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EXHIBIT 10.17
***TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. Sections 200.80(B)(4),
200.83 AND 230.406
LICENSE AND DEVELOPMENT AGREEMENT
THIS LICENSE AND DEVELOPMENT AGREEMENT (the "Agreement") is made as of
October 6, 1998 (the "Effective Date") by and among GENETRONICS BIOMEDICAL,
LTD., a corporation organized under the laws of British Columbia, a province of
Canada, and GENETRONICS, INC., a wholly-owned subsidiary of Genetronics
Biomedical, Ltd. and a corporation organized under the laws of California (both
jointly and severally hereinafter referred to as "Genetronics"), and ETHICON,
INC., a wholly-owned subsidiary of ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ and a corporation organized
under the laws of New Jersey (hereinafter referred to as "Ethicon").
RECITALS
WHEREAS, Genetronics wishes to grant to Ethicon, and Ethicon wishes to
obtain from Genetronics, an exclusive license under Genetronics' proprietary
drug delivery technology to make, use and sell products for the prevention,
detection or treatment of pre-cancer and cancer on the terms and subject to the
conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing recitals and the
mutual covenants and agreements contained herein, the parties hereto, intending
to be legally bound, do hereby agree as follows:
AGREEMENT
DEFINITIONS
1.1 "ADVISORY COMMITTEE" means the committee established pursuant to
Section 3.1.
1.2 "AFFILIATE" shall mean, in relation to either party hereto, (a)
any entity in which the relevant party directly or indirectly holds more than
50% of the voting stock or power, (b) any entity ("Holding Entity") which holds
directly or indirectly more than 50% of the voting stock or power of the
relevant party, (c) any other entity in which more than 50% of the voting stock
or power is directly or indirectly held by any Holding Entity of the relevant
party or (d) any entity in which the relevant party directly or indirectly holds
less than 50% of the voting stock or power but has management control of such
entity in that it has the ability to appoint and remove the majority of the
Board of Directors (or other governing body) of such party.
1.3 "APPLICATOR" means that component of the Drug Delivery System
which uses an electrode needle array, whether or not integrated, to deliver the
pulsed electrical field from the Generator to the patient during
Electroporation.
1.4 "BANKRUPTCY EVENT" shall mean the entity in question becomes
insolvent, or voluntary or involuntary proceedings by or against such entity are
instituted in bankruptcy or under any insolvency law, or a receiver or custodian
is appointed for such entity, or proceedings are instituted by or against such
entity for corporate
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reorganization or the dissolution of such entity, which proceedings, if
involuntary, shall not have been dismissed within sixty (60) days after the date
of filing, or such person or entity makes an assignment for the benefit of its
creditors, or substantially all of the assets of such entity are seized or
attached and not released within sixty (60) days thereafter.
1.5 "CHANGE IN CONTROL" shall mean in respect of a party hereto (i)
the liquidation or dissolution of such party or the sale or other transfer by
such party (excluding transfers to subsidiaries) of all or substantially all of
its assets; or (ii) the occurrence of a tender offer, stock purchase, other
stock acquisition, merger, consolidation, recapitalization, reverse split, sale
or transfer of assets or other transaction, as a result of which any person,
entity or group (a) becomes the beneficial owner, directly or indirectly, of
securities of such party representing more than 50% of the ordinary shares of
such party or representing more than 50% of the combined voting power with
respect to the election of directors (or members of any other governing body) of
such party's then outstanding securities, (b) obtains the ability to appoint a
majority of the Board of Directors (or other governing body) of such party, or
obtains the ability to direct the operations or management of such party or any
successor to such party's business; provided, however, that Change in Control
shall not include the issuance by a party of equity to the public through a
public offering or offerings.
1.6 "CONTROL" means possession of the ability to grant a license or
sublicense as provided for herein without violating the terms of any agreement
or other arrangement with any Third Party.
1.7 "DEEP SEATED PROBE" means a proposed device to be developed by the
parties based on the Genetronics Technology, as more particularly described in
Exhibit F hereto.
1.8 "DRUG DELIVERY SYSTEM" means any system for the delivery of drugs
by means of Electroporation, or any mechanical, electrical or software component
of the delivery system (including the Generator and the Applicator), the
manufacture, use or sale of which is covered by the Genetronics Technology.
1.9 "ELECTROPORATION" means the application of high-voltage
electrical impulses to living cells to enhance the delivery of molecules into
such cells by increasing the permeability of the membrane of such cells.
1.10 "ETHICON IMPROVEMENTS" means any improvement, Know-How, discovery
or development based on the Genetronics Technology, which is created, conceived
of, developed or first reduced to practice by Ethicon and/or its sublicensees
during the Term.
1.11 "FDA" means the United States Food and Drug Administration.
1.12 "FIELD" means the use of Electroporation for the detection,
prevention and treatment of pre-cancer and cancer, except (a) applications
involving the detection,
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prevention or treatment of basal cell skin and squamous cell skin pre-cancer and
cancer, and (b) Gene Therapy applications.
1.13 "FIRST COMMERCIAL SALE" means the date of the first sale of the
Drug Delivery System to an end user of such system but not with respect to
clinical trials and market development activities. Sale to an Affiliate shall
not constitute a First Commercial Sale unless the Affiliate is the end user of
the Drug Delivery System.
1.14 "GENE THERAPY" means applications involving the introduction of a
nucleic acid sequence such that therapeutic RNA or a protein product is produced
based on the coding sequence so introduced.
1.15 "GENERATOR" means that component of the Drug Delivery System,
which creates a pulsed electrical field for use during Electroporation.
1.16 "GENETRONICS KNOW-HOW" means all Know-How related to the Drug
Delivery System or any component thereof, which is not covered by the
Genetronics Patent Rights, but is necessary or appropriate to develop,
manufacture and commercialize the Drug Delivery System in the Field, and which
is under the Control of Genetronics as of the Effective Date or acquired by or
developed by or for Genetronics during the Term.
1.17 "GENETRONICS PATENT RIGHTS" means all Patent Rights claiming the
Drug Delivery System or any component thereof, which are necessary or
appropriate to use (in various procedures with various therapeutic agents),
develop, manufacture and commercialize the Drug Delivery System in the Field,
and which are under the Control of Genetronics as of the Effective Date or
acquired by, developed by or for Genetronics during the Term, also including the
Joint Patent Rights. The Genetronics Patent Rights as of the Effective Date are
set forth on Exhibit A.
1.18 "GENETRONICS TECHNOLOGY" means the Genetronics Patent Rights and
the Genetronics Know-How.
1.19 "JOINT PATENT RIGHTS" means all Patent Rights covering all
inventions conceived of and reduced to practice during the Term jointly by
employees or agents of Ethicon and employees or agents of Genetronics.
1.20 "KNOW-HOW" means all know-how, trade secrets, inventions, data,
processes, techniques, procedures, compositions, devices, methods, formulas,
protocols and information, whether or not patentable, which are confidential,
including, without limitation, all chemical, biochemical, toxicological and
scientific research information.
1.21 "MARKET REQUIREMENTS" shall have the meaning given in the Supply
Agreement.
1.22 "NET SALES"
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(a) Net Sales means the gross amounts invoiced for sales of
the Drug Delivery System, or any component thereof (i.e., the Generator or the
Applicator), by Ethicon, its Affiliates and sublicensees to Third Parties, less
(a) discounts actually granted, (b) credits or allowances actually granted upon
claims, damaged goods, rejections or returns of the Drug Delivery System,
including recalls, (c) freight, postage, shipping and insurance charges actually
allowed or paid for delivery of the Drug Delivery System, to the extent billed,
and (d) taxes, duties or other governmental charges (other than income taxes)
levied on, absorbed or otherwise imposed on sales of the Drug Delivery System.
(b) In the event that the Drug Delivery System is sold in the
form of a combination product containing one or more elements other than the
Drug Delivery System, Net Sales for the Drug Delivery System will be calculated
by multiplying the Net Sales of such combination product by the [...***...]
where A is the [...***...]. of the Drug Delivery System if sold separately by
Ethicon, its Affiliates or sublicensees, and B is the [...***...]. of any other
component or components in the combination product is not part of the Drug
Delivery System, if sold separately by Ethicon, its Affiliates or sublicensees.
(c) If on a country-by-country basis the other component or
components in a combination product are not sold separately in said country by
Ethicon, its Affiliates or sublicensees, Net Sales of the Drug Delivery System
included within such combination product shall be calculated by [...***...] of
such combination product [...***...] the fraction A/C where A is [...***...] of
the Drug Delivery System if sold separately and C is [...***...] of the
combination product. If on a country-by-country basis neither the Drug Delivery
System nor the combination product is sold separately in said country by
Ethicon, its Affiliates or sublicensees, Net Sales of the Drug Delivery System
shall be calculated as set forth in the previous sentence, except that A shall
be [...***...] the Drug Delivery System to Ethicon or such Affiliate or
sublicensee that makes the sale to a Third Party and C shall be [...***...] as
applicable, of the combination product. For purposes of the foregoing
calculations, all costs will be determined on a fully allocated basis consistent
with generally accepted accounting principles as consistently applied by
Ethicon, its Affiliate or sublicensees.
(d) Notwithstanding the foregoing, in the event that the
Applicator is sold as part of a surgical kit and if, as part of such kit, the
Applicator does not have a separate invoiced price, then Net Sales of such
Applicator shall equal the [...***...] of such surgical kit [...***...] of all
of the [...***...] within such surgical kit.
1.23 "PATENT RIGHTS" means all rights under patents and patent
applications, and any and all patents issuing therefrom (including utility,
model and design patents and certificates of invention), together with any and
all substitutions, extensions (including supplemental protection certificates),
registrations, confirmations, reissues, divisionals, continuations,
continuations-in-part, re-examinations, renewals and foreign counterparts of the
foregoing.
4. *CONFIDENTIAL TREATMENT REQUESTED
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1.24 "REGULATORY AGENCY" shall mean the regulatory agency in a country
which perform the same or equivalent function as the FDA in the United States,
and any reference to a rule or requirement of the FDA herein shall if the
circumstances make it applicable refer to the equivalent rule or requirement of
any Regulatory Agency.
1.25 "SOFTWARE" means the software in executable code included in or
with the Drug Delivery System.
1.26 "SUPPLY AGREEMENT" means the supply agreement to be executed by
the parties contemporaneously with this Agreement, substantially in the form
attached hereto as Exhibit B.
1.27 "STOCK PURCHASE AGREEMENT" means that certain Stock Purchase
Agreement to be executed by and among the parties hereto, and dated as of the
same date as this Agreement, substantially in the form attached hereto as
Exhibit C.
1.28 "TERRITORY" means all countries of the world, except Canada.
1.29 "TERM" has the meaning set forth in Section 13.1.
1.30 "THIRD PARTY" means any entity other than Genetronics or Ethicon
or an Affiliate of Genetronics or Ethicon.
1.31 "TIER 1 EUROPEAN COUNTRIES" means France, the United Kingdom,
Germany and Italy.
1.32 "TRADEMARKS" means the trademarks included in or with the Drug
Delivery System.
1.33 "VALID CLAIM" means a claim of an issued patent included within
the Genetronics Patent Rights, which claim has not lapsed, been canceled or
become abandoned and has not been declared invalid or unenforceable by an
unreversed and unappealable decision or judgment of a court or other appropriate
body of competent jurisdiction, and which has not been admitted to be invalid or
unenforceable through reissue, disclaimer or otherwise.
ARTICLE 2
SCOPE OF DEVELOPMENT
2.1 OBJECTIVES. During the Term, Genetronics will have primary
responsibility for the activities described in Section 4.1, and Ethicon will
have primary responsibility for the activities described in Section 4.2.
2.2 LIMITATIONS ON DEVELOPMENT. Except as specifically provided
herein, all activities of the parties outside of this Agreement are outside of
the scope of this Agreement, and nothing herein is intended to limit Genetronics
or its Affiliates from using the Genetronics Technology and any Joint Patent
Rights or Ethicon or its Affiliates from using any Joint Patent Rights for other
purposes.
