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EXHIBIT 10.33A
CONFIDENTIAL TREATMENT REQUESTED BY ABGENIX, INC.
Execution Copy
AMENDMENT NO.1
TO RESEARCH LICENSE AND OPTION AGREEMENT
This Amendment No.1 (this "Amendment"), effective as of June 18, 1998
(the "Effective Date"), to that certain Research License and Option Agreement
dated as of April 6, 1998 (the "Agreement"), is made by and between Abgenix,
Inc., a Delaware corporation ("ABX") and Genentech, Inc., a Delaware corporation
("GNE"). Capitalized terms used herein not otherwise defined herein shall have
the meanings ascribed to them in the Agreement.
RECITALS
WHEREAS, the Parties entered into the Agreement giving GNE (i) a
research license to use the XenoMouse Animals for immunization with the Product
Antigen and to perform other research related thereto, and (ii) an Option to
enter into the [***] Product License to develop and commercialize Products
resulting from research related to the Product Antigen;
WHEREAS, the Parties wish to amend the Agreement to expand the research
license and Option to include a second antigen with which GNE may immunize the
XenoMouse Animals and obtain an option to commercialize products resulting from
the research performed relating to such second antigen.
NOW, THEREFORE, in consideration of the premises and for other good and
valuable consideration the receipt and sufficiency of which is hereby
acknowledged, it is agreed by and between the parties as follows:
SECTION 1. Amendments to the Agreement.
(a) The definition of "Product Antigen" in Section 1.1 of the Agreement
is hereby deleted in its entirety and replaced with the following:
""Product Antigen" shall, for purposes of the GNE Option
Agreement, mean [***] and/or [***]; however, the parties
agree that (i) for purposes of the [***] Product License,
"Product Antigen" shall mean [***] and (ii) for purposes of
the [***] Product License, "Product Antigen" shall mean
[***]".
(b) The definition of "Product License" in Section 1.1 of the Agreement
is hereby deleted in its entirety and replaced with the following:
""Product License" shall mean (i) an "Exclusive Worldwide
Product License" as defined in the Xenotech Agreement (and
in the form attached thereto as an exhibit) granted from XT
to ABX pursuant to the terms of
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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the Xenotech Agreement (and permitting ABX, among other
things, to commercialize Products throughout the world for
all human medical uses) when used in connection with [***]
in the Agreement or when used in the [***] Product License
and (ii) either an "Exclusive Worldwide Product License",
or a "Qualified Exclusive Worldwide Product License", or a
"Co-Exclusive Worldwide Product License" as such terms are
defined in the Xenotech Agreement (and in the forms
attached thereto as exhibits) granted from XT to ABX
pursuant to the terms of the Xenotech Agreement when used
in connection with [***] in the Agreement or when used in
the [***] Product License. "
(c) The definition of "[***] " in Section 1.1 of the Agreement and in
the [***] Product License is hereby deleted in its entirety and replaced with
the following:
""[***]" shall mean [***]."
(d) The definition of "Territory" in Section 1.1 of the Agreement is
hereby deleted in its entirety and replaced with the following:
""Territory" shall, for purposes of the GNE Option
Agreement and the [***] Product License, be worldwide;
however, the parties acknowledge that, for purposes of the
[***] Product License, if ABX is unable to secure an
Exclusive Worldwide Product License, the "Territory" may
not include Japan, Taiwan and Korea (including North
Korea)."
(e) The Agreement is hereby amended by adding the following definitions
to Section 1 of the Agreement in proper alphabetical order:
(i) ""Amendment" shall mean that certain "Amendment No.1 to
Research License and Option Agreement" between the parties
effective as of June 18, 1998."
(ii) ""[***] Product License" shall mean that certain agreement
between the parties (if entered into at all) substantially
in the form attached hereto as Exhibit B and incorporated
herein, as the same may be amended from time to time;
provided, however, that (i) references therein to [***]
shall be changed to [***] and (ii) other changes reasonably
required to reflect the change in Product Antigen from
[***] to [***], including the changes provided in Section
1(p) of the Amendment, shall apply."
