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Exhibit 10.52
HEADS OF AGREEMENT:
IMMUNOGEN /GENENTECH COLLABORATIVE AGREEMENT
A. EFFECTIVE DATE: The effective date of this Heads of Agreement ("HEADS OF
AGREEMENT") shall be as of May 2, 2000 (the "EFFECTIVE DATE").
B. PARTIES: The parties to this Heads of Agreement are Genentech, Inc., a
Delaware corporation with offices located at 0 XXX Xxx, Xxxxx Xxx Xxxxxxxxx, XX
00000 ("GENENTECH") and ImmunoGen, Inc., a Massachusetts corporation with
offices located at 000 Xxxxxxxxxx Xxxxxxx, Xxxxxxx, XX 00000 ("IMMUNOGEN").
Genentech and ImmunoGen are each also referred to herein singly as a "PARTY" and
collectively as the "PARTIES".
C. PREAMBLE:
1. ImmunoGen owns or controls certain proprietary technology (including
patent rights and know-how) relating to the conjugation of maytansine
derivatives such as DM1 to binding proteins;
2. Genentech owns or controls certain proprietary technology (including
patent rights and know-how) relating to antibodies and other binding
proteins;
3. As of the Effective Date, the Parties have entered into an exclusive
license agreement pertaining to the use of ImmunoGen's proprietary
toxin conjugation technology with a particular antibody and related
binding proteins (the "GENENTECH LICENSE");
4. Concurrently with such Genentech License, the Parties have also agreed
upon the terms and conditions for a broader arrangement relating to
the conjugation of a larger array of antibodies and binding proteins
to maytansine derivatives such as DM1; and
5. The Parties desire to enter into this Heads of Agreement to evidence
their agreement to the terms and conditions, set forth hereinbelow,
relating to such broader arrangement.
D. AGREEMENT: The Parties intend shortly to enter into a detailed agreement
(the "AGREEMENT") relating to the above-referenced broader arrangement,
under which Genentech may select and test a number of antibodies and other
binding proteins together with ImmunoGen's conjugation technology, and may
acquire exclusive option rights and/or exclusive license rights from
ImmunoGen. The terms and conditions of the Agreement shall be consistent
with the terms and conditions of this Heads of Agreement, and the Parties
agree to enter into the Agreement as soon as practicable, with its final
terms to be subject to the approval of each Party's senior management.
Pursuant to this Heads of Agreement, Genentech shall be entitled to
exercise its non-exclusive research license rights and its rights to take
Exclusive Target Options and/or Exclusive Licenses, Genentech shall pay
ImmunoGen the signing fee noted below, and Genentech and ImmunoGen shall
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establish and commence the functioning of the Joint Process Development
Committee, all as provided hereinbelow.
E. BINDING TERMS AND CONDITIONS: In consideration of the mutual covenants
contained herein, the Parties hereby agree to the following terms and
conditions, which shall be binding upon the Parties with respect to this Heads
of Agreement and the Agreement to be entered into:
AB-MAY LICENSED
PRODUCT Any and all antibodies and other binding proteins owned,
controlled or made available to Genentech by any third party
"(THIRD PARTY") under a material transfer agreement
(including any fragments, derivatives, or single-chain
versions of any of the foregoing), are referred to herein
collectively as "ABS". Any maytansine or maytansine
derivative owned or controlled by ImmunoGen, including P-3
and DM1 (and any fragments or derivatives of any of the
foregoing), are referred to herein collectively as "MAY".
The term "AB-MAY LICENSED PRODUCT" means, collectively, any
Abs conjugated with any MAY, provided that each individual
Ab-MAY Licensed Product is distinguished by the Target (as
defined in the next paragraph) bound by the particular Ab
incorporated into such Ab-MAY Licensed Product. ImmunoGen
shall grant Genentech the option and license rights set
forth herein with respect to the development, manufacture,
use and sale of Licensed Products in the Field in the
Territory.
