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Exhibit 10.1
LICENSE AGREEMENT
by and between
INOVIO BIOMEDICAL CORPORATION
and
INOVIO ASIA PTE LTD.
September 15, 2006
LICENSE
AGREEMENT
This License Agreement (the " Agreement ") is entered
into this 15 th day of
September 2006 (the " Effective Date "), by and between
Inovio Biomedical Corporation, a corporation organized and existing
under the laws of the State of California, U.S.A., and having a
principal place of business at 11494 Sorrento Valley Road, San
Diego, California, U.S.A. 92121 (" Inovio " or "
Licensor "), and Inovio Asia Pte Ltd. , a corporation
incorporated and existing under the laws of the Republic of
Singapore and having a principal place of business at c/o Rajah
& Tann, 4 Battery Road #26-01 Bank of China Building,
Singapore, 049908 (" IAPL " or " Licensee ").
Inovio and IAPL may each be referred to herein individually as a
"Party" and collectively as the "Parties."
WHEREAS, Inovio is engaged in the development and
commercialization of human applications of electroporation and
possesses rights to certain intellectual property with respect
thereto;
WHEREAS, pursuant to a Securities Purchase and Exchange
Agreement dated as of the date hereof among IAPL, Inovio, and the
other investors named therein (the " Purchase Agreement "),
IAPL and Inovio are required to deliver a duly executed agreement
providing for an exclusive royalty-free license to certain rights
in and to Inovio’s intellectual property from Inovio to IAPL
as a condition to closing of the transactions contemplated
therein;
WHEREAS, IAPL desires to issue, and Inovio desires to receive
certain ordinary shares of IAPL as consideration for the license of
such rights;
NOW THEREFORE, in consideration of the mutual promises and
covenants set forth below and other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereby agree as follows:
1.
DEFINITIONS.
Capitalized Terms not otherwise defined herein shall have the
following meanings:
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1.1.
Additional Agent . "Additional
Agent" shall mean one additional chemotherapeutic agent, other than
Bleomycin®, that is used in the treatment of human cancer, the
selection of such Additional Agent to be agreed on by the Parties
after the Effective Date.
1.2.
Third Party License . "Additional
Third Party License" shall have the meaning set forth in Section
8.6.2 hereof.
1.3.
Affiliate(s). "Affiliate(s)" shall
mean, as of any point in time and for so long as such relationship
continues to exist with respect to any Person, any other Person
which controls, is controlled by or is under common control with
such Person. A Person shall be regarded as in control of
another Person if it owns or controls at least fifty percent (50%)
of the equity securities of the subject Person entitled to vote in
the election of directors (or, in
the case of a Person that is not a corporation,
for the election of the corresponding managing
authority).
1.4.
Applicator . "Applicator" shall mean
an existing Inovio intratumoral six needle electroporation product
designed for use solely with the Generator, which product is
intended to be disposed of after one administration to a patient of
a Licensed Product, or after a defined number of such
administrations of a Licensed Product.
1.5.
Change of Control . "Change of
Control" shall mean a transaction in which IAPL: (a) sells, conveys
or otherwise disposes of all or substantially all of its property
or business; or (b)(i) merges or consolidates with any other
entity; or (ii) effects any other transaction or series of
transactions; in each case of clause (i) or (ii), such that the
stockholders of IAPL immediately prior thereto, in the aggregate,
no longer own, directly or indirectly, beneficially or legally, at
least fifty percent (50%) of the outstanding voting securities or
capital stock of the surviving entity following the closing of such
merger, consolidation, other transaction or series of
transactions.
1.6.
Commercialize . "Commercialize" or
"Commercializing" shall mean to use, import, export, market,
Promote, distribute, offer for sale, sell, have sold or otherwise
commercialize or prepare to commercialize. When used as a
noun, "Commercialization" shall mean any and all activities
involved in Commercializing.
1.7.
Confidential Information.
