EXHIBIT 10.23
IL-1 LICENSE AGREEMENT
THIS LICENSE AGREEMENT dated this 26th day of June, 2002 by and among Regeneron
Pharmaceuticals, Inc., a New York corporation with principal offices located at
777 Old Saw Mill River Road, Tarrytown, New York 10591-6707 ("Regeneron"),
Immunex Corporation, a Washington corporation with principal offices located at
51 University Street, Seattle, Washington 98101 ("Immunex") and Amgen Inc., a
Delaware corporation with principal offices located at One Amgen Center Drive,
Thousand Oaks, California 91320-1799 (hereinafter referred to as "Amgen").
WITNESSETH:
WHEREAS, Regeneron is engaged in the research, development and
commercialization of human pharmaceutical products, including those certain
molecules in development known as the IL-1 Trap;
WHEREAS, Immunex controls, and has the right to grant rights under,
certain patent rights relating to soluble IL-1 receptor proteins and is the
exclusive licensee of certain rights in, and has the right to grant sublicenses
under, certain patent rights relating to soluble IL-1 receptor proteins; and
WHEREAS, Amgen controls, and has the right to grant rights under,
certain patent rights relating to soluble IL-1 receptor proteins;
WHEREAS, the Federal Trade Commission staff has raised the concern
that the proposed merger between Amgen and Immunex is likely to produce
anticompetitive effects in an alleged IL-1 inhibitor market, which would not be
in the public interest, including, but not limited to, increasing the barriers
of entry into such market by the combination of Amgen's and Immunex's IL-1
inhibitor patent portfolios; and
WHEREAS, in order to resolve the concerns raised by the Federal
Trade Commission staff in the alleged IL-1 inhibitor market, Amgen and Immunex
have agreed to grant certain rights under their respective patents to Regeneron
to permit Regeneron to commercialize such IL-1 Trap product and certain
follow-on IL-1 Trap products.
NOW THEREFORE, in consideration of the foregoing and the covenants
and promises contained in this Agreement, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
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1.1 "AFFILIATE" shall mean a corporation or other business entity controlled by,
controlling, or under common control with a Party. For this purpose, control
shall mean the direct or indirect ownership of more than fifty percent (50%) of
the voting stock or at least fifty percent (50%) interest in the income of such
corporation or other business.
1.2 "AFTER-ACQUIRED PATENT RIGHTS" shall mean any Patent Rights which come to be
exclusively Controlled, in whole or part, by Amgen or Immunex (or, in either
case, any of its Affiliates) after the Effective Date, by license or acquisition
from a Third Party after the Effective Date, and which contain one or more
issued and enforceable claims that would be infringed by the making, having
made, using, offering for sale, selling or importing of a Licensed Product. It
is contemplated that After-Acquired Patent Rights can be acquired from a Third
Party possessing such Patent Rights through (x) a license agreement with such
Third Party, (y) the outright purchase of Patent Rights from such Third Party or
(z) due to a merger with a Third Party or acquisition of either voting control
or substantially all of the stock or assets of a Third Party Controlling through
ownership or exclusive license such Patent Rights.
1.3 "AGREEMENT" shall mean this License Agreement.
1.4 "AMGEN COMBINATION PRODUCT CLAIMS" shall mean, within Amgen Patent Rights,
composition of matter, article of manufacture and/or method of use claims
specifically requiring at least two (2) components with one recited component
being directed to or otherwise covering an interleukin-1 binding molecule and
the other recited component being directed to or otherwise covering an Other
Molecule(s). For the avoidance of doubt, Amgen Combination Product Claims shall
exclude any composition of matter, article of manufacture or method of use claim
not requiring both a component being directed to or otherwise covering an
interleukin-1 binding molecule and a component being directed to or otherwise
covering an Other Molecule(s).
1.5 "AMGEN LICENSED PATENT RIGHTS" shall mean, to the extent Controlled by Amgen
or any of its Affiliates: (i) the patent applications and patents listed on
Exhibit A; (ii) all national, regional and international patent applications
filed either from such patent applications or priority applications or from an
application claiming priority from either of these, including, without
limitation, divisionals, continuations, continuations-in-part, provisionals,
converted provisional, continued prosecution application; (iii) any and all
patents that have issued (including those set forth in Exhibit A) or in the
future issue from the foregoing patent applications, including, without
limitation, utility, model and design patents and certificates of invention; and
(iv) any and all extensions or restorations by existing or future extension or
restoration mechanisms, including without limitation, substitutions,
re-examinations, revalidations, reissues, renewals, extensions (including any
supplementary protection certificate) or any confirmation patent or registration
patent or patent of additions to any such foregoing patent applications and
patents. For the avoidance of doubt, After-Acquired Patent Rights are not
included in the definition of Amgen Licensed Patent Rights.
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1.6 "AMGEN PATENT RIGHTS" shall mean all Patent Rights which are Controlled by
Amgen or any of its Affiliates and any After-Acquired Patent Rights included by
operation of Section 2.4(b). For the avoidance of doubt, Amgen Patent Rights
shall include Amgen Licensed Patent Rights.
1.7 "AVENTIS CONSENT AND AGREEMENT" shall mean a fully executed "Consent and
Agreement" by and between Aventis and Immunex, in substantially the form
attached hereto as Exhibit B. The fully executed Aventis Consent and Agreement
may vary from the form attached as Exhibit B as mutually acceptable to Immunex
and Regeneron, as affirmed in writing by Immunex and Regeneron.
1.8 "AVENTIS PASS-THROUGH ROYALTY" shall mean [********************************
*******].
1.9 "CONFIDENTIAL INFORMATION" shall mean (a) any information of any Party
disclosed to the other Party pursuant to this Agreement, which, if written, is
marked confidential by the disclosing Party or, if oral or by demonstration, is
reduced to writing, marked confidential by the disclosing Party, and provided to
a non-disclosing Party within thirty (30) days of the oral disclosure or
demonstration, (b) all information relating to the filing, prosecution,
maintenance, defense or enforcement of the Immunex Patent Rights or the Amgen
Patent Rights and (c) Regeneron's Net Sales.
1.10 "CONTROL" or "CONTROLLED" shall mean with respect to any Patent Right, in
each case the possession (whether by ownership, license or other right) by
Immunex or Amgen, as the case may be, or any of their Affiliates, of the ability
to grant to Regeneron rights as provided herein in either Sections 2.1, 2.3 or
2.4, as the case may be, without violating the terms of any written agreement
with any Third Party.
1.11 "CO-PROMOTER/CO-MARKETER" shall mean a Third Party contracted with by
Regeneron, its Affiliates or Sublicensees to engage in a part of the promotion,
marketing, detailing, sampling, distributing, and/or selling of any Licensed
Products. For purposes of this Agreement, a Co-Promoter/Co-Marketer shall be
permitted to conduct or sponsor post-approval clinical studies (in an approved
indication, but not necessarily for an approved use) with respect to a Licensed
Product. A Co-Promoter/Co-Marketer shall not be permitted to perform any part of
the pre-approval development of any indication of a Licensed Product, nor
perform any part of the bulk substance manufacturing of any Licensed Product.
1.12 "DEFAULT" shall mean with respect to a Party (i) that any representation or
warranty of such Party set forth herein shall have been untrue in any material
respect when made and/or (ii) such Party shall have failed to perform any
material obligation set forth herein; provided however, that such Party shall
have not brought such representation or warranty into conformance with such
representation or warranty or shall not have performed such material obligation,
within sixty (60) days after receipt of written notice from Regeneron (in the
case of Immunex and/or Amgen) and Immunex and/or Amgen (in the case of
Regeneron) specifying in detail the material obligation which has not been
performed and requesting that the failure to be remedied. (In those instances
where it is not possible for a Party to perform
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a material obligation or bring a representation or warranty into conformance
within 60 days after receipt of such written notice, such Party shall have
satisfied its obligations to bring its representation or warranty into
conformance and/or to perform its material obligation and thus avoid Default by
commencing substantial remedial action within sixty (60) days after receipt of
the written notice, pursuing such remedial action with reasonable diligence and
completing such remedial action within one hundred twenty (120) after receipt of
the written notice.) For Regeneron, a "material obligation" as used above shall
be limited to [******************************************]. For the avoidance of
doubt, no act or failure to act by any Sublicensee or any other Third Party
shall be considered a Default on the part of Regeneron; provided however, this
sentence shall not be interpreted to relieve Regeneron (on behalf of itself, its
Affiliates or its Sublicensees) of any of its obligations to Amgen or Immunex as
set forth in this Agreement. Without limiting the foregoing, if any Sublicensee
shall engage in any activity described in Section 10.16 of the Agreement, the
specific provisions of Section 10.16 as they apply to the actions of the
Sublicensee shall apply, and such action by the Sublicensee in violation of the
covenant in Section 10.16 shall not be considered a Default on the part of
Regeneron.
1.13 "EFFECTIVE DATE" shall mean the date the Merger is consummated by filing
articles of merger related to the Merger with the Secretary of State of the
State of Washington.
1.14 "FIELD OF USE" shall mean all uses of Licensed Product(s).
1.15 "FIRST COMMERCIAL SALE" shall mean the initial transfer of commercial
quantities of Licensed Product to a Third Party following approval of the
Biologics License Application (or foreign equivalent) in exchange for cash or
some equivalent to which value can be assigned for purposes of determining Net
Sales.
1.16 "FORCE MAJEURE" shall mean any occurrence beyond the reasonable control of
a Party that prevents or substantially interferes with the performance by a
Party of any of its obligations hereunder, if and only if the Party affected
shall have used reasonable efforts to avoid such occurrence and to remedy it
promptly if it shall have occurred.
1.17 "GRANT COMMENCEMENT DATE" shall mean the later of (i) the Effective Date
and (ii) the date on which Immunex and Aventis have fully executed the Aventis
Consent and Agreement.