TARGET The term "TARGET" means any particular antigen (whether a
protein, carbohydrate, etc.) that is bound by a particular
Ab used to create an Ab-MAY Licensed Product, and a Target
encompasses all epitopes of a particular antigen, so that a
license (or option) to Genentech to make Ab-MAY Licensed
Product to a given Target is a license to make any Ab-MAY
conjugates that are directed against any and all epitopes of
that Target.
FIELD "FIELD" means the use of Ab-MAY Licensed Product for any
human indication.
TERRITORY The scope of Genentech's option and license rights is every
country and territory in the world (the "TERRITORY").
GNE NON-EXCLUSIVE
RESEARCH LICENSE ImmunoGen hereby grants Genentech a non-exclusive
research license, under the patent rights and know-how owned
or controlled by ImmunoGen, for Genentech (with or without
Third Parties) to conduct safety, toxicity and other
pre-clinical studies in vitro and in
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
vivo in any non-human species with any Ab-MAY Licensed
Product to any Target that is not already covered by an
Exclusive Target Option (as defined below), an Exclusive
License (as defined below) to Genentech, or an exclusive
license from ImmunoGen to any Third Party for an
antibody-MAY conjugate to that such Target. [*] Genentech
(with or without Third Parties) will have full
responsibility, at its sole cost and discretion, to conduct
any and all pre-clinical work on any Ab-MAY Licensed
Products under the research license set forth herein, under
any Exclusive Target Option, and/or under any Exclusive
License. The non-exclusive research license hereunder, and
Genentech's Exclusive Target Options and Exclusive Licenses,
shall permit Genentech (with or without Third Parties) to
conjugate any antibodies for use as experimental controls in
connection with the research, development and
commercialization of Ab-MAY Licensed Products.
GNE EXCLUSIVE
TARGET OPTIONS [*] grant to Genentech of an exclusive [*] option to
take an exclusive license to all patent rights and knowhow
owned or controlled by ImmunoGen and necessary or useful for
(i) the manufacture of any Ab-MAY Licensed Product in which
the Ab binds to the Target [*] or (ii) the conduct by
Genentech (with or without Third Parties) of any
pre-clinical research using any Ab-MAY Licensed Product in
which the Ab binds such Target (the "EXCLUSIVE TARGET
OPTION"). [*].
EXCLUSIVITY OF EXCLUSIVE TARGET OPTIONS: [*] for so long as
such Exclusive Target Option is in effect, ImmunoGen may not
undertake (with or without Third Parties) any development,
manufacture or commercialization of, or pursue discussions
with a Third Party regarding, or grant any Third Party any
license or other rights with respect to, any antibody-MAY
conjugates in which the antibody or binding protein
(including any fragments, derivatives, or single-chain
versions of any of the foregoing) binds to the Target
covered by Genentech's Exclusive Target Option.
AVAILABILITY OF LIMIT ON NUMBER OF EXCLUSIVE TARGET OPTIONS: For so long as
EXCLUSIVE TARGET Genentech has in effect [*] Exclusive Target Options (for
OPTIONS Ab-MAY Licensed Products to [*] separate Targets), or when a
given Exclusive Target Option expires unexercised, or is
exercised for an Exclusive License, or is terminated early
by Genentech (all as provided below), at any such time
Genentech may request from ImmunoGen additional options up
to the limit of [*] such Exclusive Target Options in effect
at any one time, under the
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
procedures set forth above for selecting, confirming
availability of and automatically granting such Exclusive
Target Options.
EXERCISE OF EXCLUSIVE TARGET OPTIONS: Genentech in its sole
discretion may exercise any Exclusive Target Option to take
an Exclusive License to the Target covered by such Exclusive
Target Option, at any time prior to the expiration of such
Exclusive Target Option, as provided in the next paragraph.
Any exercise of an Exclusive Target Option by Genentech must
be evidenced by timely written notice of exercise to
ImmunoGen and timely payment of the Exclusive License Opt-in
Fee (as provided below). If Genentech exercises its
Exclusive Target Option prior to expiration, at such time or
thereafter, subject to the limit of [*] such Exclusive
Target Options in effect at any one time, Genentech may
select and be granted another Exclusive Target Option to
replace the one exercised.
