EXHIBIT 10.59
LICENSE AGREEMENT
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This License Agreement ("Agreement") effective as of August 4, 1999
(the "Effective Date"), is entered into by and between NORTHWESTERN UNIVERSITY,
an Illinois corporation located at 633 Clark Street, Evanston, Illinois 60201
and TECHNICLONE CORPORATION, a Delaware corporation ("TECHNICLONE") located at
14282 Franklin Avenue, Tustin, California 92780-7017.
R E C I T A L S
A. In the course of research conducted at NORTHWESTERN UNIVERSITY,
Professor Alan Epstein (the "Inventor") has produced inventions, the titles of
which are also listed in Exhibit "A" (the "Inventions").
B. WHEREAS, the Inventions described were made under support from the
National Institutes of Health of the Department of Health and Human Services and
NORTHWESTERN UNIVERSITY has acquired rights thereto pursuant to P.L. 96-517, and
if a conflict arises between the conditions of this Agreement and the rights of
the Federal Government, TECHNICLONE's rights would be subordinate to the
legitimate rights of the Federal Government, and
C. TECHNICLONE has obtained a license to the Licensed Technology (as
hereinafter defined), and NORTHWESTERN UNIVERSITY granted such a license to
TECHNICLONE pursuant to that certain License Agreement dated June 12, 1985, as
amended pursuant to that certain Amendment effective October, 1987 (the "Prior
License Agreement").
D. NORTHWESTERN UNIVERSITY and TECHNICLONE desire to amend and restate
that certain Prior License Agreement and desire that this Agreement supercede
the Prior License Agreement in its entirety.
NOW, THEREFORE, in consideration of the foregoing, and the covenants
and promises contained herein, the sufficiency of which are hereby acknowledged
by the parties, NORTHWESTERN UNIVERSITY and TECHNICLONE hereby agree as follows:
ARTICLE I
DEFINITIONS
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As used in this Agreement, the following terms shall be defined as set
forth below:
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1.1 "AFFILIATE" shall mean any person, corporation, partnership, firm,
joint venture or other entity which, directly or indirectly, through one or more
intermediaries, controls, is controlled by, or is under common control with,
another person, corporation, partnership, firm, joint venture or other entity,
as the case may be. As used in this definition, "control" means the possession
of power to direct or cause the direction of the management and policies of an
entity, whether through the ownership of the outstanding voting securities or by
contract or otherwise.
1.2 "IMPROVEMENT(S)" shall mean inventions or other improvements which
relate to or are based on the Inventions and which are within the scope of the
then existing Licensed Patents. An Improvement shall be within the scope of a
Licensed Patent if covered by a claim, either literally or under the doctrine of
equivalents.
1.3 "INVENTIONS" shall mean the inventions of the Inventor as described
in Exhibit "A" attached hereto and incorporated herein by this reference.
1.4 "LICENSED PATENTS" shall mean all United States and foreign patents
and applications for patents owned by NORTHWESTERN UNIVERSITY, and filed prior
to the date of or during the term of this Agreement relating to any of the
Invention(s), including, in each case, all foreign and domestic patents issuing
on any of the foregoing applications, and all reissues, renewals,
reexaminations, extensions, continuations, continuations-in-part, provisionals
and divisionals of each of the preceding. The Licensed Patents that are pending
or issued as of the date of this Agreement are set forth in EXHIBIT "B." For
purposes of this Agreement, any United States or foreign patents and/or
applications for patents owned by NORTHWESTERN UNIVERSITY relating to an
Improvement shall be treated as Licensed Patents for all purposes whatsoever.
1.5 "LICENSED PRODUCTS" shall mean all products derived from a
combination of LYM-1 antibody or LYM-2 antibody plus the radioactive Iodine 131
combination.
1.6 "LICENSED TECHNOLOGY" shall mean the Licensed Patents and the
Technical Information.
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1.7 "NET SALES" shall mean the revenues actually received by
Sublicensees generated from the sale of the Licensed Products by such
Sublicensees to third parties in Territory A and Territory B; less reasonable
and customary deductions applicable to the Licensed Products for: (i)
transportation charges and charges such as insurance, relating to transportation
paid by the selling party; (ii) sales and excise taxes or customers duties paid
by the selling party and any other governmental charges imposed upon the sale of
the Licensed Products and paid by the selling party; (iii) distributors' fees,
rebates or allowances; (iv) quantity discounts, cash discounts or chargebacks in
the ordinary course of business in connection with the sale of the Licensed
Products; (v) allowances or credits to customers, not in excess of the selling
price of the Licensed Products, on account of governmental requirements,
rejection, outdating, recalls or return of the Licensed Products; (vi) costs of
customer programs such as cost effectiveness or patient or physician assistance
programs designed to aid in patient compliance to maintain medication schedules
and which are reasonably required to be carried out in order to effect a sale of
the Licensed Products; and (vii) a deduction for actual bad debts no to exceed
1%. Sales of the Licensed Products solely for research or clinical testing
purposes shall be excluded from the computation of Net Sales. Licensed Products
shall be considered sold when sold or invoiced to a third party, and if not sold
or invoiced, when delivered to a third party.
