EXHIBIT 10.1
ENBREL SUPPLY AGREEMENT
THIS ENBREL SUPPLY AGREEMENT ("Agreement") is made effective as of April 12,
---------
2002, by and between Immunex Corporation, a Washington corporation, having its
principal place of business at 00 Xxxxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxx 00000
("Immunex"), and Genentech, Inc., a Delaware corporation, having its principal
-------
place of business at Xxx XXX Xxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000
("Genentech").
---------
BACKGROUND
----------
Immunex markets and sells a certain proprietary biological pharmaceutical
product known as ENBREL(R) (etanercept). Immunex desires to obtain additional
supply of commercial quantities of ENBREL bulk drug substance. Genentech has the
experience and expertise necessary to perform the manufacturing and related
services needed to supply ENBREL bulk drug substance, and Genentech owns a
facility that, with some modifications, could be suitable for production of
commercial quantities of ENBREL bulk drug substance.
Immunex desires to retain Genentech as a nonexclusive manufacturer of commercial
quantities of ENBREL bulk drug substance and purchase commercial quantities of
such product from Genentech, and Genentech desires to perform such services and
sell commercial quantities of such product to Immunex, all on the terms and
conditions set forth in this Agreement.
AGREEMENT
---------
NOW, THEREFORE, IN CONSIDERATION OF the mutual covenants set forth in this
Agreement, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties hereby agree as
follows:
ARTICLE 1. DEFINITIONS
----------------------
The following terms, whether used in the singular or plural, shall have the
meanings assigned to them below for purposes of this Agreement.
1.1 "Acquisition Cost" means the actual invoiced price paid by Genentech to any
----------------
Third Party for acquiring any materials used in the manufacture of the
Product under this Agreement, including, but not limited to, shipping and
handling costs and customs duties incurred and paid by Genentech in
connection with the acquisition of such materials, and also including [*]
percent ([*]%) of the above amounts to cover such
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Party's storage and overhead costs. This definition, including the [*]
percent ([*]%) markup, shall only apply in the circumstances set forth in
Section 6.2(a)(5) and Section 19.3(d)(1) hereof.
----------------- ------------------
1.2 "Affiliate" means, with respect to any Party, any other corporation or
---------
business entity that directly, or indirectly through one or more
intermediaries, controls, is controlled by or is under common control with
such Party. For purposes of this definition, the term "control" means
direct or indirect ownership of fifty percent (50%) or more of the
securities or other ownership interests representing the equity voting
stock or general partnership or membership interest of such entity or the
power to direct or cause the direction of the management or policies of
such entity, whether through the ownership of voting securities, by
contract, resolution or otherwise.
1.3 "Batch" or "Lot" means the quantity of Bulk Drug produced from a single
----- ---
Run, and refers to a Commercial Batch or Lot, a Development Batch or Lot,
and/or a Qualification Batch or Lot, as the context requires. A Run may
result in more than one subbatch or sublot due to splitting into tanks
downstream in the Manufacturing Process.
1.4 "Batch Records" shall have the meaning set forth in the Quality Agreement.
-------------
1.5 "BIP" means Boehringer Ingelheim Pharma KG.
---
1.6 "BIP Confidential Information" means Immunex Confidential Information that
----------------------------
has been identified in writing as confidential information of BIP, and is
referred to in Section 17.6 hereof.
------------
1.7 "Bulk Drug" means the bulk form of the Product which has been manufactured
---------
by Genentech pursuant to this Agreement, which has been purified to a
concentrated form from one or more Batches and can be stored in a liquid or
frozen form under appropriate conditions, and, except with respect to
Non-Conforming Bulk Drug, which has been manufactured in compliance with
cGMP and conforms to the Bulk Drug Specifications.
1.8 "Bulk Drug Commitment" refers to the first [*] months of each binding
--------------------
rolling Product Manufacturing Forecast (including all amendments thereto),
and means a commitment by Genentech to comply with and perform the number
of Runs set forth therein. The Bulk Drug Commitment is a rolling [*] month
commitment, and is described with more particularity in Section 4.2 hereof.
-----------
1.9. "Bulk Drug Specifications" means specifications developed by Immunex for
------------------------
Bulk Drug as set forth in the Product sBLA, including, without limitation,
testing methods and acceptance criteria for each Batch generated, a summary
of which is attached to the Quality Agreement, as such specifications may
be amended from time to time in accordance with Section 6.2 hereof,
-----------
including, without limitation, such amendments as
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 2
may be required to obtain approval from the FDA and other applicable
regulatory authorities in the United States.
1.10 "cGMP" means the regulatory requirements for current good manufacturing
----
practices promulgated by the FDA under the FD&C Act, 21 C.F.R.(S)(S)210,
211 and 600 et seq. and under the PHS Act, 21 C.F.R.(S)(S)600-610, as the
same may be amended from time to time.
1.11 "Cell Line" means a proprietary Immunex Chinese Hamster Ovary cell line
---------
that expresses the Product.
1.12 "Certificate of Analysis" means, for each Batch, a document prepared by
-----------------------
Immunex: (a) listing tests performed by Immunex, specifications, test
date(s), and test results, and certifying the accuracy of the foregoing;
(b) referring to the related Certificate of Compliance prepared by
Genentech, listing the manufacturing date, unique Batch number, and
quantity of Bulk Drug in such Batch, as certified by Genentech in such
Certificate of Compliance; and (c) referring to the related Certificate of
Testing prepared by Genentech, listing tests performed by Genentech,
specifications, test date(s), and test results, as certified by Genentech.
The Parties shall from time to time agree upon a format or formats for the
Certificate of Analysis to be used under this Agreement.
1.13 "Certificate of Compliance" means, for each Batch, a document prepared by
-------------------------
Genentech: (a) listing the manufacturing date, unique Batch number, and
quantity of Bulk Drug in such Batch, and (b) certifying that such Batch was
manufactured in accordance with the Bulk Drug Specifications and cGMP. The
Parties shall from time to time agree upon a format or formats for the
Certificate of Compliance to be used under this Agreement.
1.14 "Certificate of Testing" means, for each Batch, a document prepared by
----------------------
Genentech: (a) listing tests performed by Genentech, specifications, and
test results, and (b) certifying the accuracy of the foregoing. The Parties
shall from time to time agree upon a format or formats for the Certificate
of Testing to be used under this Agreement.
1.15 "Change of Control" means the merger, acquisition or consolidation of
-----------------
Immunex with or into Amgen Inc. or a subsidiary of Amgen Inc.
1.16 "Commercial Batch" or "Commercial Lot" means a Batch or Lot produced from a
------------------------------------
Commercial Run.
1.17 "Commercial Run" means a Run that is initiated following the commencement
--------------
of Commercial Production and is used to manufacture commercial Bulk Drug.
1.18 "Commercially Reasonable Efforts" means [*].
-------------------------------
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 3
1.19 "Commercially Reasonable Best Efforts" means: for Immunex, [*]; and for
------------------------------------
Genentech, [*].
1.20 "Confidential Information" means Immunex Confidential Information and/or
------------------------
Genentech Confidential Information, as the context requires.
1.21 "Development Batch" means a Batch or Lot produced from a Development Run.
-----------------
1.22 "Development Run" means a Run used for process demonstration and
---------------
confirmation of some or all of the Manufacturing Process steps, and is
described in Section 3.7(a) hereof.
--------------
1.23 "Effective Date" means April 12, 2002, which is the date set forth in the
--------------
first paragraph of this Agreement and shall be the effective date of this
Agreement.
1.24 "EMEA" means the European Medicines Evaluation Agency, or any successor
----
agency.
1.25 "Enbrel License Agreement" means that certain License Agreement for
------------------------
Etanercept between Immunex and Genentech dated [*].
1.26 "Facility Modifications and Services Costs" means the actual invoiced price
-----------------------------------------
paid by Genentech to any Third Party for acquiring services, including,
without limitation, design and engineering services, and necessary
equipment, for modifications to the Genentech Facility needed to implement
the Manufacturing Process at the Genentech Facility, all to the extent
incurred in accordance with the Tech Transfer Agreement, and including,
without limitation, such amounts incurred in accordance with the Letter of
Intent (and also including, without limitation, such amounts incurred in
accordance with the Letter of Intent after expiration of the Letter of
Intent and prior to or on the Effective Date of this Agreement, as if the
Letter of Intent had been extended through and including the Effective Date
of this Agreement).
1.27 "Facility Validation" shall have the meaning ascribed to it in the Tech
-------------------
Transfer Agreement.
1.28 "FD&C Act" means the United States Federal Food, Drug and Cosmetic Act, as
--------
the same may be amended from time to time.
1.29 "FDA" means the United States Food and Drug Administration, or any
---
successor agency thereto.
1.30 "Field" shall mean the manufacture of Product utilizing the manufacturing
-----
process in actual use as of the Effective Date, as well as any
modifications to such manufacturing process that are implemented in
accordance with this Agreement into the manufacturing process actually used
by Genentech in manufacturing Product pursuant to this Agreement, as well
as any other modifications to such manufacturing process
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 4
that are implemented by Immunex, its Affiliates, Product licensees or
contract manufacturers for Product either during or, with respect to [*].
1.31 "Finished Product" means Bulk Drug which has been formulated, compounded,
----------------
filled into containers, and labeled, and placed in final commercial
packaging.
1.32 "For Cause Audit" shall have the meaning set forth in the Quality
---------------
Agreement.
1.33 "Genentech Confidential Information" means all technical and other
----------------------------------
information, whether patented or unpatented, relating to the Genentech
Facility and/or Genentech processes, methods, operations, technologies,
forecasts and business information that are disclosed or supplied to, or
used on behalf of Immunex by Genentech pursuant to this Agreement, the Tech
Transfer Agreement and/or the Quality Agreement, or of which Immunex may
become aware of through the presence of their employees or agents at
Genentech offices or at the Genentech Facility, including, without
limitation, trade secrets, know-how, processes, concepts, experimental
methods and results and business and scientific plans and information and
facility layout and schematics.
1.34 "Genentech Facility" means Genentech's commercial manufacturing facility
------------------
located at One DNA Way in South San Francisco, California. In addition, in
the event Genentech, in its sole discretion, utilizes storage capacity in
its Vacaville, California facility to store Bulk Drug, then the term
"Genentech Facility" includes, when and as the context requires,
------------------
Genentech's facility located in Vacaville, California, but only to the
extent that, and with respect to those portions of, the Vacaville facility
that is used by Genentech to perform Genentech's obligations hereunder.
1.35 [*]
1.36 "Genentech Patents" shall have the same definition as set forth in the
-----------------
Enbrel License Agreement.
1.37 "Genentech [*] Patents" shall mean Patents containing claims covering [*],
---------------------
in each case which were [*].
1.38 "Immunex Confidential Information" means the Cell Line, Master Cell Bank,
--------------------------------
Working Cell Bank, Manufacturing Documentation, Manufacturing Process, and
Product, and all technical and other information, whether patented or
unpatented, relating thereto and/or to Immunex processes, methods,
operations, technologies, forecasts and business information that are
disclosed or supplied to Genentech by or on behalf of Immunex pursuant to
this Agreement, the Tech Transfer Agreement and/or the Quality Agreement,
or of which Genentech may become aware of through the presence of its
employees or agents at Immunex offices or facilities or at other facilities
that manufacture the Product, including, without limitation, trade secrets,
know-how, processes, concepts, experimental methods and results and
business and scientific plans and information and facility layout and
schematics. All portions of documents
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 5
and records describing or to the extent relating to the Manufacturing
Process at the Genentech Facility, including, without limitation, process
trend and variability data related to the Product, shall be deemed to be
Immunex Confidential Information.
1.39 "Letter of Intent" means that certain letter of intent and authorization to
----------------
proceed between the Parties dated February 4, 2002, as amended on March 22,
2002, regarding the intent of the Parties to negotiate in good faith and
execute this Agreement, and which letter is superceded in accordance with
its terms by this Agreement.
1.40 "Manufacturing Documentation" means all documents and records describing or
---------------------------
otherwise related to the Manufacturing Process or any part of the
Manufacturing Process provided to Genentech by or on behalf of Immunex
under this Agreement, the Tech Transfer Agreement or the Quality Agreement,
including, without limitation, documents and records consisting of or
containing piping and instrumentation diagrams, software logic and
descriptions, batch records, standard operating procedures, including,
without limitation, standard operating procedures for in-process quality
control testing, facility layout schematics, equipment and instrumentation
specifications and process trend and variability data.
1.41 "Manufacturing Process" means the [*] production process for the
---------------------
manufacture of Bulk Drug pursuant to this Agreement, as summarily described
in the Quality Agreement and as described in the Tech Transfer Agreement,
as such process may be changed from time to time in accordance with this
Agreement. [*]
1.42 "Master Cell Bank" means Immunex's reference deposit or collection of vials
----------------
of the Cell Line, from which the Working Cell Bank is derived.
1.43 "Milestone I" means [*], and is referred to in Section 5.2(a) hereof.
----------- --------------
1.44 "Milestone II" means [*] referred to in Section 5.2(b) hereof.
------------ --------------
1.45 "Milestone III" means [*] or, if earlier, [*], and is referred to in
-------------
Section 5.2(c) hereof.
--------------
1.46 "Milestone IV" means [*], and is referred to in Section 5.2(d) hereof.
------------ --------------
1.47 "Net Sales" shall have the same definition as set forth in the Enbrel
---------
License Agreement.
1.48 "Non-Conforming Bulk Drug" means Bulk Drug that fails to conform to any of
------------------------
the warranties set forth in Section 6.1(a) hereof.
--------------
1.49 "Non-Portable Equipment" means the Equipment (as defined in Section 14.2
---------------------- ------------
hereof), excluding any Portable Equipment. Components of the Non-Portable
Equipment, such as valves, pumps and agitators, shall also be deemed
Non-Portable Equipment. Non-Portable Equipment includes the related
documentation regarding the design,
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 6
validation, operation, calibration and maintenance of such equipment.
1.50 "PHS Act" means the Public Health Service Act, Biological Products, as
-------
amended, as the same may be amended from time to time.
1.51 "Party" or "Parties" means Genentech and/or Immunex, as the context
----- -------
requires.
1.52 "Patents" shall mean, with respect to an invention, any patent or patent
-------
application, and any patent issuing therefrom, together with any
extensions, reissues, reexaminations, substitutions, renewals, divisions,
continuations and continuations-in-part thereof, and any patent or patent
application claiming priority to any application in common with any such
patent containing a disclosure substantially similar to any such patent,
all to the extent the foregoing contain claims covering such invention.
1.53 "Portable Equipment" means the portable equipment described with
------------------
particularity in the Tech Transfer Agreement and referred to in Section 5.1
-----------
hereof, including, without limitation, the related documentation regarding
the design, validation, operation, calibration, and maintenance of such
equipment. The Portable Equipment is a part of the Equipment, as defined in
Section 14.2 hereof. Components of the Portable Equipment, such as valves,
------------
pumps and agitators, shall also be deemed Portable Equipment.
1.54 [*]
1.55 "Product" means the proprietary biological pharmaceutical product known as
-------
ENBREL(R)(etanercept), which is a [*].
1.56 "Purchase Price" means the purchase price to be paid by Immunex to
--------------
Genentech for Bulk Drug as determined in accordance with the terms of this
Agreement.
1.57 "Qualification Batch" or "Qualification Lot" means a Batch or Lot produced
------------------- -----------------
from a Qualification Run.
1.58 "Qualification Run" means a Run used to document the operability and
-----------------
reproducibility of the Manufacturing Process at the Genentech Facility, and
is described in Section 3.7(b) hereof.
--------------
1.59 "Quality Agreement" means the quality agreement between the Parties of even
-----------------
date herewith which refers to this Agreement.
1.60 "Roche" means Roche Holdings, Inc., a Delaware corporation, and its
-----
"Affiliates" (as hereinafter defined) other than Genentech and Genentech's
subsidiaries. With respect to Roche, "Affiliates" means any other
----------
corporation or business entity that directly, or indirectly through one or
more intermediaries, controls, is controlled by or is under common control
with Roche Holdings, Inc.; and, for purposes of this definition, the
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 7
term "control" means direct or indirect ownership of fifty percent (50%) or
more of the securities or other ownership interests representing the equity
voting stock or general partnership or membership interest of such entity
or the power to direct or cause the direction of the management or policies
of such entity, whether through the ownership of voting securities, by
contract, resolution or otherwise.
1.61 "Run" means a single fermentation start or run of the Manufacturing Process
---
at the [*] liter fermentation scale at the Genentech Facility, and refers
to a Commercial Run, Development Run and/or Qualification Run, as the
context requires. A fermentation start for the Product shall be deemed to
be a Run if such fermentation start proceeds to the [*] at the [*] liter
scale or later in the Manufacturing Process.
1.62 "sBLA" means a biologics license application for the Product, any
----
equivalent successor filing thereto with the FDA, and any supplements or
amendments to any of the foregoing.
1.63 "Specialized Raw Materials" means the specialized raw materials described
-------------------------
with particularity in the Tech Transfer Agreement and referred to in
Section 3.6 hereof.
1.64 [*]
1.65 "Tech Transfer Agreement" means the technology transfer agreement and
-----------------------
process implementation plan between the Parties of even date herewith which
refers to this Agreement, and which describes the agreement of the Parties
regarding the transfer of technology and implementation of the
Manufacturing Process at the Genentech Facility, and the modifications to
the Genentech Facility needed to implement the Manufacturing Process at the
Genentech Facility, including a timeline, budget and statement of work
jointly developed by the Parties, as the same may be amended from time to
time by mutual written agreement of the Parties.
1.66 "Territory" means the entire world.
---------
1.67 "Third Party" means any party other than Immunex, Genentech and their
-----------
respective Affiliates.
1.68 "United States" or "U.S." means the United States of America, its
------------- ----
territories and possessions, and the Commonwealth of Puerto Rico.