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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(f) The Agreement is hereby amended by adding the following definition
to Section 1 of the Agreement in proper alphabetical order:
""[***]" shall mean [***]."
(g) Except as provided in Sections 1(i), 1(j), 1(k) and 1(l) of this
Amendment and in Section 1.6 of the Agreement, the Agreement is hereby amended
by replacing "[***] Product License" with "[***] Product License or the [***]
Product License".
(h) The first sentence of Section 2.1.2 of the Agreement is hereby
deleted in its entirety and replaced with the following:
"ABX agrees to provide to GNE, solely for use in creating
Antibodies to [***] or [***], as the case may be, for the
creation, identification, analysis, manufacture, research,
development and commercialization of Products in accordance
with this Agreement and the [***] Product License and/or
the [***] Product License (if entered into at all by the
parties), numbers and types of sterilized male XenoMouse
Animals as follows: (a) as soon as practicable after the
Option Effective Date, ABX will ship to GNE sterilized male
XenoMouse Animals of the types, strains and quantities
specified in item number 19 of the Research Plan (regarding
[***]); and (b) as soon as practicable after the effective
date of this Amendment, ABX will ship to GNE up to [***]
sterilized male XenoMouse Animals, to be reimbursed by GNE
at [***], (regarding [***])."
(i) Section 2.2(f) of the Agreement is hereby deleted in its entirety
and replaced with the following:
"GNE shall not transfer, sell, have sold, lease, offer to
sell or lease, otherwise transfer title to, or otherwise
distribute or commercialize any Antibody or Product without
first entering into (i) the [***] Product License with ABX
in the case where the applicable Product Antigen for the
Product is [***] or (ii) the [***] Product License in the
case where the applicable Product Antigen for the Product
is [***];"
(j) Section 2.4 of the Agreement is hereby deleted in its entirety and
replaced with the following:
"2.4 Limitation. Notwithstanding any other provision of
this Agreement, in no event shall GNE (a) file, or
authorize any third party to file, an IND (or a similar
filing with an equivalent agency or regulatory body in any
country) with respect to a Product or (b) initiate, or
authorize any third party to initiate, clinical trials in
humans with respect to a Product or (c) sell, or authorize
any third party to sell, a Product, in each
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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case unless and until GNE has entered into the [***]
Product License, if the applicable Product Antigen for the
Product is [***], or the [***] Product License if the
applicable Product Antigen for the Product is [***]."
(k) Section 3.1 of the Agreement is hereby deleted in its entirety and
replaced with the following:
"3.1 Option. Subject to the terms and conditions set forth
in this Agreement, ABX hereby grants to GNE exclusive
options (the "Option" or "Options") to obtain the right to
enter into (i) the [***] Product License between GNE and
ABX with regard to [***], which Option may be exercised by
GNE pursuant to the procedures set forth in this Article 3
with respect to [***], on or before 5 o'clock p.m. (Pacific
Time) on December 10, 1998 and/or (ii) the [***] Product
License between GNE and ABX with regard to [***], which
Option may be exercised by GNE pursuant to the procedures
set forth in this Article 3 with respect to [***], on or
before 5 o'clock p.m. (Pacific Time) on June 10, 1999 but
not prior to Jan1, 1999 (each being referred to herein as
an "Option Expiration Deadline")."
