Exhibit
10.20
CONFIDENTIAL TREATMENT
REQUESTED: Certain
portions of this document have been omitted pursuant to a request
for confidential treatment and, where applicable, have been marked
with an asterisk (“[*****]”) to denote where omissions
have been made. The confidential material has been filed separately
with the Securities and Exchange Commission.
LICENSE
AGREEMENT
By and among
INTELLECT
NEUROSCIENCES, INC.
And
AHP MANUFACTURING
BV
Acting through its Wyeth Medica
Ireland Branch
And
ELAN PHARMA INTERNATIONAL
LIMITED
May 13, 2008
LICENSE
AGREEMENT
This License Agreement
("Agreement") is entered into this
day of May, 2008 (the "Execution Date") by and among INTELLECT
NEUROSCIENCES, INC., a Delaware corporation, having offices at 7
West Street, 9th Floor, New York, NY 10011, U.S.A.
together with its Affiliates (hereinafter, collectively referred to
as "Licensor") and AHP MANUFACTURING BV, acting
through its Wyeth Medica Ireland Branch, a corporation registered
in the Netherlands with offices at Great Comell, Newbridge, County
Kildare, Ireland (hereinafter "Wyeth"), and ELAN PHARMA
INTERNATIONAL LIMITED, a private company limited by shares
organized under the laws of Ireland with offices at Monksland,
Athlone, County Westmeath, Ireland (hereinafter "Elan" and,
together with Wyeth, referred to herein as "Licensees"). Licensor,
Wyeth and Elan may each be referred to herein individually as a
"Party" and collectively as the "Parties".
A. Licensor owns certain patents and patent
applications relating to certain antibodies, such patents and
patent applications designated herein as the Licensed Patents (as
defined below);
B. Wyeth Parent and Elan have entered into a
collaboration with respect to the treatment and/or prevention of
neurodegenerative conditions in humans associated with P- amyloid
deposition using immunological approaches directed at one or more
epitopes of AP Peptide (as defined below); and
C. Licensor and Licensees desire to enter into
this Agreement to provide Licensees with certain license rights
under the Licensed Patents for the research, development,
manufacture and commercialization of Licensed Products (as defined
below) and Licensor is willing to license to Licensees such rights
under the terms and conditions of this Agreement.
NOW THEREFORE, in consideration of the mutual
covenants herein contained and intending to be legally bound, the
Parties agree as follows:
All references to Exhibits, Articles and
Sections shall be references to Exhibits, Articles and Sections of
this Agreement. In addition, except as otherwise expressly provided
herein, the following terms in this Agreement shall have the
following meanings:
1.01
"Aβ
Peptide" s hall
mean [*****]
1.02
"Affiliate"
shall mean, with respect to any
person or entity, any other person or entity which controls, is
controlled by or is under common control with such person or
entity. A person or entity shall be regarded as in control of
another entity if it owns or controls at least fifty percent (50%)
of the equity securities of the subject entity entitled to vote in
the election of directors (or, in the case of an entity that is not
a corporation, for the election of the corresponding managing
authority), provided, however, that the term "Affiliate" shall not
include subsidiaries or other entities in which a Party or its
Affiliates owns a majority of the ordinary voting power necessary
to elect a majority of the board of directors or other governing
board, but is restricted from electing such majority by contract or
otherwise, until such time as such restrictions are no longer in
effect.
1.03
"Annual Net
Sales" shall mean
Net Sales for the period beginning January 1 and ending December 31
of the year in question.
1.04
"Antibody"
shall mean any molecule, which (a)
comprises one or more immunoglobulin variable domain proteins,
including, without limitation, (i) human, murine, humanized,
chimeric, complementarity determining region (CDR) grafted,
monospecific and bispecific antibodies, (ii) less than full-length
antibody forms, such as Fv, Fab, and F(ab')2, (iii) single-chain
antibodies, and (iv) antibody conjugates bound to a toxin, label or
other moiety, and (b) is directed against or binds to AP
Peptide.
1.05
"[*****]
Products" shall mean
[*****] .
1.06
"Calendar
Quarter" shall mean
the respective periods of three (3) consecutive calendar months
ending on March 31, June 30, September 30 or December 31, for so
long as this Agreement is in effect.
