Confidential treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as [Intentionally Redacted]. A complete version of the
exhibit has been filed separately with the Securities and Exchange Commission.
EXHIBIT 10.8
FIRST AMENDMENT TO LICENCE AGREEMENT
DATED AUGUST 28, 2001 BETWEEN
XXXXXXX XXXXXXX PLC
AND
NEOTHERAPEUTICS, INC.
This First Amendment to License Agreement ("FIRST AMENDMENT") is entered
into and effective this 30th day of September 2002 by and between Xxxxxxx
Matthey PLC, a company organised under the laws of England and Wales whose
registered office is at 0-0 Xxxxxxxx Xxxxxx, Xxxxxxxxx Xxxxxx, Xxxxxx, XX0X 0XX,
England, acting for itself and for its AFFILIATES including particularly Xxxxxxx
Xxxxxxx, Inc (collectively, "LICENSOR"), and NeoTherapeutics, Inc., a
corporation organized under the laws of the State of California, United States
of America whose principal place of business is at 000 Xxxxxxxxxx Xxxxx, Xxxxxx,
Xxxxxxxxxx 00000, Xxxxxx Xxxxxx of America with reference to the following facts
and on the following terms and conditions.
RECITALS
(A) Effective August 28, 2001, LICENSOR and LICENSEE entered into the
License Agreement (the "LICENSE") pursuant to which LICENSOR granted a license
for the use of technical information relating to the use of platinum complex
JM216 in the treatment of tumor cells as well as for the use of the PATENT
RIGHTS (as defined in the LICENSE). All defined terms in this FIRST AMENDMENT
(as set forth in capital letters) shall have the same meaning as set forth in
the LICENSE.
(B) The parties now wish to amend and modify the LICENSE on the terms
and conditions as set forth in this FIRST AMENDMENT.
Now therefore, for good and valuable consideration, the parties agree as
follows:
1
(1) ARTICLE I
Paragraph 16 of Article I of the LICENSE shall be amended to read
as follows:
TERM: the term commencing on the EFFECTIVE DATE and terminating on a
country-by-country basis upon the expiry of the last to expire of the
patents granted in each such country 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 patents and
reexamination certificates issuing to LICENSOR.
(2) ARTICLE II
Paragraph 1 of Article II of the LICENSE shall be amended to read
as follows:
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, with rights to sublicence, under the PATENT RIGHTS to
use 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.
Paragraph 2 of Article II of the LICENSE shall be amended to read
as follows:
2. The LICENSEE shall be entitled to sub-license any THIRD PARTY under
rights granted under Article II.1 hereof provided that the LICENSEE
shall remain responsible for all acts and omissions of such sub-licensee
as though they were by the LICENSEE. 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 LICENSEE. The terms of any
sub-license agreement shall provide that upon termination of this
Agreement, any
2
sub-licensee shall attorn to and accept the LICENSOR in place of the
LICENSEE such that any sub-license shall be deemed an agreement between
the LICENSOR and sub-licensee.
(3) ARTICLE III
Paragraph 1 of Article III of the LICENSE shall be amended to
read as follows:
1. The LICENSEE, its AFFILIATES and sub-licensees 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, its AFFILIATE and sub-licensees shall exercise in the
performance of such research technical skill and competence of a high
calibre.
(4) ARTICLE IV
Article IV of the LICENSE shall be amended to read as follows:
1. The LICENSEE, its AFFILIATES and sub-licensees shall use its best
efforts to test, evaluate and develop PRODUCTS so as to meet the
objectives detailed hereunder:
Objective
1 Submission of NDA to US FDA (hereinafter called the 'First MILESTONE')
2 Acceptance of NDA by US FDA (hereinafter called the 'Second MILESTONE')
3 Receipt of US FDA approval of NDA (hereinafter called the 'Third
MILESTONE')
4 Approval in the first European Union state of a new drug application
(hereinafter called the 'Fourth MILESTONE')
3
5 Approval by US FDA of JM216 for the first indication other than the
indication approved in Objective 2. (hereinafter called the 'Fifth
MILESTONE')
6 Approval in the first European Union state of JM216 for the first
indication other than the indication approved in Objective 3.
(hereinafter called the `Sixth MILESTONE')
(5) ARTICLE V
Paragraphs 1 through 5, inclusive of Article V of the LICENSE
shall be amended to read as follows:
1. The LICENSOR acknowledges receipt of US$100,000 which was paid by
LICENSOR on the EFFECTIVE DATE;
2. The LICENSOR acknowledges receipt of US$150,000 as required by Article
V.2 of the LICENSE.