1.18 "IMMUNEX COMBINATION PRODUCT CLAIMS" shall mean, within Immunex Patent
Rights, composition of matter, article of manufacture and/or method of use
claims specifically requiring at least two (2) components with one recited
component being directed to or otherwise covering an interleukin-1 binding
molecule and the other recited component being directed to or otherwise covering
an Other Molecule(s)). For the avoidance of doubt, Immunex Combination Product
Claims shall exclude any composition of matter, article of manufacture or use
claim not requiring both a component being directed to or otherwise covering an
interleukin-1 binding molecule and a component being directed to or otherwise
covering an Other Molecule(s).
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1.19 "IMMUNEX-HOECHST RECEPTOR AGREEMENT" shall mean that certain Receptor
Agreement dated April 6, 1998 by and between Immunex Corporation and Hoechst
Marion Roussel Deutschland GmbH, as the same may be amended from time to time,
including, without limitation, as modified by the Aventis Consent and Agreement.
1.20 "IMMUNEX-HOECHST PATENT RIGHTS" shall mean, to the extent Controlled by
Immunex, the "Behringwerke Receptor Patent Rights" as that term is defined in
the Immunex-Hoechst Receptor Agreement. A list of the Immunex-Hoechst Patent
Rights existing as of the Effective Date is set forth in Exhibit C.
1.21 "IMMUNEX LICENSED PATENT RIGHTS" shall mean, collectively, the Immunex
IL-1r Patent Rights and the Immunex-Hoechst Patent Rights. For the avoidance of
doubt, After-Acquired Patent Rights are not included in the definition of
Immunex Licensed Patent Rights.
1.22 "IMMUNEX IL-1R PATENT RIGHTS" shall mean, to the extent Controlled by
Immunex or any of its Affiliates: (i) the patent applications and patents listed
on Exhibit D; (ii) all national, regional and international patent applications
filed either from such patent applications or priority applications or from an
application claiming priority from either of these, including, without
limitation, divisionals, continuations, continuations-in-part, provisionals,
converted provisional, continued prosecution application; (iii) any and all
patents that have issued (including those set forth in Exhibit D) or in the
future issue from the foregoing patent applications, including, without
limitation, utility, model and design patents and certificates of invention; and
(iv) any and all extensions or restorations by existing or future extension or
restoration mechanisms, including without limitation, substitutions,
re-examinations, revalidations, reissues, renewals, extensions (including any
supplementary protection certificate) or any confirmation patent or registration
patent or patent of additions to any such foregoing patent applications and
patents.
1.23 "IMMUNEX PATENT RIGHTS" shall mean all Patent Rights which are Controlled
by Immunex, or any of its Affiliates and any After-Acquired Patent Rights
included by operation of Section 2.3(b). For the avoidance of doubt, Immunex
Patent Rights shall include Immunex Licensed Patent Rights.
1.24 "INTERLEUKIN-1 RECEPTOR" shall mean, [*******************************].
1.25 "LICENSED PRODUCT(S)" shall mean a molecule, or gene encoding a molecule,
comprising (i) all or an interleukin-1 binding portion of the amino acid
sequence for [******************************************]; and (ii)
[****************************]. For the avoidance of doubt, a Licensed Product
may be a [***********************]. For the further avoidance of doubt, the TRAP
Product shall be included within the definition of Licensed Product. [**********
******************].
1.26 "LOSSES" shall mean liabilities, costs, settlements, damages, expenses
and/or losses, including reasonable attorneys' fees, except as set forth in
Section 7.1(c).
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1.27 "MERGER" shall mean the merger between AMS Acquisition Inc. (a Washington
corporation and wholly owned subsidiary of Amgen) and Immunex as contemplated in
the Amended and Restated Agreement and Plan of Merger by and among Amgen Inc.,
AMS Acquisition Inc. and Immunex Corporation dated as of December 16, 2001 (or
any other means of effecting the merger between Amgen and Immunex).
1.28 "NET SALES" shall mean [************************************].
1.29 "OTHER MOLECULE(S)" shall mean any active ingredient or finished product
containing an active ingredient (or class of active ingredient(s) or finished
product(s) containing an active ingredient(s)) that is not a Licensed Product
(e.g. a TNF inhibitor).
1.30 "PARTY" shall mean Amgen, Immunex or Regeneron, as the case may be, and
"PARTIES" shall mean Amgen, Immunex and Regeneron, collectively.
1.31 "PATENT RIGHTS" shall mean all pending patent applications and issued
patents, in each case as of the Effective Date; and, solely with respect to the
subject matter contained in such patent applications and issued patents, (i) all
national, regional and international patent applications filed either from such
patent applications or priority applications or from an application claiming
priority from either of these, including, without limitation, divisionals,
continuations, continuations-in-part, provisionals, converted provisional,
continued prosecution application, (ii) any and all patents that have issued or
in the future issue from the foregoing patent applications, including, without
limitation, utility, model and design patents and certificates of invention, and
(iii) any and all extensions or restorations by existing or future extension or
restoration mechanisms, including without limitation, substitutions,
re-examinations, revalidations, reissues, renewals, extensions (including any
supplementary protection certificate) or any confirmation patent or registration
patent or patent of additions to any such foregoing patent applications and
patents.
1.32 "PERSON" shall mean an individual, a partnership, a joint venture, a
corporation, a trust, an estate, an unincorporated organization, or any other
entity, or a government or any department or agency thereof.
1.33 "PROMOTE", as used in Section 2.3(a) and Section 2.4(a), shall mean any
activity in connection with the promotion, marketing and/or detailing of a
product. For the avoidance of doubt, the making and/or actual selling and/or
distribution of a product shall not be included within the definition of
Promote.
1.34 "SUBLICENSEE" shall mean a Third Party to whom Regeneron has granted a
sublicense pursuant to Section 2.2.
1.35 "TERRITORY" shall mean all countries of the world.
1.36 "THIRD PARTY" shall mean any Person other than Amgen, Immunex, Regeneron,
and their respective Affiliates.
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1.37 "TRAP PRODUCT" shall mean a molecule comprising (i)
[**********************************]; and (ii) all or a portion (which portion
must, together with the polypeptide having the sequence referenced in subsection
(i) above, participate in the binding of interleukin-1) of the interleukin-1
accessory protein as described by [****************************]; wherein the
molecule is capable of binding interleukin-1. By way of example, TRAP Products
shall include the product identified [******************************]. For
avoidance of doubt, TRAP Product is included within the definition of Licensed
Product. [************************************].
ARTICLE 2
GRANT OF RIGHTS
2.1 GRANT TO REGENERON.
(a) On the terms and conditions set forth herein, Immunex hereby grants
to Regeneron and its Affiliates a non-exclusive license, with a limited right to
grant sublicenses solely pursuant to Section 2.2 herein, under the Immunex
Licensed Patent Rights to make, have made, use, sell, offer for sale and import
Licensed Products in the Field of Use anywhere in the Territory.
(b) On the terms and conditions set forth herein, Amgen hereby grants
to Regeneron and its Affiliates a non-exclusive license, with a limited right to
grant sublicenses solely pursuant to Section 2.2 herein, under the Amgen
Licensed Patent Rights to make, have made, use, sell, offer for sale and import
Licensed Products in the Field of Use anywhere in the Territory.
2.2 SUBLICENSES. Regeneron shall have the limited right to grant sublicenses
under the rights granted under Sections 2.1(a) and 2.1(b) on a country by
country basis, to [******************************]. For the avoidance of doubt,
[**************************] shall not be considered a Sublicensee for purposes
of this Section 2.2. Regeneron acknowledges and agrees that any sublicense
granted pursuant to this Section 2.2 shall be consistent with, and expressly
subject to, the covenants, terms and conditions set forth in this Agreement, and
shall terminate upon termination of this Agreement. Regeneron, its Affiliates
and each Sublicensee shall each be permitted to engage the services of one or
more Co-Promoters/Co-Marketers in any country in the Territory. For the
avoidance of doubt, in addition to the sublicensing rights set forth in this
Section 2.2, Regeneron and its Affiliates shall have the right to engage the
services of a contract sales force in any country in the Territory and such
service providers shall not be considered Sublicensees for purposes of this
Section 2.2. [***************************]. Regeneron agrees to remain liable
for the obligations, including the payment of royalties, of each Sublicensee as
required pursuant to this Agreement; provided that no act or failure to act by
any Sublicensee can be considered a Default on the part of Regeneron (but
Regeneron shall remain liable for its obligations (and the obligations of its
Affiliates and each Sublicensee) to Amgen or Immunex under this Agreement).
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2.3 IMMUNEX COVENANT NOT TO SUE.
(a) Neither Immunex nor any of its Affiliates shall ever, anywhere in
the world, institute or prosecute (or in any way aid any Third Party in
instituting or prosecuting), at law or in equity, any claim, demand, action or
cause of action for damages, costs, expenses or compensation, or for an
enjoinment, injunction, or any other equitable remedy, against Regeneron, its
Affiliates, Sublicensees, suppliers, distributors, Co-Promoters/Co-Marketers,
vendors or customers alleging the infringement of any Immunex Patent Rights in
its making, having made, using, selling, offering to sell, or importing of (i)
any Licensed Product, or (ii) any product which includes or incorporates a
Licensed Product in any manner to the extent that the alleged infringement is
based on the manufacture, use, sale, offer to sell, or importation of the
Licensed Product or Licensed Product portion in such product.
Pursuant to this covenant, Regeneron, its Affiliates, Sublicensees,
suppliers, distributors, Co-Promoters/Co-Marketers, vendors or customers may,
under Immunex Patent Rights, make, have made, use, sell, offer to sell or import
any Licensed Product in combination with an Other Molecule(s). Notwithstanding
the foregoing, if the making, having made, using, offering to sell, selling or
importing of an Other Molecule(s) would infringe any claim within the Immunex
Patent Rights, other than in any Immunex Combination Product Claims, Regeneron,
its Affiliates, Sublicensees, suppliers, distributors,
Co-Promoters/Co-Marketers, vendors or customers shall have no right under such
claims to make, have made, use, offer to sell, sell or import such Other
Molecule(s), except that Regeneron, its Affiliates, Sublicensees and
Co-Promoters/Co-Marketers shall have the right under all Immunex Patent Rights
solely to pre-clinically and clinically test and to Promote the combination use
of such Other Molecule(s) with the Licensed Product.
