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
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.
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
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 0 Xxxx Xxxxxx, 0xx
Xxxxx,
Xxx Xxxx, XX
00000,
X.X.X. 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 Xxxxx Xxxxxx, Xxxxxxxxx, Xxxxxx Xxxxxxx, Xxxxxxx
(hereinafter "Wyeth"), and ELAN PHARMA INTERNATIONAL LIMITED, a private company
limited by shares organized under the laws of Ireland with offices at Xxxxxxxxx,
Xxxxxxx, Xxxxxx Xxxxxxxxx, Xxxxxxx (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".
RECITALS
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);
X.
Xxxxx
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.
AGREEMENT
NOW
THEREFORE, in consideration of the mutual covenants herein contained and
intending to be legally bound, the Parties agree as follows:
1.
DEFINITIONS
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" shall 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.
2
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
[*****].
3
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:
4
(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,
[*****].
5
(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.
6
2.
RIGHTS
GRANTED
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.
7
2.05
Exclusive
Option:
(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.
8
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.
3.04
Royalties.
(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:
9
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
[*****]
|
[*****]
|
Greater
than [*****]
|
[*****]
|
(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.
3.05
Royalty Term.
(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.
10
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.
11
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):
Bank:
[*****]
[*****]
Routing
Number: [*****]
Account
Number: [*****]
Account
Holder: [*****]
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.
12
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.
THIRD
PARTIES
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 xxxxx 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.
13
(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 xxxxx 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 and comment by Licensees. If Licensor elects not to file, or ceases
to
prosecute and/or maintain any Licensed Patent (a) Licensees shall have the
right
to file and/or continue prosecution and maintenance thereof, (b) Licensor shall
execute such documents and perform such acts, at Licensees' expense, as may
be
necessary to permit Licensees to undertake responsibility for such Licensed
Patents and (c) at the request of one or both Licensees, Licensor shall assign
all right, title, and interest in and to such Licensed Patents to Licensees,
and
shall execute all necessary documents to perfect title in one or both Licensees,
as directed by Licensees, at the expense of Licensees. Further, if Licensor
elects not to file, or ceases to prosecute and/or maintain any Licensed Patent,
Licensees shall no longer be obligated to pay Licensor any patent milestone
payments under Section 3.02, any sales milestone payment under Section 3.03
or
any royalty payments under Sections 3.04 or 3.10 with respect to such Licensed
Patent, and shall be relieved of their royalty reporting obligations in respect
of such Licensed Patent under Section 3.10.
6.
REPRESENTATIONS
AND WARRANTIES
6.01
Representations
and Warranties of Each Party. Each
Licensee hereby represents and warrants to Licensor, and Licensor hereby
represents and warrants to each Licensee, that it knows of no legal reason
to
prevent it from entering into this Agreement and that:
14
(a)
as of
the Execution Date, it is a corporation or entity duly organized and validly
existing under laws of the state or other jurisdiction of incorporation or
formation;
(b)
the
execution, delivery and performance of this Agreement by such Party has been
duly authorized by all requisite corporate action and does not require any
stockholder action or approval;
(c)
it
has the power and authority to execute and deliver this Agreement and to perform
all of its obligations hereunder;
(d)
this
Agreement is a legal and valid obligation binding upon the Parties and
enforceable in accordance with its terms, subject to applicable limitation
on
such enforcement based on bankruptcy laws and other debtors' rights; and
(e)
its
execution, delivery and performance of this Agreement will not conflict in
any
material fashion with the terms of any other agreement or instrument to which
it
is or becomes a party or by which it is or becomes bound, nor violate any law
or
regulation of any court, governmental body or administrative or other
governmental agency having authority over it.
6.02
Additional
Representations by Licensor. In addition
to the representations and warranties of Licensor contained elsewhere in this
Agreement, Licensor hereby represents and warrants to Licensees that:
(a)
as of
the Execution Date, the Licensed Patents are existing and, to the best knowledge
of Licensor, are not invalid or unenforceable, in whole or in part;
(b)
the
patents, patent applications and related patent rights set forth in Exhibit
A
constitute all Licensed Patents in existence as of the Execution Date;
(c)
as of
the Execution Date, the Licensed Patents constitute all patents, patent
applications and other patent rights owned or otherwise Controlled by Licensor
which relate specifically or generally to Antibodies;
(d)
except as set forth in Schedule 6.02(d), all Licensed Patents in existence
as of
the Execution Date are properly registered and recorded in each applicable
jurisdiction in the name of Intellect Neurosciences, Inc.;
(e)
Licensor has and will have the full right, power, authority and ability to
grant
(i) all of the right, title and interest in the licenses it has granted or
is
required to grant to Licensees under this Agreement and (ii) all other rights
it
has granted or is required to grant to Licensees under this Agreement;
(f)
as of
the Execution Date, other than the Licensed Patents, Licensor does not own
or
otherwise Control any patents or other intellectual property rights that, to
the
knowledge of Licensor, may be infringed by the research, development,
use,
manufacture,
offer for sale, sale, import or export of Licensed Products in the Field in
the
Territory by Licensees or their respective Affiliates as contemplated by this
Agreement;
15
(g)
Licensor is the sole and exclusive owner of the Licensed Patents existing as
of
the
Execution Date, all of which are free and clear of any liens, charges,
encumbrances and/or other rights of any one or more Third Parties, contingent
or
otherwise, other than Third Party rights under any Licensor Third Party
Agreements in effect as of the Execution Date;
(h)
except as set forth in Schedule 6.02(h), as of the Execution Date (i) there
are
no Licensor Party Agreements, (ii) no Third Party has any right, title or any
license under, any of the Licensed Patents, (iii) no Licensor Third Party
Agreement conflicts with any license or other right granted by Licensor to
Licensees hereunder and (iv) Licensor is in compliance in all material respects
with all Licensor Third Party Agreements in effect as of the Execution Date;
(i)
as of
the Execution Date, no composition, method or other invention covered by any
Licensed Patent was developed pursuant to or is subject to any funding agreement
with any government or governmental agency; and
(j) to
the
best of its knowledge, as of the Execution Date there are no claims, judgments
or settlements against or owed by Licensor (whether existing, pending or
threatened) relating to the Licensed Patents.
