PROCESS DEVELOPMENT AGREEMENT
THIS
PROCESS DEVELOPMENT AGREEMENT (this “Agreement”)
is
entered into as of the 3rd day of May, 2006 (“Effective
Date”),
by
and between Genentech, Inc., a Delaware corporation with an office at 0 XXX
Xxx,
Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000-0000 (“Genentech”),
and
ImmunoGen, Inc., a Massachusetts
corporation with corporate headquarters at 000 Xxxxxx Xxxxxx, Xxxxxxxxx, XX
00000 (“ImmunoGen”).
In
this Agreement, Genentech and ImmunoGen each may be referred to individually
as
a “Party”
and
together as the “Parties.”
A. Genentech
and ImmunoGen are parties to the following agreements: that certain License
Agreement dated as of May 2, 2000, and amendments thereto (the “License
Agreement”);
that
certain Heads of Agreement, dated as of May 2, 2000, as amended (as so amended,
the “Heads
of Agreement”);
that
certain Process Development Heads of Agreement, dated as of June 29, 2001,
and
amendments thereto, including that certain Amendment No.1 dated November 15,
2002 (the “PD
Heads of Agreement”);
that
certain Manufacturing and Supply Agreement dated as of January 11, 2005, and
amendments thereto (the “Clinical
Supply Agreement”);
that
certain Development Agreement dated as of June 1, 2004, and amendments thereto
(the “Development
Agreement”);
and
the Quality Services Agreement dated as of June 30, 2005 (the “Quality
Services Agreement”)
(the
License Agreement, the Heads of Agreement, the PD Heads of Agreement, the
Clinical Supply Agreement, the Development Agreement and the Quality Services
Agreement, collectively the “Existing
Agreements”).
B. ImmunoGen
will develop a commercial-scale process for manufacturing the HER2 ADC, and
Genentech will assist and compensate ImmunoGen, all as set forth in this
Agreement.
In
consideration of the mutual promises and covenants hereinafter set forth herein,
and other consideration, the Parties agree as follows:
1.
Defined
Terms. The
following capitalized terms used in this Agreement have the meanings indicated
below:
1.1 “Conjugation
Process”
means
a
commercial-scale and commercial-grade process for manufacturing HER2 ADC by
conjugating its component parts, which is to be developed under this Agreement.
1.2 “Dedicated
Equipment”
means
the capital
equipment identified on the Project Document as “Dedicated
Equipment”.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
1.3 “Genentech
Materials”
means
(i) a proprietary Genentech anti-HER2 antibody identified on the Project
Document, and (ii) any other items identified on the Project Document as
“Genentech Materials” or delivered by Genentech under Section 2.6.
1.4 “HER2
ADC”
means
a
pharmaceutical product consisting of the following, in the form of a conjugate:
(i) a proprietary Genentech anti-HER2 antibody referred to as trastuzumab,
(ii[***] [***] (a linker moiety referred to as [***]), and (iii) a cytotoxic
maytansinoid compound referred to as DM1.
1.5 “Project
Document”
means
the attachments or appendices to this Agreement, which describe the Services,
set forth the Requirements, and include other information, terms and conditions
relevant to performance of the Services, as those attachments or appendices
may
be amended and updated under Section 2.1.
1.6 “Project
Materials”
means
any materials - other than Genentech Materials - used for manufacturing an
HER2
ADC and otherwise performing the Services, including SMCC and DM1.
1.7 “Requirements”
means
any specifications or requirements for any of the following: the Dedicated
Equipment, the Genentech Materials, the Project Materials, the Services, or
the
Conjugation Process.
1.8 “Services”
means
the process development work to be performed by ImmunoGen under this Agreement,
as further described on the Project Document, including delivery of the
documents embodying the Conjugation Process.
2. Services.
2.1 Project
Document.
The
Project Document is intended to describe the Services and any other relevant
terms and conditions for performance of the Services under this Agreement.
The
Project Document attached to this Agreement as of the Effective Date is
preliminary; the Parties shall work in good faith to update and expand that
preliminary Project Document, consistent with the preliminary Project Document
and the terms and conditions of this Agreement, so that a final Project Document
is complete within [***] ([***]) days after the Effective Date. The preliminary
Project Document is incorporated into and forms an integral part of this
Agreement; updated or amended Project Documents will become part of this
Agreement upon execution by both Parties. In the event of a conflict between
the
terms in the main body of this Agreement and any terms of the Project Document,
the main body of this Agreement controls.
2.2 Performance
of Services.
ImmunoGen shall
use
commercially reasonable efforts to perform the Services in accordance with
this
Agreement, the Project Document
and the
Requirements. Without limiting the foregoing, ImmunoGen shall (i) make
available facilities, utilities, equipment and computerized systems that are
adequate to perform the Services in accordance with the Project Document; and
(ii) provide an adequate number of personnel to perform the Services, all
of whom have appropriate education, training and experience to do so. At
Genentech’s request, ImmunoGen shall provide [***] or [***] for [***] [***] to
[***] the Services. ImmunoGen is responsible for procuring any and all Project
Materials, for ensuring that such Project Materials are suitable for the
intended purposes, and for inspecting, testing, as appropriate, storing and
maintaining Project Materials. Other than payment of fees under Section 3.1
and
Section 3.2 and reimbursement of certain out-of-pocket costs under Section
3.3,
ImmunoGen is responsible for all costs and expenses incurred in providing the
Services.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
2.3 Schedule
and Adjustments.
ImmunoGen shall use commercially reasonable efforts to perform the Services
on
the schedule set forth in Section 3.2 and the Project Document, including timely
completion of milestones. The schedule and milestones are material to Genentech,
as is meeting the Requirements for the Conjugation Process. If there are any
proposed changes to ImmunoGen’s personnel, facilities, utilities or equipment
that are reasonably likely to affect the quality or timing of its performance
of
the Services, ImmunoGen shall promptly notify Genentech in writing of such
proposed changes. If Genentech reasonably determines that any such proposed
changes are likely to materially affect its development and/or commercialization
of the HER2 ADC, the implementation of those changes will be subject to
Genentech’s approval. If any delay in completing the Services is due to
Genentech’s failure to perform its obligations under this Agreement, including
but not limited to delay in providing Genentech Materials under
Section 2.6,
then
the schedule (including the milestones in Section 3.2) will be adjusted
accordingly to reasonably account for Genentech’s delay, after discussion and
mutual agreement of the Parties. The schedule also will be adjusted to account
for any delay caused by unavoidable delay in obtaining the [***] [***] [***]
[***] to perform the Services; ImmunoGen shall use all reasonable efforts to
avoid that delay and to mitigate the effect of that delay on meeting the
schedule.
2.4 Project
Management and Genentech Assistance.
Each
Party shall appoint designees to coordinate activities as appropriate. Those
designees will meet on a weekly basis (more or less frequently if mutually
agreed) to assess the progress of the Services. Decisions by those designees
are
not binding except to the extent consistent with the Project Document or agreed
in writing by the Parties. Genentech shall provide ImmunoGen with guidance,
information and assistance as reasonably necessary for ImmunoGen to perform
the
Services, and shall use reasonable efforts to perform any obligations under
any
Project Document related to such guidance and assistance.
2.5 Modifications
of Services, Requirements or Project Document.
If
Genentech reasonably determines that modifications to the Services or any
Requirements are necessary, Genentech shall communicate those modifications
in
writing to ImmunoGen. If ImmunoGen believes that any requested modifications
are
a material change to the Services or the Requirements, then ImmunoGen shall
so
inform Genentech, and shall include (i) an estimate of the length of any delay
in the schedule, and/or (ii) an estimate of any revisions to the fees or costs.
In any event, (a) ImmunoGen shall use commercially reasonable efforts to assist
Genentech in implementing such modifications, (b) the Parties shall update
the
schedule in the Project Document (including the milestones), and (c) the Parties
shall mutually agree on the fees and/or costs required to implement those
modifications. Genentech shall be responsible for payment of all such agreed
fees and/or costs, as reflected in the updated schedule in accordance with
this
Agreement.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
2.6 Genentech
Materials.