1.69 [*]
1.70 "Working Cell Bank" means a vialed collection of serially subcultivated
-----------------
cells generated by Immunex that is derived from the Master Cell Bank. The
Working Cell Bank is used to establish seed cultures of the Cell Line to
initiate the Manufacturing Process.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 8
1.71 Each of the following definitions are found in the body of this Agreement,
or elsewhere, as indicated below:
Defined Term Section
------------ -------
"Acceptance Date" 4.3(e)
[*] 13.2(b)(2)(A)
"Allocable Overhead" 3.9
"Annual Maximum" 4.1
"Annual Minimum" 4.1
"Approved Suppliers" 3.6(a)
"Assigned Inventions" 14.1(d)
"Batch Record" Quality Agreement
"BIP ENBREL Supply Agreement" 17.6
"Commercial Production" 6.3
"Delivery Schedule" 4.3(a)
"Delivery Date" 4.3(b)
"Designated Carrier" 4.4
"Designated Purchaser" 3.6(a)
"Disclosing Party" 13.2(c)
"Equipment" 14.2
"FDA Approval" 3.4(d)
"Finance Contact" 3.2(b)
"Force Majeure Event" 20.1
"Genentech Improvements" 14.1(c)
"Immunex IP Rights" 13.1
"Indemnitee" 16.3(a)
"Indemnitor" 16.3(a)
"Internal Costs" 3.9
"JPT" 3.3(a)
"Liabilities" 16.1(a)
"Non-Requesting Party" 22.2(b)
"Notified Party" 17.4(a)
"Notifying Party" 17.4(a)
"Operations Team" 6.3
"Product Manufacturing Forecast" 4.2(a)
"Project Team Leader" 3.2
"Recipient" 13.2(c)
"Records" 5.4
"Term" 19.1
"Warning Letter" Quality Agreement
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 9
ARTICLE 2. COMMITMENT TO MANUFACTURE; PURCHASE
----------------------------------------------
2.1 Commitment to Manufacture; Purchase. Subject to the terms and conditions
-----------------------------------
set forth in this Agreement, during the Term, Immunex shall retain
Genentech as a non- exclusive manufacturer of Bulk Drug, Genentech shall
manufacture Bulk Drug exclusively for the benefit of Immunex and sell Bulk
Drug exclusively to Immunex, and Immunex shall purchase such Bulk Drug from
Genentech.
ARTICLE 3. TECHNOLOGY TRANSFER AND PROCESS IMPLEMENTATION
---------------------------------------------------------
3.1 Technology Transfer and Manufacturing Process Implementation.
------------------------------------------------------------
(a) Process Description and Tech Transfer Agreement. The Parties
-----------------------------------------------
acknowledge that in order to enable them to fulfill their respective
obligations under this Agreement, they have entered into the Tech
Transfer Agreement and, pursuant thereto, jointly developed a plan for
the transfer of technology and implementation of the Manufacturing
Process at the Genentech Facility. Pursuant to this Agreement and the
Tech Transfer Agreement, Immunex shall promptly disclose to Genentech
the Manufacturing Process for the Bulk Drug and the Bulk Drug
Specifications and other specifications related thereto, in order to
enable Genentech to fulfill its obligations under this Agreement. The
Tech Transfer Agreement sets forth the specific responsibilities of
the Parties in connection with technology transfer and implementation
of the Manufacturing Process at the Genentech Facility, and the
modifications to the Genentech facility needed to implement the
Manufacturing Process at the Genentech Facility, including a timeline,
budget and statement of work jointly developed by the Parties, as the
same may be amended from time to time by mutual written agreement of
the Parties. The Tech Transfer Agreement includes milestones for the
transfer of technology, exchange of information, and implementation of
the project, reasonable timelines for achieving such milestones, and
criteria for assessing the progress and success of the project as it
progresses.
(b) Commercially Reasonable Best Efforts; Cooperation; Tech Transfer
----------------------------------------------------------------
Agreement. The Parties shall use Commercially Reasonable Best Efforts
---------
to complete their respective responsibilities in a timely manner under
and in accordance with the Tech Transfer Agreement and Section 3.1 of
-----------
this Agreement. In addition, each Party agrees to use Commercially
Reasonable Best Efforts to cooperate with and assist the other Party
in its efforts to perform its obligations under the Tech Transfer
Agreement and Section 3.1 of this Agreement; and, notwithstanding
-----------
anything in this Agreement to the contrary, a Party shall not be
deemed to have failed to use Commercially Reasonable Best Efforts to
the extent the failure or delay in such Party's performance of its
obligations is caused by a Force Majeure Event (as defined in Section
-------
20.1 below), or the failure or delay on the part of the other Party in
----
performance of such other Party's obligations under this Agreement,
the Tech Transfer Agreement and/or the Quality Agreement.
(c) On-Site Participation. Pursuant to and as set forth in greater detail
---------------------
in the Tech Transfer Agreement and Quality Agreement, in order to
expedite the
Page 10
implementation of the Tech Transfer Agreement, Immunex may have its
personnel on-site at the Genentech Facility, in such numbers as may be
agreed to by the Parties but in no event less than a reasonable number
of personnel. All such personnel will coordinate closely with
Genentech in order to minimize impact on other Genentech operations.
Unless otherwise agreed by Genentech: (i) such Immunex personnel shall
have access only to those portions of the Genentech Facility
reasonably related to the technology transfer and implementation of
the Manufacturing Process, and (ii) while at the Genentech Facility,
such Immunex personnel shall, at Genentech's option, be accompanied by
a Genentech employee, in which case Genentech will make good faith
efforts to have such Genentech employee available. Employees or agents
of one Party who will be at the other Party's site may be required by
the other Party to sign confidentiality agreements protecting the
other Party's information, using a form of confidentiality agreement
mutually agreed to by the Parties in writing in advance in order to
give effect to the confidentiality provisions set forth in this
Agreement. In addition, all Parties' personnel shall have executed a
confidentiality agreement with their employer, which shall include an
obligation of maintaining the confidentiality that would cover the
other Party's confidential information.
(d) Delivery of Working Cell Bank. By not later than the applicable
-----------------------------
delivery deadline set forth in the Tech Transfer Agreement, Immunex
shall deliver to Genentech the Working Cell Bank, which shall conform
to Immunex's applicable release criteria, as set forth in Immunex's
Working Cell Bank specifications.
3.2 Appointment of Project Team Leaders and Finance Contacts.
--------------------------------------------------------
(a) Appointment of Project Team Leader. Immunex and Genentech shall each
----------------------------------
appoint a Project Team Leader (each, a "Project Team Leader") to act as the
-------------------
primary contact for such Party in connection with matters related to the
implementation of the Manufacturing Process and in connection with
activities to be performed under the Tech Transfer Agreement. The initial
Project Team Leaders are:
[*]
A Party may replace its Project Team Leader at any time and from time
to time for any reason by providing written notice of the change to
the other Party.
(b) Appointment of Finance Contacts. In addition, Immunex and Genentech
-------------------------------
shall each appoint a Finance Contact (each, a "Finance Contact") to
---------------
act as the primary contact for such Party in connection with matters
related to financial activities and issues arising hereunder.
The initial Finance Contacts are:
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 11
[*]
A Party may replace its Finance Contact at any time and from time to
time for any reason by providing written notice of the change to the
other Party.
3.3 Joint Project Team.
------------------
(a) Role and Authority Generally. The Parties will form a Joint Project
----------------------------
Team ("JPT") to facilitate the activities under the Tech Transfer
---
Agreement and to resolve issues that may arise in connection with such
activities or in connection with the other matters described in
Section 3.3(b) below. The JPT will be composed of an appropriate equal
--------------
number of representatives from each Party, to be determined by mutual
agreement, and will include the Project Team Leaders. The membership
in the JPT, and the role and authority generally of the JPT, may
change after commencement of Commercial Production of Bulk Drug under
this Agreement (see Section 6.3 below).
-----------
(b) Scope of Authority Prior to Commercial Production; Changes to Tech
------------------------------------------------------------------
Transfer Agreement; Changes to the Manufacturing Process.
--------------------------------------------------------
(1) Prior to the commencement of Commercial Production of Bulk Drug
under this Agreement (see Section 6.3 below), and subject to
-----------
Section 3.3(c) hereof, the JPT shall have the authority to modify
--------------
or supplement the Tech Transfer Agreement (to the extent
permitted in the Tech Transfer Agreement, which provides therein
that the JPT shall have the authority to amend the attachments
and exhibits attached to the Tech Transfer Agreement but shall
not have authority to amend the body of the Tech Transfer
Agreement) or the Manufacturing Process as necessary or useful to
ensure implementation of the Manufacturing Process in the
Genentech Facility in a timely manner. If the JPT is considering
a modification or supplement to the Tech Transfer Agreement or
the Manufacturing Process that would require Genentech to perform
additional or repeat work under the Tech Transfer Agreement, or
which would delay Genentech's performance, or ability to perform,
under the Tech Transfer Agreement or this Agreement, or would
result in additional capital expenditures that would not be
subject to reimbursement under this Agreement or the Tech
Transfer Agreement, then a Project Team Leader may request that
Genentech provide to the JPT (with Immunex's assistance, if
reasonably requested by Genentech) an estimate of the increased
cost of or delay to Genentech's performance caused by such
amendment or supplement. The JPT's formal written approval of
such modification or supplement shall constitute Immunex's
agreement to pay Genentech's costs and expenses for such
increased work or additional capital expenditures as set forth in
such estimate and agreed to in a writing signed by the Project
Team Leaders (or other authorized representatives of the
Parties), and/or to extend the time for performance as set forth
in such estimate and agreed to in a writing signed by the Project
Team Leaders (or other authorized representatives of the
Parties).
* Portions of this exhibit have been omitted pursuant to a request
for confidential treatment filed with the Securities and Exchange Commission.
The omitted portions of this exhibit have been filed separately with the SEC.
Page 12
(2) Similarly, the JPT shall be empowered, as and when appropriate,
acting in good faith, to adjust the reimbursement trigger dates
set forth in Section 3.4(d) hereof, to adjust the milestone dates
--------------
set forth in Section 5.2 hereof, to adjust the date set forth in
-----------
Section 19.2(c)(ii) hereof, and to reduce, extend or otherwise
-------------------
adjust the budget, timeline and scope of work in the Tech
Transfer Agreement; provided, however, that adjustments should be
made only on account of events that have a material adverse
effect on the critical path to completing the related goal. The
Parties acknowledge that there are various amounts of float time
included in the schedules, dates and deadlines set forth in the
Tech Transfer Agreement, the reimbursement trigger dates set
forth in Section 3.4(d) hereof, the milestone dates set forth in
--------------
Section 5.2 hereof, and the date set forth in Section 19.2(c)(ii)
----------- -------------------
hereof. Float time should be considered by the JPT in determining
whether to make any such adjustments, and the Parties understand
that a certain amount of float time may be appropriate for the
remainder of the schedule. Notwithstanding the foregoing, the
JPT's authority shall be subject to Section 3.3(c) below.
--------------
(3) The members of the JPT shall operate in good faith and shall act
reasonably in exercising their authority and in approving or
rejecting proposals.
(4) After Commercial Production of Bulk Drug has commenced (see
Section 6.3 hereof), the JPT shall operate in accordance with
-----------
Section 6 hereof, and all other changes to the Manufacturing
---------
Process shall be made as set forth in Section 6.2 hereof and the
-----------
Quality Agreement or as the Parties may otherwise agree in
writing.
(c) Decision-making. All decisions of the JPT shall be made by the
---------------
unanimous agreement of all of its members or their designated
representatives, and shall be reflected in written meeting minutes of
the JPT, which shall be signed by the Project Team Leaders (or other
authorized representatives of the Parties). In addition, any decision
by the JPT to adjust the reimbursement trigger dates set forth in
Section 3.4(d) hereof, to adjust the milestone dates set forth in
--------------
Section 5.2 hereof, to adjust the date set forth in Section
----------- -------
19.2(c)(ii) hereof, shall only be effective upon the written approval
-----------
of, at Immunex, the Senior Vice President of Supply Operations, and,
at Genentech, the Senior Vice President of Product Operations, or
other individuals having the same or substantially similar positions,
which approval and execution shall not be unreasonably withheld. The
JPT may amend the Tech Transfer Agreement in accordance with the terms
thereof. In the event that the JPT is unable, despite the good faith
efforts of all members, to resolve within [*] business days a disputed
issue that is within the purview of the JPT, the disputed issue shall
be referred immediately by the JPT to the Project Team Leaders. In the
event the Project Team Leaders are unable to resolve the disputed
issue within an additional [*] business days, the disputed issue will
be referred to, at Immunex, the Senior Vice President of Supply
Operations and, at Genentech, the Senior Vice President of Product
Operations or their successor in
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 13
an equivalent position. If the dispute cannot be resolved by Immunex's
and Genentech's senior management as designated above within an
additional [*] business days, it shall be referred to, at Immunex, the
Chief Operating Officer, and, at Genentech, the Executive Vice
President of Development and Product Operations, or their respective
successors in interest. If the dispute is still unresolved within an
additional [*] business days, the matter will be handled in accordance
with Section 22.2 hereof. Notwithstanding the foregoing, issues
------------
relating to quality shall be resolved in accordance with the Quality
Agreement, and disputes relating to whether Bulk Drug is Non-Conforming
Bulk Drug shall be governed by Article 8 herein.
---------
3.4 Regulatory Matters.
------------------
(a) Regulatory Approach. As set forth in greater detail below, Immunex
-------------------
shall use Commercially Reasonable Best Efforts to timely file, and
Commercially Reasonable Efforts to maintain, the sBLA for the
manufacture of Bulk Drug at the Genentech Facility, and Genentech shall
use Commercially Reasonable Best Efforts to timely file, and
Commercially Reasonable Efforts to maintain, supplements to its
existing FDA licenses for the manufacture of Bulk Drug at the Genentech
Facility.
(b) Immunex Obligations. Except with respect to obligations of Genentech
-------------------
under Section 3.4(c) below, Immunex shall use Commercially Reasonable
--------------
Best Efforts to timely prepare and obtain, and Commercially Reasonable
Efforts to maintain, all regulatory approvals that are required to
market and sell in the United States the Product resulting from the
Manufacturing Process as carried out at the Genentech Facility,
including, without limitation, the preparation, filing and maintenance
of the sBLA for the manufacture of Bulk Drug at the Genentech Facility,
and Immunex shall reasonably assist Genentech in meeting its
obligations under this Section 3.4.
-----------
(c) Genentech Obligations. Except with respect to obligations of Immunex
---------------------
under Section 3.4(b) above, Genentech shall use Commercially Reasonable
--------------
Best Efforts to timely prepare and obtain, and Commercially Reasonable
Efforts to maintain, all regulatory approvals that are required to
manufacture Bulk Drug at the Genentech Facility in South San Francisco,
California, including, without limitation, the preparation, filing and
maintenance of supplements to Genentech's existing FDA licenses (and
drug master file), and Genentech shall reasonably assist Immunex in
meeting its obligations under this Section 3.4, including, without
-----------
limitation, reasonably assisting with the preparation and review of the
drafts of the chemistry, manufacturing and controls sections of the
sBLA to be filed by Immunex with FDA. Genentech shall also reasonably
assist Immunex in responding to requests and inquiries from the FDA
prior to, during and after regulatory review periods and by attending
meetings with such regulatory authorities to the extent it is essential
for Genentech to participate given its unique
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 14
knowledge or its status as manufacturer of Bulk Drug under this
Agreement. Genentech personnel shall also facilitate pre-approval
inspection of the Genentech Facility conducted by such regulatory
authorities. The assistance to be provided by Genentech under this
Section 3.4(c) shall be provided at no additional cost to Immunex,
--------------
except as otherwise provided in Sections 3.9 and 4.5 hereof.
--------------------
(d) Target Date for FDA Approval. Each Party agrees to use Commercially
----------------------------
Reasonable Best Efforts to obtain by [*], FDA approval for the
manufacture of Bulk Drug at the Genentech Facility ("FDA Approval").
------------
[*]. In accordance with Section 3.3(b), [*] may be extended for delays
--------------
that are caused by a Force Majeure Event (as defined in Section 20.1
------------
below) affecting Genentech which, for purposes of this Section 3.4(d),
--------------
may include, without limitation, [*] all to the extent beyond the
control and without the fault or negligence of the Party affected
thereby, to the extent that such delays have a material adverse effect
on the critical path for obtaining FDA Approval. Each Party agrees to
give the other Party prompt written notice of any such potential Force
Majeure Event, the nature thereof, and the extent to which FDA
Approval is likely to be delayed. Each Party further agrees to use
Commercially Reasonable Best Efforts to cure the Force Majeure Event
as quickly as practicable. The JPT shall determine, in accordance with
Section 3.3 hereof, whether the above dates in this Section 3.4(d)
----------- --------------
that trigger Genentech's reimbursement obligations shall be extended,
and, if so, the appropriate length of time for the extension, and to
approve or adopt standards, requirements or actions intended to
correct the Force Majeure Event as quickly as practicable, and each
Party shall act in good faith and exercise reasonable judgment in
connection therewith. Notwithstanding anything in this Agreement
seemingly to the contrary, Immunex agrees that Immunex's sole
compensation under this Agreement as a result of failure to obtain FDA
Approval shall be limited to [*]. The Parties further agree that
Immunex shall use its Commercially Reasonable Efforts to [*], and, if
Immunex does not do so and the failure to do so has a material adverse
effect on the critical path to [*], then the JPT shall be empowered to
adjust the FDA Approval termination date set forth in Section
-------
19.2(c)(ii) hereof. The JPT shall determine, in accordance with
-----------
Section 3.3 hereof, whether such date shall be extended, and, if so,
-----------
the appropriate length of time for the extension, and each Party shall
act in good faith and exercise reasonable judgment in connection
therewith.