6.03
Additional
Covenants by Licensor. In
addition to the other covenants made by Licensor elsewhere in this Agreement,
Licensor hereby covenants to Licensees that, during the term of this Agreement:
(a)
Licensor shall use commercially reasonable efforts (i) to take all actions
necessary to maintain the validity and enforceability of the Licensed Patents
and preserve the rights granted to Licensees hereunder and (ii) not to take
any
action that may reasonably be expected to diminish the validity or
enforceability of the Licensed Patents or otherwise diminish the rights under
the Licensed Patents granted to Licensees hereunder;
(b)
Licensor shall (i) promptly, but in no event later than thirty (30) days
following execution, notify Licensees in writing of any Licensor Third Party
Agreement that Licensor enters into following the Execution Date and (ii) not
enter into any Licensor Third Party Agreement that adversely affects the rights
granted to Licensees under this Agreement or the ability of Licensor to perform
its obligations under this Agreement, but for the sake of clarity, a
non-exclusive license by Licensor of the Licensed Patents for products other
than [*****] Products shall not, in and of itself, be
considered as an agreement that adversely affects the rights granted to
Licensees under this Agreement;
(c)
Licensor shall notify Licensees in writing of any allegation that Licensor
has
breached its obligations under any Licensor Third Party Agreement promptly,
but
in no event later than thirty (30) days following Licensor's first receipt
or
knowledge of such allegation; and
(d)
Licensor
shall promptly execute any documents and perform any acts as may be necessary
to
ensure that all Licensed Patents are properly registered and recorded in each
applicable jurisdiction in the name of Intellect Neurosciences, Inc. and that
documentary evidence of chain of title from the inventor(s) to Intellect
Neurosciences, Inc. is recorded in each applicable jurisdiction for all such
Licensed Patents.
16
6.04
Compliance
with Applicable Law. Each
Party hereby agrees that it shall at all times comply with all applicable
material laws and regulations relating to its activities under this Agreement.
6.05
Representation
by Legal Counsel. Each
Party hereto represents that it has been represented by legal counsel in
connection with this Agreement and acknowledges that it has participated in
the
drafting hereof. In interpreting and applying the terms and provisions of this
Agreement, the Parties agree that no presumption shall exist or be implied
against the Party which drafted such terms and provisions.
7.
CONFIDENTIALITY
7.01
Confidentiality.
(a)
Licensor acknowledges that in the course of the Parties' performance under
this
Agreement that it may receive Confidential Information of Licensees and/or
their
respective Affiliates, and Licensees acknowledge that in the course of the
Parties' performance under this Agreement they may receive Confidential
Information of Licensor. "Confidential Information" means any confidential
or
proprietary information of a Party or its Affiliate(s) disclosed, created or
generated after the Execution Date, including, without limitation, information
related to Licensed Products and Antibodies, and all other data and information
relating to any compound, research project, work in process, future development,
scientific, engineering, manufacturing, marketing, business plan, financial
or
personnel matter relating to such Party or its Affiliates, its present or future
precuts, sales, suppliers, customers, employees, investors or business, whether
in oral, written, graphic or electronic form and whether or not designated
or
marked as confidential or proprietary, including, without limitation, trade
secrets, processes, formulae, data and know-how, improvements, inventions,
techniques, biological materials, marketing plans, strategies, forecasts and
customer and contact lists. Notwithstanding the foregoing, Confidential
Information shall not include any information that: (i) is already known to
the
receiving Party at the time of disclosure; (ii) is publicly known prior to
or
becomes publicly known after disclosure other than through acts or omission
or
breach of this Agreement by the receiving Party; (iii) is disclosed in good
faith to the receiving Party by a Third Party lawfully in possession thereof
and
without obligation to keep such information confidential or (iv) is
independently developed by or on behalf of the receiving Party without the
aid,
use or application of Confidential Information received from the disclosing
Party hereunder.
(b)
During the term of this Agreement and for [*****] after expiration or
termination hereof, (i) Licensor shall keep confidential, shall not disclose
and
shall not use for any purpose other than to perform its obligations under this
Agreement any and all Confidential Information received, directly or indirectly,
from Licensees and/or any of their respective Affiliates, hereunder, and (ii)
Licensees shall keep confidential, shall not disclose and not use for any
purpose, other than to perform their obligations under this Agreement and for
the development and commercial exploitation of Licensed Products, any and all
Confidential Information received, directly or indirectly from Licensor
hereunder. The obligations set forth above in this Section 7.01(b) shall not
apply to the extent that it can be demonstrated, that (A) Confidential
Information is required to be disclosed pursuant to applicable law, regulation
or an order of a court of law or governmental agency, provided that the Party
seeking to disclose such Confidential Information shall (1) promptly provide
written notice of such required disclosure to the Party or Parties owning such
Confidential Information, (2) consult with such Party or Parties with respect
to
such required disclosure and (3) provide such Party or Parties sufficient
opportunity to object to any such disclosure or to request that the Party
seeking to make such disclosure seek confidential treatment thereof, in which
event, the Party seeking to make such disclosure shall, at its sole expense,
use
all reasonable efforts to accommodate such requests of the Party or Parties
owning such Confidential Information, or (B) disclosure is made to a government
regulatory agency in the ordinary course of seeking or maintaining any necessary
Regulatory Approval of a Licensed Product.
