or its (or their) customers,
(c) any representation made or warranty given by Omnimmune, its
Affiliates or sublicensees to Third Parties with respect to the Licensed
Technology, and (d) any infringement claims relating to Licensed
Technology; provided, however, that
this indemnification shall not extend to any claims arising out of any act
or omission constituting: (1) a material breach of this Agreement by IGR
or IGR&D; (2) a material violation by IGR, IGR&D, its directors,
officers, employees or agents, of applicable law or other governmental
requirement governing IGR or IGR&D; or (3) intentional or willful
misconduct by IGR, IGR&D, its directors, officers, employees,
contractors, agents or representatives; or (4) use by IGR, IGR&D or
any employee thereof, of the Licensed Technology prior to the Effective
Date or thereafter under or pursuant to Section 5 of this
Agreement.
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14.
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Confidentiality.
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a.
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In
General. Except as may otherwise be agreed to in any
subsequent agreement, each Party agrees that all Confidential Information
disclosed by Disclosing Party to Recipient or its Designated
Representatives (1) shall not be used for any purpose whatsoever by
Recipient or its Designated Representatives, except in fulfillment of
Recipient's rights or obligations under this Agreement, (2) shall be
maintained in confidence by Recipient and its Designated Representative
for the period described below, and (3) shall not be otherwise
disclosed by Recipient or its Designated Representative to any other Third
Party to this Agreement without Disclosing Party's prior written
consent. Notwithstanding the foregoing, Recipient may disclose
Disclosing Party's Confidential Information if Recipient is required to
make such disclosure by applicable law, regulation or legal process,
including, without limitation, by the rules or regulations of the United
States Securities and Exchange Commission or similar regulatory agency in
a country other than the United States or of any stock exchange or NASDAQ,
in which event Recipient shall provide prior notice of such intended
disclosure to Disclosing Party if possible under the circumstances and
shall disclose only such Confidential Information of such Disclosing Party
as is required to be disclosed.
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b.
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Designative
Representatives. The Recipient shall remain responsible
for any failure by any such Designated Representative to treat such
Confidential Information as required under this
Section.
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c.
|
Miscellaneous. The
obligations of confidentiality in this Agreement are binding for the term
of this Agreement and a period of three (3) years from the date of
termination of this Agreement; provided, however, that
in the case of Confidential Information that constitutes a trade secret,
such period of limitation shall run for the term of this Agreement and for
such period thereafter, if longer, during which any such information
continues to constitute a trade secret as defined under applicable law.
This Section shall be construed as an agreement ancillary to the
other provisions of this Agreement, and the existence of any claim or
cause of action of one Party against the other, whether predicated on this
Agreement or otherwise, shall not constitute a defense to the enforcement
of this Section. All written documents containing Confidential
Information, together with copies of excerpts thereof, shall promptly be
returned to Disclosing Party by Recipient upon request following
termination of this Agreement. Notwithstanding anything to the
contrary herein, any information, including information that may be
considered to be part of the Invention, that is or becomes generally known
to the public through no wrongful acts of Recipient shall not be deemed to
be Confidential Information and shall not be subject to the
confidentiality restrictions imposed under this
Agreement.
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15.
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Severability. If
any provision hereof should be held invalid, illegal or unenforceable in
any respect, then, to the fullest extent permitted by law, (a) all
other provisions hereof shall remain in full force and effect and shall be
liberally construed in order to carry out the intentions of the Parties as
nearly as may be possible and (b) the Parties shall use their best
efforts to replace the invalid, illegal or unenforceable provision(s) with
valid, legal and enforceable provision(s) which, insofar as practical,
implement the purposes of such provision(s) in this
Agreement.
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16.
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Term
of Agreement.
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a.
|
This
Agreement shall be effective as of the Effective Date and shall continue
in full force and effect until its expiration or termination in accordance
with this Section.
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b.
|
Unless
terminated earlier under any provision of this Agreement, the term of this
Agreement shall extend until the later to occur of
either:
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i. The
expiration of the last to expire of the Licensed Patents in any country in which
any such patent may have been issued; or
ii. So long
as a Licensed Product or Licensed Process is available for sale based on or
derived from Know How that has not otherwise been made the subject of a public
disclosure or otherwise becomes available to the public other than pursuant to
the issuance of a Licensed Patent or Licensed Material, ten years from the date
of First Commercial Sale of any Licensed Product or Licensed Process produced
from such Licensed Patents.
c.