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2.3 DRUG DELIVERY SYSTEM.
(a) Except as permitted by Section 4.1(d), Genetronics agrees
that it shall not develop or commercially exploit the Drug Delivery System being
developed for or commercially exploited by Ethicon (an "Ethicon System").
Genetronics shall use commercially reasonable and diligent efforts to ensure
that Ethicon System will include means designed to render the Generator
non-functioning without the Applicator designed for the Ethicon System and vice
versa.
(b) Genetronics shall use commercially reasonable and diligent
efforts to ensure that other Drug Delivery Systems developed by it are not able
to be used for the detection, prevention and treatment of pre-cancer (except for
skin) or cancer; provided, however, that Genetronics may develop and
commercially exploit a Drug Delivery System for the detection, prevention and
treatment of basal cell skin pre-cancer and cancer, and squamous cell skin
pre-cancer and cancer if it (i) is substantially different in design and
operation from any Ethicon System, and (ii) provides less than acceptable
efficacy for the detection, prevention and treatment of other forms of
pre-cancer and cancer.
(c) Genetronics agrees if it enters into an agreement with an
Affiliate or Third Party concerning the subject matter of this Section 2.3, it
will require such Affiliate or Third Party to be made subject to the above
provision.
2.4 COMMERCIAL EXPLOITATION IS AT ETHICON'S DISCRETION. Except as
expressly provided hereunder, the marketing, sale or other commercial
exploitation (collectively, the "Commercial Exploitation") of the Drug Delivery
System in the Territory for use in the Field shall be exercised by Ethicon in
accordance with its own business judgment and in its sole and absolute
discretion. Accordingly, Genetronics acknowledges, understands and agrees
subject to the obligations of Ethicon in Article 6 hereof, as follows:
(a) Ethicon shall have complete control and sole discretion
with respect to the Commercial Exploitation of the Drug Delivery System in the
Territory for use in the Field and that this will have a material effect upon
the amount of any royalty payments that may be payable hereunder; and such
control and discretion over sales by Ethicon could negatively impact Genetronics
receipt of royalty payments;
(b) Ethicon has no duty to commercially exploit the Drug
Delivery System, to exert any level of efforts in commercially exploiting the
Drug Delivery System or to generate royalty payments;
(c) that whether or not Ethicon or any of its Affiliates
commercially exploit the Drug Delivery System, neither Ethicon nor any of its
Affiliates is prohibited from manufacturing, marketing or selling other products
that may compete with or reduce the Net Sales of Drug Delivery System hereunder;
(d) that personnel of Ethicon are only required to take
actions in connection with the Commercial Exploitation of the Drug Delivery
System in the
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Territory for use in the Field that such personnel believe to be in the best
interests of Ethicon and that they are not required to take into account the
interests of Genetronics at all; and
(e) not to challenge in any subsequent claim or action any
decision regarding the Commercial Exploitation of the Drug Delivery System in
the Territory for use in the Field made by any director, officer, employee or
individuals acting as agents of Ethicon or its Affiliates in what such
individual subjectively believes to be the best interests of Ethicon (or such
Affiliate), unless such action constitutes a material breach by Ethicon of any
of its obligations under this Agreement.
2.5 NO NAMING INDIVIDUALS. The parties agree that as between
themselves, the directors, officers, employees and individuals acting as agents
of or for any party to this Agreement shall not be named as parties to any suit
or arbitration proceeding brought in connection with the transactions
contemplated by this Agreement solely as a result of performing actions in their
capacity as an agent of or for a party to this Agreement.
ARTICLE 3
ADVISORY COMMITTEE
3.1 FORMATION. The activities of the parties under this Agreement
shall be managed by the Advisory Committee, which shall be comprised of three
representatives appointed by Genetronics and three representatives appointed by
Ethicon. Such representatives shall be senior members of management or
consultants from each of the parties. Either party may appoint substitute or
replacement members of the Advisory Committee to serve as their representatives
upon notice to the other party. The Advisory Committee shall have the
responsibility and authority to (a) coordinate and monitor the progress of this
Agreement, (b) encourage and facilitate communication and cooperation between
the parties in the performance of this Agreement, and (c) undertake such other
tasks and responsibilities as are set forth in this Agreement.
3.2 MEETINGS. The Advisory Committee shall meet at least once per
quarter or as it deems necessary at its discretion at locations and times to be
determined by the Advisory Committee, with the intent of meeting at alternating
locations in Somerville, New Jersey and San Diego, California, with each party
to bear all travel and related costs for its representatives. Each meeting shall
be chaired by a Advisory Committee member from the host party.
3.3 DECISION-MAKING PROCESS. Each member of the Advisory Committee
shall have one vote, and decisions by the Advisory Committee shall be made by a
majority vote. Any disagreement among members of the Advisory Committee shall be
resolved within the Advisory Committee based on the efficient achievement of the
objectives of this Agreement. Any disagreement which cannot be resolved by a
majority vote of the Advisory Committee shall be referred to the President of
each of Genetronics and Ethicon for resolution. It is the intent of the parties
to resolve issues through the Advisory Committee whenever possible and to refer
issues to the President
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of each of Genetronics and Ethicon only when resolution through the Advisory
Committee cannot be achieved. Any disagreement which cannot be resolved by the
President of each of Genetronics and Ethicon shall be resolved (a) by the
President of Ethicon if the disagreement involves issues within the Territory,
(b) by the President of Genetronics if the disagreement involves issues outside
the Territory (i.e., within Canada).
3.4 DEVELOPMENT PROGRAM. The Advisory Committee shall have executive
authority with respect to decisions on the "Development Program". The
Development Program shall be the program under which the parties manage the
development of the Drug Delivery System under this Agreement. The Advisory
Committee's role shall include supervising and managing the expenditure of funds
for research and development in accordance with Section 4.1, evaluating and
determining which products to develop. In addition, by unanimous consent only,
the Advisory Committee is responsible for reviewing (and if necessary revising)
the milestones in Section 6.2 and approving any new milestones as part of the
Development Program. The tie-breaker provisions of Section 3.3 shall not apply
to any revision of the existing milestones or to the addition of new milestones.
Genetronics shall develop and propose to the Advisory Committee annual budgets
for the Development Program for its review and consent.
3.5 PATENT STRATEGY. The Advisory Committee shall be responsible for
managing and reviewing the patent strategy in the Territory for use of the Drug
Delivery System in the Field (the "Patent Strategy"). The Patent Strategy shall
include, but not be limited to, deciding on the question of inventorship of any
inventions arising under this Agreement, agreeing on the desired scope of patent
protection to be secured by Genetronics, agreeing on the desired scope of patent
protection to be secured for Joint Inventions, and recording and advising the
parties on all patents secured in furtherance of hereunder. Genetronics shall
develop and propose to the Advisory Committee annual budgets for the Patent
Strategy for its review and consent.
3.6 CLINICAL/REGULATORY PROGRAM. The initial program will be proposed
by Genetronics. The Advisory Committee shall be responsible for managing and
reviewing the clinical and regulatory program in the Territory for use of the
Drug Delivery System in the Field (the "Clinical/Regulatory Program"). The
Clinical/Regulatory Program shall be the regulatory strategy which is adopted as
the Clinical/Regulatory Program by the Advisory Committee, subject to approval
by Ethicon. Such program is to be in writing and to be continually reviewed and
revised as necessary by the Advisory Committee, subject to approval by Ethicon.
Within 90 days of the Effective Date, the Advisory Committee shall prepare and
submit to Ethicon for its approval a strategy for the initial
Clinical/Regulatory Program for a period (to be designated by the Advisory
Committee) following the Effective Date, including a budget of clinical costs
for such period. With respect to the Clinical/Regulatory Program, Ethicon shall
have review and approval rights for all significant correspondence and filings
received from or made to any governmental entity.
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ARTICLE 4
DEVELOPMENT AND COMMERCIALIZATION ACTIVITIES
4.1 GENETRONICS CONTRIBUTIONS.
(a) SALES AND MARKETING. For the purposes of clarification
only, the parties acknowledge that Genetronics will sell, contract, distribute,
enter orders, invoice, collect, and market the Drug Delivery System (being sold
by Ethicon in the Territory for use in the Field) in Canada for use in the
Field. In Canada, Genetronics will be responsible for warranties and returns of
the Drug Delivery System and will provide the necessary staffing and inventory
to ensure a reasonable turnaround time for any defective part or all of the Drug
Delivery System
(b) CLINICAL TRIALS. Subject to Section 4.1(c) below and the
Clinical/Regulatory Program, the parties agree that Genetronics will conduct and
own the regulatory filings, at its sole cost, of all clinical trials (i) of the
Drug Delivery System in Canada, (ii) for the Head and Neck indication in the
United States, and (iii) any clinical trial commenced by Genetronics prior to
the Effective Date. Except as set forth above and subject to Section 4.1(c)
below and the Clinical/Regulatory Program, the parties agree that Genetronics
will conduct (but Ethicon will own the regulatory filings of) all clinical
trials of the Drug Delivery System in the Territory for those indications in the
Field selected by the Advisory Committee.
(c) REGULATORY.
(i) Genetronics presently has an application to obtain
the CE ▇▇▇▇ for the Drug Delivery System in the European Union. Genetronics
shall continue to maintain at its sole cost the CE ▇▇▇▇ to the extent Ethicon
wishes it reasonably to do so; provided, however, at any time after the
Effective Date, upon the written request of Ethicon, Genetronics shall promptly
assign and deliver the CE ▇▇▇▇, along with any and all supporting documentation
and other related information to Ethicon. Upon receipt of the filings from
Genetronics, Ethicon shall assume all ongoing costs associated therewith.
(ii) Genetronics presently has an approved
investigational new drug application ("IND") with the FDA. Any additional
indications filed with the FDA by Genetronics, shall be filed in Ethicon's name
and shall be at Ethicon's sole cost if filed pursuant to the Clinical/Regulatory
Program. Genetronics shall continue to maintain at its sole cost the current
filings before the FDA and Regulatory Agencies to the extent Ethicon wishes it
reasonably to do so; provided, however, that at any time after the Effective
Date, upon the written request of Ethicon, Genetronics shall within 120 days
after receipt of such request, assign and deliver the IND, NDA and all filings,
along with any and all supporting documentation and other related information to
Ethicon. Upon receipt of the filings from Genetronics, Ethicon shall assume all
ongoing regulatory costs associated therewith. Genetronics shall provide Ethicon
for its use in obtaining regulatory approvals with copies of all data, results
and related information from clinical trials and all regulatory filings and
related information in the territory (including the right
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to reference Genetronics IND or NDA in regulatory filings), all of the
information shall be considered Confidential Information of Genetronics.
(iii) Genetronics shall provide Ethicon for its use in
obtaining regulatory approvals with copies of all data, results and related
information from clinical trials and all regulatory filings and related
information (including the right to reference Genetronics regulatory filings),
all of the information shall be considered Confidential Information of
Genetronics (as defined in Article 15).
(d) CANADA. For purposes of clarification only, the parties
acknowledge that Genetronics will conduct all clinical trials of the Drug
Delivery System in Canada for those indications in the Field selected by
Genetronics, in its sole discretion and at its own expense. Genetronics will
consult with Ethicon on all clinical trials of the Drug Delivery System in
Canada for use in the Field and will provide Ethicon for its use with copies of
all data, results and related information from such clinical trials; provided,
however, that Genetronics and Ethicon will consult on all such clinical trials
related to Bleomycin and other generic drugs. Genetronics will be responsible
for regulatory filings and approvals in Canada for use of the Drug Delivery
System in the Field. Genetronics shall secure, at its own expense, any and all
licenses, permits approvals and other authorizations (collectively, "Regulatory
Approvals") required to commercialize the Drug Delivery System in Canada for use
in the Field. Genetronics shall own and maintain all such Regulatory Approvals
and related information and shall disclose such information to Ethicon for its
use in accordance with this Agreement and the license granted hereunder and in
the Supply Agreement, and to the extent necessary for Ethicon to perform its
obligations under this Agreement. Such Regulatory Approvals and related
information (including, without limitation, any and all reference rights related
thereto) shall be considered Confidential Information of Genetronics (as defined
in Article 15).