17
7.02
Permitted
Disclosure. Licensees
may disclose Confidential Information received from Licensor to each other,
to
their respective Affiliates and to those of their and their respective
Affiliates' directors, officers, employees, agents, consultants, sublicensees,
attorneys and advisors (collectively, "Licensee Representatives") who have
a
need to know such Confidential Information for purposes of performing Licensees'
obligations or exercising Licensees' rights under this Agreement, provided
that
prior to disclosure to any such Licensee Representative (i) such Licensee
Representative is advised of the confidentiality obligations hereunder with
respect to such Confidential Information and (ii) such Licensee Representative
is under obligation to such Party to maintain the confidential nature of such
Confidential Information on terms and conditions no less restrictive than those
set forth herein. Licensor may disclose Confidential Information received from
Licensees and/or their respective Affiliates to its directors, officers,
employees, agents, consultants, attorneys and advisors (collectively, "Licensor
Representatives") who have a need to know such Confidential Information for
purposes of performing Licensor's obligations or exercising Licensor's rights
under this Agreement, provided that prior to disclosure to any such Licensor
Representative (a) such Licensor Representative is advised of the
confidentiality obligations hereunder with respect to such Confidential
Information and (b) such Licensor Representative is under obligation to such
Party to maintain the confidential nature of such Confidential Information
on
terms and conditions no less restrictive than those set forth herein.
7.03
Announcements.
Following
the Execution Date, Licensor may issue a press release substantially of the
form
attached hereto as Exhibit B. Following Licensees achievement of the sales
milestone described in Section 3.03, Licensor may issue a press release
substantially of the form attached hereto as Exhibit C. Except as expressly
permitted pursuant to the foregoing provisions of this Section 7.03, no Party
shall make any public announcement regarding this Agreement or otherwise
disclose this Agreement, any of its terms or any Exhibit, Schedule or attachment
hereto or any negotiations or other discussions among the Parties relating
to
this Agreement (collectively "Agreement Information") to any Third Party without
the prior written consent of the other Parties. Notwithstanding the foregoing,
a
Party may disclose Agreement Information to the extent (a) such disclosure
is
required pursuant to applicable law, regulation or an order of a court of law
or
governmental agency, provided that the Party seeking to disclose such Agreement
Information shall (i) promptly provide written notice of such required
disclosure to the other Parties, (ii) consult with the other Parties with
respect to such required disclosure and (iii) provide the other Parties
sufficient opportunity to object to any such disclosure or to request that
the
Party seeking to make such disclosure seek confidential treatment thereof,
in
which event, the Party seeking to make such disclosure shall, at its sole
expense, use all reasonable efforts to accommodate such requests of the other
Parties, or (b) disclosure is made to a government regulatory agency in the
ordinary course of seeking or maintaining any necessary Regulatory Approval
of a
Licensed Product.
18
8.
TERM
AND
TERMINATION
8.01
Term.
Unless
earlier terminated as provided in this Article 8, this Agreement shall come
into
force on the Execution Date and shall continue on a Licensed Product-by-Licensed
Product and Covered Country-by-Covered Country basis until expiration of the
Royalty Term for the last Licensed Product in the last Covered Country.
8.02
Termination.
(a)
Licensees may terminate this Agreement in whole or in part on a Licensed
Product-by-Licensed Product and Covered Country-by-Covered Country basis at
any
time following [*****] prior written notice by Licensees to
Licensor.
(b)
If
any Party shall at any time breach any material term, condition or agreement
herein, and shall fail to have initiated and actively pursued remedy of any
such
default or breach within [*****] after receipt of written
notice thereof by the other Parties, such other Parties may, at their option,
terminate this Agreement with respect to the rights and licenses herein granted
and directly affected by the default or breach by notice in writing to such
effect. Such act shall not, however, prejudice the right of a Party giving
such
notice to recover any royalty or other sums due at the time of such
cancellation, and it being understood that if within [*****]
after receipt of any such notice the receiving Party shall
have
initiated and actively pursued remedy of its default, then the rights and
licenses herein granted shall remain in force as if no breach or default had
occurred on the part of the receiving Party, unless such breach or default
is
not in fact remedied within a reasonable period of time thereafter.
(c)
Licensor acknowledges and agrees that Licensees, in deciding to enter into
this
Agreement, have relied on the rights simultaneously granted to Licensor and
to
Licensees pursuant to that certain Agreement of Further Assurance dated as
of
the Effective Date by and among Xxxxxx X. Chain, Mindset Biopharmaceuticals,
Inc., Mindset LTD., Licensor, Wyeth and Elan (the "Assurance Agreement"), a
copy
of which is attached hereto as Exhibit D. In the event that (i) Xxxxxx X. Chain,
Mindset Biopharmaceuticals ,
Inc.,
and/or Mindset LTD. commit a material breach of any of their respective
representations, warranties or obligations under the Assurance Agreement, (ii)
such breach remains uncured [*****], measured from the date
written notice of such material breach is delivered to such breaching party
by
Licensor, Wyeth or Elan, and (iii) such breach adversely affects the ability
of
one or both Licensees to exercise any of the rights granted to them under this
Agreement, then Licensees may terminate this Agreement in its entirety for
cause. In the event that Licensees terminate this Agreement (A) pursuant to
this
Section 8.02(c) or (B) for cause resulting from Licensor's material breach
of
any of its representations or warranties set forth in Section 6.02 of this
Agreement, the licenses granted by Licensor to Licensees pursuant to Section
2.01 and Section 2.02 shall automatically become perpetual, irrevocable,
royalty-free, fully-paid-up licenses and shall survive such termination (as
modified by the provisions of this Section 8.02(c)) and the provisions of
Section 2.07 shall survive such termination.
