1
EXHIBIT 10.3.47
LICENSE & OPTION AGREEMENT
--------------------------------------------------------------------------------
THIS AGREEMENT entered into this 1st day of April, 1998, between Neoprobe
Corporation, a Delaware corporation with principal offices at 000 Xxxxx Xxxxx
Xxxxx, Xxxxx 000, Xxxxxx, Xxxx 00000-0000 (hereinafter "Neoprobe"), and Xxxx
Technologies, Inc., (hereinafter "Xxxx") a Delaware corporation having its
principal place of business at Xxxxxxx-Xxxxx Building, 0000 Xxxxxx Xxxx Xxxxx,
Xxxxxxxx, Xxxx 00000-0000.
WHEREAS, Neoprobe is a biopharmaceutical company engaged in the development and
marketing of proprietary products and methods useful in the treatment of various
diseases including cancer; and
WHEREAS, Neoprobe and Xxxx entered into a Technology Option Agreement dated
March 14, 1996 (hereinafter the "Main Agreement") wherein Xxxx granted Neoprobe
an option to acquire exclusive rights to certain Xxxx technology (copy attached
as Exhibit A); and
WHEREAS, the Parties desire to substantially amend the terms of the Main
Agreement and have decided for purposes of clarity to terminate the Main
Agreement and to execute this Agreement;
NOW, THEREFORE, in consideration of the mutual covenants exchanged herein, the
Parties agree as follows:
ARTICLE I. DEFINITIONS
1.01 Activated Lymph Node Derived Cells. As used herein, the term
"Activated Lymph Node Derived Cells" shall mean cells derived from one or more
lymph nodes excised from the same human patient, which cells are processed from
such lymph nodes, i.e., are grown up and expanded, using the Technology; such
term shall also include substances, such as soluble factors, secreted by such
activated cells.
1.02 Affiliate. The term "Affiliate" as used herein shall mean with
respect to any specified Person, any other Person that directly or indirectly
through one or more intermediaries, controls, or is controlled by, or is under
common control with, the Person specified. For purposes of this definition,
"control" including, with correlative meanings, the terms "controlled by" and
"under common control with" means ownership directly or indirectly of more
1
2
than forty percent (40%) of the equity capital having the right to vote for
election of directors in the case of a corporation and more than forty percent
(40%) of the beneficial interest in the case of a business entity other than a
corporation.
1.03 BLA. The term "BLA" as used herein means a Biologic License
Application filed with the FDA requesting marketing approval for a new biologic
product.
1.04 Far East. As used herein, the term "Far East" shall mean those
countries listed in Schedule 1.04.
1.05 Field. As used herein, the term "Field" shall mean the treatment
of human immunodeficiency virus ("HIV") infected human patients including
HIV-infected human patients co-infected with other viruses.
1.06 Effective Date. The "Effective Date" of this Agreement shall be
the date first written herein above.
1.07 FDA and Act. The term "FDA" and the term "Act" as used herein
shall mean the United States Food and Drug Administration or any successor
agency having the administrative authority to regulate the approval for testing
or marketing of human pharmaceutical or biological therapeutic products and
medical devices in the United States; and the term "Act" as used herein refers
to the Federal Food, Drug and Cosmetic Act, as amended, (21 U.S.C. '301 et
seq.) and the regulations promulgated thereunder.
1.08 Protocol. As used herein, the term "Protocol" shall mean a
detailed plan for the conduct of a clinical trial which has been reviewed and
approved by the FDA; a description of the elements of a Protocol is set forth in
21 CFR Section 312(a)(6).
1.09 IND. The term "IND" means an investigational new drug application
as defined in 21 CFR Section 312.23.
1.10 Joint Venture. As used herein the term "Joint Venture" shall mean
an association of two (2) or more Persons for the purpose of conducting a
business or commercial enterprise separate from the business of either of the
Persons.
1.11 Licensed Product. As used herein, the term "Licensed Product"
shall mean a pharmaceutical preparation approved for marketing by the FDA or
other equivalent health regulatory authority containing "Activated Lymph Nodes
Derived Cells" as an active therapeutic agent.
2
3
1.12 NDA. As used herein the term "NDA" shall mean a New Drug
Application filed with the FDA seeking marketing approval for a new drug, the
elements of an NDA are set forth in 21 CFR Section 314.50.
1.13 Net Sales. As used herein the term "Net Sales" shall mean the
actual invoice price at which Licensed Product is sold by Neoprobe or its
Affiliates in the Territory less the following: trade, cash and quantity
discounts; returns, normal trade allowances, charge-backs, and MEDICAID or other
federal or state rebates. Sale of Licensed Product by and between Neoprobe and
its Affiliates for resale and not for use by the Affiliate shall not be deemed a
sale for purposes of calculating "Net Sales" subject to earned royalty under
this Agreement.
1.14 Patent Rights. The term "Patent Rights" as used herein, shall mean
the issued United States and foreign patents and pending patent applications
listed on Schedule 1.14 attached hereto, as such Schedule 1.14 shall be amended
by Xxxx from time to time.
1.15 Person. As used herein the term "Person" shall mean any
individual, corporation, partnership, business trust, business association,
governmental entity, governmental authority or other legal entity.
1.16 Quarter. As used herein, the term "Quarter" shall mean a period of
three (3) months, the first such Quarter beginning on January 1 and ending on
March 31 of a Year.
1.17 Schedules. The Schedules to this Agreement are listed below and
are an integral part of this Agreement and are incorporated herein.
SCHEDULE DESCRIPTION
1.04 List of Countries comprising the Far East.
1.14 List of Patent Rights
1.18 Technology. The term "Technology" as used herein means proprietary
information and know-how developed by Xxxx relating the mitogenic stimulation of
cells derived from lymph nodes excised from chronically-infected and/or
autoimmune disease afflicted patients and the use of such cells or products
derived from such cells to treat human patients with chronic infections and/or
autoimmune diseases, and includes but is not limited to the Patent Rights.