1.8 "QUARTER YEAR" shall mean the three-month periods ending March
31st, June 30th, September 30th and December 31st of each Royalty Year.
1.9 "ROYALTY YEAR" shall mean each twelve-month period commencing
January 1st and ending December 31st during the term of this Agreement. For the
first year of this Agreement, the Royalty Year shall be the period of time
between the signing of this Agreement and December 31st of such year.
1.10 "SUBLICENSEE" shall mean a person or entity to whom TECHNICLONE
has granted the right under the Licensed Technology to develop, manufacture,
have manufactured, use, market, distribute and/or sell the Licensed Products.
1.11 "TECHNICAL INFORMATION" shall mean NORTHWESTERN UNIVERSITY's
technical information and know-how relating to the preparation of Licensed
Products including, but not limited to the maintenance of hybridomas, medical
diagnostic and therapeutic procedures and methods for characterizing antigenic
material utilizing monoclonal antibodies produced from such hybridomas,
purification schemes, bioassay and immunoassay procedures and methods of
evaluation.
1.12 "TERRITORY A" shall mean the United States of America [, including
Guam and Puerto Rico.]
1.13 "TERRITORY B" shall mean all countries, territories and
jurisdictions of the world, other than Territory A.
1.14 "VALID CLAIM" shall mean a claim of any issues, unexpired United
States or foreign patent, as applicable, which shall not have been withdrawn,
canceled or disclaimed or held invalid or unenforceable by a court of competent
jurisdiction in an unappealed or unappealable decision.
ARTICLE II
GRANT OF LICENSE
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2.1 GRANT. Subject to the terms and conditions of this Agreement,
NORTHWESTERN UNIVERSITY hereby grants and TECHNICLONE hereby accepts a worldwide
exclusive license under the Licensed Technology, to develop, manufacture, have
manufactured, use, market, import, have imported, offer for sale and sell
Licensed Products.
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2.2 SUBLICENSE. TECHNICLONE shall have the right to further license,
sublicense or subcontract all or any part of the rights hereby licensed to it
without the prior written consent of NORTHWESTERN UNIVERSITY. TECHNICLONE shall
promptly notify NORTHWESTERN UNIVERSITY in writing at the time of each such
license, sublicense or subcontract. Notwithstanding the foregoing, NORTHWESTERN
UNIVERSITY shall retain the right to approve any complete transfer or assignment
of this Agreement by TECHNICLONE prior to such transfer or assignment, which
approval shall not unreasonably be withheld or delayed.
2.3 RETENTION OF RIGHTS. NORTHWESTERN UNIVERSITY and its affiliates
shall retain the nontransferable right to make, use and practice the Licensed
Technology for their own noncommercial purposes. NORTHWESTERN UNIVERSITY may
publish and disseminate the Technical Information and may furnish the Licensed
Products produced by the hybridomas accepted by TECHNICLONE to third parties for
non-commercial research oriented purposes. NORTHWESTERN UNIVERSITY will inform
any third party receiving material under this Section that the hybridomas are
the property of NORTHWESTERN UNIVERSITY and that they can only be used for
non-commercial research and cannot be further distributed without the written
permission of NORTHWESTERN UNIVERSITY.
2.4 THIRD PARTY LICENSES. The parties recognize that TECHNICLONE may
encounter patents held by third parties and that licenses between NORTHWESTERN
UNIVERSITY or TECHNICLONE and such third parties may be necessary in order to
enable TECHNICLONE to develop, make or market certain Licensed Products. In that
event, TECHNICLONE has the right to enter into licensing agreements with such
third parties, provided NORTHWESTERN UNIVERSITY is consulted a reasonable time
before hand. In the event that TECHNICLONE is obligated to pay royalties to such
a third party and/or other amounts to acquire such a license, TECHNICLONE shall
be entitled to credit against the royalties otherwise payable to NORTHWESTERN
UNIVERSITY hereunder an amount equal to one-half (1/2) the sum of earned
royalties and other amounts paid to such third party(ies) to acquire access to
or use of such third party's intellectual property rights.