1.07
"Combination
Product(s)" shall
mean any product containing both a pharmaceutically active agent or
ingredient which constitutes a Licensed Product and one or more
other pharmaceutically active agents or ingredients which do not
constitute Licensed Products.
1.08
"Control"
or "Controlled"
shall mean with respect to any material, item of information or
intellectual property right, the possession, whether by ownership,
license or otherwise, of the right to grant a license, sublicense
or other right with respect thereto.
1.09
"Covered
Country(ies)" shall
mean, with respect to a given Licensed Product, the country or
countries in which there is then existing a Valid Claim covering
the manufacture, use or sale of such Licensed Product.
1.10
"Field"
shall mean the treatment, prevention
and/or diagnosis of diseases and/or conditions in humans, including
but not limited to [*****] and
[*****] .
1.11
"First Commercial
Sale" shall mean,
with respect to a given Licensed Product in a given Covered Country
in the Territory, the first sale of such Licensed Product by
Licensees or their Affiliates or sublicensees for use in the Field
to an independent Third Party who is not a sublicensee or an
Affiliate of a sublicensee of Licensees following Regulatory
Approval of such Licensed Product for use in the Field in such
country.
1.12
"Intellect
Products" shall mean
any therapeutic or prophylactic product or composition, other than
a [*****] Product, (a) that is or has been
developed, conceived and/or reduced to practice by Licensor or (b)
to which Licensor has acquired rights under a license or purchase
from or through a Third Party and which is developed by Licensor.
For the avoidance of doubt, Intellect Products include, but are not
limited to, antibodies with specificity for a free amino or carboxy
terminus of amyloid-beta protein, such as, without limitation,
[*****] and variants thereof, and exclude any such
antibodies contained in a [*****]
Product.
1.13
"Licensed
Patents" shall mean
(a) all patents and patent applications in the Territory claiming
the benefit of [*****], (b) all patents and patent applications
listed in Exhibit A attached hereto, throughout the Territory, (c)
all patents and patent applications deemed Licensed Patents
pursuant to Section 2.03, and (d) all substitutions, continuations,
continuations-in-part, divisions, renewals, patents-of-addition,
reissues, re-examinations, extensions, restorations, supplemental
protection certificates, patent applications and patents throughout
the Territory arising from, relating to or claiming priority to any
patents and/or patent applications described in clauses (a), (b)
and/or (c) above, to the full extent that each of the foregoing is
owned or otherwise Controlled by Licensor as of the Execution Date
or comes under the Control of Licensor during the term of this
Agreement.
1.14
"Licensed
Products" shall mean
any therapeutic, prophylactic and/or diagnostic product, the
composition, manufacture or use of which would, but for the
licenses granted by Licensor to Licensees herein, infringe a Valid
Claim of a Licensed Patent owned or otherwise Controlled by
Licensor.
1.15
"Licensor Third Party
Agreement" shall
mean any agreement between Licensor and any Third Party that
relates to any Licensed Patent, including, without limitation, any
license or assignment that relates to any Licensed
Patent.
1.16
"[*****]"
shall mean a state in which memory
and/or cognition has declined and is abnormal for age and
education, but the severity of which is insufficient to be
consistent with [*****] and/or
[*****] .
1.17
"Net Sales"
shall mean, with respect to a
Licensed Product, all proceeds actually received by Licensees, or
their Affiliates or sublicensees, from the sale of such Licensed
Product to unrelated Third Parties who are not sublicensees or
Affiliates of sublicensees of the Licensees, less amounts actually
paid or accrued therefore by Licensees, or such Affiliates or
sublicensees, for reasonable and customary deductions from such
gross amounts for the following:
(a) trade, cash, promotional and quantity
discounts and wholesaler fees allowed and taken directly with
respect to such sales;
(b) amounts repaid, credits or allowances
granted for damaged goods, defects, expired dating, recalls,
returns or rejections of Licensed Products and retroactive price
reductions for Licensed Products;
(c) sales, excise, use, value added or similar
taxes paid by or charged to the account of Licensees, or their
Affiliates or sublicensees, (including, without limitation, duties
or other governmental charges levied on, absorbed or otherwise
measured by the billing amount, when included in billing, but not
including franchise taxes or national, state or local taxes based
on income);
(d) charge back payments and rebates granted to
(i) managed health care organizations, (ii) federal, stated and/or
local governments or their agencies, (iii) purchasers and
reimbursers, and/or (iv) trade customers, including, without
limitation, wholesalers and chain and pharmacy buying groups;
and
(e) packing, freight, postage, shipping, customs
duties and insurance charges to the extent included in the invoice
price.