3
4
1.19 Territory. As used herein, the term "Territory" shall include all
of the countries of the world.
1.20 Year. The term "Year" shall mean a consecutive twelve (12) month
period beginning January 1 of a year and ending December 31 of such year.
ARTICLE II. LICENSE GRANT
2.01 License Grant. Xxxx hereby grants to Neoprobe and Neoprobe hereby
accepts an exclusive, royalty-bearing license to make, have made, use and sell
Licensed Product in the Territory for use in the Field.
2.02 Sublicense. The license granted pursuant to Section 2.01 shall
include the right to sublicense to third parties; provided that the sublicensee
and the sublicense terms are reasonably acceptable to Xxxx. The grant of a
sublicense by Neoprobe to a third party shall not release Neoprobe of any of its
obligations to Xxxx pursuant to this Agreement.
2.03 Term of License. The license granted pursuant to Section 2.01
shall remain in effect in a country of the Territory for a period of ten (10)
years from date of "First Commercial Sale" of a Licensed Product in such country
or until this Agreement is terminated pursuant to any of the applicable sections
of Article IV. The term "First Commercial Sale" is used in accordance with its
commonly understood meaning, i.e., an arms length sale of a Licensed Product to
a third party for a stated price. In the event Neoprobe shall sell a Licensed
Product covered by an Improvement Patent in a country of the Territory, the life
of the license granted in Section 2.01 shall be for ten (10) years from the date
of First Commercial Sale of a Licensed Product incorporating the improvement(s)
covered by the Improvement Patent.
ARTICLE III. CONSIDERATION
3.01 Royalty. Subject to the provisions of Section 3.05 herein, in
consideration of the license granted to Neoprobe pursuant to Section 2.01,
Neoprobe agrees to pay and shall pay Xxxx a royalty of six percent (6%) of Net
Sales of Licensed Product in each country of the Territory in which Patent
Rights issue. In the event Neoprobe commercializes a Licensed Product through a
Joint Venture with a third party, the royalty rate payable to Xxxx based on Net
Sales of Licensed Product by the Joint Venture shall be separately negotiated
with Xxxx within ninety (90) days after the formation of the Joint Venture;
provided however, that the royalty rate shall not exceed ten percent (10%) of
Net Sales of Licensed Product by the Joint Venture in each country of the
Territory in which Patent Rights issue.
4
5
3.02 Royalty Rate If No Patent Rights. Subject to the provisions of
Section 3.05 herein, in consideration of the license granted pursuant to Section
2.01, Neoprobe agrees to pay and shall pay Xxxx a royalty of three percent (3%)
of net sales of Licensed Product in each country of the Territory in which
Patent Rights do not exist or do not issue. In the event that Neoprobe
commercializes a Licensed Product through a Joint Venture with a third party,
the royalty rate negotiated pursuant to Section 3.01 herein shall be reduced by
one-half for Net Sales of Licensed Product in each country of the Territory in
which Patent Rights do not exist or do not issue.
3.03 Patent Rights Do Not Issue. If, in a country of the Territory, a
particular Patent Right does not issue as a patent within five (5) years from
date of filing of the patent application or if applicable, within five (5) years
from the date on which examination of the application was requested, it will be
presumed that no Patent Rights will issue and the royalty rate shall be reduced
as described in Section 3.02; provided however, that in the event a Patent Right
subsequently issues the royalty rate shall be increased to the rate specified by
Section 3.01.
3.04 Other Fees. Subject to the provisions of Section 3.05 herein, in
the event Neoprobe shall sublicense any of its rights granted pursuant to
Section 2.01 and shall receive any compensation from the sublicensee for the
grant of such sublicense (hereinafter "Sublicensing Revenue"), Xxxx shall
receive fifty percent (50%) of all such Sublicensing Revenue. The term
"Sublicensing Revenue" shall mean all cash, sublicensing fees, royalties and all
other payments and the cash equivalent thereof paid to Neoprobe by a sublicensee
of Neoprobe of its rights hereunder, but shall not include the following: (i)
research and development money paid to Neoprobe to conduct research in the Field
and other than payments to Neoprobe for patent costs associated with maintaining
Patent Rights, (ii) monies paid to Neoprobe by the sublicensee as reimbursement
for research and development costs; and (iii) monies paid to Neoprobe to build
or acquire research and/or manufacturing facilities.
3.05 No Royalties Due. No royalties shall be due to Xxxx pursuant to
Section 3.01 or Section 3.02 on Net Sales of Licensed Product in the Territory
or Sublicensing Revenue pursuant to Section 3.04, until total Net Sales of
Licensed Product in the Territory exceed one (1) times the amount of Neoprobe's
out-of-pocket research and development expenses for preclinical and clinical
research conducted up to the time of filing of an NDA or BLA with the FDA, up to
a total of $2 Million Dollars.
3.06 Reduction of Royalties. Royalties payable by Neoprobe to Xxxx
under Section 3.01 and Section 3.02 shall be reduced as follows:
5
6
(a) If Neoprobe is required in a country within the Territory, by a
final court order from which no appeal can be taken, to obtain and pay
a royalty under a license to a third party under any patent in order to
make, have made, use or sell a Licensed Product in that country,
Neoprobe's obligations in the country to pay royalties to Xxxx shall be
reduced by the amount of the cost to Neoprobe additional ROYALTY PAID
TO SUCH THIRD PARTY; provided however, that in no event shall the
royalty due Xxxx in that country be reduced by more than fifty percent
(50%).
(b) If a third party obtains, by order, decree or grant from a
competent governmental authority in any country in the Territory, a
compulsory license under the Patent Rights authorizing such third party
to make, have made, use or sell a product, in such country,
substantially equivalent to a Licensed Product, Xxxx shall give prompt
notice to Neoprobe. During the effective period of such compulsory
license, Neoprobe's obligations to pay royalties with respect to Net
Sales in such country under this Agreement shall be no more than the
rate payable to Xxxx by said third party; provided that no action or
inaction on the part of Neoprobe occasioned the grant of such
compulsory license by Xxxx.
