EXHIBIT 10.14
NON-EXCLUSIVE LICENSE AND MATERIAL TRANSFER AGREEMENT
This Non-Exclusive License and Material Transfer Agreement ("Agreement") is
entered into with an effective date as of February 5, 2007 (the "Effective
Date"), by and between ASTRAZENECA UK LIMITED a company incorporated in England
with a registered office at 00 Xxxxxxxx Xxxx, Xxxxxx X0X 0XX ("Company"), and
Regeneron Pharmaceuticals, Inc. ("Regeneron"), a New York corporation, with a
principal place of business located at 000 Xxx Xxx Xxxx Xxxxx Xxxx, Xxxxxxxxx,
Xxx Xxxx 00000-0000.
WITNESSETH
WHEREAS, Regeneron has developed antibody technology, including
genetically modified mice and related know-how, useful to generate human
monoclonal antibodies;
WHEREAS, Regeneron owns certain patents and patent applications covering
its human antibody technology;
WHEREAS, Company desires to obtain certain non-exclusive licenses under
Regeneron Technology (as defined below), including the right to commercialize
Antibodies (as defined below) generated from the Mice (as defined below), on the
terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the premises and of the mutual
promises and covenants herein contained, Company and Regeneron agree as follows:
ARTICLE I
DEFINITIONS
When used in this Agreement, each of the following terms shall have the
meanings set forth in this Article I:
1.1 "Adjusted Annual Fee" shall mean twenty million United States
dollars (US$20,000,000) adjusted in accordance with the US CPI to reflect any
increase in the US CPI from the month and year of the Transfer Date until the
month and year of the most recently reported US CPI available on the fourth
anniversary of the Transfer Date.
1.2 "Affiliate" shall mean, with respect to a Person, any Person
that controls, is controlled by, or is under common control with such Person.
For purposes of this Section 1.2, "control" shall refer to (a) in the case of a
Person that is a corporate entity, direct or indirect ownership of fifty percent
(50%) or more of the stock or shares having the right to vote for the election
of a majority of the directors of such Person or (b) in the case of a Person
that is an entity, whether or not he, she or it is a corporate entity, the
possession, directly or indirectly, of the power to direct, or cause the
direction of, the management or policies of such Person, whether through the
ownership of voting securities, by contract or otherwise.
1.3 "Antibody" shall mean any antibody, or any derivative, or
fragment thereof, including any fusions comprising any such antibody, derivative
or fragment, that has been Derived from Mice and/or Mice Materials pursuant to
this Agreement and any composition or
formulation that incorporates or includes any such antibody, derivative,
fragment or fusion molecule.
1.4 "Antibody Materials" shall mean [******************].
1.5 "Applicable Law" shall mean all applicable laws, statutes,
rules, regulations, ordinances and other pronouncements having the effect of law
of any court, tribunal, arbitrator, agency, commission, official or other
instrumentality of (a) any government of any country, (b) a federal, state,
province, county, city or other political subdivision thereof or (c) any
supranational body.
1.6 "Approved Third Party" shall mean a Third Party approved by
Regeneron pursuant to Section 3.6.
1.7 "Company Know How" shall have the meaning set forth in Section 7.1(c).
1.8 "Company Patent Rights" shall mean all Patent Rights owned or
Controlled by Company and/or its Affiliates, in each case, which claim any
composition (or portion thereof) or use of the Antibody, Antibody Materials,
Subject Products or Company Know-How.
1.9 "Company Technology" shall mean Company Patent Rights and Company
Know-How.
1.10 "Control" and cognates thereof shall mean the ability by
Regeneron or Company, as the case may be, to grant (whether directly or through
its Affiliates) the right to access or use, or to grant a licence or a
sublicense to, or the right to disclose or transfer Regeneron Technology
(including, without limitation, Mice), Company Technology or other intellectual
property right, or Confidential Information, as the case may be, without
violating the terms of any agreement or other arrangement with, or the rights
of, any Third Party.
1.11 "Derived" and cognates thereof shall mean obtained, developed,
acquired, made, invented, discovered, created, synthesized, designed, or
otherwise generated or resulting from. For the avoidance of doubt, an antibody
or antibody material shall not be deemed Derived from Mice if Company only uses
Company Know-How (other than DNA or amino acid sequence information) to derive
antibodies from sources other than Mice or Mice Materials.
1.12 "Diagnostic Subject Product" shall mean each Subject Product approved
and sold or offered for sale for diagnostic use.
1.13 "Exploit" means to make, have made, import, use, sell, or
offer for sale, including to research, develop, register, modify, enhance,
improve, manufacture, have manufactured, hold/keep (whether for disposal or
otherwise), formulate, optimise, have used, export, transport, distribute,
promote, market or have sold or otherwise dispose or offer to dispose of a
product or process and "Exploitation" shall be construed accordingly.
1.14 "Launch" shall mean the first commercial sale of any Subject
Product by Company or its Affiliate or Licensee to a Third Party in a given
country.
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1.15 "Licensee" shall mean any Third Party that licenses, either
directly or through a sublicense, a Subject Product from Company or any of its
Affiliates. For the avoidance of doubt, the term "Licensee" shall include any
Third Party that licenses a Subject Product from a Licensee but shall not
include a distributor appointed to distribute, market and sell the Subject
Products in a country or region even if that distributor is supplied Subject
Products in unpackaged bulk form; provided that such distributor does not make
any royalty or other payment to Company or any of its Affiliates or Licensees
with respect to the Subject Product or intellectual property rights outside of
the amounts included in the calculation of Net Sales.
1.16 "Mice" shall mean (a) Regeneron's proprietary, genetically
modified mice that are described in Exhibit A [***************************], and
(b) Progeny.
1.17 "Mice Inventions" shall have the meaning set forth in Section 2.4.
1.18 "Mice Materials" shall mean [***************************], but
excluding Antibodies and Antibody Materials.
1.19 "Net Sales" shall mean the gross amounts invoiced by Company,
Company's Affiliates and/or Licensees on sales of Subject Products, less the
following items:
(a) trade, cash and quantity discounts actually allowed and
taken directly with respect to such sales;
(b) tariffs, duties, excises and sales taxes imposed upon
and paid directly with respect to such sales (reduced by any
refunds of such taxes deducted in the calculation of Net Sales
for prior periods and, for the avoidance of doubt, no
deduction shall be permitted for income or similar taxes);
(c) amounts repaid or credited by reason of rejections,
defects, recalls or returns or because of chargebacks, trial
prescriptions or rebates;
(d) invoiced amounts that are written off as uncollectible
in accordance with Company's accounting policies, as
consistently applied over all products of Company, Company's
Affiliates and/or Licensees (reduced by any collections of
such amounts deducted in the calculation of Net Sales for
prior periods); and
(e) as an allowance for transportation costs, distribution
expenses, special packaging and related insurance charges,
[*****************************]
The deductions set forth in clauses (a), (b), (c), (d) and (e) above shall be
determined in accordance with generally accepted accounting principles, as
consistently applied by Company across all of its products. The amounts set
forth in clause (b) above shall only be deducted from gross invoiced sales to
the extent both (i) invoiced by Company, Company's Affiliates or Licensees
separately from sales price amounts for Subject Products and (ii) included in
gross invoiced sales.
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Transfers of Subject Products among Company and Company's Affiliates and
Licensees for the purpose of subsequent resale to Third Parties shall not be
counted for purposes of calculating Net Sales; with respect to such transfers,
the gross amounts invoiced in connection with the subsequent resale of such
Subject Products by Company or its Affiliates or Licensees to Third Parties
shall be included in the calculation of Net Sales.
For purposes of determining Net Sales, the Subject Product(s) shall be deemed to
be sold when invoiced and a "sale" shall not include transfers or dispositions
made without financial consideration for charitable, promotional, preclinical,
clinical, regulatory or governmental purposes.
As used in this paragraph, "Combination Products" means Subject Products that
contain an Antibody as an active ingredient together with one or more other
active ingredients. With respect to Combination Products, the Net Sales used for
the calculation of the royalties under Sections 4 will be adjusted by
multiplying actual Net Sales of such Combination Product by the fraction A /
(A+B), where A is the standard sales price of the Subject Product, containing
the same amount of Antibody as its sole active ingredient as does the
Combination Product in question, in the given country, and B is the standard
sales price of the ready-for-sale form of a product containing, as its sole
active ingredient(s) the same amount of the other therapeutically active
ingredient(s) that is contained in the Combination Product in question, in the
given country. If, on a country-by-country basis, the therapeutically active
ingredient(s) in the Combination Product other than the Subject Product are not
sold separately in that country, Net Sales shall be adjusted by multiplying
actual Net Sales of such Combination Product by the fraction A / C, where C is
the standard sales price of the Combination Product in such country. If, on a
country-by-country basis, neither the Subject Product nor the other active
ingredient(s) of the Combination Product is sold separately in said country, Net
Sales shall be determined between the Parties in good faith.
1.20 "Party" shall mean Regeneron or Company; "Parties" shall mean
Regeneron and Company.
1.21 "Patent Rights" shall mean all patents and patent applications
(including provisional patent applications and any continuations of any such
patent applications, claims in continuations-in-part to the extent such claims
are entirely supported by the specifications of any such patent applications,
and any divisionals, provisionals or substitute applications with respect to any
such patent applications), any patent issued with respect to any such patent
applications, any reissue, reexamination, renewal or extension (including any
supplemental patent certificate) of any such patent, and any confirmation
patent, registration patent, patent of addition, or inventor's certificate based
on or directed to the same invention as any such patent, and all patents and
patent applications anywhere in the world that at any time, directly or
indirectly, claim priority from, support a claim of priority of or contain
substantially identical disclosure as any of the foregoing.
1.22 "Person" shall mean any natural person or any corporation,
company, partnership, limited liability company, joint venture, firm or other
entity, including without limitation a Party.
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1.23 "Progeny" shall mean any mice that are produced or developed by
breeding or otherwise reproducing Mice.
1.24 "Regeneron Know-How" shall mean the trade secrets, unpatented
technical information, specifications, protocols, and procedures described or
referred to in Exhibit A and any unpatented Mice Inventions.
1.25 "Regeneron Patent Rights" shall mean all Patent Rights owned or
Controlled by Regeneron and/or its Affiliates as at the Effective Date and,
subject to Section 2.5, during the term of this Agreement, in each case, which
claim the Mice, Mice Materials or Mice Inventions or the use of the Mice, Mice
Materials or Mice Inventions to make Antibodies in general, including, without
limitation, the Patent Rights that are listed in Exhibit B. For the avoidance of
doubt, Regeneron Patent Rights shall not include (i) any Patent Rights claiming
methods relating to Antibody or Antibody Material generation that are not
directly related to the Mice or Mice Materials and (ii) any Patent Rights
claiming the use of Mice or Mice Materials to make Antibodies against any
specific target.