Net Sales shall be determined in accordance with
GAAP, consistently applied.
If, on a country-by-country basis, a Licensed
Product is sold as part of a bundle of distinct products (i.e. one
price is charged for a number of distinct products that are not (i)
packaged together with another Licensed Product or (ii) in a
Combination Product form alone), the Net Sales for such Licensed
Product shall be based on the ratio of the wholesale acquisition
cost for such Licensed Product to the sum of the wholesale
acquisition costs for each product in such bundle. By way of
example, if the wholesale acquisition cost for such Licensed
Product when sold separately is [*****], and the sum of the
wholesale acquisition costs for each product in such bundle when
sold separately if [*****], then the Net Sales attributable to the
Licensed Product when sold as part of the bundle would be [*****]
of the Net Sales of the bundle of products sold.
In the event that, on a country-by-country
basis, a Licensed Product is sold in the form of a Combination
Product, the Net Sales for such Combination Product will be
calculated as follows.
(i) If Licensees, their Affiliates and/or
sublicensees, separately sell, in such country (a) Licensed
Products containing as their sole active ingredient(s) the same
Antibody as is contained in such Combination Product and (b) other
products containing as their sole active ingredient(s) the other
active component(s) in such Combination Product,
[*****].
(ii) If Licensees, their Affiliates and/or
sublicensees separately sell, in such country, Licensed Products
containing as their sole active ingredient(s) the same Antibody as
is contained in such Combination Product but do not separately
sell, in such country, other products containing as their sole
active ingredient(s) the other active component(s) in such
Combination Product, [*****].
(iii) If Licensees, their Affiliates and/or
sublicensees do not separately sell, in such country, Licensed
Products containing as their sole active ingredient(s) the same
Antibody as is contained in such Combination Product, but do
separately sell other products containing as their sole active
ingredient(s) the other active component(s) in such Combination
Product, [*****].
(iv) If Licensees, their Affiliates and/or
sublicensees do not separately sell, in such country (a) Licensed
Products containing as their sole active ingredient(s) the same
Antibody as is contained in such Combination Product and (b) other
products containing as their sole active ingredient(s) the other
active component(s) in such Combination Product,
[*****].
Notwithstanding any provision of this Section
1.17 to the contrary, transfers of Licensed Products for testing,
pre-clinical, clinical or developmental purposes or as samples
shall not be considered a "sale" hereunder for royalty or other
purposes.
1.18
"Regulatory
Approval" shall mean
all technical, medical and scientific licenses, registrations,
authorizations and approvals (including, without limitation,
approvals of BLAs and NDAs or their foreign equivalents,
supplements and amendments, pre- and post-approvals, pricing and
third party reimbursement approvals, and labeling approvals) of any
national, supra-national, regional, state or local regulatory
agency, department, bureau, commission, council or other
governmental agency, necessary for the commercial manufacture,
distribution, marketing, promotion, offer for sale, use, import,
export and sale of Licensed Product(s) in a given regulatory
jurisdiction. For the sake of clarity, and without limiting the
foregoing, Regulatory Approval shall not be achieved for a Licensed
Product in a given country until any applicable pricing and
governmental third party reimbursement approvals have also been
obtained in such country.
1.19
"Territory"
shall mean the entire
world.
1.20
"Third
Party(ies)" shall
mean any person or entity other than Licensor or Licensees or their
respective Affiliates.
1.21
"Valid
Claim" shall mean an
issued and unexpired claim in a patent within the Licensed Patents,
which claim has not been dedicated to the public, disclaimed,
canceled, withdrawn, abandoned, revoked, or held invalid or
unenforceable by a decision of a court or government agency of
competent jurisdiction in an unappealed or unappealable
decision.
