EXHIBIT 10.5
JM 1899A
DATED AUGUST 28, 2001
JOHNSON MATTHEY PLC
AND
NEOTHERAPEUTICS, INC.
LICENCE
JOHNSON MATTHEY PLC
2-4 COCKSPUR STREET
TRAFALGAR SQUARE
LONDON SW1Y 5BR
JM 1899A
LICENCE
Date: AUGUST 28, 2001
PARTIES:
1. The LICENSOR: Johnson Matthey PLC, a company organised under the laws of
England and Wales whose registered office is at 2-4 Cockspur Street,
Trafalgar Square, London, SW1Y 5BQ, England, acting for itself and for
its AFFILIATES including particularly Johnson Matthey, Inc
2. The LICENSEE: NeoTherapeutics, Inc., a corporation organised under the
laws of the State of California, United States of America whose principal
place of business is at 157 Technology Drive, Irvine, California 92618,
United States of America, acting for itself and for its AFFILIATES
RECITALS:
(A) The LICENSOR has developed and is the beneficial owner of a substantial
body of valuable technical information relating to the use of the
platinum complex JM216 in the treatment of tumour cells, toxicity data
and other valuable information and is the beneficial owner of the Patent
Rights relating thereto as defined hereinafter
(B) The LICENSEE wishes to receive and the LICENSOR is willing to grant a
licence on the terms and conditions hereinafter set forth to use such
information and to work under the said Patent Rights for the purposes
hereinafter provided
(C) The parties have executed a Secrecy Agreement dated 13th March, 2001, and
the LICENSOR has provided or arranged the provision of certain of
LICENSOR'S INFORMATION to LICENSEE under said Secrecy Agreement
ARTICLE I DEFINITIONS
In this Agreement the following terms shall have the following meanings unless
the context otherwise requires:
1. AFFILIATE: a subsidiary company within the meaning of S.736 of the United
Kingdom Companies Act 1985.
2. EFFECTIVE DATE: the date upon which this Agreement has been executed by
representatives of LICENSOR and LICENSEE.
3. FIELD: the use of the PRODUCTS for the purpose of treating cancer in
humans and the sale of the PRODUCTS for such purpose.
4. GENERIC PRODUCT: a PRODUCT marketed by a THIRD PARTY in a country
comprising the TERRITORY.
5. IMPROVEMENTS: any new or useful invention, process or improvement,
patentable or unpatentable, relating to or arising under the PATENT
RIGHTS, conceived or first reduced to practice or demonstrated to have
utility by LICENSEE, LICENSOR, or LICENSEE AND LICENSOR jointly, during
the TERM.
6. JM216: the platinum complex
bis(acetato)amminedichloro(cyclohexyl-amine)platinum(IV)
7. LICENSOR'S INFORMATION: information, data, research results and clinical
evaluation results relating to PLATINUM COMPLEXES and in the lawful
possession of LICENSOR at the EFFECTIVE DATE (as described in Article
II.1).
8. LICENSOR'S ONGOING INFORMATION: information, data, research results, as
well as inventions made by LICENSOR subject to the PATENT RIGHTS, all
coming into the lawful possession of LICENSOR during the TERM.
9. LICENSEE'S ONGOING INFORMATION: information, data, research results,
clinical evaluation results, approval trials data and results as well as
all approvals obtained by LICENSEE during the TERM and relating to the
PLATINUM COMPLEXES.
10. NET SALES VALUE: the invoiced sales price of the PRODUCTS in an arm's
length transaction exclusively for money after deduction of normal trade
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discounts actually granted and of any credits actually given by the
LICENSEE for returned or defective goods and excluding or making proper
deductions for any costs of packing, insurance, carriage and freight and
Value Added Tax or other sales tax and, in the case of export orders, any
import duties or similar applicable governmental levies or export
insurance costs expressly subject in all cases to the same being
separately charged on customer invoices. In any sale or other disposal of
any PRODUCTS otherwise than in an arm's length transaction exclusively
for money, the fair market price (if higher) in the relevant country of
disposal shall be substituted for the Net Sales Value
11. MILESTONES : the objectives described in Article IV hereof
12. ONGOING INFORMATION: together the LICENSOR'S ONGOING INFORMATION and the
LICENSEE'S ONGOING INFORMATION.
13. PATENT RIGHTS:
(i) the patents and applications short particulars whereof are set out
in Schedule A hereto, as well as any continuation,
continuations-in-part and divisional applications, including
reissues and reexamination applications and patent term extension
and reexamination certificates issuing to LICENSOR;
(ii) all patent applications that may hereafter be filed by or on
behalf of the LICENSOR which either are based on or claim priority
from any of the foregoing patents and applications or which are in
respect of any IMPROVEMENTS to which LICENSOR is exclusively
entitled; and
(iii) all patents which may be granted pursuant to any of the foregoing
patent applications.
14. PLATINUM COMPLEXES; the platinum co-ordination compounds that are the
subject of the PATENT RIGHTS.