ARTICLE III
ROYALTIES AND OTHER PAYMENTS
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3.1 ROYALTIES. In consideration for the license granted hereunder,
during the term of this Agreement, TECHNICLONE shall pay to NORTHWESTERN
UNIVERSITY the following royalty amounts with respect to Net Sales:
TERRITORY DURATION OF ROYALTY PERIOD ROYALTY AMOUNT
Territory A Until February 5, 2009; 3% of Net Sales;
provided, that no royalties are provided, that the royalty
payable if and to the extent shall be 1.5% if there is
TECHNICLONE does not a generic form of the
receive any revenue from Net Sales Licensed Product sold
In Territory A in Territory A
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Territory B Until February 5, 2009; 1% of Net Sales;
provided, that if any patent filed by provided that the royalty
NORTHWESTERN is issued after the shall be 0.5% with respect
date of execution of this Agreement to a particular country in
for any country in Territory B, the Territory B if a generic
Royalty Period with respect to that form of the Licensed
particular country will continue until Product is sold in such
the expiration of such patent; provided, country
further that no royalties are payable if
and to the extent TECHNICLONE
does not receive any revenue from Net
Sales in any country in Territory B
Notwithstanding the foregoing, the Royalty Amount shall be subject to
adjustment if the Licensed Product consists of a LYM-1 antibody or LYM-2
antibody with a non-radiolabeled therapeutic (e.g., alpha interferon or gamma
interferon), as follows:
Where:
x = cost of goods sold attributable to the LYM component of the
Licensed Product; and
y = cost of goods sold for the entire Licensed Product;
the Royalty Amount shall be equal to the product of (i) the applicable
Royalty Amount set forth in the table above, multiplied by (ii) x divided by y.
3.2 PAYMENTS. Royalty payments are nonrefundable and shall be paid in
United States dollars at the address designated for NORTHWESTERN UNIVERSITY in
Article X of this Agreement or at such other place as NORTHWESTERN UNIVERSITY
may reasonably designate and shall be payable on the seventieth (70th) day after
each Quarter Year.
ARTICLE IV
REPORTS AND RECORDS
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4.1 ROYALTY REPORTS. TECHNICLONE shall deliver to NORTHWESTERN
UNIVERSITY true and accurate reports, giving such particulars of the business
conducted by TECHNICLONE during the preceding three-month period, under this
Agreement, that shall be pertinent to a royalty accounting hereunder. Within
seventy (70) days after each Quarter Year, TECHNICLONE shall deliver to
NORTHWESTERN UNIVERSITY true and accurate reports, giving such particulars of
the business conducted by its Sublicensees during the preceding three-month
period, under this Agreement, that shall be pertinent to a royalty accounting
hereunder. NORTHWESTERN UNIVERSITY agrees to hold all information in such
royalty reports in confidence pursuant to the provisions of SECTION 10.12,
except as necessary to communicate and/or investigate TECHNICLONE's
non-compliance with this Agreement. With each such report submitted, TECHNICLONE
shall pay to NORTHWESTERN UNIVERSITY the royalties due and payable under this
Agreement. If no royalties shall be due, TECHNICLONE shall so report.
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4.2 RETENTION OF BOOKS AND RECORDS. TECHNICLONE shall make and retain
for a period of three (3) years following the period of each report required by
this Article true and accurate records, files and books of account containing
all the data reasonably required for the full computation and verification of
gross sales, gross revenues and other information required in SECTION 4.1. Such
books and records shall be in accordance with generally accepted accounting
principles consistently applied and shall be kept at TECHNICLONE's principal
place of business. TECHNICLONE shall permit the inspection of such records,
files and books of account by an independent certified public accountant chosen
by NORTHWESTERN UNIVERSITY and reasonably acceptable to TECHNICLONE during
regular business hours upon five (5) business days' written notice to
TECHNICLONE, to the extent necessary to verify compliance with this Agreement.
Such inspection shall not be made more than two times each calendar year or more
than once for any period unless an error is discovered, or other good cause. All
costs of such inspection and copying shall be paid by NORTHWESTERN UNIVERSITY,
provided that if any such inspection shall reveal that an error has been made in
the amount equal to 5% or more of such payment, such costs shall be borne by
TECHNICLONE.
4.3 PAYMENTS AFTER TERMINATION. If this Agreement should be terminated
at any time other than at the end of the Quarter Year or Royalty Year, the last
report and payment shall be made within one hundred (100) days after the
effective date of such termination on, and shall include any royalties through
the date of termination; provided, however, TECHNICLONE shall provide
NORTHWESTERN UNIVERSITY with a report setting forth the amount of any inventory
of Licensed Products not sold as of the date of termination, and TECHNICLONE
shall continue to render royalty reports with respect to Net Revenue actually
received by TECHNICLONE from sales of such existing inventory and to make
payments in accordance with the terms of this Agreement as though this Agreement
were still in effect.
ARTICLE V
PATENT PROSECUTION
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5.1 PATENTS.
(a) If during the term of this Agreement NORTHWESTERN
UNIVERSITY elects to file patent applications or otherwise obtain patent rights
related to the Inventions or Licensed Products as defined in this Agreement,
such applications shall become included in the Licensed Patents defined
hereunder.