1.26 "Regeneron Technology" shall mean the Regeneron Know-How and
Regeneron Patent Rights including with respect to any Mice Invention.
1.27 "Royalty Term" shall have the meaning set forth in Section 4.3.
1.28 "SEC" shall mean the United States Securities and Exchange
Commission.
1.29 "Site" shall mean [************************] and any site of a
Company Affiliate or Approved Third Party upon prior written notification of the
address of such facility(ies) to Regeneron.
1.30 "Subject Product" shall mean any product (including, without
limitation, any therapeutic or diagnostic for human or veterinary use) that
contains as an ingredient or component an Antibody or Antibody Materials.
1.31 "Therapeutic Subject Products" shall mean all Subject Products except
for Diagnostic Subject Products.
1.32 "Third Party" shall mean any Person other than Regeneron,
Company, or their respective Affiliates.
1.33 "Transfer Date" shall mean the date upon which the first
delivery of Mice from Regeneron are received by [*************************]
pursuant to Section 3.3.
1.34 "US CPI" shall mean the Consumer Price Index - Urban Wage
Earners and Clerical Workers, U.S. City Average, All Items, 1982-1984 = 100,
published by the United States Department of Labor, Bureau of Statistics (or its
successor equivalent index) or such other index as may be mutually agreed upon
by the Parties.
1.35 "Valid Claim" shall mean either (a) a claim of an issued and
unexpired patent which has not been held permanently revoked, unenforceable or
invalid by a decision of a court
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or other governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which has not been admitted
to be invalid or unenforceable through re-issue or disclaimer or otherwise or
(b) a claim of a pending patent application which claim was filed in good faith
and which has not been pending for more than seven (7) years and that has not
been abandoned or finally rejected without the possibility of appeal or
refilling.
ARTICLE II
LICENSE
2.1 License Grant. Subject to the terms of this Agreement, Regeneron on
behalf of itself and its Affiliates hereby grants to Company a non-exclusive,
worldwide license under the Regeneron Technology:
(a) to make Mice at the Site (but not to have Mice made other than
by an Approved Third Party) solely by means of breeding Mice with other
Mice in accordance with the breeding practices outlined on Exhibit A as
supplemented by disclosures made by Regeneron pursuant to Section 3.1 and
Section 3.2;
(b) to use Mice at the Site (but not to have Mice used other
than by an Approved Third Party) supplied by Regeneron or made by or for
Company in accordance with (a) above to Derive Mice Materials for the
purpose of making or having made Antibodies and/or Antibody Materials for
internal research purposes, including for use in human clinical trials;
(c) to use Mice Materials at the Site (but not to have Mice
Materials used other than by an Approved Third Party) to Derive Antibodies
and Antibody Materials; and
(d) subject to the restrictions and limitations on the use of
Mice and Mice Materials included in (a), (b) and (c) above, to Exploit
Antibodies, Antibody Materials, and Subject Products, whether itself,
through one or more Affiliates or Third Parties or otherwise.
2.2 No Sublicense. Company shall not sublicense or otherwise
transfer its rights (except as specifically provided in Sections 3.6 and 10.1)
granted under Regeneron Technology; provided, however, that Company shall have
the right to grant sublicenses (a) under the licenses granted pursuant to
Section 2.1 to its Affiliates; provided, further, that Company shall ensure that
the terms of each such sublicense are consistent with the terms of this
Agreement and that its Affiliates shall not commit any act (including any act or
omission) which Company is prohibited from committing directly and (b) under the
licenses granted in Section 2.1(d) to any Third Party through multiple tiers of
Licensees; provided, further, that the terms of any such sublicense shall be
consistent with the terms of this Agreement and that Company shall ensure that
each Third Party to whom a sublicense is granted agrees to be bound by the terms
of this Agreement as and to the same extent as Company.
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2.3 No Implied Licenses. The grant of the license to Company under
Regeneron Technology set forth herein shall not constitute a grant of a license
to Company under any Patent Rights or know-how other than the Regeneron
Technology.
2.4 Mice Inventions. Company acknowledges and agrees that (a) the
licenses granted to it pursuant to Section 2.1 permit Company (and Affiliates
and Approved Third Parties) to use the Mice and Mice Materials solely for the
purposes set forth therein, (b) neither Company nor any of its Affiliates shall
use the Mice or Mice Materials other than for the purposes set forth in Section
2.1, (c) Company has no right to use and shall not use the Mice or Mice
Materials to discover, develop or otherwise make improvements that directly
relate to the Mice or Mice Materials ("Mice Inventions") under such grants
except for inventions made in the ordinary course of using the Mice and Mice
Materials for the purpose of making (or having made) and using Antibodies and
Antibody Materials under the grants in Sections 2.1(a) through (d). For the
avoidance of doubt, Regeneron acknowledges that Mice Inventions shall not
include Antibodies or Antibody Materials and general methods relating to the
generation of antibodies or antibody materials. Without limiting any of
Regeneron's right xxxxxx this Agreement or otherwise, should Company make any
Mice Inventions, Company shall promptly disclose to Regeneron, in writing, any
such Mice Inventions and shall, and hereby does, assign, for itself and on
behalf of its Affiliates, to Regeneron all right, title, and interest it or they
have in Mice Inventions without additional compensation. Company agrees, for
itself and on behalf of its Affiliates, to execute any and all further
instruments, forms of assignments and other documents, and to take such further
actions as Regeneron may request, in order to transfer all of Company's (and/or
its Affiliates) rights in the Mice Inventions. Without limiting the foregoing,
Regeneron shall have the right to prepare, file and prosecute, in Regeneron's
name as assignee, patent applications on all Mice Inventions.
2.5 New Regeneron Patent Rights.
If Regeneron acquires rights to additional intellectual property from a Third
Party required by Company for its use of the Mice or Regeneron Technology under
this Agreement that requires no payments to such Third Party and that permits
Regeneron to include such intellectual property in the scope of the license
grants in Section 2.1 of this Agreement, such intellectual property shall be
included in this Agreement at no additional charge to Company. In the event that
Regeneron acquires rights to such additional intellectual property from a Third
Party relating to the Mice or Regeneron Technology pursuant to an agreement that
requires payments to such Third Party and that permits Regeneron to include such
intellectual property in the scope of the license grants in Section 2.1 of this
Agreement, Regeneron and Company shall negotiate in good faith the terms under
which such intellectual property shall be included in this Agreement, including
without limitation, additional payments to be made by Company for the right to
use such intellectual property. Such additional payments (including, without
limitation, pass through royalties) shall not exceed the payments required to be
made by Regeneron to such Third Party in consideration for Controlling and
sublicensing the intellectual property rights. In the event Regeneron and
Company are unable to agree on such terms, then the subject matter of such
intellectual property shall not be included within the definition of Regeneron
Technology, and Company shall have no license or rights with respect to such
intellectual property.
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ARTICLE III
MATERIAL TRANSFER; OWNERSHIP OF MICE
3.1 Technology Transfer. Subject to Section 3.5, Regeneron shall
transfer to Company the materials, including Regeneron Know-How and Mice, set
forth on Exhibit A. Subject to Section 8.1, all such Regeneron Know-How and Mice
listed in Exhibit A shall be considered Confidential Information. Other than the
grant of license in Section 2.1, Regeneron retains all right, title and interest
in and to the Regeneron Technology, Mice, and Mice Materials described in
Exhibit A. Except as set forth in this Article III, Regeneron shall not have any
obligation to provide to Company any trade secrets, know-how, information,
specifications, protocols or procedures.
3.2 Transition Support. The Parties agree to work diligently and in
good faith to complete the transfers set forth in Section 3.1 from Regeneron to
Company as soon as reasonably practicable. Regeneron, at its sole cost and
expense, shall provide reasonable telephonic assistance to Company to help
identify and solve issues relating to unsuccessful breeding of Mice (including
[*************************]). At Company's request and expense, upon reasonable
prior notice and at mutually convenient dates, Regeneron personnel shall
[************************] to help identify and solve issues relating to
unsuccessful breeding of Mice.
3.3 Delivery Terms and Conditions. Regeneron shall be responsible
for (a) making arrangements for all Mice identified in Exhibit A to be shipped
from Regeneron to Company or any Approved Third Party; Regeneron shall take
reasonable steps to ensure that all Mice shall be free of any pathogen prior to
shipment; (b) the proper packaging of Mice, such packaging to comply with
Applicable Law and Regeneron's veterinary handling procedures and protocols; and
(c) shipment of all such Mice. All Mice identified in Exhibit A will be shipped
[*****] to such Sites as Company may designate from time to time (Incoterms
2000). The Mice to be shipped promptly following the Effective Date pursuant to
Section 1.33 shall be sent [*****************************]. Company shall
provide Regeneron with prompt written notice of the date that is the Transfer
Date. Company shall be responsible for (y) paying all shipment and delivery
charges and import or export duties in connection therewith and (z) complying
with all customs regulations and obtaining any and all permits, forms or
permissions that may be required for Company to accept shipment of such Mice
from Regeneron.
3.4 Failure to Produce Progeny. Company shall be responsible for
establishing a colony of Mice at the Sites.
[*******************************************].
3.5 Ownership of Mice; Assignment. Company agrees, for itself and
on behalf of its Affiliates, that Regeneron retains all right, title and
interest in the Mice and Mice Materials. Without limiting the foregoing, Company
hereby assigns, for itself and on behalf of its Affiliates, to Regeneron any
right, title and interest it or they may have in Progeny and Mice Materials.
Company agrees, for itself and on behalf of its Affiliates, to execute any and
all further instruments, forms of assignments and other documents, and to take
such further actions as Regeneron may reasonably request at Regeneron's cost, in
order to transfer all of Company's (and/or its Affiliates) rights, if any, in
Mice (including, without limitation, Progeny) and Mice
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Materials to Regeneron and on such transfer any such rights shall be included in
Regeneron Technology and subject to the licenses granted pursuant to Section
2.1. During the term of this Agreement, it is agreed that Company and its
Affiliates and Approved Third Parties may use Mice (including, without
limitation, Progeny) and Mice Materials only in the manner contemplated by
Section 2.1.
3.6 Approved Third Party. Company may use Approved Third Party
service providers (a) to have Mice made solely by means of breeding Mice with
other Mice in accordance with the terms of the license grant in Section 2.1(a);
and (b) to have Mice or Mice Materials made or used in accordance with the
license grants in Sections 2.1(b) and 2.1(c), in each case, under the following
conditions: (i) Regeneron shall within thirty (30) days of receiving written
notice from the Company of the identity of the relevant Third Party and such
other information as Regeneron may reasonably require to assess such appointment
have notified Company in writing whether such Third Party is approved or not
(such approval not to be unreasonably withheld or delayed); and (ii) such Third
Party service provider shall have entered into a separate writing with Regeneron
substantially in the form annexed hereto as Exhibit C. Company shall remain
responsible for the performance of its Approved Third Party with the obligations
of Company under this Agreement and shall ensure that any such Approved Third
Party does not commit any act (including any act of omission) which Company is
prohibited from committing directly and commits such acts as Company is
obligated to hereunder.