(e) CROSS-BORDER SALES. The parties agree not to resell the
Drug Delivery System into each other's territory. The parties agree with respect
to any distributor (or equivalent) of the Drug Delivery System it may engage,
that in the event a party receives written evidence from any source that the
Drug Delivery System (or any component thereof) previously transferred to such
distributor was resold by such distributor into the territory of the other party
on at least three occasions, then the party receiving the evidence shall take
appropriate steps to ensure such reselling does not occur in the future. The
party who has engaged such distributor shall promptly discuss the steps that are
being taken with the other party to ensure that such reselling will not reoccur.
Genetronics further agrees to include a provision in any distribution or similar
agreement it enters into during the Term to enable it to take such action.
(f) RESEARCH AND DEVELOPMENT. Genetronics shall dedicate
[...***...] of its gross revenues per year, if any, with respect to sales of the
Drug Delivery System for use in the Field, but in no event less than [...***...]
per year (hereinafter, "Research Funds"), to fund research and development
activities related to the Drug Delivery System in the Field as decided by the
Advisor Committee under Article 3 (provided that, the Advisory Committee may
agree to spend less than the total amount of Research
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Funds available in any year); the Research Funds also may be used for research
and development outside the Field if agreed to by unanimous consent of the
Advisory Committee.
(g) MANUFACTURING; TOOLING. Genetronics will have the
exclusive right to manufacture the Drug Delivery System for Ethicon pursuant to
the Supply Agreement (until there is a Failure to Supply as provided in Article
7 of the Supply Agreement); provided, however, that Ethicon shall have approval
rights with respect to the Market Requirements (as defined in the Supply
Agreement), any Third Party manufacturer and the material suppliers with respect
to the Drug Delivery System. Genetronics shall own all tooling; provided,
however, that in the event of a Failure to Supply as defined in the Supply
Agreement, Genetronics shall be required to transfer ownership of all tooling to
Ethicon. The parties shall share equally all Tooling Costs for the Applicator up
to [...***...] in the first year and up to [...***...] in each year thereafter.
Ethicon shall pay for all tooling costs for the Applicator in excess of
[...***...] in the first year and [...***...] in each year thereafter. Tooling
Costs means the direct costs for dies and molds.
4.2 ETHICON CONTRIBUTIONS. Subject to Section 2.4:
(a) SALES AND MARKETING. Ethicon will sell, contract,
distribute, enter orders, invoice, collect, and market the Drug Delivery System
in the Territory for use in the Field.
(b) CLINICAL TRIALS. As of the Effective Date, but subject to
its approval of the Clinical/Regulatory Program (including the proposed budget
for clinical trials), Ethicon shall assume all clinical costs associated with
the Clinical/Regulatory Program other than those costs with respect to the head
and neck indication. Ethicon will consult with Genetronics in an effort to
assist Genetronics with the clinical trials of the Drug Delivery System
conducted pursuant to this Agreement.
(c) REGULATORY. The parties agree that Ethicon will be
responsible for filing for regulatory approval and funding clinical studies in
the Territory except for head and neck indications in the United States and the
application for CE ▇▇▇▇ in Europe as described in Section 4.1. Ethicon shall
provide Genetronics for its use under Section 4.1(d) in obtaining regulatory
approvals with copies of all data, results and related information from clinical
trials in the Territory and all regulatory filings and related information in
the territory, all of the information shall be considered Confidential
Information of Ethicon (as defined in Article 15).
4.3 COMMERCIALLY REASONABLE AND DILIGENT EFFORTS. Each party shall
use commercially reasonable and diligent efforts to perform its responsibilities
under this Agreement. As used herein, the term "commercially reasonable and
diligent efforts" means, unless the parties agree otherwise, those efforts
consistent with the exercise of prudent scientific and business judgment, as
applied to other products of similar scientific and commercial potential within
the relevant product lines of the parties.
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4.4 AVAILABILITY OF RESOURCES. Each party shall maintain
laboratories, offices and all other facilities reasonably necessary to carry out
the activities to be performed by such party under this Agreement.
4.5 DISCLOSURE; REPORTS. Genetronics shall make available and
disclose to Ethicon promptly after the Effective Date all Genetronics Know-How
to the extent necessary for Ethicon to perform its obligations under this
Agreement. The parties shall exchange, at a minimum, quarterly written reports
(with copies to the Advisory Committee) presenting a meaningful summary of the
activities performed by such party under this Agreement. In addition, on
reasonable request by a party, the other party shall make presentations of its
activities under this Agreement.
ARTICLE 5
GRANT OF LICENSES
5.1 LICENSE TO DRUG DELIVERY SYSTEM. Subject to the terms and
conditions of this Agreement and during the Term, Genetronics hereby grants to
Ethicon an exclusive license, including the right to grant sublicenses pursuant
to Section 5.2, under the Genetronics Technology to use, offer for sale, sell
and import the Drug Delivery System in the Territory for use in the Field, and
an exclusive license to use and distribute the Software and Trademarks in the
Territory for use in the Field.
5.2 SUBLICENSES. Except as expressly provided hereunder or in the
Supply Agreement, Ethicon may sublicense any rights or obligations hereunder
without the prior written consent of Genetronics; provided, however, that
Ethicon may not sublicense its rights and obligations hereunder to a sublicensee
who is a direct competitor of Genetronics in the field of Electroporation
without Genetronics' prior written consent. Ethicon shall notify any sublicensee
hereunder of all rights and obligations of Ethicon under this Agreement which
are sublicensed to such sublicensee. Ethicon shall remain primarily liable under
this Agreement irrespective of any sublicense granted hereunder.
5.3 RIGHT OF FIRST NEGOTIATION. Genetronics shall provide Ethicon (a)
written notice of its intention to license a Drug Delivery System for either
dermatological and/or cardiovascular applications (except Gene Therapy
applications), and (b) a functional prototype of such Drug Delivery System which
demonstrates relevant pre-clinical efficacy. During the 120-day period following
receipt of such written notice and prototype Drug Delivery System from
Genetronics, Ethicon shall have the first right to negotiate a license to the
Drug Delivery System for either dermatological and/or cardiovascular
applications, as applicable, upon commercially reasonable terms mutually
acceptable to the parties. In the event the parties are unable to reach
agreement on the terms of such a license within such 120-day period, Genetronics
shall have no further obligation to Ethicon under this Section 5.3.
12.
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5.4 RIGHT OF FIRST REVIEW. Except in respect of relationships in
existence as of the Effective Date, Genetronics shall provide Ethicon (a)
written notice of its intention to license a Drug Delivery System for Gene
Therapy applications, and (b) a functional prototype of such Drug Delivery
System which demonstrates relevant pre-clinical efficacy, prior to approaching a
Third Party to license such Drug Delivery System for Gene Therapy applications.
Genetronics shall discuss with Ethicon a possible development and license
agreement to use such Drug Delivery System for Gene Therapy applications, but is
under no obligation to enter into any such agreement with Ethicon. After
providing such written notice and prototype Drug Delivery System to Ethicon,
Genetronics shall have no further obligation to Ethicon under this Section 5.4.
5.5 IMPROVEMENTS. During the Term, Ethicon hereby grants Genetronics
an non-exclusive, royalty-free license to use and practice any Ethicon
Improvements within the Field solely in Canada that are incorporated into the
Drug Delivery System being sold by Ethicon. Ethicon shall notify Genetronics
within a reasonable period of time of any such Ethicon Improvements.
ARTICLE 6
PAYMENT OBLIGATIONS
6.1 LICENSE FEE. In partial consideration of the license granted to
Ethicon by Genetronics under Section 5.1, Ethicon shall pay to Genetronics a
one-time, non-refundable fee of $4,000,000 within seven (7) days of the
Effective Date.
6.2 MILESTONES. The party that first becomes aware of the achievement
of any milestone hereunder shall provide the other party written notice of any
milestone achieved hereunder within 10 days of achievement of such milestone.
Within 30 days after achievement of each of the following milestones, Ethicon
shall pay to Genetronics the non-refundable milestone payment set forth below:
(a) RESEARCH AND DEVELOPMENT.
(i) $500,000 upon receipt of CE certification of ISO
9001 by a notified body, provided that such payment
shall be reduced by $100,000 per month on a
pro-rata daily basis following March 31, 1999;
(ii) [...***...] upon completion of a [...***...] with
respect to the Drug Delivery System for the
[...***...] or upon waiver of such [...***...];
(iii) [...***...] upon the issuance of patents
corresponding to [...***...] in the United States,
Europe and Japan; and
13. *CONFIDENTIAL TREATMENT REQUESTED
14
(iv) [...***...] upon the issuance of patents
corresponding to U.S. Patent Application Serial
Number [...***...] in the United States, Europe and
Japan.
(b) DEVELOPMENT OF DEEP SEATED PROBE.
(i) [...***...] upon agreement by the parties of the
[...***...] of the Deep Seated Probe;
(ii) [...***...] upon [...***...] of a prototype Drug
Development System for use in the Field which meets
the agreed upon [...***...];
(iii) [...***...] upon [...***...] for the first agreed
upon indication by the Advisory Committee;
(iv) [...***...] upon [...***...] by [...***...] of the
Deep Seated Probe; and
(v) [...***...] upon production of the [...***...] of
the Deep Seated probe which meets the agreed upon
product specifications.
(c) SALES AND MARKETING.
(i) [...***...] upon the First Commercial Sale of the
Drug Delivery System in [...***...];
(ii) [...***...] upon the First Commercial Sale of the
Drug Delivery System in [...***...];
(iii) [...***...] upon achievement of cumulative Net
Sales (cumulative sales of the Applicator and the
Generator) in excess of [...***...] within
[...***...]; and
(iv) [...***...] upon achievement of cumulative Net
Sales (cumulative sales of the Applicator and the
Generator) in excess of [...***...] [...***...].
(d) HEAD AND NECK CANCER.
(i) [...***...] upon [...***...] for an agreed upon
indication for head and neck cancer (the parties
agreeing to work together with [...***...] to
formulate such indication); provided that such
payment shall be reduced by [...***...] on a
pro-rata [...***...] basis following [...***...];
and
*CONFIDENTIAL TREATMENT REQUESTED
14.
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(ii) [...***...] upon the successful completion of a
[...***...] study using the Drug Delivery System;
with [...***...] paid upon the achievement of the
results set forth in each of Sections
6.2(d)(iii)(3)(a), (b) or (c) below. The payment
shall be reduced by [...***...] per month on a
pro-rata [...***...] basis following [...***...].
The study will be a [...***...]. A summary of these
studies is attached hereto as Exhibit D.
(iii) Successful completion of a [...***...] shall mean
(1) completion of the planned study with:
(a) a statistically significant number of
patients with [...***...] who have completed Electroporation therapy; and
(b) an appropriate control group of
patients (if required by the regulatory agency);
(2) completion of the data analysis and medical
regulatory report writing in sufficient detail to allow for peer review by the
medical community, and
(3) the study will confirm that in patients with
[...***...]:
(a) [...***...] of patients who have
tumors completely treated by Electroporation therapy will have [...***...] at
the treatment site (i.e. [...***...];
(b) [...***...] of patients who have a
complete response at the treatment site will have [...***...] at that site for
the earlier of [...***...] or the duration of their life; and
(c) [...***...] of patients who have
[...***...] at the end of their therapy will survive [...***...] from the last
treatment of Electroporation therapy.