Immunex further covenants and agrees that, in the event Immunex or its
Affiliate grants or transfers any rights under any Immunex Patent Rights which,
Immunex in good faith believes is reasonably likely to be subject to this
covenant, to any Third Party, such grant or transfer of rights shall be only
upon the condition that the Third Party agrees, in writing, to grant Regeneron,
its Affiliates, Sublicensees, suppliers, distributors,
Co-Promoters/Co-Marketers, vendors and customers immunity from suit as set forth
in this Section 2.3(a) and agrees to Regeneron being a third party beneficiary
under such grant or transfer to the extent it relates to such immunity from
suit. For the avoidance of doubt, subject to Section 8.3, the preceding sentence
shall not operate to require Immunex or its Affiliates to maintain or renew any
Third Party agreement pursuant to which it currently has Control of any Immunex
Patent Rights; subject to Section 8.3, the reversion of rights to the original
possessor thereof upon such failure to maintain or renew such Third Party
agreement shall not be considered a grant or transfer that is subject to the
requirements of the first sentence of this paragraph, unless such reversion is
the result of a new agreement with such Third Party pursuant to which such Third
Party pays consideration to Immunex or its Affiliates in connection with the
reversion.
(b) In the event that Immunex or any of its Affiliates comes to Control
After-Acquired Patent Rights, Immunex (on its own behalf and on behalf of its
Affiliates)
8
covenants to use good faith efforts to obtain, as part of its "Control", the
right to grant to Regeneron those rights obtainable on the following conditions
and Regeneron shall have the right to include such After-Acquired Patent Rights
within the definition of Immunex Patent Rights solely on the following
conditions:
(i) At any time following Immunex or any of its Affiliates
coming to Control any After-Acquired Patent Rights, either Immunex or Regeneron
may provide written notice to the other that such After-Acquired Patents Rights
are to be considered for inclusion within the definition of the Immunex Patent
Rights ("Initial Notice"). Regardless of which Party provides the Initial
Notice, within thirty (30) days after such Initial Notice, Immunex shall provide
to Regeneron a description of the relevant circumstances related to the
acquisition of the After-Acquired Patent Rights, and shall inform Regeneron of
the consequent consideration required for Regeneron to include such
After-Acquired Patent Rights (the "Offered After-Acquired Patent Rights") within
the definition of Immunex Patent Rights, as set forth below and in Exhibit E,
attached hereto. Such notice (the "Offering Notice") shall include (a) complete
copies of any patents included in such Offered After-Acquired Patent Rights, and
[*******************************************]. Immunex shall use all reasonable
efforts to obtain any necessary consents from the relevant Third Party to permit
the disclosure to Regeneron of the information required in the Offering Notice.
Immunex shall be required to respond promptly to all reasonable questions raised
by Regeneron in connection with Regeneron's review of the Offered After-Acquired
Patent Rights and the contractual provisions. Regeneron shall have the right,
within ninety (90) days after receipt of such notice, to notify Immunex in
writing whether Regeneron elects to include such patents in the Immunex Patent
Rights, and [********************]. Upon such election, the Offered
After-Acquired Patent Rights shall thereafter be included in the definition of
Immunex Patent Rights; if Regeneron elects not to agree to such consideration
with respect to the Offered After-Acquired Patent Rights, or fails to timely
make its election, any such Offered After-Acquired Patent Rights shall continue
to be excluded from the definition of Immunex Patent Rights. Regeneron shall
have the right to terminate its license for any After-Acquired Patent Rights on
thirty (30) days prior written notice signed by a duly authorized officer of
Regeneron; the effect of such termination shall be that such After-Acquired
Patent Rights shall thereafter be excluded from the definition of Immunex Patent
Rights. For the avoidance of doubt, each After-Acquired Patent Right (or set of
rights) is only subject to the Regeneron option for inclusion set forth in this
subsection on one occasion; that is, if Regeneron elects not to agree to include
Offered After-Acquired Patent Rights within the Immunex Patent Rights (or fails
to timely make such election) following the Offering Notice with respect to such
Offered After-Acquired Patent Rights, Regeneron shall not have the option to
later include those same Offered After-Acquired Patent Rights within the Immunex
Patent Rights. For the avoidance of doubt, the rejection of a particular patent
or claim offered as an Offered After-Acquired Patent Right under this Section
shall not operate to limit Regeneron's rights with respect to any other issued
patents or claims that were not offered as Offered After-Acquired Patent Rights,
even if such patent or claims which were not offered were obtained from the same
Third Party, or pursuant to the same Third Party Agreement, as the Offered
After-Acquired Patent Rights which were rejected.
For the avoidance of doubt, any intellectual property rights acquired
by Immunex after the Effective Date (such that Immunex's or its Affiliate's
rights to the applicable
9
patents and/or patent applications first arise after the Effective Date) shall
be excluded from the definition of Immunex Patent Rights unless meeting the
definition of After-Acquired Patent Rights and specifically included by
operation of this Section 2.3(b).
[****************************************]
[****************************************]
[****************************************]
For the avoidance of doubt, each distinct time Immunex obtains Control
of After-Acquired Patent Rights, this Section 2.3(b)
[***************************************] shall operate. All After-Acquired
Patent Rights obtained in one transaction (or series of related transactions)
from one Third Party shall be considered a set, and this Section 2.3(b)
[******************************) shall apply only once to such a set of
After-Acquired Patent Rights, regardless of how many patents or patent
applications are acquired in that one transaction (or series of related
transactions).
(c) Notwithstanding 2.3(a) above,
[************************************], Immunex shall provide reasonably timely
notice to Regeneron of the Third Party obligation with respect to any such
patent. Such notice (the "Offering Notice") shall include (a) complete copies of
any patents included in such Pass-Through Patent Rights, and
[*********************************]. Immunex shall use all reasonable efforts to
obtain any necessary consents from the relevant Third Party to permit the
disclosure to Regeneron of the information required in the notice contemplated
herein. Immunex shall be required to respond promptly to all reasonable
questions raised by Regeneron in connection with Regeneron's review of the
Pass-Through Patent Rights and the contractual provisions. Regeneron shall have
the right, [****************************************]. Upon such election, the
Pass-Through Patent Rights shall thereafter be included in the definition of
Immunex Patent Rights; if Regeneron elects not to accept such obligation with
respect to any patent or fails to timely make its election, any such patent
shall be excluded from the definition of Immunex Patent Rights. Regeneron shall
have the right to terminate its license of any Pass-Through Patent Rights on
thirty (30) days prior written notice signed by a duly authorized officer of
Regeneron. For the avoidance of doubt, each Pass-Through Patent Right (or set of
rights) is only subject to the Regeneron option for inclusion set forth in this
subsection on one occasion; that is, if Regeneron elects not to agree to include
Pass-Through Patent Rights within the Immunex Patent Rights (or fails to timely
make such election) following the Offering Notice with respect to such
Pass-Through Patent Rights, Regeneron shall not have the option to later include
those same Pass-Through Patent Rights within the Immunex Patent Rights.
This Section 2.3(c) shall not apply with respect to [********************
**************].
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(d) For the avoidance of doubt, the covenants set forth in Section
2.3(a) above shall terminate upon the termination of this Agreement, including,
without limitation, any termination arising from the breach of this Agreement by
Regeneron.
2.4 AMGEN COVENANT NOT TO SUE.
(a) Neither Amgen nor any of its Affiliates shall ever, anywhere in the
world, institute or prosecute (or in any way aid any Third Party in instituting
or prosecuting), at law or in equity, any claim, demand, action or cause of
action for damages, costs, expenses or compensation, or for an enjoinment,
injunction, or any other equitable remedy, against Regeneron, its Affiliates,
Sublicensees, suppliers, distributors, Co-Promoters/Co-Marketers, vendors or
customers alleging the infringement of any Amgen Patent Rights in its making,
having made, using, selling, offering to sell, or importing of (i) any Licensed
Product, or (ii) any product which includes or incorporates a Licensed Product
in any manner to the extent that the alleged infringement is based on the
manufacture, use, sale, offer to sell, or importation of the Licensed Product or
Licensed Product portion in such product.
Pursuant to this covenant, Regeneron, its Affiliates, Sublicensees,
suppliers, distributors, Co-Promoters/Co-Marketers, vendors or customers may,
under Amgen Patent Rights, make, have made, use, sell, offer to sell or import
any Licensed Product in combination with an Other Molecule(s). Notwithstanding
the foregoing, if the making, having made, using, offering to sell, selling or
importing of an Other Molecule(s) would infringe any claim within the Amgen
Patent Rights, other than in any Amgen Combination Product Claims, Regeneron,
its Affiliates, Sublicensees, suppliers, distributors, Co-Promoters/
Co-Marketers, vendors or customers shall have no right under such claims to
make, have made, use, offer to sell, sell or import such Other Molecule(s),
except that Regeneron, its Affiliates, Sublicensees and
Co-Promoters/Co-Marketers shall have the right under all Amgen Patent Rights
solely to pre-clinically and clinically test and to Promote the combination use
of such Other Molecule(s) with the Licensed Product.