1.22
"Wyeth
Parent" shall mean
Wyeth, a Delaware corporation, the corporate parent of AHP
Manufacturing BV.
2.01
Exclusive
License. Licensor
hereby grants Licensees an exclusive (exclusive even as to
Licensor) license, with the right to grant sublicenses, under the
Licensed Patents to research, develop, use, have used, make, have
made, offer for sale, sell, have sold, import and export
[*****] Products in the Field in the Territory.
For the avoidance of doubt, Licensor and any licensee, sublicensee,
assignee, transferee or designee of Licensor shall, subject to the
non-exclusive license granted to Licensees under Section 2.02,
retain the right under the Licensed Patents to research, develop,
use, have used, make, have made, offer for sale, sell, have sold,
import and export Intellect Products, but shall not retain any
right under the Licensed Patents to research, develop, use, have
used, make, have made, offer for sale, sell, have sold, import
and/or export any [*****] Product.
2.02
Non-Exclusive
License. Licensor
hereby grants each Licensee a non-exclusive license, with the right
to grant sublicenses, under the Licensed Patents to research,
develop, use, have used, make, have made, offer for sale, sell,
have sold, import and export Licensed Products other than
[*****] Products in the Field in the Territory.
For the avoidance of doubt, the license granted under this Section
2.02 shall in no way limit Licensees' exclusive rights to
[*****] Products under Section 2.01.
2.03
Additional
Patents. Other than
[*****] and [*****], and foreign counterparts of such applications,
Licensor represents that, as of the Execution Date, it is not aware
of any other patent or pending patent application owned or
otherwise Controlled by Licensor, which patent or patent
application (a) is not listed in Exhibit A and included within the
Licensed Patents licensed to Licensees under this Agreement, and
(b) which Licensor reasonably believes would cover any Antibody or
Licensed Product or contains claims that, once issued, would be
infringed by the manufacture, use, offer for sale, sale, import or
export of any Antibody or Licensed Product by Licensees or their
respective Affiliates or sublicensees. If, during the term of this
Agreement, Licensor acquires or otherwise obtains the right to
grant a license or sublicense to any patent or patent application
that (i) is not a Licensed Patent hereunder and (ii) Licensor
reasonably believes would be infringed by the manufacture, use,
offer for sale, sale, import or export of an Antibody or a Licensed
Product by Licensees or their respective Affiliates or sublicensees
("Additional Patent"), Licensor shall promptly notify Licensees in
writing and Licensees shall have the first right to negotiate a
license to such Additional Patent under commercially reasonable
terms. If the Parties have not concluded license negotiations
within [*****] , Licensor may then offer a Third
Party the opportunity to license such Additional Patent.
2.04
Updates to List of Licensed
Patents. No less
frequently than once per calendar year, Licensor shall provide
Licensees with a written update of Exhibit A, setting forth any
change in the status of the previously listed Licensed Patents and
listing any newly filed, developed or acquired patent rights that
constitute Licensed Patents. Upon the written approval of
Licensees, each such update shall constitute an amendment to
Exhibit A. For the avoidance of doubt, Licensor's delay in or
failure to update Exhibit A pursuant to this Section 2.04 shall not
in any way limit or otherwise impact the scope of Licensees' rights
under this Agreement.
(a)
Option
Grant. In partial
consideration of payment by Licensees of the License and Option Fee
specified in Section 3.01, Licensor hereby grants Licensees an
exclusive option to receive ownership of all of Licensor's right,
title and interest in and to the Licensed Patents (the
"Option").
(b)
Option
Exercise. If at any
time during the term of this Agreement (i) Licensor and its
sublicensees have abandoned all activities related to research,
development and commercialization of all Intellect Products that
are covered by the Licensed Patents ("Covered Intellect Program")
and (ii) no licenses granted by Licensor under the Licensed Patents
(other than the licenses granted to Licensees under this Agreement)
remain in force, Licensor shall notify Licensees in writing (such
notice referred to herein as a "Cessation Notice"). Licensor shall
have sole discretion to identify the circumstances and timing that
constitute an abandonment described in clause (i) above; provided,
however, that a failure by Licensor to incur expenses relevant to
such Covered Intellect Program of more than
[*****] , shall constitute such an abandonment.