3.5 Facility Modifications and Improvements. Genentech shall use Commercially
---------------------------------------
Reasonable Efforts to: (a) make facility modifications as required to
conduct the Manufacturing Process at the Genentech Facility; and (b)
procure, engineer, install, scale-up, test and validate the equipment and
systems necessary to conduct the Manufacturing Process at the Genentech
Facility; in each case as described in, and in accordance with, the Tech
Transfer Agreement.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 15
3.6 Raw Materials and Suppliers.
---------------------------
(a) Raw Materials. Immunex has developed specifications for the raw
-------------
materials, including, without limitation, Specialized Raw Materials,
used in the Manufacturing Process. The raw materials specifications and
a list of certain "Approved Suppliers" for raw materials will be
------------------
included in the Tech Transfer Agreement. Immunex has entered into
supply contracts with the Approved Suppliers of raw materials. During
the Term, Immunex shall provide Genentech with access to the favorable
pricing and services provided under Immunex's contracts with those
Approved Suppliers and Genentech shall become a "Designated Purchaser"
under those contracts and Immunex shall provide Genentech with a true
and correct copy of each such contract; and, if Immunex enters into new
supply contracts for raw materials used in the manufacture of the Bulk
Drug, then, during the Term, Immunex shall provide Genentech with
access to the favorable pricing and services provided thereunder and
Genentech shall become a "Designated Purchaser" thereunder, and Immunex
shall provide Genentech with a true and correct copy of each such
contract. Immunex shall provide oversight and coordination of
inventories of Specialized Raw Materials. Immunex further agrees that
to the extent Immunex controls or influences the allocation of
Specialized Raw Materials provided to Immunex for the manufacture of
Product in Rhode Island and to Genentech as a Designated Purchaser
under Immunex's supply contracts with the Approved Suppliers for the
manufacture of Bulk Drug hereunder, Immunex will use its Commercially
Reasonable Efforts to ensure that, in the event a shortage of
Specialized Raw Materials exists, or is anticipated, each shall receive
a pro rata amount of available Specialized Raw Materials under such
supply contracts based on an allocation of [*] percent ([*] %) to
Genentech for its forecasted production at the Genentech Facility with
respect to the then-current Bulk Drug Commitment, and [*] percent
([*]%) to Immunex for its forecasted production in Rhode Island with
respect to the same time period, until such shortage is abated. If any
such shortage continues beyond such period, the allocation will
continue in accordance with the foregoing sentence, on a rolling basis
for subsequent then-current Bulk Drug Commitments, until such shortage
is abated.
(b) Raw Materials for Development Runs and Qualification Runs.
---------------------------------------------------------
Notwithstanding anything seemingly to the contrary herein, Immunex
shall timely procure, at [*]'s sole cost and expense, and timely
provide to Genentech, sufficient quantities of all Specialized Raw
Materials as required for the Development Runs and Qualification Runs
described in Section 3.7 below. The Parties shall in good faith
-----------
determine the amount and value of usable Specialized Raw Materials
remaining after the Development Runs and Qualification Runs, [*], upon
the expiration or termination of this Agreement, Immunex shall pay
Genentech the amounts payable under Section 19.3(d)(1) of this
------------------
Agreement.
(c) Raw Materials Management. Genentech shall procure, at [*]'s sole cost
------------------------
and expense (except for Specialized Raw Materials [*]), maintain and
store such amounts of raw materials and components as required for the
Development Runs
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 16
and Qualification Runs described in Section 3.7 below and the
-----------
Commercial Runs. Except as set forth in Section 6.2(a)(5) or 19.3(d)(1)
----------------- ----------
hereof, Genentech will provide such raw materials and components and
such procurement and management services [*].
(d) Raw Materials Testing. Genentech shall perform testing and evaluation
---------------------
of the raw materials (including, without limitation, the Specialized
Raw Materials procured by Immunex and provided to Genentech pursuant to
Section 3.6(b) above) as required by the applicable raw material
--------------
specifications or Bulk Drug Specifications and cGMP, and otherwise in
accordance with the Quality Agreement and standard operating procedures
to be agreed upon in writing by the Parties.
3.7 Initial Runs and Batches.
------------------------
(a) Development Runs. Genentech shall perform Development Runs and
----------------
manufacture Development Batches at such size and in such number as is
set forth in the Tech Transfer Agreement. Genentech will provide the
Product resulting from such Development Runs and Development Batches
to Immunex, [*], in accordance with the delivery terms set forth in
Section 4.4 hereof. Immunex may make whatever further use of such
-----------
Product as it shall determine; provided, however, that Immunex agrees
that (i) such Product shall not be used in humans, (ii) the warranties
provided in Section 6.1(a) of this Agreement shall not apply to such
--------------
Product, (iii) the disclaimer of warranties set forth in Section
-------
6.1(c) of this Agreement shall apply to such Product, and (iv) this
------
Section 3.7(a) shall survive termination or expiration of this
--------------
Agreement.
(b) Validation and Qualification Batches. Once scale-up of the
------------------------------------
Manufacturing Process is completed at the Genentech Facility, Genentech
shall perform all required process validation and shall perform
Qualification Runs and manufacture Qualification Batches at commercial
scale as set forth in the Tech Transfer Agreement in order to document
the operability and reproducibility of the Manufacturing Process and
permit the Parties to complete and file the regulatory documents
described in Section 3.4 hereof. Genentech shall provide the Product
-----------
and Bulk Drug resulting from such Qualification Runs and Qualification
Batches to Immunex, [*], in accordance with the delivery terms set
forth in Section 4.4 hereof.
-----------
3.8 Manufacturing Documentation. In accordance with the terms of the Tech
---------------------------
Transfer Agreement, Immunex shall, by the relevant date that is set forth
in the Tech Transfer Agreement as such date may be modified by the JPT,
provide to Genentech the items listed within exhibits and schedules to the
Tech Transfer Agreement, and shall, thereafter, from time to time and in
accordance with the timeline set forth in the Tech Transfer Agreement,
provide to Genentech such additional Manufacturing Documentation as
Genentech shall reasonably require in order to implement the
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 17
Tech Transfer Agreement and the Manufacturing Process and otherwise perform
its obligations under this Agreement. In accordance with the terms of the
Tech Transfer Agreement, Genentech shall provide certain information to
Immunex, including, without limitation, the process trend and variability
data. Both Parties' obligations under this Section 3.8 shall be subject to
-----------
obligations to Third Parties as set forth in written agreements in effect
prior to the Effective Date of this Agreement. In the event an obligation
to a Third Party prohibits a Party from rendering such assistance, that
Party shall promptly seek from such Third Party permission to render such
assistance.
3.9 [*] At Immunex's request prior to [*], Genentech agrees to discuss in good
faith with Immunex and give serious consideration to [*]. The determination
as to whether Genentech could accept such a [*] would be made by Genentech,
in its sole discretion, after good faith discussion with Immunex, and after
a good-faith and serious evaluation of the following factors: [*]. If such
a [*] were acceptable to Genentech, in its sole discretion, Immunex would
be responsible for any additional costs to be agreed upon by the Parties,
including but not limited to [*] (as defined below) associated with [*],
and the Parties would agree upon new dates and deadlines set forth in this
Agreement to the extent impacted by such [*]. The Bulk Drug Commitment
outstanding at the time Immunex issues a request for [*] shall remain
binding upon the Parties; provided, however, that Immunex shall,
notwithstanding such request for [*], unless and until such [*] occurs,
purchase Bulk Drug in accordance with this Agreement up to the applicable
Annual Minimum set forth in Exhibit A hereto. [*]. For purposes of this
Agreement, the term [*]. For purposes of this Agreement, the term [*].
ARTICLE 4. RUNS; PRODUCTION AND SUPPLY;
---------------------------------------
DELIVERIES
----------
4.1 Minimum and Maximum Runs. Notwithstanding anything seemingly to the
------------------------
contrary in this Article 4, but subject to the other terms of this
---------
Agreement, in each calendar year during the Term, Genentech shall perform
at least the number of Runs identified as the "Annual Minimum" for such
--------------
calendar year on Exhibit A attached hereto and incorporated herein, and
---------
may in its sole discretion perform up to the number of Runs identified as
the "Annual Maximum" for such calendar year on said Exhibit A. Subject to
-------------- ---------
Section 3.9 and Section 4.5 hereof, Genentech shall have sole discretion
----------- -----------
to determine the actual number of Runs in any calendar year, within the
ranges set forth in Exhibit A hereto, and subject to the Product
---------
Manufacturing Forecast and applicable Bulk Drug Commitment. For purposes
of this Article 4, the term "Runs" refers to Commercial Runs, and does
----
not refer to Qualification Runs or Development Runs.
4.2 Production and Supply
---------------------
(a) Product Manufacturing Forecast. By not later than the Effective Date
------------------------------
of this Agreement and thereafter on the [*] business day of each
month, beginning [*], for
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 18
the remainder of the Term, the Parties shall issue a rolling "Product
-------
Manufacturing Forecast" which shall establish, on a monthly basis, for
----------------------
the remainder of the Term, the number of Runs to be performed and the
quantity of Bulk Drug reasonably expected to be manufactured, released
and supplied to Immunex, within the ranges set forth in Exhibit A
---------
hereto. The Product Manufacturing Forecast shall be used for joint
planning purposes and shall be nonbinding unless otherwise specified
herein, and may be amended by the Parties from time to time as the
Parties deem appropriate. Beginning [*] or such other date as agreed
upon by the Parties in writing, each Product Manufacturing Forecast
shall be binding for the first [*] months, and non-binding for the
remainder of the Term, as further described below. Beginning with the
initial binding Product Manufacturing Forecast, the forecasts for Bulk
Drug within the first [*] months of each such rolling Product
Manufacturing Forecast shall constitute a Bulk Drug Commitment and
shall be binding upon the Parties and cannot be changed except upon
mutual written consent of the Parties (or except upon mutual agreement
of the Parties under Section 3.9 or Section 4.5 hereof, which
----------- -----------
agreement shall not, without the consent of Genentech, affect any Runs
that are in process [*]), and the [*]-month period shall be that
period which commences on the first day of the month immediately
following the month in which the Product Manufacturing Forecast is
issued. By way of example only, when the rolling Product Manufacturing
Forecast for [*], is issued, the [*]-month period covered by such
forecast shall commence on [*], and shall end on [*]. The Bulk Drug
Commitment shall include approximate harvest dates for each Commercial
Run.
(b) Weekly Meetings. The Parties shall participate in a weekly meeting, in
---------------
person or via telephone, to review and discuss production, supply and
logistics operations for the next [*]-month period, including: (i)
dates or approximate dates on which Runs will occur; (ii) dates or
approximate dates for Genentech's and Immunex's release of Bulk Drug;
(iii) size or approximate size of Batches; (iv) dates or approximate
dates for delivery of Batches; (v) destination for shipment of
Batches; and (vi) status of Batches undergoing investigation, and
related matters, and to issue and, as appropriate, update the Product
Manufacturing Forecast.
4.3 Management of Product Manufacturing Forecast.
--------------------------------------------
(a) Delivery. Immunex and Genentech will work together in good faith to
--------
determine delivery dates and a shipping schedule for deliveries of
Bulk Drug under this Agreement, and shall establish a written
"Delivery Schedule" as a part of the Product Manufacturing Forecast
-----------------
and the related Bulk Drug Commitment.
(b) Delivery Dates. For each Run, the delivery date respectively set forth
--------------
in the Delivery Schedule will be the "Delivery Date" for such Run,
-------------
unless the Parties agree on an alternative delivery date; provided,
however, that for purposes of Section 8.1(a)(ii) hereof, the "Delivery
------------------
Date" for any particular Bulk Drug shall be the actual date on which
such Bulk Drug is delivered to Immunex's Designated
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 19
Carrier at Genentech's Facility in accordance with Section 4.4 hereof.
-----------
(c) Purchase Quantities. Except as otherwise set forth in this Agreement
-------------------
(including, without limitation, upon mutual agreement of the Parties
under Section 3.9 or Section 4.5 hereof, which agreement shall not,
----------- -----------
without the consent of Genentech, affect any Runs that are in process
[*]), Immunex shall purchase all Bulk Drug that complies with the
warranties set forth in Section 6.1(a), up to the applicable Annual
--------------
Maximum set forth in Exhibit A hereto.
---------
(d) Shortages; Shortfalls; Delivery Delays. If at any time during the
--------------------------------------
Term, Genentech is unable to fulfill the Bulk Drug Commitments on the
related Delivery Date(s), and which inability results from other than
a Force Majeure Event, then Genentech shall (1) immediately notify
Immunex in writing as to the reason for the shortfall, shortage and/or
delay, and provide an indication of the likely duration of the
shortfall, shortage and/or delay, and (2) unless and except to the
extent such inability to fulfill the Bulk Drug Commitment is caused by
an Immunex material breach, use Commercially Reasonable Efforts to
provide Immunex with additional Commercial Runs to meet outstanding
Bulk Drug Commitments under this Agreement, to the extent that
Genentech has excess capacity and/or can reasonably revise its
production schedule without material adverse impact to itself or its
obligations to Third Parties and/or Affiliates. In addition, Genentech
shall also promptly notify Immunex in writing when any such shortfall,
shortage and/or delay is over. Unless otherwise directed in writing by
Immunex, after Immunex's receipt of notice from Genentech that a
shortfall, shortage and/or delay as described above is over, Genentech
shall use Commercially Reasonable Efforts to make up shortfalls in
delivery as promptly as practicable, to the extent that Genentech has
excess capacity and/or can reasonably revise its production schedule
without material adverse impact to itself or its obligations to Third
Parties and/or Affiliates, and shall promptly supply Bulk Drug to
Immunex and/or their respective designee, as appropriate, to meet such
Bulk Drug Commitments. Notwithstanding the foregoing, any shortfalls,
shortages and/or delays resulting from a Force Majeure Event shall be
governed by Article 18 below.
----------
(e) Acceptance of Bulk Drug. Genentech shall deliver to Immunex samples of
------------------------
all Batches manufactured under this Agreement, as and when Batches are
manufactured, and otherwise in accordance with the Quality Agreement
and applicable standard operating procedures approved by both Parties,
to enable Immunex to perform release testing on the Bulk Drug as
required by Article 11 of this Agreement and the Quality Agreement.
----------
Genentech shall also provide the related Batch Record and other Batch
documentation described in the Quality Agreement for each Batch of
Bulk Drug as soon as practicable after each such Batch is
manufactured. Upon receipt of samples of a particular Batch of Bulk
Drug together with the related Batch Record and other Batch
documentation, Immunex shall perform release testing and review the
Batch Record and other
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 20
Batch documentation for each Batch, in good faith and as soon as
reasonably practicable, and, in the absence of an investigation for
said Batch pursuant to the Quality Agreement or Section 8.1 hereof,
-----------
such testing and review shall be completed within [*] days after
Immunex's receipt of samples of such Batch together with the related
Batch Record and other Batch documentation. Any investigation shall be
initiated and conducted in accordance with Immunex's applicable
standard operating procedure. Subject to Immunex's rights to make
claims under Article 8 hereof, a Batch shall be deemed to have been
---------
accepted by Immunex on the date (the "Acceptance Date") on which the
---------------
first of the following events occurs: (i) the receipt by Genentech of
written notice from Immunex that such Batch has been released by
Immunex pursuant to applicable release testing standard operating
protocols as described in the Quality Agreement, (ii) the failure of
Immunex to issue a notice of investigation or rejection within [*]
days after Immunex's receipt of samples of such Batch together with
the related Batch Record and other Batch documentation, and (iii) the
determination under Section 8.1(b) below that Genentech has no
--------------
liability for such non-conforming Batch. The Parties agree that,
subject to prior written approval by Immunex on a Batch by Batch
basis, Genentech may deliver Batches of Bulk Drug prior to the
Acceptance Date, provided, however, that the procedures set forth in
this Agreement for acceptance of such Batches under this Section 4.3
-----------
and payment for such Batches under Section 5.3 hereof shall
-----------
nevertheless apply to such Batches, and provided, further, that, for
the avoidance of doubt, Genentech shall have no liability to Immunex
for costs and expenses incurred by Immunex for filling and finishing
Bulk Drug that is delivered prior to the Acceptance Date in accordance
with this Section 4.3.
-----------
4.4 Delivery Terms. Genentech shall deliver Bulk Drug to Immunex's "Designated
-------------- ----------
Carrier" at Genentech's Facility, and Immunex shall arrange for shipment of
-------
Bulk Drug from Genentech's Facility to Immunex via Immunex's Designated
Carrier at the expense of Immunex. Immunex shall arrange for shipment and
take delivery of Bulk Drug within [*] days after the Acceptance Date
related thereto. Genentech shall provide storage for such Bulk Drug at no
charge during this period. Title to and risk of loss of Bulk Drug shall be
and remain with Genentech until the earlier of (i) the date on which such
Bulk Drug is delivered to Immunex's Designated Carrier at Genentech's
Facility and (ii) the expiration of such [*]-day period, at which time
title to and risk of loss for the Bulk Drug shall transfer to Immunex.
Genentech shall not be required to deliver Bulk Drug to Immunex's
Designated Carrier until Immunex's Designated Carrier informs Genentech
that it has obtained all appropriate approvals and consents of any
governmental authority necessary for the transportation or shipment of such
Bulk Drug. Genentech shall comply with all applicable laws and regulations
regarding the packaging of Bulk Drug for shipment. Product resulting from
Development Runs and Qualification Runs (see Sections 3.7(a) and (b)
-----------------------
hereof), and Non-Conforming Bulk Drug (see Section 8.1(d)) shall also be
--------------
subject to the delivery terms set forth in this Section 4.4. Immunex shall
-----------
procure, at Immunex's sole cost and expense, and provide to Genentech
sufficient quantities of freeze tanks for shipment of Bulk Drug from
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 21
Genentech's Facility to Immunex via Immunex's Designated Carrier. Title to
and risk of loss of such freeze tanks shall transfer to Genentech upon
initial delivery of such freeze tanks to Genentech; such freeze tanks shall
be deemed to be "Portable Equipment" and shall be subject to transfer to
------------------
Immunex pursuant to Sections 14.2 and 19.3 of this Agreement.
----------------------
4.5 [*] Any time following the completion of Milestone III, Immunex may request
that Genentech [*]. Upon such request, the JPT will meet to discuss
timelines, costs, activities and responsibilities necessary to [*], and
Immunex shall reimburse Genentech for such costs as agreed upon by the JPT.
[*] The supply, purchase and payment provisions of this Agreement would not
be affected by a decision to [*] hereunder unless otherwise agreed to in
writing by the Parties, and Immunex would continue to purchase the Bulk
Drug Commitment in accordance with the terms of this Agreement, at least up
to the applicable Annual Minimum set forth in Exhibit A hereto. The Parties
---------
would negotiate in good faith to amend the Agreement as appropriate to
address [*].
