THIRD AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT OF DECEMBER 7 2003
EXHIBIT
10.33
THIRD
AMENDMENT
TO
THE
MANUFACTURING
AND SUPPLY AGREEMENT OF DECEMBER 7 2003
THIS
THIRD AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT DATED DECEMBER 7
2003
("3rd Amendment")
is dated as of 06 November 2006, by and between Lonza Biologics PLC, having
its
principal place of business at 000 Xxxx Xxxx, Xxxxxx, Xxxxxxxxx XX0 0XX, Xxxxxxx
("LB"),
Lonza Biologics, Inc. having its principal place of business at 000
Xxxxxxxxxxxxx Xxxxx Xxxxxxxxxx, Xxx Xxxxxxxxx 00000 ("Lonza
Inc")
(collectively LB and Lonza Inc, hereinafter "Lonza"),
and Genentech, Inc., a Delaware corporation, having its principal place of
business at Xxx XXX Xxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000 ("Genentech").
BACKGROUND
The
Parties have executed that certain Manufacturing and Supply Agreement by and
between the Parties dated December 7, 2003, as amended 14 March 2005 (the
“1st
Amendment”),
(collectively, the “Agreement”),
as amended 19 May 2006 (the “2nd
Amendment”)
and wish now to further amend said Agreement.
Lonza
and Genentech desire to (i) re-schedule certain Campaigns to be conducted by
Lonza, (ii) amend the non-competition provisions, and (iii) remove Genentech’s
[*]
right to extend the Term of the Agreement in exchange for Lonza providing
Genentech regular forecasts with respect to capacity at the Lonza Facility
in
the years [*].
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:
1.
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Condition
Precedent. This
3rd
Amendment shall only become effective upon the closing of the purchase
and
sale of the issued and outstanding units of Genentech España S.L.,
pursuant to the terms of the Sale
Agreement (the
“3rd
Amendment Effective Date”).
As of the signing of this 3rd
Amendment, the expected closing date of the Sale Agreement is 08
December
06. As used herein, the “Sale
Agreement”
means that
certain Stock Purchase Agreement by
and among Lonza
Europe B.V.,
a Dutch company incorporated in the Netherlands, having its principal
place of business at Breda, Netherlands and Genentech,
of even date herewith, pursuant to which Genentech has agreed to
sell the
“Shares” (as defined in the Sale Agreement) to Lonza, and Lonza has agreed
to purchase the Shares from Genentech, as the same may be amended
from
time to time.
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2.
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Rescheduling
of Campaigns.
Notwithstanding
the Campaign, Campaign Minimum and Campaign Minimum Run schedule
listed on
Exhibit A of the Agreement (including any amendments thereof in the
1st
Amendment and/or 2nd
Amendment):
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(a) the
combined [*]
Campaigns
scheduled to commence on [*],
shall be rescheduled to commence on [*],
and shall continue for a Campaign Minimum of [*]
during which time Lonza shall be obligated to perform [*]
Campaign Minimum Runs; and
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(b) the
[*]
Campaigns shall each commence as currently scheduled; provided, the Parties
shall discuss in good faith a rescheduling of such Campaigns in order to
accommodate each Party’s requirements; provided further, with respect to such
Campaigns, the Campaign Minimum Runs are amended as follows:
Campaign Campaign
Minimum Runs
[*]
Campaign [*]
[*]
Campaign [*]
[*]
Campaign [*]
3.
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Competitive
Products.
A new Section 5.7.7 is hereby added to the Agreement as
follows:
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5.7.7
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Competitive
Products.
Notwithstanding the non-compete provisions of Section 5.7.6, if
any existing or new capacity becomes available at the Lonza Facility
at
any time [*],
Lonza shall have the right to use such capacity to manufacture,
either for commercial supply or clinical supply, an Existing Lonza
Customer Product (including without limitation those Existing Lonza
Customer Product that are Competing Products). Each
Party agrees that the provisions of this Section 5.7.7 shall be binding
upon the licensees, successors and/or assignees of a Party. As
used herein this Section 5.7.7:
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(i) [*],
“Singapore
Facility”
and “Competing
Product”,
respectively, means as defined in that certain Exclusive Option Agreement
(“Singapore Facility”) between Genentech and Lonza Group Ltd. and Lonza Holding
Singapore PTE Ltd. of even date herewith; and
(ii) “Existing
Lonza Customer Product” means
[*]
4.
