Exhibit 10.1
AMENDMENT AGREEMENT
THIS AMENDMENT AGREEMENT (together with the attached Schedules, the
"Amendment") is dated as of 23rd day of April, 1997 by and between Genzyme
Transgenics Corporation, a Massachusetts corporation with a business address
at Xxxx Xxxxxxxx Xxxxxxxxxx, Xxxxxxxxxxxxx 00000-0000 ("GTC") and Pharming
B.V., a Netherlands corporation with a business address at Niels Xxxxxxx
00-00, 0000 XX Xxxxxx, Xxx Xxxxxxxxxxx ("Pharming").
1. Background. GTC and Pharming (previously named Gene Pharming Europe B.V.)
are parties to a September 21, 1994 agreement, a copy of which is attached
to this Amendment as Schedule A (the "Agreement"). GTC and Pharming (which
is referred to in the Agreement as "GPE") desire to amend the Agreement, on
the terms and conditions set forth herein.
2. Section 2.4. Section 2.4 of the Agreement, including Subsections 2.4.1 and
2.4.2, are deleted in their entirety, and in place thereof the following
new Sections are added:
2.4. GTC Limited Rights to Work in Cattle.
2.4.1 No license rights are granted under any circumstances to GTC
or its Affiliates in the Field with respect to the
manufacture, use and sale of transgenic cattle to product
human lactoferrin, human lysozyme and/or human collagen.
2.4.2 GTC shall have the right under the GPE Patent Rights to
develop, manufacture, use, keep and/or import (but not sell)
transgenic cattle (including their progeny), and to develop
manufacture, use, import and/or sell the proteins produced
in transgenic cattle, and the license to the GPE Patent
Rights granted to GTC under Section 2.2 shall be extended to
include cattle and proteins produced in cattle, provided
that GTC complies with the following provisions:
a. If GTC wishes to perform all work related to the
development of transgenic cattle for a particular protein
itself or through an Affiliate, GTC shall pay to Pharming a
royalty equal to the royalty rate consistent with the formula
set forth in the last paragraph of Section 2.4.2(b), below,
plus two percent (2%), consistent with the revenue, payment,
reporting and audit terms set forth in the Biogen License
(defined in Section 4.1 as modified by Section 4.2) mutatis
mutandis.
b. GTC may contract any aspect of the development of
transgenic cattle, or the particular protein produced in such
transgenic cattle, to a third party which as not an
Affiliate, provided that GTC shall not enter a definitive
agreement with a third party to perform such development
work unless it first offers to contract such work to
Pharming in accordance with the procedures set forth in this
Section 2.4.2(b).
Any offer (the "Offer") must be in writing and shall include
the following commercial terms (the "Basic Terms") upon
which GTC proposes to contract the development work which is
the subject of the Offer:
i. a detailed description of the development work to be
performed, including a work plan and timeline;
ii. the amount of initial payment, if any;
iii. the amount of subsequent payments, if any, and any
benchmarks therefor;
iv. the royalty rates and fees applicable to sales of such
transgenic cattle and/or such transgenic protein, and
any minimum royalties and fees; and
v. the term of the proposed contract.
Within thirty (30) days after its receipt of the Offer, Pharming
shall either accept or reject the Offer. During such thirty day
period, Pharming may propose to GTC terms for the offered
cattle/protein which are different from those set forth in the
Offer. However, if, during such thirty day period, Pharming does
not accept, by written notice to GTC, the Offer (upon its
original terms or as it may be modified solely by written
agreement of Pharming and GTC), and does not represent and
warrant to GTC that Pharming has the technical capabilities to
perform the work specified in the applicable workplan on the
timeline also specified therein, Pharming shall be deemed to have
rejected the Offer.
If Pharming duly accepts the Offer, GTC shall be obligated to
contract to Pharming such development work (including any herd
development and herd expansion work related to such development
work) upon the Basic Terms set forth in the Offer, and Pharming
shall be obligated to accept such contract upon such Basic Terms.
If and to the extent that Pharming rejects or is deemed to reject
an Offer, GTC shall be free to contract to a third party such
development work, subject to the conditions set forth below.