"Confidential Information" means, with respect to a Party, all
information (and all tangible and intangible embodiments thereof),
which is Controlled by such Party, including, without limitation,
(i) scientific or medical information, material, results and data
of any type whatsoever, in any tangible or intangible form
whatsoever, including databases, inventions, practices, methods,
techniques, specifications, formulations, formulae, cell lines,
cell media, knowledge, know-how, skill, experience, manufacturing
materials, financial data, test data including pharmacological,
biological, chemical, biochemical, toxicological and clinical test
data, analytical and quality control data, quality assurance data,
stability data, and studies and procedures, (ii) all regulatory
filings and communications or any kind, and patent and other legal
information or descriptions and (iii) commercial information of any
kind, including product forecasts and sales information, sales
force information, marketing studies and marketing materials,
comparative analysis of competing products, physician education
materials, customer and distribution channel information, and any
information regarding post-approval trials, adverse event reports,
or other product information. Notwithstanding the foregoing,
Confidential Information of a Party which is disclosed by such
Party to the other Party or otherwise received by the receiving
Party shall not include information which the receiving Party can
establish by written documentation (a) was publicly known prior to
its disclosure to or receipt by the receiving Party, (b) became
publicly known, without breach of this Agreement on the part of the
receiving Party or an agent thereof, subsequent to its disclosure
to or receipt by the receiving Party, (c) was received by the
receiving Party at any time from a source, other than the
disclosing Party, rightfully having possession of and the right to
disclose such information free of confidentiality obligations, (d)
was otherwise known by the receiving Party free of confidentiality
obligations to the disclosing Party prior to its disclosure to or
receipt by the receiving Party, or (e) was independently developed
by
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employees or others on behalf of the receiving
Party without the aid, application or use of the information
disclosed to or received by the receiving Party.
1.8.
Control or Controlled . "Control" or
"Controlled" shall mean with respect to any material, item of
information, or intellectual property right, the possession,
whether by ownership, license or otherwise, of the right to grant a
license or other right with respect thereto to the extent set forth
herein.
1.9.
Device . "Device" shall mean a
Generator or Applicator. "Devices" shall mean Generators or
Applicators, or both.
1.10.
EP . "EP" shall mean intratumoral
electroporation.
1.11.
Existing EP Intellectual Property .
"Existing EP Intellectual Property" shall mean the Existing Inovio
Patent Rights and Existing Inovio Know-How.
1.12.
Existing Inovio Know-How . "Existing
Inovio Know-How" shall mean any Inovio Know-How Controlled by
Inovio or its Affiliates as of the Effective Date.
1.13.
Existing Inovio Patent Rights .
"Existing Inovio Patent Rights" shall mean the patents and patent
applications listed on Schedule 1.16 attached hereto.
1.14.
Generator . "Generator" shall mean
an intratumoral electroporation device the manufacture and/or use
of which in the Licensed Field would infringe the Inovio Patent
Rights or utilize the Inovio Licensed Technology, including but not
limited to pulse generation equipment.
1.15.
IAPL Improvements . "IAPL
Improvements" shall mean any invention, development or discovery,
whether or not patentable, made or created (i) independently by
employees or agents of IAPL or any of its Affiliates, or (ii)
jointly by employees or agents of IAPL and Inovio, or any of their
respective Affiliates, which relate to EP or arise out of, improve,
or enhance Inovio Licensed Technology.
1.16.
Inovio Competitor . "Inovio
Competitor" means any company (other than Inovio or IAPL) that is
either (i) significantly engaged in the development, Manufacturing,
Commercialization, and/or marketing of EP applicators and/or
generators or (ii) is a Sublicensee of Inovio or an Affiliate
thereof.
1.17.
Inovio Product Enhancements .
"Inovio Product Enhancements" shall mean any Inovio Patent Rights
or Inovio Know-How Controlled by Inovio or its Affiliates during
the Term that enhances or technically improves a Licensed
Product.
1.18.
Inovio Know-How. "Inovio Know-How"
shall mean all EP-related Know-How Controlled by Inovio or its
Affiliates, now or at any time during the Term, necessary for the
Development, Manufacture, use, sale or importation of a Device in a
Licensed Product in a Licensed Field and in the Territory.
Inovio Know-How shall include Existing Inovio Know-How.
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1.19.
Inovio Licensed Technology . "Inovio
Licensed Technology" shall mean Inovio’s rights in (i)
Existing EP Intellectual Property, (ii) Inovio’s interest in
Inovio Product Enhancements, (iii) IAPL Improvements, and (iv) any
other Inovio Patent Rights and Inovio Know-How required for freedom
to operate in the Field and in the Territory.
1.20.
Inovio Patent Rights . "Inovio
Patent Rights" shall mean any EP-related Patent Rights Controlled
by Inovio or its Affiliates now or at any time during the Term,
which would be infringed by the Development, Manufacture, use, sale
or importation of any Licensed Product in the Licensed Field in the
Territory. Inovio Patent Rights shall include Inovio Existing
Patent Rights.