Licensor shall deliver the Cessation Notice to Licensees within
[*****] that the conditions set forth in clauses
(i) and (ii) are met. The Option granted to Licensees under Section
2.05(a) above may be exercised by Licensees within
[*****] (the "Option Period") after receipt of the
Cessation Notice. If Licensees wish to exercise the Option,
Licensees shall provide Licensor or its legal representatives with
written notice (the "Option Exercise Notice") of an election to so
exercise the Option. Following delivery of the Option Exercise
Notice, Licensor shall and hereby does assign and agree to assign
to Licensees all of Licensor's right, title and interest in and to
the Licensed Patents and shall execute and deliver to Licensees one
or more confirmatory patent assignments covering all such Licensed
Patents in the form set forth in Exhibit B hereto, as such form may
be revised by Licensees to reflect the specific filing requirements
of each relevant patent authority in the Territory. Further,
Licensor shall execute and deliver to Licensees all documents and
perform all acts requested by Licensees for the purposes of (a)
documenting and/or recording the assignment of the Licensed Patents
to Licensees in all jurisdictions throughout the Territory and (b)
enabling Licensees or their designated Affiliates to prosecute and
maintain the Licensed Patents in all jurisdictions throughout the
Territory.
2.06
Authority and Responsibility
for Licensed Products. Licensees shall have sole and exclusive
authority, control and responsibility in all matters relating to
the research, development, Regulatory Approval, manufacture and
commercialization of Licensed Products. Except as expressly
provided in this Agreement, neither Licensee shall be deemed to
have granted to Licensor or any of its licensees, sublicensees,
assignees, transferees or designees any license or other right with
respect to the Licensed Products or any intellectual property
rights or other rights owned or otherwise Controlled by
Licensees.
2.07
Covenant Not To Assert
Certain Patent Rights. Licensor shall not, and Licensor shall not grant
any Third Party any right to, assert against either or both
Licensees, any Affiliates of either Licensee and/or any Third Party
sublicensees of one or both Licensees (collectively, the
"Non-Assert Parties") any United States or foreign patent issuing
from, relating to or claiming priority to
[*****],[*****],[*****],[*****] and/or [*****] (collectively, the
"Non-Assert Patents"). Without limiting the foregoing, Licensor
shall not, and Licensor shall not grant any Third Party any right
to, bring any lawsuit or other action against any Non-Assert Party
claiming that the research, development, manufacture, use, sale,
offer for sale and/or importation of any Antibody or Licensed
Product infringes any one or more Non-Assert Patents.
3.
PAYMENTS, ROYALTIES,
REPORTS
3.01
License and Option
Fee. Within
[*****] days after the Execution Date, in
consideration of the licenses granted under Section 2.01 and
Section 2.02 and the Option granted under Section 2.05 hereof,
Licensees collectively shall pay to Licensor
[*****] (the "License and Option Fee").
3.02
Patent
Milestones. As
consideration for Licensor's performance of its obligations under
this Agreement, including, without limitation, the performance of
Licensor's obligations under Article 5, promptly following
successful completion of each of the following events, Licensor
shall provide Licensees with written notice that such event has
occurred (each such notice referred to herein as an "Issuance
Notice"). Within [*****] following Licensees'
receipt of an Issuance Notice for each such event, Licensees
collectively shall pay Licensor the designated amount corresponding
to such event:
(a)
Upon grant in the United States of Licensed Patent with
at least one Valid Claim that covers (i) the
pharmaceutical composition of [*****] , or
(ii) the method of manufacture for [*****] , or
(iii) the use of [*****] for the treatment of
[*****] or [*****] :
|
[*****]
|
|
|
|
(b)
Upon grant by the European Patent Office of Licensed Patent
with at least one Valid Claim that covers (i) the pharmaceutical
composition of [*****] , or (ii) the method of
manufacture for [*****] , or (iii) the use of
[*****] for the treatment of
[*****] or [*****] :
|
[*****]
|
Each payment
described in clauses (a) and (b) above shall be payable one time
only, regardless of the number of times each event
occurs.