If GTC contracts to a third party such development work, the
Basic Terms of such contract, taken as a whole, shall not be
materially different than those set forth in the applicable
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Offer. If GTC desires to contract to a third party such
development work, but is unable to do so except on Basic Terms
which, taken as a whole, are materially different than those set
forth in the Offer, GTC shall not offer to contract such
development work to such third party unless it first offers to
contract such development work to Pharming on such materially
different terms in accordance with the provisions of this
Section, except that Pharming shall have twenty (20) days, rather
than thirty days, to accept or reject such Offer. In addition,
if GTC does not enter into a contract for such development work
with at least one third party within the twelve (12) month period
following the rejection of the applicable Offer by Pharming, GTC
shall not offer to contract such development work to any third
party unless it first offers such contract to Pharming in
accordance with the provisions of this Section; Pharming shall
have thirty (30) days to accept or reject such offer.
If GTC contracts to a third party such development work, GTC
shall pay to Pharming a royalty equal to X percent (as defined
below) of GTC's revenue on account of sales of such transgenic
cattle, and/or the protein produced in such transgenic cattle,
consistent with the revenue, payment, reporting and audit terms
as set forth in the Biogen License (defined in Section 4.1 as
modified by Section 4.2) mutatis mutandis; where "X" is three
percent (3%) if both the Biogen Patents and the GPE Patent Rights
cover the sales of such transgenic cattle, and/or the proteins
produced in such transgenic cattle, as applicable, but if only
the GPE Patent Rights cover the sales of such transgenic cattle,
and/or the proteins produced in such transgenic cattle, as
applicable, then X shall be the royalty rate scheme as set forth
in the Biogen License (i.e., 1-3%) plus 3% so that the resultant
royalty shall be 4-6% operating in similar manner as the royalty
scheme set forth in Appendix C of the Biogen License. The
Parties agree, however, that in no event will the royalty due
Pharming on the sales of such transgenic cattle, and/or the
proteins produced in such transgenic cattle, as applicable, ever
exceed six percent (6%) in total under this Agreement and the
Biogen License.
2.4.3. Notwithstanding anything contained in this Agreement to the
contrary, the limitations and restrictions on the license
and other terms set forth in this Section 2.4 shall apply
only with respect to the GPE Patent Rights licensed to GTC
under this Agreement, as amended.
If GTC desires to sell transgenic cattle covered by or made under
a claim of the GPE Patent Rights licensed to GTC under this
Agreement, it must first secure Pharming's prior written
approval.
Notwithstanding anything contained in this Agreement to the
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contrary, GTC may contract non-development work (for example,
without limitation, fill, finish, labeling and distribution) but
not development work (for example, without limitation, herd
development and herd expansion work) to a third party without
offering to contract such work to Pharming under Section
2.4.2(b).
3. Section 2.5. Section 2.5 of the Agreement, including Subsections 2.5.1 and
2.5.2, are deleted in their entirety, and in place thereof the following
new Sections are added:
2.5 Pharming Limited Rights to Work in Goats.
2.5.1 No license rights are granted under any circumstances to GPE
or its Affiliates in the Field with respect to the manufacture,
use and sale of transgenic goats to produce human
antithrombin-III and/or cystic fibrosis transmembrane
conductance regulator.
2.5.2 Pharming shall have the right under the GTC Patent Rights to
develop, manufacture, use, keep and/or import (but not sell)
transgenic goats (including their progeny), and to develop,
manufacture, use, import and/or sell the proteins produced in
transgenic goats, and the license to the GTC Patent Rights
granted to Pharming under Section 2.1 shall be extended to
include goats and proteins produced in goats, provided that
Pharming complies with the following provisions:
a. If Pharming wishes to perform all work related to the
development of transgenic goats for a particular
protein itself or through an Affiliate, Pharming shall
pay to GTC a royalty equal to the royalty rate
consistent with the formula set forth in the last
paragraph of Section 2.5.2(b), below, plus two percent
(2%), consistent with the revenue, payment, reporting
and audit terms as set forth in the Biogen License
(defined in Section 4.1 as modified by Section 4.2)
mutatis mutandis.
b. Pharming may contract any aspect of the development of
transgenic goats, or the particular protein produced in
such transgenic goats, to a third party which is not an
Affiliate, provided that Pharming shall not enter a
definitive agreement with a third party to perform such
development work unless it first offers to contract
such work to GTC in accordance with the procedures set
forth in this Section 2.5.2(b).
