Exhibit 10.6
LICENSE AGREEMENT
BETWEEN
BRISTOL-MYERS SQUIBB COMPANY
AND
NEOTHERAPEUTICS INC.
DATED AS OF
OCTOBER 24, 2001
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this "Agreement"), dated as of October 24, 2001
is entered into by and between Bristol-Myers Squibb Company, a corporation
organized and existing under the laws of the State of Delaware, having offices
at P.O. Box 206 and Province Line Road, Princeton, New Jersey 08543-4000, for
and on behalf of itself and its Affiliates ("BMS"), and NeoTherapeutics Inc., a
corporation organized and existing under the laws of Delaware, having offices at
157 Technology Drive, Irvine, California 92618 ("NeoTherapeutics").
PRELIMINARY STATEMENTS
A. BMS has developed, is the owner of and has all right, title and
interest in and to certain valuable technology, including know-how and patents
or patent applications, for the treatment of diseases and conditions in humans.
B. NeoTherapeutics is interested in developing and commercializing such
technology and desires to obtain a license from BMS to manufacture, market and
sell products using such technology in the Territory.
C. BMS is willing to grant such license to NeoTherapeutics on the terms
and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the foregoing Preliminary Statements
and the mutual covenants and agreements of the Parties contained in this
Agreement, the Parties agree as follows:
1. DEFINITIONS.
As used in this Agreement, the following terms will have those meanings
set forth in this Section 1 unless the context dictates otherwise.
1.1 "Affiliate", with respect to any Party, shall mean any Person
controlling, controlled by, or under common control with, such Party. For these
purposes, "control" shall refer to (a) the possession, directly or indirectly,
of the power to direct the management or policies of a Person, whether through
the ownership of voting securities, by contract or otherwise or (b) the
ownership, directly or indirectly, of at least 50% of the voting securities or
other ownership interest of a Person.
1.2 "Effective Date" shall have the meaning assigned thereto in
Section 5.1.
1.3 "FDA" shall mean the U.S. Food and Drug Administration, or the
successor thereto.
1.4 "First Commercial Sale" shall mean, with respect to any
Product, the first sale for use or consumption by the general public of such
Product in a country in the Territory after all required marketing and pricing
approvals have been granted, or otherwise permitted, by the
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governing health authority of such country. "First Commercial Sale" shall not
include the sale of any Product for use in clinical trials or for compassionate
use.
1.5 "Generic Product" shall mean, on a country-by-country basis, a
product marketed by an unlicensed Third Party or Parties in such country in
competition with any Product.
1.6 "Improvement" shall mean any new or useful invention, process
or improvement, patentable or unpatentable, relating to or arising from the
Licensed Technology, conceived or first reduced to practice or demonstrated to
have utility by NeoTherapeutics, its Affiliates or sublicensees, either alone,
jointly with a Third Party or jointly with BMS, during the term of this
Agreement, including, without limitation, any Products developed and marketed by
NeoTherapeutics, its Affiliates or sublicensees.
1.7 "IND" shall mean an investigational new drug application filed
with the FDA.
1.8 "Know-How" shall mean any and all technical data, information,
material and other know-how, if any, currently owned by BMS that is necessary or
useful to practice the Patents.
1.9 "Licensed Technology" shall mean the Patents set forth in
Exhibit A, the Material and, with respect to each Patent, the Know-How that is
necessary or useful to practice such Patent, collectively. When no Patent(s) is
specified, "Licensed Technology" shall mean all of the Patents, Material and
Know-How, collectively.
1.10 "Major Market" shall mean each of France, Germany, Japan,
Italy, Spain, the United Kingdom and the United States.
1.11 "Material" shall mean the culture from the American Type
Culture Collection identified by accession number ATCC 39417.
1.12 "Net Sales" shall mean, with respect to any Product, the
gross amount invoiced for such Product by NeoTherapeutics, its Affiliates, and
sublicensees to Third Parties, less deductions for: (i) trade, quantity and/or
cash discounts, allowances and rebates (including, without limitation,
promotional or similar allowances) actually allowed or given; (ii) freight,
postage, shipping, insurance and transportation expenses and similar charges (in
each instance, if separately identified in such invoice); (iii) credits or
refunds actually allowed for rejections, defects or recalls of such Product,
outdated or returned Product, or because of rebates or retroactive price
reductions; and (iv) sales, value-added, excise taxes, tariffs and duties, and
other taxes directly related to the sale, to the extent that such items are
included in the gross invoice price (but not including taxes assessed against
the income derived from such sale). Such amounts shall be determined from the
books and records of NeoTherapeutics, its Affiliates or its sublicensees,
maintained in accordance with the reasonable accounting principles used by such
entity, consistently applied.
In the event that a Product is sold as part of a Combination Product (as
defined below), the Net Sales from the Combination Product, for the purposes of
determining royalty payments, shall be determined by multiplying the Net Sales
of the Combination Product (calculated using the standard Net Sales definition)
during the applicable royalty reporting period by the fraction A/A+B, where A is
the average sale price of the Product when sold separately in finished form and
B is the
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average sale price of the other product(s) included in the Combination Product
when sold separately in finished form, in each case during the applicable
royalty reporting period or, if sales of both the Product and the other
product(s) did not occur in such period, then in the most recent royalty
reporting period in which sales of both occurred. In the event that such average
sale price cannot be determined for both the Product and all other product(s)
included in the Combination Product, Net Sales for the purposes of determining
royalty payments shall be calculated by multiplying the Net Sales of the
Combination Product (calculated using the standard Net Sales definition) by the
fraction C/C+D, where C is the fair market value of the Product and D is the
fair market value of all other pharmaceutical product(s) included in the
Combination Product. In such event, NeoTherapeutics shall in good faith make a
determination of the respective fair market values of the Product and all other
pharmaceutical products included in the Combination Product, and shall notify
BMS of such determination and provide BMS with data to support such
determination. BMS shall have the right to review such determination and
supporting data. If BMS disagrees with such determination, BMS shall notify
NeoTherapeutics of such disagreement within 30 days following receipt by BMS of
the fair market values determination made by NeoTherapeutics. If the Parties
cannot reach agreement as to fair market values within 30 days from the date
upon of BMS advises NeoTherapeutics of the disagreement as to fair market
values, an independent expert shall be selected by NeoTherapeutics with the
consent of BMS (which consent will not be unreasonably withheld) to make the
determination of fair market values. The independent expert shall render a
determination within 10 days of appointment.
As used above, the term "Combination Product" shall mean any
pharmaceutical product which comprises the Product and any other active
compounds and/or ingredients.
1.13 "Party" shall mean BMS or NeoTherapeutics and, when used in
the plural, shall mean BMS and NeoTherapeutics.
