EXHIBIT 10.52
ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
HEADS OF AGREEMENT
between
Amgen Inc......and
Kirin-Amgen, Inc......on the one hand
and
X. Xxxxxxxx-Xx Xxxxx Ltd......on the other hand.
Whereas:
Amgen and Roche have entered into various agreements on G-CSF in the
European Union ("AMRO Agreements") and other European countries
("XXX") and Kirin-Amgen and Roche have entered into such agreements
for the rest of the world ("ROW").
Roche entered into a license agreement with *********** on a
********** ********************* ("***** Product") on January 1, 1996
("*********** License").
Amgen and Roche have agreed to modify their present relationship as
follows:
1. Certain Rights
1.1 *********** License Concurrently herewith, Roche will
terminate or relinquish the ***********
License for
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********** and Roche shall cause its
affiliate company - Xx Xxxxx Inc.,
Nutley, New Jersey USA to terminate or
relinquish the *********** license for
the United States as of the date
hereof, such that the rights to the
***** Product in those territories will
revert to ***********.
1.2 License Xxxxx Xxxxx will xxxxx to and cause Xxxxxxxx-
Xx Xxxxx Inc. to grant to Amgen and
Kirin-Amgen
*********************************** for
the U.S., ******************** covering
all intellectual property, now owned or
hereafter developed or acquired by
Roche and Xxxxxxxx-Xx Xxxxx Inc., which
relates to the
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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************************* Such
************ shall be limited to:
(*)*******************************
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(**)******************************
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*
(***)**********************************
(**)******************************
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****************
(*)*******************************
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************
(**)******************************
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*************
Such ************ other than G-CSF
(Neupogen) are referred to elsewhere
herein as "Second Generation Products."
Such license shall terminate upon the
date of termination of the AMRO
Agreements as extended herein;
provided, however, that if the AMRO
Agreements are terminated for "Good
Cause" (as defined therein) by Amgen,
such license will continue in effect
until the date specified in Section
2.1.
2. Extension of AMRO
2.1 Extension of AMRO; In consideration of the rights granted
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
Term and relinquished pursuant to Section 1,
above, and the other terms contained
herein, the AMRO Agreements between
Amgen and Roche will be extended and
modified, as set forth below. The term
of the AMRO Agreements shall be
extended to December 31, 2010, or
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***************** whichever is later.
If, however,
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*, the term of the AMRO Agreement
******* ******** until the
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*****************
2.2 AMRO Territory All countries ************* and those
countries which
******************************* of the
AMRO Agreements.
2.3 Profit Split The profit split *******************
shall be:
Amgen/Roche
**** *****
**** *****
**** *****
**** and beyond *****
2.4 ************** Effective upon the date of this Heads
of Agreement, ************** shall
include
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******* required to be paid
***************************************
********************************* The
************* payable as of the date
hereof are set forth on Exhibit A
attached hereto.
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** shall be included in **************
than those related in Exhibit A
(***********************************).
2.5 Roche Sales Force
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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3. Other Matters
3.1 Continuation of Except as provided in Section 2.5,
Other AMRO Changes the process of shifting to Amgen
marketing, licensing/regulatory,
distribution, invoicing, etc. which is
currently underway for G-CSF (Neupogen)
shall continue as per the AMRO
Agreements and not be affected by this
extension and amendment.
3.2 Development
3.2.1 Products It is the desire of the parties to
develop a Second Generation Product.
The decision by Amgen and Roche to
develop a Second Generation Product
shall be
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******************************, the
Second Generation Product shall be
deemed to be a "Product" within the
meaning of the AMRO Agreement and
development will be governed by the
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
terms thereof. The specific product to
be developed shall be
********************, in accordance
with the Evaluation Plan attached
hereto as Exhibit B. Upon selection of
a Product for development following
completion of the Evaluation Plan,
Amgen and Roche shall prepare a
Development Plan. Thereafter, Amgen
and Roche shall exercise commercially
reasonable efforts to develop and
commercialize the Product in accordance
with the Development Plan in the AMRO
territory. Amgen shall control
development, preclinical, clinical,
regulatory and marketing of a Second
Generation Product and shall
distribute, and
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The Development Plan including launch
date shall be mutually agreed upon.