(b) TECHNICLONE shall, upon written request from
NORTHWESTERN UNIVERSITY, bear all (100%) of the reasonable costs for the
preparation, filing and prosecuting of the United States patent applications
included in the Licensed Patents, but in no case beyond an appeal to and a
decision by the United States Patent and Trademark Office Board of Appeals,
unless TECHNICLONE specifically agrees otherwise in writing.
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(c) TECHNICLONE shall indicate to NORTHWESTERN UNIVERSITY in
which countries, if any, it wishes NORTHWESTERN UNIVERSITY to file patent
applications related to United States patent applications in the Licensed
Patents. Such selection of countries will be made in writing by TECHNICLONE to
NORTHWESTERN UNIVERSITY within nine (9) months after the filing date of any
corresponding U.S. application. Notwithstanding the foregoing, nothing shall
prevent or otherwise limit TECHNICLONE and/or its Sublicensees from preparing,
filing, prosecuting, maintaining patent applications and patents in such
countries other than the United States which TECHNICLONE or its Sublicensees
wishes to include under the Licensed Patents of this Agreement.
(d) TECHNICLONE agrees to pay or to cause its Sublicensees
to pay for all reasonable fees and expenses for preparation, prosecution,
maintenance and taxes relating to the filing and maintenance of patent
applications and patents in such countries other than the United States which
TECHNICLONE or its Sublicensees wishes to include under the Licensed Patents of
this Agreement.
(e) If TECHNICLONE elects to discontinue any patents under
this Section for preparation, filing, prosecuting or maintaining any patent
application or, patent in any country, the license granted under this Agreement
with respect to said patent application or patent in such country shall
terminate.
ARTICLE VI
INFRINGEMENT
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6.1 NOTICE OF INFRINGEMENT BY THIRD PARTIES. TECHNICLONE shall inform
NORTHWESTERN UNIVERSITY promptly in writing of any apparent infringement by a
third party discovered by it with respect to any patent issuing from the
Licensed Patents and of any available evidence thereof.
6.2 PROSECUTION OF INFRINGEMENT CLAIMS. During the term of this
Agreement, NORTHWESTERN UNIVERSITY shall have the right, but shall not be
obligated, to prosecute at its own expense all infringements of any patent
issuing from the Licensed Patents and, in furtherance of such right, TECHNICLONE
hereby agrees that NORTHWESTERN UNIVERSITY may include TECHNICLONE as a party
plaintiff (but not as a defendant or respondent or counter claimant) in such
suit, without expense to TECHNICLONE. The full cost and expense of any such
action so commenced or so defended by NORTHWESTERN UNIVERSITY shall be the
responsibility of and paid for by NORTHWESTERN and NORTHWESTERN shall keep any
recovery or damages for past infringement derived therefrom. No settlement,
consent judgment or other voluntary final disposition of the suit may be entered
into without the consent of TECHNICLONE, which consent shall not unreasonably be
withheld or delayed. NORTHWESTERN UNIVERSITY shall indemnify TECHNICLONE against
any order for costs that may be made against TECHNICLONE in such proceedings.
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6.3 TECHNICLONE RIGHT TO PROSECUTE. If within six (6) months after
having been notified of any alleged or apparent infringement, NORTHWESTERN
UNIVERSITY shall have been unsuccessful in persuading the alleged infringer to
cease and desist such alleged infringement and shall not have brought and shall
not be diligently prosecuting an infringement action, or if NORTHWESTERN
UNIVERSITY shall notify TECHNICLONE at any time prior thereto of its intention
not to bring suit against any alleged infringer, then TECHNICLONE shall have the
right, but shall not be obligated, to prosecute at its own expense any
infringement of any patent issuing from the Licensed Patents and, in furtherance
of such right, NORTHWESTERN UNIVERSITY hereby agrees that TECHNICLONE may
include NORTHWESTERN UNIVERSITY as a party plaintiff (but not as a defendant or
respondent or counter claimant) in such suit; provided, however, that such right
to bring such infringement action shall remain in effect only for so long as the
license granted herein remains exclusive in accordance with the terms hereof. No
settlement, consent judgment or other voluntary final disposition of the suit
may be entered into without the consent of NORTHWESTERN UNIVERSITY, which
consent shall not unreasonably be withheld or delayed. TECHNICLONE shall
indemnify NORTHWESTERN UNIVERSITY against any order for costs that may be made
against NORTHWESTERN UNIVERSITY in such proceedings. TECHNICLONE shall keep any
recovery or damages for past infringement derived therefrom; provided, however,
that such recovery, less expenses (including reasonable attorneys' fees and
disbursements) shall be treated as Net Sales for the purpose of calculating
royalties under paragraph 3.1 hereof.