3.03
Sales
Milestone. Within
[*****] after Licensees achieve Annual Net Sales
in excess of [*****] for any Licensed Product in
the Covered Countries, Licensees collectively shall pay Licensor
[*****] . Such payment is payable one time only,
regardless of the number of Licensed Products that reach such
Annual Net Sales in such Covered Countries.
(a) Subject to the reductions, offsets and
withholdings specified in Sections 3.06, 3.09, 3.12 and 4.03, and
in further consideration of the rights and licenses granted under
Article 2, on a Licensed Product-by-Licensed Product and Covered
Country-by-Covered Country basis during the applicable Royalty Term
(as defined below), Licensees collectively shall pay Licensor the
following marginal royalties on Annual Net Sales of each Licensed
Product in each Covered Country:
|
|
Marginal Royalty
Rate
|
|
Annual Net Sales
Level
|
(% of Annual Net
Sales)
|
Up to and
including [*****]
|
[*****]
|
Greater than
[*****] and up to and including
[*****]
|
[*****]
|
Greater than
[*****] and up to and including
[*****]
|
[*****]
|
|
|
[*****]
|
(b) The
percentages set forth above apply only to the amount of Annual Net
Sales for a given Licensed Product that falls within the specified
range. For example, if Annual Net Sales for such a Licensed Product
in a given Covered Country were [*****] ,
Licensees would pay a royalty of [*****] on the
first [*****] of such Net Sales in such Covered
Country and a royalty of [*****] on the remaining
[*****] of such Net Sales in such Covered
Country.
(c) For the
avoidance of doubt, Licensees shall not be required to pay any
royalties to Licensor with respect to Net Sales of any Licensed
Product in any country that is not a Covered Country with respect
to such Licensed Product.
(d) The
obligation to pay royalties under this Agreement shall be imposed
only once with respect to the sale of the same unit of a Licensed
Product, regardless of how many Valid Claims included within the
Licensed Patents would, but for the licenses granted to Licensees
under this Agreement, be infringed by the manufacture, use or sale
of such Licensed Product in the Covered Countries.
(a) The royalty
term shall be, on a Covered Country-by-Covered Country and Licensed
Product-by-Licensed Product basis, the period
[*****] (the "Royalty Term").
(b) At the end
of the Royalty Term for a given [*****] Product in
a given country, the licenses granted by Licensor to Licensees
under this Agreement shall become fully paid-up, perpetual,
irrevocable, royalty-free, exclusive licenses with respect to such
[*****] Product in such country.
(c) At the end
of the Royalty Term for a given Licensed Product other than a
[*****] Product in a given country, the licenses
granted by Licensor to Licensees under this Agreement shall become
fully paid-up, perpetual, irrevocable, royalty-free, non-exclusive
licenses with respect to such Licensed Product in such
country.
3.06
Royalties to Third
Parties. In the
event that one or both Licensees are required to pay to one or more
Third Parties any royalties based on the sale of any Licensed
Product in any country ("Third Party Royalties"), Licensees may
deduct [*****] of such Third Party Royalties from
the royalties otherwise payable to Licensor under Section 3.04(a),
provided, however, that in no event shall such
deduction based on Third Party Royalties reduce the amount of the
royalty otherwise payable to Licensor for the sale of such Licensed
Product in such country by more than [*****]
.
3.07
Most Favored
Licensee. In the
event that Licensor grants or has granted to any Third Party a
license under the Licensed Patents, which license requires such
Third Party to pay less than any of the payments and/or royalties
set forth in this Article 3, such lesser payments and royalties
shall be substituted for the payments and royalties payable by
Licensees under this Agreement, and any amounts paid by Licensees
prior to the issuance of such Third Party license in excess of such
lesser payments and royalties shall be credited against future
payments and/or royalties payable by Licensees to Licensor under
this Agreement.
3.08
Sales Among Affiliates and
Sublicensees. Sales
or other transfers between and among Licensees and their Affiliates
or sublicensees of Licensed Products which are subsequently resold
by Licensees or their Affiliates or sublicensees shall not be
subject to royalty, but in such cases royalties shall accrue and be
calculated on the subsequent sale or other transfer of such
Licensed Products to a Third Party, other than a sublicensee or
their Affiliates.