3. Within 30 (thirty) days of the date of the attainment of each MILESTONE
by the LICENSEE, an AFFILIATE or sub-licensee, the LICENSEE shall pay to
the LICENSOR the following sums:
(i) the First MILESTONE: [Intentionally Redacted]
(ii) the Second MILESTONE:[Intentionally Redacted]
(iii) the Third MILESTONE: [Intentionally Redacted]
(iv) the Fourth MILESTONE:[Intentionally Redacted]
(v) the Fifth MILESTONE: [Intentionally Redacted]
(vi) the Sixth MILESTONE: [Intentionally Redacted]
In no event will LICENSEE be liable for more than one payment upon the
occurrence of each MILESTONE.
4
[Intentionally Redacted] Certain information on this page has been omitted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
4. The LICENSEE shall during the TERM of this Agreement pay to the LICENSOR
a royalty calculated at the rate set forth below 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.
Royalty Rate NET SALES during calendar year
------------ ------------------------------
[Intentionally Redacted]
5. Payments due under Article V.4 shall be made within 45 days of the end
of each calendar quarter in respect of royalties accruing on PRODUCTS
invoiced in that calendar quarter. Paragraphs 7 and 8 of Article V of
the LICENSE shall be amended to read as follows:
7. The LICENSEE agrees during for a period of three (3) years following the
accrual of any royalty it will keep and maintain accurate records and
books of account containing all data necessary for 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 of LICENSEE shall upon reasonable notice by
LICENSOR be open at all reasonable times during reasonable 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 as LICENSOR's
5
[Intentionally Redacted] Certain information on this page has been omitted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
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 for inspection at all
reasonable times during business hours for inspection by such
independent accountant no less than once per year for purposes of
verifying the accuracy of the LICENSEE'S reports hereunder.
8. The LICENSEE shall submit to the LICENSOR within 45 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.
(6) ARTICLE VII
Paragraph 6 of Article VII of the LICENSE shall be amended by
inserting the following after the first sentence:
LICENSOR further represents and warrants that it is not aware of any
patents, whether granted to LICENSOR, an AFFILIATE, or any THIRD PARTY,
which would be infringed by: (i) the making, using and selling of any
PRODUCT; (ii) or utilization of any PLATINUM COMPLEX by LICENSEE in
accordance with the license granted by this AGREEMENT; or (iii) the
metabolites of JM216. To the best of LICENSOR's knowledge and belief,
the practice of the PATENT RIGHTS and the exercise of the rights granted
LICENSEE under Article II.1 do not infringe upon or conflict with any
patent, copyright or other proprietary right of any THIRD PARTY.
6
(7) ARTICLE IX
The first sentence of Paragraph 1 of Article IX of the LICENSE
shall be amended by to read as follows:
1. During the continuance of this Agreement the LICENSEE, its AFFILIATES,
and its sub-licensees shall:
(8) ARTICLE XI.
Paragraph 3 of Article XI shall be amended to read as follows
3. Intentionally deleted.
Subparagraph 8.3 of Article XI shall be amended to read as
follows:
8.3 Upon any termination of this Agreement, sublicenses
granted by the LICENSEE shall be automatically assigned
to the LICENSOR which shall thereafter receive all
benefits and have all obligations under the sublicenses
as in place and stead of the LICENSEE.
(9) [Intentionally Redacted]
(10) GENERAL PROVISIONS
(a) This FIRST AMENDMENT may be executed in two or more
counterparts, including facsimile signatures, each of which will be deemed an
original, but all of which together will constitute one and the same instrument.
(b) This FIRST AMENDMENT and the AGREEMENT constitute the
complete and integrated agreement of the parties with respect to the subject
matter hereof and
7
[Intentionally Redacted] Certain information on this page has been omitted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
thereof. Except as provided in this FIRST AMENDMENT, the AGREEMENT will remain
in full force and effect and unchanged in all other respects.
(c) LICENSOR represents that it is not aware of any default by
LICENSEE under the Agreement, or aware of any event or omission which with the
passage of time might be reasonable foreseen to lead to a default under the
Agreement.
The parties have caused this FIRST AMENDMENT to be executed by
their respective authorized representatives effective as of the date first set
forth above.
LICENSOR LICENSEE
Xxxxxxx Xxxxxxx PLC NeoTherapeutics, Inc.
By: /s/ Xxx Xxxxxxx By: /s/ Xxxxxx Xxxxxxxxx
------------------------------ ------------------------------
Its: Group Patents and Its: Chairman, CEO and
Licensing Controller President
------------------------------ ------------------------------
8