3.07 Right to Verify Research & Development Expenses. Neoprobe shall
have the obligation to provide Xxxx with sufficient documentation to enable Xxxx
to verify the following: (i) all monies received by Neoprobe from a sublicensee
for research and development activities are actually expended by Neoprobe for
R&D purposes; and (ii) the amount of past R&D expenses that are reimbursed by a
sublicensee. In the event Xxxx questions the correctness or accuracy of any
documentation provided to it by Neoprobe pursuant to this Section 3.07, Xxxx
shall have the right to have an independent auditor inspect Neoprobe's records.
ARTICLE IV. PAYMENT OF ROYALTIES AND REPORTING
4.01 Payment of Royalties and Report. Royalties shall be paid Quarterly
and shall be due within thirty (30) days after the end of each Quarter. A report
shall accompany the royalty payment which shall contain sufficient detail to
enable Xxxx to ascertain the basis for the royalty calculation. The full amount
of any royalties due to Xxxx for the preceding Quarter shall accompany the
report. This report shall state Net Sales upon which such royalties are computed
including as a minimum:
i) the quantity of Licensed Product sold;
ii) deductions permitted under this Agreement to arrive at Net
Sales; and
iii) royalty computations.
6
7
4.02 Period for Retention of Records. Neoprobe shall keep, for a period
of at least six (6) years after the date of entry, full, accurate and complete
books and records consistent with sound business practices and in such form and
in such detail as to enable Xxxx to determine amounts due it pursuant to Section
3.01, Section 3.02 and Section 3.03 herein.
4.03 Right to Inspect Records. Upon Xxxx'x request, Neoprobe shall
permit an independent certified accountant selected by Xxxx (except one to whom
Neoprobe has some reasonable objection) to inspect, once each Year during
ordinary business hours, such books and records of Xxxx covering a period not
more than the prior six (6) Quarters as may be necessary to verify the
correctness of the royalty payments made to Xxxx pursuant to Section 4.01.
4.04 Discrepancy in Royalty Payments. Unless otherwise agreed to by the
parties, if as a result of the audit performed pursuant to Section 4.03, the
independent auditor determines that Neoprobe has underpaid any payment due Xxxx,
Neoprobe shall, no later than three (3) business days after receiving notice of
such underpayment, remit to Xxxx the full amount of the underpayment. Unless
otherwise agreed to by the parties, if such audit reveals an overpayment to
Xxxx, such overpayment shall be refunded to Neoprobe within three (3) business
days after Xxxx becomes aware of such overpayment.
4.05 Penalty for Underpayment. If as a result of an audit performed
pursuant to Section 4.03, it is determined that Neoprobe has underpaid any
payment due Xxxx by more than ten percent (10%) of the amount which was due, in
addition to remitting the amount of the underpayment as described in Section
4.03, Neoprobe shall pay Xxxx interest on such amount at the rate per annum of
"prime" (interest changing as and when the "prime" changes); such interest being
payable on demand together with all costs incurred by Xxxx collect the amounts
due hereunder, including, but not limited to, the cost of the audit performed
pursuant to Section 4.03, reasonable attorneys fees and disbursements. As used
herein, the term "prime" refers to the prime rate of interest per annum
announced, from time to time, by major money center banks in the United States
and as published daily in The Wall Street Journal; provided, however, that if
The Wall Street Journal should ever cease, for any reason, to publish such rate
on a daily basis, then the Prime Rate shall be at the rate of interest
designated and in effect from time to time, by Citibank, N.A., in New York, New
York as its Prime Rate.
4.06 Dispute Relating to Audit. In the event an audit conducted
pursuant to Section 4.03 finds an underpayment by Neoprobe and if Neoprobe
disagrees with the results of such audit and further in the event the parties
can not resolve such disagreement, the parties shall mutually chose an
independent accountant acceptable to both to conduct a second audit. The parties
agree to be bound by the results of the second independent audit. The cost of an
audit conducted pursuant to this Section 3.07 shall be borne by Xxxx if the
independent accountant finds no underpayment and by Neoprobe if an underpayment
is found.
7
8
ARTICLE V. TERM & TERMINATION
5.01 Term. The "Term" of this Agreement shall be for the life of the
last to expire of the licenses granted to Neoprobe pursuant to Section 2.01 and
Section 2.03 herein unless otherwise earlier terminated pursuant to any of the
provisions of this Article V.
5.02 Termination by Neoprobe. Neoprobe shall have the right, at its
sole discretion, at any time subsequent to twenty four (24) months after the
Effective Date to terminate this Agreement upon one hundred and eighty (180)
days prior notice to Xxxx. Unless otherwise agreed to by Xxxx, termination of
this Agreement pursuant to this Section 5.02 shall terminate all sublicenses
granted by Neoprobe. In the event the Agreement is terminated pursuant to this
Section 5.02, Xxxx shall have the right to have all technical data or
information, including any regulatory submission (hereinafter the Neoprobe
Information") owned or controlled by Neoprobe relating the Technology,
transferred to Xxxx at Xxxx'x expense and Xxxx shall have the right to use such
Neoprobe Information in its business. In the event Xxxx decides to transfer
Neoprobe Information, by license or otherwise, to a third party, Xxxx and
Neoprobe shall negotiate in good faith prior to such transfer the consideration
to be paid to Neoprobe for such Neoprobe Information.
5.03 Termination for Material Breach. Either party may terminate this
Agreement for a material breach or default if such material breach or default is
not cured within sixty (60) days after the giving of written notice by the party
specifying such breach or default. In the case the complained of breach is a
failure by Neoprobe to pay to Xxxx any payments due hereunder, Neoprobe shall
have fifteen (15) days to cure such breach upon receipt of written notice from
Xxxx specifying such breach or default.