15. PRODUCTS: PLATINUM COMPLEXES formulated for administration to patients.
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16. TERM: the term commencing on the EFFECTIVE DATE and terminating three (3)
years following the expiry of the last to expire of the patents granted
in the United States of America or any of the countries currently
comprising the European Union which have expiration dates specified on
Schedule A. The date of expiration of a patent described in this Section
shall include any extension granted to LICENSOR by virtue of any
continuation, continuations-in-part and divisional applications,
including reissues and reexamination applications and patent term
extension and reexamination certificates issuing to LICENSOR.
17. TERRITORY: Each country of the world.
18. THIRD PARTY: any person or entity other than the LICENSOR and its
AFFILIATES and the LICENSEE and its AFFILIATES.
ARTICLE II GRANT OF RIGHTS
1. Subject to Article II.3 below, the LICENSOR agrees to grant and hereby
grants to the LICENSEE an exclusive worldwide royalty-bearing revocable
right and licence under the PATENT RIGHTS, with rights to sub-license, to
use the PLATINUM COMPLEXES, the LICENSOR'S INFORMATION and the LICENSOR'S
ONGOING INFORMATION to make, have made, use, offer to sell, and have sold
PRODUCTS for use within the FIELD.
2. The LICENSEE shall be entitled to sub-license any THIRD PARTY under the
rights granted under Article II.1 hereof provided that: (i) the LICENSEE
shall remain responsible for all acts and omissions of such sub-licensees
as though they were by the LICENSEE; and (ii) the sub-license agreement
shall be in the form to be attached to this Agreement as Exhibit 1. In
particular, the LICENSEE shall be responsible to the LICENSOR for
payments due in respect of sales by sub-licensees as though they were
sales by the LICENSEE. The parties shall use their best endeavours to
draft, negotiate and finalize the form sub-license agreement within 15
(fifteen) days of the EFFECTIVE DATE, which form sub-license agreement
shall provide that upon termination of this Agreement, any sub-licensee
shall attorn to and accept the LICENSOR
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in the place of the LICENSEE such that any sub-license shall be deemed an
agreement between the LICENSOR and sub-licensee.
3. For the avoidance of doubt, it is hereby declared that the LICENSEE shall
have no right hereunder to manufacture the PLATINUM COMPLEXES except in
the circumstances of Article VI.2, nor to use or sell them otherwise than
for use within the FIELD and, without prejudice to the foregoing, the
LICENSEE accepts that the licence hereby granted does not include the
right to manufacture the PLATINUM COMPLEXES other than in the
circumstances set forth in Article VI.2, or in accordance with the supply
agreement between the LICENSOR and LICENSEE.
ARTICLE III ONGOING RESEARCH AND DEVELOPMENT
1. The LICENSEE shall diligently perform research and development on the use
of JM 216 and other PLATINUM COMPLEXES within the FIELD and on the
formulation of PRODUCTS. The LICENSEE shall exercise in the performance
of such research and development technical skill and competence of a high
calibre.
2. Throughout the TERM of this Agreement, the LICENSOR shall promptly
disclose to the LICENSEE all LICENSOR'S ONGOING INFORMATION developed or
acquired by LICENSOR except insofar as such disclosure would disclose
information derived from and subject to confidentiality obligations in
favour of a THIRD PARTY. Solely for the purposes set forth in Article
VI.2, LICENSEE shall also promptly disclose to LICENSOR any LICENSEE
ONGOING INFORMATION necessary for LICENSOR to perform its obligations set
forth in Article VI.2.
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ARTICLE IV MILESTONES
1. The LICENSEE shall use its best efforts to test, evaluate and develop
PRODUCTS so as to meet the objectives detailed hereunder within ninety
(90) days of the target date specified for each such objective:
Objective Target Date
- --------- -----------
1 Submission of NDA in the United States
of America
(hereinafter called `a First MILESTONE') 1st January 2004
2 Receipt of US FDA approval of NDA
(hereinafter called `a Second MILESTONE') 1st January 2005
3 Approval in the first European Union state
of a new drug application
(hereinafter called `a Third MILESTONE') 1st January 2006
4 Approval by US FDA of JM216 for the first
indication other than the indication approved
in Objective 2.
(hereinafter called `a Fourth MILESTONE') 1st January 2007
5 Approval in the first European Union state of JM216
for the first indication other than the indication
approved in Objective 3.
(hereinafter called a `Fifth MILESTONE') 1st January 2008
ARTICLE V PAYMENT
1. Upon the EFFECTIVE DATE the LICENSEE shall pay to the LICENSOR the
initial sum of US$100,000 (one hundred thousand);
2. Upon the earlier of: (i) execution by LICENSOR of the supply agreement
described in Article V; or (ii) January 31, 2002, the LICENSEE shall pay
to the LICENSOR the sum of US$150,000 (one hundred and fifty thousand).