19
(d)
Licensees may terminate this Agreement in its entirety by providing written
notice to Licensor at any time during the term of this Agreement in the event
that any of the following events (each an "Insolvency Event") occur with respect
to Licensor: (i) a case is commenced by or against Licensor under Title
11of
the
United States Code (the "Bankruptcy Code"); (ii) Licensor files for or is
subject to the institution of bankruptcy, liquidation or receivership
proceedings (other than a case under the Bankruptcy Code); (iii) Licensor
assigns all or a substantial portion of its assets for the benefit of creditors;
(iv) a receiver or custodian is appointed for Licensor's business; or (v) a
substantial portion of Licensor's business is subject to attachment or similar
process; provided,
however, that
in
the case of any involuntary case under the Bankruptcy Code with respect to
Licensor, such termination right shall only become effective if such case is
not
dismissed [*****] after the commencement thereof.
8.03
Provisions for Insolvency.
(a)
All
rights and licenses now or hereafter granted by Licensor to Licensees under
or
pursuant to this Agreement, including, for the avoidance of doubt, the licenses
granted to Licensees pursuant to Section 2.01 and Section 2.02, are, for all
purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to
"intellectual property" as defined in the Bankruptcy Code. Upon the occurrence
of any Insolvency Event with respect to Licensor, Licensor agrees that
Licensees, as licensees of such rights under this Agreement, shall retain and
may fully exercise all of their rights and elections under the Bankruptcy Code.
Further, each Party agrees and acknowledges that all payments by Licensees
to
Licensor hereunder, other than the License and Option Fee pursuant to Section
3.01, royalty payments pursuant to Section 3.04 and Section 3.10, and the sales
milestone pursuant to Section 3.03, do not constitute royalties within the
meaning of Section 365(n) of the Bankruptcy Code or relate to licenses of
intellectual property hereunder. Licensor shall, during the term of this
Agreement, create and maintain current copies or, if not amenable to copying,
detailed descriptions or other appropriate embodiments, to the extent feasible,
of all such intellectual property. If a case is commenced under the Bankruptcy
Code by or against Licensor, Licensor (in any capacity, including
debtor-in-possession) and its successors and assigns (including a trustee)
shall:
(i)
as
Licensees may elect in a written request, immediately upon such request (A)
perform all of the obligations provided in this Agreement to be performed by
Licensor including, where applicable, providing to Licensees portions of such
intellectual property (including embodiments thereof) held by Licensor and/or
such successors and assigns or otherwise available to them; or (B) provide
to
Licensees all such intellectual property (including all embodiments thereof)
held by Licensor and/or such successors and assigns or otherwise available
to
them: and
20
(ii)
not
interfere
with Licensee's rights under this Agreement, or any agreement supplemental
hereto, to such intellectual property (including such embodiments), including
any right to obtain such intellectual property (or such embodiments) from
another entity, to the extent provided in Section 365(n) of the Bankruptcy
Code.
(b)
If
(i) a
case under the Bankruptcy Code is commenced by or against Licensor, (ii) this
Agreement is rejected as provided in the Bankruptcy Code, and (iii) Licensees
elect to retain their rights hereunder as provided in Section 365(n) of the
Bankruptcy Code, then Licensor (in any capacity, including debtor-in-possession)
and its successors and assigns (including any trustee) shall provide to
Licensees all such intellectual property (including all embodiments thereof)
held by Licensor and such successors and assigns, or otherwise available to
them, immediately upon Licensees' written request. Whenever Licensor or any
of
its successors or assigns provides to Licensees any of the intellectual property
licensed hereunder (or any embodiment thereof) pursuant to this Section 8.03(b),
Licensees shall have the right to perform Licensor's obligations hereunder
wit11
respect to such intellectual property, but neither such provision nor such
performance by Licensees shall release Licensor from liability resulting from
rejection of the license or the failure to perform such obligations.
(c)
All
rights, powers and remedies of Licensees provided herein are in addition to
and
not in substitution for any and all other rights, powers and remedies now or
hereafter existing at law or in equity (including the Bankruptcy Code) in the
event of the commencement of a case under the Bankruptcy Code with respect
to
Licensor. The Parties agree that they intend the following rights to extend
to
the maximum extent permitted by law, and to be enforceable under Bankruptcy
Code
Section 365(n):
(i)
the
right of access to any intellectual property (including all embodiments thereof)
of Licensor, or any Third Party with whom Licensor contracts to perform an
obligation of Licensor under this Agreement, and, in the case of the Third
Party, which is necessary for the manufacture, use, sale, import or export
of
Licensed Products; and
(ii)
the
right to contract directly with any Third Party to complete the contracted
work.
8.04
No
Waiver. The
right
of either Party to terminate this Agreement as provided herein shall not be
affected in any way by its waiver of, or failure to take action with respect
to,
any previous failure to perform hereunder.
8.05
Survival.
Termination
for any reason hereunder shall not affect any accrued rights or obligations
of
the Parties arising in any manner under this Agreement prior to the effective
date of termination. In any event, the provisions of Article 7, the provisions
of Section 8.03, the provisions of Section 8.06, any
payment and/or reporting obligations that have accrued under Article 3 prior
to
the effective date of termination, the provisions of Article 9, any provisions
that expressly survive termination, and any other provision or provisions that
are necessary to interpret the preceding surviving provisions shall survive
any
termination of this Agreement.
21
8.06
Disposition
of Confidential Information upon Termination. Upon
termination of this Agreement, upon written request from the disclosing
Party(ies), each Party shall return to the other Parties any Confidential
Information disclosed by the other Parties under this Agreement, provided,
however, that such Party's legal department may retain one copy of such
Confidential Information in its confidential files solely for the purpose of
ascertaining such Party's continuing obligations hereunder.
9.
MISCELLANEOUS
9.01
Assignment.