EXPIRATION OF EXCLUSIVE TARGET OPTIONS: If an Exclusive
Target Option is not exercised or renewed (as provided in
the next paragraph), such Exclusive Target Option shall
expire on the date that is [*] after the date of automatic
grant of such Exclusive Target Option as part of ImmunoGen's
confirmation in writing to Genentech of the availability of
the requested Target, as provided in "SELECTION AND
CONFIRMATION OF EXCLUSIVE TARGET OPTIONS", above. [*] In
connection with any expiration of an Exclusive Target
Option, with respect to such expired Target Genentech
automatically shall lose the exclusivity set forth above in
"EXCLUSIVITY OF EXCLUSIVE TARGET Options" but shall retain
the following non-exclusive rights. In the event of such
expiration (or early termination, as provided below)
Genentech automatically shall be granted a fully paid up
non-exclusive license under the patent rights and knowhow
owned or controlled by ImmunoGen as necessary or desirable
for (i) the manufacture (with or without Third Parties) of
any Ab-MAY Licensed Product in which the Ab binds the
expired Target, and (ii) the conduct by Genentech (with or
without Third Parties) of pre-clinical research using any
such Ab-MAY Licensed Product, in each case until such time
as ImmunoGen notifies Genentech in writing that ImmunoGen
has (if at all) granted an exclusive Third Party License
that prohibits any further non-exclusive license to
Genentech hereunder.
EARLY TERMINATION OR RENEWAL OF EXCLUSIVE TARGET OPTIONS: As
to a given Exclusive Target Option, at any time after [*]
from the date of automatic grant of any Exclusive Target
Option as provided above, but prior to the date of
expiration of such Exclusive Target
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
Option as provided above, Genentech may notify ImmunoGen
that Genentech is terminating such Exclusive Target Option
prior to its expiration, in which event at such time
Genentech automatically shall have the non-exclusive license
rights set forth in the preceding paragraph (subject to
continued availability as provided above), and at such time
or thereafter Genentech may select and be granted another
Exclusive Target Option to replace the one terminated,
subject to the limit of [*] Exclusive Target Options in
effect at any one time. In addition, prior to expiration of
any Exclusive Target Option, Genentech may elect to renew
such Exclusive Target Option for an additional [*] period
from the date of such renewal; PROVIDED, HOWEVER, that such
renewal may be accomplished only if prior to the expiration
of such Exclusive Target Option, Genentech provides written
notice to ImmunoGen of Genentech's election to take a
second, consecutive Exclusive Target Option for such Target,
which shall continue on and after the date of expiration of
the first Exclusive Target Option for such Target.
SIGNING OF SIGNING FEE: In consideration for the rights granted to
AGREEMENT Genentech under this Heads of Agreement and under the
Agreement (including rights to utilize any technology
arising from prior work of ImmunoGen), Genentech will pay
ImmunoGen a non- refundable $3 million signing fee on
execution and delivery of the Heads of Agreement by both
Parties.
EXCLUSIVE TARGET OPTION ELECTION TERM: Genentech may elect to take
OPTION TERM Exclusive Target Options as provided herein until the
[*] anniversary of the effective date of the Agreement (the
"OPTION ELECTION TERM"), subject to extension as provided in
the next paragraph. In any event (including any extension of
the Option Election Term) Genentech shall be entitled to
elect to take Exclusive License(s) until the expiration of
the last-to-expire Exclusive Target Option.
EXCLUSIVE TARGET
OPTION TERM EXTENSION OF OPTION ELECTION TERM: Upon payment of a
EXTENSION non- refundable extension fee of [*] to ImmunoGen prior to
the expiration of the Option Election Term, Genentech in its
discretion may extend the Option Election Term for an
additional [*] years.