Amgen further covenants and agrees that, in the event Amgen or its
Affiliate grants or transfers any rights under any Amgen Patent Rights which,
Amgen in good faith believes is reasonably likely to be subject to this
covenant, to any Third Party, such grant or transfer of rights shall be only
upon the condition that the Third Party agrees, in writing, to grant Regeneron,
its Affiliates, Sublicensees, suppliers, distributors, Co-Promoters/
Co-Marketers, vendors and customers immunity from suit as set forth in this
Section 2.4(a) and agrees to Regeneron being a third party beneficiary under
such grant or transfer to the extent it relates to such immunity from suit. For
the avoidance of doubt, subject to Section 8.3, the preceding sentence shall not
operate to require Amgen or its Affiliates to maintain or renew any Third Party
agreement pursuant to which it currently has Control of any Amgen Patent Rights;
subject to Section 8.3, the reversion of rights to the original possessor
thereof upon such failure to maintain or renew such Third Party agreement shall
not be considered a grant or transfer that is subject to the requirements of the
first sentence of this paragraph, unless such reversion is the result of a new
agreement with such Third Party pursuant to which such Third Party pays
consideration to Amgen or its Affiliates in connection with the reversion.
11
(b) In the event that Amgen or any of its Affiliates comes to Control
After-Acquired Patent Rights, Amgen (on its own behalf and on behalf of its
Affiliates) covenants to use good faith efforts to obtain, as part of its
"Control", the right to grant to Regeneron those rights obtainable on the
following conditions and Regeneron shall have the right to include such
After-Acquired Patent Rights within the definition of Amgen Patent Rights,
solely on the following conditions:
(i) At any time following Amgen or any of its Affiliates
coming to Control any After-Acquired Patent Rights, either Amgen or Regeneron
may provide written notice to the other that such After-Acquired Patents Rights
are to be considered for inclusion within the definition of the Amgen Patent
Rights ("Initial Notice"). Regardless of which Party provides the Initial
Notice, within thirty (30) days after such Initial Notice, Amgen shall provide
to Regeneron a description of the relevant circumstances related to the
acquisition of the After-Acquired Patent Rights, and shall inform Regeneron of
the consequent consideration required for Regeneron to include such
After-Acquired Patent Rights (the "Offered After-Acquired Patent Rights") within
the definition of Amgen Patent Rights, as set forth below and in Exhibit E,
attached hereto. Such notice (the "Offering Notice") shall include (a) complete
copies of any patents included in such Offered After-Acquired Patent Rights, and
[*************************************]. Amgen shall use all reasonable efforts
to obtain any necessary consents from the relevant Third Party to permit the
disclosure to Regeneron of the information required in the Offering Notice.
Amgen shall be required to respond promptly to all reasonable questions raised
by Regeneron in connection with Regeneron's review of the Offered After-Acquired
Patent Rights and the contractual provisions. Regeneron shall have the right,
within ninety (90) days after receipt of such notice, to notify Amgen in writing
whether Regeneron elects to include such Patents in the Amgen Patent Rights,
[*******************************]. Upon such election, the Offered
After-Acquired Patent Rights shall thereafter be included in the definition of
Amgen Patent Rights; if Regeneron elects not to agree to such consideration with
respect to the Offered After-Acquired Patent Rights, or fails to timely make its
election, any such Offered After-Acquired Patent Rights shall continue to be
excluded from the definition of Amgen Patent Rights. Regeneron shall have the
right to terminate its license for any After-Acquired Patent Rights on thirty
(30) days prior written notice signed by a duly authorized officer of Regeneron;
the effect of such termination shall be that such After-Acquired Patent Rights
shall thereafter be excluded from the definition of Amgen Patent Rights. For the
avoidance of doubt, each After-Acquired Patent Right (or set of rights) is only
subject to the Regeneron option for inclusion set forth in this subsection on
one occasion; that is, if Regeneron elects not to agree to include Offered
After-Acquired Patent Rights within the Amgen Patent Rights (or fails to timely
make such election) following the Offering Notice with respect to such Offered
After-Acquired Patent Rights, Regeneron shall not have the option to later
include those same Offered After-Acquired Patent Rights within the Amgen Patent
Rights. For the avoidance of doubt, the rejection of a particular patent or
claim offered as an Offered After-Acquired Patent Right under this Section shall
not operate to limit Regeneron's rights with respect to any other issued patents
or claims that were not offered as Offered After-Acquired Patent Rights, even if
such patent or claims which were not offered were obtained from the same Third
Party, or pursuant to the same Third Party Agreement, as the Offered
After-Acquired Patent Rights which were rejected.
12
For the avoidance of doubt, any intellectual property rights acquired
by Amgen after the Effective Date (such that Amgen's or its Affiliate's rights
to the applicable patents and/or patent applications first arise after the
Effective Date) shall be excluded from the definition of Amgen Patent Rights
unless meeting the definition of After-Acquired Patent Rights and specifically
included by operation of this Section 2.4(b).
[*******************************************]
[*******************************************]
[*******************************************]
For the avoidance of doubt, each distinct time Amgen obtains Control of
After-Acquired Patent Rights, this Section 2.4(b) [****************************]
shall operate. All After-Acquired Patent Rights obtained in one transaction (or
series of related transactions) from one Third Party shall be considered a set,
and this Section 2.4(b) [*******************************************] shall
apply only once to such a set of After-Acquired Patent Rights, regardless of how
many patents or patent applications are acquired in that one transaction (or
series of related transactions).
(c) [***********************************************************],
Amgen shall provide reasonably timely notice to Regeneron of the Third Party
obligation with respect to any such patent. Such notice (the "Offering Notice")
shall include (a) complete copies of any patents included in such Pass-Through
Patent Rights, [*******************************************************] Amgen
shall use all reasonable efforts to obtain any necessary consents from the
relevant Third Party to permit the disclosure to Regeneron of the information
required in the notice contemplated herein. Amgen shall be required to respond
promptly to all reasonable questions raised by Regeneron in connection with
Regeneron's review of the Pass-Through Patent Rights and the contractual
provisions.[*******************************************************************]
Upon such election, the Pass-Through Patent Rights shall thereafter be included
in the definition of Amgen Patent Rights; if Regeneron elects not to accept such
obligation with respect to any patent or fails to timely make its election, any
such patent shall be excluded from the definition of Amgen Patent Rights.
Regeneron shall have the right to terminate its license of any Pass-Through
Patent Rights on thirty (30) days prior written notice signed by a duly
authorized officer of Regeneron. For the avoidance of doubt, each Pass-Through
Patent Right (or set of rights) is only subject to the Regeneron option for
inclusion set forth in this subsection on one occasion; that is, if Regeneron
elects not to agree to include Pass-Through Patent Rights within the Amgen
Patent Rights (or fails to timely make such election) following the Offering
Notice with respect to such Pass-Through Patent Rights, Regeneron shall not have
the option to later include those same Pass-Through Patent Rights within the
Amgen Patent Rights.
This Section 2.4(c) shall not apply [*********************************
************************]
13
(d) For the avoidance of doubt, the covenants set forth in Section
2.4(a) above shall terminate upon the termination of this Agreement, including,
without limitation, any termination arising from the breach of this Agreement by
Regeneron.
2.5 NO OTHER RIGHTS. Except for the rights expressly granted under this
Agreement, no right, title or interest of any nature is granted under this
Agreement by any Party to any other Party, or any Affiliate of any Party, or to
any Third Party. For the avoidance of doubt, Amgen and Immunex are only
licensing Patent Rights under this Agreement and neither Amgen nor Immunex (nor
any of their respective Affiliates) shall have any obligation to transfer or
grant licenses to any know-how including, without limitation, trade secrets,
inventions, information and data, results, and materials, even if such know-how
is claimed by any Patent Rights subject to this Agreement. The Parties
acknowledge that the Amgen Licensed Patent Rights and the Immunex Licensed
Patent Rights include claims not covering Licensed Product(s), as defined
herein, such as claims only covering TNF receptors, and the Parties further
acknowledge that it is not the intent of the Parties to convey to Regeneron any
rights to such claims pursuant to this Agreement.
2.6 CONDITION PRECEDENT. For the avoidance of doubt, all licenses and other
rights provided in this Article 2 shall commence effective as of the Grant
Commencement Date.
ARTICLE 3
CONSIDERATION
3.1 ROYALTIES. In consideration for the licenses and other rights granted under
Article 2, Regeneron agrees to pay royalties with respect to its total sales of
Licensed Product if and to the extent required by the terms of Article 3.
(a) Regeneron shall pay to Immunex (or Amgen if applicable) a royalty,
calculated as a sum of the following royalties:
(i) Base Royalty. (A) [*******************************] of each
Licensed Product in any country in the Territory if the making, having made,
using, offering to sell, selling or importing of such Licensed Product by
Regeneron, its Affiliates or its Sublicensees (or the distributors of any of
them), in the absence of this Agreement, would infringe one or more issued
claims of the Immunex Licensed Patent Rights in the country where such making,
having made, using, offering to sell, selling or importing took place, that have
not lapsed, been abandoned or been declared invalid by an unappealable judgment
of a court of competent jurisdiction in such country.
(B) In the event that sales of a Licensed Product by
Regeneron would not trigger a royalty payment pursuant to Section 3.1(a)(i)(A)
above, but the making, having made, using, offering to sell, selling or
importing of such Licensed Product by Regeneron, its
14
Affiliates or its Sublicensees (or the distributors of any of them), in the
absence of this Agreement, would infringe one or more issued claims of the Amgen
Licensed Patent Rights in the country where such making, having made, using,
offering to sell, selling or importing took place, that have not lapsed, been
abandoned or been declared invalid by an unappealable judgment of a court of
competent jurisdiction in any such country, Regeneron shall pay
[************************] of each such Licensed Product in such country to
Amgen, rather than Immunex. For the avoidance of doubt, if a royalty is due
Immunex under Section 3.1(a)(i)(A), no royalty shall be due Amgen pursuant to
this Section 3.1(a)(i)(B).