5.04 Termination for Insolvency. Xxxx shall have the right to
immediately terminate this Agreement, upon ten (10) days prior notice to
Neoprobe, if Xxxx ascertains that Neoprobe has become insolvent or bankrupt.
5.05 Termination Does Not Affect Accrued Rights. Termination or
expiration of this Agreement, pursuant to any of the provisions of this Article
V shall not affect any rights or obligations which may have accrued to either
party prior to the effective date of such termination or expiration.
5.06 Obligations Surviving Termination. The obligations of
confidentiality as provided in Article XI and of Indemnification as provided in
Article XII shall survive the expiration or termination of this Agreement.
8
9
5.07 Termination by Either Party. In the event this Agreement is
terminated by Neoprobe pursuant to Section 5.02 or Section 5.03, or by Xxxx
pursuant to Section 5.03, Neoprobe shall have no further rights under the Patent
Rights; except that, Neoprobe shall have the right for a period of four (4)
months after such termination to: (i) sell off in the ordinary course of
business, any existing inventory of Licensed Product;and (ii) finish any work in
progress and to sell off Licensed Product resulting from such work in progress
in the ordinary course of business. Neoprobe shall pay Xxxx royalties on any
Licensed Product sold pursuant to this Section 5.07 in accordance with the
provisions of Article IV.
ARTICLE VI. NEOPROBE RESEARCH OBLIGATIONS
6.01 Pilot Clinical Research. Neoprobe agrees that it will continue to
fund the pilot clinical research begun in HIV patients at the University of
South Florida under the direction of Xx. Xxxxx Xxxxxx. Unless otherwise agreed
to by the parties, such pilot clinical studies shall be completed by the end of
Fourth Quarter 1998. Neoprobe shall provide Xxxx with a written report(s)
detailing the results of the studies conducted by Xx. Xxxxxx within thirty (30)
days after receipt of a final written report(s) from Xx. Xxxxxx.
6.02 Filing of IND. Unless otherwise agreed to by Xxxx, within one
hundred twenty (120) days after receipt of the final written report from Xx.
Xxxxxx described in Section 6.01, Neoprobe shall file information and data with
the FDA sufficient to support an IND and a Protocol for the next appropriate
clinical study. Unless otherwise agreed to by Xxxx, Neoprobe shall initiate the
next study Protocol within one hundred twenty (120) days after approval of such
study Protocol by the FDA.
6.03 Research Plan. Within thirty (30) days after filing of the
information and data described in Section 6.02, Neoprobe shall provide Xxxx with
a written Research Plan outlining the clinical and non-clinical research to be
conducted by or on behalf of Neoprobe which Neoprobe proposes to use to support
the filing of a BLA or NDA for a Licensed Product, including key milestone
events to achieve filing of the BLA or NDA. Xxxx shall have the right to comment
on such Research Plan and to suggest modifications to such Research Plan.
Neoprobe agrees to carefully and in good faith consider Xxxx'x comments;
provided however, that the final content of the Research Plan shall be the sole
responsibility of Neoprobe. The parties acknowledge that one of the purposes of
the Research Plan is to set forth a concise plan for conducting research that
will attract appropriate business partners for both Neoprobe and Xxxx.
Accordingly, although Neoprobe shall be responsible for the final Research Plan,
Neoprobe shall make reasonable efforts to incorporate Xxxx'x comments into such
plan where appropriate.
9
10
6.04 Due Diligence. On or before each January 1 of each Year of the
term of this Agreement beginning in 2000 and until marketing approval for a
Licensed Product is received from the FDA, Neoprobe shall provide Xxxx with an
updated Research Plan summarizing results achieved against key milestones for
the preceding year as well as outlining key milestones for the forthcoming year
and detailing work remaining to be done under the Research Plan. In the event
Neoprobe fails to provide Xxxx with the updated Research Plan as described in
this Section 6.04, Xxxx may notify Neoprobe that it considers Neoprobe to be in
default of this Section 6.04. Neoprobe shall have thirty (30) days to cure such
default by providing Xxxx with the updated Research Plan. If Neoprobe does not
cure the default within the specified time, Xxxx shall have the right to
terminate this Agreement pursuant to Section 5.03 herein.
6.05 Marketing Approval. In the event the FDA issues a "non-approvable"
letter for a Licensed Product within two (2) years after filing the BLA or NDA,
and if Neoprobe can not overcome such non-approvable letter within twelve (12)
months after its receipt from the FDA, Xxxx shall have the right to terminate
this Agreement upon thirty (30) days prior written notice to Neoprobe.
6.06 Access to Data. Xxxx shall have the right to access all clinical
and non-clinical data developed by Neoprobe as a result of its activities in
carrying out the Research Plan. Such access shall include the right to use such
data in patent applications and for patent prosecution if such use is allowed by
applicable patent law.
6.07 Cell Growth Media. Neoprobe shall provide Xxxx with Xxxx'x
requirements for cell growth media manufactured by Life Technologies, Inc.
having the specifications listed in the attached Schedule 6.07. Neoprobe shall
supply such media to Xxxx at Neoprobe's acquisition cost plus ten percent (10%)
markup. Neoprobe's obligation to supply media to Xxxx hereunder shall remain in
effect until the earlier of the (i) termination of Neoprobe's supply arrangement
with Life Technologies, Inc.; or (ii) the termination of this Agreement. Xxxx
agrees to provide Neoprobe with a Quarterly forecast of its media needs on or
before the 10th day of the first month of each Quarter.
10
11
ARTICLE VII. OPTION AND OTHER RIGHTS
7.01 Termination of Neoprobe's Option to Chronic Technology. In partial
consideration of the rights granted to Neoprobe pursuant to Section 2.01 and
Section 7.02 herein, Neoprobe hereby specifically grants back to Xxxx the option
to Chronic Technology granted to Neoprobe pursuant to Section 2.1(b) of the Main
Agreement and, except as set forth in Section 7.02 below, shall have no further
rights or obligations with respect to such Chronic Technology. As used in this
Section 7.01, the term "Chronic Technology" shall have the same meaning as that
set forth in the Main Agreement.