1.14 "Patents" shall mean all patents and patent applications
throughout the Territory, and any substitutions, extensions, renewals,
continuations, continuations-in-part, divisions, patents-of-addition and/or
reissues or extensions thereof, which are (i) at present owned or controlled by
BMS and are set forth in Exhibit A, or (ii) are owned or controlled by
NeoTherapeutics, jointly by BMS and NeoTherapeutics, or jointly by a Third Party
and NeoTherapeutics, as the case may be, and cover any Improvements.
1.15 "Person" shall mean any natural person, corporation, firm,
business trust, joint venture, association, organization, company, partnership
or other business entity, or any government or any agency or political
subdivision thereof.
1.16 "Product" shall mean any pharmaceutical formulation developed
by NeoTherapeutics, its Affiliates or sublicensees during the term of this
Agreement, the manufacture, use or sale of which is either: (i) based upon or
derived from any of the Know-How; or (ii) covered by one or more Patents and,
but for this Agreement, would constitute an infringement of a Valid Claim
thereof.
1.17 "Results" shall mean any and all technical data, information,
material and other know-how, whether patentable or not, including but not
limited to analytical methodology,
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chemical, toxicological, pharmacological and clinical data, formulae,
procedures, drafts and/or protocols, techniques, and results of experimentation
and testing, developed or acquired by NeoTherapeutics, its Affiliates or
sublicensees during the term of this Agreement which relate to the Licensed
Technology, except Improvements. "Results" shall include data and information
generated for the purpose of obtaining marketing approvals of the Products in
any country in the Territory. The Results shall be owned by NeoTherapeutics.
1.18 "Royalty Term" shall mean, with respect to each Product in
each country in the Territory, the period of time commencing on the Effective
Date and ending on the date that is the latest of (i) 10 years from the date of
the First Commercial Sale of such Product in such country, or (ii) the
expiration of the last to expire of the Valid Claims necessary for the
manufacture, use and sale of such Product in such country.
1.19 "Territory" shall mean the world.
1.20 "Third Party" shall mean any Person who or which is neither a
Party nor an Affiliate of a Party.
1.21 "Valid Claim" shall mean a claim of any Patent which has not
been held invalid or unenforceable by final decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal, and which is not admitted to be invalid or
unenforceable through reissue, disclaimer or otherwise.
2. EXCHANGE OF DATA AND MATERIALS.
2.1 Licensed Technology. As soon as practicable after the
Effective Date, but in any event within 90 days thereafter, BMS shall deliver to
NeoTherapeutics copies of all data, studies and materials comprising the
Licensed Technology then in the possession of or reasonably available to BMS.
Apart from the obligation set forth in the foregoing sentence, BMS shall have no
obligation to provide any scientific, technical or other consulting or
assistance of any kind to NeoTherapeutics with respect to the Licensed
Technology.
2.2 Transfer of INDs. Promptly after the Effective Date, but in
any event within 90 days thereafter, BMS shall transfer to NeoTherapeutics
ownership of all INDs and other regulatory filings, if any, filed by BMS with
respect to any products based upon, derived from or related to any of the
Know-How or covered by one or more Patents. In addition to such transfer, BMS
shall deliver to NeoTherapeutics copies of all material correspondence in its
possession directly related to such transferred INDs, including, without
limitation, such correspondence to and from the FDA. All INDs and other
regulatory filings filed with respect to any Products after the Effective Date
shall be owned by NeoTherapeutics.
2.3 Access to Material. As soon as practicable after the Effective
Date, but in any event within 90 days thereafter, BMS shall provide to
NeoTherapeutics any Material then in the possession of or reasonably available
to BMS. EXCEPT AS EXPRESSLY PROVIDED FOR HEREIN, THE MATERIAL IS PROVIDED "AS
IS" AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION ANY
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IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR
ANY WARRANTY THAT THE USE OF THE MATERIAL WILL NOT INFRINGE OR VIOLATE ANY
PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.
2.4 Exceptions and Limitations. All of the information exchanged
by the Parties pursuant to this Section 2 shall be deemed to be Confidential
Information and shall be subject to the confidentiality provisions of Section
11.
3. DEVELOPMENT AND COMMERCIALIZATION.
3.1 Development Obligations. NeoTherapeutics shall, at its own
expense, use commercially reasonable efforts to develop Products, which efforts
shall include the performance of all studies necessary to obtain approval for at
least one indication of such Products from governmental agencies in at least one
Major Market where governmental approval is necessary in order to market such
indications of such Products.
3.2 Conduct of Development by NeoTherapeutics. During the term of
this Agreement, NeoTherapeutics shall:
(a) undertake its development obligations, as set forth in
this Agreement, and such other activities which are reasonably contemplated to
be necessary for the commercial success of the Products;
(b) conduct all research pursuant to this Agreement in good
scientific manner, and in compliance in all material respects with all
requirements of applicable laws, rules and regulations, and all other
requirements of any applicable good laboratory or clinical practices to attempt
to achieve its objectives efficiently and expeditiously;
(c) within 60 days following the end of each twelve-month
period during the term of this Agreement, furnish BMS with written status
reports, in summary form, on all NeoTherapeutics activities under this Agreement
during such twelve-month period;
(d) file for marketing approval following the completion of
the development of any Product in all Major Markets; and
(e) allow representatives of BMS, upon reasonable notice
and during normal business hours, to visit the facilities where the research is
being conducted; provided that such visits shall not be made more than one time
per calendar year.
3.3 Records. NeoTherapeutics shall maintain records, in sufficient
detail and in good scientific manner, which shall be complete and accurate and
shall fully and properly reflect all work done and results (including, without
limitation, the Results) achieved in the performance of its development
obligations under this Agreement (including all data in the form required under
all applicable laws and regulations).
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3.4 Commercialization Responsibilities. During the term of this
Agreement, following the completion of the development of any Product,
NeoTherapeutics and/or its Affiliates or sublicensees shall:
(a) Market and sell such Product under a trademark or
trademarks owned or acquired by NeoTherapeutics. NeoTherapeutics shall be solely
responsible for all matters relating to such trademark(s), including without
limitation the registration, maintenance and prosecution of such trademark(s) in
each country in the Territory where such Product is being marketed and sold.
NeoTherapeutics shall bear all liability of any kind with respect to such
trademark(s) and the use of such trademark(s) by NeoTherapeutics, its Affiliates
and its sublicensees.
(b) Promptly provide BMS with a copy of all reasonably
material correspondence to or from health authorities in any country in the
Territory relating to any material development affecting such Product (including
both its approval and labeling), and, within one month of receipt by
NeoTherapeutics, its Affiliates or sublicensees, NeoTherapeutics shall provide,
or cause its Affiliates or sublicensees to provide, BMS with copies of all
approvals and labeling changes received from the health authorities in any
country in the Territory.