(e) QUALITY OF LIFE
(i) [...***...] upon [...***...] of a [...***...]
quality of life study on a statistically significant head and neck cancer
patient pool, which demonstrates such cancer patients who have undergone
Electroporation therapy using the Product (as defined in the Supply Agreement)
have [...***...] in such [...***...] quality of life study and [...***...] as
compared to alternative conventional therapy for recurrent head and neck cancer
patients. Electroporation therapy need not be a curative means for this study.
*CONFIDENTIAL TREATMENT REQUESTED
15.
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(ii) [...***...] upon [...***...] of a [...***...]
quality of life study on a statistically significant patient pool for a cancer
indication (other than head and neck) approved by the Advisory Committee, which
demonstrates such cancer patients who have undergone Electroporation therapy
using the Product (as defined in the Supply Agreement) have [...***...] in such
[...***...] quality of life study and [...***...] as compared to alternative
conventional therapy for similar patients with the same type of cancer (such
indication for Electroporation cancer therapy being different from 6.2(e)(i) and
6.2(e)(iii)). Electroporation therapy need not be a curative means for this
study.
(iii) [...***...] upon [...***...] of a [...***...]
quality of life study on a statistically significant patient pool for a cancer
indication (other than head and neck or the indication approved in paragraph
(ii) above) approved by the Advisory Committee, which demonstrates such cancer
patients who have undergone Electroporation therapy using the Product (as
defined in the Supply Agreement) have [...***...] in such [...***...] quality of
life study and [...***...] as compared to alternative conventional therapy for
similar patients with the same type of cancer (such indication for
Electroporation cancer therapy being different from 6.2(e)(i) and 6.2(e)(ii)).
Electroporation therapy need not be a curative means for this study.
6.3 PAYMENTS OBLIGATIONS.
(a) During the Term, Ethicon shall pay to Genetronics
[...***...] of Net Sales.
(b) No multiple or stacked royalties shall be due on the Drug
Delivery System if the Drug Delivery System is within the scope of more than one
Valid Claim or more than one patent licensed under this Agreement.
6.4 ETHICON OBLIGATIONS.
(a) Ethicon will launch the Drug Delivery System in one or
more of the Tier 1 European Countries for use in the Field within [...***...]
following the satisfaction by Genetronics at its sole cost and expense of the
following: (i) CE Certification of the Drug Delivery System, (ii) be capable of
supplying commercial quantities of the Drug Delivery System reasonably
acceptable to Ethicon in accordance with the Supply Agreement, (iii) completion
of the current French clinical trials EPT-04, EPT-06, and EPT-07, and (iv)
provided that the Drug Delivery System complies with the mutually agreed upon
Specifications set forth in the Supply Agreement. In the event Ethicon fails to
launch the Drug Delivery System in the Tier 1 European Countries within such
[...***...] period, Ethicon shall pay to Genetronics (1) for the first
[...***...] delay, on a month by month basis, a payment equal to [...***...] of
Net Sales assuming the most current agreed upon production forecast for the Drug
Delivery System for the next month was sold in the Tier 1 European Countries,
thereafter (2) for the next [...***...] months of delay, on a month by month
basis, a payment equal to [...***...] of Net Sales assuming the most current
agreed upon production forecast for the Drug Delivery System for the next month
was sold in the Tier 1 European Countries; thereafter, the license granted
hereunder shall be converted to a non-exclusive license and Ethicon shall pay
based on actual sales as provided in paragraph 6.3. Notwithstanding the
foregoing, if the manufacture, use or
*CONFIDENTIAL TREATMENT REQUESTED
16.
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sale of the Drug Delivery System [...***...] an [...***...] in the applicable
[...***...], the [...***...] in such [...***...] shall be [...***...], at its
[...***...].
(b) Ethicon will launch the Drug Delivery System in the United
States for use in the Field within [...***...] following the satisfaction by
Genetronics at its sole cost and expense of the following for the U.S.: (i) FDA
approval to use the Drug Delivery System for such indication and, (ii) be
capable of supplying commercial quantities of the Generator reasonably
acceptable to Ethicon in accordance with the Supply Agreement; and (iii)
provided that the Drug Delivery System complies with the mutually agreed upon
Specifications set forth in the Supply Agreement. In the event Ethicon fails to
launch the Drug Delivery System in the United States within such [...***...]
period, Ethicon shall pay to Genetronics (1) for the first [...***...] delay, on
a month by month basis, a payment equal to [...***...] of Net Sales assuming the
most current agreed upon production forecast for the Drug Delivery System for
the next month was sold in the United States; thereafter, (2) for the next
[...***...] of delay, on a month by month basis, a payment equal to [...***...]
of Net Sales assuming the most current agreed upon production forecast for the
Drug Delivery System for the next month was sold in the United States thereafter
the license granted hereunder shall be converted to a non-exclusive license and
Ethicon shall pay based on actual sales as provided in paragraph 6.3.
Notwithstanding the foregoing, if the [...***...] of the Drug Delivery System
[...***...] an [...***...] in the [...***...], the [...***...] in the
[...***...] shall be [...***...], at [...***...].
6.5 CNRS AND IGR LICENSE. The parties agree that if Ethicon (which
for the purpose of this paragraph shall also include its affiliate Ethnor)
should decide in its sole discretion to exercise its option with the LeCentre
National De La Recherche Scientifique ("CNRS") and L'Institut ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
("IGR") to license French Patent No. 93 03688 and its corresponding counterparts
(the "French Patent"), then Ethicon will notify Genetronics in writing promptly
following the exercise of the option. Ethicon shall be responsible for paying
the sums required to exercise the option in the expanded territory [...***...]
and the yearly lump sum required until the first commercial sale in the expanded
territory [...***...] and one half of the sum due upon the launch of a product
in the expanded territory [...***...]. Genetronics agrees to pay half the sum
due upon the launch of a product in the expanded territory [...***...]. In the
event of and for so long as Ethicon is obligated under the agreement with the
CNRS and IGR to pay fees for the license of the French Patent, Genetronics
agrees to permit Ethicon to deduct from the amounts due Genetronics under the
Supply Agreement, on a country by country basis:
*CONFIDENTIAL TREATMENT REQUESTED
17.
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(a) [...***...] of the Purchase Price (as defined in the
Supply Agreement) in countries where the French Patent has been filed and
remains in full force and effect, or
(b) [...***...] of the Purchase Price (as defined in the
Supply Agreement) in countries where no patent has been filed or in which the
French Patent has expired or been forfeited;
provided, however, that in no event will Ethicon be allowed to deduct from any
amount due Genetronics under the Supply Agreement more than the royalty due to
the CNRS and IGR. Since the minimum royalty due under the agreement with the
CNRS and IGR has not been negotiated, Ethicon and Genetronics agree to meet and
negotiate in good faith to determine what, if any, minimum royalty to offer to
the CNRS and IGR. Ethicon shall initiate discussions with the CNRS and IGR or
their representatives to reach agreement on such minimum royalty. Genetronics at
its sole discretion may attend and participate in such discussions. Ethicon
shall use reasonable commercial efforts to convince the CNRS and IGR or their
representative that the minimum royalty determined to be reasonable by Ethicon
and Genetronics is appropriate. If Ethicon is unable to convince the CNRS and
IGR that such minimum royalty is reasonable, Ethicon and Genetronics shall
negotiate in good faith to determine an appropriate course of action.
ARTICLE 7
PAYMENTS; RECORDS; AUDITS
7.1 PAYMENT; REPORTS. Royalty payments shall be calculated and
reported for each fiscal quarter of Ethicon. All royalty payments due to
Genetronics under this Agreement shall be paid within 45 days of the end of each
fiscal quarter, unless otherwise specifically provided herein. Each payment of
royalties shall be accompanied by a report in sufficient detail to permit
confirmation of the accuracy of the royalty payment made, including, without
limitation, Net Sales, the royalties payable in United States dollars, the
method used to calculate the royalty and the exchange rates used.
7.2 EXCHANGE RATE; MANNER AND PLACE OF PAYMENT. All payments
hereunder shall be payable in United States dollars. With respect to each
quarter, for countries other than the United States, whenever conversion of
payments from any foreign currency shall be required, such conversion shall be
made at the rate of exchange reported in The Wall Street Journal on the last
business day of the applicable reporting period. All payments owed under this
Agreement shall be made by wire transfer to a bank account designated by
Genetronics, unless otherwise specified in writing by Genetronics.
7.3 LATE PAYMENTS. In the event that any payment, including royalty
payments, due hereunder is not made when due, the payment shall accrue interest
from that date due at the rate of 1.5% per month; provided however, that in no
event shall such rate exceed the maximum legal annual interest rate. The payment
of such interest shall not limit Genetronics from exercising any other rights it
may have as a consequence of the lateness of any payment.
18. *CONFIDENTIAL TREATMENT REQUESTED
19
7.4 RECORDS AND AUDITS. During the Term, and for a period of one year
thereafter, Ethicon shall keep complete and accurate records in sufficient
detail to permit Genetronics to confirm the accuracy of all payments due
hereunder. Genetronics shall have the right to cause an independent, certified
public accountant reasonably acceptable to Ethicon to audit such records to
confirm royalty payments for the preceding year. Such audits may be exercised
during normal business hours no more than once in any 12-month period upon at
least 30 days' prior written notice to Ethicon. Genetronics shall bear the full
cost of such audit unless such audit discloses an underpayment by more than 5%
of the amount due under this Agreement. In such case, Ethicon shall bear the
full cost of such audit. In all events, Ethicon shall pay any underpayment with
interest in accordance with Section 7.3. Any dispute regarding any payments due
hereunder shall be subject to the dispute resolution procedures set forth in
Article 15.
7.5 TAXES. All taxes levied on account of the royalties and other
payments accruing to Genetronics under this Agreement shall be paid by
Genetronics for its own account, including taxes levied thereon as income to
Genetronics. If provision is made in law or regulation for withholding, such tax
shall be deducted from the royalty or other payment made by Ethicon to the
proper taxing authority and a receipt of payment of the tax secured and promptly
delivered to Genetronics. Each party agrees to assist the other party in
claiming exemption from such deductions or withholdings under any double
taxation or similar agreement or treaty from time to time in force.
7.6 PROHIBITED PAYMENTS. Notwithstanding any other provision of this
Agreement, if Ethicon is prevented from paying any such royalty by virtue of the
statutes, laws, codes or governmental regulations of the country from which the
payment is to be made, then such royalty may be paid by depositing funds in the
currency in which accrued to Genetronics' account in a bank acceptable to
Genetronics in the country whose currency is involved.
ARTICLE 8
TRADEMARKS
All uses by Ethicon of Genetronics' name, or any trademark, service ▇▇▇▇
or tradename (or any ▇▇▇▇ or name closely resembling the same), now or hereafter
owned or licensed by Genetronics or any of its Affiliates shall be subject to
the prior written consent of Genetronics. Ethicon is not authorized to use
Genetronics' name or any such trademark, service ▇▇▇▇ or tradename in connection
with any aspect of its business, other than in connection with the sales,
marketing, promotion and distribution of the Drug Delivery System in accordance
with the terms of this Agreement and the Supply Agreement. Ethicon (a) shall not
use any trademark, service ▇▇▇▇ or trade name of Genetronics as part of its
name, and (b) shall not do or permit any act to be done at any time which may in
any way impair the rights of Genetronics in any such trademark, service ▇▇▇▇ or
trade name. All uses of any trademark, service ▇▇▇▇ or trade name of Genetronics
shall inure to the benefit of Genetronics. Ethicon shall not
19.
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adopt, use or attempt to register any trademark, service ▇▇▇▇ or trade name
which is confusingly similar to any trademark, service ▇▇▇▇ or trade name of
Genetronics.