Licensees
may not assign the Agreement without the prior written consent of Licensor,
which consent shall not be unreasonably withheld, provided, however, that each
Licensee may, without such consent, assign its rights and obligations under
the
Agreement to an Affiliate, to the other Licensee, to any purchaser of all or
substantially all of its assets or research to which the subject matter of
the
Agreement relates, or to any successor corporation resulting from any merger
or
consolidation of either or both Licensees with or into such corporation.
Licensor may not assign any of its rights or obligations under this Agreement
without the prior written consent of Wyeth and Elan, which consent shall not
be
unreasonably withheld, provided, however, that Licensor may, without such
consent, assign its rights and obligations under this Agreement to any purchaser
of all or substantially all of the Licensed Patents, or to any successor
corporation resulting from any merger or consolidation of Licensor with or
into
such corporation.
9.02
Entire
Agreement. This
Agreement constitutes the entire agreement between the Parties hereto with
respect to the within subject matter hereof and supersede all previous
Agreements, whether written or oral. Without limiting the foregoing, each of
the
following agreements is hereby terminated as of the Execution Date: (a) that
certain Non-Disclosure Agreement between Wyeth Parent acting through its Wyeth
Pharmaceuticals Division, Elan Pharmaceuticals, Inc. and Mindset
BioPharmaceuticals, Inc. dated as of August 8, 2003; (b) that certain Non-
Disclosure Agreement between Wyeth Parent acting through its Wyeth
Pharmaceuticals Division and Intellect Neurosciences, Inc. dated as of November
17, 2005; and (c) that certain Non-Disclosure Agreement between Elan
Pharmaceuticals, Inc. and Intellect Neurosciences, Inc. dated as of November
7,
2006 (the agreements described in clauses (a), (b) and (c) collectively referred
to herein as the "Pre-Existing NDAs"), provided, however, that each Pre-Existing
NDA shall continue to govern information disclosed thereunder prior to the
Execution Date according to its terms. Further, the Parties acknowledge and
agree that the Assurance Agreement has been executed simultaneously with this
Agreement and shall remain in full force and effect in accordance with its
terms.
9.03
Amendment.
Any
changes to this Agreement must be in writing and signed by authorized
representatives of each Party. This Agreement shall not be changed or modified
orally, but only by an instrument in writing signed by all Parties.
22
9.04
Severability.
If
any
provision of this Agreement is declared invalid by a court of last resort or
by
any court, the decision of which appeal is not taken within the time provided
by
law, then and in such event, this Agreement will be deemed to have been
terminated only in the relevant jurisdiction, but this Agreement, in all other
respects and all other jurisdictions, will remain in force provided, however,
that if the provision so invalidated is essential to the Agreement as a whole,
then the Parties shall negotiate in good faith to amend the terms hereof as
nearly as practical to carry out the original intent of the Parties and, failing
such amendment, either Party may submit the matter to a court of competent
jurisdiction for resolution.
9.05
Notices.
Any
notice or report required or permitted to be given under this Agreement shall
be
in writing and shall be sent by expedited delivery or telecopied and confirmed
by mailing, as follows and shall be considered received three (3) days after
such delivery:
All
correspondence to LICENSOR
shall
be
addressed as follows:
Intellect
Neurosciences, Inc. 0 Xxxx 00" Xxxxxx, 0" Xxxxx Xxx Xxxx, XX 00000 Attention:
Chief Executive Officer Fax No.: 000-000-0000
All
correspondence to WYETH
shall
be
addressed as follows:
AHP
Manufacturing BV, acting through its Wyeth Medica Ireland Branch
Xxxxx
Xxxxxxx Xxxxxxxxx
Xxxxxx
Xxxxxxx
Xxxxxxx
Attn:
Managing Director Fax No.: 000-000-00-000000
with
copies to each of the following:
Wyeth
000
Xxxxxx Xxxx Xxxxxxxxxxxx, XX 00000
Attn:
Senior Vice President, Global Licensing
Fax
No.:
000-000-0000
Wyeth
000
Xxxxxx Xxxx Xxxxxxxxxxxx, XX 00000
Attn:
Chief Counsel, Global Business Development
Fax
No.:
000-000-0000
Wyeth
0
Xxxxxxx
Xxxxx Xxxxxxx, XX 00000
Attn:
General Counsel Fax No.: 000-000-0000
All
correspondence to ELAN
shall
be
addressed as follows:
Elan
Pharma International, Limited
Monksland,
Athlone County Westmeath
Ireland
Attn:
VP
Legal
Fax
No.:
000000000000000
23
with
copies to:
Elan
Pharmaceuticals, Inc.
000
Xxxxxxx Xxxxxxxxx Xxxxx
Xxx
Xxxxxxxxx, XX 00000
Attn:
Chief Intellectual Property Counsel
Fax
No.:
000-000-0000
9.05
Choice
of Law. This
Agreement shall be governed by and construed in accordance with the laws of
the
State of New York, except for their conflict of laws principles. The Parties
agree to exclusive jurisdiction and venue of any actions or proceedings relating
to this agreement in the state and federal courts of New York, NY.
9.06
Force
Majeure. No
party(ies) shall be responsible to the others for failure or delay in performing
any of its obligations under this Agreement or for other non- performance hereof
provided that such delay or non-performance is occasioned by a cause beyond
the
reasonable control and without fault or negligence of such Party, including,
but
not limited to war, terrorism, earthquake, fire, flood, explosion, discontinuity
in the supply of power, court order or governmental interference, act of God,
strike or other labor trouble and provided that such Party will inform the
other
Party as soon as is reasonably practicable and that it will entirely perform
its
obligations immediately after the relevant cause has ceased its effect.
9.07
Headings.
The
captions used herein are inserted for convenience of reference only and shall
not be construed to create obligations, benefits, or limitations.