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The
license granted under this Agreement may be terminated by Omnimmune at any
time upon thirty days’ written notice to IGR&D; provided, however, that
in no event shall any such termination obviate Omnimmune’s obligation to
pay IGR&D any payments accrued through the date of
termination.
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d.
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This
Agreement may be terminated by either IGR&D or Omnimmune if the other
Party (1) makes an assignment for the benefit of creditors, petitions or
applies to any court or other tribunal for the appointment of a custodian,
receiver, or trustee for it or a substantial part of its assets; (2)
commences any proceeding under any bankruptcy, reorganization,
arrangement, readjustment of debt, dissolution, or liquidation law or
statute of any jurisdiction, whether now or hereafter in effect; (3) has
any petition or application, or other proceeding, commenced against it
(including, but not limited to, involuntary bankruptcy proceedings), in
which an order for the appointment of a custodian, receiver or trustee for
it or all or a substantial part of its assets is sought and in which the
requested relief is substantially granted or adjudication or appointment
is made, and which proceeding, petition or application remains undismissed
for a period of not more than (30) thirty days; (4) by any act or omission
indicates its consent to, approval of, or acquiescence in any petition,
application, or proceeding under any bankruptcy,
reorganization, arrangement, readjustment of debt, dissolution or
liquidation law, or its consent to, approval of, or acquiescence in any
petition, application or proceeding for the appointment of a custodian,
receiver, or trustee for all or any substantial part of its properties; or
(5) is subject to third-party custodianship, receivership, or trusteeship
for a period of not more than thirty (30)
days.
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e.
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Failure
by any Party to substantially comply with any respective material
obligation or condition contained in this Agreement shall entitle
Omnimmune (in the case of such a default by either IGR or IGR&D) or
IGR&D (in the case of such a default by Omnimmune) to give to the
Party in default notice requiring it to cure such default. If
such default is not cured within ninety (90) days after receipt of such
notice by the defaulting Party, the notifying Party shall be entitled
(without prejudice of any of its other rights conferred on it by this
Agreement) to terminate this Agreement by giving termination notice to
take effect immediately; provided, however, that
notwithstanding the foregoing, if in the event the defaulting Party
disputes an alleged Default claimed as to any matter other than for the
failure to pay an amount during and owing under Section 3 of this
Agreement (a “Nonmonetary Default”), then such cure period shall be tolled
for the period during which any such dispute of a Nonmonetary
Default remains pending before any judicial tribunal or
arbitrator and this Agreement shall remain in full force and
effect. Should it be finally determined that the defaulting
Party was in Default under this Agreement for such a NonMonetary Default,
then such defaulting Party shall have the remainder of the cure period to
cure the same. Any notice of Default shall state the nature of
the defaults claimed by the non-breaching party. Subject to the
forgoing, the defaulting Party during said ninety (90) day period, or such
longer period as may be indicated by the Nondefaulting Party, may correct
any default stated in said notice and if such default is corrected, this
Agreement shall continue in full force and effect as if such notice had
not been given. An Affiliate or Sublicensee shall have the
right to cure any Default by Omnimmune. The right of either
such Party to terminate this Agreement as provided in this Section shall
not be affected in any way by its waiver of, or failure to take action
with respect to any previous default. This provision shall not be
interpreted as as waiver of any claim of damages in
court.
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f.
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Upon
any termination of this Agreement, all sublicenses granted by Omnimmune
hereunder shall be assigned to
IGR&D.
|
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g.
|
Sections 1,
2(b), 2(d), 4, 14, 16, 17, 18, 20 and 21 shall survive the
termination or expiration of this
Agreement.
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17.
|
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
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if
to IGR, to
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[Contact
Person
Address]
|
if
to IGR&D, to:
|
Xxxxxxxx
Xxxxxxxxx Bressac
General
Manager
IGR&D
S.A.
00
xxx Xxxxxxx Xxxxxxxxxx
00000
XXXXXXXXX
XXXXXX
Fax
: + 00 0 00 00 0000
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if
to Omnimmune, to:
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Xxxxxx X.
Xxxxxxxxxxxx, Ph.D.
President &
CEO
Omnimmune
Corp.