(a) Procurement:
Genentech shall deliver to ImmunoGen, at its own expense, the Genentech
Materials in the form and amounts identified on the Project Document, unless
the
Project Document states that ImmunoGen is responsible for procurement. For
any
Genentech Materials to be procured by ImmunoGen, ImmunoGen shall procure those
Genentech Materials in the form and in amounts identified on the Project
Document and Genentech shall reimburse ImmunoGen
under Section 3.3 or as set forth in the Project Document. Regardless of the
Party responsible for procurement, ImmunoGen shall inspect the Genentech
Materials (including by performing standard assays and other assays reasonably
requested by Genentech in writing) to determine whether Genentech Materials
comply with the applicable Requirements (or the written description of those
Genentech Materials if no Requirements are stated), and shall inform Genentech
of the results of that inspection. Genentech reserves the right to perform
its
own inspection or testing of the Genentech Materials. In either case, if
Genentech determines that the Genentech Materials are not conforming,
then:
(1) If
procurement is ImmunoGen’s responsibility, then as ImmunoGen’s entire liability
and Genentech’s sole remedy for provision of non-conforming Genentech Materials,
ImmunoGen shall procure replacement Genentech Materials, subject to the same
cost reimbursement as in the Project Document; or
(2) If
procurement is Genentech’s responsibility, then as Genentech’s entire liability
and ImmunoGen’s sole remedy for provision of non-conforming Genentech Materials,
(i) Genentech shall provide new or replacement Genentech Materials or, if that
is not possible, then suggest an alternative and pay any additional costs for
ImmunoGen to procure the alternative, and (ii) the Parties shall, as soon as
practicable, agree to an adjusted schedule as necessary to account for any
delay
caused by non-conforming Genentech Materials.
(b) Handling
of Genentech Materials:
ImmunoGen shall handle Genentech Materials in accordance with the following:
(i) any labeling or documentation included with those Genentech Materials,
(ii) any written instructions provided by Genentech, and
(iii) reasonable handling procedures comparable to those ImmunoGen employs
for similar materials. ImmunoGen may use Genentech Materials only for the
Services and in accordance with any other restrictions set forth in the relevant
Project Document. ImmunoGen may not transfer Genentech Materials to any third
parties, including authorized subcontractors, unless it first obtains written
permission from Genentech. ImmunoGen shall not chemically or biologically modify
the Genentech Materials or use the Genentech Materials in connection with the
development of any derivatives of the Genentech Materials, except as
contemplated in the Project Document or except to the extent ImmunoGen receives
written permission from Genentech. Any information describing or characterizing
the Genentech Materials is Genentech’s Confidential Information.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
2.7 Dedicated
Equipment.
(a) Selection
and Procurement:
ImmunoGen
shall select and procure the Dedicated Equipment. ImmunoGen shall use
commercially reasonable efforts to ensure that the Dedicated Equipment conforms
to the applicable Requirements, will work in its facility and is otherwise
suitable for the intended purposes.
(b) Use
of Dedicated Equipment:
ImmunoGen may use the Dedicated Equipment only for performing its obligations
under this Agreement. ImmunoGen shall use the Dedicated Equipment only in
accordance with any written instructions prescribed by Genentech or the
manufacturer of the Dedicated Equipment, and shall perform such routine
maintenance for the Dedicated Equipment as is required by such written
instructions at no additional charge to Genentech. Except
in
connection with such routine maintenance or as directed in writing by Genentech,
ImmunoGen shall not make any alterations, additions or improvements to
the Dedicated
Equipment. All alterations, additions or improvements so approved will be at
Genentech’s sole cost and expense and will be the property of
Genentech.
(c) Ownership
and Risk of Loss; Disposition of Equipment:
Genentech owns and shall continue to own all right, title and interest in and
to
any Dedicated Equipment. ImmunoGen assumes any risk of loss, damage, theft
or
destruction of the Dedicated Equipment while that Dedicated Equipment is in
ImmunoGen’s possession or on ImmunoGen’s premises. Dedicated Equipment returned
to Genentech must be returned in its original condition, reasonable wear and
tear excepted. ImmunoGen shall [***] for all [***] to Dedicated Equipment that
is [***] by ImmunoGen’s [***] or [***]. Upon termination or expiration of this
Agreement, Genentech
shall
have the right to reclaim possession of such Dedicated Equipment at its expense
upon reasonable notice and ImmunoGen shall reasonably cooperate with Genentech
to
return
such Dedicated Equipment to Genentech in accordance with Genentech’s
instructions.
3. Compensation.
3.1 Services
Fees; Excluded Items.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
(a) Services
Fees.
Genentech
shall pay to ImmunoGen fees, based on hours worked by ImmunoGen employees
performing the Services, at a rate of $[***] per hour (the “Services Fees”).
ImmunoGen shall [***] and [***] the [***] [***] based on [***] [***] [***]
using
an [***] [***] [***] and [***] of [***] in a [***] [***] by the [***] of [***]
[***] to the Services.
(b) Maximum
Amounts.
Genentech has no obligation to pay ImmunoGen for Services Fees that, in any
given month, exceed the estimated cumulative Services Fees up to and including
that month by more than [***] percent ([***]%), unless the Parties have agreed,
in writing, to increase the Services Fees and that increase was agreed prior
to
Services Fees being incurred. Estimated Services Fees will be set forth in
the
Project Document (Exhibit A), and ImmunoGen shall notify Genentech promptly
in
the event that ImmunoGen reasonably estimates that the estimated Services Fees
incurred by it through a given month will exceed those cumulative estimates.
(c) Excluded
Items.
Consistent with Section 2.6, Section 2.7, and Section 3.3, the
transfer price for DM1 and the cost of Dedicated Equipment purchased by
ImmunoGen are not included in the Services Fees described in this Section
3.1.
3.2 Milestone-Based
Fees.
Genentech shall pay ImmunoGen milestone-based fees upon mutual agreement that
the associated milestones have been met within the time indicated.
Milestones and associated milestone fees are set forth in the table below,
although the schedule underlying the milestones may be adjusted as described
in
Section 2.5. The Parties acknowledge and agree that (a) each such milestone
payment is not contingent upon completion of any other subsequent milestone
or
deliverable, and (b) if ImmunoGen fails to achieve a milestone and such failure
is attributable to a delay caused by Genentech, all milestone dates that occur
on and after the date of such delay shall be extended as described in Section
2.3. ImmunoGen shall provide Genentech with prompt written notice upon its
achievement of each of the milestones set forth in this Section 3.2. In the
event that Genentech reasonably disagrees with the achievement of any such
milestone, it shall so notify ImmunoGen in writing within [***] ([***]) days.
Within [***] ([***])
business days of any such notice by Genentech, the Parties shall use reasonable
efforts to resolve the dispute. Any dispute that is not resolved within such
[***] ([***]) business day period shall be submitted for resolution under
Section 9.6.
Milestone
Activity
|
Deliverables
|
Timing
(T=Effective Date)*
|
Payment
|
[***]
[***]
|
Per
Project Document
|
[***]:
T+[***]
[***]:
T+[***]
|
[***]$[***]
if the [***] [***] is [***], and $[***] [***] [***] if the [***]
[***] is
[***]
|
[***]
of [***] [***]
|
Per
Project Document
|
[***]:
T+[***] [***]
|
$150,000
if the[***]is [***]
|
[***]
[***]/
[***]
|
Per
Project Document
|
[***]:
T+[***]: T+[***]
|
$[***]
if the [***] [***] is [***]and [***]$[***] [***]if the [***]is
[***]
|
[***]
[***]
|
Per
Project Document
|
Per
Project Document
|
$[***]
|
*The
exact timing for each milestone is subject to the preparation of the final
Project Document; however, the Project Document must reflect the relative timing
(i.e.,
the amount of time from “T”) in the above table.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
3.3 Cost
Reimbursement.
Genentech shall reimburse ImmunoGen for any DM1 consumed in performance of
the
Services based on [***] [***] cost of such DM1,[***]which will be included
in
the final Project Document, along with the amount expected to be consumed.
Genentech has no obligation to reimburse ImmunoGen for amounts in excess of
that
expected amount unless mutually agreed in writing. Genentech also is responsible
for the direct and actual cost of any Genentech Materials to be procured
directly by ImmunoGen (if any) and for the Dedicated Equipment (including
shipping), with those Genentech Materials and the method of compensating
ImmunoGen to be set forth in the Project Document (whether providing the
Dedicated Equipment directly to ImmunoGen, advancing ImmunoGen the amounts
to
purchase the Dedicated Equipment, or reimbursing ImmunoGen its actual
out-of-pocket costs for the Dedicated Equipment).
3.4 Invoices
and Payment Terms.