3. Within 30 (thirty) days of the date of the attainment of each MILESTONE
the LICENSEE shall pay to the LICENSOR the following sums:
(i) the First MILESTONE: US$750,000 (seven hundred and fifty thousand)
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(ii) the Second MILESTONE: US$3,000,000 (three million)
(iii) the Third MILESTONE: US$1,000,000 (one million)
(iv) the Fourth MILESTONE: US$1,000,000 (one million)
(v) the Fifth MILESTONE: US$1,000,000 (one million)
4. The LICENSEE shall during the TERM of this Agreement pay to the LICENSOR
a royalty calculated at the rate of 8.5% of the NET SALES VALUE of all
PRODUCTS sold or otherwise supplied for use whether within the FIELD or
outside the FIELD for money or money's worth by LICENSEE or any AFFILIATE
or sublicensee thereof; provided, however, that in any country in the
TERRITORY where a GENERIC PRODUCT is sold in competition with the
PRODUCT, the royalty payable to LICENSOR with respect to NET SALES of
such PRODUCTS in such country shall be reduced to 0%, commencing with the
calendar quarter during which any such GENERIC PRODUCT first becomes
available in competition with the PRODUCT in such country.
5. Payments due under Article V.4 shall be made within 30 days of the end of
each calendar quarter in respect of royalties accruing on PRODUCTS
invoiced in that calendar quarter.
6. All sums due to be paid to the LICENSOR under this Agreement:
5.1 are exclusive of any Value Added, Sales, or any other tax which
shall be payable in addition;
5.2 shall be made in United States dollars to the credit of one or
more bank accounts to be designated from time to time in writing
by the LICENSOR. Conversion into United States dollars shall be
calculated where appropriate;
5.3 in the case of each sale in a currency other than United States
dollars, the royalty shall be calculated in United States dollars
at the New York foreign exchange rate quoted in The Wall Street
Journal on the date that payment is due; provided always that
where any payment is made
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after the date provided therefor herein conversion shall be at the
foreign exchange rate on the date of payment if this is more
favourable to the LICENSOR;
5.4 shall be made in full without deduction of taxes charges and other
duties that may be imposed except in so far as any such deduction
may be credited in full by the LICENSOR against the LICENSOR's own
tax liabilities. The parties agree to co-operate in all respects
necessary to take advantage of such double taxation agreements as
may be available
7. The LICENSEE agrees during the TERM and for a period of two (2) years
thereafter to keep true and accurate records and books of account
containing all data necessary for the determination of royalties payable
under this Agreement, including records and books of account relating to
sales of PRODUCTS by sub-licensees, which records and books of account
shall upon reasonable notice by LICENSOR be open at all reasonable times
during business hours for inspection by an independent accountant
appointed by LICENSOR for the purpose of verifying the accuracy of the
LICENSEE's reports hereunder. Such accountant shall be entitled to take
copies solely of LICENSEE's records pertaining to such reports at
LICENSOR's expense. The LICENSEE shall ensure that its sub-licensees (if
any) also keep true and accurate records and books of account containing
all data necessary for the determination of royalties payable in respect
of their activities and shall ensure that such records and books of
account shall upon reasonable notice by the LICENSOR be open at all
reasonable times during business hours for inspection by such independent
accountant for the purpose of verifying the accuracy of the LICENSEE's
reports hereunder.
8. The LICENSEE shall submit to the LICENSOR within 30 days of the end of
each calendar quarter a statement setting forth with respect to the
operations of the LICENSEE hereunder, as well as with regard to each
sub-licensee during that period, the quantity of PRODUCTS made and sold
and the NET SALES VALUE of all PRODUCTS sold together with payments due.
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9. The accountant selected to inspect the LICENSEE'S books and records
pursuant to Article V.7 shall agree in writing to maintain in confidence
all financial and other information received with respect to the
LICENSEE's operations pursuant to the foregoing Article V.7.
ARTICLE VI SUPPLY OF PLATINUM COMPLEXES
1. The LICENSOR shall supply to the LICENSEE, LICENSEE's reasonable
requirements of the PLATINUM COMPLEXES used in the manufacture of the
PRODUCTS at reasonable commercial prices under the terms of one or more
separate supply agreements the terms of which are to be agreed.
2. Within 15 (fifteen) days of the EFFECTIVE DATE, LICENSOR shall deliver a
proposal for the supply of 200 grams of the PLATINUM COMPLEXES as
follows: (i) 80 grams to be delivered on or before September 15, 2001,
and 120 grams to be delivered on or before October 31, 2001. The PLATINUM
COMPLEXES supplied pursuant to this Section shall be manufactured by the
LICENSOR in accordance with its Standard Operation Procedures, but not be
certified as being manufactured in accordance with Good Manufacturing
Practices. The obligation of the LICENSOR pursuant to this Section shall
be independent of the existence of the supply agreement described in
Article VI.1.
3. LICENSOR understands the requirement of LICENSEE to have security of
supply. In the event that either: (i) the parties have not entered into a
definitive supply agreement as described in Article VI.1 by January 31,
2002; or (ii) the LICENSOR is unable or unwilling to supply the LICENSEE
with its reasonable requirements of the PLATINUM COMPLEXES at reasonable
prices, the parties agree that the LICENSEE shall have the right and
license to manufacture or have manufactured the PLATINUM COMPLEXES itself
or through any THIRD PARTY, subject to the terms and conditions of this
Agreement.