(c) Initiate a commercial launch and diligently promote the
sale of such Product in each Major Market as soon as practicable after: (i)
receiving all governmental approvals (including reimbursement price approval, if
any) necessary to market and sell such Product in such Major Market; and (ii)
NeoTherapeutics reasonably and in good faith determines it can profitably market
such Product in such Major Market. In the event NeoTherapeutics (i) determines
it can not profitably market such Product in such Major Market, or (ii) has not
initiated the commercial launch and diligent promotion of the sale of such
Product in such Major Market; in either case, within one year of receiving all
governmental approvals (including reimbursement pricing approval, if any, and
any appeals or other similar proceedings with respect thereto) necessary to
market and sell such Product in such Major Market, then, at the request of BMS,
(x) NeoTherapeutics shall grant BMS an exclusive, royalty-free, perpetual
license (with the unrestricted right to grant sublicenses) to exploit the
Improvements to develop, use, make, have made, import, register, market,
distribute and sell such Product in such Major Market, (y) NeoTherapeutics shall
transfer to BMS all approvals necessary or useful for the commercial launch
and/or promotion of the sale of such Products in such Major Market, and (z) the
license and rights granted to NeoTherapeutics and its sublicenses under Sections
4.1 and 4.2 shall terminate as to such Product in such Major Market.
4. GRANT OF LICENSE AND OTHER RIGHTS.
4.1 License Grant. Subject to the terms and conditions of this
Agreement, BMS hereby grants to NeoTherapeutics an exclusive right and license
under the Licensed Technology, to make, have made, use, offer to sell, sell and
have sold Products in the Territory. BMS shall retain no right to use the
Licensed Technology to make, use or sell Products in the Territory; provided,
that BMS shall retain all rights to exploit the Licensed Technology to develop,
use, make, have made, import, register, market, distribute and sell any product
in the Territory that is not a Product.
4.2 Right to Sublicense.
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(a) Subject to Sections 4.2(b) and (c), NeoTherapeutics
shall have the right to grant sublicenses, without restriction on use, to Third
Parties under the rights and licenses granted to NeoTherapeutics under this
Agreement. In the event of any such sublicensing, within 30 days of the
effective date of each sublicense (or modification of a sublicense)
NeoTherapeutics shall submit to BMS a copy of such sublicense (or modification
thereof) and evidence acceptable to BMS of such sublicensee's insurance coverage
(such insurance coverage to be in accordance with Section 10.5).
(b) NeoTherapeutics shall be primarily responsible for all
payments due and the making of reports under this Agreement by its sublicensees
and shall guarantee their compliance with all applicable terms of this
Agreement. Each prospective sublicensee shall agree in writing (i) to maintain
insurance coverage at the same levels and on the same terms and conditions as
set forth in Section 10.5, which insurance shall name BMS as an additional
insured and (ii) to keep books and records and permit BMS to review such books
and records pursuant to Sections 6.3, 6.4 and 6.5 and to observe all other
applicable terms of this Agreement.
(c) In the event of a breach by a sublicensee of
NeoTherapeutics in the observance of applicable terms of this Agreement, BMS
shall be entitled to proceed, at the sole discretion of BMS, against such
sublicensee and/or NeoTherapeutics to enforce this Agreement. In furtherance of
the foregoing and the rights of BMS thereunder, each sublicense granted by
NeoTherapeutics pursuant to this Section 4.2 shall explicitly provide that BMS
is a third party beneficiary of such sublicense.
5. INITIAL PAYMENT; ROYALTIES.
5.1 Initial Payment. In partial consideration of the right and
license granted by BMS to NeoTherapeutics under this Agreement, NeoTherapeutics
shall pay BMS a license fee of $100,000 within 10 days after the date of this
Agreement (the date on which such payment is made, the "Effective Date").
Notwithstanding any other provision of this Agreement, such fee shall be
non-refundable and non-creditable against any other payments to be made by
NeoTherapeutics under this Agreement.
5.2 Milestone Payments. As further consideration of the right and
license granted by BMS to NeoTherapeutics under this Agreement, NeoTherapeutics
shall pay to BMS the following non-refundable milestone payments upon the first
occurrence of each event set forth below with respect to a Product:
(a) a one-time payment of $200,000 upon the commencement of
Phase III clinical trials (enrollment of the first patient);
(b) a one-time payment of $200,000 upon the first filing of
a new drug application with either the FDA or any equivalent foreign regulatory
authority, which ever occurs first; and
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(c) a one-time payment of $500,000 upon first receipt of
approval of a new drug application by either the FDA or any equivalent foreign
regulatory authority, whichever occurs first.
Each of the milestone payments required pursuant to this Section 5.2 shall be
paid within 10 days after such milestone has been achieved.
5.3 Royalties. In further consideration of the right and license
granted by BMS to NeoTherapeutics under this Agreement, subject to Sections 5.5
and 8.1(b), during the Royalty Term, NeoTherapeutics shall pay to BMS a royalty
on Net Sales of Products commencing on the First Commercial Sale of any Product
by NeoTherapeutics, its Affiliates or its sublicensees in any country in the
Territory, with respect to Products covered by Licensed Technology, at the rate
of 10%.
5.4 Third Party Royalties. NeoTherapeutics, at its sole expense,
shall pay all royalties accruing to any Third Party after the Effective Date
that result from NeoTherapeutics's or its Affiliates' or sublicensees'
activities and that NeoTherapeutics determines, in its reasonable business
judgment, are necessary in order to exercise NeoTherapeutics's rights hereunder
to make, have made, use, sell or have sold any Product (all such royalties,
"Third Party Royalties").
5.5 Reduction for Generic Competition. With respect to any country
in the Territory where a Product is a Generic Product, the royalties payable to
BMS under Section 5.2 with respect to Net Sales of such Product in such country
shall be reduced. The amount of such reduction shall be determined by reference
to the following table and the market penetration, which Third Party or Parties
have, in the aggregate, achieved through sales of such Generic Product, shown as
a percentage of the unit volume of sales for such Product in any calendar
quarter in such country, as measured by IMS, commencing with the calendar
quarter during which such Product first becomes a Generic Product in such
country. Such reduction shall be in lieu of any other reduction with respect to
such royalties under this Agreement to which NeoTherapeutics otherwise would be
entitled.