ImmunoGen
shall generate invoices for all fees and cost reimbursements. Invoices for
Services Fees and for cost reimbursements must be generated monthly and provided
to Genentech promptly after the end of the month in which the fees were
incurred; invoices for milestone-based fees may be generated any time after
completion of the milestone (as completion is determined under the Project
Document and Section 3.2). Invoices for cost reimbursement must include
appropriate documentation of costs incurred; invoices for Services Fees must
detail the [***] [***] Services and the number of hours spent in performing
Services, as calculated in accordance with Section 3.1, during the month for
which the invoice applies; and invoices for milestone-based fees must identify
the milestone completed. Genentech shall pay [***] invoices within [***] ([***])
days after receipt of each invoice or a facsimile
copy of each invoice. Receipt or acceptance by Genentech of any invoices under
this Agreement does not and will not preclude Genentech from questioning the
correctness of the underlying information at a later date, or from exercising
its rights under Section 3.5. If any [***] inconsistencies or mistakes are
discovered in an invoice, the Parties shall make immediate adjustment, by
reimbursement or credit, as applicable. Invoices
that remain unpaid more than [***] ([***]) days beyond the scheduled payment
due
date may be subject to an interest charge equal to one percent (1%) per month
(twelve percent (12%) per annum), calculated from the scheduled payment due
date
forward; provided that in no event shall such annual rate exceed the maximum
interest rate permitted by law in regard to such payments. Such payments when
made shall be accompanied by all interest so accrued. All payments shall be
made
by wire transfer of immediately available funds to the following
account:
[***]
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
ABA
(routing): [***]
F/C
Client Funds # [***]
Account:
[***]
Account
Title: ImmunoGen, Inc.
3.5 Records
Maintenance.
ImmunoGen
shall maintain all records and accounts pertaining to the Services under this
Agreement for a period of at least [***] ([***]) years from the date of final
payment for the Services, or longer if required by law. At the request of
Genentech, upon at least [***] ([***]) business days’ prior written notice, but
no more often than once per calendar year, and at its sole expense, ImmunoGen
shall permit an independent certified public accountant selected by Genentech
and reasonably acceptable to ImmunoGen to inspect (during regular business
hours) the relevant records required to be maintained by ImmunoGen under this
Section 3.5. To the extent requested by ImmunoGen, the accountant shall enter
into a confidentiality agreement with both Parties reasonably acceptable to
each. The
results of any such audit shall be made available to both Parties. Genentech
agrees to treat the results of any such accountant’s review of ImmunoGen’s
records under this Section 3.5 as Confidential Information of ImmunoGen subject
to the terms of Section 5.
3.6 Sole
Compensation.
Genentech has no obligation to pay any amounts not specified in this Agreement
(including the Project Document). The fees and costs under Section 3.1, Section
3.2 and Section 3.3 are inclusive of all costs associated with the Services,
including time, materials, and indirect and direct overhead (where applicable
and authorized to be included in the invoiced amount). The milestone-based
fees
in Section 3.2 are payable only if the milestones are achieved by ImmunoGen
as
described in the Project Document, are within the dates indicated (as such
dates
may be adjusted per Section 2.5), and are accepted by Genentech as described
in
Section 3.2, all regardless of the level of effort expended by ImmunoGen.
4. Inventions.
4.1 Definitions.
For
purposes of this Agreement, the following capitalized terms have the meanings
set forth below:
(a) Project
Inventions: “Project
Inventions”
are
inventions, original works of authorship, developments, concepts, know-how,
improvements or trade secrets, whether or not patentable,
arising out ImmunoGen’s activities in connection with its performance of the
Services.
(b) Project
Patents: “Project
Patents”
are
rights in and to U.S. and ex-U.S. patents and patent applications and any
patents issuing therefrom, and in and to any reissues, extensions,
registrations, continuations, divisions, continuations-in-part, reexaminations,
substitutions or renewals thereof, and supplementary protection certificates
based on any of the foregoing, all to the extent having a priority date after
the Effective Date and claiming Project Inventions.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
(c) ImmunoGen
Field: “ImmunoGen
Field”
has
the
definition set forth in the (amended) License Agreement which for convenience
is
as follows:
“ImmunoGen
Field” means any and all uses other
than
any use
that involves an antibody that binds to an antigen that is subject to an
exclusive license from ImmunoGen under, or arising from, the Heads of Agreement
or an antigen that is subject to an Exclusive Target Option under the Heads
of
Agreement, during the period that such exclusive license or Exclusive Target
Option remains in effect.
4.2 Disclosure.
ImmunoGen shall disclose to Genentech, promptly (but no later than upon each
milestone or upon completion of a phase) any and all Project Inventions.
4.3 Project
Inventions and Project Patents.
All
Project Inventions, and any Project Patents, will be jointly owned by Genentech
and ImmunoGen. As such, each Party shall retain an undivided one-half interest
in and to those Project Inventions and Project Patents, and each Party is free
to exploit any Project Invention or Project Patent in any field and for any
purpose, without the consent of and without any duty of payment or accounting
to
the other Party, subject to the following limits and exceptions:
(i) ImmunoGen’s use and exploitation of Project Inventions and Project
Patents is limited to the ImmunoGen Field; and (ii) Genentech may grant
licenses of Project Patents and Project Inventions to third parties only in
connection with: (A) the grant of a license to research, develop, manufacture
or
commercialize any products researched, developed, manufactured or commercialized
by Genentech; (B) the grant of a license to a portfolio of rights controlled
by
Genentech (which, for purposes of clarity shall not include any license grant
that covers only the Project Patents or Project Inventions); or (C) solely
for the purpose of performing services for Genentech. Where the laws of any
jurisdiction would grant one Party a right to require payment, accounting or
consent not consistent with the above, that Party hereby waives any such right.
Each Party shall execute, acknowledge and deliver further instruments, and
undertake other acts, as reasonably necessary and appropriate to implement
any
of the foregoing.
4.4 Relationship
to License Agreement.
It is
understood that to the extent that Project Inventions and/or Project Patents
are
covered by the definitions of “Licensed Patent Rights” or “Licensed Technology”
under the License Agreement, such Project Inventions and Project Patents shall
be included as part of the licenses granted under the License Agreement. This
Agreement is not intended to, and the terms of this Agreement will not be deemed
to, modify or amend any licenses, terms or definitions in the License Agreement.
4.5 Patent
Prosecution, Maintenance and Enforcement.
Drafting, prosecution, defense and maintenance of the Project Patents will
be
handled by outside counsel reasonably acceptable to both Parties. The outside
counsel will be instructed to provide copies of all material prosecution
documents and correspondence with all patent offices to both ImmunoGen and
Genentech, to incorporate to the extent reasonably possible suggestions from
both ImmunoGen and Genentech, and to inform each Party of contradictory or
potentially contradictory positions. If Genentech and ImmunoGen are unable
to
reconcile those positions, then [***] will make the final determination. Costs
of drafting, prosecution, defense and maintenance will be shared equally.
Neither Party may enforce a Project Patent without the consent of the other
Party which consent shall not be unreasonably withheld or delayed; costs and
proceeds of enforcement will be determined by mutual agreement, but consistent
with the relative value each Party receives from those Project Patents in the
marketplace. In any event, to the extent doing so would not prejudice or limit
a
right or privilege either Party may have, the Parties will consult with each
other in good faith regarding the best manner in which to proceed in connection
with any actual, alleged or threatened infringement of any Project Patents,
including actions against any alleged infringer.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
5. Confidential
Information.
5.1 Definition.
For
purposes of this Agreement, “Confidential
Information”
means:
(a) with
respect to both Parties, the terms and conditions of this Agreement (including
the Project Document); and
(b) with
respect to Genentech, (i) any proprietary or non-public descriptions or
characterizations of the Genentech Materials or of the HER2 ADC, and (ii) any
and all information related to any clinical program, any development
determinations, any research information, and any other information related
to
any Genentech Materials, Genentech’s anti-HER2 antibody program, the HER2 ADC,
and any other antibody-drug conjugates on which Genentech is working and (iii)
the Conjugation Process and any nonpublic descriptions or other non-public
and
proprietary information about the Conjugation Process (“Conjugation Process
Confidential Information”); and
(c) with
respect to ImmunoGen, (i) any proprietary or non-public information in relation
to DM1, other maytansinoid compounds or any conjugation processes other than
the
Conjugation Process (“Process-Related Confidential Information”), and (ii) any
scientific, technical or financial information of ImmunoGen disclosed through
an
audit report prepared pursuant to this Agreement.