6.4 DECLARATORY JUDGMENT ACTION. If a declaratory judgment action
alleging invalidity or noninfringement of any patent issuing from the Licensed
Patents shall be brought against TECHNICLONE, NORTHWESTERN UNIVERSITY, at its
option, shall have the right, within thirty (30) days after it receives notice
of the commencement of such action, to intervene and take over the sole defense
of the action at its own expense. No settlement, consent judgment or other
voluntary final disposition of such action may be entered into without the
consent of TECHNICLONE, which consent shall not unreasonably be withheld or
delayed. NORTHWESTERN UNIVERSITY shall indemnify TECHNICLONE against any order
for costs that may be made against TECHNICLONE in such action or the related
proceedings.
6.5 COOPERATION OF THE PARTIES. In any infringement suit or action that
either party may institute to enforce the patents issuing from the Licensed
Patents pursuant to this Agreement, the other party hereto shall, at the
reasonably request and expense of the party initiating such suit, cooperate in
all reasonably respects and, to the extent possible, have its employees testify
when reasonably requested to do so and make available relevant records, papers,
information, samples, specimens and the like, subject to an order or agreement
of confidentiality reasonably acceptable to such other party with respect to any
such records, papers, information, samples, specimens or the like which are not
within the public domain or are not otherwise already generally disclosed or
available to the public.
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6.6 RIGHT TO LICENSE OR SUBLICENSE TO ALLEGED INFRINGER. TECHNICLONE,
during the term of this Agreement, shall have the sole right in accordance with
the terms and conditions hereof, to license or sublicense to any alleged
infringer for future use of any of the patents issuing from the Licensed
Patents. Any upfront fees as part of such a license or sublicense shall be
shared equally between TECHNICLONE and NORTHWESTERN UNIVERSITY and any royalties
generated from such a license or sublicense shall be treated as Net Sales for
the purpose of calculating royalties under paragraph 3.1 hereof.
6.7 RIGHT TO MONITOR PROCEEDINGS. With respect to any suit, action or
proceeding which only one of the parties has instituted as provided above in
this Article VI, if reasonably requested by the other party, such party shall
make available to the other party any documents and materials that are relevant
to the other party's interests in such suit, action or proceeding; provided,
that the disclosure of such documents and materials to the other party would not
impair such party's prosecution of such suit, action or proceeding.
ARTICLE VII
INDEMNIFICATION
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TECHNICLONE agrees to indemnify, hold harmless and defend NORTHWESTERN
UNIVERSITY, its officers, employees, and agents against any and all claims,
suits, losses, damage, costs, fees, and expenses resulting from or arising out
of the development, manufacture, use, marketing or sale of the Licensed Products
by TECHNICLONE, its Sublicensee(s) and others purchasing and/or receiving the
Licensed Product. If any claims is asserted against NORTHWESTERN UNIVERSITY or
TECHNICLONE, or any of their respective officers, directors, trustees,
employees, agents or representatives, or such person is made a party defendant
in any action involving a matter which is the subject of TECHNICLONE's
indemnification hereunder, or NORTHWESTERN UNIVERSITY or TECHNICLONE becomes
aware of a claim or patent which might provide the basis for a third party's
claim of infringement against TECHNICLONE, its Affiliates, Sublicensee(s) or
permitted assignees as a result of the development, manufacture, use, marketing
or sale of a Licensed Product, then within thirty (30) days of receipt by
NORTHWESTERN UNIVERSITY or by TECHNICLONE of notice of any such event, and
within ten (10) days of such party's receipt of a written complaint or other
formal pleading regarding any such event, such party shall give the other party
hereto written notice thereof.
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If TECHNICLONE or NORTHWESTERN UNIVERSITY receives notice of a claim or
action by a third party alleging infringement of such third party's rights in
connection with the development, manufacture, use, marketing or sale of a
Licensed Product by TECHNICLONE, its Sublicensees or permitted assignees,
TECHNICLONE or its Sublicensees shall have the right to conduct the legal
defense, but shall not enter into any settlement, consent judgment or final
voluntary disposition that admits that any Licensed Product infringes any third
party right, without NORTHWESTERN UNIVERSITY's prior written consent to such
disposition, which consent shall not be unreasonably withheld or delayed. All
costs of TECHNICLONE's and its Sublicensees' defense, including their respective
attorneys' fees and costs, and any damages awarded or amounts paid in settlement
in any such claim or action shall be the sole responsibility of TECHNICLONE and
such Sublicensees, except to the extent that such damages or amounts relate to
the validity of any of the patents issuing from a Licensed Product. NORTHWESTERN
UNIVERSITY shall cooperate with TECHNICLONE if requested to do so by TECHNICLONE
or its Sublicensees, in its defense of such infringement claim or action,
provided that TECHNICLONE or such Sublicensees shall reimburse NORTHWESTERN
UNIVERSITY for all out-of-pocket expenses incurred by it in providing such
cooperation.