(l) Section 3.2.2 is hereby deleted in its entirety and
replaced with the following: "3.2.2. Obtaining Product
License from XT to ABX for [***] and/or [***]. As soon as
practicable after GNE's exercise of an Option (if any) in
accordance with Section 3.2.1 above with respect to a
particular Product Antigen, ABX shall exercise its option
under the Xenotech Agreement to obtain a Product License
with respect to such Product Antigen from XT. In the event
that GNE timely exercises the Option, ABX shall enter into
such Product License with XT as soon as reasonably
practicable and in any event prior to when GNE and ABX
enter into the [***] Product License or the [***] Product
License, as the case may be, and ABX shall send written
notice to GNE at such time ABX has entered into such
Product License with XT, together with a complete copy
(excepting only financial terms) of the fully signed
Product License. At such time as ABX enters into such
Product License and notifies GNE thereof as required
hereunder, GNE and ABX shall promptly execute either the
[***] Product License, as set forth in the form attached
hereto as Exhibit B, or the [***] Product License, as the
case may be. If GNE timely exercises its Option hereunder,
ABX shall use its best efforts to enter into (i) the
specified Product License with XT and the [***] Product
License with GNE with regard to the Option for [***], by
not later than 5 o'clock p.m. (Pacific Time) on December
31, 1998 and (ii) the specified Product License with XT and
the [***] Product License with GNE with regard to the
Option for [***], by not later than 5 o'clock p.m. (Pacific
Time) on June 30, 1999. If GNE timely exercises an Option
hereunder and ABX fails or is unable to enter into the
specified Product License with XT and the [***] Product
License or the [***] Product License with GNE, as the case
may be,
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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(i) with regard to the Option for [***], by not later than
5 o'clock p.m. (Pacific Time) on December 31, 1998 and (ii)
with regard to the Option for [***], by not later than 5
o'clock p.m. (Pacific Time) on June 30, 1999, GNE shall
(subject to the notice and cure provisions of Section 8.3)
be entitled to all available remedies conferred on it under
this Agreement and by law or in equity. Subject to the
foregoing and to the proviso at the end of this sentence,
it is understood that once GNE has exercised an Option with
regard to a particular Product Antigen, GNE shall be
obligated to enter into the [***] Product License or the
[***] Product License, as the case may be, and promptly
thereafter pay ABX the License Fee as set forth in Section
3.1 thereof, it being understood and agreed that if GNE
fails or is unwilling to enter into the [***] Product
License or the [***] Product License, as the case may be,
after having exercised the relevant Option and unless such
failure is due to inaction of ABX or breach of ABX of its
obligations, then GNE shall pay to ABX an amount equal to
such License Fee within fifteen (15) days of the date that
ABX offers to execute and enter into the [***] Product
License or the [***] Product License, as the case may be,
with GNE; provided, however, that in the event that
anything is contemplated to be set forth on Schedule A of
the [***] Product License or the [***] Product License, as
the case may be, GNE shall not be obligated to enter into
such license or pay the amount set forth in this sentence.
It is understood and agreed that, notwithstanding any other
provision of this Agreement, in the event that the Product
License entered into by ABX with XT is a "Qualified
Exclusive Worldwide Product License" (or a "Co-Exclusive
Worldwide Product License" in the case of [***]) rather
than an "Exclusive Worldwide Product License" (as each term
is defined in the Xenotech Agreement), then (a) GNE shall
not be obligated to enter into the [***] Product License or
the [***] Product License, as the case may be, with ABX or
pay the amount set forth in the previous sentence, (b) ABX
shall not, if ABX used commercially reasonable best efforts
to obtain an "Exclusive Worldwide Product License," be in
breach of this Agreement and (c) in the event that GNE
enters the [***] Product License or the [***] Product
License notwithstanding the fact that the Product License
is a "Qualified Worldwide Exclusive Product License" (or a
"Co-Exclusive Worldwide Product License" in the case of
[***]), then the definitions of "Product License" and
"Territory" in the [***] Product License and/or the [***]
Product License, as the case may be, shall be amended
accordingly, and the parties shall make such other changes
as are necessary to reflect the nature of the relevant
Product License."
(m) Section 4.3 of the Agreement is hereby amended by adding the
following sentence to the end thereof:
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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"It is understood that the "Territory" for purposes of this
Section 4.3 shall be worldwide, whether or not the
"Territory" for purposes of the [***] Product License is
worldwide."