ARTICLE 9
INDEMNIFICATION
In order to distribute among themselves the responsibility for claims
arising out of this Agreement, and except as otherwise specifically provided for
herein, the parties agree as follows:
(a) Genetronics agrees to defend and indemnify and hold Ethicon
harmless against any and all claims, suits, proceedings, expenses, recoveries
and damages (including, but not limited to, any expenses incurred in connection
with any recall of the Drug Delivery System), including court costs and
reasonable attorneys fees and expenses, arising out of, based on, or caused by
(i) any product liability claim related to alleged defects in materials, design,
construction or workmanship of the Drug Delivery System in the form supplied to
Ethicon by Genetronics hereunder, (ii) in connection with the Drug Delivery
System manufactured by Ethicon, product liability claims related to alleged
defects in design of the Drug Delivery System to the extent designed by
Genetronics, (iii) the breach by Genetronics of any representation or warranty
contained in this Agreement, or (iv) clinical trials performed by Genetronics in
each case except to the extent that such claims, suits, proceedings, expenses,
recoveries or damages arise from or are aggravated by acts of or failure to act
by Ethicon. Ethicon will promptly notify Genetronics of any such claim or demand
which comes to its attention.
(b) Ethicon agrees to defend and indemnify and hold Genetronics
harmless against any and all claims, suits, proceedings, expenses, recoveries,
and damages including court costs and reasonable attorneys fees and expenses, in
connection with the Drug Delivery System sold by Ethicon or its Affiliates
arising out of, based on, or caused by (i) statements, whether written or oral,
made or alleged to be made by Ethicon or its Affiliates on the packaging or
labeling of the Drug Delivery System, or in the advertising, publicity,
promotion, or sale of the Drug Delivery System, (ii) the storage, sale,
shipment, promotion or distribution of the Drug Delivery System by Ethicon or
its Affiliates, (iii) the breach by Ethicon of any representation or warranty
contained in this Agreement, or (iv) any product liability claim related to
alleged defects in materials, design (unless designed by Genetronics),
construction or workmanship of the Drug Delivery System manufactured by or for
Ethicon hereunder by a party other than Genetronics or its Affiliates, in each
case except to the extent that such claims, suits, proceedings, expenses,
recoveries or damages arise from or are aggravated by acts of or failure to act
by Genetronics. Genetronics will promptly notify Ethicon of any such claim or
demand which comes to its attention.
ARTICLE 10
PATENT RIGHTS AND INFRINGEMENT
20.
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ARTICLE 1
10.1 OWNERSHIP OF PATENT RIGHTS. Ownership of inventions conceived of
or reduced to practice in the course of the Collaboration shall be determined in
accordance with the rules of inventorship under United States patent law.
Ethicon shall own all inventions conceived of and reduced to practice solely by
its employees and agents, and all patent applications and patents claiming such
inventions. Genetronics shall own all Genetronics Technology and all inventions
conceived of and reduced to practice solely by its employees and agents, and all
patent applications and patents claiming such inventions. All inventions
conceived of and reduced to practice jointly by employees or agents of
Genetronics and employees or agents of Ethicon, and all Joint Patent Rights
shall be owned jointly by Genetronics and Ethicon.
10.2 PROSECUTION AND MAINTENANCE OF PATENT RIGHTS.
(a) Subject to commercially appropriate and reasonable efforts
(subject to oversight by the Advisory Committee), Genetronics shall at its own
expense and by counsel of its own choice, file, prosecute and maintain all
patent applications and patents within the Genetronics Patent Rights and any
inventions conceived of and reduced to practice solely by its employees and
agents hereunder. Genetronics shall do everything commercially appropriate and
reasonable (subject to oversight by the Advisory Committee), including without
limitation filing all documents and paying all fees to the appropriate patent
offices to maintain the patents and pending patent applications in effect.
Genetronics agrees to promptly provide Ethicon with copies of all correspondence
to and from the patent offices related to the pending patent applications within
the Genetronics Patent Rights. Ethicon shall have the right to provide comments
to Genetronics regarding the content of such correspondence, and to comment
thereon. Genetronics shall consider all such comments offered by Ethicon;
provided, that all final decisions with respect to such prosecution shall rest
solely in the discretion of Genetronics. In the event that Genetronics desires
to abandon any such patent application or patent within the Genetronics Patent
Rights, or if Genetronics later declines to prosecute or maintain any such
patent application or patent, Genetronics shall provide reasonable prior written
notice to Ethicon of such intention and Ethicon shall have the right, but not
the obligation at its own expense, to file, prosecute, and maintain such patent
application or patent, which Genetronics shall assign to Ethicon and shall no
longer be subject to the terms of this Agreement.
(b) The Advisory Committee shall determine which party shall be
responsible for the filing, prosecution and maintenance of patent applications
and patents within the Joint Patent Rights on a case by case basis, with the
understanding that it is the parties' intent that Genetronics shall be initially
responsible for the filing, prosecution and maintenance of patent applications
and patents within the Joint Patent Rights related to the Drug Delivery System.
In the event that a party responsible for the filing, prosecution and
maintenance of any patent application or patent within the Joint Patent Rights
desires to abandon such patent application or patent, or if such party later
declines responsibility for such patent application or patent, such party shall
provide reasonable prior written notice to the other party of its intention to
abandon or decline responsibility, and the other party shall have the right, but
not the obligation, to prepare, file, prosecute, and maintain any such patent
application or patent within the Joint
21.
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Patent Rights. The parties shall share equally the costs of filing, prosecuting
and maintaining patents or patent applications within the Joint Patent Rights.
10.3 COOPERATION OF THE PARTIES. Each party agrees to cooperate fully
in the preparation, filing, and prosecution of any Joint Patent Rights under
this Agreement. Such cooperation includes, but is not limited to:
(a) executing all papers and instruments, or requiring its
employees or agents, to execute such papers and instruments, so as to effectuate
the ownership of Joint Patent Rights set forth in Section 10.1 and to enable the
other party to apply for and to prosecute joint patent applications in any
country; and
(b) promptly informing the other party of any matters coming
to such party's attention that may affect the preparation, filing, or
prosecution of any such joint patent applications.
10.4 INFRINGEMENT OF THIRD PARTY RIGHTS. Genetronics and Ethicon shall
promptly notify the other in writing of any allegation by a Third Party that the
activity of either of the parties in connection with this Agreement infringes or
may infringe the intellectual property rights of such Third Party. Genetronics
shall have the right to control the defense of any claims with respect to the
Genetronics Technology, at its own expense and by counsel of its own choice, and
Ethicon shall have the right to be represented in any such action, at its own
expense and by counsel of its own choice. In the event that such matter includes
claims with respect to the Joint Patent Rights, the party responsible for
prosecution and maintenance of the applicable Joint Patent Rights under Section
10.2(b) shall have the right to control the defense of such claims by counsel of
its own choice and the parties shall share equally the costs with respect
thereto. If Genetronics fails to proceed in a timely fashion with regard to the
defense of any claims with respect to the Genetronics Technology, Ethicon shall
have the right to control any such defense of such claim at its own expense and
by counsel of its own choice, and Genetronics shall have the right to be
represented in any such action, at its own expense and by counsel of its own
choice. Neither party shall have the right to settle any patent infringement
litigation under this Section 10.4 in a manner that diminishes the rights or
interests of the other party or obligates the other party to make any payment or
take any action without the consent of such other party.
If as a result of the manufacture, use or sale of the Drug Delivery
System in any country of the Territory, Genetronics or Ethicon or any Affiliate
of either of them is sued for patent infringement or threatened with such a
lawsuit or other actions by a Third Party, Genetronics and Ethicon shall meet to
analyze the infringement claim and avoidance of same. If it is necessary to
obtain a license from such Third Party, Genetronics and Ethicon in negotiating
such a license shall make every effort to minimize the license fees and/or
royalty payable to such Third Party. If Ethicon shall be obligated to pay a
license fee, royalty or both, then Genetronics shall elect within ten (10) days
of the execution of the license with such Third Party to
22.
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[...***...].
10.5 INFRINGEMENT BY THIRD PARTIES. Genetronics and Ethicon shall
promptly notify the other in writing of any alleged or threatened infringement
of any patent included in the Genetronics Patent Rights or the Joint Patent
Rights of which they become aware. Both parties shall cooperate with each other
to terminate such infringement without litigation. Genetronics shall have the
right to bring and control any action or proceeding with respect to infringement
of any patent included in the Genetronics Patent Rights, at its own expense and
by counsel of its own choice, and Ethicon shall have the right to be represented
in any such action, at its own expense and by counsel of its own choice. In the
event any patent included in the Joint Patent Rights is infringed by a Third
Party, the party responsible for prosecution and maintenance of the applicable
Joint Patent Rights under Section 10.2(b) shall have the right to bring and
control any action or proceeding with respect to such patent, and the other
party shall have the right to be represented in any such action by counsel of
its own choice, and the parties shall share equally in the expenses thereof.
With respect to infringement of any patent included in the Genetronics Patent
Rights, if Genetronics fails to bring an action or proceeding within (a) 90 days
following the notice of alleged infringement or (b) 10 days before the time
limit, if any, set forth in the appropriate laws and regulations for the filing
of such actions, whichever comes first, Ethicon shall have the right to bring
and control any such action, at its own expense and by counsel of its own
choice, and Genetronics shall have the right to be represented in any such
action, at its own expense and by counsel of its own choice. In the event a
party brings an infringement action, the other party shall cooperate fully,
including if required to bring such action, the furnishing of a power of
attorney. Neither party shall have the right to settle any patent infringement
litigation under this Section 10.5 in a manner that diminishes the rights or
interests of the other party without the consent of such other party. In the
event Genetronics brings such action, any recovery realized as a result of such
litigation, after reimbursement of any litigation expenses of Genetronics and
Ethicon, shall belong to Genetronics.
10.6 ENFORCEMENT OR DEFENSE BY ETHICON. In the event Ethicon brings
any action to enforce or defend the Genetronics Patent Rights, Ethicon may
withhold up to 50% of the royalties otherwise due to Genetronics hereunder for
the duration of such action and may apply such withheld amounts toward
reimbursement of its litigation expenses, including reasonable attorneys' fees,
in connection with such action. Any recovery realized by Ethicon as a result of
such litigation shall be applied first in satisfaction of any unreimbursed
litigation expenses of Ethicon and any litigation expenses of Genetronics, and
next toward reimbursement of royalties withheld by Ethicon and due to
Genetronics, and the remainder shall belong to Ethicon, subject to payment of
royalties as if such recovery were Net Sales.
ARTICLE 11
THIS ARTICLE HAS BEEN INTENTIONALLY LEFT BLANK
23. *CONFIDENTIAL TREATMENT REQUESTED
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ARTICLE 12
REPRESENTATIONS AND WARRANTIES
12.1 CORPORATE POWER. Each party hereby represents and warrants that
such party is duly organized and validly existing under the laws of the state of
its incorporation and has full corporate power and authority to enter into this
Agreement and to carry out the provisions hereof.
12.2 DUE AUTHORIZATION. Each party hereby represents and warrants that
such party is duly authorized to execute and deliver this Agreement and to
perform its obligations hereunder.
12.3 BINDING OBLIGATION. Each party hereby represents and warrants
that this Agreement is a legal and valid obligation binding upon it and is
enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement by such party does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it.
12.4 INCONSISTENT AGREEMENT. Neither party has entered into, nor will
they enter into any agreements that are inconsistent with the rights conferred
to the other party under this Agreement.
12.5 REPRESENTATIONS AND WARRANTIES OF GENETRONICS. Genetronics hereby
represents and warrants to Ethicon that:
(a) During the Term, Genetronics is the sole and exclusive
owner of or, for licenses executed after the date hereof, licenses with the
right to sublicense, the Genetronics Technology; provided, however, that there
are no such licenses as of the Effective Date.
(b) As of the Effective Date, Genetronics has not received any
notice from any person or entity claiming to have any right, title or interest
in or to the Genetronics Technology and, to the best of its knowledge, has no
reason to expect that any such notice is forth coming.