Any offer (the "Offer") must be in writing and shall
include the following commercial terms (the "Basic
Terms") upon which Pharming proposes to contract the
development work which is the subject of the Offer:
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i. a detailed description of the development work to
be performed, including a work plan and timeline;
ii. the amount of the initial payment, if any;
iii. the amount of subsequent payments, if any, and any
benchmarks therefor;
iv. the royalty rates and fees applicable to sales of
such transgenic cattle and/or such transgenic
protein, and any minimum royalties and fees; and
v. the term of the proposed contract.
Within thirty (30) days after its receipt of the Offer,
GTC shall either accept or reject the Offer. During
such thirty day period, GTC may propose to Pharming terms
for the offered goats/protein which are different from those
set forth in the Offer. However, if, during such thirty day
period, GTC does not accept, by written notice to Pharming,
the Offer (upon its original terms or as it may be modified
solely by written agreement of GTC and Pharming), and does
not represent and warrant to Pharming that GTC has the
technical capabilities to perform the work specified in the
applicable workplan on the timeline also specified therein,
GTC shall be deemed to have rejected the Offer.
If GTC duly accepts the Offer, Pharming shall be obligated
to contract to GTC such development work (including any herd
development and herd expansion work related to such
development work) upon the Basic Terms set forth in the
Offer, and GTC shall be obligated to accept such contract
upon such Basic Terms.
If and to the extent that GTC rejects or is deemed to
reject an Offer, Pharming shall be free to contract to
a third party such development work, subject to the
conditions set forth below.
If Pharming contracts to a third party such development
work, the Basic Terms of such contract, taken as a
whole, shall not be materially different than those set
forth in the applicable Offer. If Pharming desires to
contract to a third party such development work, but is
unable to do so except on Basic Terms which, taken as a
whole, are materially different than those set forth in
the Offer, Pharming shall not offer to contract such
development work to such third party unless it first
offers to contract such development work to GTC on such
materially different terms in accordance with the
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provisions of this Section, except that GTC shall have
twenty (20) days, rather than thirty days, to accept or
reject such Offer. In addition, if Pharming does not
enter into a contract for such development work with at
least one third party within the twelve (12) month
period following the rejection of the applicable Offer
by GTC, Pharming shall not offer to contract such
development work to any third party unless it first
offers such contract to GTC in accordance with the
provisions of this Section; GTC shall have thirty (30)
days to accept or reject such offer.
If Pharming contracts to a third party such development
work, Pharming shall pay to GTC a royalty equal to
three percent (3%) of Pharming's revenue on account of
sales of such transgenic goats, and/or the protein
produced in such transgenic goats, consistent with the
revenue, payment, reporting and audit terms as set
forth in the Biogen License (defined in Section 4.1 as
modified by Section 4.2) mutatis mutandis.
2.5.3. Notwithstanding anything contained in this Agreement to
the contrary, the limitations and restrictions on the
license and other terms set forth in this Section 2.5
shall apply only with respect to Pharming's use of the
GTC Patent Rights licensed to Pharming under this
Agreement, as amended.
If Pharming desires to sell transgenic goats covered by
or made under a claim of the GTC Patent Rights licensed
to Pharming under this Agreement, it must first secure
GTC's prior written approval.
Notwithstanding anything contained in this Agreement to
the contrary, Pharming may contract non-development
work (for example, without limitation, fill, finish,
labeling and distribution) but not development work
(for example, without limitation, herd development and
herd expansion work) to a third party without offering
to contract such work to GTC under Section 2.5.2(b).
4. Section 5.1. At the end of Section 5.1 of the Agreement, the following new
sentence is added: "For purposes of clarification, the Parties acknowledge
that no license rights, either express or implied, are granted or deemed to
be granted under this Agreement other than those specified in Section 2 of
the Agreement, as amended."
5. No Other Changes. Other than as set forth in this Amendment, all other
terms and conditions of the Agreement remain in effect and binding on the
parties.
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IN WITNESS WHEREOF, duly-authorized representatives of the parties have
signed this Agreement as of the date first written above.
GENZYME TRANSGENICS CORPORATION
By /s/ Xxxxx X. Xxxxxxxx
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Print Name Xxxxx X. Xxxxxxxx
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Title President
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duly authorized
PHARMING B.V.
By /s/ Xxxxxx X. X. Xxxxxxxx
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Print Name Xxxxxx X. X. Xxxxxxxx
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Title President & CEO
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duly authorized
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