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ARTICLE VII PATENTS
1. The LICENSOR shall at its own cost diligently prosecute to grant all
subsisting patent applications within the PATENT RIGHTS so as to secure
the broadest monopoly reasonably obtainable consistent with avoiding
serious prejudice to the validity of such granted patents and shall
maintain all patents within the PATENT RIGHTS in force for the full terms
thereof. In the event that LICENSOR elects to abandon the prosecution or
maintenance of any such PATENT RIGHTS in any country in the Territory,
LICENSOR shall give LICENSEE notice thereof at least 60 days prior to the
date on which LICENSEE is required by law to make a filing in order to
preserve rights to patent protection in such country, and LICENSEE shall
have the right to do so, at its own expense. In the event that LICENSOR
elects to abandon the prosecution or maintenance in any country in the
Territory any of its PATENT RIGHTS and LICENSEE elects to assume such
prosecution and maintenance, then LICENSOR shall assign its rights it may
have therein in such country to LICENSEE.
2. Neither party hereto shall publish any matter forming part of the ONGOING
INFORMATION that might prejudice the validity of any patent that might
subsequently be granted on it. Each party shall notify the other whether
it intends to seek any relevant protection for any part of its respective
ONGOING INFORMATION. If it does not wish to do so and if the other party
within three (3) calendar months notifies the first party that it would
like to seek patent or other protection then this obligation shall
continue for such time as may be reasonably required to prepare and file
an application for a patent or other protection after which period it
shall lapse.
3. IMPROVEMENTS that are made by an employee or agent of LICENSEE, solely or
jointly, other than with an employee or agent of LICENSOR, shall be owned
by LICENSEE. IMPROVEMENTS that are made jointly by employees or agents of
LICENSOR and LICENSEE shall be jointly owned by LICENSOR and LICENSEE and
treated as joint inventions under the laws applicable to joint
inventions. In those countries in which the LICENSEE deems it
commercially reasonable, the LICENSEE shall process and pay for patent
applications for any jointly owned IMPROVEMENTS (including the
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cost of filing and prosecuting applications as well as maintaining
granted patents) which are to be utilised in the FIELD. In prosecuting
and filing for protection, the LICENSEE shall have the right to make any
decisions which it deems necessary to carry out such filing and
prosecution. While any patent issued shall be jointly owned, the LICENSEE
shall have the sole and exclusive right with regard to utilisation of the
jointly owned patent in the FIELD to: (i) license such jointly owned
IMPROVEMENTS to a THIRD PARTY; (ii) to enforce such patents against any
THIRD PARTY; and (iii) make, have made, use, sell, and have sold all
jointly owned Improvements. In the event the term of a jointly owned
patent covering an IMPROVEMENT extends beyond the TERM, the LICENSOR and
LICENSEE agree to undertake best endeavours to reach an agreement on the
terms under which LICENSEE will retain the sole and exclusive rights as
described in the prior sentence.
4. Unless otherwise agreed, the costs of filing and prosecuting any
application for patent and maintaining such granted patents shall rest
with the party making the application.
5. If, with respect to a given country, the LICENSEE becomes aware of
substantial infringement (greater than thirty percent (30%) of the
LICENSEE'S NET SALES VALUE of PRODUCTS in such country) by a THIRD PARTY
of the PATENT RIGHTS in such country the LICENSEE will promptly notify
the LICENSOR and the parties will confer and attempt to agree on what
action should be taken. Should the LICENSOR and the LICENSEE agree that
suit should be brought in any such country, the LICENSEE shall have the
right to control, bear the cost of, and retain any recovery from any such
suit. Should the LICENSEE not wish to bring suit, the LICENSOR shall have
the option to do so, in which case the LICENSOR shall control, bear the
cost of, and retain any recovery from any such suit and the LICENSEE
shall reasonably co-operate in the effort. Should the LICENSEE provide
the LICENSOR with reasonable evidence of substantial infringement by a
THIRD PARTY of the PATENT RIGHTS in any country and the parties are
unsuccessful in abating the infringement within one hundred and twenty
(120) days after the LICENSOR has promptly notified the
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infringer of the infringement, and should the LICENSOR have failed to
file suit for infringement at the end of such one hundred and twenty
(120) day period, the LICENSEE shall be entitled to reduce the amount of
royalty due in such country in accordance with Article V.4 by a
percentage equal to the percentage of such substantial infringement, but
in no event by more than fifty per cent (50%). Said reduced royalty shall
continue to be the prevailing royalty rate on NET SALES VALUE of PRODUCTS
in such country until said substantial infringement ceases and,
thereafter, the royalty shall revert to the full royalty defined herein.
6. The LICENSOR represents that it is not aware that any PRODUCTS or
PLATINUM COMPLEXES infringes upon or falls within any THIRD PARTY patent
rights. In the event that a THIRD PARTY accuses or brings suit against
either party alleging patent infringement, the parties shall meet and
agree on the response to the THIRD PARTY and the conduct of and costs
arising from any suit.