ARTICLE 5. PAYMENTS
-------------------
5.1 Reimbursement for Facility Modifications and Services Costs. Immunex shall
-----------------------------------------------------------
reimburse Genentech for Facility Modifications and Services Costs, in
accordance with the Tech Transfer Agreement, including, without limitation,
the acquisition of Portable Equipment (provided, however, that Immunex
shall not be required to reimburse Genentech for the costs of acquiring
Portable Equipment under the Tech Transfer Agreement or this Agreement if
Immunex paid for such Portable Equipment directly or if Immunex has already
reimbursed Genentech for such costs),and Genentech shall bear all of
Genentech's internal costs and expenses (including, without limitation,
Genentech's internal labor and material costs) for the modifications needed
to implement the Manufacturing Process at the Genentech Facility, except as
otherwise provided in Section 3.9 or Section 4.5 hereof. All Portable
----------- -----------
Equipment acquired by Genentech under this Agreement (including, without
limitation, the freeze tanks referred to in Section 4.4 above) or the Tech
-----------
Transfer Agreement shall be subject to Sections 14.2 and 19.3 of this
----------------------
Agreement.
5.2 Milestone Payments. For each Milestone that is completed by the deadline
------------------
respectively described below, Immunex shall pay the related milestone,
within [*] days of receipt of a correct invoice, which may be delivered
on or after the date earned:
(a) Completion of Milestone I: [*]: Immunex shall pay Genentech [*]
------------------------------
Dollars ($[*]) upon the completion of Milestone I.
(b) Completion of Milestone II: [*]: Immunex shall pay Genentech [*]
-------------------------------
Dollars ($[*]) upon the completion of Milestone II, provided that [*];
and, in addition, Genentech shall also be entitled to receive
additional payments of [*] Dollars
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 22
$([*]) [*], which such additional payment amounts shall be payable
upon [*].
(c) Completion of Milestone III: [*]: Immunex shall pay Genentech [*]
--------------------------------
Dollars ($[*]) upon the completion of Milestone III, provided that
this milestone has been completed by not later than [*].
(d) Completion of Milestone IV: [*]: If Milestone IV is completed by not
-------------------------------
later than [*], then Immunex shall pay Genentech [*] Dollars ($[*]).
(e) Adjustment of Milestone Dates. In accordance with Section 3.3(b)
----------------------------- --------------
hereof, the dates in Sections 5.2(b), (c) and (d) above may be
----------------------------
extended for delays occasioned by a Force Majeure Event (as defined in
Section 20.1 below), which, for purposes of this Section 5.2(e), may
------------ --------------
include, without limitation, [*], all to the extent beyond the control
and without the fault or negligence of the Party affected thereby, and
to the extent that such delays have a material adverse effect on the
critical path for completing the related milestone. Each Party agrees
to give the other Party prompt written notice of any such potential
Force Majeure Event, the nature thereof, and the extent to which
completion of the related milestone is likely to be delayed. Each
Party further agrees to use Commercially Reasonable Best Efforts to
cure the Force Majeure Event as quickly as practicable. The JPT shall
determine, in accordance with Section 3.3 hereof, whether the date(s)
-----------
in this Section 5.2(b), (c) or (d) that trigger the related milestone
--------------------------
payment shall be extended, and, if so, the appropriate length of time
for the extension, and to approve or adopt standards, requirements or
actions intended to correct the Force Majeure Event as quickly as
practicable, and each Party shall act in good faith and exercise
reasonable judgment in connection therewith.
5.3 Bulk Drug Pricing; Invoicing.
----------------------------
(a) Bulk Drug Pricing. Except as otherwise expressly set forth in this
-----------------
Agreement, including, without limitation, in Sections 3.7, 6.2, and
------------ ---
8.1 hereof, Immunex shall pay Genentech [*] Dollars ($[*]) per gram
---
for all Bulk Drug manufactured in compliance with this Agreement and
cGMP that conforms with the Bulk Drug Specifications and the
warranties provided in Section 6.1(a) hereof, and such amount shall be
--------------
the Purchase Price for such Bulk Drug. The Purchase Price may be
adjusted in accordance with Section 5.3(d) below. Notwithstanding
--------------
anything in this Section 5.3(a) seemingly to the contrary, the
--------------
Purchase Price for Bulk Drug [*].
(b) Invoicing Immunex for Bulk Drug. Invoices may be issued on or after
-------------------------------
the related Acceptance Date, and amounts due thereunder shall be due
and payable in U.S. currency within [*] days after receipt of invoice.
Such invoices shall reference the Acceptance Date, the quantity
delivered and the total Purchase Price. Payments shall be made by wire
transfer. Past due amounts shall bear interest at a floating rate
equal to [*] percent ([*]%) per annum above the rate of interest set
forth from
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 23
time to time in the Wall Street Journal and identified therein as the
prime rate of interest. Invoices may be issued prior to the completion
of [*].
(c) Changes in Cost of Raw Materials. In case the net average cost of raw
--------------------------------
materials or components used for a Batch in the Manufacturing Process
for producing Bulk Drug increases or decreases by more than [*]
percent ([*]%) with respect to production of Bulk Drug for a Calendar
Year, as compared to the net average cost of raw materials or
components used for a Batch in the Manufacturing Process for producing
Bulk Drug (including both Immunex's and Genentech's combined costs for
such raw materials or components) in Calendar Year [*], which change
must be reasonably substantiated, the Parties shall, acting reasonably
and in good faith, within [*] days agree upon the direct amount of
such increase or decrease, for each Batch that is manufactured after
the date of the Parties' agreement to the change, and the effective
date for such increase or decrease, based on good faith negotiations.
In the event of an increase, if Immunex can reasonably demonstrate to
Genentech that any equivalent materials or components used for
producing Bulk Drug can be purchased at a lower price than Genentech's
cost of such materials, and that such materials or components can be
supplied on a reasonably consistent and reliable basis, then Genentech
shall accept such lower price for purposes of this Section 5.3(c). The
--------------
Purchase Price shall not be adjusted as a result of any such increase
or decrease; instead, the direct amount of any such increase or
decrease as agreed upon shall be payable to the other Party by Immunex
or Genentech, as appropriate, pursuant to a separate invoice within
[*] days after receipt thereof.
(d) Adjustment to Purchase Price. The Purchase Price shall be adjusted
----------------------------
prior to the first Commercial Run to a price equal to:
[*]
5.4 Commercial Audit. For at least three (3) years after final payment under
----------------
this Agreement (or for such longer period of time as may be required by
applicable laws and regulations), Genentech shall maintain complete and
accurate books, records, documents, and other evidence of costs, expenses
and allowances pertaining to this Agreement and/or the Tech Transfer
Agreement and the Facility Modifications and Services Costs (for purposes
of this Section 5.4, hereinafter collectively called "Records") to the
----------- -------
extent and in such detail as will properly reflect all costs and expenses
incurred by Genentech in connection with this Agreement and/or the Tech
Transfer Agreement. Immunex, acting through its independent public
accountants of recognized national standing selected by Immunex and
reasonably acceptable to Genentech, shall have a right to examine and audit
Genentech's Records once annually, upon at least [*] days' prior written
notice, but only in the event that Immunex makes payments under either
Section 6.2(a)(5) hereof (Specification and Process Changes) or Section
----------------- -------
19.3(d)(1) hereof, or under the Letter of Intent or the Tech Transfer
----------
Agreement, and only to the extent that such Records are applicable to
determining the accuracy of such payments.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 24
ARTICLE 6. GENENTECH PRODUCT WARRANTIES; SPECIFICATIONS
-------------------------------------------------------
6.1 Warranties by Genentech.
-----------------------
(a) Product Warranties. Genentech hereby warrants to Immunex that the Bulk
------------------
Drug, at the time of Delivery to Immunex's Designated Carrier, shall:
(1) conform to the Bulk Drug Specifications; provided, however, that
solely with respect to Bulk Drug that is delivered prior to the
Acceptance Date, Genentech hereby warrants to Immunex, effective
as of the Acceptance Date for such Bulk Drug, that, as of the
time of Delivery to Immunex's Designated Carrier, such Bulk Drug
shall conform to the Bulk Drug Specifications;
(2) be manufactured in compliance with the requirements of cGMP;
(3) be manufactured in compliance with the requirements of all
applicable material national, state and local laws, ordinances
and governmental rules and regulations of the U.S. [*]; and
(4) be transferred free and clear of any liens or encumbrances of any
kind to the extent arising through or as a result of the acts or
omissions of Genentech, its Affiliates or their respective
agents.
(b) Genentech Facility. Genentech hereby warrants that it owns or lawfully
------------------
controls the Genentech Facility, and that, provided the Manufacturing
Process is successfully implemented in accordance with the Tech
Transfer Agreement, and provided no Force Majeure Event shall occur,
it has sufficient manufacturing capacity to enable Genentech to
manufacture Bulk Drug throughout the Term in quantities sufficient to
fulfill, in each calendar year, the minimum Runs for such year as set
forth in Exhibit A hereto, in accordance with this Agreement.
---------
Genentech hereby covenants that it will use Commercially Reasonable
Efforts to ensure that the Genentech Facility shall be maintained in
accordance with cGMP and in such condition as will allow Genentech to
manufacture the Bulk Drug in compliance with cGMP and in conformance
with the Bulk Drug Specifications.
(c) Disclaimer by Genentech. OTHER THAN AS SET FORTH IN THIS SECTION 6.1
----------------------- -----------
AND SECTION 15.2 HEREOF, ALL OTHER WARRANTIES, BOTH EXPRESS AND
----------------
IMPLIED, ARE HEREBY EXPRESSLY DISCLAIMED, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A
PARTICULAR PURPOSE.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 25
6.2 Specification and Manufacturing Process Changes. Except as otherwise
-----------------------------------------------
expressly set forth to the contrary in the Quality Agreement, the Parties
agree as follows:
(a) Specification and Process Changes. In the event that (i) Immunex is
---------------------------------
required to change the Bulk Drug Specifications or the Manufacturing
Process pursuant to applicable law, rule or regulation or in response
to the order or request of a governmental authority or in response to
the order or request of a governmental authority or regulatory body,
or (ii) Immunex requests the change pursuant to its strategy for
global synchronization and worldwide consistency of Product, or (iii)
Immunex wishes to change the Bulk Drug Specifications or the
Manufacturing Process after commencement of Commercial Production
hereunder, the following provisions will apply:
(1) Immunex shall promptly advise Genentech in writing of any such
change(s), and provide information reasonably necessary for
Genentech to evaluate the effect of such change(s), and Genentech
shall promptly advise Immunex as to scheduling and/or Purchase
Price adjustments, if any, which may result from such change(s).
The notification and approval procedure shall be in accordance
with standard operating procedures (i.e., change control
procedures) agreed upon by the Parties from time to time. The
Parties shall hold a JPT meeting in a timely manner with
appropriate advisors invited to discuss such changes as
appropriate.
(2) Prior to implementation of such change(s) to the Bulk Drug
Specifications or Manufacturing Process, the Parties agree to
negotiate in good faith in an attempt to reach agreement on (i)
the new Purchase Price for any Bulk Drug manufactured under this
Agreement by Genentech which embodies such change, giving due
consideration to the effect of such change on Genentech's direct
manufacturing costs for Bulk Drug, and (ii) any other amendments
to this Agreement which may be necessitated by such changes.
(3) Prior to implementation of such change(s), Genentech will provide
Immunex with an estimate of the reasonable and necessary expenses
that would be incurred by Genentech as a result of the
implementation of any such change(s) to the Bulk Drug
Specifications or Manufacturing Process, including, but not
limited to, its validation and analytical development costs,
capital expenditure costs, and [*], as defined in Section 3.9
-----------
above. If such change(s) are implemented, Immunex will reimburse
Genentech for the reasonable and necessary expenses as agreed
upon in advance and incurred by Genentech as a result of any such
change(s) to the Bulk Drug Specifications or Manufacturing
Process, including, but not limited to, reimbursing Genentech for
its validation and analytical development costs, capital
expenditure costs, and Internal Costs.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 26
(4) Genentech shall use Commercially Reasonable Best Efforts to
accommodate changes described in Section 6.2(a)(i) hereof as soon
-----------------
as practicable after notice thereof, but in any event within [*]
days' lead time, unless otherwise agreed upon by the Parties or
required by an applicable regulatory authority. Immunex shall not
unreasonably require Genentech to implement changes to the
Manufacturing Process or Bulk Drug Specifications within such
[*]-day period if such changes would typically require Genentech
a longer period of time to implement, or that would have a
material adverse effect on Genentech's then current operations.
Genentech shall use Commercially Reasonable Efforts to
accommodate changes described in Section 6.2(a)(ii) and (iii)
----------------------------
hereof in light of, among other considerations, Genentech's
facilities and resource constraints, current operations and
commercial goals; and notwithstanding the foregoing, Genentech
shall not be required to implement any changes to the
Manufacturing Process or Bulk Drug Specifications if such changes
would have a material adverse effect on Genentech's then current
operations. Genentech shall cooperate with Immunex in good faith
to implement all agreed upon changes to the Bulk Drug
Specifications or Manufacturing Process in accordance with the
agreed upon schedule. During the pendency of Genentech
implementing any such changes to the Manufacturing Process or
Bulk Drug Specifications, Genentech shall produce and Immunex
shall purchase Bulk Drug in accordance with the terms of the
Agreement.
(5) If any such changes to the Bulk Drug Specifications or
Manufacturing Process renders obsolete or unusable any raw
materials (including, without limitation, Specialized Raw
Materials), components or supplies used to manufacture the Bulk
Drug, and to the extent such materials may not be either returned
to the appropriate vendor for a credit or utilized by Genentech
for its other manufacturing operations, Immunex shall purchase
from Genentech, at Genentech's Acquisition Cost, that amount of
inventory of such raw materials, components or supplies, as the
case may be, so rendered obsolete or unusable, not to exceed the
amount of such raw materials, components or supplies which would
have been required for Genentech to manufacture and supply the
total quantity of Bulk Drug specified in Bulk Drug Commitments
outstanding under this Agreement.
(6) The notification and formal approval procedure for those changes
to the Bulk Drug Specifications or Manufacturing Process approved
by the Parties under this Section shall be in accordance with the
Quality Agreement and standard operating procedures (i.e., change
----
control procedures) agreed upon in writing by Immunex and
Genentech from time to time.
(b) Procedure for Specification or Manufacturing Process Changes by
---------------------------------------------------------------
Genentech. Genentech shall not change the Bulk Drug Specifications or
---------
the Manufacturing Process except as set forth in Section 6.2(a)
--------------
hereof, or in the Quality Agreement
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 27
and standard operating procedures to be agreed upon by Immunex and
Genentech from time to time.
(c) Vendor or Supplier Changes. Genentech shall not change any vendor or
--------------------------
supplier of raw materials or analytical reagents used in the
manufacture or testing of Bulk Drug except as set forth in the Quality
Agreement and standard operating procedures to be agreed upon by
Immunex and Genentech from time to time or with the prior written
consent of Immunex.
(d) Ongoing Process Improvement Obligations. Immunex agrees to provide
---------------------------------------
assistance to Genentech [*] in "trouble-shooting" and optimizing the
Manufacturing Process, at such times and to such extent as Genentech
may reasonably request, given Immunex's unique expertise and
understanding of the Product and the Manufacturing Process.
6.3 JPT as Commercial Operations Team. Following [*], "Commercial Production"
--------------------------------- ---------------------
of Bulk Drug will commence under this Agreement, with the first Commercial
Run performed after the completion of [*]. After commencement of Commercial
Production under this Agreement, the membership in the JPT may change to
reflect the changing nature of the project. During Commercial Production,
the JPT shall meet (i) in person or by telephone in accordance with Section
-------
4.2(b) hereof to review the Bulk Drug Commitment and Product Manufacturing
------
Forecast, and (ii) at least twice a year to review the overall results of
the manufacturing operations, and (iii) at such additional times as
appropriate and as may be requested by either Party. Issues relating to
quality of Product shall be resolved in accordance with the Quality
Agreement.
ARTICLE 7. PACKAGING
--------------------
7.1 In General. Genentech shall package and label the Bulk Drug according to
the Bulk Drug Specifications and according to packaging procedures
mutually agreed upon by Immunex and Genentech in writing.
ARTICLE 8. CLAIMS
-----------------
8.1 Claims.
------
(a) Notice of Claims. In the event that any Bulk Drug is Non-Conforming
----------------
Bulk Drug, Immunex may reject the same by giving written notice
thereof to Genentech (1) within the later of (i) [*] after the
applicable Acceptance Date for such Bulk Drug, and (ii) [*] days after
the applicable Delivery Date for such Bulk Drug, based on an
inspection of such Bulk Drug and related freeze tanks and packing and
shipping materials and components, for matters that were not readily
ascertainable by the release testing of the related samples and review
of the related Batch Record and other Batch documentation described in
Section 4.3(e) hereof, or, (2) in the case of a latent defect, within
--------------
[*] days after discovery of such latent defect,
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 28
but in no event later than [*] after delivery to Immunex's Designated
Carrier at the Genentech Facility), which notice shall specify the
manner in which such Bulk Drug fails to conform to any warranty and
shall be accompanied by any test results or reports evidencing such
non-conformity. Alternatively, rather than initially issuing a notice
of rejection, Immunex may give written notice to Genentech within the
applicable time period set forth in this Section 8.1(a) of an Immunex
--------------
decision to investigate whether a potentially Non-Conforming shipment
should be rejected, which investigation shall, unless otherwise agreed
by Immunex and Genentech, be completed within the applicable time
period set forth in this Section 8.1(a), and in accordance with the
--------------
procedures set forth in the Quality Agreement.
(b) No Genentech Liability. If it is determined by agreement of the
----------------------
Parties (or in the absence of such agreement, by a mutually acceptable
qualified independent Third Party whose fees shall be paid by the
non-prevailing Party) that either (1) there is no nonconformity, in
which case Immunex shall pay to Genentech the Purchase Price for such
Bulk Drug, or (2) there is nonconformity but the nonconformity was not
caused by Genentech's failure to perform its obligations under the
Agreement, in which case Genentech shall have no liability to Immunex
with respect thereto, and Immunex shall pay to Genentech the Purchase
Price for such Bulk Drug and the Bulk Drug shall be treated in all
other respects under this Agreement as though it conformed with all of
the warranties set forth in Section 6.1(a) of this Agreement.