(d) None
of
the foregoing (a), (b), or (c) will be considered Confidential Information
if:
(i) as of the date of disclosure, it is known to the receiving Party or its
Affiliates, as
demonstrated by credible written documentation, other than by virtue of a prior
confidential disclosure to such receiving Party or its Affiliates; (ii) as
of
the date of disclosure it is in the public domain, or it subsequently enters
the
public domain through no fault of the receiving Party or its Affiliates; (iii)
it is obtained by the receiving Party from a Third Party having a lawful right
to make disclosure free from any obligation of confidentiality to the disclosing
Party; or (iv) it is independently developed by or for the receiving Party
without reference to or use of any Confidential Information of the disclosing
Party as demonstrated by credible written documentation.
5.2 Obligations
of Non-Disclosure and Non-Use.
During
the term of this Agreement and for a period of [***] ([***]) years after
expiration or earlier termination of this Agreement, a Party receiving
Confidential Information of the other Party shall, except to the extent
authorized under Section 5.3 or in writing by the disclosing Party:
(i) hold such Confidential Information in strict trust and confidence and
not disclose such Confidential Information to any Third Party without prior
written consent of the other Party; and (ii) not use such other Party’s
Confidential Information for any purpose except those permitted by this
Agreement. Genentech shall have the right to use for internal research and
development purposes any Process-Related Confidential Information but shall
only
have the right to disclose such Process-Related Confidential Information to
Third Parties pursuant to Section 5.3 and (b) ImmunoGen shall have the
right to use for internal research and development purposes, in the ImmunoGen
Field, any Conjugation Process Confidential Information.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
5.3 Authorized
Disclosure and Use of Confidential Information.
(a) Terms
of this Agreement:
Although the terms of this Agreement are the Confidential
Information of both Parties and subject to Section 5.2, such terms may be
disclosed to potential collaborators and licensees (including potential
co-marketing and co-promotion contractors), research collaborators, employees,
third party contractors, and consultants whose tasks are related to performance
of this Agreement and to
attorneys and accountants retained to represent a Party in connection with
transactions related to this Agreement,
each of
whom prior to disclosure are bound by similar obligations of confidentiality
and
non-use at least equivalent in scope to those set forth in this Article;
provided that the Party disclosing such information to any of the above other
than its employees,
attorneys and accountants
shall
use reasonable efforts to obtain the prior written consent of the Party whose
information is being disclosed, which consent may be conditioned upon redacting
certain terms prior to disclosure.
(b) Authorized
Disclosure and Use of Confidential Information:
Each
receiving Party may disclose the other Party’s Confidential Information to the
extent such disclosure is reasonably necessary in the following instances,
and
after providing notice of such disclosure to the disclosing Party: (i) filing
or
prosecuting Project Patents in accordance with Article 4; (ii) regulatory
filings related to the HER2 ADC; (iii) prosecuting or defending litigation,
provided that the disclosing Party must seek and use reasonable efforts to
obtain a protective order or other appropriate confidential treatment; or
(iv) where Genentech is the receiving Party, and where Genentech is
developing, distributing, marketing or commercializing a product, Genentech
may
disclose Process-Related Confidential Information in connection with
commercialization of those products, including to sublicensees, potential
sublicensees, and contract manufacturers that are subject to obligations of
confidentiality comparable to Genentech’s
obligations set forth in this Article 5. Further,
each receiving Party may use and disclose the other Party’s Confidential
Information, when Confidential Information constitutes intellectual property
licensed to a Party under this Agreement, to the extent of the license
granted.
5.4 Press
Releases.
Neither
ImmunoGen nor Genentech shall issue any press release or make any other public
announcement concerning the existence of this Agreement, the relationship
between the Parties, the subject matter of this Agreement, the scope or subject
of the Services, or the results or success of the Services (“Public
Release”),
except: (i) to the extent permitted by prior consent of the other Party;
(ii) to the extent required by law or by the requirements of the Securities
and Exchange Commission or the national securities exchange, quotation system
or
over-the-counter stock market on which such Party’s securities are traded
(together, the “Exchange”),
but
only after approval, which will not be unreasonably withheld; and (iii) a
one-time press release, after the execution of this Agreement, in the form
of
Exhibit B to this Agreement. Requests for consent to any Public Release
(including (i) and (ii) above must be submitted to the other Party no less
than
[***] ([***]) business days prior to the proposed date of such Public Release;
provided
that
each Party’s approval may be delayed until the occurrence of the event
triggering such Public Release. If the Parties agree that a disclosure or filing
needs to be made more quickly, then the reviewing Party shall use reasonable
efforts to provide review more quickly. Proposed filings with an Exchange must
be submitted no less than [***] ([***]) business days prior to the date of
the
proposed filing; however, if the Parties agree that a disclosure or filing
needs
to be made more quickly, then the reviewing Party shall use reasonable efforts
to provide review more quickly. When information is required to be filed with
an
Exchange, the filing Party shall redact the Confidential Information of the
other Party to the extent its disclosure is not legally required, and shall
seek
confidential treatment of the Agreement if filed as an Exhibit. Each Party
shall
obtain its own legal advice regarding compliance with securities laws and,
upon
request of the non-disclosing Party, shall provide evidence of the necessity
of
such disclosure, by means of an opinion of counsel or similar
document.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
6. Representations,
Warranties, and Disclaimers.
6.1 By
ImmunoGen.
ImmunoGen represents and warrants that its performance of the Services does
and
will continue to comply with all applicable federal, state and local laws,
requirements and regulations. ImmunoGen further represents and warrants that,
to
the best of its knowledge, the Conjugation Process and any documents delivered
by ImmunoGen under this Agreement in connection with delivery of the Conjugation
Process, do not, and will not, infringe a third party’s intellectual property
rights, except to the extent ImmunoGen so informs Genentech prior to developing
that Conjugation Process.
6.2 No
Conflict.
Each
Party represents and warrants that the execution of this Agreement, and its
performance of the Agreement does not and will not conflict with any agreement,
instrument or understanding, oral or written, to which it is a party or by
which
it is bound, nor violate any law or regulation of any court, governmental body
or administrative or other agency having jurisdiction over it.
6.3 Disclaimer
of Warranties.
EXCEPT
AS OTHERWISE PROVIDED IN SECTION 6.1 AND 6.2, IMMUNOGEN DISCLAIMS ANY IMPLIED
OR
STATUTORY WARRANTIES, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF THE SERVICES PROVIDED
HEREUNDER. The provisions of this Section will not be deemed to limit any
obligations ImmunoGen has under the written terms of this Agreement.
6.4 [***]
of [***] [***].
IN NO
EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY OF ITS AFFILIATES FOR
ANY
CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES
(INCLUDING, WITHOUT LIMITATION, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED
OR
INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH THIS
AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING
DISCLAIMER AND EXCLUSION [***] [***] [***] TO THE [***] [***] [***] ARISE OUT
OF
[***] AND [***] [***] OF THE [***] TO [***] WITH [***] [***] OR FROM [***]
AND
[***] [***] OF THE [***] OF [***]. THE FOREGOING DISCLAIMER AND [***] WILL
[***]
BE [***] TO [***] OR [***] ANY [***] [***] TO BE [***] TO A [***] [***] PURSUANT
TO THE [***] PROVISIONS.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
6.5 Limitation
of Liability.
BOTH
PARTIES HEREBY AGREE THAT TO THE FULLEST EXTENT PERMITTED BY LAW, EACH PARTY’S
LIABILITY TO THE OTHER, FOR ANY AND ALL INJURIES, CLAIMS, LOSSES, EXPENSES,
OR
DAMAGES, WHATSOEVER, ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREEMENT
FROM
ANY CAUSE OR CAUSES, INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE, ERRORS,
OMISSIONS OR STRICT LIABILITY, SHALL NOT EXCEED UNDER THIS AGREEMENT AN AMOUNT
EQUAL TO [***] [***] DOLLARS ($[***]), OR, IF GREATER, THE AGGREGATE
CONSIDERATION PAID BY GENENTECH TO IMMUNOGEN UNDER THIS AGREEMENT. [***] FOR
THE
[***] AND [***] [***] OF [***] OF [***], AND AMOUNTS PAID TO THIRD PARTIES
PURSUANT TO THE INDEMNIFICATION PROVISIONS, ARE NOT SUBJECT TO THE LIMITATIONS
IN THIS SECTION. TO THE EXTENT THAT THIS CLAUSE CONFLICTS WITH ANY OTHER CLAUSE,
THIS CLAUSE SHALL TAKE PRECEDENCE OVER SUCH CONFLICTING CLAUSE. IF APPLICABLE
LAW PREVENTS ENFORCEMENT OF THIS CLAUSE, THEN THIS CLAUSE SHALL BE DEEMED
MODIFIED TO PROVIDE THE MAXIMUM PROTECTION FOR THE PARTY FROM WHICH DAMAGES
ARE
BEING SOUGHT AS IS ALLOWABLE UNDER APPLICABLE LAW.