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Term.
Section 20.1 of the Agreement is amended in its entirety to read
as
follows:
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20.1
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Term.
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,
2008.
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5.
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Capacity
at the Lonza Facility in the [*].
A new Section 5.10 is hereby added to the Agreement as
follows:
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5.10
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Capacity
at
the Lonza Facility in [*].
Lonza hereby agrees to provide to Genentech notice of any capacity
(new or
existing) at the Lonza Facility (and not already committed under
written
agreement with a Third Party as of the date of such notice), for
so long
as such capacity is available for production during [*].
This
Section 5.10 shall survive the termination or expiration of this
Agreement.
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5.10.1
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Forecast
Notice.
Commencing on [*],
and continuing every six (6) months thereafter until [*],
Lonza shall provide Genentech with a forecast of available capacity
(including without limitation that portion of capacity, if any, under
discussion by Lonza with a Third Party) at the Lonza Facility in
[*].
Lonza shall offer such capacity to Genentech [*].
Genentech shall have [*]
(as may be extended by mutual agreement) following its receipt of
each
such forecast to provide written notification to Lonza regarding
its
decision [*]
with
respect to any of such capacity.
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5.10.2
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Exercise.
If written notice is given by Genentech to Lonza within such [*]
period that Genentech may desire to obtain some or all of such capacity,
Lonza shall provide Genentech with all information reasonably useful
for
Genentech to make a decision regarding such capacity. Following
Genentech’s receipt of all such information, [*].
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5.10.3
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Failure
to Exercise; Election to Not Exercise.
If written notice is given that Genentech does not want to accept
some or
all of such capacity, or written notice is not given by Genentech
within
[*]
(as may be extended by mutual agreement), Genentech will have waived
its
right to [*]
capacity (or, as applicable, that portion thereof that it specifies
in
such written notice that it does not want [*])
unless and until Lonza notifies Genentech in a subsequent forecast
that
such capacity is available.
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5.10.4
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Additional
Rights/Obligations.
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(a) With
respect to capacity subject to this Section 5.10 and under written proposal
by
Lonza with a Third Party prior to the date of Lonza’s notice Genentech under
Section 5.10.1 above, during said [*],
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Lonza
shall be free to talk with and enter into an agreement to sell such capacity
to
such Third Party;
(b) With
respect to all other capacity subject to this Section 5.10 and under a written
proposal by Lonza with Genentech, during [*],
Lonza shall be free to talk to any Third Party; provided Lonza does not
[*].
6.
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Milestone
Payment for Calendar Year 2006.
Section 6.4.3(d)(ii) is amended in entirety as
follows:
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(ii) a
one-time additional payment of [*]
upon Lonza quality release by [*]
of
a total number of Successful Commercial Batches greater than or equal to
[*]
of the total Commercial Runs commenced by Lonza during the [*]
Campaign and [*]
Campaign (it being understood that the [*]
Campaign consists of the [*]
of the [*]
Campaign). For the avoidance of doubt, no Successful Commercial Batches
resulting from the [*]
Campaign shall count toward such milestone. Such additional amount shall be
payable upon Genentech’s final release of such Commercial Batches.
7.
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All
terms and conditions of the Agreement not modified by this 3rd
Amendment shall continue in full force and effect in accordance with
their
terms. All capitalized terms not otherwise defined herein shall have
the
same definition as in the
Agreement.
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IN
WITNESS WHEREOF, the Parties have caused this 3rd
Amendment to be executed as of the Effective Date.
GENENTECH,
INC.
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By:
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/s/ XXXXXX
XXXXXXX
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Name:
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Xxxxxx
Xxxxxxx
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Title:
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Vice
President, Manufacturing
Collaborations
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LONZA
BIOLOGICS, INC.
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By:
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/s/ XXXXXXX
XXXXXX
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Name:
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Xxxxxxx
Xxxxxx
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Title:
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Chief
Operating Officer
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LONZA
BIOLOGICS, PLC
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By:
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/s/ XXXXXXX
XXXXXX
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Name:
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Xxxxxxx
Xxxxxx
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Title:
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Chief
Operating Officer
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