(c) As of the Effective Date, to the best of its knowledge,
that the patents included in the Genetronics Patents Rights are valid and
enforceable in those countries listed on Exhibit E hereto.
(d) As of the Effective Date, Genetronics has no knowledge of
(i) any existing published patent application or issued patent which the
manufacture, use or sale of the Drug Delivery System would infringe, and (ii)
any infringement of the Genetronics Patent Rights by a Third Party.
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(e) All authorizations, approvals, or permits, if any, of any
governmental authority or regulatory body of the United States or of any country
or state that are required in connection with this Agreement including, but not
limited to, the notification requirements under the ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ Antitrust
Improvements Act of 1976, if required, shall have been duly obtained and shall
be effective on and as of the Effective Date.
12.6 DISCLAIMER OF WARRANTIES. EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT OR THE SUPPLY AGREEMENT:
(a) NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY TO THE
OTHER PARTY OF ANY KIND;
(b) NOTHING HEREIN SHALL BE CONSTRUED AS A REPRESENTATION OR
WARRANTY BY GENETRONICS TO ETHICON THAT THE GENETRONICS TECHNOLOGY IS VALID,
ENFORCEABLE, OR NOT INFRINGED BY ANY THIRD PARTY OR THAT THE PRACTICE OF SUCH
RIGHTS DOES NOT INFRINGE ANY INTELLECTUAL PROPERTY RIGHT OF ANY THIRD PARTY; AND
(c) NEITHER PARTY MAKES ANY WARRANTIES, EXPRESS OR IMPLED,
CONCERNING THE SUCCESS OF THE DEVELOPMENT OR THE COMMERCIAL EXPLOITATION OF THE
DRUG DELIVERY SYSTEM.
ARTICLE 13
TERM AND TERMINATION
13.1 TERM. This Agreement shall commence as of the Effective Date and
shall continue, until the expiration of the last to expire of the Genetronics
Patent Rights covering the Drug Delivery System in any country, unless
terminated earlier as provided herein (the "Term"). Following the expiration of
this Agreement in accordance with this Section 13.1, Ethicon shall have a
fully-paid license on the same terms as set forth in Section 5.1, except that
such license shall be a non-exclusive, worldwide, fully-paid, irrevocable
license with the right to make and have made the Drug Delivery System in the
Territory for use in the Field.
13.2 TERMINATION BY ETHICON. Ethicon may terminate this Agreement
without cause upon 180 days' prior written notice to Genetronics. Upon
termination of this Agreement by Ethicon pursuant to this Section 13.2, (i)
Ethicon shall have no right to practice the Genetronics Patent Rights or use any
of the Genetronics Technology, (ii) all right, title or interest in, or other
incidents of ownership under, the Genetronics Technology shall revert to and
become the sole property of Genetronics, and (iii) any sublicenses granted
hereunder by Ethicon shall remain in effect, but shall be assigned to
Genetronics.
13.3 EVENTS OF DEFAULT. The occurrence of any one or more of the
following acts, events or occurrences shall constitute an "Event of Default"
under this Agreement:
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(a) a failure by Ethicon to pay 60 days after written notice
thereof by Genetronics any amount due in accordance with Article 6 hereof; or
(b) either party becomes the subject of a Bankruptcy Event; or
(c) in the event Ethicon terminates the Supply Agreement upon
breach by Genetronics; or
(d) in the event of a Change in Control of Genetronics, and
such Change in Control involves (i) a Competitor (as defined below); (ii) any
entity which has a documented and consistent history of Good Manufacturing
Practice problems with the FDA or equivalent problems with any Regulatory
Agency, or (iii) a party which does not have the financial, production or other
resources necessary for it to meet all of the obligations of Genetronics under
this Agreement. For purposes of this paragraph, a "Competitor" shall mean any
entity which is involved in the same business as any operating company among the
▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ Family of Companies ("J&J") that: (A) belongs to the
Professional Sector of (J&J), (B) is engaged in the business of commercially
exploiting surgical oncology products.
13.4 TERMINATION RIGHTS UPON AN EVENT OF DEFAULT. Upon the occurrence
of an Event of Default, the non-defaulting party in its sole discretion may
terminate this Agreement upon written notice to the defaulting party. If the
Event of Default is caused by Genetronics (a) Ethicon shall have a fully-paid
license on the same terms as set forth in Section 5.1, except that such license
shall be non-exclusive, worldwide, fully-paid, irrevocable license with the
right to make and have made the Drug Delivery System in the Territory for use in
the Field, and (b) Genetronics shall provide such assistance and other
information as shall be necessary in order for Ethicon to manufacture or have
manufactured the Drug Delivery System. If the Event of Default is caused by
Ethicon all rights granted to Ethicon's by Genetronics under this Agreement
shall terminate immediately upon such Event of Default. Disputes over Events of
Default shall be subject to Article 14.
13.5 FORCE MAJEURE EVENTS.
(a) If either party is prevented from performing any of its
obligations hereunder (other than payment obligations) due to any cause which is
beyond the non-performing party's reasonable control, including, without
limitation, fire, explosion, flood, or other acts of God; acts, regulations, or
laws of any government; war or civil commotion; strike, lock-out or labor
disturbances; or failure of public utilities or common carriers (a "Force
Majeure Event"), such non-performing party shall not be liable for breach of
this Agreement with respect to such non-performance to the extent such
non-performance is due to a Force Majeure Event. Such non-performance will be
excused for three months or as long as such event shall be continuing (whichever
period is shorter), provided that the non-performing party gives immediate
written notice to the other party of the Force Majeure Event. Such
non-performing party shall exercise all reasonable efforts to eliminate the
Force Majeure Event and to resume performance of its affected obligations as
soon as practicable. Should the event of force majeure
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continue unabated for a period of sixty (60) days or more, the parties shall
enter into good faith discussions with a view to alleviating its affects or to
agreeing upon such alternative arrangements as may be fair and reasonable having
regard to the circumstances prevailing at that time.
(b) In the event that such alternative arrangements cannot be
agreed upon within thirty (30) days after the expiration of such initial sixty
(60) day period, and in the event Genetronics is the party which is the subject
of the force majeure event, then Ethicon shall have the right and option, upon
written notice to Genetronics (the "Force Majeure Notice"), to either
manufacture itself the components of the Drug Delivery System which are the
subject of such force majeure event, or to have a Third Party so manufacture
such components. The Force Majeure Notice shall specify the components which are
the subject thereof. Upon delivery of the Force Majeure Notice to Genetronics,
(i) Ethicon shall be entitled to manufacture the Drug Delivery System itself,
and (ii) Genetronics shall provide such assistance and other information as
shall be necessary in order for Ethicon to manufacture or have manufactured the
Drug Delivery System.
13.6 REASONABLENESS. Genetronics expressly acknowledges that the
termination provisions contained in this Article 13 are reasonable considering
the intended nature and scope of this Agreement.
13.7 RIGHTS UPON INSOLVENCY. All rights and licenses granted under or
pursuant to this Agreement or the Supply Agreement by Genetronics to Ethicon are
for all purposes of Section 365(n) of Title 11, U.S. Code (the "Bankruptcy
Code"), licenses of rights to "intellectual property" as defined in the
Bankruptcy Code. The parties agree that Ethicon, as a licensee of such rights
under this Agreement or the Supply Agreement, shall retain and may fully
exercise all of its rights and elections under the Bankruptcy Code. If a case is
commenced by or against Genetronics under the Bankruptcy Code, then, unless and
until this Agreement is rejected as provided in the Bankruptcy Code, Genetronics
(in any capacity, including debtor-in-possession) and its successors and assigns
(including, without limitation, a Bankruptcy Code trustee) shall either perform
or caused to be performed all of the obligations provided in this Agreement to
be performed by Genetronics or provide or cause to be provided to Ethicon all
such intellectual property (including all embodiments thereof) held by
Genetronics and such successors and assigns. If this Agreement is rejected as
provided in the Bankruptcy Code and Ethicon elects to retain its rights
hereunder as provided in the Bankruptcy Code, then Genetronics (in any capacity,
including debtor-in-possession) and its successors and assigns (including,
without limitation, a Bankruptcy Code trustee) shall provide or cause to be
provided to Ethicon all such intellectual property (including all embodiments
thereof) held by Genetronics and such successors and assigns immediately upon
Ethicon's written request therefor. All rights, powers and remedies of Ethicon
provided under this Article are in addition to and not in substitution for any
and all other rights, powers and remedies now or hereafter existing at law or in
equity (including, without limitation, the Bankruptcy Code) in the event of any
such commencement of a bankruptcy proceeding by or against Genetronics. Ethicon,
in addition to the rights, powers and remedies expressly provided herein, shall
be entitled to exercise all other such rights
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and powers and resort to all other such remedies as may now or hereafter exist
at law or in equity (including the Bankruptcy Code) in such event.
ARTICLE 14
DISPUTE RESOLUTION
14.1 DISPUTES. The parties recognize that disputes as to certain
matters may from time to time arise which relates to either party's rights and
obligations hereunder. It is the objective of the parties to establish
procedures to facilitate the resolution of such disputes in an expedient and
cost effective manner by mutual cooperation and without resort to litigation. To
accomplish this objective, the parties agree that any dispute, claim or
controversy arising from or related in any way to this Agreement or the
interpretation, application, breach, termination or validity thereof, including
any claim of inducement of this Agreement by fraud or otherwise (a "Dispute"),
shall be referred to the President of each party, who or whose designee shall
attempt to resolve it in good faith to negotiate a resolution of the Dispute
prior to pursuing other remedies. If within 21 days after referral of the
Dispute to such officers, the parties have not succeeded in negotiation a
resolution of the dispute, such dispute shall be submitted to non-binding
mediation pursuant to Section 14.2. If the parties are unable to resolve the
Dispute within 45 days after initiation of non-binding mediation, such dispute
shall be submitted to arbitration pursuant to Section 14.3.
14.2 MEDIATION.
(a) Any Dispute submitted to non-binding mediation shall be
mediated in accordance with the Model Procedures for the Mediation of Business
Disputes promulgated by the Center for Public Resources ("CPR") then in effect,
except where those rules conflict with these provisions, in which case these
provisions control. The mediation shall be conducted in Trenton, New Jersey and
shall be attended by a senior executive with authority to resolve the dispute
from each of the operating companies that are parties.
(b) The mediator shall be an attorney specializing in business
litigation who has at least 15 years of experience as a lawyer with a law firm
or corporation of over 25 lawyers or was a judge of a court of general
jurisdiction and who shall be appointed from the list of neutrals maintained by
CPR.
(c) The parties shall promptly confer in an effort to select a
mediator by mutual agreement. In the absence of such an agreement, the mediator
shall be selected from a list generated by CPR with each party having the right
to exercise challenges for cause and two peremptory challenges within 72 hours
of receiving the CPR list.
(d) The mediator shall confer with the parties to design
procedures to conclude the mediation within no more than 45 days after
initiation. Under no
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circumstances shall the commencement of arbitration under Section 14.3 below be
delayed more than 45 days by the mediation process specified herein.
(e) Each party agrees to toll all applicable statutes of
limitation during the mediation process and not to use the period or pendancy of
the mediation to disadvantage the other party procedurally or otherwise. No
statements made by either side during the mediation may be used by the other
during any subsequent arbitration.
(f) Each party has the right to pursue provisional relief from
any court, such as attachment, preliminary injunction, replevin, etc., to avoid
irreparable harm, maintain the status quo, or preserve the subject matter of the
arbitration, even though mediation has not been commenced or completed.
14.3 DISPUTE RESOLUTION; ARBITRATION.
(a) Any Dispute will be submitted for resolution to
arbitration pursuant to the commercial arbitration rules then pertaining of the
CPR, except where those rules conflict with these provisions, in which case
these provisions control. The arbitration will be held in Trenton, New Jersey.