--------------
(c) Genentech Liability; Replacement of Product. If it is determined by
-------------------------------------------
agreement of the Parties (or in the absence of such agreement, by a
mutually acceptable qualified independent Third Party whose fees shall
be paid by the non-prevailing Party) that the nonconformity was caused
by Genentech, Genentech shall as soon as practicable use Commercially
Reasonable Efforts to replace such Non-Conforming Bulk Drug with
conforming Bulk Drug, to the extent that Genentech has excess capacity
and/or can reasonably revise its production schedule without adverse
impact to itself or its obligations to Third Parties and/or
Affiliates, at no additional cost to Immunex except for payment of the
Purchase Price for the replacement conforming Bulk Drug, which shall
be payable as follows: if Immunex previously paid the Purchase Price
for the Non-Conforming Bulk Drug, then Genentech shall promptly and in
any event within [*] days credit such amount to Immunex on the next
invoice (or, at Immunex's option, Immunex may set off such amount
against amounts owed to Genentech under this Agreement), and Immunex
shall pay the Purchase Price for the replacement conforming Bulk Drug;
and, if Immunex did not previously pay the Purchase Price for the
Non-Conforming Bulk Drug, then Immunex shall pay the Purchase Price
for the replacement conforming Bulk Drug. In addition, if, despite its
use of Commercially Reasonable Efforts, to the extent that Genentech
has excess capacity and/or can reasonably revise its production
schedule without adverse impact to itself or its obligations to Third
Parties and/or Affiliates, Genentech
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 29
cannot replace Non-Conforming Bulk Drug with conforming Bulk Drug by a
date that is acceptable to Immunex, then Genentech shall upon demand
by Immunex reimburse Immunex for any amount of the applicable Purchase
Price that Immunex paid to Genentech for such Non-Conforming Bulk
Drug. Notwithstanding anything herein seemingly to the contrary, with
respect to latent defects only, if it is determined by agreement of
the Parties (or in the absence of such agreement, by a mutually
acceptable qualified independent Third Party, whose fees shall be paid
by the non-prevailing Party) that the nonconformity was caused by both
Genentech and Immunex, Genentech's obligation to reimburse Immunex for
any amount of the applicable Purchase Price that Immunex paid to
Genentech for such Non-Conforming Bulk Drug shall be measured in terms
of proportionate liability and shall be diminished in proportion to
the amount of causation attributable to Immunex.
(d) Cooperation in Investigations; Disposition of Non-Conforming Bulk
-----------------------------------------------------------------
Drug. If Immunex desires to make a claim against Genentech with
-----
respect to and reject a Batch of Non-Conforming Bulk Drug pursuant to
Section 8.1(c), Immunex agrees that it shall not dispose of or allow
--------------
such Bulk Drug to be disposed of without written authorization and
instructions from Genentech either to dispose of or return to
Genentech such Non-Conforming Bulk Drug. Upon written request by
Immunex, Genentech agrees promptly to give Immunex such authorization
and instructions within a reasonable period of time. Each Party shall
act in good faith and shall cooperate with the other Party and with
any mutually acceptable qualified independent Third Party in
connection with an investigation as to the existence of or source of
any nonconformity of Bulk Drug supplied under this Agreement. At the
request of Immunex, Genentech will provide all Non-Conforming Bulk
Drug to Immunex, at no cost to Immunex (except for shipping and
delivery expenses payable under Section 4.4 hereof), in accordance
-----------
with the delivery terms set forth in Section 4.4 hereof, and Immunex
-----------
may make whatever further use of such Product as it shall determine;
provided, however, that Immunex agrees that (i) such Product shall not
be used in humans, (ii) the warranties provided in Section 6.1(a) of
--------------
this Agreement shall not apply to such Product, and (iii) the
disclaimer of warranties set forth in Section 6.1(c) of this Agreement
--------------
shall apply to such Product.
ARTICLE 9. MANUFACTURING AUDITS; CERTIFICATE OF
-----------------------------------------------
COMPLIANCE; REGULATORY MATTERS
------------------------------
9.1 Manufacturing Audits. Immunex shall have the right to perform, directly or
--------------------
through its representatives, one annual standard cGMP compliance audit, and
additional For Cause Audits, all in accordance with the audit provisions
set forth in the Quality Agreement. During the standard audits, personnel
of Immunex or its representatives shall have access only to those areas
that are directly related to the performance of Genentech's obligations
under this Agreement, including the manufacture, testing, storage and
shipping of Bulk Drug. No more than a reasonable number of representatives
shall be permitted on Genentech's premises for any such audit and, at
Genentech's option, each representative shall be accompanied by a Genentech
employee at all times while on Genentech's premises.
Page 30
9.2 Certificates; Manufacturing Issues; Records.
-------------------------------------------
(a) Certificates; Manufacturing Issues. As soon as possible after
----------------------------------
manufacture and, unless otherwise agreed by Immunex, in any event by
not later than the date of each shipment of Bulk Drug, Genentech shall
furnish to Immunex the Batch Records and Manufacturer's Release
Documentation described in the Quality Agreement, including, without
limitation, a Certificate of Testing, a Certificate of Compliance and
a summary (in a format to be agreed upon by Immunex and Genentech) of
any deviations or investigations that occurred during the
manufacturing or testing of the Bulk Drug that is part of such
shipment. The provisions set forth in the Quality Agreement regarding
deviations shall control whether a deviation results in Non-Conforming
Bulk Drug.
(b) Records. Genentech shall maintain all of its manufacturing and
-------
analytical records, all records of shipments of Bulk Drug and all
validation data relating to Bulk Drug for the time periods required by
applicable laws and regulations of the FDA. Genentech agrees that, in
response to any complaint, or in the defense by Immunex of any
litigation, hearing, regulatory proceeding or investigation relating
to Bulk Drug, Genentech shall use reasonable efforts to make available
to Immunex during normal business hours and upon reasonable prior
written notice, such Genentech employees and records reasonably
necessary to permit the effective response to, defense of, or
investigation of such matters, subject to appropriate confidentiality
protections. Immunex shall reimburse Genentech for all reasonable
costs and expenses incurred by Genentech in connection with the
performance of Genentech's obligations under the immediately preceding
sentence.
9.3 Complaints. Immunex shall have responsibility for reporting any
----------
complaints relating to the Product to the FDA and any other regulatory
authorities, including, but not limited to, complaints relating to the
manufacture of the Product and adverse drug experience reports. Immunex
shall maintain complaint files in accordance with cGMP. Genentech shall
provide Immunex with a copy of any complaints received by Genentech with
respect to the Product in accordance with the Quality Agreement and
standard operating procedures to be agreed upon by Immunex and Genentech
from time to time. Immunex shall have responsibility for responding to all
complaints, and for promptly providing Genentech with a copy of any
responses to complaints relating to the manufacture of the Product.
Genentech shall use Commercially Reasonable Efforts to respond to requests
from Immunex for information in Genentech's possession that is necessary
for Immunex to respond to complaints arising out of the manufacture of the
Bulk Drug.
9.4 Regulatory Correspondence.
-------------------------
(a) Notification to Other Parties of Regulatory Correspondence. Each
----------------------------------------------------------
Party shall immediately and within at least [*] business days
notify the other Party in writing
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 31
of, and shall provide the other Party with copies of, any
correspondence and other documentation received or prepared by such
Party in connection with any of the following events: (1) receipt of a
regulatory letter, Warning Letter, or similar item, from the FDA or
any other regulatory authority directed to the manufacture, packaging,
and storage of Bulk Drug, or in connection with any general cGMP
inspections applicable to any Genentech Facility to the extent
associated with Genentech's activities under this Agreement; (2) any
recall, market withdrawal or correction of any Batch of Bulk Drug or
resulting Finished Product; and (3) any regulatory comments related to
the manufacture of Bulk Drug or resulting Finished Product requiring a
response or action by a Party.
(b) Regulatory Correspondence Requiring a Genentech Response. In the event
--------------------------------------------------------
Genentech receives any regulatory letter or comments from any federal,
state or local regulatory authority directed to its manufacture of
Bulk Drug requiring a response or action by Genentech, including, but
not limited to, receipt of a Form 483 (Inspectional Observations) or a
Warning Letter, Immunex promptly will provide Genentech with any data
or information required by Genentech in preparing any response related
to Genentech's manufacture of Bulk Drug and will cooperate fully with
Genentech in preparing such response. Genentech shall provide Immunex
with a copy of each such response (redacted to remove information not
related to the manufacture of Bulk Drug or Genentech's other
obligations under this Agreement) for Immunex's review and comment
prior to Genentech's submission of its detailed written response.
Genentech shall give all due consideration to any Immunex comments to
each such proposed Genentech response provided Immunex timely
responds. Likewise, in the event Immunex receives any regulatory
letter or comments from any federal, state or local regulatory
authority directed to the manufacture of Bulk Drug at the Genentech
Facility requiring a response or action by Immunex, including, but not
limited to, receipt of a Form 483 (Inspectional Observations) or a
Warning Letter, Genentech will, to the extent within its control or
possession, promptly provide Immunex with relevant data or information
sufficient for Immunex to prepare any response related to the
manufacture of Bulk Drug and will cooperate fully with Immunex in
preparing such response. Immunex shall provide Genentech with a copy
of each such response (redacted to remove information not related to
the manufacture of Bulk Drug at Genentech's Facility or Immunex's
obligations under this Agreement) for Genentech's review and comment
prior to Immunex's submission of its detailed written response.
Immunex shall give all due consideration to any Genentech comments to
each such proposed Immunex response provided Genentech timely
responds.
9.5 Inspections; Non-Compliance; Failure to Manufacture.
---------------------------------------------------
(a) Inspections. In the event the Genentech Facility is inspected, or
-----------
Genentech is notified that the Genentech Facility will be inspected, by
representatives of any federal, state or local regulatory agency
directed to Genentech's manufacture of Bulk Drug, Genentech shall
notify Immunex promptly after receipt of notice of such inspection, and
shall supply Immunex with copies of any correspondence or portions of
correspondence which relate to Bulk Drug. Immunex may send, and
Page 32
upon the request of Genentech shall send, representatives to the
Genentech Facility to participate in any portion of such inspection
directed to Bulk Drug.
(b) Non-Compliance; Failure to Manufacture. In the event that the FDA shall
--------------------------------------
determine, as a result of an inspection described in Section 9.5(a)
--------------
above, that Genentech is not in compliance with applicable laws or
regulations or otherwise not in compliance with cGMP with respect to
the manufacture of Bulk Drug, Genentech shall at its expense use
Commercially Reasonable Best Efforts to cure any such non-compliance
with cGMP, and use Commercially Reasonable Efforts to cure any other
such non-compliance as soon as practicable. In the event that any
regulatory agency other than the FDA shall determine that Genentech is
not in material compliance with applicable laws and regulations
relating to the manufacture of Bulk Drug, the Parties shall discuss any
potential Genentech curative efforts in good faith. In the event
Genentech receives a Warning Letter from the FDA and as a result
Genentech is unable to manufacture Bulk Drug for a particular period,
then, except in the event of Genentech's gross negligence or willful
misconduct, the provisions of Sections 20.3, 20.4 and 20.5 hereof shall
----------------------------
apply, it being understood that Genentech's inability to manufacture
Bulk Drug for the reasons set forth in this Section 9.5 shall be deemed
-----------
to be a Force Majeure Event unless Genentech's inability to manufacture
was caused by Genentech's gross negligence or willful misconduct.
ARTICLE 10. RECALLS
-------------------
10.1 Recalls. Immunex shall notify Genentech promptly (and in any event within
-------
[*] business days of receipt of written notice) if any batch of Bulk Drug
or resulting Finished Product is the subject of a recall, market withdrawal
or correction. Immunex shall (i) bear the cost of and be responsible for
conducting all recalls, market withdrawals or corrections of Bulk Drug or
Finished Product, (ii) remain obligated to pay Genentech the Purchase Price
for the Bulk Drug recalled or used to make such recalled Finished Product
and (iii) reimburse Genentech for its out-of-pocket expenses related to the
recall, if any. Notwithstanding the foregoing, [*] recall, market
withdrawal or correction was caused by Genentech's breach of any of its
warranties set forth in Section 6.1 hereof, [*] Genentech shall credit
-----------
Immunex for all or a portion of the Purchase Price for the Bulk Drug
recalled or used to make such recalled Finished Product and shall reimburse
Immunex for [*] Immunex's out-of-pocket expenses related to the recall, if
any, [*]. Immunex or its agent shall in all events be responsible for
conducting any recalls, market withdrawals or corrections with respect to
the Product in the Territory.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 33
ARTICLE 11. QUALITY ASSURANCE; QUALITY CONTROL; VALIDATION; STABILITY
---------------------------------------------------------------------
11.1 Responsibility for Quality Assurance and Quality Control. Responsibility
--------------------------------------------------------
for quality assurance and quality control of Bulk Drug shall be allocated
between Immunex and Genentech as set forth in the Quality Agreement and in
standard operating procedures agreed upon in writing by Immunex and
Genentech from time to time. In general, (a) Genentech shall be responsible
for performing certain in-process testing and selected acceptance testing
on the Bulk Drug as set forth in the Tech Transfer Agreement and the
Quality Agreement, and (b) Immunex shall be responsible for all final
acceptance testing and authorizing final release of all Bulk Drug. In the
event the Parties disagree on whether a Batch shall be released, the
dispute shall be resolved in compliance with the provisions set forth in
Section 8.1 hereof.
------------------
11.2 Validation of Genentech Facility; Utilities and Equipment. Genentech shall
---------------------------------------------------------
maintain cGMP validation status of the Genentech Facility, as well as the
utilities and equipment used in the manufacture of Bulk Drug at the
Genentech Facility, and shall make relevant validation reports applicable
thereto (redacted to remove information not related to the manufacture of
Bulk Drug) available to Immunex for review at Genentech's Facility, at
Immunex's reasonable request.
11.3 Validation of Bulk Manufacturing Process. In accordance with the
----------------------------------------
requirements of and timelines set forth in the Tech Transfer Agreement,
Immunex shall provide Genentech with Manufacturing Documentation related to
the validation of the Manufacturing Process, as further described therein,
including, without limitation, drafts of the product comparability protocol
and the process validation protocol related to the Manufacturing Process.
Immunex is responsible for Process Validation. A Process Qualification plan
to be developed by Genentech and approved by Immunex will identify
additional process validation related to the technology transfer to
Genentech, if required, at commercial scale. Genentech shall provide
Immunex with copies of documentation related to the validation of the
Manufacturing Process, as implemented by Genentech, and validation reports
applicable thereto, to Immunex, at Immunex's reasonable request, on a
frequency and in a format to be agreed upon by Genentech and Immunex.
11.4 Change Control. Any changes to the Genentech Facility, utilities, equipment
--------------
or processes used by Genentech in its performance under this Agreement,
including those relating to the manufacturing, storage, testing, shipping
and cleaning procedures that are used by Genentech in the manufacture of
Bulk Drug under this Agreement, shall occur pursuant to change control
procedures agreed upon by Genentech and Immunex and as set forth in the
Quality Agreement.
11.5 Stability. Immunex shall conduct all necessary stability testing to comply
---------
with cGMP and other applicable regulatory guidelines. Such stability
testing shall include testing to validate the lead times for shipment, the
shelf life of Bulk Drug and the Bulk Drug Specifications applicable to
shipment, storage and handling of Bulk Drug. Genentech shall prepare all
stability samples, and shall sublot stability samples and package and ship
stability samples to Immunex, all in accordance with timelines, protocols
and procedures agreed upon by Genentech and Immunex and set forth in the
Quality Agreement.
Page 34
11.6 Person in the Plant. As further described in the Quality Agreement, Immunex
-------------------
shall have the right to designate one employee of Immunex to be present in
the Genentech Facility in South San Francisco during normal business hours
during the Term of this Agreement to observe the Runs and observe
Genentech's performance of its obligations under this Agreement. Such
person shall have sufficient technical expertise and delegated corporate
authority to, at a minimum, approve change control authorizations and
deviations. While at the Facility, such representative of Immunex shall be
restricted to such areas as are directly relevant to the manufacture of the
Bulk Product, or as otherwise authorized by Genentech, and shall comply
with all applicable Genentech policies and procedures and may, at
Genentech's option, be escorted by Genentech personnel. Such representative
shall have no right to direct or supervise Genentech personnel.
ARTICLE 12. GENENTECH'S OBLIGATIONS AS MANUFACTURER
---------------------------------------------------
12.1 Control of Working Cell Bank. Genentech shall maintain all portions of the
----------------------------
Working Cell Bank that it receives in safe and secure storage under its
control in the Genentech Facility at One DNA Way in South San Francisco,
California, and shall not permit the transfer of the Working Cell Bank to
any Genentech Affiliate or any Third Party that is not specifically
authorized in advance and in writing by Immunex. Genentech shall comply
with all applicable FDA regulatory requirements relating to general safety
in handling the Working Cell Bank and any raw materials and components used
in manufacturing Product and Bulk Drug.
12.2 Manufacturing Capabilities. Genentech shall at all relevant times
--------------------------
throughout the Term use Commercially Reasonable Efforts consistent with the
terms of this Agreement to (a) own or lawfully control all the necessary
plant, equipment and facilities, and (b) have sufficient numbers of
appropriately qualified personnel, in each case to enable Genentech to
manufacture Bulk Drug in accordance with the Bulk Drug Specifications and
in quantities sufficient to fulfill its obligations to supply Bulk Drug
under this Agreement.
12.3 Compliance with Law. Genentech shall perform all work and services under
-------------------
this Agreement in conformance with cGMP and in conformance with the
substantive requirements of all applicable material national, state and
local laws, ordinances and governmental rules or regulations of the United
States, the noncompliance with which would materially adversely affect the
marketability of the Bulk Drug, and shall have all applicable licenses and
permits required to perform the work and services hereunder, the absence of
which would materially adversely affect the marketability of the Bulk Drug.
12.4 Genentech Facility. Genentech will use Commercially Reasonable Efforts to
------------------
ensure that the Genentech Facility shall be maintained in accordance with
cGMP and in such condition as will allow Genentech to manufacture the Bulk
Drug in accordance with the Bulk Drug Specifications.