7. In the event that any PLATINUM COMPLEXES infringe or fall within any
THIRD PARTY patent rights, the LICENSOR shall at its own expense use its
best endeavours either to modify the PLATINUM COMPLEXES to be
non-infringing or to obtain at its own expense for the LICENSEE a licence
to continue using PLATINUM COMPLEXES, provided that in the event that the
parties reasonably agree that it is not possible either to modify the
PLATINUM COMPLEXES to be non-infringing or to obtain for the LICENSEE a
licence to continue using the PLATINUM COMPLEXES then the LICENSEE may
terminate this Agreement and all licences granted hereunder forthwith on
written notice, and the parties shall co-operate with respect to an
orderly termination of the same. Termination under this sub-clause shall
be without prejudice to the rights of either party accrued at the date of
termination.
8. If at any time during the TERM the LICENSEE directly or indirectly
opposes or assists any THIRD PARTY to oppose the grant of letters patent
on any patent application within the PATENT RIGHTS or disputes or
directly or indirectly assists any THIRD PARTY to dispute the validity of
any patent within the PATENT RIGHTS or any of the claims thereof the
LICENSOR
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shall be entitled to terminate all or any of the licences granted
hereunder forthwith by notice thereof to the LICENSEE.
ARTICLE VIII CONFIDENTIALITY
1. Any information communicated by one party to the other pursuant to this
Agreement or prior to and in contemplation of it, whether technical or
commercial, and which is identified on the face of a document as
confidential, or if an oral or visual communication is confirmed as
confidential within 30 days, or would be reasonably be assumed as
confidential in the circumstances, shall be treated by the party
receiving the information as confidential. The receiving party shall
afford such confidential information the same protection as it affords
its own confidential information, but no less than reasonable protection.
The receiving party shall respect the other's proprietary rights therein,
shall use the same exclusively for the purposes of this Agreement, and
shall disclose the same only to those of its contractors and
sub-licensees (if any) pursuant to this Agreement to whom and to the
extent that such disclosure is reasonably necessary for the purpose of
this Agreement and who shall enter into obligations of confidentiality
direct with the other in similar terms to this Article.
2. The foregoing obligations of Article VIII.1 above shall not apply to
information which:
2.1 prior to receipt thereof from one party was in the possession of
the other and at its free disposal;
2.2 is subsequently disclosed to the recipient party without any
obligations of confidence by a third party who has not derived it
directly or indirectly from the other;
2.3 is or becomes generally available to the public through no act or
default of the recipient party or its agents or employees;
2.4 is required to be disclosed by order of a court or administrative
authority but only after the owner of the information has been
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informed by the party subject to the order, if such informing is
possible in the circumstances.
3. The restrictions imposed in this Article shall not apply to disclosure of
information necessary for the obtaining of patents, nor shall they
restrict disclosure or any other action which is necessary for obtaining
or maintaining registration or approval of the Food and Drug
Administration or any other regulatory agency of the United States or any
other country for the evaluation and sale of PRODUCTS.
ARTICLE IX PERFORMANCE
1. During the continuance of this Agreement the LICENSEE shall:
1.1 use its best endeavours to obtain appropriate regulatory approvals
for PRODUCTS in the United States of America or any of the
countries currently comprising the European Union and to promote
the distribution and sale of PRODUCTS in the FIELD in the such
countries as widely as its resources reasonably permit and will
make available all necessary selling facilities to meet in full
all demands for PRODUCTS for use in the FIELD throughout such
countries;
1.2 ensure that all literature prepared by the LICENSEE and relating
to PRODUCTS bears an acknowledgement to the effect that they are
subject to a licence from the LICENSOR, and attach to all PRODUCTS
a label quoting relevant patent numbers and stating that such
PRODUCTS are made under licence from the LICENSOR;
1.3 not act as agent of the LICENSOR and specifically not give any
indication that it is acting otherwise than as principal and in
advertising or selling PRODUCTS not make any representation or
give any warranty on behalf of the LICENSOR;
1.4 advise LICENSOR immediately of all approvals granted and assist
LICENSOR in all reasonable ways to obtain any form of patent term
extension for medicines.
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ARTICLE X LIABILITY
1. The LICENSEE shall defend, indemnify (and keep indemnified) and hold the
LICENSOR harmless from and against all claims, liabilities damages costs
and expenses (including legal costs) which may be brought or made against
or incurred by the LICENSOR arising from the use or sale of the PRODUCTS.
LICENSOR acknowledges that this indemnity does not include those items
for which LICENSOR is indemnifying LICENSEE below. The LICENSOR shall as
soon as reasonably practicable notify the LICENSEE of any such claims and
shall give to the LICENSEE all reasonable assistance that the LICENSEE
may request in connection therewith.