1.21.
Inovio Third Party Agreement .
"Inovio Third Party Agreement" shall mean any agreement between
Inovio and any Third Party that involves a license by such Third
Party to Inovio that comprises Inovio Licensed Technology.
1.22.
Know-How . "Know-How" shall mean any
confidential unpatented or unpatentable technology, compound, cell
line or other biological material, probe, sequence, technical
information, method, or other confidential information or material,
in all cases to the extent, but only to the extent, not in the
public domain and necessary for the Commercialization of the
Licensed Product in the Field.
1.23.
Licensed Field . "Licensed Field"
shall mean the ablation treatment of all human solid tumors by
means of EP, using either Bleomycin® or the Additional
Agent.
1.24.
Licensed Product . "Licensed
Product" shall mean any product that uses Bleomycin® or the
Additional Agent with the Device to treat patients in the Licensed
Field.
1.25.
Manufacture . "Manufacture,"
"Manufactured" or "Manufacturing" means all activities involved in
the production, packaging and labeling of a Licensed Product to be
Commercialized under this Agreement.
1.26.
Patent Rights . "Patent Rights"
shall mean any and all (a) U.S. or foreign patents, (b) U.S. or
foreign patent applications, including, without limitation, all
provisional applications, substitutions, continuations,
continuations-in-part, divisions, renewals, and all patents granted
thereon, (c) all U.S. or foreign patents-of-addition, reissues,
reexaminations and extensions or restorations by existing or future
extension or restoration mechanisms, including, without limitation,
patent term adjustments, patent term extensions, supplementary
protection certificates or the equivalent thereof, and (d) any
other form of government-issued right substantially similar to any
of the foregoing.
1.27.
Person . "Person" shall mean any
individual or legal entity.
1.28.
Product Data . "Product Data" shall
mean all pre-clinical data and results, clinical protocols,
studies, clinical data and results, post-marketing data and
results, manufacturing data and results, and other information
necessary or useful for obtaining Regulatory Approval of a Licensed
Product in the Licensed Field.
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1.29.
Promotion . "Promotion" shall mean
those activities normally undertaken by a pharmaceutical
company’s sales force to implement marketing plans and
strategies aimed at encouraging the approved use of a particular
Licensed Product. When used as a verb, "Promote" means to
engage in such activities.
1.30.
Recall . "Recall" shall mean, with
respect to any pharmaceutical product, a "recall" or a "product
withdrawal" or a "stock recovery" or any similar term as utilized
by any Regulatory Authority under such Regulatory Authority’s
procedures regarding the recall of pharmaceutical products, as the
same may be amended from time to time, and shall include any
post-sale warning or mailing of information regarding such product,
including any warnings or mailings described in the Regulatory
Authority’s product recall procedures.
1.31.
Regulatory Approval . "Regulatory
Approval" means any technical, medical, scientific or other
license, registration, authorization or approval of any Regulatory
Authority regarding the research, development, clinical testing,
commercial manufacture, distribution, marketing, pricing,
reimbursement, Promotion, offer for sale, use, import, export or
sale of any pharmaceutical product, proposed pharmaceutical
product, medical device, proposed medical device, or any
combination thereof.
1.32.
Regulatory Authority . "Regulatory
Authority" shall mean, with respect to a country in the Territory,
any national, supra-national, regional, state or local regulatory
agency, department, bureau, commission, council or other
governmental entity involved in the granting of a Regulatory
Approval including Market Clearance for such country or
countries.
1.33.
Sublicense . When used as a verb,
"Sublicense" shall mean to, directly or indirectly, sublicense, or
grant any other right with respect to, or agree not to assert, any
intellectual property right granted to a Party under this
Agreement. When used as a noun, "Sublicense" shall mean any
agreement to Sublicense.
1.34.
Sublicensee . "Sublicensee" shall
mean any IAPL Sublicensee or any Inovio Sublicensee.
1.35.
Term . "Term" shall mean the period
of time from the Effective Date until the expiration or earlier
termination of this Agreement.
1.36.
Territory . "Territory" shall mean
China, Hong Kong, Taiwan, Korea, Singapore, Malaysia, Indonesia,
and Thailand and such other countries as the Parties may agree in
writing from time to time.