MARKET PENETRATION ROYALTY REDUCTION
------------------ -----------------
20% 50%
30% 75%
40% 100%
5.6 Obligation to Pay Royalties. There shall be no obligation to
pay royalties to BMS under this Section 5 on sales of Products among
NeoTherapeutics, its Affiliates and its sublicensees, but in such instances the
obligation to pay royalties shall arise upon the sale by NeoTherapeutics, its
Affiliates or its sublicensees to unrelated Third Parties.
6. PAYMENTS AND REPORTS.
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6.1 Payment. All royalty payments payable to BMS under this
Agreement shall be paid quarterly within 60 days of the end of each calendar
quarter. Each such payment shall be accompanied by a statement,
Product-by-Product and country-by-country of the amount of Net Sales during such
quarter and the amount of royalties due on such Net Sales.
6.2 Mode of Payment. NeoTherapeutics shall make all payments
required under this Agreement as directed by BMS from time to time in U.S.
Dollars. Whenever for the purpose of calculating royalties, conversion from any
foreign currency shall be required, such conversion shall be at the rate of
exchange published in The Wall Street Journal, Eastern U.S. edition, for the
last business day of the calendar quarter in which such sales were made.
6.3 Records Retention. NeoTherapeutics, its Affiliates and its
sublicensees shall keep complete and accurate records (specifically including
originals or copies of documents supporting entries in the books of account)
pertaining to the sale of Products in the Territory and covering all
transactions from which Net Sales are derived for a period of three calendar
years after the year in which such sales occurred, and in sufficient detail to
permit BMS to confirm the accuracy of royalty calculations hereunder.
6.4 Audit Request. At the request of BMS, NeoTherapeutics, its
Affiliates and its sublicensees shall permit an independent certified public
accountant appointed by BMS, at reasonable times and upon reasonable notice (but
in no event more than once per calendar year), to examine those records and all
other material documents relating to or relevant to Net Sales in the possession
or control of NeoTherapeutics, its Affiliates or its sublicensees, for a period
of three years after such royalties have accrued, as may be necessary to: (i)
determine the correctness of any report or payment made under this Agreement; or
(ii) obtain information as to the royalties payable for any calendar quarter in
the case of NeoTherapeutics's failure to report or pay pursuant to this
Agreement. Said accountant shall not disclose to BMS any information other than
information relating to said reports, royalties, and payments. The results of
any such examination shall be made available to both Parties. BMS shall bear the
full cost of the performance of any such audit except as hereinafter set forth.
If, as a result of any inspection of the books and records of NeoTherapeutics or
its Affiliates or its sublicensees, it is shown that NeoTherapeutics's royalty
payments under this Agreement were less than the amount which should have been
paid, then NeoTherapeutics shall make all payments required to be made to
eliminate any discrepancy revealed by said inspection within 15 days after
demand of BMS therefor. Furthermore, if the royalty payments made by
NeoTherapeutics were less than 95% of the amount of royalty payments which
should have been paid with respect to the period in question, NeoTherapeutics
shall also reimburse BMS for the cost of such examination.
6.5 Taxes. All payments due under this Agreement shall be paid in
full without deduction except for withholding taxes, if any, required by law in
any country in the Territory with respect to such payment. In the event that
NeoTherapeutics is required to withhold any tax to the revenue authorities in
any country in the Territory regarding any payment to BMS due to the laws of
such country, such amount shall be deducted by NeoTherapeutics, and it shall
notify BMS and promptly furnish BMS with copies of any tax certificate or other
documentation evidencing such withholding.
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6.6 Interest on Late Payments. NeoTherapeutics shall pay interest
on any payment to BMS under this Agreement that is not made by the date due
hereunder at a rate equal to the prime rate plus 2%, compounded quarterly,
obtained from The Wall Street Journal, Eastern U.S. edition, on the business day
next preceding the date such payment was due, from such date until payment in
full has been made.
7. REPRESENTATIONS AND WARRANTIES.
7.1 Representations and Warranties of Both Parties. Each Party
represents and warrants to the other Party that: (i) it is free to enter into
this Agreement; (ii) in so doing, it will not violate any other agreement to
which it is a party; (iii) it has taken all corporate action necessary to
authorize the execution and delivery of this Agreement and the performance of
its obligations under this Agreement; and (iv) to the knowledge of BMS (without
any obligation to conduct any inquiry), the information delivered to
NeoTherapeutics pursuant to Sections 2.1 and 2.2, as and when delivered, is true
and correct in all material respects.
7.2 BMS Disclaimer of All Representations and Warranties. EXCEPT
AS SET FORTH IN SECTION 7.1, BMS DOES NOT MAKE ANY EXPRESS OR IMPLIED
WARRANTIES, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF QUALITY, PERFORMANCE,
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT, WITH
RESPECT TO THE LICENSED TECHNOLOGY, THE PRODUCTS OR ANY MATERIALS TRANSFERRED TO
NEOTHERAPEUTICS UNDER THIS AGREEMENT. Except as expressly set forth herein,
NeoTherapeutics acknowledges and agrees that BMS is licensing the Licensed
Technology to NeoTherapeutics strictly on an "AS IS, WHERE IS" basis and that
NeoTherapeutics shall have no claims or causes of action of any kind against BMS
with respect thereto.
8. PATENTS; IMPROVEMENTS.
8.1 Patent Filing, Maintenance and Prosecution. NeoTherapeutics
shall have the right, in its sole discretion and at its sole cost and expense,
to determine whether to prosecute or maintain any Patents regarding the Licensed
Technology or the Products. "Patents" shall mean any and all patents and patent
applications throughout the Territory, and any substitutions, extensions,
renewals, continuations, continuations-in-part, divisions, patents-of-addition
and/or reissues or extensions thereof, which may be prosecuted or maintained by
NeoTherapeutics or jointly by BMS and NeoTherapeutics, as the case may be,
relating to the Licensed Technology or Products, and cover any Improvements.
With regard to any Patent issued jointly to the Parties, NeoTherapeutics shall
have the exclusive right to license all of BMS's rights to such jointly owned
Patent.
8.2 Information; Consultation; Cooperation.
(a) With respect to the filing, prosecution and maintenance
of any Patent pursuant to Section 8.1(a), the filing Party shall keep the other
Party informed of its decisions and actions in this regard by providing a report
thereof to such other Party. Further, in connection with any such filing,
prosecution or maintenance by either Party, such Party shall consult with the
other Party and in good faith consider and give due respect to such other
Party's position with respect
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thereto. In the event that the sole owning or controlling Party elects not to
file for patent protection or prosecute or maintain any Patent pursuant to
Section 8.1(a) and the other Party elects to do so, such owning or controlling
Party shall cooperate with the other Party in such filing, prosecution or
maintenance.