7.02 Option. Xxxx hereby grants to Neoprobe and Neoprobe hereby accepts
the following:
(a) an option to acquire a worldwide, royalty-bearing, exclusive
license with the right to sublicense to make, have made, use and sell a
Licensed Product useful for the treatment of hepatitis in humans;
(b) an option to acquire a royalty-bearing, exclusive license with the
right to sublicense in the Far East to make, have made, use and sell a
Licensed Product covered by the Technology other than a Licensed
Product used to treat a human patient infected with HIV or hepatitis
which license is covered by Section 2.01 hereinabove.
7.03 Time to Exercise Option. The time period for exercising the option
rights granted in Section 7.02 are as follows:
(a) the period for exercise of the option granted pursuant to Section
7.02(a) shall be ninety (90) days starting from the date Neoprobe
provides Xxxx with a report as described in Section 6.01 hereinabove;
(b) the option granted to Neoprobe pursuant to Section 7.02(b) above
must be exercised by Neoprobe on or before December 31, 1999.
As used in this Section 7.03 the term "Exercised" or "Exercise" shall
mean the giving of written notice by Neoprobe to Xxxx as provided by Section
12.04 herein within the specified time period of Neoprobe's intent to exercise
the option. Upon exercise of either of the options described in Section 7.02,
the parties shall have ninety (90) days to negotiate in good faith the terms of
a definitive license agreement.
11
12
7.04 Consideration. In partial consideration of the options granted in
Section 7.02 herein, Neoprobe agrees to fund certain preclinical laboratory
studies conducted by Xxxx up to the level of Fifty Thousand Dollars ($50,000).
Xxxx has until December 31, 1999 to spend the $50,000 committed by Neoprobe in
this Section 7.04. An initial payment in the amount of $10,000 shall be made
upon notice by Xxxx to Neoprobe that Xxxx has begun such laboratory studies;
thereafter, Xxxx shall invoice Neoprobe on a monthly basis as study expenses are
incurred. Neoprobe shall pay such invoices within fifteen (15) days of receipt.
ARTICLE VIII. OWNERSHIP OF DATA
8.01 Ownership of Data and Regulatory Filing. Neoprobe has the
responsibility for and shall bear the expense of conducting all pre-clinical and
clinical studies needed, for purposes of preparing an NDA or BLA covering a
Licensed Product. Neoprobe shall own all resulting data and all rights arising
therefrom including, but not limited to, all data and rights arising out of any
BLA or NDA submitted by Neoprobe or any FDA approval thereof. Neoprobe grants to
Xxxx or its designees a right to reference such NDAs or BLAs and FDA approvals
thereof for the purposes of registration and governmental filing in the
Territory for products outside the scope of this Agreement.
8.02 Foreign Marketing Approvals. Neoprobe shall use reasonable
commercial efforts to carry out, at its own expense, all product development,
including, without limitation, regulatory and clinical work, testing or studies
relating to Licensed Products reasonably required for obtaining all regulatory
approvals needed to market, sell or use Licensed Products in countries of the
Territory other than the United States and Europe.
8.03 Maintenance of Regulatory Filings. Neoprobe shall use its
reasonable efforts to prepare, file, prosecute and maintain, during the term of
this Agreement, all necessary and appropriate applications, submissions and
filings, to the appropriate governmental authorities, to obtain marketing
approval for a Licensed Product in each country within the Territory.
8.04 Access to Regulatory Filings. In the event Neoprobe shall
terminate the Agreement pursuant to Section 5.02 herein or Xxxx shall terminate
this Agreement pursuant to Section 5.03, Section 5.04 or Section 6.05 herein,
Xxxx shall have the right to acquire rights to all regulatory submissions,
filing, data packages, e.g., INDs, NDAs, BLAs, European Dossiers owned by
Neoprobe at the time of such termination. The parties agree to negotiate in good
faith an agreement covering the nature of such rights and fee or cost to Xxxx
for such rights.
12
13
ARTICLE IX. PATENTS
9.01 Filing and Maintenance of Patents. Xxxx shall have responsibility
for the preparation, prosecution and maintenance of patent applications and
patents covering the Technology. Neoprobe shall have the right to designate the
countries in which foreign counterparts will be filed corresponding to a United
States patent application. Neoprobe shall bear all costs associated with such
foreign filing; provided however, that Xxxx shall be responsible for the
prosecution of such foreign applications. In the event Xxxx should license the
same foreign Patent Rights to a third party for use in a field outside the scope
of this Agreement, Xxxx shall equitably apportion the foreign patent expenses
among all of the licensees of foreign Patent Rights.
9.02 Patent Expenses. If Neoprobe decides at any time not to undertake
or continue incurring patenting expenses for any particular patent(s) or
application(s) included in the Patent Rights in or for any country other than
the United States, it shall notify Xxxx in writing ninety (90) days before such
patent(s) or patent application(s) will lapse or become abandoned or reasonably
timely before the time for filing such application(s) will expire. In such
event, Xxxx shall have the right to assume filing, prosecution, and maintenance
of such application(s) or patent(s) at its own expense and to terminate
Neoprobe's license with respect thereto.
9.03 Patent Term Extension. Neoprobe shall cooperate with Xxxx in
connection with the filing of all applications and filings necessary to obtain
the benefits under the Drug Price Competition and Patent Term Restoration Act of
1984 and any amendments thereto.
9.04 Response to Infringement of Patent Rights by Third Parties. If,
during the term of this Agreement, either party becomes aware of any third party
infringement or threatened infringement of any Patent Rights in the Territory,
the following provisions shall apply:
(a) The party having such knowledge shall promptly give notice to the
other party, with all available details.
(b) Xxxx shall have the right, but not the obligation, to bring suit in
its name, or in the name of Neoprobe if necessary, at its own expense
to restrain such infringement and to recover profits and damages.