ARTICLE VIII
LAWS AND REGULATIONS
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TECHNICLONE shall use commercially reasonable best efforts to comply
with all foreign and United States federal, state and local laws, regulations,
rules and orders applicable to the testing, production, transportation,
packaging, labeling, export, sale and use of the Licensed Products. NORTHWESTERN
UNIVERSITY agrees to use reasonable efforts to cooperate with TECHNICLONE at
TECHNICLONE's expense, in connection with any filings required by any
governmental entity.
ARTICLE IX
TERM OF LICENSE; TERMINATION OF LICENSE
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9.1 TERM. Unless sooner terminated according to the provisions of this
Agreement, the term of the license granted hereunder shall commence upon the
execution hereof, and shall terminate on February 5, 2009; provided, that if any
patent filed by NORTHWESTERN is issued after the date of execution of this
Agreement for any country in Territory B, the term of the license granted
hereunder with respect to that particular country will continue until the
expiration of such patent (which shall be deemed to be a Licensed Patent for
purposes of this Agreement). Notwithstanding the foregoing, the term of the
license granted hereunder shall terminate with respect to a particular country
if and to the extent that TECHNICLONE no longer receives Net Sales from sales of
the Licensed Products in such country for a period of four (4) consecutive
fiscal quarters after commercial sales of such Licensed Product have commenced
in such country.
9.2 TERMINATION.
(a) If TECHNICLONE shall become bankrupt or insolvent and/or
if the business of TECHNICLONE shall be placed in the hands of a receiver,
assignee, or trustee. whether by the voluntary act of TECHNICLONE or otherwise,
this License Agreement may be terminated at the option of NORTHWESTERN
UNIVERSITY upon written notice to TECHNICLONE; provided, however, that such
termination shall not terminate any obligations of TECHNICLONE to NORTHWESTERN
UNIVERSITY that may have accrued thereto.
(b) Upon any breach or default under this Agreement by
TECHNICLONE, NORTHWESTERN UNIVERSITY may terminate this Agreement by giving
ninety (90) days written notice by certified or registered mail, return receipt
requested. Said notice shall become effective at the end of said period, unless
during said period TECHNICLONE shall cure such breach or default to the
reasonable satisfaction of NORTHWESTERN UNIVERSITY.
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(c) TECHNICLONE may terminate this Agreement at any time
upon ninety (90) days written notice by certified or registered mail, return
receipt requested, to NORTHWESTERN UNIVERSITY.
(d) Upon termination of this Agreement for any reason, all
rights granted hereunder shall revert to NORTHWESTERN UNIVERSITY for the sole
benefit of NORTHWESTERN UNIVERSITY.
(e) TECHNICLONE's obligations and responsibilities to report
to NORTHWESTERN UNIVERSITY and pay royalties to NORTHWESTERN UNIVERSITY under
this Agreement as a result of activity prior to any termination or expiration
hereof shall survive such termination or expiration if and to the extent that
TECHNICLONE actually receives Net Sales from sales of the Licensed Products
attributable to such activity prior to such termination or expiration.
ARTICLE X
MISCELLANEOUS
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10.1 NOTICES. Any notice, demand, report, statement, request or other
communication required or permitted to be given hereunder ("NOTICE") by a party
to the other parties shall be in writing and shall be either (i) hand-delivered
(including delivery by courier), or (ii) mailed by first-class registered or
certified mail (airmail if international), return receipt requested, postage
prepaid, addressed as follows:
To NORTHWESTERN UNIVERSITY: Director
Technology Transfer Program
Northwestern University
1801 Maple Avenue
Evanston, IL 60201
If to TECHNICLONE: Techniclone Corporation
14282 Franklin Avenue
Tustin, CA 92780
Attn: President
Each party may designate by notice in writing a new address or telecopy number
to which any Notice, may thereafter be so given, served or sent. Any Notice sent
by (a) registered or certified (air)mail shall be deemed to have been given at
the time of the receipt thereof by the other party or three (3) calendar days
after the time of mailing, whichever is earlier; or (b) hand-delivery (including
delivery by courier) shall be deemed to have been given at the time of receipt
of same.
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10.2 ENTIRE AGREEMENT. This Agreement and the schedules and documents
referenced herein and therein) contains the entire agreement with respect to the
subject matter hereof and supersedes any and all prior agreements, written or
oral, with respect thereto, including, without limitation, the Prior License
Agreement.
10.3 WAIVERS AND AMENDMENTS: NON-CONTRACTUAL REMEDIES: PRESERVATION OF
REMEDIES. This Agreement shall not be modified or amended except pursuant to an
instrument in writing executed by duly authorized representatives of each party
and delivered on behalf of each party to be bound. No delay on the part of any
party in exercising any right, power or privilege hereunder shall operate as a
waiver thereof. Neither any waiver on the part of any party of any such right,
power or privilege, nor any single or partial exercise of any such right, power
or privilege shall preclude any further exercise thereof or the exercise of any
other such right, power or privilege unless waived in writing. The rights and
remedies hereunder provided are cumulative and except as otherwise provided
herein are not exclusive of any rights or remedies that any party may otherwise
have at law or in equity.