(n) The Agreement is hereby amended such that each reference to "[***]"
in the Agreement is also a reference to [***], unless the circumstances dictate
otherwise. The parties acknowledge that references to the "Product Antigen"
and/or "[***]" in Sections 7.1(i), (j) and (k) shall not also be references to
[***].
(o) The Agreement is hereby amended by adding the following subsection
7.1(p) immediately after Section 7.1(o):
"(p) ABX shall promptly nominate [***] under Section 7.1 of
the Xenotech Agreement, at the next meeting of the Xenotech
board of directors following the effective date of this
Amendment, and use reasonable efforts to take every step
necessary under the Xenotech Agreement to obtain the right
to acquire an "Exclusive World Wide Product License" under
the Xenotech Agreement to [***]; it is understood and
agreed that ABX is nominating [***] under Section 7.1 of
the Xenotech Agreement at the request of GNE and ABX cannot
promise that it will be successful in obtaining an
Exclusive Worldwide Product License;"
(p) In the case where Exhibit B is used to generate a [***] Product
License, Section 9.1(h) of Exhibit B is hereby deleted in its entirety and
replaced with the following:
"(a) on or before the Effective Date, ABX entered into a
Product License for the Product Antigen with XT under the
Xenotech Agreement and that Product License is an
[Exclusive Worldwide Product License] [Exclusive Qualified
Worldwide Product License] [Co-Exclusive Worldwide Product
License]* (as such term is defined in the Xenotech
Agreement), and GNE is ABX's exclusive sublicensee of ABX
for all uses of the Licensed Technology under the Product
License relating to Products in the Field throughout the
Territory, as provided in this Agreement; [provided,
however, JTI will have co-exclusive rights in certain
territories]*;
* in the case the Product License is a Co-Exclusive
Worldwide Product License;"
SECTION 2. Effect on [***] Product License. The parties agree that, in
the event that GNE exercises its Option with regard to [***], the Form of [***]
Product License attached to the Agreement as Exhibit B will be used to generate
a [***] Product License and will be changed only to the extent required (i) to
reflect the change in Product Antigen from [***] to [***], (ii) by the amendment
provided for in Section 1(n) of this Amendment, and (iii) pursuant to clause (c)
of the last sentence of Section 3.2.2 of
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with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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the Agreement, as amended by this Amendment, but that the economic terms and
other terms not specific to the Product Antigen, unless otherwise agreed to by
the parties in writing, shall remain unchanged.
SECTION 3. Representations and Warranties. Both parties hereby reaffirm
and remake the representations, warranties and covenants contained in Section 7
of the Agreement, in each case as of the Effective Date of this Amendment,
provided, however, that ABX reaffirms and remakes the representations contained
in Sections 7.1(i), (j) and (k) only with respect to [***], and not with respect
to [***].
SECTION 4. Reference to and Effect on the Agreement. (a) On and after
the date hereof, each reference in the Agreement to "this Agreement",
"hereunder", "hereof", herein", or words of like import referring to the
Agreement, and each reference to the Agreement in the [***] Product License,
shall mean and be a reference to the Agreement as amended hereby.
(b) Except as specifically amended under Section 1 hereof, the Agreement
shall remain in full force and effect and is hereby ratified and confirmed.
SECTION 5. Governing Law. This Amendment shall be interpreted and
construed in accordance with the laws of the State of California, without regard
to conflict of law principles.
SECTION 6. Counterparts. This Amendment may be executed in counterparts,
each of which shall be deemed to be an original and both together shall be
deemed to be one and the same agreement.
[Rest of Page Intentionally Left Blank]
[***] Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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IN WITNESS WHEREOF, the parties have caused this Amendment to be
executed by their respective duly authorized officers as of the day and year
first above written.
ABGENIX, INC. GENENTECH, INC.
By: /s/ Xxxxxxx Xxxxx By: /s/ [unreadable]
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