(b) The panel shall consist of three arbitrators chosen from
the CPR Panels of Distinguished Neutrals each of whom is a lawyer specializing
in business or patent litigation with at least 15 years experience with a law
firm or corporation of over 25 lawyers or was a judge of a court of general
jurisdiction. In the event the aggregate damages sought by the claimant are
stated to be less than $5 million, and the aggregate damages sought by the
counterclaimant are stated to be less than $5 million, and neither side seeks
equitable relief, then a single arbitrator shall be chosen, having the same
qualifications and experience specified above.
(c) The parties agree to cooperate (1) to obtain selection of
the arbitrator(s) within 30 days of initiation of the arbitration, (2) to meet
with the arbitrator(s) within 30 days of selection and (3) to agree at that
meeting or before upon procedures for discovery and as to the conduct of the
hearing which will result in the hearing being concluded within no more than 9
months after selection of the arbitrator(s) and in the award being rendered
within 60 days of the conclusion of the hearings, or of any post-hearing
briefing, which briefing will be completed by both sides with 20 days after the
conclusion of the hearings. In the event no such agreement is reached, the CPR
will select arbitrator(s), allowing appropriate strikes for reasons of conflict
or other cause and three peremptory challenges for each side. The arbitrator(s)
shall set a date for the hearing, commit to the rendering of the award within 60
days of the conclusion of the evidence at the hearing, or of any post-hearing
briefing (which briefing will be completed by both sides in no more than 20 days
after the conclusion of the hearings), and provide for discovery according to
these time limits, giving recognition to the understanding of the parties hereto
that they contemplate reasonable discovery, including document demands and
depositions, but that such discovery be limited so that the time limits
specified herein may be met without undue difficulty. In no event will the
arbitrator(s) allow either side to obtain more than a total of 40 hours of
deposition testimony from all
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witnesses, including both fact and expert witnesses. In the event multiple
hearing days are required, they will be scheduled consecutively to the greatest
extent possible.
(d) The arbitrator(s) shall render their award following the
substantive law of New Jersey. The arbitrator(s) shall render an opinion setting
forth findings of fact and conclusions of law with the reasons therefor stated.
A transcript of the evidence adduced at the hearing shall be made and shall,
upon request, be made available to either party.
(e) To the extent possible, the arbitration hearings and award
will be maintained in confidence.
(f) The United States District Court for the District of New
Jersey may enter judgment upon any award. In the event the panel's award exceeds
$5 million in monetary damages or includes or consists of equitable relief, then
the court shall vacate, modify or correct any award where the arbitrators'
findings of fact are clearly erroneous, and/or where the arbitrators'
conclusions of law are erroneous; in other words, it will undertake the same
review as if it were a federal appellate court reviewing a district court's
findings of fact and conclusions of law rendered after a bench trial. An award
for less than $5 million in damages and not including equitable relief may be
vacated, modified or corrected only upon the grounds specified in the Federal
Arbitration Act. The parties consent to the jurisdiction of the above-specified
Court for the enforcement of these provisions, the entry of judgment on any
award, and the vacatur, modification and correction of any award as above
specified. In the event such Court lacks jurisdiction, then any court having
jurisdiction of this matter may enter judgment upon any award and provide the
same relief, and undertake the same review, as specified herein.
(g) Each party has the right before or during the arbitration
to seek and obtain from the appropriate court provisional remedies such as
attachment, preliminary injunction, replevin, etc. to avoid irreparable harm,
maintain the status quo, or preserve the subject matter of the arbitration.
(h) EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE
BY JURY.
(i) EACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE OR
EXEMPLARY DAMAGES FROM THE OTHER.
(j) EACH PARTY HERETO WAIVES ANY CLAIM OF INDIRECT, SPECIAL,
INCIDENTAL AND CONSEQUENTIAL DAMAGES FROM THE OTHER.
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ARTICLE 15
MISCELLANEOUS
15.1 CONFIDENTIALITY; PRESS RELEASES.
(a) Ethicon and Genetronics will be exchanging information
relating to the Drug Delivery System at the inception of and from time to time
during the term of this Agreement. Any such information which is considered by
the disclosing party to be confidential will be identified in writing as
confidential information or, if disclosed orally or in another non-written
manner, shall be confirmed in writing as being confidential promptly after the
disclosure thereof. The party receiving such information will maintain the
information in confidence using the same standard of care it uses to maintain
its own information in confidence during the term of this Agreement and for a
period of five years thereafter. Such obligation of confidentiality shall not
apply to information which (i) is known to the receiving party prior to the
disclosure, (ii) is publicly known as of the date of the disclosure, (iii)
becomes publicly known after the date of disclosure through no fault of the
receiving party, (iv) is received from a Third Party who has no obligation of
confidentiality to the disclosing party, (v) is developed independently by the
receiving party, (vi) is required to be disclosed to comply with a court or
administrative subpoena or order, provided the receiving party first uses
reasonable effort to obtain an order preserving the confidentiality of the
confidential information and provided that the receiving party gives the other
party timely notice off the contemplated disclosure to provide the disclosing
party the opportunity to intervene to preserve the confidentiality of the
information, or (vii) is required to be disclosed under applicable laws, rules
or regulations, including, without limitation, the rules and regulations of the
Toronto Stock Exchange or other governmental bodies.
(b) Notwithstanding paragraph (a) above, Ethicon shall be
permitted to disclose to its wholesalers and other direct customers such
confidential information relating to the Drug Delivery System as Ethicon shall
reasonably determine to be necessary in order to effectively market and
distribute the Drug Delivery System provided that such entities are bound the
same confidentiality obligations that Ethicon has with respect to Genetronics
confidential information.
(c) No party to this Agreement shall originate any publicity,
news release or other public announcement, written or oral, whether relating to
this Agreement or the existence of any arrangement between the parties, without
the prior written consent of any other party named in such publicity, news
release or other public announcement, except where such publicity, news release
or other public announcement is required by law; provided that in such event,
the party issuing same shall still be required to consult with the other party
or parties named in such publicity, news release or public announcement a
reasonable time (being not less than 48 hours) prior to its release to allow the
named party or parties to comment on the use of its name and, after its release,
shall provide the named party or parties with a copy thereof. No prior approval
will be required for a press release substantially in the form attached hereto
as Exhibit G to be issued by Genetronics on or about the Effective Date.
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(d) Neither party shall use the name of the other for
advertising or promotional claims without the prior written consent of the other
party.
15.2 INSURANCE. Genetronics agrees to procure and maintain in full
force and effect during the term of this Agreement and, with respect to the
manufacture and/or design of the Drug Delivery System by Genetronics, for so
long as the Drug Delivery System is manufactured by Genetronics or marketed by
either party, respectively, valid and collectible insurance policies in
connection with this Agreement, which policies shall provide for the type of
insurance and amount of coverage described in Exhibit F of the Supply Agreement.
Upon Ethicon's request, Genetronics shall provide to Ethicon a certificate of
coverage or other written evidence reasonably satisfactory to Ethicon of such
insurance coverage.
15.3 SURVIVAL. Those provisions of this Agreement dealing with rights
and obligations upon and/or after termination of this Agreement shall survive
termination of this Agreement to the extent necessary to give effect to such
provisions.
15.4 PENALTIES. If either party terminates this Agreement in
accordance with the terms herein, the terminating party shall owe no penalty or
indemnity to the terminated party on account of such termination.
15.5 INDEPENDENT CONTRACTOR STATUS. Neither party shall have any
authority to obligate the other in any respect nor hold itself out as having any
such authority. All personnel of Genetronics shall be solely employees of
Genetronics and shall not represent themselves as employees of Ethicon, and all
personnel of Ethicon shall be solely employees of Ethicon and shall not
represent themselves as employees of Genetronics.
15.6 BINDING EFFECT; BENEFITS; ASSIGNMENT.
(a) This Agreement shall inure to the benefit of and be
binding upon the parties hereto and their respective permitted successors and
assigns. Nothing contained herein shall give to any other person any benefit or
any legal or equitable right, remedy or claim. Anything to the contrary herein
notwithstanding, Genetronics agrees that the right and obligations under this
Agreement of Ethicon may, from time to time, be exercised or performed, as the
case may be, in whole or in part by Affiliates of Ethicon.
(b) Genetronics shall be permitted to assign all or part of
this Agreement to any Affiliate of Genetronics upon written notice to Ethicon,
such assignment shall be subject to the assignee agreeing in writing to assume
the benefits and obligations of this Agreement. Anything contained herein to the
contrary notwithstanding, this Agreement shall not be assignable by Genetronics
without the prior written consent of Ethicon, such consent not to be
unreasonably withheld; provided; however, that if such assignment involves any
entity of the type referred to in Section 13.3(d), then Ethicon's refusal of
consent to such an assignment shall be deemed to have been reasonable.
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(c) Ethicon shall be permitted to assign all or part of this
Agreement to any Affiliate of Ethicon upon written notice to Genetronics, such
assignment shall be subject to the assignee agreeing in writing to assume the
benefits and obligations of this Agreement. Anything contained herein to the
contrary notwithstanding, this Agreement shall not be assignable by Ethicon
without the prior written consent of Genetronics, such consent not to be
unreasonably withheld.
15.7 ENTIRE AGREEMENT; AMENDMENTS. Before signing this Agreement the
parties have had numerous conversation, including without limitation preliminary
discussions, formal negotiations and informal conversations at meals and social
occasions, and have generated correspondence and other writings, in which the
parties discussed the transaction which is the subject of this Agreement and
their aspirations for success. In such conversations and writings, individuals
representing the parties may have expressed their judgments and beliefs
concerning the intentions, capabilities and practices of the parties, and may
have forecasted future events. The parties recognize that such conversations and
writings often involve an effort by both sides to be positive and optimistic
about the prospects for the transactions. However, it is also recognized that
all business transactions contain an element of risk, as does the transaction
contemplated by this Agreement, and that it is normal business practice to limit
the legal obligations of contracting parties to only those promises and
representations which are essential to their transaction so as to provide
certainty as to their future rights and remedies. Accordingly, this Agreement is
intended to define the full extent of the legally enforceable undertakings of
the parties hereto, and no promise or representation, written or oral, which is
not set forth explicitly in this Agreement is intended by either party to be
legally binding. Each of the parties acknowledge that in deciding to enter into
this Agreement and to consummate the transaction contemplated hereby none of
them has relied upon any statements or representations, written or oral, other
than those explicitly set forth herein or therein. No subsequent alteration,
amendment, change or addition to this Agreement shall be binding upon the
parties hereto unless reduced to writing and signed by the respective authorized
officers of the parties.
15.8 SEVERABILITY. In the event that any provision of this Agreement
would be held in any jurisdiction to be invalid, prohibited or unenforceable for
any reason, such provision, as to such jurisdiction, shall be ineffective,
without invalidating the remaining provisions of this Agreement or affecting the
validity or enforceability of such provision in any other jurisdiction.
Notwithstanding the foregoing, if such provision could be more narrowly drawn so
as not to be invalid, prohibited or unenforceable in such jurisdiction, it
shall, as to such jurisdiction, be so narrowly drawn, without invalidating the
remaining provisions of this Agreement or affecting the validity or
enforceability of such provision in any other jurisdiction.
15.9 REMEDIES. Unless otherwise expressly provided, all remedies
hereunder, are cumulative, are in addition to any other remedies provided for by
law and may, to the extent permitted by law, be exercised concurrently or
separately, and the exercise of any one remedy shall not be deemed to be an
election of such remedy or to preclude the exercise of any other remedy.
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15.10 NOTICES. Any notice, request, consent or communication
(collectively, a "Notice") under this Agreement shall be effective if it is in
writing and (i) personally delivered, (ii) sent by certified or registered mail,
postage prepaid, return receipt requested, (iii) sent by an internationally
recognized overnight delivery service, with delivery confirmed, or (iv) telexed
or telecopied, with receipt confirmed, addressed as set forth in this Section or
to such address as shall be furnished by either party hereto to the other party
hereto. A Notice shall be deemed to have been given as of (i) the date when
personally delivered, (ii) seven (7) business days after being deposited with
the United States Postal Service, certified or registered mail, properly
addressed, return receipt requested, postage prepaid, (iii) two business days
after being delivered to said overnight delivery service properly addressed, or
(iv) confirmation of receipt of the telex or telecopy, as the case may be. All
Notices shall specifically state: (i) the provision (or provisions) of this
Agreement with respect to which such Notice is given, and (ii) the relevant time
period, if any, in which the party receiving the Notice must respond.