EXCLUSIVE LICENSES EXCLUSIVE LICENSES: For (a) any Target that is covered by an
unexpired and unexercised Exclusive Target Option, at any
time prior to the expiration of the [*] option period (as
may be renewed as provided above), and (b) any other Target
not then covered by an Exclusive Target Option, provided
that such uncovered Target
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
is selected by Genentech by written notice to ImmunoGen and
confirmed by ImmunoGen to be available as provided in the
next paragraph, Genentech in its discretion may elect, on a
Target-by-Target basis, to take an exclusive license (with
rights to sublicense) in the Territory under all patent
rights and know-how owned or controlled by ImmunoGen which
are necessary or useful for the development, manufacture,
use or sale of any Ab-MAY Licensed Products in the Field in
the Territory (an "EXCLUSIVE LICENSE"). The Agreement shall
contain a form of Exclusive License agreement with
provisions substantially identical to the Genentech License.
GRANTING AND AVAILABILITY OF EXCLUSIVE LICENSES: With
respect to any Target covered by an unexpired and
unexercised Exclusive Target Option, the grant of such
Exclusive License shall be deemed to occur automatically on
Genentech's exercise of its Exclusive Target Option as
provided above in "EXERCISE OF EXCLUSIVE TARGET OPTIONS",
and the Parties shall enter into an Exclusive License
agreement as provided above. Genentech may also notify
ImmunoGen in writing of Genentech's selection of a Target
not then covered by an Exclusive Target Option, in which
event ImmunoGen may only deny a request by GNE to take an
Exclusive License to such Target if the circumstances set
forth above in "NON-AVAILABILITY OF EXCLUSIVE TARGET
OPTIONS" apply with respect to such Target. In such event
ImmunoGen shall notify Genentech promptly in writing (and in
any event within [*] business days after Genentech's notice
to ImmunoGen hereunder) of the non-availability of the
Exclusive License to such Target and the reason(s) therefor.
Otherwise the grant of the Exclusive License to the
uncovered Target shall be deemed to occur automatically on
ImmunoGen's written confirmation of its availability, and
the Parties shall enter into an Exclusive License agreement
as provided above. In connection with any Genentech exercise
of an unexpired and unexercised Exclusive Target Option, or
promptly after the written confirmation by ImmunoGen of the
availability of an uncovered Target selected by Genentech as
provided herein, Genentech shall pay ImmunoGen the Exclusive
License Opt-in Fee (as provided below), as well as the
future milestone payments and royalties as outlined below,
if achieved and owed in accordance with the terms of such
Exclusive License.
GENENTECH PROPERTY AND JOINTLY OWNED PROPERTY: Under no
circumstances (including a decision by Genentech not to take
an Exclusive License) shall anything set forth herein or in
the Agreement grant ImmunoGen any rights with respect to any
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technology, data, intellectual property, or know-how of
Genentech (including any technology, data, intellectual
property or know-how developed solely by Genentech). As to
any inventions, know-how or other proprietary information
jointly developed by the Parties (under the JPDC or
otherwise) and jointly owned by the Parties, Genentech and
ImmunoGen shall have the same rights with respect thereto as
set forth in the Genentech License as to any such jointly
owned technology thereunder.
DEVELOPMENT AND For any and all Ab-MAY Licensed Products covered by an
COMMERCIALIZATION Exclusive License to Genentech, Genentech (with or without
Third Parties) will have sole responsibility, at its sole
cost and discretion, for all research and development of
Ab-MAY Licensed Products, including any pre-clinical work,
any IND-enabling work, selection of any drug candidate(s),
any clinical trials (including Phase I, II, III and IV
clinical trials), and any other development of such Ab-MAY
Licensed Products. GNE shall also have sole responsibility,
at its sole cost and discretion, for all regulatory filings
relating to any development, manufacture or
commercialization (including sale) of such Ab-MAY Licensed
Products. Except as otherwise provided herein with respect
to jointly owned inventions, know-how or other proprietary
information of the Parties, all data, results, know-how,
inventions, regulatory filings and information relating to
the research, development, manufacture, use, sale or
commercialization of any Ab-MAY Licensed Product shall be
held and owned solely and exclusively by Genentech.