(b) In addition, with respect to the filing, prosecution
and maintenance of any Patent pursuant to Section 8.1(a) that covers an
Improvement by a Party that does not solely own such Improvement, the filing
Party shall cooperate with the other Party in determining strategies for such
filing, prosecution and maintenance, and the filing Party shall make its patent
counsel available for consultation with patent counsel for the other Party for
this purpose.
8.3 Improvements. Improvements that are made by an employee or
agent of NeoTherapeutics, solely or jointly other than with an employee or agent
of BMS, shall be owned by NeoTherapeutics. Improvements that are made jointly by
employees or agents of NeoTherapeutics and BMS shall be jointly owned by
NeoTherapeutics and BMS and treated as joint inventions under U.S. laws
applicable to joint inventions. As to BMS, Improvements that are made jointly by
employees or agents of NeoTherapeutics and any Third Party shall be owned by
NeoTherapeutics. Except as otherwise set forth in this Agreement, each of BMS
and NeoTherapeutics shall retain its unrestricted rights to make, have made,
use, sell and have sold all Improvements that are owned by it solely, jointly
with the other Party or jointly by NeoTherapeutics and a Third Party.
9. PATENT ENFORCEMENT; INFRINGEMENT.
9.1 Patent Enforcement. As soon as it shall have knowledge
thereof, each Party shall promptly advise the other Party of any infringement of
the Patents in the Territory by a Third Party. With respect to any Patent that
is licensed to NeoTherapeutics under this Agreement or any Patent claiming or
covering an Improvement (regardless of the ownership of such Patent),
NeoTherapeutics shall have the first right, but not the duty, to institute
infringement actions against Third Parties. If the Party having the first right
to institute an infringement proceeding against an offending Third Party does
not do so within 90 days after receipt of notice from the other Party, such
other Party shall have the right, but not the duty, to institute such an action.
The costs and expenses of any such action (including reasonable fees of
attorneys and other professionals) shall be borne by the Party instituting the
action, or, if the Parties elect to cooperate in instituting and maintaining
such action, such costs and expenses shall be borne by the Parties in such
proportions as they may agree in writing. Each Party shall execute all necessary
and proper documents and take such actions as shall be appropriate to allow the
other Party to institute and prosecute such infringement actions. Any award paid
by Third Parties as a result of such an infringement action (whether by way of
settlement or otherwise) shall be paid to the Party who instituted and
maintained such action, or, if both Parties instituted and maintained such
action, such award shall be allocated among the Parties in proportion to their
respective contributions to the costs and expenses incurred in such action.
9.2 Infringement Action by Third Parties. As soon as it shall have
knowledge thereof, each Party shall promptly advise the other Party of any
infringement action instituted by a Third Party with respect to any Product or
of any grounds for any such action, regardless of whether such action has been
instituted. In the event of the institution of any suit by a Third Party against
NeoTherapeutics for patent infringement involving the manufacture, sale,
distribution or marketing
11
of any Product in the Territory, NeoTherapeutics shall have the right to defend
such suit at its own expense, and BMS hereby agrees to assist and cooperate with
NeoTherapeutics, at its own expense, to the extent necessary in the defense of
such suit. For so long as BMS shall continue to provide such assistance and
cooperation at its expense, NeoTherapeutics shall not enter into any settlement
arrangement or other amicable arrangement without the prior written consent of
BMS. During the pendency of such action, NeoTherapeutics shall continue to make
all payments due under this Agreement. If, as a result of any judgment, award,
decree or settlement resulting from an action instituted by a Third Party,
NeoTherapeutics is required to pay damages and/or a royalty to such Third Party,
NeoTherapeutics shall be solely responsible for the payment of such damages
and/or such royalties for such Products to such Third Party and shall continue
to pay royalties pursuant to this Agreement in the country which is the subject
of such action. Any payment made to a Third Party pursuant to this Section shall
not be deemed to be Third Party Royalties.
10. INDEMNIFICATION.
10.1 By NeoTherapeutics. NeoTherapeutics, including any successor
to NeoTherapeutics, shall, and shall obligate its Affiliates or its
sublicensees, if any, to, indemnify and hold BMS and its Affiliates, and their
respective directors, officers, employees and agents harmless from and against
any and all liability, damage to or loss of property or injury to or death of
any person or persons, costs and expenses (including reasonable attorney's fees)
resulting from claims arising out of:
(a) negligence, recklessness or wrongful intentional acts
or omissions of NeoTherapeutics, its Affiliates or its sublicensees, if any, and
their respective directors, officers, employees and agents, in connection with
the use or development of any Licensed Technology or Patents claiming or
covering Improvements; or
(b) any warranty claims, Product recalls or any tort claims
of personal injury (including death) or property damage relating to or arising
out of the manufacture, use, distribution or sale of any Product or services by
NeoTherapeutics, its Affiliates or its sublicensees, if any, due to any
negligence, recklessness or wrongful intentional acts or omissions by, or strict
liability of, NeoTherapeutics, its Affiliates or its sublicensees, if any, and
their respective directors, officers, employees and agents.
10.2 By BMS.
(a) BMS shall, and shall obligate its Affiliates to,
indemnify, defend, and hold NeoTherapeutics, its Affiliates, and their
respective directors, officers, employees and agents harmless from and against
any and all liability, damage to or loss of property or injury to or death of
any person or persons, costs and expenses (including reasonable attorney's fees)
resulting from claims arising out of gross negligence, recklessness or wrongful
intentional acts or omissions of BMS, its Affiliates or its sublicensees, if
any, and their respective directors, officers, employees and agents, in
connection with the use or development of any Licensed Technology or Patents
claiming or covering Improvements.
12
(b) In the event that BMS makes, has made, uses, sells or
has sold any Product pursuant to Section 12.5(c), BMS shall, and shall obligate
its sublicensees, if any, to, indemnify NeoTherapeutics and its Affiliates, and
their respective directors, officers, employees and agents with respect thereto
to the same extent as the indemnification required to be provided by
NeoTherapeutics in Section 10.1.
10.3 Notice. In the event that either Party is seeking
indemnification under Section 10.1 or Section 10.2, such Party shall inform the
indemnifying Party of a claim as soon as reasonably practicable after it
receives notice of the claim, shall permit the indemnifying Party to assume
direction and control of the defense of the claim (including the sole right to
settle it at the sole discretion of the indemnifying Party, provided that such
settlement does not impose any obligation on the indemnified Party), and shall
cooperate as requested (at the expense of the indemnifying Party) in the defense
of the claim.
10.4 Complete Indemnification. As the Parties intend complete
indemnification, all costs and expenses of enforcing this Section 10 shall also
be reimbursed by the indemnifying Party.