(C) In the event that sales of a Licensed Product by
Regeneron would not trigger a royalty payment pursuant to Section 3.1(a)(i)(A)
above nor pursuant to Section 3.1(a)(i)(B) above, but the making, having made,
using, offering to sell, selling or importing of such Licensed Product by
Regeneron, its Affiliates or its Sublicensees (or the distributors of any of
them), infringe or in the absence of this Agreement, would infringe one or more
issued claims of the Immunex Patent Rights or Amgen Patent Rights subject to the
covenants contained in Section 2.3(a) above or Section 2.4(a) above, in the
country where such making, having made, using, offering to sell, selling or
importing took place, that have not lapsed, been abandoned or been declared
invalid by an unappealable judgment of a court of competent jurisdiction in any
such country, Regeneron shall pay [**************************] of each such
Licensed Product in such country to Immunex or Amgen, as appropriate, based on
whether it is the Immunex Patent Rights that are implicated or the Amgen Patent
Rights. (If both, payment shall be made half to Immunex, and half to Amgen.) For
the avoidance of doubt, if a royalty is due under either Section 3.1(a)(i)(A) or
Section 3.1(a)(i)(B) with respect to a Licensed Product, no royalty shall be due
pursuant to this Section 3.1(a)(i)(C) with respect to such Licensed Product.
(D) For the avoidance of doubt, in no event shall the
royalty payments pursuant to this Section 3.1(a)(i) exceed
[*************************] of each Licensed Product subject to the royalty
provisions of (A), (B) and/or (C) above.
(ii) Aventis Pass-Through Royalty. Regeneron shall pay to
Immunex [***********************************************************]unless all
of the issued claims of the Amgen Patent Rights and Immunex Patent Rights,
collectively, expire prior to the royalty term specified in the Aventis Consent
and Agreement, in which case, from the time of such expiration, royalties shall
no longer be due under this Section 3.1(ii).
(A) Acknowledgement. Regeneron and Immunex
acknowledge that the Aventis Pass-Through Royalty is owed by
Immunex to Aventis under the Immunex-Hoechst Receptor
Agreement (as modified by the Aventis Consent and Agreement)
on sales of any Licensed Products by Regeneron under this
Agreement, for the duration and under such terms set forth in
the Aventis Consent and Agreement, provided the
Immunex-Hoechst Receptor Agreement has not expired or been
terminated. [**************************************]
(b) [*****************************************************]
(c) [*****************************************************]
15
3.2 COMPENSATION TERM.
(a) Unless this Agreement is earlier terminated in accordance with
Article 9 hereof, Regeneron's obligation to pay royalties under
Section 3.1(a) shall expire on a Licensed Product-by-Licensed
Product and country-by-country basis:
(i) under Section 3.1(a)(i), [**************************
*****]
(ii) under Section 3.1(a)(ii), [*************************
******]
(b) [******************************************]
(c) [******************************************]
(d) [************************************]
3.3 [************************************************************]
3.4 PAYMENT OF ROYALTIES; REPORTS.
(a) First Commercial Sale. Regeneron shall report to an independent
certified public accountant chosen jointly by Amgen and Immunex and reasonably
acceptable to Regeneron ("Independent Accountant") the date of First Commercial
Sale of a Licensed Product in each country in the Territory within
[****************] after such occurrence.[************************************].
(b) Statements. Beginning with the calendar quarter during which
occurred the First Commercial Sale of a Licensed Product, Regeneron shall
deliver to Independent Accountant, within [***************] after the end of
each calendar quarter, a statement separately setting forth
[**********************************************].
(c) Currency. If Net Sales are received in a currency other than United
States Dollars, the Net Sales for the purpose of calculating payments hereunder
shall be determined in the applicable foreign currency and then converted into
its equivalent in United States Dollars at the rate of exchange applicable on
the last business day of the calendar quarter in respect of which the funds are
payable using the currency exchange rates quoted by the Wall Street Journal,
Eastern Edition, during the period of such Net Sales.
[**************************************]
(d) Taxes. [***********************************************] Regeneron
will furnish Immunex or Amgen, as appropriate, with the original copies of all
official receipts for such taxes. In the event of any such withholding,
Regeneron and
16
Immunex or Amgen, as appropriate, shall confer regarding other measures to
minimize such withholding.
(e) Overdue Payments. Overdue payments hereunder shall be subject to a
late payment charge calculated at an annual rate of
[****************************]. If the amount of such charge exceeds the maximum
permitted by law, such charge shall be reduced to such maximum.
ARTICLE 4
RECORDS; AUDIT
4.1 RECORD RETENTION. Regeneron shall use commercially reasonable efforts to
maintain, and shall use commercially reasonable efforts (which shall include
obtaining and enforcing a contractual commitment) to cause each of its
Affiliates and its Sublicensees to maintain, full, true and accurate books and
records, in all material respects, containing particulars required to determine
the correctness of any payment of royalties due pursuant to this Agreement. Such
records shall be retained for at least the longer of one (1) year after
completion of an audit thereof pursuant to Section 4.2 if an audit has been
requested or of three (3) years following the year in which any such payments
were made hereunder.
4.2 ROYALTY AUDIT. [*************************], Regeneron agrees to make its
records for payment of royalties due, available for examination by the
Independent Accountant at the expense of Amgen and Immunex (except as otherwise
set forth in this Section 4.2), to examine, in confidence (upon at least thirty
(30) days prior written notice and during Regeneron's regular business hours),
Regeneron's records as may be necessary to determine the correctness of any
payment of royalties hereunder made by Regeneron. Regeneron shall enter into a
separate confidentiality agreement directly with such Independent Accountant.
The report of such Independent Accountant shall be limited to a certificate
verifying any report made or payment submitted by Regeneron during such period
but may include, in the event the Independent Accountant shall be unable to
verify the correctness of any or all of such payment, the unverifiable amount of
such payment and information relating to why any or all of such payment is
unverifiable, and Regeneron shall receive a copy of each such report
concurrently with receipt by Immunex or Amgen, as appropriate. All information
contained in any such certificate shall be deemed to be the Confidential
Information of Regeneron. [****************************************]
ARTICLE 5
PATENTS
5.1 IMMUNEX PATENT RIGHTS. As among the Parties, Immunex shall have the sole
right, at its sole discretion and at its expense, to file, prosecute, defend,
maintain (subject to Section 8.3) and enforce Immunex Patent Rights.
17
5.2 AMGEN PATENT RIGHTS. As among the Parties, Amgen shall have the sole right,
at its sole discretion and expense, to file, prosecute, defend, maintain
(subject to Section 8.3) and enforce Amgen Patent Rights.
5.3 PATENT STATUS. Immunex and Amgen each agrees to keep Regeneron advised on of
the status of patent applications and patents within (i) Amgen Patent Rights and
Immunex Patent Rights, as appropriate, for which compensation is then being paid
by Regeneron, (ii) the Amgen Licensed Patent Rights and (iii) the Immunex
Licensed Patent Rights, upon reasonable written request by Regeneron, no more
than once per calendar year.
5.4 NOTIFICATION OF INFRINGEMENT. If Regeneron learns of an infringement by a
Third Party of the Immunex Licensed Patent Rights or the Amgen Licensed Patent
Rights, Regeneron shall promptly notify and shall provide Immunex and Amgen with
available evidence of such infringement.
ARTICLE 6
CONFIDENTIALITY
6.1 CONFIDENTIALITY. For the term of this Agreement and any extensions and for a
period of five (5) years thereafter, each Party agrees to keep confidential and
not publish or otherwise disclose or use for any purpose other than as provided
for in this Agreement, any Confidential Information disclosed to it by another
Party, except that each Party receiving such Confidential Information shall not
be prevented from using or disclosing information:
(a) which it can demonstrate by written records was previously known to
it;
(b) which is, or becomes in the future, public knowledge through no
fault or omission attributable to it;
(c) which is lawfully obtained without restriction by it from sources
independent of the disclosing Party without breach of a confidentiality
obligation; or
(d) which was independently discovered or developed by the disclosing
Party without access to or the use of the disclosing Party's Confidential
Information, as can be documented by written records created at the time of such
independent discovery or development.
6.2. THIS AGREEMENT. The Parties agree that the material terms of the Agreement
shall be considered Confidential Information of all Parties. Notwithstanding the
foregoing, the Parties shall be permitted to disclose in filings with the
Securities Exchange Commission ("SEC") and the Federal Trade Commission ("FTC")
those terms of this Agreement required to be disclosed to either of those
agencies by law or regulation; provided, however, that the Parties shall consult
with one another concerning which terms of this Agreement shall be requested to
be redacted by the SEC or FTC in any public filings by such agencies and,
18
further provided, however, that in the event of a filing, each Party shall seek
confidential treatment in its SEC filings and FTC filings for the royalty rates
set forth in Article 3. In addition, Regeneron shall have the right to issue a
press release concerning this Agreement substantially in the form annexed hereto
as Exhibit F, or, if not provided in Exhibit F, subject to the consent of Amgen
and Immunex, following a reasonable opportunity for review (not to exceed three
(3) business days), such consent not to be unreasonably withheld. Regeneron will
not issue such press release before such time as Immunex and Aventis have fully
executed the Aventis Consent and Agreement. Notwithstanding the above, each
Party shall have the right to disclose in confidence the terms of the Agreement
(a) to parties retained by such Party to perform legal, accounting or similar
services and who have a need to know such terms in order to provide such
services or (b) to prospective assignees, Sublicensees, or
Co-Promoters/Co-Marketers.
6.3 AUTHORIZED DISCLOSURE.
(a) Each Party may disclose Confidential Information belonging to the
disclosing Party to the extent such disclosure is reasonably necessary in the
following:
(i) enforcing and/or defending rights or obligations under this
Agreement; and/or
(ii) complying with any disclosure obligation required by law,
order, rule or regulation of a governmental agency or a court of competent
jurisdiction;
provided however, that the Party required to or intending to disclose the
disclosing Party's Confidential Information under this Section 6.3 shall have
first given prompt notice to the disclosing Party to enable it to seek any
available exemptions from or limitations on such disclosure, and shall
reasonably cooperate in such efforts by the disclosing Party.