ImmunoGen will transfer to Genentech all licensed technology
necessary or useful for such purposes.
MANUFACTURING For any and all Ab-MAY Licensed Products covered by an
Exclusive License to Genentech, Genentech (with or without
Third Parties) will have sole responsibility, at its sole
cost and discretion, for the manufacture of any and all Abs,
MAY compound(s), and any Ab-MAY Licensed Products for all
pre-clinical, clinical, and commercial use of such
materials, including all process development and scale-up
work. ImmunoGen will transfer to Genentech all licensed
technology necessary or useful for such purposes. For
purposes of Genentech's non-exclusive research license, any
Exclusive Target Option and any Exclusive License, ImmunoGen
agrees to supply Genentech (in accordance with an ordering
process to be agreed upon) with P3, DM1, other MAY
compounds, and conjugated Ab-MAY Licensed Products (and/or
conjugated control antibodies) as requested for pre-clinical
testing, with Genentech to reimburse ImmunoGen's fully
burdened manufacturing costs for any such pre-clinical
materials.
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JOINT PROCESS DEVELOPMENT
COMMITTEE JPDC: Upon execution of the Genentech License, the Parties
have formed a "Joint Process Development Committee"
("JPDC"). The same JPDC shall be responsible for
coordinating and monitoring of process development efforts
relating to MAY production and/or Ab-MAY conjugation in
connection with the development, manufacture and
commercialization of any Ab-Licensed Products hereunder. The
meetings and functioning of the JPDC shall be as provided in
the Genentech License.
JOINTLY OWNED CONFIDENTIAL INFORMATION: All data, know-how
and other proprietary information developed jointly by the
Parties through the JPDC will be considered joint
confidential information of Genentech and ImmunoGen and will
not be disclosed to any Third Party without prior written
consent of both Parties. All such jointly owned confidential
information shall be included within the scope of any
Exclusive License to Genentech hereunder, and Genentech and
ImmunoGen shall have the same rights with respect thereto as
set forth in the Genentech License as to any such jointly
owned confidential information thereunder.
SALES / MARKETING For any and all Ab-MAY Licensed Products covered by an
Exclusive License to Genentech, Genentech (with or without
Third Parties) will have sole responsibility, at its sole
cost and discretion, for all promotion, sales, marketing,
export, import and distribution of any and all Ab-MAY
Licensed Products covered by an Exclusive License.
MILESTONES Under any Exclusive License, Genentech will pay the
following milestones to ImmunoGen upon successful completion
of the following goals achieved by any Ab-MAY Licensed
Products covered by such Exclusive License to Genentech
(provided that under each such Exclusive License taken, each
milestone shall be paid only once, for the first Ab-MAY
Licensed Product thereunder to achieve such milestone):
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
Milestone reached Cash
----------------- ----
[*].
[*]
PAYMENTS [*]
[*]
[*]
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
ROYALTIES ROYALTIES: Under any Exclusive License, except if the [*]
set forth below apply, Genentech will pay to ImmunoGen a
royalty on worldwide net sales of each Ab-MAY Licensed
Product covered by such Exclusive License equal to the
following [*] figures for such Product in [*]:
[*]
[*]
F. MISCELLANEOUS: This Heads of Agreement shall be deemed to incorporate by
reference the following provisions of the Genentech License as if set out in
full herein, such that such provisions shall also apply with respect to this
Heads of Agreement: Section 5 (confidential information), Section 6 (patent
rights), Section 8 (representations and warranties), Section 9 (indemnification
and liability) and Section 10 (miscellaneous). The Agreement (including the form
of Exclusive License agreement attached thereto) shall contain provisions
substantially identical to the foregoing provisions of the Genentech License.
This Heads of Agreement shall terminate automatically upon the execution and
delivery of the Agreement by the Parties.
IN WITNESS WHEREOF, the Parties have caused this Heads of Agreement to be
executed as of the Effective Date by their duly authorized representatives in
two (2) originals.
GENENTECH, INC. IMMUNOGEN, INC.
By: _________________ By: _________________
Its: ________________ Its: ________________
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