If to Genetronics:
Genetronics, Inc.
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: Vice President, Corporate Development
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to:
▇▇▇▇▇▇ Godward LLP:
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: ▇. ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Esq.
Fax: No. (▇▇▇) ▇▇▇-▇▇▇▇;
If to Ethicon:
Ethicon, Inc.
▇▇▇▇▇ ▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attention: Vice President, New business Development
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to:
Office of General Counsel
▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Fax: ▇-▇▇▇-▇▇▇-▇▇▇▇;
34.
35
15.11 WAIVERS. The failure of either party to assert a right hereunder
or to insist upon compliance with any term or condition of this Agreement shall
not constitute a waiver of that right or excuse a similar subsequent failure to
perform any such term or condition by the other party.
15.12 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, and execution by each of the parties of any one of such
counterparts will constitute due execution of this Agreement. Each such
counterpart hereof shall be deemed to be an original instrument, and all such
counterparts together shall constitute but one agreement.
15.13 HEADINGS. The article and section headings contained in this
Agreement are for reference purposes only and shall not affect in any way the
meaning or interpretation of this Agreement.
15.14 CONSTRUCTION. The parties hereto agree that any rule of
construction to the effect that ambiguities are to be resolved against the
drafting party shall not be applied in the construction or interpretation of
this Agreement.
15.15 PATENT MARKINGS. To the extent it is commercially reasonable to
do so, Ethicon agrees (a) to ▇▇▇▇ the Drug Delivery System sold in the United
States with all applicable United States patent numbers and/or trademarks, and
(b) to ▇▇▇▇ the Drug Delivery System shipped to or sold in other countries in
such a manner as to conform with the patent and trademark laws and practices of
the country of manufacture or sale.
35.
36
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed in duplicate by their duly authorized officers as of the date first
above written.
GENETRONICS BIOMEDICAL, INC.
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
----------------------------------------
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Title: President and Chief Executive Officer
By: /s/ ▇▇▇▇▇▇ ▇▇▇▇
Name: ▇▇▇▇▇▇ ▇▇▇▇
Title: Senior Vice President
GENETRONICS, INC.
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
----------------------------------------
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Title: President and Chief Executive Officer
By: /s/ ▇▇▇▇▇▇ ▇▇▇▇
----------------------------------------
Name: ▇▇▇▇▇▇ ▇▇▇▇
Title: Senior Vice President
ETHICON, INC.
By: /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
----------------------------------------
Name: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
Title: Vice President, Growth Technologies/
New Business Development
36.
37
EXHIBIT A
GENETRONICS PATENT RIGHTS
Genetronics, Inc. Page 1
Electroporation Therapy of
Cancer
-----------------------------------------------------------------------------------------------------------------------------------
Attorney Serial/Patent Date Issued
Patent Title Docket No. Country Number Status or Filed Key Claims
-----------------------------------------------------------------------------------------------------------------------------------
Electroporation System with 15-27 US 5,439,440 Issued 8/8/95 Apparatus and method for
Voltage Control Feedback for laparascopic EPT with
Clinical Applications needle array and caliper
-----------------------------------------------------------------------------------------------------------------------------------
[...***...]
-----------------------------------------------------------------------------------------------------------------------------------
Injection and 15-21 US 5,273,525 Issued 12/28/93 Needle apparatus and
Electroporation Apparatus method
for Drug and Gene Delivery
-----------------------------------------------------------------------------------------------------------------------------------
Needle Electrodes for 15-44 US 5,702,359 Issued CIP of 15-27 12/30/97 Apparatus and method for
Electroporation Mediated variety of needle arrays
Delivery of Drugs and Genes
-----------------------------------------------------------------------------------------------------------------------------------
[...***...]
-----------------------------------------------------------------------------------------------------------------------------------
Electroporetic Gene and Drug 15-69 + 15-104 Europe EP# 788 392 Issued 5/27/98 6/27/95 Apparatus and method for
Delivery by induced Electric (Ireland) contact free
Fields electroporation of blood
in vivo
-----------------------------------------------------------------------------------------------------------------------------------
[...***...]
-----------------------------------------------------------------------------------------------------------------------------------
Applicator for 15-20 US 5,318,514 Issued Parent of 6/7/94 Apparatus for
Electroporation of Drugs and 31, 35 and 46 electroporation through
Genes into Surface Cells the skin, needles and
meander electrodes
-----------------------------------------------------------------------------------------------------------------------------------
37. *CONFIDENTIAL TREATMENT REQUESTED
38
EXHIBIT B
SUPPLY AGREEMENT
(SEE EXHIBIT 10.18 FILED AS AN EXHIBIT
TO THE REGISTRANT'S S-1 ON OCTOBER 5, 1999)
38.
39
EXHIBIT C
STOCK PURCHASE AGREEMENT
(SEE EXHIBIT 10.16 FILED AS AN EXHIBIT
TO THE REGISTRANT'S S-1 ON OCTOBER 5, 1999)
39.
40
EXHIBIT D
CLINICAL STUDIES REFERRED TO IN SECTION 6.2(D)
A PHASE II TRIAL OF ELECTROPORATION THERAPY (EPT) USING THE GENETRONICS, INC.
MEDPULSER(TM) SYSTEM AND INTRATUMOR BLEOMYCIN IN PATIENTS WITH SQUAMOUS CELL
CARCINOMA OF THE HEAD AND NECK WHO HAVE FAILED STANDARD THERAPY AND WHO HAVE
DISEASE PROGRESSION FOLLOWING INTRATUMOR BLEOMYCIN ALONE
PROTOCOL NUMBER EPT-97-01
(IND NO. 54,146)
Genetronics, Inc. November 5, 1997
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
I have received and read the Investigator's Brochure for Electroporation Therapy
(EPT) for the Delivery of Bleomycin Sulfate dated September 19, 1997, and the
Protocol dated November 5, 1997, and the Statement of Investigator Obligations.
I, the Principal Investigator of this trial, approve of, and will comply with,
all conditions, instructions and restrictions described in this protocol. I
affirm that my subordinates in this trial will also comply strictly with this
protocol. I am aware that my adherence to the above protocol is mandatory and
that any changes in the protocol or consent form, except those necessary to
eliminate apparent immediate hazards to human subjects, must first be approved
by Genetronics, Inc. and the Institutional Review Board. Failure to adhere to
these stipulations may constitute a breach of federal regulations and may result
in termination of the trial.
----------------------------------- ----------------------------
Principal Investigator Name Date
Site Name
City, State
Country
----------------------------------- ----------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, M.S. Date
Director, Clinical Programs
Genetronics, Inc.
CONFIDENTIAL
Information in this protocol is confidential and may not be disclosed to parties
other than trial personnel and the Institutional Review Board directly involved
with this trial. All parties must understand that confidential information may
not be disseminated further without prior written permission from Genetronics,
Inc.
40.
41
A PHASE II TRIAL OF ELECTROPORATION THERAPY (EPT) USING THE GENETRONICS, INC.
MEDPULSER(TM) SYSTEM AND INTRATUMOR BLEOMYCIN IN PATIENTS WITH SQUAMOUS CELL
CARCINOMA OF THE HEAD AND NECK WHO HAVE FAILED STANDARD THERAPY
PROTOCOL NUMBER EPT-97-02
(IND NO. 54,146)
Genetronics, Inc. November 5, 1997
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
I have received and read the Investigator's Brochure for Electroporation Therapy
(EPT) for the Delivery of Bleomycin Sulfate dated September 19, 1997, and the
Protocol dated November 5, 1997, and the Statement of Investigator Obligations.
I, the Principal Investigator of this trial, approve of, and will comply with,
all conditions, instructions and restrictions described in this protocol. I am
aware that my adherence to the above protocol is mandatory and that any changes
in the protocol or consent form, except those necessary to eliminate apparent
immediate hazards to human subjects, must first be approved by Genetronics, Inc.
and the Ethics Committee. Failure to adhere to these stipulations may constitute
a breach of federal regulations and may result in termination of the trial.
----------------------------------- ----------------------------
Principal Investigator Name Date
Site Name
City, State
Country
----------------------------------- ----------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇, M.S. Date
Director, Clinical Programs
Genetronics, Inc.
CONFIDENTIAL
Information in this protocol is confidential and may not be disclosed to parties
other than trial personnel and the Ethics Committee directly involved with this
trial. All parties must understand that confidential information may not be
disseminated further without prior written permission from Genetronics, Inc.
41.
42
INVESTIGATIONAL NEW DRUG (IND) PROTOCOL
AN OPEN-LABEL STUDY OF ELECTROPORATION THERAPY (EPT) FOR THE
TREATMENT OF NONRESECTABLE PANCREATIC CANCER USING THE
GENETRONICS, INC. MEDPULSER(TM) SYSTEM AND BLEOMYCIN
PROTOCOL NUMBER: EPT-97-03
PROMOTER:
Genetronics, Inc.
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Date Prepared: May 26, 1997
42.
43
INVESTIGATIONAL NEW DRUG (IND) PROTOCOL
AN OPEN-LABEL STUDY OF ELECTROPORATION THERAPY (EPT) FOR THE
TREATMENT OF NONRESECTABLE METASTATIC CANCER IN THE LIVER
USING THE GENETRONICS, INC. MEDPULSER(TM) SYSTEM AND BLEOMYCIN
PROTOCOL NUMBER: EPT-97-04
PROMOTER:
Genetronics, Inc.
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Date Prepared: May 22, 1997
43.
44
AN OPEN LABEL LESION CONTROLLED STUDY OF ELECTROPORATION
THERAPY (EPT) FOR THE TREATMENT OF CUTANEOUS KAPOSI'S SARCOMA
USING THE GENETRONICS, INC. MEDPULSER(TM) SYSTEM AND BLEOMYCIN
PROTOCOL NUMBER: EPT-97-05
SPONSOR:
Genetronics, Inc.
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Date Prepared: July 3, 1997
44.
45
AN OPEN LABEL LESION CONTROLLED STUDY OF ELECTROPORATION
THERAPY (EPT) FOR THE TREATMENT OF CUTANEOUS METASTATIC
MELANOMA THE GENETRONICS, INC. MEDPULSER(TM) SYSTEM AND BLEOMYCIN
PROTOCOL NUMBER: EPT-97-06
SPONSOR:
Genetronics, Inc.
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Date Prepared: July 1, 1997
45.
46
INVESTIGATIONAL NEW DRUG (IND) PROTOCOL
AN OPEN-LABEL STUDY OF ELECTROPORATION THERAPY (EPT) FOR THE
TREATMENT OF HEAD & NECK TUMORS USING THE GENETRONICS, INC.
MEDPULSER(TM) SYSTEM AND BLEOMYCIN
PROTOCOL NUMBER: EPT-97-07
SPONSORED BY:
Genetronics, Inc.
▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Date Prepared: October 16, 1997
46.
47
EXHIBIT E
COUNTRIES REFERRED TO IN SECTION 12.5
UNITED STATES OF AMERICA
TIER 1 EUROPEAN COUNTRIES
MEXICO
▇▇▇▇▇
▇▇▇▇▇
▇▇▇▇▇
▇▇▇▇▇▇
▇▇.
48
EXHIBIT F
CONCEPT DRAWING OF THE PROPOSED DEEP SEATED PROBE REFERRED TO IN SECTION 6.2
48.
49
EXHIBIT G
PRESS RELEASE REFERRED TO IN SECTION 15.1
49.