2. The LICENSOR shall defend, indemnify (and keep indemnified) and hold
LICENSEE harmless from and against any claims, liabilities, damages,
costs and expenses (including legal costs) arising out of or otherwise
relating to any claims: (a) alleging that the PLATINUM COMPLEXES and/or
the LICENSOR INFORMATION or LICENSOR'S ONGOING INFORMATION infringes upon
the intellectual property rights of any THIRD PARTY, and (b) arising out
of defects present in any PLATINUM COMPLEXES supplied to the LICENSEE by
the LICENSOR pursuant to Article VI herein, up to a maximum cap of $5
million. The LICENSEE shall as soon as reasonably practicable notify the
LICENSOR of any such claims and shall give to the LICENSOR all reasonable
assistance that the LICENSOR may request in connection therewith.
ARTICLE XI TERM AND TERMINATION
1. This Agreement shall commence on the EFFECTIVE DATE and shall continue in
force in each country of the TERRITORY for the TERM.
2. The LICENSOR may terminate this Agreement by written notice to the
LICENSEE in the event of failure by the LICENSEE to make any of the
payments specified in Article V hereof on the due date or any reasonable
and mutually agreed upon extension of any such date.
3. The LICENSOR shall have the right to terminate this Agreement upon
forty-five (45) days written notice to LICENSEE in the event of failure
by the
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LICENSEE to attain the FIRST, SECOND OR THIRD MILESTONES in Article IV
hereof within ninety (90) days of the target date specified for such
MILESTONE or any reasonable and mutually agreed upon extension of such
MILESTONE target date. LICENSOR agrees that it shall grant all reasonable
requests by LICENSEE for extensions of such target dates and LICENSOR
further agrees that it shall not exercise its right to terminate except
where it has good faith reason to believe that LICENSEE will be unable to
comply with any requested extended dates.
4. LICENSEE shall have the right to terminate this Agreement at any time by
giving written notice to LICENSOR, which shall be effective 60 (sixty)
days from the date such notice is given.
5. In the event of a breach of this Agreement by either party, and if
remedial action is possible the party fails to remedy such breach within
a period of 45 (forty five) days after written notice thereof from the
other party, the other party shall have the right forthwith to terminate
this Agreement by giving written notice of termination to the party in
breach, except where the cause of such default is a reason of force
majeure under Article XII hereof, in which event the other party shall
have no such right of termination under this Article XI.5
6. Either party shall have the right forthwith to terminate this Agreement
by giving written notice of termination to the other if the other shall
have a receiver or manager appointed of its undertaking or assets or
shall have an administration order made against it or shall go into
liquidation whether voluntary or otherwise (other than for the purposes
of and followed by an amalgamation or reconstruction) or shall enter into
any composition or arrangement with its creditors or if it shall cease to
carry on business.
7. Termination under this Article shall be without prejudice to the rights
of the either party existing at the date of termination.
8. Termination of this Agreement for any reason shall not bring to an end:
8.1 the secrecy obligations on the parties hereto, which shall
continue for a further period of ten years after termination;
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8.2 the LICENSEE's obligations to pay royalties or other sums which
have accrued due or which will become due in respect of sales
under Article XI.9 hereof;
8.3 Upon any termination of this Agreement, all sublicenses granted by
the LICENSEE utilising the form sub-license agreement attached as
Exhibit 1 to this Agreement shall be automatically assigned to the
LICENSOR which shall thereafter receive all benefits and have all
obligations under the sublicenses as in the place and stead of the
LICENSEE. All other sub-licenses shall terminate simultaneously
with this Agreement.
9. On termination of this Agreement for any reason the LICENSEE shall
continue to have the right for a period of six months from the date of
termination to complete deliveries on contracts in force at that date and
to dispose of PRODUCTS already manufactured subject to payment to the
LICENSOR of royalties thereon in accordance with Article V hereof.
10. Upon termination by LICENSOR due to LICENSEE'S breach, the LICENSEE shall
pass to the LICENSOR all information and data in the LICENSEE'S
possession concerning the PRODUCTS and the LICENSEE'S ONGOING
INFORMATION. All regulatory approvals made or acquired by the LICENSEE
with respect to the PRODUCTS shall become the sole property of the
LICENSOR, and the LICENSOR shall have an exclusive royalty-free licence
without limit of time, with the right to grant sub-licences thereunder,
to use all LICENSEE's ONGOING INFORMATION and to work under all
intellectual property rights in respect thereof owned by the LICENSEE or
any successor in title of the LICENSEE.
11. After termination of this Agreement by LICENSOR due to LICENSEE'S breach,
and in the event that the LICENSOR shall grant a licence to any THIRD
PARTY to use PLATINUM COMPLEXES in the manufacture of PRODUCTS for use
within the FIELD and in the event that such licence includes the right to
use LICENSEE'S ONGOING INFORMATION, then LICENSOR shall pay to the
LICENSEE a proportion of any royalties obtained from such THIRD PARTY,
such proportion to be agreed between the parties
18
hereto, taking into account the proportion of the value of the licensed
LICENSEE'S ONGOING INFORMATION to the value of the licensed rights as a
whole.
12. Following the expiration of the TERM of this Agreement, LICENSEE shall
have the royalty-free, non-exclusive, perpetual right and license to
continue to use the PLATINUM COMPLEXES to make, have made, use, sell, and
have sold PRODUCTS in all countries in the TERRITORY.