7. Term
and Termination.
7.1 Term.
This
Agreement commences on the Effective Date and, unless earlier terminated,
continues until either completion of the Services or, if the Services are not
completed, then three (3) years after the Effective Date.
7.2 Termination.
Subject
to Section 7.3 (Obligations Upon Termination or Expiration), this Agreement
may
be terminated, or any particular Services under this Agreement may be
terminated: (i) automatically upon expiration of the License Agreement;
(ii) subject to the termination fees in Section 7.3 below, (a) by
Genentech, at any time, and for any reason or no reason,
by providing written notice of termination to ImmunoGen at least [***] ([***])
days prior to the date of termination, which notice specifies the scope of
the
terminated activities, whether all or a part of the Services; and (b) by
Genentech, upon written notice after a Change of Control of ImmunoGen (as
“Change of Control” is defined in Section 9.1);
and
(iii) by either Party, by providing written notice of termination to the
other Party at least [***] ([***]) days after having provided to the other
Party
notice of such Party’s material breach of this Agreement, unless such material
breach has been cured within the [***] ([***]) day period after the initial
notice of breach; provided, however, that when a Party allegedly in breach
disputes in good faith that a breach has occurred, then both Parties shall
continue performance during the pendency of any dispute resolution procedure
for
up to a maximum of [***] ([***]) months after notice of an alleged material
breach.
7.3 Obligations
Upon Termination or Expiration.
(a) Payment
by Genentech:
Upon
termination or expiration of this Agreement, Genentech shall pay ImmunoGen:
(i) Services Fees under Section 3.1 that were authorized to be incurred and
were actually incurred prior to termination; (ii) reimbursable costs not
already paid, to the extent such costs already have been incurred (subject
to
return of the Dedicated Equipment as specified herein); and (iii) any early
termination fee as calculated under subsection (b) below.
(b) Early
Termination [***]:
If
Genentech terminates this Agreement under Section 7.2 (ii) above for its
convenience prior to [***] after initiation of the Services (i.e.,
T
+ [***]
in the chart in Section 3.2),
then
Genentech shall [***] if that termination occurs prior to [***] after initiation
of the Services or (ii) [***] if that termination occurs between [***] and
[***] after initiation of the Services. If ImmunoGen has achieved the milestones
for the Services, and if Genentech had paid ImmunoGen the associated milestone
fees, then the foregoing [***] of the milestone-based fees [***]; provided
that in
the above circumstance the [***] if Genentech terminates for its convenience
prior to [***] after initiation of the Services and at least [***] if Genentech
terminates for its convenience prior to [***] after initiation of the Services.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
(c) Assistance
and Works in Progress:
At
Genentech’s request at any time prior to termination or expiration or within
[***] ([***]) days after termination or expiration of this Agreement, ImmunoGen
shall: (i) provide to Genentech reasonable assistance with transition of
the Services to Genentech or to a third party selected by Genentech, subject
to
payment of ImmunoGen’s direct costs for such assistance; (ii) deliver to
Genentech copies of all works in progress for any documentation or other items
to be delivered as part of the Services, whether or not the underlying Services
had been completed prior to termination; (iii) for up to [***] ([***])
months after delivery of the items in clause (ii), respond to inquiries
from Genentech regarding such works in progress or documentation; and (iv)
arrange for the return of any Dedicated Equipment required under
Section 2.7.
7.4 Survival.
The
following Articles and Sections survive any termination or expiration of this
Agreement: Section 1 (Defined Terms), 2.6
(Genentech Materials), Article 3 (Compensation) (to the extent the obligation
arose prior to the end of the term), Article 4 (Inventions), Article 5
(Confidential Information) (for the period indicated), Article 6
(Representations, Warranties and Disclaimers), Section 7.3 (Obligations Upon
Termination or Expiration),
Article 8 (Indemnity and Insurance) (for the period indicated), and Article
9
(Miscellaneous).
8. Indemnity
and Insurance.
8.1 Indemnification
by ImmunoGen.
Subject
to Section 8.3 below and the remainder of this Section 8.1, ImmunoGen shall
indemnify, defend and hold harmless Genentech, its Affiliates and their
respective directors, officers, employees, and agents and their respective
successors, heirs and assigns (the “Indemnitees”),
from
and against any liability, damage, loss or expense (including reasonable
attorney’s fees and expenses of litigation) incurred by or imposed upon such
Indemnitees, or any of them, in connection with any third party claims, suits,
actions, demands or judgments, including without limitation, personal injury
and
product liability matters that arise out of or relate to (i) the material breach
of this Agreement by ImmunoGen, (ii) the negligence or willful misconduct
on the part of ImmunoGen, and (iii) ImmunoGen’s failure to comply with
applicable laws.
8.2 Indemnification
by Genentech.
Subject
to Section 8.3 below and the remainder of this Section 8.2, Genentech shall
indemnify, defend and hold harmless ImmunoGen, its Affiliates and their
respective directors, officers, employees, and agents and their respective
successors, heirs and assigns (the “Indemnitees”),
from
and against any liability, damage, loss or expense (including reasonable
attorney’s fees and expenses of litigation) incurred by or imposed upon such
Indemnitees, or any of them, in connection with any third party claims, suits,
actions, demands or judgments, including without limitation, personal injury
and
product liability matters (but excluding any patent, trademark or tradename
infringement matters, which are governed by the License Agreement), that arise
out of or relate to (i) any actions or omissions of Genentech or of its
sublicensee in the development, testing, production, manufacture, supply,
promotion, import, sale or use by any person of any product that is manufactured
using the Conjugation Process provided under this Agreement, which product
is
manufactured or sold by Genentech or any of its sublicensees, (ii) the material
breach of this Agreement by Genentech, or (ii) the negligence or willful
misconduct on the part of Genentech, in any such case under this Section 8.2,
except to the extent of ImmunoGen’s responsibility therefore under Section 8.1
above.
8.3 Indemnification
Procedures.
As a
condition of obtaining indemnification under Section 8.1 or Section 8.2 above
(as applicable), the Party seeking indemnification shall (i) promptly
inform the indemnifying Party, in writing, of the third party claim for which
it
will be seeking indemnification, (ii) provide to the indemnifying Party all
right and authority to defend or settle that third party claim, and
(iii) provide all necessary assistance in such defense or settlement. An
indemnifying Party has no indemnity obligation if the indemnified Party has
settled or compromised a claim without its consent. An indemnifying Party shall
not settle or compromise a claim by admitting fault of the indemnified Party,
or
entering into a settlement in which the indemnified Party has any obligation
other than the payment of money damages. If the indemnifying Party is defending
a claim, the indemnified Party may participate, at its own expense and with
its
own counsel.
8.4 Insurance.
Genentech and ImmunoGen each shall maintain insurance with respect to its
activities hereunder. Such insurance shall be in such amounts and subject to
such deductibles as the Parties may agree, based upon standards prevailing
in
the industry at the time. If
the
Parties do not agree, then the requirements below apply. Genentech may satisfy
its obligations under this Section through self-insurance to the same
extent.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
(a) Coverage
Types:
(1) Commercial
General Liability:
ImmunoGen shall maintain commercial general liability coverage (including
contractual liability and personal advertising coverage) for limits no less
than
$[***] per occurrence and $[***] in the aggregate. The policy form will be
an
“occurrence” form. If claims made, ImmunoGen shall maintain coverage including
completed operations for a minimum of [***] ([***]) years following termination
or completion of the Services.
(2) Product
Liability:
ImmunoGen shall maintain product liability coverage for limits no less than
$[***] per occurrence and $[***] in the aggregate.
(3) Workers’
Compensation Coverage:
ImmunoGen shall maintain statutory limits and Employer’s Liability for limits no
less than $[***]. Coverage will include a waiver of subrogation endorsement
in
favor of Genentech where applicable by law.
(b) OtherRequirements:
(1) Additional
Insured:
ImmunoGen shall name Genentech as an additional insured by endorsement.