12.5 Storage Facilities. Subject to Section 4.4, Genentech shall provide
------------------ -----------
sufficient and suitable storage facilities that meet the Bulk Drug
Specifications for Bulk Drug and raw
Page 35
materials.
12.6 Regulatory Documentation.
------------------------
(a) Genentech shall provide Immunex in a timely manner with a copy of any
Genentech manufacturing and control records for Bulk Drug which are
required for any Immunex regulatory filings with respect to the
Product, which records shall be in Genentech's standard formats unless
otherwise agreed upon by the Parties.
(b) Genentech shall provide Immunex promptly after the end of each annual
reporting period for the Product (as calculated consistent with
appropriate regulations and guidelines) with such information as is
reasonably requested in writing by Immunex for the preparation of the
annual report with respect to the manufacturing and control of the
Product for such annual reporting period. Thereafter, Immunex shall
provide to Genentech at least [*] days prior to Immunex's filing with
the respective regulatory authorities a copy of such Immunex annual
report, and Immunex shall take into consideration any Genentech
comments to such annual report with respect to the manufacture of
Product.
12.7 Manufacturing Data. Genentech shall collect data on the yield from each
------------------
Batch, as well as the date of manufacture of each such Batch and make
reports of the same available to Immunex in the form of a monthly
manufacturing status report in Genentech's standard format or in such other
format as may be agreed by the Parties. Genentech shall retain such
manufacturing data in accordance with the requirements of applicable laws,
rules and regulations.
12.8 Retention and Reserve Samples. Genentech shall isolate, identify and,
-----------------------------
subject to Section 19.3 hereof, retain retention and reserve samples of all
------------
raw materials and in-process production steps used in the production of
Bulk Drug as may be required by standard operating procedures to be agreed
upon in writing by Genentech and Immunex from time to time.
12.9 Analytical Testing. Except as otherwise contemplated by this Agreement or
------------------
expressly set forth in the Quality Agreement, Genentech shall not perform
any analytical testing on Bulk Drug unless agreed to by Genentech and
Immunex.
12.10 Accurate Documentation. Each Party shall use diligent efforts to ensure
----------------------
all records and documentation provided to the other Party in connection
with the manufacture of Bulk Drug shall be accurate in all material
respects.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 36
ARTICLE 13. LICENSE GRANTS
--------------------------
13.1 License to Genentech. During the Term (subject to early termination in
--------------------
accordance with Article 19 hereof), Immunex hereby grants to Genentech a
----------
royalty-free, non-exclusive license under any and all intellectual property
rights owned or controlled by Immunex (including, without limitation, such
rights as are licensed to Immunex by a Third Party and which may be
sublicensed to Genentech in accordance with the terms set forth herein) and
which are necessary for Genentech to perform its obligations under this
Agreement, including, without limitation, all rights necessary to the use
of the Cell Line, the Manufacturing Process, and/or the Immunex
Confidential Information (such rights are collectively the "Immunex IP
----------
Rights") for the sole and limited purpose of Genentech's performance of its
------
obligations under this Agreement, including, without limitation, to
manufacture and supply Bulk Drug to Immunex.
13.2 [*].
(a) [*] Expressly conditioned on Immunex' representation and warranty
under Section 15.1(e) hereof, Genentech, for itself and its
--------------
subsidiaries, hereby [*]. The terms of this Section 13.2(a) shall [*],
--------------
and shall survive expiration or termination of this Agreement, and
shall be binding upon and inure to the benefit of the successors and
assigns of the Parties. In the event that Genentech [*]; provided,
however, that Genentech's good faith and inadvertent failure to do so
shall not be considered a material breach of this Agreement.
(b) [*].
(1) License to [*]. Except for Genentech Improvements assigned to
--------------
Immunex pursuant to Section 14.1(c) hereof, Genentech hereby grants
---------------
Immunex [*] to make, have made, use, market, distribute, import, offer
for sale and sell Product within the Territory within the Field. The
license granted under this Section 13.2(b)(1) is also subject to the
------------------
last sentence of [*].
(2) [*]
(A) [*].
(B) [*]
(3) [*]
(c) [*] Subject to the exceptions below in this Section 13.2(c)(1), the [*]
------------------
provisions of this Section 13.2(c) shall apply to the Confidential
---------------
Information of a Party ("Disclosing Party") disclosed to or received by the
other Party ("Recipient") in the course of performance of this Agreement,
the Tech Transfer Agreement or the Quality Agreement, or in the course of
negotiating said agreements, or effecting
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 37
the technology transfer of the Product manufacturing process in effect
as of the Effective Date or the Manufacturing Process, or information
relating to the Product or to the manufacture thereof disclosed to a
Party by the other Party or received by a Party from the other Party
pursuant to the Confidentiality Agreements between the Parties dated
August 16, 2000, December 13, 2001 and March 29, 2002 (collectively,
the "CDAs"). The obligations of this Section 13.2(c) shall cease to
--------------
apply to Confidential Information of a Party, as well as to knowledge
and information obtained by Recipient from access to said Confidential
Information, upon said Confidential Information becoming subject to
the exclusions listed in Section 17.3 hereof. Neither Party shall
------------
disclose its ) confidential information to other Party that is not
reasonably necessary or appropriate for the performance of its
obligations under this Agreement, the Tech Transfer Agreement or the
Quality Agreement, and this Section 13.2(c) shall not apply to the
--------------
Disclosing Party's Confidential Information that is not reasonably
necessary or appropriate to be disclosed by the Disclosing Party for
purposes of the Recipient's performance of its obligations under this
Agreement, the Tech Transfer Agreement or the Quality Agreement,
including, without limitation, any information on manufacturing
processes for other products. Notwithstanding the foregoing, the
Disclosing Party's Confidential Information of which the Recipient
becomes aware due to the presence of its employees, agents or
contractors at the Disclosing Party's facilities, either through
inadvertent good faith disclosures or through misappropriation, shall
be subject to the provisions of this Section 13.2(c). Each Party shall
--------------
use good faith efforts to provide the Disclosing Party's Confidential
Information to the Recipient through the Disclosing Party's employees
having responsibility for the performance of the Disclosing Party's
obligations under this Agreement, the Tech Transfer Agreement or the
Quality Agreement, but inadvertent failures to do so shall not limit
the applicability of this Section 13.2(c).
--------------
(1) [*]
(2) [*]
(d) Survival. The obligations of the Parties set forth in this Section
-------- -------
13.2 shall survive the expiration or termination of this Agreement.
----
ARTICLE 14. OWNERSHIP OF INTELLECTUAL PROPERTY, MATERIALS AND EQUIPMENT
-----------------------------------------------------------------------
14.1 Ownership of Intellectual Property, Confidential Information,
-------------------------------------------------------------
Biological Materials and Manufacturing Documentation.
----------------------------------------------------
(a) Intellectual Property. In accordance with the rules of inventorship of
---------------------
the United States of America, each Party shall solely own any and all
inventions or discoveries that are conceived or reduced to practice in
the course of or resulting
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 38
from this Agreement, the Tech Transfer Agreement and/or the Quality
Agreement by the Party or its employees or agents, and the Parties
shall jointly own inventions or discoveries that are conceived or
reduced to practice in the course of or resulting from this Agreement,
the Tech Transfer Agreement and/or the Quality Agreement with an
inventive contribution by employees or agents of both Parties.
Licenses to the foregoing are described in Article 13 above. The
----------
Parties hereby agree that neither Party shall be considered an
"employee or agent" of the other Party.
(b) Confidential Information. As between the Parties, Immunex shall own
------------------------
all Immunex Confidential Information, and Genentech shall own all
Genentech Confidential Information; provided, however, that the
foregoing shall not limit Immunex' ownership of, or ability to use,
the Cell Line, Master Cell Bank, Working Cell Bank, and/or the
Product, including, without limitation, aspects of Genentech
Confidential Information that result in or contribute to modifications
to said Cell Line, Master Cell Bank, Working Cell Bank, and/or the
Product in the course of or resulting from this Agreement, the Tech
Transfer Agreement and/or the Quality Agreement, either by Immunex in
an authorized manner under said agreements or by Genentech.
(c) Biological Materials. As between the Parties, Immunex shall own all
--------------------
rights in and title to the biological materials described as the Cell
Line, Master Cell Bank, Working Cell Bank, and/or the Product, and any
and all improved or enhanced versions of the foregoing that are
created by either Party in the course of or resulting from this
Agreement, the Tech Transfer Agreement and/or the Quality Agreement,
including, without limitation, any derivatives or variants of the
foregoing created by either Party in the course of or resulting from
this Agreement, the Tech Transfer Agreement and/or the Quality
Agreement. Genentech hereby assigns to Immunex any Genentech
Improvements that relate solely to the Cell Line, Master Cell Bank,
Working Cell Bank, and/or the Product. For purposes of this provision,
"Genentech Improvements" shall mean any and all patentable inventions
made in the course of or resulting from this Agreement, the Tech
Transfer Agreement and/or the Quality Agreement, solely by Genentech
or its employees or agents, or jointly by the employees and/or agents
of each Party, and all intellectual property rights therein. [*].
(d) Manufacturing Documentation. As between the Parties, Immunex shall own
---------------------------
the Manufacturing Documentation.
(e) Survival. The terms of this Section 14.1 shall survive the expiration
-------- ------------
or termination of this Agreement, and shall be binding upon and inure
to the benefit of the successors and assigns of the Parties. The
Parties will continue to reasonably cooperate with each other to
perfect the rights granted in this Section 14.1.
------------
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 39
14.2 Ownership of Equipment. Genentech shall own all right, title and interest
----------------------
in and to any and all equipment, materials, facilities improvements and
other assets purchased by Genentech and which are required to be reimbursed
by Immunex under the Tech Transfer Agreement, including, without
limitation, the Portable Equipment and the Non-Portable Equipment
(collectively, the "Equipment"), free and clear of any right or claim of
---------
Immunex and anyone claiming through Immunex. All Equipment shall be
maintained in good repair. Notwithstanding the foregoing, however, at the
expiration or termination of this Agreement, Immunex may, at its option,
take title to and possession of some or all of the Portable Equipment (at
no charge but with Immunex paying reasonable costs and expenses to remove
such equipment from Genentech's facilities and ship and deliver it to
Immunex's facilities), and Genentech may, at no cost, retain all other
portions of the Equipment. The freeze tanks described in Section 4.7 hereof
-----------
shall be deemed to be "Portable Equipment" and shall be subject to transfer
to Immunex pursuant to the terms of this Section 14.2. In addition, all of
------------
the Equipment shall also be subject to the provisions of Section 19.3
------------
below. If Genentech fails to timely arrange for the removal of the Portable
Equipment from the Genentech Facility, Immunex shall send written notice
requesting such removal. If such removal has not occurred within [*] days
of such notice, then Immunex shall be entitled to hire a qualified Third
Party at Genentech's reasonable expense to enter the Genentech Facility
with written notice at least [*] business days in advance and remove the
Portable Equipment, which shall be removed in a reasonable manner without
damage to the Genentech Facility. For clarification purposes, removal of
the Portable Equipment shall not in and of itself be considered damage to
the Genentech Facility.
ARTICLE 15. REPRESENTATIONS AND WARRANTIES
------------------------------------------
15.1 Immunex. Immunex hereby represents and warrants to Genentech that:
-------
(a) To the best of Immunex's knowledge, after reasonable inquiry, Immunex
is free to supply to Genentech the Working Cell Bank, Immunex
Confidential Information (including, without limitation, the
Manufacturing Documentation), and all information to be supplied by
Immunex to Genentech under the Tech Transfer Agreement; and Immunex's
supply to Genentech of the Working Cell Bank and Immunex Confidential
Information (including, without limitation, the Manufacturing
Documentation), and all information supplied by Immunex to Genentech
under the Tech Transfer Agreement, and Genentech's use thereof in
accordance with the terms of and in performance of its obligations
under this Agreement, does not, to the best of Immunex's knowledge,
after reasonable inquiry, infringe any valid claim of any Third Party
patent; and, to the best of Immunex's knowledge, after reasonable
inquiry, except for the pending suit brought by ZymoGenetics, Inc.,
there is no suit pending against Immunex or Wyeth in the U.S. that
alleges patent infringement by the manufacture or sale of the Product;
and to the best of Immunex's knowledge, after reasonable inquiry,
Immunex has not received written notice alleging infringement of a
Third Party
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 40
patent by the manufacture or sale of the Product;
(b) Immunex has made Genentech aware of any known hazards involved in
handling the Cell Line, Working Cell Bank, the Specialized Raw
Materials and the Bulk Drug, and will continue to make Genentech aware
of such matters in the future;
(c) Immunex has the corporate power and authority and consents and the
legal right to enter into this Agreement and to perform its
obligations under this Agreement, including, but not limited to,
consents of [*], Immunex's Board of Directors, and Amgen Inc.;
(d) Immunex has taken all necessary corporate action on its part to
authorize the execution and delivery of this Agreement and the
performance of its respective obligations under this Agreement. This
Agreement has been duly executed and delivered on behalf of Immunex,
and constitutes a legal, valid, binding obligation, enforceable
against Immunex and its successors and assigns in accordance with its
terms;
(e) [*]; and
(f) To the best of Immunex' knowledge after reasonable inquiry, Immunex
has the legal right to [*] set forth in [*] above and the [*] set
forth in [*] above.
15.2 Genentech. Genentech hereby represents and warrants to Immunex that:
---------
(a) To the best of Genentech's knowledge, after reasonable inquiry,
Genentech is free to supply the Genentech Confidential Information to
Immunex;
(b) Genentech has the corporate power and authority and the legal right to
enter into this Agreement and to perform its obligations under this
Agreement;
(c) Genentech has taken all necessary corporate action on its part to
authorize the execution and delivery of this Agreement and the
performance of its obligations under this Agreement. This Agreement
has been duly executed and delivered on behalf of Genentech, and
constitutes a legal, valid, binding obligation, enforceable against
Genentech in accordance with its terms;
(d) Genentech owns or lawfully controls the Genentech Facility, and, to
the best of its knowledge after reasonable inquiry, has a sufficient
number of employees with such expertise and experience as is necessary
or appropriate to produce Bulk Drug in accordance with the terms
hereof and in quantities sufficient to fulfill the Annual Minimums set
forth in Exhibit A hereof; and
---------
(e) To the best of Genentech's knowledge after reasonable inquiry,
Genentech has the legal right to [*] above and to [*]; as of the
Effective Date, Genentech has not [*].
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 41
ARTICLE 16. INDEMNIFICATION
---------------------------
16.1 Indemnification by Immunex.
--------------------------
(a) Indemnification by Immunex. Subject to and except to the extent of any
--------------------------
indemnification from Genentech pursuant to Section 16.2 below, Immunex
------------
shall indemnify, defend and hold Genentech, its Affiliates, and their
respective directors, officers, employees and agents harmless from and
against all losses, damages, liabilities, settlements, penalties,
fines, costs and expenses (including, without limitation, reasonable
attorneys' fees and expenses), (collectively, the "Liabilities") to
-----------
the extent such Liabilities arise out of or result from (1) any claim,
lawsuit or other action or threat by a Third Party arising out of the
manufacture, use, handling, distribution, marketing or sale of the
Product, in any form, (2) any material breach of the representations,
warranties and covenants made by Immunex under this Agreement, (3)
Immunex's grossly negligent acts or omissions or willful misconduct,
and/or (4) any recall of the Product, except and to the extent arising
out of or resulting from any material breach of the representations,
warranties and covenants made by Genentech under this Agreement, or
Genentech's grossly negligent acts or omissions or willful misconduct.
(b) Additional Indemnification by Immunex. Immunex shall indemnify, defend
-------------------------------------
and hold Genentech, its Affiliates, and their respective directors,
officers, employees and agents harmless from and against all
Liabilities to the extent such Liabilities arise out of or result from
any claim by a Third Party that Genentech's manufacture of Bulk Drug
for Immunex hereunder, to the extent such manufacture of Bulk Drug
hereunder is in compliance with the Manufacturing Documentation,
Manufacturing Process and Bulk Drug Specifications, infringes the
intellectual property rights of such Third Party. [*]
16.2 Indemnification by Genentech. Subject to and except to the extent of any
----------------------------
indemnification from Immunex pursuant to Section 16.1(a) and (b) above,
-----------------------
Genentech shall indemnify, defend and hold Immunex, and its Affiliates,
directors, officers, employees and agents harmless from and against all
Liabilities to the extent such Liabilities arise out of or result from (a)
any material breach of the representations and warranties made by Genentech
under this Agreement or any material breach of any of the covenants made by
Genentech [*], or (b) Genentech's grossly negligent acts or omissions or
willful misconduct. For the purposes of this Section 16.2, "willful
------------
misconduct" shall not include [*].
16.3 Indemnification Procedures.
--------------------------
(a) Identification of Indemnitor and Indemnitee. An "Indemnitor" means
------------------------------------------- ----------
Immunex with respect to Section 16.1(a) and (b) hereof, and Genentech
--------------- ---
with respect to
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 42
Section 16.2 hereof. An "Indemnitee" means any of Genentech, its
------------ ----------
Affiliates, and their respective directors, officers, employees and
agents with respect to Section 16.1(a) and (b) hereof, and any of
-------------- ---
Immunex, and its respective Affiliates, directors, officers, employees
and agents with respect to Section 16.2 hereof.
------------
(b) Indemnification Procedures. An Indemnitee which intends to claim
--------------------------
indemnification under Section 16.1 or 16.2 hereof shall promptly
------------ ----
notify the Indemnitor in writing of any claim, lawsuit or other action
in respect of which the Indemnitee, its Affiliates, or any of their
respective directors, officers, employees and agents intend to claim
such indemnification. The Indemnitee shall permit, and shall cause its
Affiliates and their respective directors, officers, employees and
agents to permit, the Indemnitor, at its discretion, to settle any
such claim, lawsuit or other action and agrees to the complete control
of such defense or settlement by the Indemnitor; provided, however,
such settlement does not adversely affect the Indemnitee's rights
under this Agreement or impose any obligations on the Indemnitee in
addition to those set forth herein in order for the Indemnitor to
exercise such rights. No such claim, lawsuit or other action shall be
settled without the prior written consent of the Indemnitor and the
Indemnitor shall not be responsible for any legal fees or other costs
incurred other than as provided herein. The Indemnitee, its Affiliates
and their respective directors, officers, employees and agents shall
cooperate fully with the Indemnitor and its legal representatives in
the investigation and defense of any claim, lawsuit or other action
covered by this indemnification, all at the reasonable expense of the
Indemnitor. The Indemnitee shall have the right, but not the
obligation, to be represented by counsel of its own selection and
expense.