ARTICLE XII FORCE MAJEURE
If the performance of any part of this Agreement by either party is prevented
restricted, interfered with or delayed by reason of any cause beyond the
reasonable control of the party liable to perform, unless conclusive evidence to
the contrary is provided, the party so affected shall, upon giving written
notice to the other party, be excused from such performance to the extent of
such prevention, restriction, interference or delay, provided that the affected
party shall use its reasonable best efforts to avoid or remove such causes of
non-performance and shall continue performance with the utmost dispatch whenever
such causes are removed. In the event that the event of Force Majeure continues
uninterrupted for a period of six months, the party not directly affected by the
event may terminate this Agreement upon one month's written notice, subject to
the termination being ineffective if the even of Force Majeure ends during that
notice period.
ARTICLE XIII PERSONNEL
1. The LICENSOR agrees that it will not, nor will its AFFILIATES, for the
term of this Agreement and for a period of six months after termination
for whatsoever cause employ or appoint as its partner, consultant or
agent any person who has been within a period of one year from the date
of such intended employment or appointment employed by the LICENSEE in
research or other technical or commercial work associated with the
purposes of this Agreement.
2. The LICENSEE agrees that it will not, nor will its AFFILIATES, for the
term of this Agreement and for a period of six months after termination
for whatsoever cause employ or appoint as its partner, consultant or
agent any
19
person who has been within a period of one year from the date of such
intended employment or appointment employed by the LICENSOR in research
or other technical or commercial work associated with the purposes of
this Agreement.
ARTICLE XIV GENERAL
1. This Agreement shall be binding upon and inure to the benefit of the
parties hereto and their respective legal successors but shall not
otherwise be assignable by either party without the written consent of
the other party, other than to an assignee of such party of all or
substantially all of such party's business.
2. No variation or amendment of this Agreement shall bind either party
unless made in writing and agreed to in writing by duly authorised
officers of both parties.
3. If any provision of this Agreement is agreed by the parties to be illegal
void or unenforceable under any law that is applicable hereto or if any
court or administrative authority of competent jurisdiction in a final
decision so determines this Agreement shall continue in force save that
such provision shall be deemed to be excised herefrom with effect from
the date of such agreement or decision or such earlier date as the
parties may agree. In such event, the parties shall endeavour to
substitute the excised provision by another provision that achieves the
intentions of the parties at the date hereof.
4. The headings in this Agreement are for convenience only and are not
intended to have any legal effect.
5. A failure by either party hereto to exercise or enforce any rights
conferred upon it by this Agreement shall not be deemed to be a waiver of
any such rights or operate so as to bar the exercise or enforcement
thereof at any subsequent time or times.
6. This Agreement shall not give any rights of enforcement or otherwise to
any THIRD PARTY.
20
7. Each of the parties acknowledges and agrees that in entering into this
Agreement, and the documents referred to in it, it does not rely on, and
shall have no remedy in respect of, any statement, representation,
warranty or understanding (whether negligently or innocently made) of any
person (whether party to this Agreement or not) other than as expressly
set out in this Agreement as a warranty or representation. The only
remedy available to it for breach of the such warranties or
representations shall be for breach of contract under the terms of this
Agreement. Nothing in this clause shall, however, operate to limit or
exclude any liability for fraud.
ARTICLE XV NOTICES
1. Any notice required to be given hereunder by either party to the other
shall be in writing and shall be served by sending the same by registered
or recorded delivery post or by telefax to the address of the other party
as given herein or to such other address as that party may have
previously notified to the party giving notice as its address for such
service. Such notice shall be deemed to be received, if given by post,
three days after mailing, and if given by telefax, on the day of
transmission.
2. The parties' address for service are as follows:
For the LICENSOR
Johnson Matthey PLC
2-4 Cockspur Street
Trafalgar Square
London SW1Y 5BQ
United Kingdom
attention: Company Secretary
Telefax:
For the LICENSEE
NeoTherapeutics Inc
PO Box 57052
Irvine
California 92619 -- 7052
U.S.A.
attention: President
Telefax: 949-788-6706:
21
ARTICLE XVI INTEREST
Any payment required to be made by the LICENSEE under the provisions of this
Agreement shall bear interest as well after as before judgment from the date the
payment becomes due until the date of actual payment at a rate equal to 3% over
the base rate from time to time of Lloyds Bank PLC
ARTICLE XVII GOVERNING LAW AND DISPUTES
1. The construction validity and performance of this Agreement shall be
governed in all respects by English Law.
2. Subject to Article XVII 3, all disputes arising in any way out of or
affecting this Agreement shall be referred to arbitration under the rules
of conciliation and arbitration of the International Chamber of Commerce
whose decision shall be final. The place of arbitration shall be
California if the LICENSOR is the plaintiff and London if the LICENSEE is
the Plaintiff.
3. Notwithstanding Article XVII 2, either party may seek interlocutory
relief in respect of any dispute arising in any way out of or affecting
this Agreement from the English courts and the parties agree that such
courts shall have non-exclusive jurisdiction in this regard.