ARTICLE IV
PAYMENTS AND RECORDS
4.1 Up-Front Fee/Annual Fees. Company shall pay Regeneron a
non-refundable amount of twenty million United States dollars (US$20,000,000)
within seven (7) days of the execution of this Agreement. In addition, Company
shall pay Regeneron a non-refundable amount of twenty million United States
dollars (US$20,000,000) on each of the first, second, and third anniversaries of
the Transfer Date. Company shall pay to Regeneron the Adjusted Annual Fee on
each of the fourth and fifth, anniversaries of the Transfer Date unless this
Agreement shall have been terminated prior to the fourth anniversary of the
Transfer Date in accordance with Section 9.2. All payments to be made pursuant
to this Section 4.1 shall be made by bank wire transfer in immediately available
funds to an account designated by Regeneron.
4.2 Royalties. Subject to Section 4.3, Company shall pay royalties
to Regeneron on aggregate worldwide Net Sales of all Subject Products sold
during the Royalty Term.
[*********************************************************]. Payments due under
this section shall be due in each calendar quarter in arrears, and shall be paid
no later than sixty (60) days after the last business day of each such calendar
quarter. An example of an annual royalty calculation [**********] is set forth
on Schedule 4.2 for purposes of illustration.
4.3 Royalty Term. The royalties payable under Section 4.2 shall be
paid to Regeneron for the period of time, as determined on a Subject Product by
Subject Product and country-by-country basis, commencing on the Effective Date
and ending on the later of (a) [*************] after the Launch of a given
Subject Product in a given country and (b) the expiration of the last Valid
Claim of Royalty Bearing Company Patent Rights claiming or
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covering such Subject Product in such country (the "Royalty Term"). For the
avoidance of doubt, the Royalty Term may extend beyond the term of this
Agreement. As used above, the term "Royalty Bearing Company Patent Rights" shall
mean with respect to an Antibody either (i) all issued patents in a country
owned or Controlled by Company and/or its Affiliates, in each case, which claim
the composition of such Antibody, [******************] or (ii) if a patent
described in (i) above never issues in a country, then the first issued patent
in such country that is owned or Controlled by Company and/or its Affiliate
claiming [********************] or any use of such an Antibody [**********].
4.4 Reports. Company shall keep and maintain, and shall cause its
Affiliates and Licensees to keep and maintain, records and books of account, in
accordance with generally accepted accounting practices, detailing full written
accountings of Net Sales of Subject Products subject to royalty obligations to
Regeneron, and all other information necessary for the accurate determination of
royalty payments (including, without limitation, currency conversion rate
methodologies). Company shall deliver to Regeneron each calendar quarter
commencing upon the first calendar quarter following the first sale of a Subject
Product, a report detailing the information on which the royalty payments were
calculated, including a breakdown of Net Sales of each Subject Product on a
country-by-country basis, which report shall accompany the royalty due under
Section 4.2. Furthermore, for each Subject Product, Company shall notify
Regeneron in writing promptly following (a) the date on which Company first
files an IND (or its non-US equivalent) for a Subject Product, and (b) each
receipt, on a country-by-country basis, by Company (or by any of its Affiliates
or Licensees) of regulatory approval to market and sell Subject Products.
4.5 Records and Audits.
(a) Company shall keep, and shall cause its Affiliates and Licensees
to keep, complete and accurate records of the latest three (3) years
relating to gross sales, Net Sales, and all information reasonably
relevant under Sections 4.2 and 4.3. For the sole purpose of verifying
amounts payable to Regeneron, Regeneron shall have the right, no more than
once each calendar year, to review such records, through independent
certified public accountants proposed by Regeneron and reasonably
acceptable to Company (such consent not to be unreasonably withheld or
delayed), upon fifteen (15) days' prior written notice. The accounting
firm shall disclose to Regeneron and Company only whether the royalty
reports are correct and details concerning any discrepancies, but no other
information shall be disclosed to Regeneron.
(b) If any review pursuant to Section 4.5(a) reflects an
underpayment to Regeneron, such underpayment shall be promptly remitted to
Regeneron, together with interest calculated in the manner provided in
Section 4.8. If the underpayment is equal to or greater than five percent
(5%) of the amount that was otherwise due for any calendar quarter,
Regeneron shall be entitled to have Company pay all of the reasonable
costs of such review otherwise such costs will be paid by Regeneron. If
the review reflects an overpayment by Company, then, at Company's option,
such overpayment shall either be
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promptly refunded to Company by Regeneron or creditable against amounts payable
by Company in subsequent payment periods.
4.6 United States Dollars (or U.S. dollars). All dollar ($) amounts
specified in this Agreement are United States (U.S.) dollar amounts.
4.7 Currency Exchange. With respect to sales of Subject Products
invoiced in a currency other than U.S. dollars and other amounts received by
Company, Company's Affiliates and/or Licensees in a currency other than U.S.
dollars, such amounts shall be expressed in their local currency and in their
U.S. dollar equivalents calculated using the exchange rate conversion
methodology then in consistent use by Company throughout its business in
accordance with generally accepted accounting principles and used in its
preparation of the financial statements filed with the SEC (or similar
regulatory agency in another country if no financial statements are filed with
the SEC).
4.8 Late Payments. Company shall pay interest to Regeneron on the
aggregate amount of any payments that are not paid on or before the date such
payments are due under this Agreement at a rate per annum equal to the lesser of
(a) [**********] above LIBOR; or (b) the highest rate permitted by Applicable
Law, calculated on the number of days such payments are received by Regeneron
after the date such payments are due. In addition, Company shall reimburse
Regeneron for all costs and expenses, including without limitation reasonable
attorney fees and legal expenses, incurred in the collection of late payments.
For the purposes of this Agreement, LIBOR shall mean the London Interbank
Offered Rate as calculated by the British Bankers' Association or, if LIBOR
ceases to be available, the base rate of a London bank selected by Regeneron.
4.9 No Set Off. Except as set forth in Section 4.10, (a) Company
shall not set off any obligation of Regeneron against or otherwise withhold
from, any amount payable by Company to Regeneron hereunder without Regeneron's
prior written consent and (b) there shall be no deduction or withholding from
the amounts payable hereunder.
4.10 Taxes.
(a) General. The royalties and other amounts payable by
Company to Regeneron pursuant to this Agreement ("Payments") shall not be
reduced on account of any taxes unless required by Applicable Law.
Regeneron alone shall be responsible for paying any and all taxes (other
than withholding taxes required by Applicable Law to be paid by Company)
levied on account of, or measured in whole or in part by reference to, any
Payments it receives. Company shall deduct or withhold from the Payments
any taxes that it is required by Applicable Law to deduct or withhold.
Notwithstanding the foregoing, if Regeneron is entitled under any
applicable tax treaty to a reduction of rate of, or the elimination of,
applicable withholding tax, it may deliver to Company or the appropriate
governmental authority (with the assistance of Company to the extent that
this is reasonably required and is expressly requested in writing) the
prescribed forms necessary to reduce the applicable rate of withholding or
to relieve Company of its obligation to withhold tax, and Company shall
apply the reduced rate of withholding, or dispense with withholding, as
the case may be, provided that Company has received
11
evidence, in a form satisfactory to Company, of Regeneron's delivery of all
applicable forms (and, if necessary, its receipt of appropriate governmental
authorization) at least fifteen (15) days prior to the time that the Payments
are due. If, in accordance with the foregoing, Company withholds any amount, it
shall pay to Regeneron the balance when due, make timely payment to the proper
taxing authority of the withheld amount, and send to Regeneron proof of such
payment within sixty (60) days following that payment.
(b) Indirect Taxes. Notwithstanding anything contained in Section 4.10(a),
this Section 4.10(b) shall apply with respect to value added taxes, sales taxes,
consumption taxes and other similar taxes ("Indirect Taxes"). All Payments are
exclusive of Indirect Taxes. If any Indirect Taxes are chargeable in respect of
any Payments, Company shall pay such Indirect Taxes at the applicable rate in
respect of any such Payments following the receipt, where applicable, of an
Indirect Taxes invoice in the appropriate form issued by Regeneron in respect of
those Payments, such Indirect Taxes to be payable on the due date of the payment
of the Payments to which such Indirect Taxes relate.
(c) Changes Following Assignment. If following an assignment of this
Agreement under Section 10.1 the treatment of any Payments or Indirect Taxes for
either Party is affected by the assignment, then the Parties shall use their
best efforts to promptly negotiate a provision in replacement of the affected
sections of this Agreement that is consistent with and achieves as nearly as
possible the original treatment of such Payments and Indirect Taxes immediately
prior to any such assignment.
ARTICLE V
REPRESENTATIONS AND WARRANTIES; COVENANTS
5.1 Representations and Warranties of Company. Company represents and
warrants as follows:
(a) Company is validly incorporated under the laws of England
and Wales;
(b) Company has the corporate and legal right, authority and
power to enter into this Agreement and to perform its obligations
hereunder;
(c) Company has taken all necessary action to authorize the
execution, delivery and performance of this Agreement;
(d) upon the execution and delivery of this Agreement, this
Agreement shall constitute a valid and binding obligation of Company,
enforceable in accordance with its terms, except as enforceability may be
limited by applicable bankruptcy, insolvency, reorganization, moratorium
or similar laws affecting creditors' and contracting parties' rights
generally and except as enforceability may be subject to general
principles of equity (regardless of whether such enforceability is
considered in a proceeding in equity or at law); and
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(e) the performance of Company's obligations under this Agreement
will not conflict with its charter documents or result in a breach of any
agreements, contracts or other arrangements to which it is a party.