(2) Occurrence
Form:
The
insurance policies above will be under an occurrence form; however, if only
a
claims-made form is available, then in such a case, ImmunoGen shall maintain
the
claims-made insurance policy for at least [***] ([***]) years following
completion of services under the Agreement.
(3) Financial
Rating:
The
above insurance must be carried with insurance companies with an
A.M. Best’s rating of A-VII or better.
(4) Certificate
of Insurance:
Upon
[***] ([***]) days of executing this Agreement, ImmunoGen shall provide
Genentech with its certificate of insurance evidencing the insurance coverage
set forth in this section. ImmunoGen shall provide to Genentech at least [***]
([***]) days prior written notice of any cancellation, non-renewal or material
change in any of such insurance coverage.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
9. Miscellaneous.
9.1 Subcontracting
and Use of Contract Manufacturing Organizations.
ImmunoGen shall not subcontract any of its obligations under this Agreement
without Genentech’s prior written consent. Even under an authorized subcontract,
ImmunoGen shall not provide Genentech Materials to a third party without
Genentech’s written authorization. To the extent Genentech Materials are
required for performance under an authorized subcontract, Genentech either
shall
provide the Genentech Materials directly to the authorized subcontractor, or
shall authorize ImmunoGen to provide the Genentech Materials to the authorized
subcontractor, in either case subject to an appropriate material transfer
agreement or other agreement between Genentech and the authorized subcontractor.
9.2 Assignment
and Change of Control.
Except
to the extent authorized in writing by Genentech in advance, ImmunoGen shall
not
assign or otherwise transfer any right or obligations under this Agreement
to a
third party without Genentech’s prior written consent. Assignment without such
consent is void and of no effect. However, if ImmunoGen is the subject of a
Change of Control, then this Agreement will be deemed assigned and transferred
in connection with that Change of Control. For purposes of this Agreement,
a
“Change
of Control”
is
a
transaction or a series of related transactions in which one or more affiliated
parties that previously did not own at least a fifty percent (50%) interest
in
ImmunoGen obtains at least a fifty percent (50%) interest in ImmunoGen, or
(ii)
a third party acquires all or substantially all of ImmunoGen’s assets to which
this Agreement relates. ImmunoGen shall provide to Genentech written notice
of
any Change of Control within [***] ([***]) business days after entering into
an
agreement for a Change of Control (or, if such Change of Control is not
disclosed publicly, then at the same time as public disclosure). At any time
within [***] ([***]) months after any Change of Control of ImmunoGen, Genentech
may terminate this Agreement, subject to Section 7.3. Whether or not this
Agreement is terminated, any permitted assignee shall assume all rights and
obligations of its assignor under this Agreement.
9.3 Severability
and Invalidity.
Each
Party hereby agrees that it does not intend to violate any public policy,
statutory or common laws, rules, regulations, treaty or decision of any
government agency or executive body thereof of any country or community or
association of countries. Should one or more provisions of this Agreement be
or
become invalid, the Parties hereto shall substitute, by mutual consent, valid
provisions for such invalid provisions which valid provisions in their economic
effect are sufficiently similar to the invalid provisions that it can be
reasonably assumed that the Parties would have entered into this Agreement
with
such provisions. In case such provisions cannot be agreed upon, the invalidity
of one or several provisions of this Agreement shall not affect the validity
of
this Agreement as a whole, unless the invalid provisions are of such essential
importance to this Agreement that it is to be reasonably assumed that the
Parties would not have entered into this Agreement without the invalid
provisions.
9.4 Notices.
Any
consent, notice or report required or permitted to be given or made under this
Agreement by one of the Parties hereto to the other shall be in writing,
delivered personally or by facsimile (and promptly confirmed by personal
delivery, first class air mail or courier), first class air mail or courier,
postage prepaid (where applicable), addressed to such other Party at its address
indicated below, or to such other address as the addressee shall have last
furnished in writing to the address or in accordance with this Section 9.4
and
(except as otherwise provided in this Agreement) shall be effective upon receipt
by the addressee.
If
to
ImmunoGen:
ImmunoGen,
Inc.
000
Xxxxxx Xxxxxx
Xxxxxxxxx,
XX 00000
Attention:Senior
Vice President
Corporate
Development and
Operations
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
With
copy to:
ImmunoGen,
Inc.
000
Xxxxxx Xxxxxx
Xxxxxxxxx,
XX 00000
Attention:
Chief Financial Officer
If
to
Genentech:
Genentech,
Inc.
0
XXX
Xxx
Xxxxx
Xxx
Xxxxxxxxx, XX 00000
Telephone:
(000) 000-0000
Facsimile:
(000) 000-0000
|
Attention:
Corporate Secretary
|
With
copy to:
|
Genentech,
Inc.
0
XXX
Xxx
Xxxxx
Xxx
Xxxxxxxxx, XX 00000
Attention:
Vice President, Manufacturing Collaborations
|
9.5 Governing
Law.
The
Agreement shall be governed by and construed in accordance with the laws of
the
State of California applicable to contracts entered into and to be performed
entirely within the State of California.
9.6 Dispute
Resolution.
The
Parties shall attempt to resolve any dispute between them amicably and if a
dispute should arise, either Party may, by written notice to the other Party,
have such dispute referred to Genentech’s designated officer with settlement
authority and ImmunoGen’s Chief Executive Officer for attempted resolution by
good faith negotiations commencing promptly after such notice is received.
If
the senior officials are not able to resolve the dispute, then the Parties
may
seek to mediate that dispute, on terms and with a mediator mutually agreeable
to
the Parties. The Parties also may seek to arbitrate that Dispute, on mutually
agreed terms and conditions. Neither Party is required or obligated to mediate
or arbitrate. The dispute resolution provisions of this Section are in addition
to any other relief and remedies available to either Party at law or in equity.
9.7 Entire
Agreement.
The
License Agreement, the Development Agreement, the Clinical Supply Agreement,
the
Heads of Agreement, the PD Heads of Agreement and the Quality Services Agreement
remain in force, in accordance with their terms, with respect to the subject
matter thereof. To the extent the terms and conditions of this Agreement
necessarily would conflict with any of the terms and conditions of the License
Agreement, the Development Agreement, the Clinical Supply Agreement, the Heads
of Agreement, the PD Heads of Agreement and the Quality Services Agreement,
the
terms and conditions of this Agreement control, but only with respect to the
Services that are the subject of this Agreement. Except for the foregoing
agreements, this Agreement contains the entire understanding of the Parties
with
respect to the Services, and supersedes any prior agreements and understandings,
either oral or written, related to the subject matter hereof. This Agreement
may
be amended, or any term hereof modified, only by a written instrument duly
executed by both Parties hereto.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
9.8 Waiver.
The
terms or conditions of this Agreement may be waived only by a written instrument
executed by a duly authorized representative of the Party waiving compliance.
The failure of either party at any time or times to require performance of
any
provision hereof shall in no manner affect its rights at a later time to enforce
the same. No waiver by either Party of any condition or term shall be deemed
as
a continuing waiver of such condition or term or of another condition or term.
9.9 Independent
Contractors.
ImmunoGen and Genentech each acknowledge that they shall be independent
contractors and that the relationship between the two Parties shall not
constitute a partnership, joint venture, agency or any type of fiduciary
relationship. Neither ImmunoGen nor Genentech shall have the authority to make
any statements, representations or commitments of any kind, or to take any
action, which shall be binding on the other Party, without the prior consent
of
the other Party to do so.
9.10 Affiliates.
Any
licenses granted under this Agreement will be deemed to be granted both to
a
Party’s Affiliates, and by a Party’s Affiliates. Each Party shall cause its
respective Affiliates to comply fully with the provisions of this Agreement
to
the extent such provisions specifically relate to, or are intended to
specifically relate to, such Affiliates, as though such Affiliates were
expressly named as joint obligors hereunder. For purposes of this Agreement,
“Affiliate”
means
any person, corporation, partnership or other entity that directly or indirectly
controls or is controlled by or is under common control with a Party, where
“control” is determined by direct or indirect ownership of fifty percent (50%)
or more of the shares of stock entitled to vote for the election of directors,
but excluding any parent entity that controls Genentech, including X. Xxxxxxx
Xx
Xxxxx, Ltd. and its successors (“Roche”), entities that control, are under
common control (as defined in this Section) with any such parent entity, and
any
entities that are controlled by such parent entity other than through Genentech.
9.11 Counterparts
and Facsimile.