16.4 Survival of Indemnification Obligations. The provisions of this Article 16
--------------------------------------- ----------
shall survive the termination or expiration of this Agreement.
16.5 Disclaimer of Consequential Damages. Except for claims arising from [*], in
-----------------------------------
no event shall either Party be liable to the other Party for incidental,
indirect, special, punitive or consequential damages arising from or
related to breach of this Agreement, including, without limitation, any
claims for damages based upon lost profits [*].
ARTICLE 17. CONFIDENTIALITY
---------------------------
17.1 Confidentiality Obligations.
---------------------------
(a) Genentech Confidentiality Obligations. Genentech shall not disclose
-------------------------------------
Immunex Confidential Information to any third party other than
(1) its employees or employees of its subsidiaries who have a need to
know such information in order to perform their duties in
carrying out Genentech's obligations under this Agreement, the
Tech Transfer Agreement and/or the Quality Agreement,
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 43
(2) contractors who are bound by similar obligations of
confidentiality and nonuse and who have a need to know such
information in order to provide direction to Genentech or Immunex
regarding their respective obligations under this Agreement, the
Tech Transfer Agreement and/or the Quality Agreement, or
(3) regulatory authorities, for example, the FDA, that require such
information in order to review a BLA or sBLA for the Product or
other regulatory filing.
For purposes of clarity, Genentech shall not be authorized to disclose
any Immunex Confidential Information to Roche without Immunex' prior
written consent. Further, Genentech shall not disclose any
confidential information of Roche to Immunex.
(b) Immunex Confidentiality Obligations. Immunex shall not disclose any
-----------------------------------
Genentech Confidential Information to any third party (including,
without limitation, Amgen, prior to the effective date of the Change
of Control, if any) other than
(1) employees, consultants, agents or contractors of Immunex or
Immunex's Affiliates who are bound by similar obligations of
confidentiality and nonuse and who have a need to know such
information in order to perform their duties in carrying out
Immunex's obligations under this Agreement, the Tech Transfer
Agreement and/or the Quality Agreement, or in order to provide
direction to Immunex regarding production, testing, storage or
quality of the Product or regulatory or compliance issues related
to the Product, or
(2) regulatory authorities, for example, the FDA, that require such
information in order to review a BLA or sBLA for the Product or
other regulatory filing.
For purposes of this Section 17.1(b), American Home Products
---------------
Corporation, now known as Wyeth, and its Affiliates shall not be
deemed to be affiliates of Immunex [*].
(c) Responsibility for Compliance with Confidentiality and Nonuse
-------------------------------------------------------------
Obligations. Each Party shall be responsible for any intentional
-----------
misuse or misappropriation, by such Party, its Affiliates, or the
employees, consultants, agents or contractors of such Party or such
Party's Affiliates, of the other Party's Confidential Information.
17.2 Terms of Agreement. Subject to Sections 17.4 and 18.1 hereof, and except
------------------ ------------- ----
for any disclosure as is deemed necessary, in the reasonable judgment of
the responsible Party, to comply with national, federal or state laws or
regulations (including the rules and regulations of any national stock
exchange on which such Party's securities are traded),
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 44
neither Party shall, without the prior written consent of the other Party,
disclose in any manner to any Third Party the terms and conditions of this
Agreement; provided that this Section 17.2 shall not prohibit the
------------
disclosure of this Agreement by Immunex to Amgen Inc., and shall not
prohibit the disclosure of this Agreement by Genentech to Roche.
17.3 Exclusions. The obligations of confidentiality and nonuse applicable
----------
hereunder to Genentech with respect to Immunex Confidential Information and
to Immunex with respect to Genentech Confidential Information shall not
apply to any information which:
(a) at the time of disclosure, is known publicly or thereafter becomes
known publicly through no fault of the recipient, its Affiliates or
agents;
(b) becomes available to the recipient from a Third Party which is not
legally prohibited from disclosing such information, provided such
information was not acquired directly or indirectly from the
disclosing Party;
(c) was developed by the recipient independently of information obtained
from the disclosing Party as evidenced by written records;
(d) was already known to the recipient before receipt from the disclosing
Party, as shown by its prior written records, provided that such
information was not acquired directly or indirectly from the
disclosing Party; or
(e) is released with the prior written consent of the Party that had
originally disclosed such information to the other Party hereunder.
In determining whether or not the disclosing Party's Confidential
Information has entered the public domain, the obligations of
confidentiality shall no longer apply to only that portion of said
Confidential Information that has become public, and portions remaining
confidential shall retain their status as Confidential Information.
17.4 Notification of Mandatory Disclosure.
------------------------------------
(a) Notification and Consultation. In the event that a Party (in such
-----------------------------
case, the "Notifying Party") believes it is required by applicable
---------------
statute or regulation (including the rules and regulations of any
national stock exchange on which such Party's securities are traded),
or by judicial or administrative process to disclose any part of the
other Party's (in such case, the "Notified Party") Confidential
--------------
Information which is disclosed to it under this Agreement, the
Notifying Party shall (1) promptly notify the Notified Party of each
such requirement and identify the documents so required thereby, so
that the Notified Party may seek an appropriate protective order or
other remedy and/or waive compliance by the Notifying Party with the
provisions of this Agreement, and (2) consult with the Notified Party
on the advisability of taking legally available steps to resist or
narrow the scope of such requirement.
Page 45
(b) Limited Disclosure. If, in the absence of such a protective order or
------------------
such a waiver by the Notified Party of the provisions of this
Agreement, the Notifying Party is nonetheless required by mandatory
applicable law to disclose any part of the Notified Party's
Confidential Information which is disclosed to it under this
Agreement, the Notifying Party may disclose such Confidential
Information without liability under this Agreement, except that the
Notifying Party shall furnish only that portion of the Confidential
Information which is legally required.
17.5 No Licenses; Maintenance of Confidentiality; Nonuse Obligations.
---------------------------------------------------------------
(a) No Licenses. Except as expressly provided in [*], no right or license,
-----------
either express or implied, under any intellectual property right is
granted under this Agreement, the Tech Transfer Agreement, or the
Quality Agreement, by virtue of the disclosure of Confidential
Information under this Agreement, the Tech Transfer Agreement, or the
Quality Agreement, or otherwise.
(b) Maintenance of Confidentiality. Each Party shall use reasonable and
------------------------------
customary precautions to safeguard the other Party's Confidential
Information, including ensuring that all employees, consultants,
agents or contractors who are provided access to such Confidential
Information are informed of the confidential and proprietary nature of
such Confidential Information and have contractual confidentiality and
nonuse obligations that are at least as restrictive as those contained
in this Agreement.
(c) Nonuse Obligations. Immunex Confidential Information shall not be
------------------
utilized by Genentech for any purpose other than performing its
obligations under this Agreement, the Tech Transfer Agreement, or the
Quality Agreement, without first obtaining Immunex's prior written
consent to each such utilization. Genentech Confidential Information
shall not be utilized by Immunex except as set forth in this
Agreement, the Tech Transfer Agreement, or the Quality Agreement, or
except for the limited purpose of production, testing, storage or
quality of the Product or regulatory or compliance issues related to
the Product, without first obtaining Genentech's prior written consent
to each such utilization.
(d) Equitable Relief. Each Party agrees that the other Party and their
----------------
respective Affiliates would be irreparably injured by a material
breach of the confidentiality and nonuse provisions of this Agreement
by the breaching Party or by its employees or the employees of its
Affiliates, consultants, agents or contractors, that monetary remedies
would be inadequate to protect the other Party against any actual or
threatened material breach of the provisions of this Article 17 by the
----------
breaching Party or by its employees or the employees of its
Affiliates, consultants, agents or contractors, and, without prejudice
to any other rights and remedies otherwise available to the other
Party, the breaching Party agrees, upon proof of any such actual or
threatened material breach, to the granting of equitable relief,
including injunctive relief and specific performance, in the other
Party's favor
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 46
without proof of actual damages. It is further understood and agreed
that no failure or delay by either Party in exercising any right, power
or privilege hereunder shall operate as a waiver thereof, nor shall any
single or partial exercise thereof preclude any other or further
exercise thereof or the exercise of any other right, power or privilege
hereunder.
17.6 Survival of Confidentiality Obligations. The provisions of this Article 17
--------------------------------------- ----------
shall survive the termination or expiration of this Agreement for a period
of [*] years; provided, however, that with respect to Immunex Confidential
Information that is identified by Immunex as "BIP Confidential
----------------
Information," the provisions of this Article 17 shall survive for the
----------- ----------
longer of the following time periods: [*] years after the termination or
expiration of the ENBREL supply agreement among BIP, American Home Products
Corporation, and Immunex dated November 5, 1998, as amended (the "BIP
---
ENBREL Supply Agreement"); and (b) [*] years after the termination or
-----------------------
expiration of this Agreement.
17.7 Termination of Certain Prior Agreements and Letter of Intent. This
------------------------------------------------------------
Agreement supersedes (a) the Confidentiality Agreements between the Parties
dated August 16, 2000 and December 13, 2001, (b) the Letter of Intent, and
(c) the Confidential Disclosure Agreement between the Parties dated March
29, 2002. All Confidential Information (as defined in such Confidentiality
Agreements, Letter of Intent and Confidential Disclosure Agreement),
exchanged between the Parties under such Confidentiality Agreements, Letter
of Intent and Confidential Disclosure Agreement shall be deemed
Confidential Information under this Agreement (either Immunex Confidential
Information or Genentech Confidential Information, as the context requires)
and shall be subject to the terms of this Agreement.
17.8 No Disclosure of Unrelated Information. Neither Party shall disclose
--------------------------------------
confidential information to the other Party that is not reasonably
necessary for performance of a Party's obligations under this Agreement,
the Tech Transfer Agreement and/or the Quality Agreement, including but not
limited to manufacturing processes for other products, marketing plans and
clinical development plans. Notwithstanding the foregoing, nothing in this
provision shall limit the confidentiality and non-use obligations and
rights herein.
ARTICLE 18. PRESS RELEASES; USE OF NAMES
----------------------------------------
18.1 Press Releases. The Parties agree that the public announcement of the
--------------
execution of this Agreement shall be in the form of a draft press release
to be agreed upon by the Parties, and, after the press release is
published, each Party shall be entitled to make or publish any public
statement consistent with the contents thereof. Except as set forth in the
preceding sentence, no press release, publicity or other form of public
written disclosure related to this Agreement shall be permitted by either
Party unless the other Party has indicated its consent to the form of the
release in writing. This Section shall not apply
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 47
to any disclosure as is deemed necessary, in the reasonable judgment of the
responsible Party, to comply with national, federal or state laws or
regulations (including the rules and regulations of any national stock
exchange on which such Party's securities are traded).
18.2 Use of Names. No Party shall make use of the name of any other Party in any
------------
advertising or promotional material, or otherwise, in connection with this
Agreement or any related agreements, without the prior written consent of
such other Party; provided, however, either Party may include the other
Party on a general list of business partners or collaborations.
ARTICLE 19. TERM; TERMINATION
-----------------------------
19.1 Term; Option to Extend. Unless sooner terminated pursuant to the terms of
----------------------
this Agreement, the term of this Agreement (the "Term") shall commence on
----
the Effective Date and shall continue until December 31, 2005. The Parties
may, by mutual written agreement, extend the Term of this Agreement for an
additional year, and, in such case, the Term would be extended through
December 31, 2006.
19.2 Termination. This Agreement may be terminated prior to the end of the Term
-----------
as follows:
(a) Material Breach.
---------------
(1) Genentech Material Breach. This Agreement may be terminated in
-------------------------
its entirety by Immunex upon written notice thereof to Genentech
in the event of a material breach by Genentech which is not cured
within [*] days after receipt of written notice from Immunex to
Genentech, specifying in reasonable detail the nature of such
breach, or such longer period of time if Genentech delivers a
certificate that such material breach is not reasonably capable
of being cured within [*] days and that Genentech is working
diligently to cure such breach, but in no event shall the time
for curing such breach exceed an additional [*] days. In the
event such breach is not cured within such cure period, this
Agreement shall terminate as set forth in Immunex's notice of
breach and in accordance with the terms of this Article;
provided, however, that this Agreement shall not be terminated
prior to the end of such cure period.
(2) Immunex Material Breach. This Agreement may be terminated by
-----------------------
Genentech upon written notice thereof to Immunex in the event of
a material breach by Immunex which is not cured within [*] days
from written notice to Immunex specifying in reasonable detail
the nature of such breach or longer if Immunex delivers a
certificate that such material breach is not reasonably capable
of being cured within [*] days and that
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 48
Immunex is working diligently to cure such breach, but in no
event shall the time for curing such breach exceed an additional
[*] days. Notwithstanding the foregoing, if the material breach
referred to in this Section 19.2(a)(2) arises out of or consists
------------------
of the failure to pay Genentech amounts due under this Agreement
in accordance with the terms hereof, there shall be a single
period of [*] days after notice of breach within which Immunex
shall have the right to cure such default by making payment in
full of the amount then due and payable. In the event such breach
is not cured within such cure period, this Agreement shall
terminate as set forth in Genentech's notice of breach and in
accordance with the terms of this Article; provided, however,
that this Agreement shall not be terminated prior to the end of
such cure period.
(b) Force Majeure; No Fault Termination. This Agreement may be terminated
-----------------------------------
as follows: If, as a result of a Force Majeure Event, a Party is
unable fully to perform its obligations under this Agreement for any
consecutive period of [*] days, unless the Parties mutually agree in
writing upon a shorter time period, Immunex (in the case of a Force
Majeure Event affecting Genentech) or Genentech (in the case of a
Force Majeure Event affecting Immunex) shall have the right to
terminate this Agreement, upon providing written notice thereof to the
other Party, such termination to be effective [*] days from the
effective date of such notice.
(c) Failure to Obtain FDA Approval for Genentech Facility. This Agreement
-----------------------------------------------------
may be terminated as follows: (i) in the event FDA Approval for the
manufacture of Bulk Drug at the Genentech Facility is not received by
[*], or if at any time either Party receives information which
indicates that FDA approval by [*] would be highly unlikely, the
Parties agree to enter into good faith discussions to determine
whether this Agreement should be terminated and, upon agreement of the
Parties, this Agreement shall be terminated on the date agreed to by
the Parties; and (ii) in the event FDA Approval for the manufacture of
Bulk Drug at the Genentech Facility is not received by [*], Immunex
may, in its sole discretion, terminate this Agreement in its entirety
upon at least [*] days' prior written notice to Genentech; provided,
however, that Immunex may not issue a termination notice pursuant to
this Section 19.2(c)(ii) after FDA Approval for the manufacture of
-------------------
Bulk Drug at the Genentech Facility has been received. The date set
forth in Section 19.2(c)(ii) hereof may be adjusted by the JPT in
-------------------
accordance with Section 3.4(d). Immunex may exercise its termination
--------------
rights under Section 19.2(c)(ii) hereof so long as Immunex has not
-------------------
acted in bad faith to materially and adversely affect the critical
path to FDA Approval.
(d) Withdrawal of Product. This Agreement may be terminated by Immunex, in
---------------------
its sole discretion, upon at least [*] days' prior written notice to
Genentech, in the event the BLA for the Product is irrevocably
withdrawn by Immunex.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 49
19.3 Consequences of Termination.
---------------------------
(a) Payment of Amounts Due; Cumulative Remedies. Expiration or termination
-------------------------------------------
of this Agreement for any reason shall not exempt any Party from
paying to any other Party any amounts owing to such Party at the time
of such expiration or termination. Except as expressly stated
otherwise herein, remedies under this Agreement are cumulative, and
nothing in this Agreement shall prevent any Party, in the case of a
material breach (after expiration of applicable cure period and notice
periods), from terminating this Agreement and seeking to enforce its
rights under this Agreement.
(b) [intentionally omitted]
-----------------------
(c) Termination of Bulk Drug Commitment.
-----------------------------------
(1) Upon termination of this Agreement in its entirety by Immunex
pursuant to Section 19.2(a(1)(Genentech Material Breach),
-----------------
Immunex may, in its discretion, cancel, in whole or in part, any
Runs that were scheduled to be initiated on or after the
effective date of such termination. Likewise, upon termination of
this Agreement in its entirety by Genentech pursuant to
Section 19.2(a(2)(Immunex Material Breach), Genentech may, in
-----------------
its discretion, cancel, in whole or in part, any Runs that were
scheduled to be initiated on or after the effective date of such
termination. Runs that are in process and [*] as of the effective
date of any such termination shall not be cancelled without the
mutual agreement of the Parties, and the Agreement shall continue
to survive with respect to those in-process Runs.
(2) Upon the issuance of a notice of termination of this Agreement
pursuant to Section 19.2(b)(Force Majeure; No Fault Termination)
---------------
hereof, all Runs which were scheduled to be initiated after the
date on which the notice of termination was issued shall be
automatically cancelled. Runs that are in process and [*] on the
date on which the notice of termination was issued shall not be
cancelled without the mutual agreement of the Parties, and the
Agreement shall continue to survive with respect to those
in-process Runs.
(3) Upon the termination of this Agreement pursuant to
Section 19.2(c) (Failure to Obtain FDA Approval for Genentech
---------------
Facility), Genentech shall immediately stop all Bulk Drug
manufacturing hereunder, other than completing testing and
release of Bulk Drug that has been fully-manufactured as of the
date of termination. Bulk Drug that has been fully-manufactured
as of the date of termination but for which testing and release
has not been completed shall remain subject to the terms of this
Agreement, and the Agreement shall continue to survive with
respect to such Bulk Drug.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 50
(4) Upon the issuance by Immunex of a notice of termination of this
Agreement pursuant to Section 19.2(d) (Withdrawal of Product),
---------------
Genentech shall immediately stop all Bulk Drug manufacturing
hereunder, other than completing testing and release of Bulk Drug
that has been fully manufactured as of the date on which the
notice of termination was issued. Bulk Drug that has been
fully-manufactured as of the date on which the notice of
termination was issued but for which testing and release has not
been completed shall remain subject to the terms of this
Agreement, and the Agreement shall continue to survive with
respect to such Bulk Drug. In lieu of termination, it shall be
Immunex's option to request that Genentech [*].