10.4 BINDING EFFECT; NO ASSIGNMENT. This Agreement shall be binding
upon and inure to the benefit of the parties named herein and their respective
successors and permitted assigns.
10.5 VARIATIONS IN PRONOUNS. All pronouns and any variations thereof
refer to the masculine, feminine or neuter, singular or plural, as the context
may require.
10.6 COUNTERPARTS. This Agreement may be executed by the parties hereto
in separate counterparts, each of which when so executed and delivered shall be
an original, but all such counterparts shall together constitute one and the
same instrument. Each counterpart may consist of a number of copies hereof
signed by less than all, but together signed by all of the parties hereto.
10.7 EXHIBITS AND SCHEDULES. The documents referred to herein are a
part of this Agreement as if fully set forth herein. All references herein to
sections, subsections, clauses, documents and schedules shall be deemed
references to such parts of this Agreement, unless the context shall otherwise
require.
10.8 HEADINGS. The headings in this Agreement are for reference only,
and shall not affect the interpretation of this Agreement.
10.9 SEVERABILITY OF PROVISIONS: REFORMATION. If any term, clause,
word, condition, provision or agreement in this Agreement or the application
thereof or any portion thereof to any person or circumstance, shall be held
illegal, invalid, void or unenforceable, the remainder of the term, clause,
word, condition, provision or agreement and the application thereof shall remain
in full force and effect, and the illegal, invalid, void or unenforceable term,
clause, word, condition, provision or agreement shall be reformed to the extent
possible in order to give its intended effect and/or meaning.
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10.10 GOVERNING LAW. This Agreement shall be construed in accordance
with and governed by the laws of the State of Illinois as applied to contracts
that are executed and performed entirely in Illinois.
10.11 CONFIDENTIAL INFORMATION. Except as expressly provided herein,
the parties agree that, for the term of this Agreement and for five (5) years
thereafter, the receiving party shall keep completely confidential and shall not
publish or otherwise disclose and shall not use for any purpose except for the
purposes contemplated by this Agreement any Confidential Information furnished
to it by the disclosing party hereto pursuant to this Agreement, except to the
extent that it can be established by the receiving party by competent proof that
such Confidential Information:
(a) was already known to the receiving party, other than
under an obligation of confidentiality, at the time of disclosure;
(b) was generally available to the public or otherwise part
of the public domain at the time of its disclosure to the receiving
party;
(c) became generally available to the public or otherwise
part of the public domain after its disclosure and other than through
any act or omission of the receiving party in breach of this Agreement;
(d) was independently developed by the receiving party as
demonstrated by sufficiently documented evidence prepared
contemporaneously with such independent development; or
(e) was subsequently lawfully disclosed to the receiving
party by a person other than a party hereto.
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Each party hereto may use or disclose information disclosed to it by the other
party to the extent such use or disclosure is reasonably necessary in filing or
prosecuting patent applications, prosecuting or defending litigation, complying
with applicable governmental laws, rules and regulations (including, without
limitation, rules and regulations promulgated by the Securities and Exchange
Commission) or otherwise submitting information to tax or other governmental
authorities, conducting clinical trials, or making a permitted sublicense or
otherwise exercising its rights hereunder, provided that if a party is required
to make any such disclosure of another party's Confidential Information, other
than pursuant to a confidentiality agreement, it will give reasonable advance
notice to the latter party of such disclosure and, save to the extent
inappropriate in the case of patent applications, will use its best efforts to
secure confidential treatment of such information prior to its disclosure
(whether through protective orders or otherwise.) Except as expressly provided
herein, each party agrees not to disclose any terms of this Agreement to any
third party without the consent of the other party; provided disclosures may be
made as required by securities or other applicable laws, or to actual or
prospective investors or corporate partners, or to a party's accountants,
attorneys and other professional advisors. As used herein, "CONFIDENTIAL
INFORMATION" shall mean (i) any proprietary or confidential information or
material in tangible form disclosed hereunder that is marked as "confidential"
at the time it is delivered to the receiving party, and/or (ii) any written
reports marked "confidential" furnished by either party to the other pursuant to
the terms of this Agreement.
10.12 FURTHER ASSURANCES. Each party to this Agreement shall, at the
request of the other, furnish, execute, and deliver such documents, instruments,
certificates, notices or other further assurances as the requesting party shall
reasonably request as necessary or desirable to effect complete consummation of
this Agreement and the transactions contemplated hereby.