5.2 Representations and Warranties of Regeneron. Regeneron represents and
warrants to Company that, subject to the terms
of Schedule 5.2,
(a) Regeneron is a corporation duly organized, validly
existing and in good standing under the laws of the State of New York,
United States of America;
(b) Regeneron has the corporate and legal right, authority
and power to enter into this Agreement and to perform its obligations
hereunder;
(c) Regeneron has taken all necessary action to authorize the
execution, delivery and performance of this Agreement;
(d) upon the execution and delivery of this Agreement, this
Agreement shall constitute a valid and binding obligation of Regeneron,
enforceable in accordance with its terms, except as enforceability may be
limited by applicable bankruptcy, insolvency, reorganization, moratorium
or similar laws affecting creditors' and contracting parties' rights
generally and except as enforceability may be subject to general
principles of equity (regardless of whether such enforceability is
considered in a proceeding in equity or at law); and
(e) the performance of Regeneron's obligations under this
Agreement will not conflict with its charter documents or result in a
breach of any agreements, contracts or other arrangements to which it is a
party;
(f) Regeneron has the right to grant the licenses granted to
Company on the terms set forth herein;
(g) as of the Effective Date and with no further duty to
update (except pursuant to Section 7.3), (i) there is no pending
litigation that alleges that any of Regeneron's activities directly
relating to the Regeneron Technology, Mice, or Mice Materials have
violated, or would violate, any of the intellectual property rights of any
Third Party (nor has it received any written communication threatening
such litigation); and (ii) to its knowledge, no litigation has been
otherwise threatened which alleges that any of its activities directly
relating to the Regeneron Technology, Mice, or Mice Materials have
violated or would violate, any of the intellectual property rights of any
Third Party;
(h) Regeneron has disclosed or made available to Company all the
Regeneron Technology needed for Company to make and use "VelocImmune 2"
Mice pursuant to Section 2.1 (a) and (b) of this Agreement;
(i) to its knowledge, Company's use of the Mice and other
Regeneron Technology generally hereunder (but not with respect to a
specific Antibody or antigen or any methods relating to Antibody or
Antibody Material generation) will not infringe or
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otherwise violate any Patent Rights or other intellectual property or
proprietary right of any Third Party claiming genetically modified mice or
the use thereof to make antibodies;
(j) to its knowledge, the issued patents included in the Regeneron
Technology existing at the Effective Date are not invalid or unenforceable
in whole or part;
(k) to its knowledge, the development or reproduction of the Mice or
the conception, development and reduction to practice of the Regeneron
Technology existing as of the Effective Date has not constituted or
involved the misappropriation of trade secrets or other rights of any
Person; and
(l) to its knowledge, the Know-How listed or referred to in Exhibit
A is sufficient to establish a colony of Mice.
For purposes hereof, "to its knowledge" shall mean actual knowledge with
no duty of inquiry or investigation
5.3 Disclaimer of Warranty. EXCEPT AS EXPRESSLY PROVIDED IN THIS
AGREEMENT, ALL REGENERON TECHNOLOGY AND MICE ARE PROVIDED TO COMPANY (a) "AS IS"
AND WITHOUT ANY WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY, TITLE OR FITNESS FOR A PARTICULAR PURPOSE AND (b) WITHOUT ANY
REPRESENTATION OR WARRANTY THAT THE USE OF REGENERON TECHNOLOGY OR MICE WILL NOT
INFRINGE ANY THIRD PARTY'S PATENT OR OTHER RIGHT.
5.4 Covenants. Company agrees, for itself and on behalf of its Affiliates,
that it and they:
(a) will abide by all industry accepted guidelines applicable
to the use, handling and disposal of genetically modified animals and
comply in all material respects with all Applicable Laws which relate to
the use of the Mice and Mice Materials, ;
(b) will use diligent efforts to ensure that the Mice do not
come into contact with any mice other than Mice; and in particular will
not intentionally or recklessly breed Mice with any mice other than Mice,
(c) will use the Mice and Mice Materials solely for internal
purposes and will not for the direct or indirect benefit of any Third
Party make using the Mice or Mice Materials any Antibodies or Antibody
Materials for such Third Party;
(d) will not make any heritable genetic modifications to the
Mice;
(e) will not Derive embryonic or other stem cells from the
Mice or other Mice Material that could be used to make Mice;
(f) will not use Mice or Mice Materials to directly
manufacture or produce Subject Products for sale. For the avoidance of
doubt, Regeneron acknowledges that
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Company may (i) isolate cDNA from Mice which code for a given antibody (the
"Isolated Mice Sequences"), (ii) modify DNA sequences of cell lines derived from
sources other than the Mice and mice to incorporate the Isolated Mice Sequence
or modifications thereof, and (iii) manufacture Subject Products for sale using
such modified cell lines or using other Antibody Materials and such use shall
not constitute a breach of Section 5.4(f);
(g) will not use Mice Materials to create Mice, mice or any
transgenic animals; and
(h) will ensure that all Mice (including Progeny) and Mice
Material supplied to it or Derived under this Agreement remain in the
possession of Company, its Affiliates or Approved Third Parties.
ARTICLE VI
INDEMNIFICATION
6.1 Indemnification by Company. Company agrees to indemnify and
hold harmless Regeneron and Regeneron's Affiliates and their respective
shareholders, directors, officers, employees and agents ("Regeneron
Indemnitees") from and against any liabilities, losses, costs, damages, fees or
expenses arising out of any Third Party claim relating to (a) any breach by
Company or any of its Affiliates of any of its representations, warranties or
obligations pursuant to this Agreement, (b) any product liability, personal
injury, property damage or other damage resulting from the testing, manufacture,
use, offer for sale, sale or importation of Antibodies, Antibody Materials, or
Subject Products, or (c) infringement or misappropriation of any patent or other
intellectual property rights of any Third Party (other than Third Party patents
specifically covering Regeneron Technology, such patents being referred to as
"Regeneron Technology Blocking Patents") resulting from the manufacture, use,
offer for sale, sale or importation of Antibodies, Antibody Materials, or
Subject Products, by Company or Company's Affiliates, Licensees or contract
manufacturers, provided, however, that Company shall not be obligated to
indemnify or hold harmless Regeneron Indemnitees from any such liabilities,
losses, costs, damages, fees or expenses to the extent that (i) such
liabilities, losses, costs, damages, fees or expenses have resulted from the
grossly negligent (or more culpable) act or omission of a Regeneron Indemnitee
or (ii) Regeneron has an obligation to indemnify any Company Indemnitee pursuant
to Section 6.2 in respect of such liabilities, losses, costs, damages, fees or
expenses.
6.2 Indemnification by Regeneron. Regeneron agrees to indemnify and
hold harmless Company and Company's Affiliates and their respective
shareholders, directors, officers, employees and agents ("Company Indemnitees")
from and against any liabilities, losses, costs, damages, fees or expenses
arising out of any Third Party claim relating to any breach by Regeneron of any
of its representations, warranties or obligations pursuant to this Agreement,
provided, however, that Regeneron shall not be obligated to indemnify or hold
harmless Company Indemnitees from any such liabilities, losses, costs, damages,
fees or expenses to the extent that such liabilities, losses, costs, damages,
fees or expenses have resulted from the grossly negligent (or more culpable) act
or omission of a Company Indemnitee.
15
6.3 Claims for Indemnification. A Person entitled to indemnification under
this Article VI (an "Indemnified Party") shall give prompt written notification
to the Person from whom indemnification is sought (the "Indemnifying Party") of
the commencement of any action, suit or proceeding relating to a Third Party
claim for which indemnification may be sought or, if earlier, upon the assertion
of any such claim by a Third Party (it being understood and agreed, however,
that the failure by an Indemnified Party to give notice of a Third-Party claim
as provided in this Section 6.3 shall not relieve the Indemnifying Party of its
indemnification obligation under this Agreement except and only to the extent
that such Indemnifying Party is actually damaged as a result of such failure to
give notice). Within fourteen (14) days after delivery of such notification, the
Indemnifying Party may, upon written notice thereof to the Indemnified Party,
assume control of the defense of such action, suit, proceeding or claim with
counsel reasonably satisfactory to the Indemnified Party. If the Indemnifying
Party does not assume control of such defense, the Indemnified Party shall
control such defense and, without limiting the Indemnifying Party's
indemnification obligations, the Indemnifying Party shall reimburse the
Indemnified Party for all reasonable and verifiable costs, including attorney
fees, incurred by the Indemnified Party in defending itself within thirty (30)
days after receipt of any invoice therefor from the Indemnified Party. The Party
not controlling such defense may participate therein at its own expense;
provided that, if the Indemnifying Party assumes control of such defense and the
Indemnified Party in good faith concludes, based on advice from counsel, that
the Indemnifying Party and the Indemnified Party have conflicting interests with
respect to such action, suit, proceeding or claim, the Indemnifying Party shall
be responsible for the reasonable and verifiable fees and expenses of counsel to
the Indemnified Party in connection therewith. The Party controlling such
defense shall keep the other Party advised of the status of such action, suit,
proceeding or claim and the defense thereof and shall consider recommendations
made by the other Party with respect thereto. The Indemnified Party shall not
agree to any settlement of such action, suit, proceeding or claim without the
prior written consent of the Indemnifying Party, which shall not be unreasonably
withheld, delayed or conditioned. The Indemnifying Party shall not agree to any
settlement of such action, suit, proceeding or claim or consent to any judgment
in respect thereof that does not include a complete and unconditional release of
the Indemnified Party from all liability with respect thereto, that imposes any
liability or obligation on the Indemnified Party or that acknowledges fault by
the Indemnified Party without the prior written consent of the Indemnified
Party.
ARTICLE VII
INTELLECTUAL PROPERTY PROTECTION AND RELATED MATTERS
7.1 Ownership of Intellectual Property.
(a) Subject to the licence grants to Company under Section 2.1 and
the ownership and assignment provisions in Section 2.4 and Section 3.5, as
between the Parties, each Party shall own and retain all right, title and
interest in and to any and all information, improvements and inventions
that are conceived, discovered, developed or otherwise made, as necessary
to establish authorship, inventorship or ownership, by or on behalf of
such Party (or its Affiliates or its licensees (excluding, in the case of
Regeneron, Company, its Affiliates and Licencees) under or in connection
with this Agreement, whether or not patented or patentable, and any and
all Patent Rights and intellectual
16
property rights with respect thereto. Determination of authorship,
inventorship or ownership shall be made in accordance with applicable
United States law.
(b) Except as specifically set forth herein, Regeneron and
Regeneron's Affiliates shall retain all right, title and interest in and
to all Regeneron Technology.
(c) Company and Company's Affiliates shall retain all right,
title and interest in and to (i) all Antibodies, Antibody Materials and
Subject Products and (ii) subject to Section 2.4 and Section 3.5, all
results, technical information, inventions, materials and data, and any
intellectual property rights therein, or otherwise resulting from
Company's or Company's Affiliates use of (i) the Mice and Mice Materials
in accordance with this Agreement, (ii) Antibodies, (iii) Antibody
Materials and (iv) Subject Products ("Company Know-How").
7.2 Prosecution of Patent Rights.
(a) Regeneron shall have the right and option (but not the
obligation) to file and prosecute any patent applications and to maintain
any patents within the Regeneron Patent Rights in Regeneron's name, and to
control any interferences, reissue proceedings and re-examinations
relating thereto.
(b) Company shall have the right and option (but not the
obligation) to file and prosecute any patent applications and to maintain
any patents within the Company Patent Rights in Company's name, and to
control any interferences, reissue proceedings and re-examinations
relating thereto.