3.09
Currency
Conversion. All
amounts payable to Licensor under this Agreement shall be payable
in U.S. Dollars by wire transfer to a bank account designated in
writing by Licensor. In the case of royalties payable pursuant to
Section 3.04, all amounts payable shall first be calculated in the
currency of the Covered Country of sale and then converted into
U.S. Dollars in accordance with Licensee's customary and usual
translation procedures, consistently applied. Notwithstanding the
foregoing, if by reason of any restrictive exchange laws or
regulations, Licensees shall be unable to convert to U.S. Dollars
the amount, determined as provided above, which is equivalent to
the amount due to Licensor hereunder (or if able to convert, where
restricted or prohibited from remitting such royalties in U.S.
Dollars) then Licensees shall notify Licensor promptly with a
written explanation of the circumstances. In such event, all such
payments, or the balance due hereunder shall be remitted in U.S.
Dollars as soon as reasonably possible after and to the extent that
such restrictive exchange laws or regulations are lifted to permit
conversion of the above-mentioned amount to U.S.
Dollars.
3.10
Royalty
Report. Licensees
agree to make written reports and royalty payments to Licensor
within [*****] after the close of each Calendar
Quarter during the term of this Agreement, beginning with the
Calendar Quarter in which the date of the First Commercial Sale of
a Licensed Product following Regulatory Approval occurs. These
reports shall state for the Calendar Quarter in question:
[*****] . No later than at the time of the making
of each such report, Licensees shall make any payment due to
Licensor of royalties for the Calendar Quarter covered by such
report by wire transfer to the following account (or such other
account as Licensor may designate in writing to Licensees from time
to time):
All information
contained in reports made by Licensees pursuant to this Section
3.10 shall be deemed to be Confidential Information of Licensees
and shall be treated as such by Licensor in accordance with Article
7 hereof.
3.11
Inspection.
Licensees agree to keep, and to
require their applicable Affiliates and sublicensees to keep, clear
and accurate records of Net Sales of Licensed Products for a period
of at least [*****] after the Calendar Quarter
during which such Net Sales were generated. Such records shall
include sufficient detail to enable the royalties payable hereunder
to be accurately determined. Licensees further agree to permit such
records, and to require any of their applicable Affiliates or
sublicensees to permit such records, to be examined by an
independent accounting firm selected by Licensor and reasonably
satisfactory to Licensees from time-to-time, but not more than once
each calendar year and provided that such examination shall be
limited to the records pertaining to the
[*****] period preceding
the examination. Licensees and their applicable Affiliates and
sublicensees may require such independent accountant to sign a
standard non-disclosure agreement prior to allowing such accountant
to examine such records. Upon completion of such examination, the
accountant shall report in writing to Licensor and Licensees only
whether the royalty reports and royalties paid were correct or
incorrect, the amount of any overpayment or underpayment and the
basis for any discrepancies. No other information shall be provided
to Licensor. Such examination shall occur during Licensees' and
their applicable Affiliates' and sublicensees' normal business
hours at one or more facilities reasonably designated by Licensees.
Such examination is to be made at the expense of Licensor, except
in the event that the results of the audit reveal that Licensees
underpaid royalties to Licensor by [*****] or
more, then the audit fees shall be paid by Licensees. Any payment
discrepancy identified by the independent accountant will be
promptly corrected by a payment or refund, as
appropriate.
3.12
Withholding.
Licensees may withhold from
payments and royalties due to Licensor amounts for payment of any
tax, duties, levies or other charges on Licensor that Licensees are
required to withhold on Licensor's behalf in accordance with
applicable laws and/or regulations. Proof of payment of such taxes
shall be secured, if available, and sent to Licensor as evidence of
such payment in such form as required by the taxing or other
governmental authorities having jurisdiction over Licensees.
Licensees agree to reasonably cooperate with Licensor to take
advantage of any tax treaty, including without limitation, any
double taxation agreements or similar agreements that may be
available, in order to enable Licensees to make such payments to
Licensor without any deduction or withholding.
3.13
Disclaimer.