10.5 Insurance.
(a) In furtherance and not in limitation of any indemnity
obligations of NeoTherapeutics under this Agreement: (i) commencing on the
Effective Date and thereafter for the period of time required hereinbelow, each
of NeoTherapeutics and its sublicensees shall obtain and maintain on an on-going
basis their own insurance policies for comprehensive general liability insurance
in the amount of $1,000,000 per occurrence and $2,000,000 annual aggregate
combined single limit for bodily injury and property damage liability; and (ii)
commencing not later than 30 days prior to the first use in humans of the first
potential Product and thereafter for the period of time required hereinbelow,
each of NeoTherapeutics and its sublicensees shall obtain and maintain on an
on-going basis their own insurance policies for products liability insurance
(including contractual liability coverage of such party's indemnification
obligations under this Agreement and any sublicense agreements) in the amount of
at least $25,000,000 per occurrence and annual aggregate combined single limit
for bodily injury and property damage liability. All of such insurance coverage
shall be maintained with a insurance company or companies having an A. M. Best
rating of "A-" or better and an aggregate deductible not to exceed $100,000 per
occurrence.
(b) Not later than the Effective Date with respect to the
comprehensive general liability coverage, and not later than 30 days prior to
the first use in humans of the first potential Product with respect to the
products liability coverage, each of NeoTherapeutics and its sublicensees shall
provide to BMS a certificate(s) evidencing all such required coverage hereunder.
Thereafter each of NeoTherapeutics and its sublicensees shall maintain such
insurance coverage without interruption during the term of this Agreement and
for a period of at least 10 years after the expiration or termination of the
term and shall provide certificates evidencing such insurance coverage without
interruption on an annual basis (by no later than the annual renewal date for
such coverage) during the period of time for which such coverage must be
maintained.
13
(c) Each of NeoTherapeutics's and its sublicensees'
insurance shall name BMS as an additional insured, shall state that such
insurance is primary to any valid and collectible insurance available to BMS
that also insures the same loss for which NeoTherapeutics and/or its
sublicensees has liability pursuant to this Agreement and/or the sublicense
agreements (including, without limitation, under applicable indemnification
provisions in such agreements), shall contain a cross-liability or severability
of interest clause, and shall state that BMS shall be provided at least 60 days'
prior written notice of any cancellation or material change in the insurance
policy. Each of NeoTherapeutics and its sublicensees shall promptly provide BMS
with a copy of all communications passing between such inured party and the
carrier(s) providing the coverage required under this Section 10.5. The failure
of NeoTherapeutics's or any of its sublicensees to comply with the provisions of
this Section 10.5 shall be deemed to be a material breach of this Agreement.
11. CONFIDENTIALITY.
11.1 Confidentiality; Exceptions. Except to the extent expressly
authorized by or required for the performance of this Agreement or otherwise
agreed in writing, the Parties agree that, for the term of this Agreement and
for five years thereafter the receiving Party, its Affiliates and its
sublicensees (collectively, the "receiving Party") shall keep, and shall ensure
that its officers and directors keep, completely confidential and shall not
publish or otherwise disclose and shall not use for any purpose inconsistent
with this Agreement any information furnished to it by the disclosing Party, its
Affiliates or its sublicensees that is marked as confidential or, if furnished
orally, that the disclosing Party notifies the receiving Party is confidential
within 30 days after such information is furnished, or any information developed
pursuant to this Agreement (collectively, "Confidential Information"). This
Section 11.1 shall not apply to information that the receiving Party can
establish: (i) is or hereafter becomes generally available to the public other
than by reason of any default with respect to a confidentiality obligation; (ii)
was already known to the receiving Party when disclosed by the disclosing Party,
as evidenced by prior written records; or (iii) is disclosed to the receiving
Party by a Third Party who reasonably was not known by the receiving Party to be
in default of any confidentiality obligation to the disclosing Party.
11.2 Exceptions.
(a) The restrictions contained in Section 11.2 shall not
apply to Confidential Information that (i) is submitted by the receiving Party
to governmental authorities to facilitate the issuance of marketing approvals
for a Product, provided that reasonable measures shall be taken to assure
confidential treatment of such information; (ii) is provided by the receiving
Party to Third Parties under appropriate terms and conditions, including
confidentiality provisions equivalent to those in this Agreement, for
consulting, manufacturing development, manufacturing, external testing and
marketing trials; or (iii) is otherwise required to be disclosed in compliance
with applicable laws or regulations or order by a court or other regulatory body
having competent jurisdiction; provided that if a receiving Party is required to
make any such disclosure of the other Party's Confidential Information it will,
except where impracticable for necessary disclosures, for example to physicians
conducting studies or to health authorities, give reasonable advance notice to
the other Party of such disclosure requirement and, except to the extent
inappropriate in the case
14
of patent applications, will use its best efforts to secure confidential
treatment of such Confidential Information required to be disclosed.
(b) Nothing in Section 11.2 shall prevent NeoTherapeutics:
(i) in connection with efforts to secure financing at any time during the term
of this Agreement, from issuing statements and sharing information as to
NeoTherapeutics's agreements with BMS, achievements made, and the status of the
work being done, under this Agreement, so long as such statements or information
do not jeopardize the ability to obtain patent protection on Improvements or
disclose technical or scientific Confidential Information; or (ii) from issuing
statements that NeoTherapeutics determines to be necessary to comply with
applicable law (including the disclosure requirements of the U.S. Securities and
Exchange Commission, Nasdaq or any other stock exchange on which securities
issued by NeoTherapeutics are traded); provided that, in the case of statements
made to or information shared with the general public, to the extent practicable
under the circumstances, NeoTherapeutics shall provide BMS with a copy of the
proposed text of such statements sufficiently in advance of the scheduled
release thereof to afford BMS a reasonable opportunity to review and comment
upon the proposed text.
11.3 Limitations on Use. Each Party shall use, and cause each of
its Affiliates and its sublicensees to use, any Confidential Information
obtained by it from the other Party, its Affiliates or its sublicensees,
pursuant to this Agreement or otherwise, solely in connection with the
activities or the transactions contemplated hereby.
11.4 Remedies. Each Party shall be entitled, in addition to any
other right or remedy it may have, at law or in equity, to an injunction,
without the posting of any bond or other security, enjoining or restraining the
other Party, its Affiliates and/or its sublicensees from any violation or
threatened violation of this Section 11.
12. TERM; TERMINATION.
12.1 Term. The term of this Agreement shall commence as of the
Effective Date and, unless sooner terminated as provided hereunder, shall
terminate as follows:
(a) As to each Product in each country in the Territory,
this Agreement shall terminate upon the expiration of the Royalty Term.
(b) This Agreement shall terminate in its entirety upon its
termination in all countries in the Territory.