3.2.2 *********** License If the agreed upon Second Generation
Product includes any technology covered
by the *********** patents, Roche will
grant Amgen *************************
sublicense for the EU under any rights
Roche may have with respect to the
*********** patents under the
*********** license.
3.2.3 Amgen Products
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***** This paragraph shall not apply
to G-CSF (Neupogen) or a Second
Generation Product which Amgen or its
licensee/partner brings to the EU in a
cell therapy ex-vivo expansion
application.
3.2.4 Roche Products
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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*****
3.2.5 Development Costs Effective upon the date of this Heads
of Agreement, Amgen and Roche shall
share, in accordance with the then
current profit split under the AMRO
Agreement,
************************************ in
the AMRO territory, including:
- ********************************;
-
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**; and
-
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*********** License. Such costs shall
include ********* payable to
*********** as follows:
a) ***************** of the net
sales of ***** Product
*******************; provided,
however, that in the event that
(1) certain ********* have to
be paid to a third party due to
a patent issue, in such case
the ******* payable to *****
shall be
*******************************
*******************************
; or
(2) such ***** Product shall
face significant competition
from a third party
*******************************
*******************************
************* the *******
payable to ***** in any such
country shall be
*******************************
*******************************
*******;
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
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provided further that the
*************** in the aggregate
from (1) and (2) shall not cause
the ************ payable to *****
to be less than *****************.
If both (1) and (2) are
applicable, the calculation in (1)
shall be made first and then (2)
shall be calculated.
b) For a Second Generation Product
covered by ******* patents
other than the product in a)
all ************* as per a)
will be ******* by
*****************.
c) For a Second Generation Product
which would not be covered by
******* patents, all
************* as per a) will be
******* by ***.
d) The ********* under c) above
shall be payable so long as the
*********** License is in full
force and effect.
Such costs shall also include the
********** payable to ***********
as follows:
(1) ************
***************
***************************
**************** shall be
payable within *********
after the signature of
these Heads of Agreement.
(2) ********************
***************
***************************
******* shall be payable
within ****************
after the first entry of a
patient in a **************
with a Second Generation
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
Product or in any EU
country or
********************** as
agreed to in the time and
events schedule in the
Development Plan (to be
established after the
evaluation period),
whichever is earlier.
(3) ******************
***************
***************************
******* shall be payable
within ****************
after 50% of patients have
been enrolled in a
*************** with a
Second Generation Product
in any EU country, or to
***************************
****** as agreed to in the
time and events schedule of
Development Plan, whichever
occurs earlier.
(4) ****************
***************
***************************
***************************
** shall be payable within
**************** after the
submission of the first
Second Generation Product
license
***************************
******** to the Authority
in
***************************
******* or the
*********************** as
agreed to in the time and
events schedule in the
Development Plan, whichever
is earlier.
(5) With respect to
***************************
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
* of (3) above and
***************************
***************************
***************** of (4)
above, shall be
****************** the
payment of ******* payable
to *****.
3.2.6 ********* of Second *************************************
Generation Products
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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3.2.7 Rest of Europe If a Second Generation Product is
successfully developed and approved for
the EU, it is the intention of the
parties that if such rights are
available Roche be granted the rights
to sell the Product in *************
("XXX") under the terms of the existing
agreements; provided, however, that
Amgen and Roche shall negotiate in good
faith the terms of such license, in
accordance with the following
principles:
3.2.7.1 if the Second Generation
Product is not a *****
Product and does not use the
********************* covered
by the *********** License,
the royalty payable by Roche
to Amgen will be
*********************,
3.2.7.2 if the Second Generation
Product is not a *****
Product but does use the
********************* covered
by the *********** License,
the royalty payable by Roche
to Amgen will be
***************** that
specified in Section 3.2.7.1,
and
3.2.7.3 if the Second Generation
Product is a ***** Product,
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
the royalty payable by Roche to Amgen will be ***************** that
specified in Section 3.2.7.2.