7.3 Infringement. Company shall promptly report in writing to
Regeneron during the term of this Agreement any (a) known or suspected
infringement of any of the Regeneron Patent Rights, or (b) unauthorized use of
any of the Regeneron Know-How of which the Company becomes aware. In the event
that either Party or any of its Affiliates shall receive written notice from a
Third Party claiming that the Mice or Regeneron Technology infringes or
otherwise violates the intellectual property rights of such Third Party, then
such Party shall promptly notify the other Party in writing of this notice of
infringement. Regeneron shall promptly report to Company the initiation of any
formal legal proceedings during the term of this Agreement claiming the
infringement of or unauthorized use of any Regeneron Patent Rights or Regeneron
Know-How.
7.4 Enforcement. Regeneron shall have the sole right to initiate a
suit or take other appropriate action that it believes is reasonably required to
protect Regeneron Patent Rights from any known or suspected infringement or to
prevent the unauthorised use or disclosure of Regeneron Know-How ____ Company
shall have the sole right to initiate a suit or take other appropriate action
that it believes is reasonably required to protect Company Patent Rights from
any known or suspected infringement or to prevent the unauthorised use or
disclosure of any Company Know-How.
7.5 Defence. In the event that a Third Party asserts, as a defence
or as a counterclaim in any infringement action under Section 7.4 or in a
declaratory judgment action or similar action or claim filed by such Third
Party, that Regeneron Patent Rights or Company Patent Rights are
17
invalid or unenforceable Regeneron, with respect to any Regeneron Patent Rights,
and Company, with respect to any Company Patent Rights, shall have the sole
right, but not the obligation, through counsel of its choosing, to respond to
such defence or defend against such counterclaim, action or claim (as
applicable), including the right to settle or otherwise compromise such claim.
7.6 Third Party Litigation. Notwithstanding Section 7.4 or Section 7.5, in
the event of any actual or threatened suit against Company, or its Affiliates,
Licensees, distributors or customers alleging that the use of Regeneron
Technology, the Mice, Mice Materials, Antibodies or Antibody Materials or the
Exploitation of Subject Products by or on behalf of Company under this Agreement
infringes the Patent Rights or other intellectual property rights of any Person
(an "Infringement Suit"), Company shall be solely responsible for assuming
direction and control of the defence of claims arising therefrom (including the
right to settle such claims at its sole discretion), unless Company is seeking
indemnification under the terms of Section 6.2.
7.7 Co-operation. Each Party shall provide to the other all
reasonable assistance requested by other Party (and at the other Party's
reasonable expense) in connection with any action claim or suit under this
Article VII, including allowing access to the other Party's files and documents
and to such other Party's personnel who may have possession of relevant
information.
7.8 Recoveries.
(a) With respect to any suit or action to protect Regeneron
Technology brought or taken by Regeneron, Regeneron shall retain one
hundred percent (100%) of any recovery obtained by it as a result of any
suit or action to protect Regeneron Technology.
(b) With respect to any suit or action to protect Company
Technology brought or undertaken by Company, Company shall retain one
hundred percent (100%) of any recovery obtained by it as a result of or in
connection with any such suit or action to protect Company Technology;
provided that any recovery for lost sales of Subject Products shall be
subject to the royalty obligations in Section 4.2.
ARTICLE VIII
CONFIDENTIALITY
8.1 Definition of Confidential Information. Subject to the last
sentence in this Section 8.1, Confidential Information includes all information,
data and know-how disclosed by either Party or its Affiliates (the "Receiving
Party") to the other Party or its Affiliates (the "Receiving Party") hereunder,
whether orally or as embodied in tangible materials, including research,
inventions, discoveries, writings, drawings, graphs, charts, photographs,
recordings, designs, plans, processes, models, technical information,
facilities, methods, assays, data, chemical formulas, compositions, compounds,
instrumentation, trade secrets, copyrights, systems, patents, patent
applications, procedures, manuals, specifications, prototypes, samples,
structures, models, any other intellectual property, and confidential reports.
Notwithstanding the foregoing, Confidential Information shall not include
information which the Receiving Party can demonstrate is:
18
(a) already in the possession of the Receiving Party, without
obligation of confidentiality, at or before the time of disclosure
hereunder as shown by the Receiving Party's files existing at the time of
disclosure; or
(b) now or hereafter becomes publicly known through no
wrongful act of the Receiving Party (provided that if Confidential
information becomes publicly known this shall not excuse a prior
disclosure by the Receiving Party); or
(c) lawfully received by the Receiving Party from a Third
Party not under an obligation of confidence to the Disclosing Party; or
(d) developed by the Receiving Party independent of the
Confidential Information received hereunder; or
(e) approved for release by written authorization of the
Disclosing Party.
Specific aspects or details of Confidential Information will not be deemed
to be within the public knowledge or in the prior possession of a Person merely
because such aspects or details of the Confidential Information are embraced by
general disclosures in the public domain. In addition, any combination of
Confidential Information will not be considered in the public knowledge or in
the prior possession of either Person merely because individual elements thereof
are in the public domain or in the prior possession of a Person unless (i) the
combination and its principles are in the public knowledge or in the prior
possession of that Person and (ii) the combination is documented, in a single
contemporaneous document, as in the public knowledge or in the prior possession
of a Person.
Notwithstanding anything to the contrary in this Section 8.1, Company's
Confidential Information shall be limited to (i) information in the reports
delivered to Company in accordance with Section 4.4, (ii) information discovered
during any site visit or audit conducted pursuant to Section 4.5, and (iii)
information disclosed by prior mutual agreement specifically certified by
Company as being confidential prior to its disclosure. All other information,
data or know-how disclosed by Company or its Affiliates hereunder shall be
non-confidential and shall not be subject to the confidentiality obligations and
restrictions on use in this Article VIII.
8.2 Confidentiality and Non-Use Obligations. Each Party agrees,
subject to Section 8.4, that it will hold in strict confidence and not disclose,
disseminate or distribute to any Third Party Confidential Information received
from the Disclosing Party and use such Confidential Information for no purpose
other than those contemplated by this Agreement. Each Party agrees that access
to Confidential Information will be limited to their employees, agents or other
authorized representatives who: (a) need to know such Confidential Information
in connection with their work and (b) have signed agreements obligating them to
maintain the confidentiality of the Confidential Information, provided that each
Party shall remain responsible for any failure by its Affiliates and its
Affiliates' respective employees, consultants, advisors, to treat such
information and materials as Confidential Information. Each Party further agrees
to inform such employees, agents or authorized representatives of the
confidential nature of Confidential Information received from the Disclosing
Party and agrees to take all necessary steps to ensure that the terms of this
Agreement are not violated by them.
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8.3 Loss of Confidential Information. Each Party shall maintain
reasonable procedures to prevent accidental or other loss of any Confidential
Information received from the Disclosing Party and shall exert at least the same
degree of care as it uses to protect its own Confidential Information. Each
Party shall immediately notify the other in the event of any actual or suspected
loss or unauthorized disclosure of that Party's Confidential Information. Each
Party will take all reasonable further steps requested by the other Party to
prevent, control or remedy such violation.
8.4 Permitted Disclosure. Each Party may disclose Confidential Information
to the extent that such disclosure is:
(a) made in response to a valid order of a court of competent
jurisdiction or other competent authority; provided, however, that the
Receiving Party shall first have given notice to the Disclosing Party and
given the Disclosing Party a reasonable opportunity to quash any such
order or obtain a protective order requiring that the Confidential
Information and documents that are the subject of such order be held in
confidence by such court or authority or, if disclosed, be used only for
the purpose for which the order was issued; and provided further that if
such order is not quashed or a protective order is not obtained, the
Confidential Information disclosed in response to such court or
governmental order shall be limited to that information that is legally
required to be disclosed in response to such court or governmental order;
(b) otherwise required by Applicable Law or the requirements
of a national securities exchange or another similar regulatory body;
provided, however, that the Receiving Party shall (i) provide the
Disclosing Party with reasonable advance notice of and an opportunity to
comment on any such required disclosure, (ii) if requested by the
Disclosing Party, seek confidential treatment with respect to any such
disclosure to the extent available, and (iii) consider in good faith the
comments of the Disclosing Party in any such disclosure or request for
confidential treatment; or
(c) made by Company, its Affiliates or Licensees to a
regulatory authority in connection with any filing, application or request
for any approval, license, registration or authorization relating to a
Subject Product; provided, however, that Company will (i) provide
Regeneron with reasonable advance notice of and an opportunity to comment
on any such required disclosure, (ii) seek confidential treatment with
respect to any such disclosure to the extent available, and (iii) consider
in good faith the comments of Regeneron in any such disclosure or request
for confidential treatment;
8.5 Return of Confidential Information. Confidential Information
disclosed by the Disclosing Party, including permitted copies, shall remain the
property of the Disclosing Party. Subject to Section 8.6, upon termination or
expiration of this Agreement, or upon written request of the Disclosing Party,
the Receiving Party shall promptly return to the Disclosing Party or, at the
Disclosing Party's request, destroy, all documents or other tangible materials
representing the Disclosing Party's Confidential Information (or any designated
portion thereof); provided that one (1) copy may be maintained in the
confidential files of the Receiving Party for the purpose of complying with the
terms of this Agreement. An officer of the Receiving Party also
20
shall certify in writing that it has satisfied its obligations under this
Section 8.5 within ten (10) days of a written request by the Disclosing Party.
8.6 Retention of Confidential Information by Company. Section 8.5
shall not apply to Regeneron Confidential Information during the term of this
Agreement or on the expiry or termination of this Agreement if and to the extent
that Company's rights under the Regeneron Technology survive such termination or
expiry pursuant to Section 9.4(a).
8.7 Publicity. During the term of this Agreement, the content of
any press release or public disclosure relating to this Agreement shall be
mutually agreed by the Parties, which agreement shall not be unreasonably
withheld, delayed or conditioned, except that a Party may, without the other
Party's agreement, (a) issue such press release or make such public disclosure
if the contents of such press release or public disclosure have previously been
made public other than through a breach of this Agreement by the issuing Party
or (b) subject to Section 8.4(c) issue such press release or make such public
disclosure if such press release or public disclosure is required by Applicable
Law, regulation or legal process, including without limitation by the rules or
regulations of the SEC (or similar regulatory agency in a country other than the
United States) or of any stock exchange or other securities trading institution.
It is the intent of the Parties to issue one press release announcing the
execution of this Agreement. In any press releases issued by Company regarding
the discovery, development or approval of a Subject Product, Antibody or
Antibody Materials, Company shall include a statement regarding the role of
Regeneron Technology and Mice, which statement shall be reasonably acceptable to
Regeneron. The Parties shall issue a joint press release on the Effective Date
with respect to the execution of this Agreement in the form annexed hereto as
Exhibit D.
8.8 Disclosure of Provisions of Agreement.
(a) Subject to Section 8.7 and 8.8(b), each Party agrees to
hold as confidential the terms of this Agreement that have not been
disclosed publicly except that (i) each Party shall have the right to
disclose such terms to investors, potential investors, lenders, potential
lenders, acquirers, potential acquirers, investment bankers and other
Third Parties in connection with financing and acquisition activities,
provided that any such Third Party has entered into a written obligation
with the disclosing Party to treat such information and materials as
confidential which is at least as stringent as the conditions imposed by
this Agreement and (ii) each Party shall have the right to disclose such
terms as required by applicable law, regulation or legal process,
including without limitation by the rules or regulations of the SEC (or
similar regulatory agency in a country other than the United States) or of
any stock exchange or other securities trading institution.