This
Agreement may be executed in two or more counterparts, each of which shall
be
deemed an original, but all of which together shall constitute one and the
same
instrument.
9.12 Force
Majeure.
Neither
Party shall be liable for failure of or delay in performing obligations set
forth in this Agreement, and neither shall be deemed in breach of its
obligations, if such failure or delay is due to natural disasters or any causes
beyond the reasonable control of such Party. In event of such force majeure,
the
Party affected thereby shall use reasonable efforts to cure or overcome the
same
and resume performance of its obligations hereunder.
9.13 Non-Solicitation
of Employees.
During
the term of this Agreement, Genentech shall not solicit any employee of
ImmunoGen then performing Services (i.e.,
[***]
[***] has [***] on a [***] to [***] for the [***] or previous [***]) to
discontinue his or her employment with ImmunoGen in order to become an employee
or an independent contractor of Genentech; provided, however, that Genentech
is
not prohibited under this Section 9.13 from (a) employing any employee who
contacts Genentech, directly or indirectly through an intermediary, at his
or
her own initiative without any solicitation by Genentech, or (b) placing an
advertisement or making known an available job in any media, with any employment
service or with a recruiter, provided such recruiters have not been directed
to
solicit employees of ImmunoGen who have performed Services under this
Agreement.
[Signature
page follows.]
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
IN
WITNESS WHEREOF, the Parties have caused this PROCESS DEVELOPMENT AGREEMENT
to
be duly executed, effective as of the Effective Date, by their respective duly
authorized officers.
GENENTECH, INC
|
|
IMMUNOGEN, INC.
|
||
|
|
|
|
|
|
|
|
|
|
By:
|
|
|
By:
|
|
Name:
|
Xxxxxxx X. Xxxx, Ph.D.
|
|
Name:
|
Xxxxxxx Xxx Xxxx
|
Title:
|
Senior Vice President,
|
|
Title:
|
Senior Vice President
|
|
Product Operations
|
|
|
Corporate Development and
Operations
|
|
|
|
|
|
Date:
|
|
|
Date:
|
|
|
|
|
|
|
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
Exhibit
A: Project Document
[***]
[***] [***] Conjugation Process Development Project
The
[***]
[***] [***] Conjugation Process Development Project (the “Project”)
with
an effective date of May 3, 2006 is being undertaken under the PROCESS
DEVELOPMENT AGREEMENT between ImmunoGen and Genentech dated as of May 3, 2006
(the “Agreement”).
The
work plan is described in the following attachment. This is considered a
“Project Document” under the Agreement.
Accepted
and Agreed:
GENENTECH, INC.
|
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IMMUNOGEN, INC.
|
||
|
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|
|
|
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|
|
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By:
|
|
|
By:
|
|
Name:
|
Xxxxxxx X. Xxxx, Ph.D.
|
|
Name:
|
Xxxxxxx Xxx Xxxx
|
Title:
|
Senior Vice President,
|
|
Title:
|
Senior Vice President
|
|
Product Operations
|
|
|
Corporate Development and
Operations
|
|
|
|
|
|
Date:
|
|
|
Date:
|
|
|
|
|
|
|
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
10. Attachment
1
11. Work
Plan
12. Project
Stages & Key Deliverables
(Assumes
a start date of May 3, 2006)
13. stage
|
14. description
|
15. duration
|
16. milestone
|
17. date
|
I
|
[***]
[***]
|
[***]
- [***] [***]
|
[***]
process [***]
Process
[***] [***] ([***])
Process
[***] [***] ([***])
|
[***]
[***] [***], [***]
|
II
|
[***]
[***] [***]
|
[***]
- [***] [***]
|
[***]
[***]
|
[***]
[***], [***]
|
III
|
[***]
[***] and [***]
|
[***]
- [***] [***]
|
Final
[***] × [***] [***]
|
end
[***] [***]
|
IV
|
[***]
[***] to [***]
|
[***]
[***]
|
Process
[***] [***]
|
end
[***] [***]
|
18. Project
Timeline: Schedule
[***]
|
[***]
|
[***]
|
|||||||||||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
[***]
|
|||||||||||||
[***]
[***] [***]
|
|||||||||||||
[***]
[***] & [***]
|
|||||||||||||
[***]
[***]
to
[***] [***]
|
19.
20. Team
Communication
The
joint
development team expects to have weekly teleconferences and bimonthly face
to
face meetings or others as deemed necessary. A meeting agenda will be agreed
to
and provided prior to each meeting. Meeting slides and data will be provided
prior to each meeting as needed. Meeting action items and follow up will be
provided following each meeting as needed. The team will utilize a joint shared
repository site to store project documents.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
21. Requirements
& Scale
[***]
[***]: [***] or as [***] [***] by process [***] and equipment
[***].
Process
[***]: The process used to generate the [***] [***] x [***] [***] should meet
the following requirements:
1) |
Minimum
[***] [***] per [***] should be >
[***]%
|
2) |
Process
[***] for DM1 [***]
|
3) |
[***]
[***] established (up to [***]
cycles)
|
4) |
[***]
[***] [***]
|
5) |
Process
[***]:
|
a) |
[***]
[***] [***]
|
b) |
[***]
of [***] of [***] [***], removal of
[***]
|
c) |
Process
[***]
|
i) |
[***]
and [***] [***]
|
ii) |
[***]
[***] (to allow for [***] [***])
|
Product
[***]: The product should be [***] to the [***] [***] [***]. Product [***]
[***]
are:
1) |
[***]/[***]
[***]: target = [***], range [***] to ≤
[***]
|
2) |
%
[***]: > [***]%
|
3) |
[***]:
same [***] as [***] [***], [***] [***] of [***] and
[***]
|
4) |
[***]
[***] ([***] to [***]): < [***]%
|
5) |
%
[***] [***] upon [***]
|
a) |
[***]
([***] [***] [***] after [***] [***] by [***]-[***] [***]): <
[***]%
|
b) |
[***]
[***]: ≤ [***]%
|
6) |
[***]
by [***] [***] [***]: [***]
|
NOTE:
if
[***] [***] is [***], then [***] will be [***], [***] [***]
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
22. STAGE
I: [***] [***]
Purpose: To
define
[***] [***] for the [***] [***] [***]. This includes the initial [***] of the
[***] [***] [***] that [***] the [***] [***] and [***] [***] [***] equipment
to
be purchased by [***] [***] [***].
Activities:
1) |
[***]
[***] - [***] will identify [***] [***] and [***] [***]. Factors
that will
be considered include [***] [***], [***] [***] and [***] of
[***]
|
2) |
[***]
[***] - [***] will perform the necessary studies to determine if
[***] is
sufficient for producing material with [***] [***] [***] [***] to
enable a
[***] vs. [***] decision. Factors evaluated will
include
|
a) |
[***]
[***] profile - Assess if [***] [***] during processing and determine
if
[***] [***] is needed. Demonstrate [***] [***] [***] that is consistent
with a [***] process.
|
b) |
Data
to support [***] of [***] [***] - Confirm [***] [***] for a minimum
of
[***] [***]
|
c) |
Evaluate
potential effects on [***] [***] from [***] system elements ([***],
[***],
and [***]) that would be [***] of [***] [***] [***]
equipment.
|
3) |
[***]
[***] [***] -
|
a) |
[***]
will investigate and [***] as possible the [***] to [***] or other
[***]
assay to [***] [***] [***] as required by the [***]
[***]
|
b) |
[***]
[***] - IMGN and GNE will collaborate on development of suitable
assay to
monitor [***] and related [***]
[***].
|
4) |
[***]
[***]- to broadly understand impact of [***] [***] and
[***].
|
GNE: ·
[***]
g
[***]
· Method for [***] [***]
· Info on [***] [***]/[***]/[***]
· [***] #[***] studies & # [***] as agreed by IMGN and GNE
· Final [***] (by month [***])
· [***] [***] not provided by [***] ([***] [***] [***], [***], [***] [***] and
other [***] [***] methods)
IMGN:
·
Laboratory [***] ([***] to [***])
· [***] [***] reports
· [***] [***] [***] [***]
· [***] Report
· Draft [***] [***] [***] [***] method
Duration:
[***]
[***]
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
23. STAGE
II: [***] [***] [***]
Purpose: To
[***]
process [***] at [***] [***]. This will be used to initiate [***] [***] of
the
[***] to the [***] [***].