In such good faith negotiations the
parties will take into account all
factors relevant to each of them,
including without limitation royalties
each party may be required to pay to
third parties, the relative
contribution of the parties to the
particular Second Generation Product
and who is the manufacturer and at what
cost. The term of the XXX Agreement
shall be until
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whichever date is later.
3.2.8 Rest of World If a Second Generation Product is
successfully developed and approved for
the EU, it is the intention of the
parties that if such rights are
available Roche be granted the rights
to sell the Product throughout the
world,
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********** ("ROW") under the terms of
the existing agreements. Kirin-Amgen
or Amgen, as the case may be, and Roche
shall negotiate in good faith a
modification of the terms of such
license, in accordance with the
following principles:
3.2.8.1 if the Second Generation
Product is not a *****
Product and does not use the
********************* covered
by the *********** License,
the royalty payable by Roche
to Kirin-Amgen will be
*****************************
***,
3.2.8.2 if the Second Generation
Product is not a *****
Product but does use the
********************* covered
by the *********** License,
the royalty payable by Roche
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
to Kirin-Amgen will be
***************** that
specified in Section 3.2.8.1,
and
3.2.8.3. if the Second Generation
Product is a ***** Product,
the royalty payable by Roche
to Kirin-Amgen will be
***************** that
specified in Section 3.2.8.2.
In such good faith negotiations the
parties will take into account all
factors relevant to each of them,
including without limitation royalties
each party may be required to pay to
third parties, the relative
contribution of the parties to the
particular Second Generation Product
and who is the manufacturer and at what
cost. The term of the ROW Agreement
shall be until the
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*********************************,
whichever date is later. Roche agrees
to ********* with Kirin such Second
Generation Product in the following
countries:
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**********.
3.3 Manufacture by If the Second Generation Product is
*********** the ***** Product, ***** shall have the
rights to manufacture the product for
the EU, XXX and ROW.
3.4 Manufacture by Amgen All Second Generation Products other
than a *********** Product will be
manufactured by Amgen for the EU.
3.5 Definitive Agreement The parties shall enter into a
definitive agreement within ninety (90)
days following execution of this Heads
of Agreement.
3.6 Miscellaneous Sections 7.01 (a) and 11.01 of the AMRO
Agreements shall be revised to reflect
the new profit splits and to provide
for the sharing of Operating Losses in
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
accordance with the profit splits for
the term of AMRO.
The AMRO Agreements shall be revised to
change the functional currency from
Swiss Francs to U.S. Dollars.
The AMRO Agreements shall no longer
provide for ***************** to Roche.
There is nothing in the Kirin-Amgen
Agreements that restricts Amgen or
Kirin-Amgen from fulfilling its
obligations under this Agreement
regarding any Second Generation Product
in the EU, XXX and ROW.
There is nothing in this Agreement that
restricts any party from
commercializing in the XXX and ROW a
Second Generation Product that is not
being commercialized in the EU.
The Heads of Agreement will become binding upon the parties upon the
execution hereof. Although binding upon the parties, the terms
hereof shall be incorporated in a definitive amendment to the AMRO
Agreements containing additional terms, including terms addressing
individual country issues that exist between the parties.
Dated: April 10, 1997
X. XXXXXXXX-XX XXXXX LTD AMGEN INC.
By: /s/ Xxxxxx Xxxxxxx By: /s/ Xxxxxx X. Xxxxxxxx
Dated: April 10, 1997 Dated: April 10, 1997
KIRIN-AMGEN, INC.
BY AMGEN INC.
By: /s/ Xxxxxx X. Xxxxxxxx
Dated: April 10, 1997
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
Exhibit A
Party *******
*********** ************************
************************ *********************************
******* *********************
******** ****
*********************** **
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
Exhibit B
Evaluation Plan
*******
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ASTERISKS (*) INDICATE CONFIDENTIAL INFORMATION OMITTED AND FILED
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