Neoprobe agrees to being joined as a party plaintiff and to cooperate
in the prosecution thereof as is reasonably necessary, at Xxxx'x
expense. If Xxxx decides to undertake such suit, then Xxxx shall have
sole right to control prosecution, and the right to settle and
compromise such action with Neoprobe's prior written consent, which
shall not be unreasonably withheld.
13
14
9.05 Neoprobe's Rights If Xxxx Does Not Pursue Infringer. If Xxxx fails
to take action against an infringer pursuant to Section 9.04, within sixty (60)
days after notice from Neoprobe, then Neoprobe, at any time prior to Xxxx
thereafter filing an action, shall have the right but not the obligation to take
such action in its own name or in the name of Xxxx as it deems necessary or
appropriate. Xxxx shall cooperate with Neoprobe as is reasonably necessary in
any such action brought by Neoprobe. If Neoprobe brings legal action, Neoprobe
shall have the sole right to control prosecution, and the right to settle and
compromise such action with Xxxx'x prior written consent, which shall not be
unreasonably withheld.
9.06 Application of Monies Recovered From Infringer. In the event any
monetary recovery in connection with an infringement action brought pursuant to
either of Section 9.04 or Section 9.05 is obtained, such recovery shall be
applied in the following priority: first, to reimburse Xxxx and Neoprobe by the
proportion and up to the extent of their out-of-pocket expenses (including
reasonable attorneys' fees) in prosecuting such infringement; second, to be
shared by the proportion and up to the extent of any damages established,
including but not limited to Neoprobe's lost profits and Xxxx'x lost royalties;
third, the balance, if any, to be shared one-half by Xxxx and one-half by
Neoprobe.
9.07 Improvement Patents. During the term of this Agreement, if Xxxx
develops an improvement to any of the Technology licensed hereunder, such
improvement shall be included and shall become part of the Technology licensed
pursuant to the terms of this Agreement.
ARTICLE X. TERMINATION OF MAIN AGREEMENT
10.01 Termination. Effective immediately upon execution of this
Agreement by the last of the parties to sign. Xxxx and Neoprobe hereby agree,
that in consideration of the respective rights and obligations of the parties
set forth in this Agreement, the Technology Option Agreement dated March 14,
1996 attached hereto as Exhibit A shall be terminated and shall have no further
force and effect except that the obligation of confidentiality set forth in
Section 5.8 shall survive such termination.
ARTICLE XI. CONFIDENTIALITY
11.01 Confidential Information. Except for the proper exercise of any
rights granted or reserved under other provisions of this Agreement, each party
agrees that it will take such precautions as it normally takes with its own
confidential or proprietary information to keep confidential and not to publish
or otherwise disclose to a third party except as permitted or anticipated
herein, any information of a confidential or proprietary nature furnished by the
other
14
15
party to it in connection with this Agreement, including, without limitation,
technology, marketing strategy, specifications, product information, preclinical
and clinical data, inventions, processes, know-how, sales force information,
sales data, plans, trade secrets, call lists, business information, and adverse
reaction reports (together called "Confidential Information") without the prior
written consent of the other party, except to the extent that such Confidential
Information is required to be disclosed for the purpose of complying with law or
government regulations.
11.02 Period of Confidentiality. The obligation of confidentiality set
forth in Section 11.01 shall remain in effect for five (5) years from the
expiration or termination of this Agreement; provided that nothing in this
Article XI shall prevent disclosure or use by the receiving party of any part of
the Confidential Information of the other party which:
(a) was known or used by the receiving party prior to disclosure, as
evidenced by its written records made prior to the time of disclosure
hereunder;
(b) either before or after the time of disclosure becomes known to the
public other than by an unauthorized act or omission of the receiving
party;
(c) is lawfully disclosed to the receiving party by a third party
having the right to disclose said Confidential Information; or
(d) is developed by the receiving party independently from the
Confidential Information provided by the other party hereto as
evidenced by the receiving party's written records.
11.03 Right to Use Confidential Information. Notwithstanding the
restrictions set forth in this Article XI, each party shall be entitled at all
times to use all Confidential Information provided by the other party in order
to perform its obligations or exercise its rights under this Agreement.
11.04 Public Announcement. No press releases or other public
announcements concerning Neoprobe's appointment hereunder or concerning this
Agreement shall be made without the prior mutual consent of the parties.
11.05 Specific Terms Not To Be Disclosed. Neither Xxxx nor Neoprobe
shall publicly disclose the specific terms of this Agreement other than what may
be required by the Securities and Exchange Commission (SEC). Except as required
by SEC filings, the transactions contemplated hereby or performance hereunder
shall not be disclosed
15
16
without first obtaining the written consent of the other party unless there has
been a prior public disclosure of the information being disclosed by the other
party or with the other party's consent. Disclosure of the terms of this
Agreement to a third party under a written Confidentiality Agreement the terms
of which are equal in scope with the terms of this Article XI shall not be
considered a "public" disclosure that is prohibited by the Section 11.05.
ARTICLE XII. INDEMNIFICATION AND INSURANCE
12.01 Neoprobe Indemnity. Neoprobe agrees to indemnify, protect, and
defend Xxxx and hold Xxxx harmless from and against any claims, damages,
liabilities, harm, loss, costs, penalties, lawsuits, threats of lawsuit, recalls
or other governmental action, including reasonable attorneys' fees, which (i)
arise out of Neoprobe's breach of this Agreement or of any warranty or
representation made to Xxxx under this Agreement; or, (ii) which result from any
claim made against Xxxx or its Affiliates in connection with Neoprobe's
manufacture or sale of Licensed Product. Xxxx, upon the filing of any such legal
claim or lawsuit against it, shall promptly notify Neoprobe, in writing of any
such claim and Neoprobe shall, at its expense, with attorneys reasonably
acceptable to Xxxx, handle, defend, and control such claim or lawsuit.