(b) In the event that this Agreement shall be included in any
report, statement or other document filed by either Party or an Affiliate
of either Party with the SEC or similar regulatory agency in a country
other than the United States or any stock exchange or other securities
trading institution, such Party shall consider in good faith any requests
for confidential treatment as may be reasonably requested by the other
Party.
8.9 Approvals. Each party shall submit any press release or any
disclosure requiring the other Party's approval pursuant to this Article VIII to
the other Party, and the Party receiving
21
such request shall have three (3) business days to review and approve any such
press release or disclosure, which approval shall not be unreasonably withheld.
If the Party receiving such request does not respond in writing within such
three (3) business day period, the press release or disclosure shall be deemed
approved. In addition, if a public disclosure is required by law, rule or
regulation, including without limitation in a filing with the Securities and
Exchange Commission, other than a filing on Form 10K or Form 10Q, the disclosing
party shall provide copies of the disclosure reasonably in advance of such
filing or other disclosure for the no disclosing party's prior review and
comment, which comments shall be considered in good faith by the disclosing
party.
8.10 Term. All obligations of confidentiality imposed under this Article
VIII shall only survive the expiration or early termination of this Agreement
for a period of seven years (7) years.
ARTICLE IX
TERM AND TERMINATION
9.1 Term. The term of this Agreement shall commence on the
Effective Date and shall expire on the sixth anniversary of the Transfer Date
unless earlier terminated under the terms of this Agreement. For the avoidance
of doubt, Company shall have the right but not the obligation to terminate this
Agreement without cause upon written notice prior to the fourth anniversary of
the Transfer Date in accordance with Section 9.2(a).
9.2 Termination.
(a) Convenience. Company may elect to terminate this Agreement at
any time by providing ninety (90) days' prior written notice to Regeneron. If
such notice is sent with an effective date of termination prior to the fourth
anniversary of the Transfer Date, such notice shall be accompanied (or preceded)
by the payment of all sums which were not previously paid and which have become
or would have become due and payable pursuant to the first or second sentence of
Section 4.1 but for the termination under this Section 9.2(a). For example, if
the Transfer Date is January 30, 2007 and Company pays to Regeneron twenty
million United States dollars (US$20,000,000) on January 30, 2007 and on July
15, 2007 delivers a notice of termination with an effective date of termination
on October 15, 2007, Company would be obligated to pay to Regeneron on July 15,
0000 xxxxx xxxxxxx Xxxxxx Xxxxxx dollars (US$60,000,000) representing twenty
million United States dollars (US$20,000,000) that would have otherwise been
payable on January 30, 2008, plus twenty million United States dollars
(US$20,000,000) that would otherwise have been payable on January 30, 2009, plus
twenty million United States dollars (US$20,000,000) that would have otherwise
been payable on January 30, 2010. However, for example, if the Transfer Date is
January 30, 2007 and Company has paid all amounts previously due and payable
under Section 4.1 and on July 15, 2010 delivers a notice of termination with an
effective date of termination on October 15, 2010, Company would not be
obligated to pay to Regeneron any further sums pursuant to Section 4.1. If such
notice of termination under this Section 9.2(a) is sent with an effective
termination date on or after the fourth anniversary of the Transfer Date, such
notice shall be accompanied (or preceded) by the payment of all sums which were
not previously paid and which have become or would have become due and payable
pursuant to the first, second, or third sentence of Section 4.1 but
22
for the termination under this Section 9.2(a). For example, if the Transfer Date
is January 30, 2007 (and Company has paid all amounts previously due and payable
under Section 4.1) and on March 20, 2011 Company delivers a notice of
termination with an effective date of termination on June 20, 2011, Company
would be obligated to pay Regeneron on March 20, 0000 xxxxxx xxxxxxx Xxxxxx
Xxxxxx dollars (US$20,000,000), as adjusted to reflect the Adjusted Annual Fee
pursuant to the terms of the third sentence of Section 4.1, representing the
Adjusted Annual Fee that would have otherwise been payable on January 30, 2012.
(b) Breach. Either Party shall have the right (but not the obligation) to
terminate this Agreement upon written notice to the other Party if the other
Party materially breaches or defaults in the performance of any of the
provisions of this Agreement; provided that such material breach or default has
not been cured (if capable of being cured) within sixty (60) days after the
giving of notice by the first Party specifying such breach or default. For
purposes of this Section 9.2(b), the term "material breach" shall mean a breach
or default in performance hereunder by a Party that substantially undermines the
contractual rights, protections or benefits of the non-breaching Party under
this Agreement.
(c) Technical Event. Company may terminate this Agreement upon providing
thirty(30) days prior written notice to Regeneron together with adequate written
records to document its claim of the occurrence of a Technical Event. Such
records shall be subject to review by an independent Third Party expert
designated by Regeneron within ten (10) business days of receipt of the written
notice of termination and approved by Company, such approval not to be
unreasonably withheld or delayed. Such expert shall review such written records
and promptly determine whether or not a Technical Event has occurred. The
expert's decision shall be final and binding upon the Parties as to this issue.
Following the provision of any such notice of termination all obligations to
make payments due under this Agreement by the Company to Regeneron shall be
suspended from the date of such notice until the date of the publication of the
expert's determination. Any notice of termination shall be deemed effective from
the date of the notice of termination in the event that the expert determines
that a Technical Event has occurred. As used above, the term "Technical Event"
shall mean, [********************]
[*******************************************************].
..
(d) [*********************************************]
9.3 Rights in Bankruptcy. All rights and licenses granted under or
pursuant to this Agreement by Regeneron are, and shall otherwise be deemed to
be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or analogous
provisions of Applicable Law outside the United States, licenses of right to
"intellectual property" as defined under Section 101 of the U.S. Bankruptcy Code
or analogous provisions of Applicable Law outside the United States (hereinafter
"IP"). The Parties agree that Company, as licensee of such rights under this
Agreement, shall retain and may fully exercise all of its rights and elections
under the U.S. Bankruptcy Code or any other provisions of Applicable Law outside
the United States that provide similar protection for IP. The Parties further
agree that, in the event of the
23
commencement of a bankruptcy proceeding by or against Regeneron under the U.S.
Bankruptcy Code or analogous provisions of Applicable Law outside the United
States, Company shall be entitled to a complete duplicate of (or complete access
to, as appropriate) any such IP and all embodiments of such IP, which, if not
already in Company's possession, shall be promptly delivered to it upon
Company's written request therefor.
9.4 Effects of Termination.
(a) Termination or Expiration of License. Except as set forth
below in this Section 9.4, upon expiration or termination of this
Agreement, the licenses granted by Regeneron to Company under Section 2.1
shall terminate and revert to Regeneron as of the effective date of such
expiration or termination. Subject to the terms of the last sentence of
Section 9.4(c), upon termination of this Agreement for any reason, the
license grant in Section 2.1(d) shall continue to apply solely with
respect to any Antibodies, Antibody Materials and Subject Products
generated pursuant to this Agreement and Company shall pay royalties
during the Royalty Term in accordance with Article IV. Upon termination of
this Agreement by Company in accordance with Section 9.2(b), 9.2(c), or
9.2(d), Company shall not be required to make any further payments to
Regeneron under Section 4.1, except that neither Party shall be relieved
of any obligations arising prior to such termination, including any
payment obligations which arose and are due with respect to any period
prior to such termination. Upon termination of this Agreement by Regeneron
in accordance with Section 9.2(b), (i) in addition to any other amounts
payable by Company to Regeneron under this Agreement, under law or
pursuant to any contractual remedies available to Regeneron (but giving
full allowance in due course for any sums paid hereunder), Company shall
pay the amounts otherwise payable by Company under Section 9.2(a) as if
Company had terminated this Agreement for convenience, and (ii) Regeneron
may seek equitable remedies from a court of competent jurisdiction,
including, if appropriate, destruction of Antibodies and Antibody
Materials.
(b) Discontinuation of Use; Return of Material. Upon
expiration of the term of the Agreement or earlier termination of this
Agreement, Company (and its Affiliates and, if applicable, Third Party
service providers pursuant to Section 3.6) will discontinue use of
Regeneron's Confidential Information as of the effective date of such
expiration or termination, except to the extent that such use of such
Confidential Information is reasonably necessary for the Company to
exercise any rights granted pursuant to Section 2.1(d) that survive such
expiry or termination and if requested by Regeneron will return
Regeneron's Confidential Information to which Company does not retain any
rights hereunder in accordance with Section 8.5.
(c) Destruction of Mice and Mice Materials; Treatment of
Antibodies and Antibody Materials. Except as set forth in paragraph (d)
below, within ten (10) business days after the effective date of
expiration or termination of this Agreement for any reason, Company shall
destroy (or cause the destruction of) all Mice (including any Progeny) and
Mice Materials held by Company, its Affiliates and, if applicable, Third
Party service providers. Within seven (7) days of destruction, an officer
of Company shall deliver to Regeneron a signed letter, in form and
substance reasonably acceptable to
24
Regeneron and the Company, certifying that all Mice (including, without
limitation, any Progeny) and, if applicable, Mice Materials have been destroyed.
Except as set forth in the next sentence, upon expiration or termination of this
Agreement for whatever reason, Company shall have the right to continue to use
and Exploit all Antibodies and Antibody Materials generated using the Mice and
Mice Materials prior to the date of termination, subject to Company's
obligations to pay royalties to Regeneron during the Royalty Term pursuant to
Article IV. [**************************************]
(d) Tail Period. No later than sixty (60) days prior to the
expiration date of this Agreement or the termination of this Agreement by
Company pursuant to Section 9.2 (such date being referred to herein as
"the Expiration Date"), Company may provide a written notice to Regeneron,
which shall be accompanied by a payment of [*********************] to
permit Company to retain and use for a period of one calendar year from
the Expiration Date (the "Tail Period") any Mice Materials generated by
Company prior to the Expiration Date solely in order to allow Company to
[********************] prior to the Expiration Date to optimize the
development of Antibodies. At the end of such one year Tail Period,
Company shall destroy and certify as destroyed all Mice Materials in
accordance with the terms in paragraph (c) above.
9.5 Survival. The expiration or termination of this Agreement shall not
relieve the parties of any obligation accruing prior to such expiration or
termination. Section 2.1 (d), the second sentence of Section 3.1, Section 3.5,
Article IV (to the extent applicable, including without limitation, Section 4.2
during the Royalty Term), Section 5.3, Article VI, Section 7.1, Article VIII,
subject to Section 8.10, Article IX and Article X, together with any relevant
defined terms, shall survive any termination or expiration of this Agreement.