1.37.
Third Party . "Third Party" shall
mean any Person other than IAPL, Inovio or their respective
Affiliates.
1.38.
Trademark . "Trademark" shall mean
any trademark used by the Parties in connection with a Licensed
Product, other than the Parties’ trade names and trademarks
used by the Parties to identify their companies generally.
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1.39.
Valid Claim . "Valid Claim" shall
mean a claim of an issued and unexpired Patent Right that has not
been held permanently revoked, unenforceable or invalid by a
decision of a court or other governmental agency of competent
jurisdiction, unappealed or unappealable within the time allowed
for appeal, and that has not been admitted to be invalid or
unenforceable through reissue, disclaimer or otherwise.
2.
License Fee. In consideration of
the rights granted to licensee hereunder and licensor’s
performance of its obligations hereunder, licensee shall issue
licensor 6,584,364 ordinary shares of licensee, valued at $2.43 per
share (the "shares"). The parties agree that the shares shall
be the sole compensation to licensor for the rights and licenses
provided by licensor hereunder.
2.1.1. Organization; Authority . The Licensor is an
entity duly organized, validly existing and in good standing under
the laws of the jurisdiction of its organization with full right,
corporate, partnership or limited liability company power and
authority to enter into and to consummate the transactions
contemplated by this Agreement and otherwise to carry out its
obligations thereunder.
2.1.2. Experience of Licensor . The Licensor, either
alone or together with its representatives, has such knowledge,
sophistication and experience in business and financial matters so
as to be capable of evaluating the merits and risks of the
prospective investment in the Shares, and has so evaluated the
merits and risks of such investment. The Licensor is able to
bear the economic risk of an investment in the Shares and, at the
present time, is able to afford a complete loss of such
investment. The Licensor is an "accredited investor," as that
term is defined in Regulation D, promulgated pursuant to the
Securities Act of 1933, as amended (the "Securities Act").
The Licensor, by reason of the Licensor’s business or
financial experience or the business or financial experience of the
Licensor’s professional advisors has the capacity to protect
his/her/its own interests in connection with the acceptance of
shares of the Licensee’s common stock as consideration
hereunder.
2.1.3. Investment Intent . The Licensor understands that
the Shares are "restricted securities" and have not been registered
under the Securities Act, the Securities and Futures Act or any
applicable state securities law. The Licensor is acquiring
the Shares as principal for its own account for investment purposes
only and not with a view to or for distributing or reselling such
Shares or any part thereof, has no present intention of
distributing any of such Shares and has no arrangement or
understanding with any other persons regarding the distribution of
such Shares. The Licensor is acquiring the Shares hereunder
in the ordinary course of its business. The Licensor does not have
any agreement or understanding, directly or indirectly, with any
person to distribute any of the Shares.
2.1.4. No Registration, Review or Approval . The Licensor
acknowledges and understands that the offering and issuance of the
Shares to the Licensor has not been reviewed or approved by the
Securities and Exchange Commission or by any state or other
international
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securities commission, authority or agency, and
is not registered under the Securities Act, the Securities and
Futures Act, or under the securities or "blue sky" laws, rules or
regulations of any state. The Licensor acknowledges,
understands and agrees that the Securities are being issued
pursuant to an offering exemption to the registration provisions of
the Securities and Futures Act. The Licensor understands that
IAPL is relying upon the truth and accuracy of the representations,
warranties, agreements, acknowledgments and understandings set
forth herein in order to determine the applicability of such
exemptions and the suitability of the Licensor to acquire the
Securities.
2.1.5. No General Solicitation or Directed Selling Efforts
. The Licensor is not acquiring the Shares as a result of any
advertisement, article, notice or other communication regarding the
Shares published in any newspaper, magazine or similar media or
broadcast over television or radio or presented at any seminar or
any other general solicitation or general advertisement. The
Licensor has not paid and is not obligated to pay any promotional
expense in connection with the purchase and/or acquisition of any
Shares other than those incurred for administrative or professional
services.