ARTICLE 7
INDEMNIFICATION
7.1 INDEMNIFICATION.
(a) Regeneron shall indemnify, defend and hold harmless Immunex, Amgen
and their respective officers, directors, employees, stockholders, agents and
representatives, (collectively, "Amgen/Immunex Indemnitees") from any and all
Losses arising out of or relating to (i) Regeneron's representations or
warranties set forth in this Agreement being untrue in any material respect when
made; (ii) any material breach or material default by Regeneron of its material
covenants and material obligations under this Agreement and (iii) the research,
development, marketing, design, manufacture, distribution, use and/or sale of
Licensed Product by, on behalf of, or under authority of, Regeneron, its
Affiliates or its Sublicensees. Notwithstanding the foregoing, no Amgen/Immunex
Indemnitee shall be
19
entitled to indemnification under this Section 7.1 against any Losses arising
out of an Amgen/Immunex Indemnitee's negligence or willful misconduct.
(b) Amgen and/or Immunex, as appropriate, shall indemnify, defend and
hold harmless Regeneron and its officers, directors, employees, stockholders,
agents and representatives, (collectively, "Regeneron Indemnitees") from any and
all Losses arising out of or relating to (i) Amgen's or Immunex's
representations or warranties set forth in this Agreement being untrue in any
material respect when made; and (ii) any material breach or material default by
Amgen or Immunex of its material covenants and material obligations under this
Agreement. Notwithstanding the foregoing, no Regeneron Indemnitee shall be
entitled to indemnification under this Section 7.1 against any Losses arising
out of a Regeneron Indemnitee's negligence or willful misconduct.
(c) An indemnified Party shall give prompt notice to the indemnifying
Party of any claim for which the indemnified Party may seek indemnification
under Section 7.1 and, provided that the indemnifying Party is not contesting
the indemnity obligation, shall permit the indemnifying Party to control any
litigation relating to such claim and disposition of any claim; provided
however, that the indemnifying party shall not settle or otherwise resolve any
claim that would materially adversely affect the indemnified Party, without
prior approval by the indemnified Party. The indemnified Party shall cooperate
with the indemnifying Party in its defense of any claim for which
indemnification is sought under this Agreement and shall not settle or offer to
settle any such claim without the indemnifying Party's prior written consent. If
the indemnifying Party elects to defend the claim, it shall not be responsible
for attorneys' fees incurred by the indemnified Party without the indemnifying
Party's consent; provided however, that the indemnified Party shall have the
right to retain its own counsel, at its own expense. The failure by the
indemnified Party to deliver notice to the indemnifying party within a
reasonable time after commencement of any such action, if prejudicial to its
ability to defend such action, shall relieve such indemnifying Party of any
liability to the indemnified Party under this Section 7.1 (to the extent the
failure to be provided such notice shall have been prejudicial to the
indemnifying Party's ability to defend such action), but the omission to deliver
notice to the indemnifying Party will not relieve the indemnifying Party of any
liability that it may have to the indemnified Party other than under this
Section 7.1.
7.2 DAMAGES. Except pursuant to Section 7.1, notwithstanding anything to the
contrary in this Agreement, in no event shall a Party be responsible for any
incidental or consequential damages, including without limitation lost profits
or opportunities, and/or damages in connection with Default and/or termination
of this Agreement, incurred by another Party or its Indemnitees hereunder,
provided however, nothing in this Agreement limits or excludes either Party's
liability for fraud or for death or personal injury caused by such Party's own
negligence.
7.3 INSURANCE. Each Party shall maintain, through self-insurance or
commercially-placed insurance, adequate coverage for the indemnification
obligations set forth herein, consistent with biopharmaceutical industry
practices.
20
ARTICLE 8
REPRESENTATIONS, WARRANTIES AND COVENANTS
8.1 REPRESENTATIONS AND WARRANTIES. Each Party represents and warrants as
of the Effective Date:
(a) Corporate Power. It is duly organized and validly existing under the
laws of its state of incorporation and has full corporate power and authority to
enter into this Agreement and to carry out the provisions hereof.
(b) Due Authorization. It is duly authorized to execute and deliver
this Agreement and to perform its obligations hereunder. The Person
executing this Agreement on its behalf has been duly authorized to do so by
all requisite corporate action.
(c) Binding Agreement. The execution, delivery and performance of this
Agreement by it does not conflict with any material agreement, instrument or
understanding, oral or written, to which it is a party or by which it may be
bound, nor violate any material law or regulation of any court, governmental
body or administrative or other agency having jurisdiction over it.
(d) No Action. It is aware of no action, suit, or inquiry or
investigation instituted by any Third Party or governmental agency which
questions or threatens the validity of this Agreement.
Amgen represents and warrants that, to the current actual knowledge of the
appropriate members of its legal and licensing departments following due
inquiry, that, except as set forth in Exhibit G, it is not aware of any
agreements with Third Parties that would limit Amgen's right to grant to
Regeneron and its Affiliates a non-exclusive license under the patent and patent
applications identified in Exhibit A to make, have made, use, sell, offer for
sale and import Licensed Products in the Field of Use anywhere in the Territory.
Immunex represents and warrants that, to the current actual knowledge of the
appropriate members of its legal and licensing departments following due
inquiry, that, except as set forth in Exhibit G, it is not aware of any
agreements with Third Parties that would limit Immunex's right to grant to
Regeneron and its Affiliates a non-exclusive license under the patent and patent
applications identified in Exhibit C or Exhibit D to make, have made, use, sell,
offer for sale and import Licensed Products in the Field of Use anywhere in the
Territory.
8.2 NO OTHER WARRANTIES. Other than as set forth in Section 8.1, no Party makes
any other warranties. Each of Immunex and Amgen does not warrant the validity or
enforceability of its respective Patent Rights and makes no representations
whatsoever with regard to the scope of such Patent Rights, or that such Patent
Rights may be exploited without infringing other patents or other intellectual
property rights of Third Parties. Each of Immunex and Amgen MAKES NO WARRANTIES,
EXPRESSED OR IMPLIED, OF THE MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
of any subject matter defined by the claims of its respective Patent Rights.
Each of Immunex and Amgen
21
does not represent that it will commence legal actions of any kind against Third
Parties for infringement of any of its respective Patent Rights.
8.3 COVENANTS. Immunex and Amgen each agree and covenant that neither it, nor
any of its Affiliates, shall grant, transfer or return any right to any Third
Party which would (a) limit or impair the Control of any Amgen Licensed Patent
Right or any Immunex Licensed Patent Right or (b) conflict with the rights
granted to Regeneron hereunder. Immunex further agrees and covenants that it
shall maintain its right to grant Regeneron rights under Section 2.1 or 2.3, as
the case may be, for the following Immunex Patent Rights: (i) the
Immunex-Hoechst Patent Rights, (ii) After-Acquired Patent Rights for which
Regeneron has paid any Pre-Existing Burden Payments, and (iii) Pass Through
Patent Rights for which Regeneron has paid compensation pursuant to Section
2.3(c). Amgen further agrees and covenants that it shall maintain its right to
grant Regeneron rights under Section 2.4, as the case may be, for the following
Amgen Patent Rights: (i) After-Acquired Patent Rights for which Regeneron has
paid any Pre-Existing Burden Payments, and (ii) Pass Through Patent Rights for
which Regeneron has paid compensation pursuant to Section 2.4(c). Immunex
further covenants that it shall use all reasonable efforts to cause the Aventis
Consent and Agreement to be fully executed by Immunex and Aventis as promptly as
possible following the execution of this Agreement.
ARTICLE 9
TERMINATION
9.1 TERM AND TERMINATION. This Agreement shall automatically terminate upon the
expiration of Regeneron's obligation to pay any compensation under Article 3 of
this Agreement, but not earlier than the expiration of the last to expire of the
issued claims of the Immunex Patent Rights and the Amgen Patent Rights,
collectively.
(a) Termination by Regeneron. Regeneron shall have the unilateral right
to terminate this Agreement at any time on thirty (30) days prior
written notice signed by a duly authorized officer of Regeneron.
(b) Termination for Merger not being Consummated. If the Effective Date
is not on or before July 31, 2003 and the Amended and Restated
Agreement and Plan of Merger by and among Amgen Inc., AMS
Acquisition Inc. and Immunex Corporation dated as of December 16,
2001 has been terminated for any reason, this Agreement shall
automatically terminate.
9.2 DEFAULT.
(a) Default by Regeneron of its Obligations to Immunex. In the event
Immunex believes there has been a Default by Regeneron, Immunex may seek a
remedy, including, if appropriate under the circumstances, to terminate the
rights granted under the Immunex Patent Rights by providing written notice to
Regeneron as provided in the definition of Default, and proceeding in accordance
with the provisions set forth below.
22
(i) If after receipt of the written notice required under the
definition of Default, Regeneron gives notice to Immunex that
it disputes the alleged Default, the Parties will promptly
attempt to resolve the dispute pursuant to paragraph 10.11. If
the dispute is not resolved under paragraph 10.11 at the
expiration of the sixty (60) day cure period referred to in
the definition of Default, Immunex may commence legal
proceedings (or arbitration if agreed upon) to resolve the
dispute whether Regeneron is in Default as alleged and to seek
damages and/or any other remedy, including, if appropriate,
termination of this Agreement. If it is determined that a
Default occurred, the judge (or arbitrator, if appropriate)
shall determine what is the appropriate remedy for the Default
in question. If no such legal claim or cause of action has
been filed (including in arbitration, if appropriate) by
Immunex within one-hundred twenty (120) days following the
written notice required under the definition of Default,
Immunex shall be considered to have waived its right to seek
termination or monetary damages with respect to the actions
underlying the alleged Default; provided, however, that
Immunex shall not be precluded from offering into evidence for
any purpose the events giving rise to any previous allegation
of Default in any legal proceeding brought following a
subsequently alleged Default based on actions other than those
underlying the previously alleged Default. The rights granted
under this Agreement may not be terminated pending resolution
of any legal or arbitration proceedings brought in accordance
with this Section 9.2(a)(i), provided Regeneron timely pays
all consideration due under the Agreement. Upon the successful
termination of such rights pursuant to the procedures set
forth in this Section 9.2(a)(i), all rights granted to
Regeneron under the Immunex Patent Rights shall revert to
Immunex. Moreover, upon the successful termination of such
rights, Amgen shall have the immediate right to terminate the
rights granted to Regeneron under the Amgen Patent Rights by
providing written notice to Regeneron and, upon Regeneron's
receipt of such notice, all rights granted to Regeneron under
the Amgen Patent Rights shall revert to Amgen.