ARTICLE X
MISCELLANEOUS
10.1. Assignment; Successors and Assigns. (a) Company may not assign
its rights or delegate its obligations under this Agreement in whole or in part
without the prior written consent of Regeneron, except that Company shall have
the right, without such consent, (i) to perform any or all of its obligations
and exercise any or all of its rights under this Agreement through any of its
Affiliates, or (ii) on written notice to Regeneron, to assign all its rights and
obligations under this Agreement to any successor in interest in connection with
a merger, consolidation or sale of all or substantially all of the assets of
Company; provided, that Company's rights and obligations under this Agreement
shall be assumed by its successor in interest in any such transaction. Company
absolutely, unconditionally and irrevocably guarantees to Regeneron prompt
performance when due and at all times thereafter of the responsibilities,
liabilities, covenants, warranties, agreements and undertakings of its
Affiliates pursuant to this Agreement. (b) Regeneron may not assign its rights
or delegate its obligations under this Agreement in whole or in part without the
prior written consent of Company, except that Regeneron shall have the right,
without such consent, (i) to perform any or all of its obligations and exercise
any or all of its rights under this Agreement through any of its Affiliates, or
(ii) on written notice to Company, to assign all its rights and obligations
under this Agreement (A) to any of its Affiliates that has the resources to meet
Regeneron's obligations under this Agreement, or (B) to a successor in interest
in connection with (1) a merger,
25
consolidation or sale of substantially all or substantially all of the assets of
Regneron, or (2) the sale or license of all or substantially all of the assets
of Regeneron related to the Regeneron Technology; provided that Regeneron's
rights and obligations under this Agreement shall be assumed by its successor in
interest in any such transaction. Regeneron absolutely, unconditionally and
irrevocably guarantees to Company prompt performance when due and at all times
thereafter of the responsibilities, liabilities, covenants, warranties,
agreements and undertakings of its Affiliates pursuant to this Agreement. (c)
Any purported assignment in violation of this Section 10.1 shall be void ab
initio. Without limiting the foregoing, neither Party shall cause or permit any
of its Affiliates to commit any act (including any act or omission) which such
Party is prohibited hereunder from committing directly. No assignment of this
Agreement shall be made in bad faith to limit or restrict the contractual rights
and benefits of the other Party under this Agreement.
10.2. Notices.
Notices to Company shall be addressed to:
AstraZeneca UK Limited
Xxxxxxxx Xxxxx
Xxxxxxxx Xxxx
Xxxxxxxxxxxx
Xxxxxxxx
XX00 0XX
Fax [******************]
Attention: Assistant General Counsel
Notices to Regeneron shall be addressed to:
Regeneron Pharmaceuticals, Inc.
000 Xxx Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx, Xxx Xxxx 00000-0000
XXX
Telefacsimile: [****************]
Attention: Vice President, Strategic Alliances
With a copy to: Vice President & General Counsel
Any Party may change its address by giving notice to the other Party in
the manner herein provided. Any notice required or provided for by the terms of
this Agreement shall be in writing and shall be (a) sent by registered or
certified mail, return receipt requested, postage prepaid, (b) sent via a
reputable international courier service, (c) sent by facsimile transmission with
an original following the same day via a reputable international courier service
or (d) personally delivered, in each case properly addressed in accordance with
the paragraph above. The effective date of notice shall be the actual date of
receipt by the Party receiving the same.
26
10.3. Governing Law. This Agreement shall be construed and the
respective rights of the Parties determined according to the substantive laws of
the State of New York notwithstanding any provisions governing conflict of laws
under such New York law to the contrary and without giving effect to the United
Nations Convention on Contracts for the International Sale of Goods.
10.4. Submission to Jurisdiction. Each Party (a) submits to the
exclusive jurisdiction of any state or federal court sitting in New York, New
York, with respect to actions or proceedings arising out of or relating to this
Agreement, (b) agrees that all claims in respect of such action or proceeding
may be heard and determined only in any such court, subject to any rights of
removal from state court in New York to federal court in New York, and (c)
agrees not to bring any action or proceeding arising out of or relating to this
Agreement in any other court; provided that either Party may bring an action in
any court of competent jurisdiction to enforce a final judgment entered by such
New York courts. Each Party waives any defense of inconvenient forum to the
maintenance of any action or proceeding so brought and waives any bond, surety
or other security that might be required of the other Party with respect
thereto. Each Party may make service on the other Party by sending or delivering
a copy of the process to the Party to be served at the address and in the manner
provided for the giving of notices in Section 10.2. Nothing in this Section
10.4, however, shall affect the right of any Party to serve legal process in any
other manner permitted by law.
10.5. Force Majeure. No Party shall be held liable or responsible to
the other Party nor be deemed to have defaulted under or breached this Agreement
for failure or delay in fulfilling or performing any obligation under this
Agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected Party, including fire, floods, pandemic,
epidemic, embargoes, war, acts of war (whether war is declared or not), acts of
terrorism insurrections, riots, civil commotions, strikes, lockouts or other
labor disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other Party; provided, however, that the Party so
affected shall use reasonable commercial efforts to avoid or remove such causes
of nonperformance, and shall continue performance hereunder with reasonable
dispatch whenever such causes are removed. Each Party shall provide the other
Party with prompt written notice of any delay or failure to perform that occurs
by reason of force majeure. The Parties shall mutually seek a resolution of the
delay or the failure to perform as noted above.
10.6. Independent Contractors. It is understood and agreed that the
relationship between the Parties hereunder is that of independent contractors
and that nothing in this Agreement shall be construed as authorization for
either Regeneron or Company to act as agent for the other.
10.7. Headings. The captions or headings of the sections or other
subdivisions hereof are inserted only as a matter of convenience or for
reference and shall have no effect on the meaning of the provisions hereof.
10.8. Entire Agreement. The Parties acknowledge that this Agreement
(together with the confidentiality agreement dated May 23, 2006) sets forth the
entire Agreement and understanding of the Parties as to the subject matter
hereof and each Party confirms that it is not
27
relying on any representations, warranties or covenants of the other Party
except as specifically set out in this Agreement. This Agreement shall not be
subject to any change or modification except by the execution of a written
instrument subscribed to by the Parties. All other previous or currently
existing agreements and understandings or other arrangements of any kind with
respect to the said subject matter shall be canceled and superseded completely
by this Agreement as of the date hereof. Nothing in this Agreement is intended
to limit or exclude any liability for fraud. All Schedules and Exhibits referred
to in this Agreement are intended to be and are hereby specifically incorporated
into and made part of this Agreement. In the event of any inconsistency between
any such Schedules or Exhibits and this Agreement, the terms of this Agreement
shall govern.
10.9. No Implied Waivers; Rights Cumulative. No failure on the part
of Regeneron or Company to exercise, and no delay in exercising, any right,
power, remedy or privilege under this Agreement, or provided by statute or at
law or in equity or otherwise, shall impair, prejudice or constitute a waiver of
any such right, power, remedy or privilege or be construed as a waiver of any
breach of this Agreement or as an acquiescence therein. To be effective any
waiver must be in writing. No right, power, remedy or privilege herein conferred
upon or reserved to a Party is intended to be exclusive of any other right,
power, remedy or privilege, and each and every right, power, remedy and
privilege of a Party pursuant to this Agreement or now or hereafter existing at
law or in equity shall to the extent permitted by law be cumulative, concurrent
and in addition to every other right, power, remedy or privilege pursuant to
this Agreement or now or hereafter existing at law or in equity.
10.10. Severability. To the fullest extent permitted by Applicable Law,
the Parties waive any provision of law that would render any provision of this
Agreement invalid or illegal or unenforceable in any respect. To the fullest
extent permitted by Applicable Law and if the rights or obligations of any Party
will not be materially and adversely affected: (a) such provision will be given
no effect by the Parties and shall not form part of this Agreement, (b) all
other provisions of this Agreement shall remain in full force and effect, and
(c) the Parties shall use their best efforts to negotiate a provision in
replacement of the provision held invalid, illegal or unenforceable that is
consistent with Applicable Law and achieves, as nearly as possible, the original
intention of the Parties.
10.11. Execution in Counterparts; Facsimile Signatures. This Agreement may
be executed in counterparts, each of which counterparts, when so executed and
delivered, shall be deemed to be an original, and all of which counterparts,
taken together, shall constitute one and the same instrument even if both
Parties have not executed the same counterpart. Signatures provided by facsimile
transmission shall be deemed to be original signatures.
10.12. Construction. Except where the context requires otherwise, whenever
used the singular includes the plural, the plural includes the singular, the use
of any gender is applicable to all genders and the word "or" has the inclusive
meaning represented by the phrase "and/or". Whenever this Agreement refers to a
number of days, unless otherwise specified, such number refers to calendar days.
The headings of this Agreement are for convenience of reference only and do not
define, describe, extend or limit the scope or intent of this Agreement or the
scope or intent of any provision contained in this Agreement. The term
"including" or "includes" as used in this Agreement means including, without
limiting the generality of any description preceding
28
such term. The wording of this Agreement shall be deemed to be the wording
mutually chosen by the Parties and no rule of strict construction shall be
applied against any Party.
10.13. No Benefit to Third Parties. The provisions of this Agreement
are for the sole benefit of the Parties and their successors and permitted
assigns, and they shall not be construed as conferring any rights in any other
Persons except as otherwise expressly provided in Section 10.1.
10.14 Limitation of Damages EXCEPT AS PROVIDED BELOW IN THIS SECTION
10.14, IN NO EVENT SHALL REGENERON OR COMPANY BE LIABLE FOR SPECIAL, PUNITIVE,
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION,
LOSS OF PROFITS) SUFFERED BY THE OTHER PARTY, REGARLDESS OF THE THEORY OF
LIABILITY AND REGLARDLESS OF ANY PRIOR NOTICE OF SUCH DAMAGES. HOWEVER, NOTHING
IN THIS SECTION 10.14 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION
RIGHTS AND OBLGIATIONS OF EITHER PARTY HEREUNDER WITH RESPECT TO THIRD-PARTY
CLAIMS. MOREOVER, NOTHING IN THIS SECTION 10.14 IS INTENDED TO LIMIT OR RESTRICT
ANY LIABILITY FOR FRAUD OR ANY LIABILITY ARISING FROM A BREACH OF SECTION 5.4.
10.15 Further Assurance. Each Party shall perform all further acts
and things and execute and deliver such further documents as may be necessary or
as the other Party may reasonably require to implement or give effect to this
Agreement.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
Effective Date.
REGENERON PHARMACEUTICALS, INC.