0000
Xxxx Xxx Xxxxx
Xxxxx
000
Xxxxxxx,
Xxxxx 00000
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with
a copy to:
|
Xxxxx
XxXxxxxx, Esq.
Dinur,
McDaniel, XxXxxx & Xxxxx, LLP
XX
Xxx 000000
Xxxxxxxx,
Xxxxxxx 00000-0000
000.000.0000
fax
xxxxx.xxxxxxxx@xxxxxx.xxx
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or to
such other address as a Party may specify by notice hereunder.
18.
|
Force
Majeure. Any delays in or failures of performance by
either Party under this Agreement shall not be considered a breach of this
Agreement if and to the extent caused by occurrences beyond the reasonable
control of the Party affected, including, but not limited to, acts of god;
acts regulations, or laws of any government (including, without
limitation, drug, pharmaceutical, device, import and export regulations);
strikes or other concerted acts of workers; fires; floods; explosions;
riots; wars; rebellion and sabotage; and any time for performance
hereunder shall be extended by the actual time of delay cause by such
occurrence. Each Party shall promptly give notice to the other
of any such failure or delay and shall provide a reasonable estimate of
its expected duration.
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19.
|
Assignment. This
Agreement shall be binding upon and inure to the benefit of the Parties
and their respective permitted successors and permitted
assigns. This Agreement may not be assigned by either Party
without the prior written consent of the other Party, which consent shall
not be unreasonably withheld; provided, however, that
Omnimmune may assign this Agreement by operation of law, whether by merger
or otherwise, or sale of all or substantially all of its
assets. IGR&D may assign IGR&D’s rights to receive
royalties payable pursuant to this Agreement without the consent of
Omnimmune.
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20.
|
Entire
Agreement. This Agreement constitutes the entire
understanding by and between the Parties with respect to the subject
matter hereof, and supersedes and replaces all prior agreements,
understandings, writings, and discussions between the Parties relating to
said subject matter.
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21.
|
Governing
Law. This Agreement shall be governed by USA law
applicable to agreements made and to be fully performed in the State of
Texas, except as to Confidential Information and the restrictions relating
thereto, which shall be governed by the laws of the State of Texas, USA in
the case where Omnimmune is the Disclosing Party, and by the laws of the
Republic of France in the case where IGR or IGR&D is the Disclosing
Party. In the event a dispute should arise, the Parties agree
to attempt to settle their differences out of court. In case
they are unable to resolve any such dispute amongst themselves, then if
the defendant is Omnimmune, the disagreement shall be taken before the
competent courts located in Houston, Texas, USA; if the defendant is IGR
or IGR&D, the disagreement shall be taken before the competent French
courts.
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22.
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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.
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IN WITNESS THEREOF, IGR&D
and Omnimmune have caused this Agreement to be executed by their duly authorized
representatives as of the day and year written below.
IGR
|
|
Institut
Xxxxxxx Xxxxxx
|
|
By: /s/
|
|
IGR&D,
à Villejuif le 26 Octobre 2007
|
|
IGR&D,
SA
|
|
By: /s/ Xxxxxxxx Xxxxxxxxx
Bressac
|
|
Xxxxxxxx
Xxxxxxxxx Bressac
General
Manager
|
|
OMNIMMUNE
|
|
Omnimmune
Corp.
|
|
By: /s/
Xxxxxx X. Xxxxxxxxxxxx
|
|
Xxxxxx X.
Xxxxxxxxxxxx, Ph.D.
President &
CEO
|
|
ATTACHMENT
A
LICENSED
PATENTS:
1.
|
Malignant
human cell transformation detection method, U.S. Patent No. 6,194,154,
issued 27 February, 2001
|
2.
|
Process
for detecting the malignant transformation of human cells, U.S. Patent No.
6,514,708, issued 4 February, 2003
|
LICENSED MATERIALS AND
LICENSED PROCESSES:
1.
|
Any
and all antibodies or antibody cell lines referred to in the claims of the
Licensed Patents or otherwise relating
thereto.
|
2.
|
Any
and all hCG protein (or epitopes) referred to in the claims of the
Licensed Patents or otherwise relating
thereto.
|
3.
|
Any
and all hCG genetic sequences referred to in the claims of the Licensed
Patents or otherwise relating
thereto.
|
4.
|
All
formulae, algorithms or data management or interpretive systems, including
or otherwise related to the CG117 Assay and related Transformation
Index.
|