22
SCHEDULE A
Patent Rights
1. Case MBUS 1044
Country Application No. Patent No. Expiration
------- --------------- ----------- ----------
Austria EP891300787 0328274 26Jan09
Belgium " " 26Jan09
France " " 26Jan09
Germany " " 26Jan09
Great Britain " " 26Jan09
Greece " " 26Jan09
Italy " " 26Jan09
Luxembourg " " 26Jan09
Netherlands " " 26Jan09
Spain " " 26Jan09
Sweden " " 26Jan09
Switzerland " " 26Jan09
Australia 28971/89 618310 31Jan09
Brazil 1100963-2 1100963-2 14May17
Canada 589796 1340286 22Dec15
Denmark 0491/89 -- 1Feb09
Finland 89/0512 91260 1Feb09
Hungary 52289 205767 3Feb09
Hungary P/P00163 210872 9Dec08
Ireland 31989 65503 31Jan 06(can be extended
to 31Jan09)
Israel 89119 89119 29Jan09
Japan 01/24751 2781403 1Feb09
S. Korea 89/1069 147270 15May13
Mexico 9203596 181357 10Dec08
New Zealand 227839 227839 1Feb09
Norway 89/0426 177569 1Feb09
Portugal 89608 89608 2Feb09
23
Country Application No. Patent No. Expiration
------- --------------- ----------- ----------
Romania C-20256 -- 2Feb08
South Africa 89/0831 89/0831 1Feb09
Taiwan 78/100752 51931 20Oct06
USA 07/602931 5072011 9Dec08
USA 07/723971 5244919 14Sep10
2. Case MBUS 1192
Country Application No. Patent No. Expiration
------- --------------- ----------- ----------
Austria EP 95302629.1 0 679 656 19Apr15
Belgium EP 95302629.1 0 679 656 19Apr15
Denmark EP 95302629.1 0 679 656 19Apr15
France EP 95302629.1 0 679 656 19Apr15
Germany EP 95302629.1 0 679 656 19Apr15
Greece EP 95302629.1 0 679 656 19Apr15
GB EP 95302629.1 0 679 656 19Apr15
Holland EP 95302629.1 0 679 656 19Apr15
Ireland EP 95302629.1 0 679 656 19Apr15
Italy EP 95302629.1 0 679 656 19Apr15
Portugal EP 95302629.1 0 679 656 19Apr15
Spain EP 95302629.1 0 679 656 19Apr15
Sweden EP 95302629.1 0 679 656 19Apr15
Switzerland EP 95302629.1 0 679 656 19Apr15
Australia 17661/95 692521 23Apr15
Canada 2147567 -- 20Apr15
Japan 7-100870 -- 24Apr15
USA 08/428444 5519155 24Apr15
24
IN WITNESS whereof the parties have caused this Agreement to be executed
the day and year first above written
SIGNED by: /s/ Barry Murrer
------------------------- ------
For and on behalf of )
JOHNSON MATTHEY PUBLIC )
LIMITED COMPANY )
SIGNED by: /s/Rajesh C. Shrotriya
--------------------------------
Rajesh C. Shrotriya, M.D., President and Chief Operating Officer
For and on behalf of )
NEOTHERAPEUTICS INC. )
25
SCHEDULE A
Patent Rights
1. Case MBUS 1044
Country Application No. Patent No. Expiration
------- --------------- ---------- ----------
Austria EP891300787 0328274 26Jan09
Belgium " " 26Jan09
France " " 26Jan09
Germany " " 26Jan09
Great Britain " " 26Jan09
Greece " " 26Jan09
Italy " " 26Jan09
Luxembourg " " 26Jan09
Netherlands " " 26Jan09
Spain " " 26Jan09
Sweden " " 26Jan09
Switzerland " " 26Jan09
Australia 28971/89 618310 31Jan09
Brazil 1100963-2 1100963-2 2Feb08
Canada 589796 1340286 22Dec15
Denmark 0491/89 - 1Feb09
Finland 89/0512 91260 1Feb09
Hungary 52289 205767 3Feb09
Hungary P/P00163 210872 9Dec08
Ireland 31989 65503 31Jan 06 (can be extended
to 31Jan09)
Israel 89119 89119 29Jan09
Japan 01/24751 2781403 1Feb09
S. Korea 89/1069 147270 15May13
Mexico 9203596 181357 10Dec08
New Zealand 227839 227839 1Feb09
Norway 89/0426 177569 1Feb09
Portugal 89608 89608 2Feb09
Country Application No. Patent No. Expiration
------- --------------- ----------- ----------
Romania C-20256 - 2Feb08
South Africa 89/0831 89/0831 1Feb09
Taiwan 78/100752 51931 20Oct06
USA 07/602931 5072011 9Dec08
USA 07/723971 5244919 14Sep10
2. Case MBUS 1192
Country Application No. Patent No. Expiration
------- --------------- ----------- ----------
Europe 95302629 0 679 656 19Apr15
Australia 17661/95 692521 23Apr15
Canada 2147567 - 20Apr15
Japan 7-100870 - 24Apr15
USA 08/428444 5519155 24Apr15