10.13 INDEPENDENT CONTRACTORS. The relationship of NORTHWESTERN
UNIVERSITY and TECHNICLONE established by this Agreement is that of independent
contractors, and nothing contained in this Agreement shall be construed to (i)
give either party the power to direct and control the day-to-day activities of
the other, or (ii) allow TECHNICLONE to create or assume any obligation on
behalf of NORTHWESTERN UNIVERSITY for any purpose whatsoever. All financial
obligations associated with TECHNICLONE's business are the sole responsibility
of TECHNICLONE. All sales and other agreements between TECHNICLONE and its
customers are TECHNICLONE's exclusive responsibility and shall have no effect on
NORTHWESTERN UNIVERSITY's obligations under this Agreement.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement, as
of the date set forth below.
NORTHWESTERN UNIVERSITY: NORTHWESTERN UNIVERSITY
By: /s/ Lydia Ville Kamarolf
----------------------------------
Its: AUG - 4 1999
---------------------------------
TECHNICLONE: TECHNICLONE CORPORATION,
a Delaware corporation
By: /s/ John N. Bonfiglio
----------------------------------
John N. Bonfiglio, Vice President of
Technology and Business Development
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EXHIBIT "A"
INVENTIONS
----------
1. "Hybridoma 173-9, Lym-1" (NU 8314-A)
------------------------------------
A hybridoma clone, designated Lym-1, was produced from the fusion of
primed mouse splenocytes and mouse myeloma NS-a cells. Hybridoma Lym-1 produced
a murine IgG2a monoclonal antibody which recognizes a 31, 32, 33 and 35
kilodalton cell surface protein expressed in normal and malignant B lymphocytes.
Immunoperoxidase staining of a panel of normal human tissues shows that Lym-1
reacts with germinal center and mantle zone B lymphocytes and interdigitating
histiocytes of the lymph node, medullary dendritic cells of the thymus, and
weakly with surface epithlium of the colon. A subset of peripheral blood B cells
are positive and no reactivity has been observed in human bone marrow by flow
cytometric analysis. The antigen recognized by Lym-1 is not shed from the
surface of lymphoma cells either in cell culture or in patients and is not
modulated after Lym-1 binding. Lym-1 itself has been shown to have high avidity
to human lymphoma cells IN VIVO as demonstrated by radionuclide binding studies
in lymphoma patients using I-123 conjugates. Binding to normal tissues such as
the bone marrow, spleen, lymph node, liver, kidney, lung or central nervous
system has not been demonstrated in over 30 patients studied. Lym-1 has further
been found to be highly stable to radionuclide conjugation methods and may be
prepared as F(ab1)2 or F(ab) fragments without significant loss of antibody
activity. Collectively, these data suggest that Lym-1 will be an appropriate
reagent for IN VIVO diagnosis and therapy of the human B-cell lymphomas and
leukemias.
2. "Hybridoma Clone 1010-9, Lym-2" (NU 8314-B)
-------------------------------------------
A hybridoma clone, designated Lym-2, was produced from the fusion of
primed mouse splenocytes and mouse myeloma NS-1 cells. Hybridoma Lym-2 produced
a murine IgG1 monoclonal antibody which recognizes a cell surface protein
expressed in normal and malignant B lymphocytes. Immunoperoxidase staining of a
panel of normal human tissues show that Pym-2 reacts with germinal center and
mantle zone B lymphocytes and interdigitating histiocytes of the lymph node. A
subset of peripheral blood B cells are positive and no reactivity has been
observed in human bone marrow by flow cytometric analysis. Because of the
remarkable specificity of Lym-2 for human B-cells and derived malignancies,
these data suggest that Lym-2 will be appropriate for reagent for in vivo
diagnostic and therapy of the human B-cell lymphomas and leukemias.
3. "Hybridoma Clone 818-18, BM-1" (NU 8216-C)
------------------------------------------
A hybridoma clone, designated 818-18, was produced from the fusion of
primed mouse splenocytes and mouse myeloma NS-1 cells. Clone 818-18 produces a
murine IgG1 monoclonal antibody which recognizes a nuclear antigen expressed in
human granulocytes and myeloid precursors and acute and chronic myeloid
leukemia. Immunoperoxidase staining with 818-18 on B5 fixed, paraffin embedded
clot preparations of bone marrow aspirates shows positive nuclear staining of
myeloid cells with normal non-specific background staining. The remarkable
specificity of this reagent and its ability to stain B5 fixed, paraffin embedded
tissues makes it a unique reagent for the diagnosis of myeloid derived
leukemias.
EXHIBIT "B"
ISSUED LICENSED PATENTS
-----------------------
United States Patent 4,724,213 issued February 9, 1988; Epstein, "Murine
Hybridoma LYM-1 and Diagnostic Antibody Produced Thereby."
United States Patent 4,724,212 issued February 9, 1988; Epstein, "Murine
Hybridoma LYM-2 and Diagnostic Antibody Produced Thereby."