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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 15 Stanhope Gate, London W1K 1LN
("Company"), and
Regeneron Pharmaceuticals, Inc. ("Regeneron"), a New York
corporation, with a
principal place of business located at 777 Old Saw Mill River Road,
Tarrytown,
New York 10591-6707.
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
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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 sunder 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
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<PAGE>
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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<PAGE>
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
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