9.08
Independent
Contractors. The
Parties are independent contractors under this Agreement. Nothing herein
contained shall be deemed to create an employment, agency, joint venture or
partnership relationship between the Parties hereto or any of their agents
or
employees, or any other legal arrangement that would impose liability upon
one
(1) Party for the act or failure to act of the other Parties. No Party shall
have any express or implied power to enter into any contracts or commitments
or
to incur any liabilities in the name of, or on behalf of, the other Parties
or
to bind the other Parties in any respect whatsoever.
9.09
Further
Actions. Each
Party agrees to execute, acknowledge and deliver such further instruments,
and
to do all such other acts, as may be necessary or appropriate in order to carry
out the purposes and intent of this Agreement.
9.10
Waiver.
Any
delay
in enforcing a Party's rights under this Agreement or any waiver as to a
particular default or other matter shall not constitute a waiver of such Party's
rights to the future enforcement of its rights under this Agreement, excepting
only as to an express written and signed waiver as to a particular matter for
a
particular period of time.
9.11
Counterparts.
This
Agreement may be executed in any number of counterparts, each of which shall
be
deemed to be an original, and such counterparts together shall constitute one
agreement. Execution and delivery of this Agreement by facsimile copies bearing
the facsimile signatures of the Parties shall constitute a valid and binding
execution and delivery of this Agreement by the signing Party, and such
facsimile copies shall constitute original documents.
[Signature
Page Follows]
24
IN
WITNESS WHEREOF, the Parties hereto have duly executed this License Agreement
as
of the Execution Date.
Licensor:
|
Licensee:
|
||
Intellect Neurosciences, Inc. | AHP Manufacturing BV, acting through Its Wyeth Medica Ireland Branch | ||
By: | By: | ||
25
EXHIBIT
A
|
||
LICENSED
PATENTS
|
||
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****]
|
[*****] |
[*****]
|
[*****]
|
[*****] |
[*****]
|
26
EXHIBIT
B
FORM
OF EXECUTION DATE PRESS RELEASE
Intellect
press release re: license
DRAFT
-NOT
FOR
DISTRIBUTION
Intellect
Neurosciences, Inc. Grants License for Certain Patents and Patent Applications
to Wyeth and Elan Pharma International Ltd.
New
York,
NY, February [XX],2008,
/
PRNewswire
/
--Intellect
Neurosciences, Inc. (OTCC: ILNS), a
biopharmaceutical company focused on development of disease-modifying
therapeutic agents for the treatment and prevention of Alzheimer's disease
(AD),
announced today that it has entered into a license agreement with Wyeth
(NYSE:
WYE) and
Elan
Pharrna International Ltd. (Elan) regarding certain of Intellect's patents
and
patent applications related to antibodies and methods of treatment for
Alzheimer's disease. Under the terms of the agreement, Wyeth and Elan may pay
Intellect potential future milestone payments and royalties based on sales
of
potential products, if it is determined that they are covered by patents that
issue from Intellect's patent applications.
Dr.
Chain, Intellect's Chairman and CEO and inventor of the licensed patents and
patent applications, commented: "We are delighted to enter into this licensing
agreement, which provides Intellect a share in the future success of potential
Wyeth and Elan products while we continue to develop our proprietary monoclonal
antibodies for the treatment of AD."
About
Alzheimer's disease
Alzheimer's
disease, the most common form of dementia, is characterized by progressive
loss
of memory and cognition, ultimately leading to complete debilitation and death.
A hallmark feature of Alzheimer's pathology is the presence of insoluble protein
deposits known as beta-amyloid on the surface of nerve cells, which results
from
the accumulation of soluble beta-amyloid in the brain. The effects of the
disease are devastating to the patients as well as the caregivers, with
significant associated health care costs. It is estimated that there are over
12
million people suffering from Alzheimer's disease in the in the developed
countries with the number increasing also in developing countries as the global
population ages. Currently marketed drugs transiently affect some of the
symptoms of the disease, but there are no drugs on the market today that slow
or
arrest the progression of the disease. These symptomatic drugs are projected
to
generate approximately $4
billion
in sales by 2008, indicating both the size of the market and the demand for
effective treatment beyond symptomatic improvements.
About
Intellect Neurosciences, Inc.
Intellect
Neurosciences, Inc. is a biopharmaceutical company engaged in the discovery
and
development of disease-modifying therapeutic agents for the treatment and
prevention of Alzheimer's disease and other disorders. The company has a broad
proprietary immunotherapy platform for both passive and active immunization
against Alzheimer's disease. Also, Intellect has recently completed Phase I
clinical trials for OXIGONTM,
a
unique antioxidant and anti-amyloid compound .that has potential to treat
Alzheimer's disease and other disorders. For additional information, please
visit xxx.xxxxxxxxxxx.xxx
27
Xxxxxx
Xxxx, JD,
President
&
Chief
Financial Officer
Intellect
Neurosciences, Inc.
0
Xxxx
00'
Xxxxxx, 0xx Xxxxx
Xxx
Xxxx,
XX 00000,
Tel:
x0-000-000-0000
28
EXHIBIT
C
FORM
OF SALES MILESTONE PRESS RELEASE
Intellect
press release re: sales milestone
DRAFT
-NOT
FOR
DISTRIBUTION
Intellect
Neurosciences, Inc. Receives $[*****]
Milestone Payment from Wyeth and Elan Pharma International Ltd. Related to
Product Sales
New
York,
NY, [month],[xx][Year],
/
PRNewswire
/
--Intellect
Neurosciences, Inc. (OTCC:
ILNS),
a
biopharmaceutical company focused on development of disease-modifying
therapeutic agents for the treatment and prevention of [*****],
announced today that it has received a $[*****] sales based
milestone payment pursuant to its existing license agreement with Wyeth
(NYSE:
WYE)
and
Elan
Pharma International Ltd. (Elan) regarding certain of Intellect's patents and
patent applications related to antibodies and methods of treatment for
Alzheimer's disease. Xx. Xxxxxx Chain, Intellect's Chairman and CEO, is inventor
of the licensed patents and patent applications.