(ii) If the substance of the legal proceeding is whether
royalties or other payments are due under the Agreement and/or
the amount of such royalty or other payment due, and Regeneron
pays the disputed royalty or other amount in order to maintain
the Agreement in effect, and final resolution of the legal
proceedings determines that such disputed royalty or other
payment was not due as alleged, Regeneron shall be entitled to
a full refund of any such disputed royalties or other amounts
paid, together with a payment charge calculated at an annual
rate of three (3) percentage points over the prime rate or
successive
23
prime rates (as posted in the Wall Street Journal) during the
period such amounts were held by Immunex. If the amount of
such charge exceeds the maximum permitted by law, such charge
shall be reduced to such maximum.
(iii) The process provided for in paragraph 10.11 shall be
deemed concluded for purposes of sub-paragraph (i) herein at
such point as either Party sends written notice to the other
Party or Parties stating that the process has concluded.
(iv) For the avoidance of doubt, Immunex may not seek to
terminate this Agreement due to a breach of this Agreement by
Regeneron other than as a result of Regeneron's failure to
perform the specific enumerated obligations identified in the
definition of Default. Termination is not the sole and/or
exclusive remedy for such Defaults. Nothing in this clause
shall be construed as preventing any Party from seeking
recovery of monetary damages for breach of the Agreement,
whether such breach is a Default or not.
(b) Default by Regeneron of its Obligations to Amgen. In the event Amgen
believes there has been a Default by Regeneron, Amgen may seek a remedy,
including, if appropriate, to terminate the rights granted under the Amgen
Patent Rights by providing written notice to Regeneron as provided in the
definition of Default, and proceeding in accordance with the provisions set
forth below.
(i) If after receipt of the written notice required under the
definition of Default, Regeneron gives notice to Amgen that it
disputes the alleged Default, the Parties will promptly
attempt to resolve the dispute pursuant to paragraph 10.11. If
the dispute is not resolved under paragraph 10.11 at the
expiration of the sixty (60) day cure period referred to in
the definition of Default, Amgen may commence legal
proceedings (or arbitration if agreed upon) to resolve the
dispute whether Regeneron is in Default as alleged and to seek
damages and/or any other remedy, including, if appropriate,
termination of this Agreement. If it is determined that a
Default occurred, the judge (or arbitrator, if appropriate)
shall determine what is the appropriate remedy for the Default
in question. If no such legal claim or cause of action has
been filed (including in arbitration, if appropriate) by Amgen
within one-hundred twenty (120) days following the written
notice required under the definition of Default, Amgen shall
be considered to have waived its right to seek termination or
monetary damages with respect to the actions underlying the
alleged Default; provided, however, that Amgen shall not be
precluded from offering into evidence for any purpose the
events giving rise to any previous allegation of Default in
any legal proceeding brought following a
24
subsequently alleged Default based on actions other than those
underlying the previously alleged Default. The rights granted
under this Agreement may not be terminated pending resolution
of any legal or arbitration proceedings brought in accordance
with this Section 9.2(a)(i), provided Regeneron timely pays
all consideration due under the Agreement. Upon the successful
termination of such rights pursuant to the procedures set
forth in this Section 9.1(b)(i), all rights granted to
Regeneron under the Amgen Patent Rights shall revert to Amgen.
Moreover, upon the successful termination of such rights,
Immunex shall have the immediate right to terminate the rights
granted to Regeneron under the Immunex Patent Rights by
providing written notice to Regeneron and, upon Regeneron's
receipt of such notice, all rights granted to Regeneron under
the Immunex Patent Rights shall revert to Immunex.
(ii) If the substance of the legal proceeding is whether
royalties or other payments are due under the Agreement and/or
the amount of such royalty or other payments due, and
Regeneron pays the disputed royalty or other amount in order
to maintain the Agreement in effect, and final resolution of
the legal proceedings determines that such disputed royalty or
other payment was not due as alleged, Regeneron shall be
entitled to a full refund of any such disputed royalties or
other amounts paid, together with a payment charge calculated
at an annual rate of three (3) percentage points over the
prime rate or successive prime rates (as posted in the Wall
Street Journal) during the period such amounts were held by
Amgen. If the amount of such charge exceeds the maximum
permitted by law, such charge shall be reduced to such
maximum.
(iii) The process provided for in paragraph 10.11 shall be
deemed concluded for purposes of sub-paragraph (i) herein at
such point as either Party sends written notice to the other
Party or Parties stating that the process has concluded.
(iv) For the avoidance of doubt, Amgen may not seek to
terminate this Agreement due to a breach of this Agreement by
Regeneron other than as a result of Regeneron's failure to
perform the specific enumerated obligations identified in the
definition of Default. Termination is not the sole and/or
exclusive remedy for such Defaults. Nothing in this clause
shall be construed as preventing any Party from seeking
recovery of monetary damages for breach of the Agreement,
whether such breach is a Default or not.
9.3 INSOLVENCY OR BANKRUPTCY. All rights and licenses granted under or pursuant
to this Agreement to Regeneron are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the United States Bankruptcy Code, licenses of
rights to "intellectual property" as
25
defined under Section 101 of the United States Bankruptcy Code. The Parties
agree that Regeneron shall retain all licenses granted to it hereunder and may
fully exercise all of its rights and elections under the United States
Bankruptcy Code, subject to payment to Immunex or Amgen, as appropriate, of any
compensation due pursuant to Article 3.
9.4 ACCRUED RIGHTS, SURVIVING OBLIGATIONS. Termination, relinquishment or
expiration of this Agreement for any reason shall be without prejudice to any
rights which shall have accrued to the benefit of either Party prior to such
termination, relinquishment or expiration.
9.5 EFFECTS OF TERMINATION. Upon termination or expiration of this Agreement,
(a) The following provisions shall remain in full force and effect:
Article 1, Article 4 (as provided therein), Article 6 (as provided therein),
Article 7, Section 9.4, Section 9.5 and Article 10.
(b) Regeneron, its Affiliates and its Sublicensees shall thereupon have
the right to sell that amount of any such Licensed Product they then have in
their possession or control, provided however, that with respect to any such
Licensed Product for which compensation is due under Article 3, Regeneron shall
pay the amounts due thereunder at the time provided for.
(c) Each Party will upon request promptly return all copies of any
documents, samples or other physical embodiments of the Confidential Information
to the originating Party except each Party may retain one copy in its corporate
files (or with the Independent Accountant) for reference.
(d) No Party hereto shall be released from any liability which, at the
time of such termination, shall have already accrued or which shall be
attributable to a period prior to such termination nor preclude a Party from
pursuing any rights and remedies it may have hereunder or at law or in equity
with respect to any breach of this Agreement.
(e) Except as specifically provided herein, all other rights and
obligations under this Agreement shall terminate upon termination or expiration
of this Agreement, and Regeneron shall no longer be a licensee pursuant to this
Agreement.
ARTICLE 10
MISCELLANEOUS PROVISIONS
10.1 ASSIGNMENT. Neither this Agreement nor any interest hereunder shall be
assignable by any Party without the prior written consent of the other Parties;
provided however, that a Party may assign this Agreement and all of its rights
and obligations hereunder, without such consent, (i) to any Affiliate, provided
such interest shall be retransferred to the relevant Party if such entity ceases
to be an Affiliate of such Party, and provided further that the assigning Party
shall remain responsible for acts and omissions of (including the performance of
this Agreement by) its Affiliate or (ii) to an entity which acquires all or
substantially all of the
26
business to which this agreement pertains, whether by merger, consolidation,
reorganization, acquisition, sale, license or otherwise. This Agreement shall be
binding upon the successors and permitted assigns of a Party, and the name of a
Party appearing herein shall be deemed to include the names of such Party's
successors and permitted assigns to the extent necessary to carry out the intent
of this Agreement. For the avoidance of doubt, Immunex may assign this entire
Agreement and its interests hereunder to Amgen or an Affiliate of Amgen at any
time after the closing of the acquisition of Immunex by Amgen; and, upon such
assignment, reference to "Immunex", "Immunex and Amgen", "Immunex or Amgen" and
"Immunex and/or Amgen", in each instance, shall be deemed reference to "Amgen"
alone. Any assignment not in accordance with this Section 10.1 shall be void.
10.2 COSTS. Each Party shall bear its own legal costs and expenses arising out
of the negotiation, execution and delivery of this Agreement.
10.3 FORCE MAJEURE. No Party shall be liable to the other for Losses, nor shall
have any right to terminate this Agreement for any default or delay attributable
to any Force Majeure, if the Party affected shall give prompt notice of any such
cause to the other Parties. The Party giving such notice shall thereupon be
excused from such of its obligations hereunder as it is thereby disabled from
performing for so long as it is so disabled, provided however, that such
affected Party commences and continues to take reasonable and diligent actions
to cure such cause.
10.4 NOTICES. All notices and other communications required by this Agreement
shall be in writing and shall be deemed given if delivered personally or by
facsimile transmission (receipt verified), mailed by registered or certified
mail (return receipt requested), postage prepaid, or sent by express courier
service, to the Parties at the following addresses (or at such other address for
a Party as shall be specified by like notice, provided however, that notices of
a change of address shall be effective only upon receipt thereof):
If to Regeneron, addressed to:
Regeneron Pharmaceuticals, Inc.