12.2 Termination by NeoTherapeutics. NeoTherapeutics shall have
the right to terminate this Agreement in its entirety at any time by giving
written notice thereof to BMS, which shall be effective 30 days from the date
such notice is given.
12.3 Breach. Failure by either Party to comply with any of the
material obligations contained in this Agreement shall entitle the other Party
to give to the Party in default notice specifying the nature of the default and
requiring it to cure such default. If such default is not cured within 60 days
after the receipt of such notice (or, if such default cannot be cured within
such 60-day period, if the Party in default does not commence and diligently
continue actions to cure such
15
default), the notifying Party shall be entitled, without prejudice to any of its
other rights conferred on it by this Agreement and in addition to any other
remedies available to it by law or in equity, to terminate this Agreement by
giving written notice to take effect immediately upon delivery of such notice.
The right of either Party to terminate this Agreement, as hereinabove provided,
shall not be affected in any way by its waiver or failure to take action with
respect to any previous default.
12.4 Failure to Maintain Insurance. This Agreement shall terminate
automatically and without necessity of any action by either Party in the event
that (i) NeoTherapeutics fails to maintain all insurance coverage that it is
required to maintain under Section 10.5, or (ii) a sublicensee of
NeoTherapeutics fails to maintain all insurance coverage that it is required to
maintain under Section 4.2(b) and NeoTherapeutics does not, prior to the
cancellation or non-renewal of such coverage, either (A) terminate such
sublicense, or (B) obtain the requisite coverage on behalf and for the benefit
of such sublicense, unless, in each event, such termination of this Agreement is
waived in writing by BMS.
12.5 Effect of Termination.
(a) Following the expiration of NeoTherapeutics's
obligation to pay royalties with respect to any Product in any country in the
Territory pursuant to Section 12.1(a), NeoTherapeutics shall have the
royalty-free, non-exclusive, perpetual right and license to continue to use the
Licensed Technology to make, have made, use, sell and have sold such Product in
such country.
(b) Following the expiration of the term of this Agreement
in its entirety pursuant to Section 12.1(b), NeoTherapeutics shall have the
royalty-free, non-exclusive, perpetual right and license to continue to use the
Licensed Technology to make, have made, use, sell and have sold the Product in
all countries in the Territory.
(c) Upon the termination of this Agreement by BMS pursuant
to Section 12.3, or automatically pursuant to Section 12.4, NeoTherapeutics
shall promptly: (i) return to BMS all relevant records, materials or
confidential information, including the Results, concerning the Patents, the
Know-How and any Products in the possession or control of NeoTherapeutics or any
of its Affiliates or sublicensees; and (ii) assign to BMS, or the designee of
BMS, its registrations with governmental health authorities, licenses, and
approvals of the Products in the Territory, at NeoTherapeutics's sole expense.
Thereafter, NeoTherapeutics shall have no rights whatsoever to use the Licensed
Technology for any purpose.
12.6 Termination of Sublicenses. Except as otherwise expressly
provided in this Agreement, upon any termination of this Agreement, all
sublicenses granted by NeoTherapeutics under this Agreement shall terminate
simultaneously. Upon any termination of this Agreement for any reason, except a
termination by BMS due to a breach of this Agreement by NeoTherapeutics where
such breach has been contributed to by any act or omission by a sublicensee, any
sublicensee (except such a contributing sublicensee) may assume all of
NeoTherapeutics's obligations under this Agreement (including, without
limitation all past amounts due and breaches requiring cure) and, upon such
assumption, such sublicensee's rights under this Agreement shall be limited to
the territory and field of such sublicensee's sublicense grant from
NeoTherapeutics. If such sublicensee
16
desires to assume such obligations of NeoTherapeutics, such sublicensee must
execute and deliver a copy of this Agreement (reflecting any limit on
sublicensee's territory and field) to BMS within 30 days of receiving notice of
such termination from BMS.
12.7 Accrued Rights, Surviving Obligations.
(a) Termination, relinquishment or expiration of this
Agreement for any reason shall be without prejudice to any rights which shall
have accrued to the benefit of either Party prior to such termination,
relinquishment or expiration. Such termination, relinquishment or expiration
shall not relieve either Party from obligations which are expressly indicated to
survive termination or expiration of this Agreement.
(b) Termination of this Agreement shall not terminate
NeoTherapeutics's obligation to make all payments which have accrued through the
date of such termination. All of the Parties' rights and obligations under
Sections 2.4, 3.3, 6, 7.2, 8.4, 9, 10, 11, 12.5, 12.6, 12.7, 14.14 and 14.15
shall survive termination.
13. FORCE MAJEURE.
13.1 Events of Force Majeure. Neither Party shall be held liable
or responsible to the other Party or be deemed to be in default under or in
breach of any provision of this Agreement for failure or delay in fulfilling or
performing any obligation of this Agreement when such failure or delay is due to
force majeure, and without the fault or negligence of the Party so failing or
delaying. For purposes of this Agreement, force majeure shall be defined as
causes beyond the control of the Party, including, without limitation, acts of
God; acts, regulations, or laws of any government; war; civil commotion;
destruction of production facilities or materials by fire, flood, earthquake,
explosion or storm; labor disturbances; epidemic; and failure of public
utilities or common carriers. In such event NeoTherapeutics or BMS, as the case
may be, shall immediately notify the other Party of such inability and of the
period for which such inability is expected to continue. The Party giving such
notice shall thereupon be excused from such of its obligations under this
Agreement as it is thereby disabled from performing for so long as it is so
disabled and the 30 days thereafter. However, the Party giving such notice shall
use all reasonable efforts to remedy such inability as soon as reasonably
possible or seek an alternative arrangement during the period of such inability.
14. MISCELLANEOUS.
14.1 Relationship of Parties. Nothing in this Agreement is
intended or shall be deemed to constitute a partnership, agency,
employer-employee or joint venture relationship between the Parties. No Party
shall incur any debts or make any commitments for the other, except to the
extent, if at all, specifically provided herein.
14.2 Assignment. Neither Party shall be entitled to assign its
rights hereunder without the express written consent of the other Party hereto,
except that both NeoTherapeutics and BMS may otherwise assign their respective
rights and transfer their respective duties hereunder to any assignee of all or
substantially all of their respective businesses or in the event of their
respective
17
merger or consolidation or similar transaction. No assignment and transfer shall
be valid and effective unless and until the assignee/transferee shall agree in
writing to be bound by the provisions of this Agreement. Any assignment not in
accordance with this Section 14.2 shall be void.
14.3 Binding Effect. This Agreement shall be binding upon the
successors and permitted assigns of the Parties and the name of a Party
appearing herein shall be deemed to include the names of such Party's successors
and permitted assigns to the extent necessary to carry out the intent of this
Agreement.