Under
the
terms of the agreement, Wyeth and Elan have paid Intellect the one-time
milestone of $[*****] as a result of achieving certain sales
goals.
Dr.
Chain
commented: 'We are delighted regarding the success of Wyeth and Elan's product."
About
Alzheimer's disease
Alzheimer's
disease, the most common form of dementia, is characterized by progressive
loss
of memory and cognition, ultimately leading to complete debilitation and death.
A hallmark feature of Alzheimer's pathology is the presence of insoluble protein
deposits known as beta-amyloid on the surface of nerve cells, which results
from
the accumulation of soluble beta-amyloid in the brain. The effects of the
disease are devastating to the patients as well as the caregivers, with
significant associated health care costs. It is estimated that there are over
12
million people suffering from Alzheimer's disease in the in the developed
countries with the number increasing also in developing countries as the global
population ages. Currently marketed drugs transiently affect some of the
symptoms of the disease, but there are no drugs on the market today that slow
or
arrest the progression of the disease. These symptomatic drugs are projected
to
generate approximately $4
billion
in sales by 2008, indicating both the size of the market and the demand for
effective treatment beyond symptomatic improvements.
About
Intellect Neurosciences, Inc.
Intellect
Neurosciences, Inc. is a biopharmaceutical company engaged in the discovery
and
development of disease-modifying therapeutic agents for the treatment and
prevention of Alzheimer's disease and other disorders. The company has
a
broad
proprietary immunotherapy platform for both passive and active immunization
against Alzheimer's disease. Also, Intellect has recently completed Phase I
clinical trials for OXIGONTM,
a
unique antioxidant and anti-amyloid compound that has potential to treat
Alzheimer's disease and other disorders. For additional information, please
visit xxx.xxxxxxxxxxx.xxx
Xxxxxx
Xxxx, JD,
CPA
President
&
Chief
Financial Officer
Intellect
Neurosciences, Inc.
0
Xxxx
x0xx Xxxxxx, 0xx Xxxxx
Xxx
Xxxx,
XX 0000 1, USA
Tel:
000-000-0000
29
EXHIBIT
D AGREEMENT OF FURTHER ASSURANCE
See
Attached.
SCHEDULE
6.02(d)
REGISTRATION
OF LICENSED PATENTS
None.
SCHEDULE
6.02(h)
LICENSOR
THIRD PARTY AGREEMENTS
None.
30
AGREEMENT
OF FURTHER ASSURANCE
This
Agreement of Further Assurance ("Agreement") is entered into this 13th
day of
May, 2008 (the "Effective Date") by and among Xx. Xxxxxx X. Chain, an individual
with an address at 000 Xxxx 00xx Xxxxxx, Xxx. 0X, Xxx Xxxx, Xxx Xxxx 00000
("Dr.
Chain"), Mindset Biopharmaceuticals, Inc., a Delaware corporation with offices
at 000 Xxxx 00xx Xxxxxx, Xxxxx 000X, Xxx Xxxx, Xxx Xxxx 00000, together with
its
Affiliates (collectively referred to herein as "Mindset USA"), Mindset, LTD.,
a
company incorporated under the laws of the British Virgin Islands with offices
at 000 Xxxx 00xx Xxxxxx, Xxx. 0X, Xxx Xxxx, Xxx Xxxx 00000, together with its
Affiliates (collectively referred to herein as "Mindset LTD"), Intellect
Neurosciences, Inc., a Delaware corporation with offices at 0
Xxxx
00xx
Xxxxxx, 0xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000 ("Intellect"), Elan Pharma
International Limited, a private company limited by shares organized under
the
laws of Ireland with offices at Xxxxxxxxx, Xxxxxxx, Xxxxxx Xxxxxxxxx, Xxxxxxx
("Elan"), and AHP Manufacturing BV, acting through its Wyeth Medica Ireland
Branch, a corporation registered in the Netherlands with offices at Xxxxx
Xxxxxxx, Xxxxxxxxx, Xxxxxx Xxxxxxx, Xxxxxxx ("Wyeth"). Dr. Chain, Mindset USA,
Mindset LTD, Intellect, Elan and Wyeth may each be referred to herein
individually as a "Party" and collectively as the "Parties." Further, Mindset
USA and Mindset LTD may be referred to herein collectively as "Mindset," Dr.
Chain, Mindset USA and Mindset LTD may be referred to herein collectively as
"Grantors," and Elan and Wyeth may be referred to herein collectively as
"Recipients."
BACKGROUND
A.
Pursuant
to a series of written assignments executed prior to the Effective Date
(collectively, the "Patent Assignments"), Grantors have assigned their entire
right, title and interest in and to the Intellect Patents (as defined below)
to
Intellect.
B.
The
terms
of the Patent Assignments require Grantors to execute all documents, take all
rightful oaths and affidavits and perform all other acts necessary to vest
their
entire right, title and interest in and to the Intellect Patents in Intellect.
C.
As
of the
Effective Date, Intellect, Wyeth and Elan have entered into the License
Agreement (as defined below) pursuant to which Intellect has granted to Wyeth
and Elan certain exclusive and non-exclusive rights under the Intellect Patents.
D.
Dr.
Chain
has served as the chief executive officer of Mindset USA and Mindset LTD and,
as
of the Effective Date, serves as the chief executive officer and chairman of
the
board of directors of Intellect.
E.
The
Parties desire to clarify Grantors' continuing obligations with respect to
the
Intellect Patents, including, without limitation, the rights under the Intellect
Patents that have been granted to Wyeth and Elan pursuant to the License
Agreement.