Attention: President
777 Old Saw Mill River Road
Tarrytown, NY 10591-6707
Facsimile: [******************]
With a copy to: Vice President and General Counsel
Facsimile: [*******************]
If to Immunex, addressed to:
Immunex Corporation
51 University Street
Seattle, WA 98101
Facsimile: [*****************]
27
With a copy to: General Counsel
Facsimile: [*****************]
If to Amgen, addressed to:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California USA 91320-1799
Attention: Corporate Secretary
Facsimile: [*****************]
With a copy to: Vice President, Product Licensing
Facsimile: [*****************]
10.5 AMENDMENT. No amendment, modification or supplement of any provision of
this Agreement shall be valid or effective unless made in writing and signed by
a duly authorized officer of each Party.
10.6 WAIVER. Except as set forth herein, no provision of the Agreement shall be
waived by any act, omission or knowledge of any Party or its agents or
employees, except by an instrument in writing expressly waiving such provision
and signed by a duly authorized officer of the waiving Party.
10.7 COUNTERPARTS. This Agreement may be executed in any number of counterparts,
each of which need not contain the signature of more than one Party, but all
such counterparts taken together shall constitute one and the same agreement.
10.8 DESCRIPTIVE HEADINGS. The descriptive headings of this Agreement (including
the headings in any exhibits hereto) are for convenience only, and shall be of
no force or effect in construing or interpreting any of the provisions of this
Agreement.
10.9 GOVERNING LAW. This Agreement shall be governed and interpreted in all
respects under the substantive laws of the State of Delaware as applied to
agreements executed and performed entirely in the State of Delaware by residents
of the State of Delaware, without giving effect to those provisions governing
conflicts of law. The Parties consent to the exclusive jurisdiction of the
Delaware Courts for all matters arising out of or relating to this Agreement,
and further consent that any process, notice of motion or other application to
either such court or judge thereof may be served outside of Wilmington, Delaware
by registered or certified mail or by personal service, provided that a
reasonable time for appearance is allowed. Any dispute, controversy or claim
relating to the scope, validity, enforceability or infringement of Amgen Patent
Rights and/or Immunex Patent Rights in a country shall be governed by the laws
of that country.
10.10 SEVERABILITY. Whenever possible, each provision of this Agreement shall be
interpreted in such manner as to be effective and valid under applicable law,
but if any provision of this Agreement is held to be prohibited by or invalid
under applicable law, such
28
provision shall be ineffective only to the extent of such prohibition or
invalidity, without invalidating the remainder of this Agreement. The Parties
shall make a good faith effort to replace the invalid or unenforceable provision
with a valid one which in its economic effect is most consistent with the
objectives contemplated by the Parties as evidenced by the terms and conditions
of this Agreement when entering into such invalid or unenforceable one.
Invalidity, non-enforceability or expiration of any or all of the Amgen Patent
Rights or Immunex Patent Rights shall not affect Regeneron's license rights in
and to the remaining Amgen Patent Rights and Immunex Patent Rights.
10.11 DISPUTE RESOLUTION. The Parties agree that in the event of a dispute
between and/or among them arising from, concerning or in any way relating to
this Agreement, the Parties shall undertake good faith efforts to resolve any
such dispute in good faith. In the event the Parties shall be unable to resolve
any such dispute, the matter shall be first referred to the general counsel for
each Party for further review and resolution and, if necessary, then to the
chief executive officer of each Party. If after such efforts the Parties are
unable to resolve such dispute, a Party may seek any legal or equitable remedy
available to it.
10.12 INDEPENDENT CONTRACTORS. The relationship among the Parties created by
this Agreement is one of independent contractors, and no Party shall have the
power or authority to bind or obligate the other except as expressly set forth
in this Agreement.
10.13 USE OF NAME. In addition to being subject to Article 6, no right, express
or implied, is granted to a Party by this Agreement to use in any manner any
trademark or trade name of another Party or its Affiliates, including the names
"Amgen", "Immunex" and "Regeneron", without the prior written consent of the
owning Party.
10.14 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.
10.15 NO ADMISSION. This Agreement shall not be construed as an admission of any
Party that any patent is valid, infringed, enforceable, or invalid, not
infringed or not enforceable. This Agreement may not be offered into evidence or
referred to by any Party in any action against another Party for patent
infringement as evidence of an admission respecting infringement or validity of
any patent. Other than in connection with the enforcement of this Agreement,
this Agreement may not be offered into evidence for the purpose of establishing
appropriate damages for infringement of any Patent Rights covered by this
Agreement.
10.16 [*********************************]
* * *
[remainder of page intentionally left blank]
* * *
29
10.17 ENTIRE AGREEMENT OF THE PARTIES. This Agreement (including all Exhibits
attached hereto, which are incorporated herein by reference) shall constitute
and contain the complete, final and exclusive understanding and agreement of the
Parties and cancels and supersedes any and all prior negotiations,
correspondence, representations, promises, understandings and agreements,
whether oral or written, between the Parties respecting the subject matter
thereof.
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement in
duplicate by their respective duly authorized officers.
REGENERON PHARMACEUTICALS, INC.
/s/ Stuart Kolinski
- ------------------------------------------
By: Stuart Kolinski
--------------------------------------
Title: General Counsel
-----------------------------------
Date: June 26, 2002
-----------------------------------
IMMUNEX CORPORATION AMGEN INC.
/s/ Edward V. Fritzky /s/ Scott J. Foraker
- --------------------------------------- -------------------------------------
By: Edward V. Fritzky By: Scott J. Foraker
----------------------------------- -------------------------------------
Title: Chairman and CEO Title: Vice President Licensing
-------------------------------- ------------------------------
Date: June 26, 2002 Date: June 26, 2002
-------------------------------- ------------------------------
30
EXHIBIT A
Amgen Licensed Patent Rights
[********************************************]
F-1
EXHIBIT B
Consent and Agreement Modifying Receptor Agreement
[**********************************************]
F-2
EXHIBIT C
Immunex-Hoechst Patent Rights
[*********************************************]
F-3
EXHIBIT D
Immunex IL-1r Patent Rights
[********************************************]
F-4
EXHIBIT E
Payment Terms for After-Acquired Patent Rights
Pursuant to Section 2.3(b) and 2.4(b), should Regeneron elect to have
After-Acquired Patent Rights included within the Immunex Patent Rights or the
Amgen Patent Rights, respectively, Regeneron must pay the consideration set
forth herein:
[****************************************************************************]
F-5
EXHIBIT F
PRESS RELEASE
REGENERON GRANTED LICENSE BY AMGEN AND IMMUNEX TO INTERLEUKIN-1 INHIBITOR
PATENTS
Tarrytown, NY (June XX, 2002) -- Regeneron Pharmaceuticals (Nasdaq: REGN)
announced that it has entered into an agreement with Amgen Inc. and Immunex
Corporation for a non-exclusive license to certain intellectual property rights
which may be used in the development and commercialization of Regeneron's
interleukin-1 (IL1) Trap. Amgen and Immunex agreed to grant the license to
Regeneron in connection with Amgen's pending acquisition of Immunex, which is
currently under review by the Federal Trade Commission. The license to Regeneron
becomes effective upon the completion of the acquisition.
This license follows two other licensing arrangements under which Regeneron
obtained rights to practice intellectual property for potential use in its IL1
Trap program. The Company gained nonexclusive rights to patents owned by
ZymoGenetics, Inc. covering immunoglobulin-fusion proteins. In addition, [ ]
"The IL1 Trap demonstrated clinical activity in patients with rheumatoid
arthritis in a Phase I trial and a Phase II trial is scheduled to begin
shortly," noted Stuart Kolinski, Regeneron's Vice President and General Counsel.
"Regeneron was able to secure these three licenses to intellectual property
rights, which enhance our existing patent portfolio for the IL1 Trap, in
exchange for total royalties in the mid-single digits.
This news release discusses historical information and includes forward-looking
statements about Regeneron and its products, programs, finances, and business,
all of which involve a number of risks and uncertainties, such as risks
associated with preclinical and clinical development of drugs and biologics,
determinations by regulatory and administrative governmental authorities,
competitive factors, technological developments, the availability and cost of
capital, the costs of developing, producing,
F-6
and selling products, the potential for any collaboration agreement to be
canceled or to terminate without any product success, and other material risks.
A more complete description of these risks can be found in Regeneron's filings
with the United States Securities and Exchange Commission, including its Form
10-K for the year ended December 31, 2001. Regeneron does not undertake any
obligation to update publicly any forward-looking statement, whether as a result
of new information, future events, or otherwise, unless required by law.
Regeneron is a biopharmaceutical company that discovers, develops, and intends
to commercialize therapeutic medicines for the treatment of serious medical
conditions. Regeneron has therapeutic candidates in clinical trials for the
potential treatment of obesity, rheumatoid arthritis, and cancer, and has
preclinical programs in asthma, allergies, and other diseases and disorders.
Regeneron's platform technologies include Targeted Genomics(TM),
Functionomics(TM), and Designer Protein Therapeutics(TM).
###
Contact: Charles Poole
Vice President, Investor Relations
Regeneron Pharmaceuticals, Inc.
charles.poole@regn.com
(914) 345-7641
Media Contact: Jeanne Abi-Nader
Vice President
Robinson, Lerer, Montgomery
jabi-nader@rlmnet.com
(212) 484-7954
Additional information about Regeneron and recent news releases are available on
Regeneron's Worldwide Web Home Page at www.regn.com. Fax copies of news releases
can be obtained from Regeneron's News-on-Demand Service by dialing (800)
311-0841.
F-7
EXHIBIT G
SCHEDULE OF LIMITATIONS OF LICENSED PATENT RIGHTS
[********************************************]
F-8