2.1.6. Restrictions on Resale; Legends . The Licensor
acknowledges that the transfer, resale or other disposition of the
Shares is subject to the certain restrictions and that the
certificates evidencing the Shares, if any, may bear a restrictive
legend in substantially the same form as below:
"THESE SECURITIES HAVE NOT BEEN REGISTERED WITH THE
SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF
ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE
SECURITIES ACT OF 1933, AS AMENDED (THE "SECURITIES ACT"), OR THE
SECURITIES LAWS OF ANY STATE OF THE UNITED STATES, NOR REGISTERED
UNDER THE SECURITIES AND FUTURES ACT (CHAPTER 289) OF SINGAPORE AND
MAY NOT BE SOLD, OFFERED FOR SALE, ASSIGNED, TRANSFERRED, PLEDGED,
ENCUMBERED OR OTHERWISE DISPOSED OF WITHIN SINGAPORE OR TO A U.S.
PERSON (AS THAT TERM IS DEFINED IN REGULATION S PROMULGATED UNDER
THE SECURITIES ACT) UNLESS OFFERED, SOLD OR TRANSFERRED UNDER AN
AVAILABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THOSE
LAWS. IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT FILED
UNDER THE SECURITIES ACT, THE SECURITIES AND FUTURES ACT AND ANY
APPLICABLE STATE SECURITIES LAWS, UNLESS AN EXEMPTION FROM SUCH
REGISTRATION IS AVAILABLE."
3.
LICENSE GRANTS.
3.1.1. Exclusive License from Inovio to IAPL .
Subject to the terms and conditions of this Agreement, Inovio
hereby grants to IAPL an exclusive, royalty-free license, with the
right to grant Sublicenses solely pursuant to the terms of Section
3.1.3, under the Inovio Licensed Technology to Manufacture and
Commercialize Licensed Products in the Licensed Field in the
Territory.
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3.1.2. Trademark License from Inovio to IAPL . Upon
IAPL’s written request at any time during the Term and
subject to the terms and conditions of this Agreement, Inovio shall
grant to IAPL a non-exclusive, fully paid-up, royalty-free,
non-transferable Trademark license, with the right to grant
sublicenses, to use Inovio’s Trademarks and/or trade names in
connection with Inovio Licensed Technology solely to Manufacture
and Commercialize Licensed Products in the Licensed Field in the
Territory. Termination
3.1.3. IAPL Sublicenses to Third Parties . Subject to the
terms and conditions of this Agreement, IAPL may, upon prior
written consent from Inovio, Sublicense any rights licensed or
otherwise granted to IAPL under this Agreement to (i) IAPL’s
Affiliates; (ii) IAPL’s distributors of Licensed Products
pursuant to bona fide arm’s length distribution agreements;
and (iii) any Third Party other than a Inovio Competitor or
Sublicensee, in each case that enters into a bona fide license
agreement with IAPL to Manufacture or Commercialize Licensed
Products in the Licensed Field in the Territory. Any
Sublicense by IAPL shall be subject to the provisions of this
Agreement and may, at Inovio’ sole discretion, survive
termination of the licenses or other rights granted to IAPL under
this Agreement in accordance with Section 9.2.4 hereof; provided,
further, that IAPL shall remain legally liable to Inovio for the
performance by each such Sublicensee of its obligations
thereunder.
2.1.4 IAPL Sublicenses from Third Parties . In the event
that any of the rights licensed or otherwise granted by Inovio to
IAPL under this Agreement comprise rights also licensed or
otherwise granted by Inovio to a Third Party, then neither IAPL nor
any IAPL Affiliate shall enter into any arrangement with that Third
Party whereby the Third Party would sublicense such rights to IAPL
or an IAPL Affiliate on terms any different from those contained
herein.
3.2.1. License for Product Enhancements to IAPL . Subject
to the terms and conditions of this Agreement, Inovio hereby grants
to IAPL an exclusive, fully paid-up, royalty-free license, with the
right to grant Sublicenses solely pursuant to the terms of Section
3.1.3, to Inovio Product Enhancements under the Inovio Licensed
Technology solely to Manufacture and Commercialize Licensed
Products in the Licensed Field in the Territory.
3.2.2. License for IAPL Improvements . Subject to the
terms and conditions of this Agreement, Inovio grants to IAPL an
exclusive, fully paid-up, royalty-free license, with the right to
grant Sublicenses solely pursuant to the terms of Section 3.1.3,
under Inovio’s rights in the IAPL Improvements solely to
Manufacture and Commercialize Licensed Products in the Licensed
Field in the Territory.
3.3.
No Other Rights . No rights, other
than those expressly set forth in this Agreement, are granted to
either Party hereunder, and no additional rights shall be deemed
granted to either Party by impli
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