By: /s/ Xxxxxx X. Xxxxxxxx
--------------------------------
Name: Xxxxxx X. Xxxxxxxx
Title: Senior Vice President,
Finance & Administration and Chief
Financial Officer
ASTRAZENECA UK LIMITED
By: /s/ Xxxx Xxxxxxxx
--------------------------------
Name: Xxxxxxx "Liam" Mcllveen
Title: Authorised Signatory
29
EXHIBIT A
REGENERON KNOW-HOW AND MICE
[**********************************************]
30
EXHIBIT B
REGENERON PATENT RIGHTS
Patent No.: 6,586,251
USSN: 09/732,234
Inventors: Economides, Murphy, Valenzuela, Yancopoulos
Title: Methods of Modifying Eukaryotic Cells
Filing Date: 7 Dec 2000
Patent No.: 6,596,541
USSN: 09/784,859
PCT: 2003/6275
Inventors: Xxxxxx, Yancopoulos
Title: Methods of Modifying Eukaryotic Cells
Filing Date: 16 Feb 2001 (continuation-in-part of 09/732,234)
Patent No.: US 7,105,348
USSN: 10/076,840
Inventors: Xxxxxx, Yancopoulos
Title: Methods of Modifying Eukaryotic Cells
Filing Date: 15 Feb 2002
780D NZ Patent No. 527629
Granted 7 July 2005
780D SG Patent No. 100103
Granted 30 Nov 2005
780D SA Patent No. 2003/3129
Granted 29 Sept 2005
[********************************]
31
EXHIBIT C
LETTER AGREEMENT WITH APPROVED THIRD PARTIES
Regeneron Pharmaceuticals, Inc.
000 Xxx Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx, Xxx Xxxx XXX 00000
Ladies and Gentlemen:
In connection with the [ ] agreement (the "Agreement") dated
[ ] between [ ] ("Service Provider"), a [ ], with principal
offices located at [ ] and [ASTRAZENECA AFFILIATE] ("AstraZeneca"), a [ ]
with principal offices located at [ ], Service Provider hereby enters into
the following agreement with Regeneron Pharmaceuticals, Inc. ("Regeneron"), a
New York corporation, with principal offices located at 000 Xxx Xxx Xxxx Xxxxx
Xxxx, Xxxxxxxxx, Xxx Xxxx XXX 00000:
1) Service Provider acknowledges that in connection with the Agreement
it shall be receiving (i) confidential and proprietary genetically
modified mice owned by Regeneron (referred to as "Regeneron Mice"),
[(ii) [***********************] from Regeneron Mice (referred to as
"Mice Materials")] and (iii) Regeneron's confidential information
related to the breeding of Regeneron Mice and information from
breeding Regeneron Mice (referred to as "Regeneron Information").
2) [Service Provider agrees that it shall not use the Regeneron Mice
for any purposes other than to breed the Mice solely by means of
breeding Regeneron Mice with other Regeneron Mice solely in
accordance with the breeding practices supplied by AstraZeneca.] [IF
APPLICABLE]
3) Service Provider agrees that Regeneron retains all right, title and
interest in the Regeneron Mice and Mice Materials. Without limiting
the foregoing, Service Provider hereby assigns to Regeneron any
right, title and interest in the Regeneron Mice and Mice Materials.
Service Provider agrees to execute any and all further instruments,
forms of assignments and other documents, and to take such further
actions as Regeneron may request, in order to transfer all of
Service Provider's rights, if any, in the Regeneron Mice and Mice
Materials to Regeneron without additional consideration.
4) Service Provider agrees that it has no right to use the Regeneron
Mice or Mice Materials to discover, develop or otherwise make
improvements to the Regeneron Mice or Mice Materials (referred to as
"Mice Inventions"). Accordingly, Service Provider shall promptly
disclose to Regeneron, in writing, any Mice Inventions and shall,
and hereby does, assign, all right, title, and interest it has in
Mice Inventions without additional compensation.
5) Service Provider agrees that it: (a) will use diligent
efforts to ensure that the Regeneron Mice do not come into contact
with any mice other than Regeneron Mice;
32
and, in particular, will not intentionally or recklessly breed
Regeneron Mice with any mice other than Regeneron Mice; (b) will not
make any heritable genetic modifications to the Regeneron Mice; (c)
will not derive embryonic or other stem cells from the Regeneron
Mice or other Mice Material that could be used to make Regeneron
Mice; (d) will not use Regeneron Mice or Mice Materials to
manufacture or produce products for sale; and (e) will not use Mice
Materials to create Regeneron Mice, mice or any transgenic organism.
6) Service Provider agrees to keep Regeneron Information
confidential and not disclose to any third party or use for any
purpose other than the performance of the Agreement.
7) Service Provider will not distribute or allow the transfer
of Regeneron Mice to any third party other than AstraZeneca or its
Affiliates and will destroy all Regeneron Mice and Mice Materials in
its possession within five (5) business days after notice from
AstraZeneca.
8) This letter agreement shall be construed and the rights of
the parties hereto shall be determined according to the laws of the
State of New York notwithstanding any provisions governing conflict
of laws under such New York law to the contrary and without giving
effect to the United Nations Convention on Contracts for the
International Sale of Goods.
9) This letter agreement may be executed in counterparts, each
of which counterpart, when so executed and delivered, shall be
deemed to be an original, and all of which counterparts, taken
together, shall constitute one and the same instrument even if both
parties have not executed the same counterpart. Signatures provided
by facsimile transmission shall be deemed to be original signatures.
10) For the avoidance of doubt, it is understood that Regeneron
shall not be responsible for AstraZeneca's performance of its
obligations under the Agreement and Regeneron shall have no
liability or responsibilities under the Agreement.
IN WITNESS WHEREOF, the parties have caused a duly authorized
representative to execute this letter agreement as of the date set forth below.
[ ] REGENERON PHARMACEUTICALS, INC.
By: By:
------------------------------ ----------------------------
Name: Name:
---------------------------- ---------------------------
Title: Title:
--------------------------- --------------------------
Date: Date:
---------------------------- --------------------------
33
EXHIBIT D
PRESS RELEASE
ASTRAZENECA LICENSES REGENERON'S VELOCIMMUNE(R)
TECHNOLOGY FOR DISCOVERING HUMAN MONOCLONAL
ANTIBODIES
ASTRAZENECA IS FIRST LICENSEE OF NOVEL VELOCIMMUNE TECHNOLOGY
LICENSE FEES TOTAL UP TO $120 MILLION OVER SIX YEARS
Tarrytown, NY and Wilmington, DE - (February 5, 2007) - Regeneron
Pharmaceuticals, Inc. (Nasdaq: REGN) and AstraZeneca (LSE: AZN, NYSE: AZN)
announced today that they have entered into a non-exclusive license agreement
that will allow AstraZeneca to utilize Regeneron's VelocImmune(R) technology in
their internal research programs to discover human monoclonal antibodies.
AstraZeneca will pay $20 million upfront and will make up to five additional
annual payments of $20 million, subject to the ability to terminate the
agreement after making the first three additional payments. Upon
commercialization of any antibody products discovered utilizing VelocImmune,
AstraZeneca will pay to Regeneron a mid-single-digit royalty on product sales.
"VelocImmune is the centerpiece of Regeneron's suite of technologies for the
discovery and development of fully human antibodies," said Xxxxxx X.
Xxxxxxxxxxx, M.D., Ph.D., President of Regeneron Research Laboratories and
Regeneron's Chief Scientific Officer. "We are pleased that AstraZeneca, a
company with a clear strategic commitment to developing therapeutic antibodies,
has selected the VelocImmune platform for its internal development program."
"AstraZeneca is committed to becoming a leader in the area of biologicals and
VelocImmune is an important part of our strategy to succeed in this field," said
Xxx Xxxxxxxx, Ph.D., Executive VP Global Discovery Research.
34
VELOCIMMUNE AND REGENERON'S DISCOVERY PLATFORMS
Regeneron's VelocImmune technology offers the potential to increase dramatically
the speed and efficiency of discovering fully-human, therapeutic monoclonal
antibodies. The VelocImmune platform generates fully human monoclonal antibodies
(hMAbs) to address clinically relevant targets of therapeutic interest. The
VelocImmune mouse, unlike other hMAb mice, mounts a robust immune response that
is virtually indistinguishable from that of a wild type mouse, resulting in a
reliable and efficient platform for discovering fully human monoclonal
antibodies.
Regeneron has developed and validated a suite of inter-related technology
platforms - VelociGene(R), VeliciMouse(R), and VelocImmune -- that the Company
believes can accelerate its therapeutic drug discovery programs and improve its
ability to discover new hMAb product candidates through VelocImmune. These
discovery platforms are designed to identify specific genes of therapeutic
interest for a particular disease or cell type and validate targets through
high-throughput production of mammalian models. VelociGene uses a proprietary
process to create genetic modifications in a mouse in a precise and
high-throughput manner and was recently selected by the National Institutes of
Health for use in its Knockout Mouse Project. VelociGene allows Regeneron to
produce mouse embryonic stem (ES) cells rapidly for elucidating the function of
the altered genes. VelociMouse allows Regeneron scientists to generate mammalian
models directly from ES cells without the need for chimeras or breeding.
VelocImmune provides antibodies that address the targets identified in the
mammalian models that can be developed as potential therapeutics.
ABOUT ASTRAZENECA
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription pharmaceuticals
and the supply of healthcare services. It is one of the world's leading
pharmaceutical companies with healthcare sales of $23.95 billion and leading
positions in sales of gastrointestinal, cardiovascular, neuroscience,
respiratory, oncology and infection products. AstraZeneca is listed in the Dow
Xxxxx Sustainability Index (Global) as well as the FTSE4 Good Index.
ABOUT REGENERON PHARMACEUTICALS, INC.
35
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 cancer, eye diseases, and inflammatory diseases, and has
preclinical programs in other diseases and disorders.
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 our drug candidates,
determinations by regulatory and administrative governmental authorities which
may delay or restrict our ability to continue to develop or commercialize our
drug candidates, competing drugs that are superior to our product candidates,
unanticipated expenses, the availability and cost of capital, the costs of
developing, producing, and selling products, the potential for any collaboration
agreement, including our agreements with the sanofi-aventis Group and Bayer
HealthCare, to be canceled or to terminate without any product success, risks
associated with third party intellectual property, and other material risks. A
more complete description of these and other material risks can be found in
Regeneron's filings with the United States Securities and Exchange Commission
(SEC), including its Form 10-K for the year ended December 31, 2005 and Form
10-Q for the quarter ended September 30, 2006. 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 CONTACTS:
MEDIA:
Xxxxxx Xxxxxxxxx, Tel: 000 000 0000
xxxxxxxxxx@xxxxxxxxx0.xxx
INVESTOR RELATIONS:
Xxxxxxx Xxxxx, Tel: 000 000 0000
xxxxxxx.xxxxx@xxxxxxxxx.xxx
ASTRAZENECA CONTACTS:
MEDIA ENQUIRIES:
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SCHEDULE 4.2
SAMPLE ROYALTY CALCULATION
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SCHEDULE 5.2
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