14.4 Further Actions. Each Party agrees to execute, acknowledge
and deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
14.5 Costs and Expenses. Except as otherwise expressly provided in
this Agreement, each Party shall bear all costs and expenses associated with the
performance of such Party's obligations under this Agreement.
14.6 Inconsistency. If there is any inconsistency between the
provisions of this Agreement and any other document passing between the Parties,
the provisions of this Agreement shall control and be determinative.
14.7 Notice. Any notice, request or other communication required
or permitted to be given under or in connection with this Agreement shall be
deemed to have been sufficiently given if in writing and personally delivered or
sent by registered or certified mail (return receipt requested), facsimile
transmission (receipt verified), express courier service (signature required),
or telegram, prepaid, to the Party for which such notice is intended, at the
address set forth for such Party below:
(a) In the case of BMS, to:
Bristol-Myers Squibb Company
P.O. Box 4000
Route 206 & Province Line Road
Princeton, New Jersey 08543-4000
Attention: Vice President & Senior Counsel,
Pharmaceutical Research Institute
and Worldwide Strategic Business
Development
Facsimile No.: (609) 252-4232
(b) In the case of NeoTherapeutics, to:
NeoTherapeutics Inc.
157 Technology Drive
Irvine, California 92618
Attention: President
18
Facsimile No.: (949) 788-6706
or to such other address for such Party as it shall have specified by like
notice to the other Party, provided that notices of a change of address shall be
effective only upon receipt thereof. If sent by mail, facsimile transmission,
express courier service, or telegram, the date of mailing or transmission shall
be deemed to be the date on which such notice or request has been given.
14.8 Use of Name. Except as otherwise provided herein, neither
Party shall have any right, express or implied, to use in any manner the name or
other designation of the other Party or any other trade name or trademark of the
other Party for any purpose in connection with the performance of this
Agreement.
14.9 Public Announcements. Except as required by law, neither
Party shall make any public announcement concerning this Agreement or the
subject matter hereof prior to the Effective Date. Thereafter, neither Party
shall make any such public announcement without the prior written consent of the
other, which shall not be unreasonably withheld. In the event of a required
public announcement, the Party making such announcement shall provide the other
Party with a copy of the proposed text prior to such announcement sufficiently
in advance of the scheduled release of such announcement to afford such other
Party a reasonable opportunity to review and comment upon the proposed text.
Following approval of a proposed text, such text may be used in subsequent
public announcements without further approval, to the extent it remains
accurate, complete and not misleading.
14.10 Waiver. A waiver by either Party of any of the terms and
conditions of this Agreement in any instance shall not be deemed or construed to
be a waiver of such term or condition for the future, or of any subsequent
breach hereof. All rights, remedies, undertakings, obligations and agreements
contained in this Agreement shall be cumulative and none of them shall be in
limitation of any other remedy, right, undertaking, obligation or agreement of
either Party.
14.11 Compliance with Law. Nothing in this Agreement shall be
deemed to permit a Party to: (i) import, export, reexport, store, sell,
distribute or otherwise transfer any Product sold under this Agreement without
compliance with applicable laws; or (ii) make any claims with respect to any
Product, in promotional materials or otherwise, in any country that is
inconsistent with applicable laws.
14.12 Severability. When possible, each provision of this
Agreement will be interpreted in such manner as to be effective and valid under
applicable law, but if any provision of this Agreement is held to be prohibited
by or invalid under applicable law, such provision will be ineffective only to
the extent of such prohibition or invalidity, without invalidating the remainder
of this Agreement. In such event, the Parties agree to substitute a valid and
enforceable provision therefor which, as nearly as possible, achieves the
desired economic effect and mutual understanding of the Parties under this
Agreement.
14.13 Amendment. No amendment, modification or supplement of any
provisions of this Agreement shall be valid or effective unless made in writing
and signed by a duly authorized officer of each Party.
19
14.14 Governing Law. This Agreement shall be governed by and
interpreted in accordance with the laws of the State of New York, without regard
to any choice of law principles.
14.15 Arbitration.
(a) Any dispute arising out of or relating to any
provisions of this Agreement shall be finally settled by arbitration to be held
in New York, New York, under the auspices and then current commercial
arbitration rules of the American Arbitration Association. Such arbitration
shall be conducted by three arbitrators appointed according to said rules. The
Parties shall instruct such arbitrators to render a determination of any such
dispute within 90 days after their appointment. Judgment upon any award rendered
may be entered in any court having jurisdiction, or application may be made to
such court for a judicial acceptance of the award and an order of enforcement,
as the case may be.
(b) Section 14.15(a) shall not prohibit a Party from
seeking injunctive relief from a court of competent jurisdiction in the event of
a breach or prospective breach of this Agreement by the other Party which would
cause irreparable harm to the first Party.
14.16 Entire Agreement. This Agreement sets forth the entire
agreement and understanding between the Parties as to the subject matter hereof
and merges all prior discussions and negotiations between them, and neither of
the Parties shall be bound by any conditions, definitions, warranties,
understandings or representations with respect to such subject matter other than
as expressly provided herein or as duly set forth on or subsequent to the date
hereof in writing and signed by a proper and duly authorized officer or
representative of the Party to be bound thereby.
14.17 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall constitute an original document, and all of
which together shall constitute one and the same instrument. This Agreement may
be executed by facsimile signatures and such signatures shall be deemed to bind
each party hereto as if they were original signatures.
14.18 Descriptive Headings. The descriptive headings of this
Agreement are for convenience only, and shall be of no force or effect in
construing or interpreting any of the provisions of this Agreement.
* * *
20
IN WITNESS WHEREOF, each of the Parties has caused this Agreement
to be executed by its duly authorized officer as of the day and year first above
written.
BRISTOL-MYERS SQUIBB COMPANY
By: /s/ Steven E. Brenner
------------------------------------------
Name: Steven E. Brenner, M.D.
----------------------------------------
Title: Vice President, Licensing
---------------------------------------
NEOTHERAPEUTICS INC.
By: /s/ Rajesh Shrotriya
------------------------------------------
Name: Rajesh C. Shrotriya, M.D.
----------------------------------------
Title: President and Chief Operating Officer
---------------------------------------
21
EXHIBIT A
LICENSED TECHNOLOGY
The following U.S. patents relating to elsamitrucin (elsamicin, BMY 28090):
U.S. PATENT NUMBER DESCRIPTION
------------------ -----------
5,508,268 covers parenteral solution formulations of BMY-28090 (elsamicin)
4,518,589 covers the compound BMY-28090 (elsamicin)
22