Activities: [***]
[***] × [***] [***] [***]
Deliverables
IMGN:
·
[***]
[***] [***] to facilitate [***] [***] ([***] [***] [***])
· Report
containing [***] [***] (part of [***] [***] [***]), [***] [***] and [***] [***]
[***] [***] that [***] and [***] meet [***] as indicated in the [***] and [***]
section (summary of the [***] × [***] [***] [***]).
· [***]
[***]
Duration: [***]
-
[***] [***]
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
24. STAGE
III: [***] [***] and [***]
Purpose: To
[***]
the [***] and [***] that the [***] [***] is [***] and [***]. The goal is to
[***] a [***] [***] to the [***] [***] that can be [***] [***] [***] [***]
[***]
[***] during routine [***].
Activities: [***]
will identify parameters that are [***] to the [***] and will [***] the [***]
[***]. [***] [***] for each [***] [***], including [***] [***] will be
evaluated. Studies will be done to [***] the [***] towards [***], to [***]
the
[***] of process [***] and to understand what [***] if the [***] [***] [***]
[***] [***]. [***] [***] [***] [***] will be [***] to [***] [***] [***], [***]
for [***], [***] [***] and [***] [***]. These [***] will serve as a [***] for
[***] of the [***] to the [***] [***].
Deliverables
GNE:
·
[***]
[***] on [***] [***] and [***] [***]
· [***] [***] not provided [***] [***] ([***] [***] [***], [***], [***] [***]
and other [***] [***] methods)
Deliverables
IMGN:
·
[***]
[***] [***] [***] (or as determined appropriate by [***] [***] and [***] [***],
and meeting [***] as [***] in the [***] [***] of the [***] [***]
[***])
·
[***]
including [***] of [***] [***] [***] and [***] [***].
·
[***]
[***]
Weekly
or
biweekly updates as agreed to by both parties
25. Duration:[***]
[***]
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
STAGE
IV: [***] [***] to [***]
Purpose:
To
[***]
the [***] [***] from [***] to the [***] [***].
[***] will have overall responsibility to [***] [***]. [***] will provide [***]
[***] and is [***] [***] [***] [***] - [***] [***] to this
activity.
Activities:
[***]
will support [***] to [***] the process to [***] [***] [***]. This will
start
with [***] [***] [***] on [***] and will [***] with the [***] of [***] [***]
[***]
for the [***] [***] [***]. [***] will provide all the necessary [***] and [***]
[***] for the [***] of [***] [***].
Deliverables: [***]
[***] [***] of [***] [***] [***] required for [***] of [***] [***]
[***].
Duration: [***]
[***]
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
26. Total
FTE Requirement at ImmunoGen
First
[***] months:
|
[***]
FTE in [***] [***] and [***]
|
[***]
FTE in [***]
|
[***]
FTE for [***] [***], [***] [***]
|
[***]
FTE Total on average
|
Beyond
first [***] months: [***]
-
[***] FTE until completion of activities (completion expected end of
[***])
Estimated
FTEs by [***]
The
estimated [***] and cumulative FTE-based Services fees are listed below,
assuming project initiation on [***] [***], 2006. A range has been estimated
for
the period after [***] [***] until [***] of [***] to the [***] to [***] [***]
over the activities for this phase.
[***]
|
FTE’s
Allocated
|
Estimated
[***] FTE Fee
|
Cumulative
FTE Fee
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
|
$[***]
|
$[***]
|
[***]
[***]
|
[***]
- [***]
|
$[***]
- $[***]
|
$[***]
- $[***]
|
[***]
[***]
|
[***]
- [***]
|
$[***]
- $[***]
|
$[***]
- $[***]
|
[***]
[***]
|
[***]
- [***]
|
$[***]
- $[***]
|
$[***]
- $[***]
|
[***]
[***]
|
[***]
- [***]
|
$[***]
- $[***]
|
$[***]
- $[***]
|
[***]
[***]
|
[***]
- [***]
|
$[***]
- $[***]
|
$[***]
- $[***]
|
[***]
[***]
|
[***]
- [***]
|
$[***]
- $[***]
|
$[***]
- $[***]
|
[***]
[***]
|
[***]
- [***]
|
$[***]
- $[***]
|
$[***]
- $[***]
|
[***]
[***]
|
[***]
- [***]
|
$[***]
- $[***]
|
$[***]
- $[***]
|
[***]
[***]
|
[***]
- [***]
|
$[***]
- $[***]
|
$[***]
- $[***]
|
Estimated
Materials Requirements
[***]:
[***] [***]
[***]:
[***] - [***] [***]
[***]:
[***] - [***] [***]
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
EXHIBIT
B: PRESS RELEASE
ImmunoGen,
Inc. to Develop Commercial-Scale Manufacturing Process for Trastuzumab-DM1
for
Genentech
-Companies
also amend 2000 agreement for TAP compounds targeting HER2, potentially
providing increased royalties and milestones to ImmunoGen -
CAMBRIDGE,
MA, May 4, 2006-
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops
targeted anticancer therapeutics using its Tumor-Activated Prodrug (TAP)
technology, today announced that the Company has entered into an agreement
to
collaborate with Genentech to create a commercial manufacturing process for
Genentech’s trastuzumab-DM1 TAP compound. ImmunoGen and Genentech also have
agreed to amend their 2000 agreement that grants Genentech exclusive rights
to
use ImmunoGen’s TAP technology with therapeutic antibodies to HER2. This
amendment increases the total potential milestone payments to ImmunoGen under
this agreement to $44 million and the royalties to ImmunoGen on
HER2-targeting TAP compounds developed by Genentech, including
trastuzumab-DM1.
“We’re
delighted that Genentech chose to access our process development expertise
in
order to gain a commercial-scale manufacturing process for trastuzumab-DM1,”
commented Xxxxxxx Xxxxxx, Chairman and CEO. “We believe that the considerable
increase in the milestone payments and royalties that ImmunoGen potentially
can
earn with Genentech’s successful development of HER2-targeting TAP compounds
reflects the value of our manufacturing expertise in this area as well as the
significance of our technology.”
Under
the process development agreement announced today, ImmunoGen and Genentech
will
develop a production method for Genentech to manufacture trastuzumab-DM1 at
amounts up to and including commercial scale, and ImmunoGen will receive
research support payments in return. ImmunoGen
and Genentech also have amended the 2000 agreement that
grants Genentech exclusive rights to use ImmunoGen’s maytansinoid TAP technology
with therapeutic antibodies to HER2.
This
amendment increases the potential milestone payments to ImmunoGen under this
agreement by $6.5 million and the potential royalties to ImmunoGen on any
HER2-targeting TAP compound that may be developed by Genentech.
A
TAP
compound uses a tumor-targeting antibody to deliver a potent, cell-killing
agent
specifically to cancer cells. During the manufacturing process, the cell-killing
agent is attached to the antibody in a manner that does not significantly impact
the binding properties of the antibody. In the past
few years, ImmunoGen has manufactured numerous TAP compounds for
preclinical and initial clinical testing at the Company's production facility
in
Norwood, MA. ImmunoGen developed each production method used, providing the
Company with extensive experience in the development of manufacturing processes
for TAP compounds.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
About
ImmunoGen, Inc.
ImmunoGen,
Inc. develops targeted anticancer biopharmaceuticals. The Company’s proprietary
TAP technology uses tumor-targeting antibodies to deliver a potent cell-killing
agent specifically to cancer cells. Four TAP compounds are in clinical testing
-
huN901-DM1 and huC242-DM4, which are wholly owned by ImmunoGen, and AVE9633
and
trastuzumab-DM1, which are in development by the sanofi-aventis Group and
Genentech, respectively. The sanofi-aventis Group, Genentech, Centocor, Biogen
Idec, Boehringer Ingelheim, Millennium Pharmaceuticals, Inc., and Amgen
(formerly Abgenix), have licensed the right to develop and/or test TAP compounds
to specific targets; ImmunoGen also has a broader collaboration with the
sanofi-aventis Group.
This
press release includes forward-looking statements. For these statements,
ImmunoGen claims the protection of the safe harbor for forward-looking
statements provided by the Private Securities Litigation Reform Act of 1995.
It
should be noted that there are risks and uncertainties related to the Company’s
development of its own products, as well as to the development of products,
including trastuzumab-DM1, by our collaborators. A review of these risks can
be
found in ImmunoGen’s Annual Report on Form 10-K for the fiscal year ended June
30, 2005 and other reports filed with the Securities and Exchange
Commission.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 of the Securities Exchange Act of
1934.