12.02 Xxxx Indemnity. Xxxx agrees to indemnify, protect, and defend
Neoprobe and hold Neoprobe harmless from and against any claims, damages,
liability, harm, loss, costs, penalties, lawsuits, threats of lawsuit, recalls
or other governmental action, including reasonable attorneys' fees, which arise
as the result of Xxxx'x breach of this Agreement or of any warranty or
representation made to Neoprobe under this Agreement. Neoprobe shall, upon the
filing of any such legal claim or lawsuit against it, promptly notify Xxxx, in
writing, of any such claim and Xxxx shall, at its expense, with attorneys
reasonably acceptable to Neoprobe, handle, defend and control such claim or
lawsuit.
12.03 Neoprobe Insurance. Neoprobe shall obtain and/or keep in force
during the term of this Agreement, including any renewals thereof, policies of
insurance covering the Licensed Product and general comprehensive liability
covering the sale and distribution of Licensed Product, in the Territory. Such
insurance shall include the name Xxxx as an additional insured and shall provide
that it shall not be canceled by the insurer without thirty (30) days' prior
written notice thereof to Xxxx. Neoprobe shall supply Xxxx with a certificate of
insurance evidencing that such insurance is in force.
16
17
ARTICLE XIII. REPRESENTATIONS & WARRANTIES
13.01 Xxxx Authorization. Xxxx hereby represents and warrants that it
is a corporation duly organized, validly existing and in good standing under the
laws of the State of Delaware, and that the execution, delivery and performance
of this Agreement have been fully authorized by the Board of Directors of Xxxx.
13.02 Ownership of Patent Rights. Xxxx hereby represents and warrants
that it holds full right and title to the Patent Rights listed in Schedule 1.14
attached hereto and that it has not entered into any other contract, or
agreement which prohibits or would prohibit the execution and delivery of this
Agreement or the granting of the license set forth herein.
13.03 Third Party Infringement. Xxxx hereby represents and warrants
that as of the Effective Date, to the best of its knowledge and belief, there
are no third party infringements of the Patent Rights of which it is aware.
13.04 Neoprobe Authorization. Neoprobe hereby represents and warrants
that it is a corporation duly organized, validly existing and in good standing
under the laws of the State of Delaware, and that the execution, delivery and
performance of this Agreement have been fully authorized by the Board of
Directors of Neoprobe.
13.05 Diligent Efforts. Neoprobe represents and warrants that it shall
diligently exert good faith efforts to obtain health regulatory approvals to
market Licensed Product in the countries of the Territory and to develop and
promote the most extensive sales of Licensed Products under the license granted
in Section 2.01 herein as are commercially practical and compatible with good
business practice in the pharmaceutical industry.
ARTICLE XIV. MISCELLANEOUS
14.01 Force Majeure. Except as specifically set forth herein, neither
Xxxx nor Neoprobe shall be in default under this Agreement nor liable for any
failure to perform or for delay in performance resulting from any cause beyond
its reasonable control or due to compliance with any regulations, orders, or act
of any federal, provincial, state or municipal government, or any department or
agency thereof, civil or military authority; acts of God, acts or omissions of
the other party, fires, floods or weather; strikes or lockouts; factory
shutdowns, embargoes, wares, hostilities or riots; delays or shortages in
transportation; or inability to obtain labor, manufacturing facilities or
material.
14.02 Taxes. Each of the parties shall bear all taxes imposed on it as
a result of its performance or receipt of funds under this Agreement including,
but not restricted to, any sales tax, any tax on or measured by any royalty or
other payment required to be made by it hereunder, any registration tax, any tax
imposed with respect to the granting of or transfer of licenses or other rights
hereunder or the payment or receipt of royalties hereunder. The parties shall
cooperate fully with each other in obtaining and filing all requisite
certificates and documents with the appropriate authorities and shall take such
further action as may reasonably be necessary to avoid the deduction of any
withholding or similar taxes from any remittance of funds by Neoprobe to Xxxx
hereunder.
17
18
14.03 Marking. The labeling and/or packaging of all Licensed Product
made by or for Neoprobe and sold by or for Neoprobe in the United States shall
contain the following legend: "Licensed Under U.S. Xxx. ______________."" or
such other legend as shall be mutually agreed to by the parties and which shall
be sufficient to provide notice of the existence of the Patent Rights to third
parties.
14.04 Notice. All notices, proposals, submissions, offers, approvals,
agreements, elections, consents, acceptances, waivers, reports, plans, requests,
instructions and other communications required or permitted to be made or given
hereunder (all of the foregoing hereinafter collectively referred to as
"Communications") shall be in writing, and shall be deemed to have been duly
made or given when: a) delivered personally with receipt acknowledged; b) sent
by registered or certified mail or equivalent, return receipt requested, or c)
sent by facsimile or telex (which shall promptly be confirmed by a writing sent
by registered or certified mail or equivalent, return receipt requested), or d)
sent by recognized overnight courier for delivery within twenty-four (24) hours,
in each case addressed or sent to the parties at the following addresses and
facsimile numbers or to such other or additional address or facsimile as any
party shall hereafter specify by Communication to the other parties:
TO NEOPROBE: TO XXXX TECHNOLOGIES, INC.:
Xxxxx X. Xxxx President
President and CEO Xxxx Technologies, Inc.
Neoprobe Corporation Xxxxxxx-Xxxxx Building
000 Xxxxx Xxxxx Xxxxx, Xxxxx 000 0000 Xxxxxx Xxxx Xxxxx
Xxxxxx, Xxxx 00000 Xxxxxxxx, Xxxx 00000-0000
Fax No.: 000-000-0000 Fax No.: 000-000-0000
Copy to: P.A. Xxxxxx
Vice President and General Counsel
Communications shall be deemed to have been given, received and dated
on the Notice of change of address shall be deemed given when actually received,
all other earlier of: (i) when actually received, or on the date when delivered
personally; (ii) one (1) day after being sent by facsimile, cable, telex (each
promptly confirmed by a writing as aforesaid) or overnight courier; or four (4)
business days after mailing.