(d) Other Financial Obligations.
---------------------------
(1) Raw Materials. Upon expiration of this Agreement or termination
-------------
of this Agreement pursuant to Section 19.2(a(2) (Immunex
-----------------
Material Breach), Immunex shall purchase from Genentech, at the
request of Genentech, at Genentech's Acquisition Cost, all
remaining usable raw materials, intermediates and packaging
components acquired and paid for by Genentech for the manufacture
and packaging of Bulk Drug under this Agreement, and, upon
termination of this Agreement pursuant to Section 19.2(b) (Force
---------------
Majeure; No Fault Termination), Section 19.2(c) (Failure to
---------------
Obtain FDA Approval for Genentech Facility), or Section 19.2(d)
---------------
(Withdrawal of Product) hereof, Immunex shall purchase from
Genentech, at the request of Genentech, at Genentech's
Acquisition Cost, all remaining usable Specialized Raw Materials,
and Immunex may purchase from Genentech, at the request of
Genentech, at Genentech's Acquisition Cost, all remaining usable
raw materials (other than Specialized Raw Materials),
intermediates and packaging components acquired and paid for by
Genentech for the manufacture and packaging of Bulk Drug under
this Agreement; provided, however, that Immunex shall not be
obligated to purchase an amount of such raw materials,
intermediates and packaging components in excess of the amount
reasonably necessary to fulfill the outstanding Bulk Drug
Commitment for Bulk Drug that are outstanding at the time of such
termination plus a reasonable safety stock; and provided,
further, that Genentech shall have an obligation upon receipt of
a notice of termination to place no further orders for raw
materials, intermediates or packaging components except as may be
necessary for completion of any portion of Genentech's services
hereunder that are not immediately terminated. Upon expiration of
this Agreement, Immunex shall purchase from Genentech, at the
request of Genentech, at Genentech's Acquisition Cost, all
remaining usable raw materials, intermediates and packaging
components acquired and paid for by Genentech for the manufacture
and packaging of Bulk Drug under this Agreement; provided,
however, that Immunex shall not be obligated to purchase an
amount of such raw materials, intermediates and packaging
components in excess of the amount
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 51
reasonably necessary to fulfill the outstanding Bulk Drug
Commitment for Bulk Drug that are outstanding at the time of such
expiration plus a reasonable safety stock; and provided, further,
that Genentech shall have an obligation to place no orders for
raw materials, intermediates or packaging components except as
may be necessary for completion of any portion of Genentech's
services hereunder prior to expiration.
(2) Termination Fee for Withdrawal of Product. Upon termination of
-----------------------------------------
this Agreement pursuant to Section 19.2(d) (Withdrawal of
---------------
Product), Genentech shall be entitled to payment by Immunex of an
amount which shall be equal to and calculated as of the notice of
termination is received, as follows: [*]
(e) Return of Materials and of Immunex Confidential Information; Transfer
---------------------------------------------------------------------
of Portable Equipment. Upon expiration or termination of this
---------------------
Agreement, unless otherwise directed by Immunex, Genentech shall
promptly (1) return or, at Immunex's election, destroy all quantities
of the Cell Line, Master Cell Bank, and Working Cell Bank received by
Genentech under this Agreement, the Tech Transfer Agreement or the
Quality Agreement, with any such destruction to be certified in
writing to Immunex by an authorized Genentech officer, (2) return all
Immunex Confidential Information to Immunex, except for a single copy
and/or sample which may be retained for documentation purposes only
and which shall remain subject to the obligations of nonuse and
confidentiality set forth in this Agreement, and (3) return to Immunex
all retention and reserve samples being held by Genentech pursuant to
Section 12.8 hereof, provided that Genentech may retain one set of
------------
such samples for documentation purposes only. In addition, if
requested by Immunex, Genentech shall transfer the Equipment to
Immunex in accordance with Section 14.2 hereof.
------------
(f) Return of Genentech Confidential Information. Upon expiration or
--------------------------------------------
termination of this Agreement, and at Genentech's written request,
Immunex shall promptly return all Genentech Confidential Information
to Genentech, except for a single copy and/or sample to be retained by
Immunex and Immunex for documentation purposes only and which shall
remain subject to the obligations of nonuse and confidentiality set
forth in this Agreement.
(g) Accrued Rights. Except as otherwise expressly set forth herein, any
--------------
termination or expiration of this Agreement shall be without prejudice
to any right which shall have accrued to the benefit of either Party
and shall not relieve either Party of any obligation which has accrued
prior to the effective date of such termination or expiration, which
obligations shall remain in full force and effect for the period
provided therein or, if no period is provided therein, then such
obligations shall remain in full force and effect indefinitely.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 52
ARTICLE 20. FORCE MAJEURE
-------------------------
20.1 Effects of Force Majeure. No Party shall be in breach of this Agreement if
------------------------
there is any failure of performance under this Agreement (except for
payment of any amounts due under this Agreement) occasioned by any reason
beyond the control and without the fault or negligence of the Party
affected thereby, including, without limitation, an act of God, fire, act
of government or state, war, civil commotion, insurrection, embargo, [*],
prevention from or hindrance in obtaining energy or other utilities, a
market shortage of raw materials or necessary components, labor disputes of
whatever nature, or any other reason beyond the control and without the
fault or negligence of the Party affected thereby (a "Force Majeure
-------------
Event"). Such excuse shall continue as long as the Force Majeure Event
-----
continues. Upon cessation of such Force Majeure Event, the affected Party
shall promptly resume performance under this Agreement.
20.2 Notice of Force Majeure. Each Party agrees to give the other Party prompt
-----------------------
written notice of the occurrence of any Force Majeure Event, the nature
thereof, and the extent to which the affected Party will be unable fully to
perform its obligations under this Agreement. Each Party further agrees to
use Commercially Reasonable Efforts to correct the Force Majeure Event as
quickly as practicable and to give the other Party prompt written notice
when it is again fully able to perform such obligations.
20.3 Allocation of Capacity. If, as a result of a Force Majeure Event, Genentech
----------------------
at any time is unable fully to supply outstanding Bulk Drug Commitments for
Bulk Drug, Genentech shall use reasonable efforts to equitably allocate its
available resources and production capacity among Genentech, Immunex and
Genentech's other Third Party customers, as the case may be, taking into
consideration the respective requirements of each during a reasonable time
period prior to the allocation, as well as such requirements during the
allocation period. Genentech shall not grant a higher priority to itself or
any Third Party than to Immunex with respect to manufacture or shipment of
products from the Genentech Facility except as required by contractual
obligations pre-dating this Agreement and except and to the extent such
Force Majeure Event affects only the manufacture or shipment of Bulk Drug
and does not affect the manufacture or shipment of other products.
20.4 Termination. This Agreement may be terminated as a result of a Force
-----------
Majeure Event in accordance with Section 19.2(b) hereof.
---------------
20.5 Reduction in Annual Maximum Amount and Annual Minimum Amount. If a Force
------------------------------------------------------------
Majeure Event prevents Genentech from manufacturing Bulk Drug under this
Agreement in any calendar year, the parties shall in good faith discuss and
Genentech shall use Commercially Reasonable Efforts to increase
proportionately the Annual Maximum and Annual Minimum in the subsequent
calendar year, if Genentech has excess capacity or can reasonably revise
its production schedule without adversely impacting itself or its
obligations to Third Parties and/or Affiliates.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 53
ARTICLE 21. ASSIGNMENT
----------------------
21.1 Assignment. This Agreement shall be binding upon the successors and assigns
----------
of the Parties and the name of a Party appearing herein shall be deemed to
include the names of its successors and assigns. Neither Party may assign
its interest under this Agreement without the prior written consent of the
other Party, such consent not to be unreasonably withheld; provided,
however, either Party may assign its interest under this Agreement, without
the prior written consent of the other Party, (a) to an Affiliate, so long
as the assigning Party unconditionally guarantees the obligations of such
Affiliate or (b) to a successor of the assigning Party's business by reason
of merger, sale of all or substantially all of its assets or other form of
acquisition. Any purported assignment without a required consent shall be
void. No assignment shall relieve any Party of responsibility for the
performance of any obligation that accrued prior to the effective date of
such assignment.
ARTICLE 22. DISPUTE RESOLUTION
------------------------------
22.1 Exclusions. Section 22.2 below shall not apply to any disputes arising
---------- ------------
under Article 17 (Confidentiality) or Section 23.9 [*].
---------- ------------
22.2 Dispute Resolution.
------------------
(a) Disputes. The Parties recognize that a bona fide dispute as to certain
--------- ---------
matters may from time to time arise during the term of this Agreement
that relates to a Party's rights and/or obligations under this
Agreement. In the event of the occurrence of such a dispute, any Party
may, by written notice to the other Parties, have such dispute referred
to their respective officers designated below, or their respective
designees, for attempted resolution by good faith negotiations within
[*] days after such notice is received. Such designated officers are as
follows:
For Immunex - Chief Executive Officer
For Genentech - Chief Executive Officer
In the event the designated officers, or their respective designees,
are not able to resolve such dispute within such [*]-day period, or
such other period of time as the Parties may mutually agree in writing,
either Party may, by written notice to the other, invoke the following
provisions of this Section 22.2 hereinafter.
------------
(b) Mediation and Arbitration. The Parties agree that, except as otherwise
-------------------------
set forth in Section 22.1 above or Section 22.2(d) below, any dispute,
------------ ---------------
controversy or claim arising out of or relating to this Agreement, the
Tech Transfer Agreement, or the Quality Agreement, or the breach,
termination, or invalidity thereof, shall be resolved
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 54
through mediation and binding arbitration. If a dispute arises between
the Parties, and if such dispute cannot be resolved pursuant to
Section 22.2(a) above, the Parties agree to try in good faith to
---------------
resolve such dispute by mediation administered by the American
Arbitration Association (unless otherwise agreed in writing by the
Parties) in accordance with its Commercial Mediation Rules (unless
otherwise agreed in writing by the Parties). If efforts at mediation
are unsuccessful within [*] days, any unresolved controversy or claim
between the Parties shall be resolved by binding arbitration
administered by the American Arbitration Association (unless otherwise
agreed in writing by the Parties) in accordance with its Commercial
Arbitration Rules (unless otherwise agreed in writing by the Parties),
except as modified herein. Each Party shall select one arbitrator and
the two (2) arbitrators so selected shall choose a third arbitrator to
resolve the dispute. A reasoned arbitration decision shall be rendered
in writing within [*] months of the conclusion of arbitration and
shall be binding and not be appealable to any court in any
jurisdiction. The prevailing Party may enter such decision in any
court having competent jurisdiction. Unless otherwise mutually agreed
upon by the Parties, the mediation and arbitration proceedings shall
be conducted at the location of the Party not originally requesting
the resolution of the dispute (the "Non-Requesting Party"), and, if
--------------------
the Non-Requesting Party is Immunex, then the location shall be, at
Immunex's option, Seattle, Washington, or Los Angeles, California, or
such other location as may be agreed in writing by the Parties and, if
the Non-Requesting Party is Genentech, then the location shall be, at
Genentech's option, San Francisco, California, or such other location
as may be agreed in writing by the Parties. The Parties agree that
they shall share equally the cost of the mediation and arbitration
filing and hearing fees, and the cost of the mediator/arbitrator. Each
Party must bear its own attorneys' fees and associated costs and
expenses.
(c) Jurisdiction. For the purposes of this Article 22, the Parties agree to
------------
accept the jurisdiction of the federal courts located in (a) the
Northern District of California for the purposes of enforcing awards
entered on behalf of Genentech pursuant to this Article 22 and for
enforcing the agreements reflected in this Article, or to a state court
in such jurisdiction if the applicable rules of civil procedure
preclude federal court jurisdiction, and (b) the Western District of
Washington, or the Southern District of California, for the purposes of
enforcing awards entered on behalf of Immunex pursuant to this Article
22 and for enforcing the agreements reflected in this Article, or to a
state court in such jurisdiction if the applicable rules of civil
procedure preclude federal court jurisdiction, and the Parties hereby
consent to the jurisdiction and venue of such courts.
(d) Determination of Patents and Other Intellectual Property.
--------------------------------------------------------
Notwithstanding the foregoing, any dispute relating to the
determination of validity of a Party's patents or other issues
relating to a Party's intellectual property shall be submitted
exclusively to the federal court located in the jurisdiction of the
defendant, or to a state court in such jurisdiction if the applicable
rules of civil procedure preclude federal court jurisdiction, and the
Parties hereby consent to the jurisdiction and venue of such courts.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 55
ARTICLE 23. MISCELLANEOUS
-------------------------
23.1 Notices. Other than notices within the jurisdiction of the respective
-------
Project Team Leaders, which shall be given to those individuals, any notice
required or permitted to be given under this Agreement by any Party shall
be in writing and shall be (a) delivered personally, (b) sent by registered
mail, return receipt requested, postage prepaid, (c) sent by a
nationally-recognized courier service guaranteeing next-day or second day
delivery, charges prepaid, or (d) delivered by facsimile (with the original
promptly sent by any of the foregoing manners), to the addresses or
facsimile numbers of the other Parties set forth below, or at such other
addresses as may from time to time be furnished by similar notice by any
Party. The effective date of any notice under this Agreement shall be the
date of receipt by the receiving Party.
If to Genentech: Corporate Secretary
Genentech, Inc.
0 XXX Xxx
Xxxxx Xxx Xxxxxxxxx, XX 00000
Fax: (000) 000-0000
Phone: (000) 000-0000
with a copy to: Senior Vice President of Product Operations
Genentech, Inc.
0 XXX Xxx, XX 00
Xxxxx Xxx Xxxxxxxxx, XX 00000
Fax: (000) 000-0000
Phone: (000) 000-0000
with a copy to: Vice President of Business & Commercial Development
Genentech, Inc.
0 XXX Xxx
Xxxxx Xxx Xxxxxxxxx, XX 00000
Phone: (000) 000-0000
Fax: (000) 000-0000
If to Immunex: Immunex Corporation
00 Xxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Senior Vice President, Supply Operations
Fax: (000) 000-0000
Phone: (000) 000-0000
with a copy to: Immunex Corporation
00 Xxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention: General Counsel
Fax: (000) 000-0000
Phone: (000) 000-0000
Page 56
23.2 Applicable Law. This Agreement shall be construed, interpreted and enforced
--------------
in accordance with the internal substantive laws of the State of [*],
without reference to the choice of law doctrine of such state.
23.3 Headings. The table of contents and all headings in this Agreement are for
--------
convenience of reference only and shall not affect the interpretation of
this Agreement.
23.4 Exhibits. All exhibits referred to herein form an integral part of this
--------
Agreement and are incorporated into this Agreement by such reference.
23.5 Severability. Each Party hereby expressly agrees that it has no intention
------------
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; that if any word,
sentence, paragraph, clause or combination thereof in this Agreement is
found by a court or executive body with judicial powers having jurisdiction
over this Agreement or any Party hereto, in a final unappealed order, to be
in violation of any such provisions in any country or community or
association of countries, such words, sentences, paragraphs, clauses or
combination shall be inoperative in such country or community or
association of countries and the remainder of this Agreement shall remain
binding upon the Parties, so long as enforcement of the remainder does not
violate the Parties' overall intentions in this transaction.
23.6 Independent Contractors. Each of the Parties is an independent contractor
-----------------------
and nothing herein contained shall be deemed to constitute the relationship
of partners, joint venturers, nor of principal and agent between the
Parties. Neither Party shall hold itself out to Third Parties as purporting
to act on behalf of, or serving as the agent of, the other Party.
23.7 Waiver. No waiver of any term, provision or condition of this Agreement
------
whether by conduct or otherwise in any one or more instances shall be
deemed to be or construed as a further or continuing waiver of any such
term, provision or condition or of any other term, provision or condition
of this Agreement.
23.8 Counterparts. This Agreement and any amendment hereto may be executed in
------------
any number of counterparts, each of which shall for all purposes be deemed
an original and all of which shall constitute the same instrument. This
Agreement shall be effective upon full execution by facsimile or original,
and a facsimile signature shall be deemed to be and shall be as effective
as an original signature.
23.9 [*]
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 57
23.10 Entirety; Amendments. This Agreement, including any exhibits attached
--------------------
hereto and referenced herein, constitutes the full understanding of the
Parties and a complete and exclusive statement of the terms of their
agreement with respect to the specific subject matter hereof (i.e.,
----
purchase and supply of Bulk Drug), and no terms, conditions,
understandings or agreements purporting to modify or vary the terms
thereof shall be binding unless it is hereafter made in writing and signed
by each of the Parties. No modification to this Agreement shall be
effected by the acknowledgment or acceptance of any purchase order or
shipping instruction forms or similar documents containing terms or
conditions at variance with or in addition to those set forth herein. In
the event of a conflict between this Agreement and the exhibits hereto,
the terms of this Agreement shall control. This Agreement may be amended
and supplemented only by a written instrument signed by each of the
Parties.
23.11 Preference. Unless otherwise specifically provided for in the Quality
----------
Agreement and/or Tech Transfer Agreement, the terms of this Agreement
shall prevail in the event of a conflict between this Agreement and any
of the aforementioned agreements.
[the remainder of this page intentionally blank]
Page 58
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of
the Effective Date.
Immunex Corporation
By: /s/ Xxxxxx Xxxxx-Xxxxx
--------------------------------------------
Xxxxxx Xxxxx-Xxxxx
Senior Vice President, Supply Operations
Genentech, Inc.
By: /s/ Xxxxx Xxxxxxxx
--------------------------------------------
Xxxxx Xxxxxxxx
Senior Vice President of Product Operations
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 59
Exhibit A
Minimum and Maximum Runs*
Calendar Year Minimum Runs Maximum Runs
--------------------------------------------------------------------
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
*When used in this Exhibit, the term "Runs" is a defined term, and it shall have
the meaning given in the Agreement.
* Portions of this exhibit have been omitted pursuant to a request for
confidential treatment filed with the Securities and Exchange Commission. The
omitted portions of this exhibit have been filed separately with the SEC.
Page 60