Licensor acknowledges and agrees
that nothing in this Agreement shall be construed as representing
any estimate or projection of either (a) the number of Licensed
Products that will or may be successfully developed, manufactured
or commercialized or (b) anticipated sales or the actual value of
any Licensed Product. Licensees make no representation or warranty,
either express or implied, that (i) Licensees will be able to
successfully develop, manufacture or commercialize any Licensed
Product, (ii) if commercialized, any Licensed Product will achieve
any particular sales level, or (iii) Licensees will devote any
level of diligence or resources to the development, manufacture or
commercialization of any Licensed Product.
4.01
Existing
Agreements. Subject
to the provisions of Section 3.06, Licensees shall be solely
responsible for all of their existing contractual obligations to
all Third Parties relating to the Licensed Products. Licensor shall
be solely responsible for all of its existing contractual
obligations to all Third parties relating to the Licensed
Patents.
4.02
Future
Licenses. In the
event Licensees determine that it is necessary or useful to obtain
additional licenses to intellectual property of Third Parties that
relate to the Licensed Patents or the Licensed Products in order to
research, develop, manufacture or commercialize the Licensed
Product(s), Licensees shall, at their sole discretion, control the
negotiation and procurement of any such license agreements, but
Licensees would not be obligated to procure any such license
agreements. Any royalties paid by one or both Licensees to one or
more Third Parties under any such additional licenses shall be
considered to be Third Party Royalties in accordance with Section
3.06.
4.03
Third Party Infringement.
(a) In the
event a Party becomes aware of any possible or actual Third Party
infringement of the Licensed Patents, that Party shall promptly
notify the other Parties and provide each of them with full
details.
(b) With
respect to any Licensed Product made, used, sold, imported or
exported by a Third Party which Licensees reasonably believe
infringes a claim of one or more Licensed Patents, at the written
request of Licensees ("Written Request"), Licensor shall, at
Licensee's expense, commence suit or other proceedings and/or file
any claims appropriate to abate such infringement ("Enforcement"),
engaging legal counsel mutually acceptable to all Parties.
Licensees, at their sole election, shall have the right, but not
the obligation, to be joined as party plaintiffs in any such
Enforcement to the full extent permitted by law in the relevant
jurisdiction. In resolving any Enforcement (or related settlement)
initiated by Licensor as described above, Licensor and Licensees
shall first be reimbursed [*****] of any funds
remaining from the sums recovered in the Enforcement or its
settlement. In the event Licensor has not commenced Enforcement
(through mutually agreed upon counsel) within thirty (30) days
after receiving such Written Request from Licensees, then Licensees
shall have the right, but not the obligation, to initiate
Enforcement at their own expense and to join Licensor as a party
plaintiff in any such suit or proceeding, if required by law in the
relevant jurisdiction and at no cost or expense to Licensor. In
resolving any such Enforcement initiated by Licensees, Licensees
shall be entitled to receive and retain any and all sums recovered
in the Enforcement or its settlement.
(c) With
respect to any infringing activity set forth in clause b above, and
any other infringement of Licensed Patents by a Third Party, if
Licensor fails to commence any suit or proceeding or otherwise
abate such infringement within [*****] of the date
that Licensor first becomes aware of such infringement, all
royalties and other payments payable by Licensees hereunder shall
automatically be reduced by [*****] ("Infringement
Abatement"). For the avoidance of doubt, any such Infringement
Abatement shall be calculated independently of, and applied in
addition to, any abatement for Third Party Royalties pursuant to
Section 3.06.
(d) For the
sake of clarity, it shall not be an act of infringement of Licensed
Patents for Licensor or any licensee, sublicensee, assignee,
transferee or designee of Licensor to research, develop, use, have
used, make, have made, offer for sale, sell, have sold, import or
export Intellect Products.
5.
PROSECUTION AND MAINTENANCE
OF LICENSED PATENTS
Subject to the provisions of this Article 5,
Licensor shall have the sole right and obligation to prepare, file,
prosecute and maintain the Licensed Patents in the Territory.
Licensor shall keep Licensees advised of the status of all patent
filings, including, without limitation, the grant of Licensed
Patents and shall promptly provide advance copies of any official
correspondence received in respect of the filing, prosecution and
maintenance of such patent filings for review
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