18
19
14.05 Agreement Subject to Applicable Law. Xxxx agrees that its rights
under this Agreement shall be subject to any limitations or restrictions imposed
on Neoprobe by the laws or regulations of the U.S. or any respective agency
thereof, and Xxxx agrees to take no action which would cause Neoprobe to be in
violation of any such laws or regulations.
14.06 Governing Law. This Agreement shall be construed and governed by
the laws of the State of Ohio and adjudicated within the exclusive jurisdiction
of the courts of the State of Ohio, Franklin County. If any provision of this
Agreement including, but not limited to, the waiver of claims under any
particular statute, should be deemed unenforceable, the remaining provisions
shall, to the extent possible, be carried into effect, taking into account the
general purpose and spirit of this Agreement.
14.07 Other Instruments. The parties hereto covenant and agree that
they will execute such other and further instruments and documents as are or may
become reasonably necessary or convenient to effectuate and carry out the
provisions of this Agreement or may be reasonably requested by the other party.
14.08 Legal Construction. In case any one or more of the provisions
contained in this Agreement shall be invalid or unenforceable in any respect,
the validity and enforceability of the remaining provisions contained herein
shall not in any way be affected or impaired thereby and the parties will
attempt to agree upon a valid and enforceable provision which shall be a
reasonable substitute for such invalid and unenforceable provision in light of
the tenor of this Agreement, and, upon so agreeing, shall incorporate such
substitute provision in this Agreement.
14.09 Entire Agreement, Modification, Consents and Waivers. This
Agreement supersedes all prior agreements, written or oral, between the parties
whether with respect to the subject matter herein, and contains the entire
agreement of the parties with respect to the subject matter hereof and, except
as provided herein, no interpretation, change, termination or waiver of or
extension of time for performance under any provision of this Agreement shall be
binding upon any party unless in writing and signed by the party intended to be
bound thereby. Receipt by any party of money or other consideration due under
this Agreement, with or without knowledge of breach, shall not constitute a
waiver of such breach or any provision of this Agreement. Except as otherwise
provided in this Agreement, no waiver of or other failure to exercise any right
under, or default or extension of time for performance under, any provision of
this Agreement shall affect the right of any party to exercise any subsequent
right under or otherwise enforce said provision or any other provision hereof or
to exercise any right or remedy in the event of any other default, whether or
not similar.
14.10 Relationship. Nothing contained in this Agreement shall be deemed
to create a partnership or joint venture between the parties, and each of the
parties shall in all matters connected herewith be independent contractors.
Neither of the parties hereto shall hold itself out as the agent of the other,
nor shall either of the parties incur any indebtedness or obligation in the name
of, or which shall be binding on the other, without the prior written consent of
19
20
the other. No employees, agents, or sales representatives of either party shall
be deemed employees, agents or sales representatives of the other party.
14.11 Section Headings; Construction. The section headings and titles
contained herein are each for reference only and shall not be deemed to affect
the meaning or interpretation of this Agreement. The words "hereby", "herein",
"hereinabove", "hereinafter", "hereof" and "hereunder, when used anywhere in
this Agreement, refer to this Agreement as a whole and not merely to a
subdivision in which such words appear, unless the context otherwise requires.
The singular shall include the plural, the conjunctive shall include the
disjunctive and the masculine gender shall include the feminine and neuter, and
vice versa, unless the context otherwise requires.
14.12 Execution Counterparts. This Agreement may be executed in any
number of counterparts and each duplicate counterpart shall constitute an
original, any one of which may be introduced in evidence or used for any other
purpose without the production of its duplicate counterpart. Moreover,
notwithstanding that any of the parties did not execute the same counterpart,
each counterpart shall be deemed for all purposes to be an original, and all
such counterparts shall constitute one and the same instrument, binding on all
of the parties hereto. 14.13 Consents and Approval. Unless otherwise expressly
provided herein, whenever in this Agreement a consent or approval is to be given
by any party hereto, such consent or approval may be given or withheld, as the
case may be, in the sole and absolute discretion of such party.
ARTICLE XV. BINDING EFFECT, ASSIGNMENT
15.01 Binding Effect, Assignment. This Agreement shall inure to the
benefit and be binding upon each of the parties hereto and their respective
successors and assigns. Neither this Agreement, nor any of the rights and
obligations under this Agreement, may be assigned, transferred or otherwise
disposed of by either party without the prior consent of the other party, such
consent not to be unreasonably withheld.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to
be executed by their respective officer hereunto duly authorized as of the date
first written hereinabove.
NEOPROBE CORPORATION XXXX TECHNOLOGIES, INC.
By: /s/ XXXXX XXXX By: /s/ XXXXXXX X. XXXXX
----------------------------------- ---------------------------
Xxxxx Xxxx
Title: President and Title: President
Chief Executive Officer
20
21
EXHIBIT A
(Copy of Technology Option Agreement Dated March 14, 1996)
21
22
SCHEDULE 1.03
List of Countries Making Up the Far East
----------------------------------------
Australia Phillippines
China Singapore
Xxxxxxxxx Xxxxx Xxxxx
Xxxxx Xxxxxx
Xxxx Xxxx Xxxxxxxx
Malaysia New Zealand
22
23
SCHEDULE 1.14
Patent Rights
-------------
CELLULAR IMMUNOTHERAPY
Docket #: CIR001-4 Serial #: 943993 Filing Date: 03 - OC - 0000
Xxxxxxx: Xxxxxx Xxxxxx Patent #: Patent Date: None
Atty.: X. X. Xxxxxxx, Xx. Assignee: XXXX TECH, INC. Exp. Date: None
EXPANSION OF CYTOKINE-PRODUCING CELLS FROM LYMPH NODES INFECTED WITH HIV
Docket #: CIR001PC Serial #: US97/02309 Filing Date: 20 - FE - 1997
Country: Patent Coop Treaty Patent #: Patent Date: None
Atty: X. X. Xxxxxxx, Xx. Assignee: Xxxx Tech, Inc. Exp. Date: None
23