31
NOW
THEREFORE, the
Parties agree as follows:
1.
DEFINITIONS.
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:
1.1
|
"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.
|
|
1.2
|
"Government
Authority" shall
mean any court of competent jurisdiction, any relevant patent authority
or
any other government agency with the authority to determine or
assign any
ownership or other rights under the Intellect Patents.
|
|
1.3
|
"Intellect
Patents" shall
mean (a) all patents and patent applications throughout the world
claiming
the benefit of [*****], (b) all patents and patent applications
listed in
Exhibit A attached hereto, throughout the world and (c) 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 world arising from, relating to or claiming priority
to any
patents and/or patent applications described in clauses (a) and/or
(b)
above.
|
|
1.4
|
"License
Agreement" shall
mean that certain License Agreement dated as of the Effective Date
by and
among Intellect, Wyeth and Elan, a copy of which is attached hereto
as
Exhibit B.
|
|
1.5
|
"Third
Party" shall
mean any person or entity other than Dr. Chain, Mindset USA, Mindset
LTD,
Intellect, Wyeth, Elan or their respective Affiliates
|
2.
INVENTORSHIP;
ACKNOWLEDGEMENT OF ASSIGNMENT; FURTHER ASSURANCES.
32
2.1
|
Inventorship.
Dr.
Chain hereby represents and warrants to Wyeth and Elan that (a)
he is the
sole inventor of each invention claimed by [*****] and each invention
claimed by each of the patents and patent applications listed in
Exhibit A
and (b) he was the sole owner of each such invention and all related
patent rights at the time he assigned his entire right, title and
interest
in and to the Intellect Patents to Mindset.
|
|
2.2
|
Assignment
by Dr. Chain. Dr.
Chain hereby acknowledges and agrees that (a) prior to the Effective
Date,
he has assigned his entire right, title and interest in and to
the
Intellect Patents to Mindset, (b) Mindset has subsequently assigned
its
entire right, title and interest in and to the Intellect Patents
to
Intellect, and (c) he retains no right, title or interest, licensed
or
otherwise, under any of the Intellect Patents.
|
|
2.3
|
Assignment
by Mindset USA. Mindset
USA hereby acknowledges and agrees that (a) prior to the Effective
Date,
it has assigned its entire right, title and interest in and to
the
Intellect Patents to Intellect and (b) it retains no right, title
or
interest, licensed or otherwise, under any of the Intellect Patents.
|
|
2.4
|
Assignment
by Mindset LTD. Mindset
LTD hereby acknowledges and agrees that (a) prior to the Effective
Date,
it has assigned its entire right, title and interest in and to
the
Intellect Patents to Mindset USA and (b) it retains no right, title
or
interest, licensed or otherwise, under any of the Intellect Patents.
|
|
2.5
|
Further
Assurances. Without
limiting any obligation owed by any of the Grantors to Intellect,
whether
pursuant to the Patent Assignments, any fiduciary duty or otherwise,
each
Grantor shall execute all further assignments, cooperate in any
legal
proceeding, sign all papers, make all rightful oaths, provide all
reasonable assistance and deliver any and all additional instruments
or
documents necessary or useful to perfect and record Intellect's
ownership
in and to the Intellect Patents as reasonably requested by Intellect,
Wyeth and/or Elan. Further, each Grantor shall promptly execute
any
documents and perform any acts as may be necessary to ensure that
all
Intellect Patents are properly registered in each applicable jurisdiction
in the name of Intellect and that documentary evidence of chain
of title
from Grantors to Intellect is recorded in each applicable jurisdiction
for
all Intellect Patents. Intellect shall reimburse each Grantor for
any
reasonable out-of-pocket costs that they may incur in the performance
of
their respective obligations pursuant to this Section 2.5.
|
3.
ACKNOWLEDGEMENT
OF LICENSE AGREEMENT; NON-DISTURBANCE.
Each
of
Dr. Chain, Mindset USA and Mindset LTD hereby acknowledges and agrees that
Intellect, as the sole and exclusive owner of the Intellect Patents, has the
full right, power, authority and ability to grant all of the right, title and
interest in the licenses granted by Intellect to Wyeth and Elan pursuant to
the
License Agreement. Dr. Chain, Mindset USA, and/or Mindset LTD shall not take
any
action, or cause or enable any Third Party to take any action, to challenge,
limit, invalidate or otherwise disturb any right granted to Wyeth and/or Elan
under the License Agreement.
33
4.
COVENANT
NOT TO ASSERT RESIDUAL INTERESTS IN INTELLECT PATENTS.
In
the
event that, despite the express intentions of Dr. Chain, Mindset USA, Mindset
LTD and Intellect, following the Effective Date Dr. Chain, Mindset USA and/or
Mindset LTD (a) retains any right, title or interest in or to the Intellect
Patents, (b) is determined by any Government Authority to hold any right, title
or interest in the Intellect Patents, or (c) is awarded any right, title or
interest in or to the Intellect Patents by any Government Authority, Dr. Chain,
Mindset USA and/or Mindset LTD shall not, and Dr. Chain, Mindset USA and/or
Mindset LTD shall not grant any Third Party any right to, assert against either
or both Recipients, any Affiliates of either Recipient and/or any Third Party
sublicensees of one or both Recipients (collectively, the "Non-Assert Parties")
any Intellect Patent. Without limiting the foregoing, Dr. Chain, Mindset USA
and/or Mindset LTD shall not, and Dr. Chain, Mindset USA and/or Mindset LTD
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 therapeutic,
prophylactic and/or diagnostic product infringes any one or more of the
Intellect Patents. Each of Dr. Chain's, Mindset USA's and Mindset LTD's
obligations under this Article 4 shall be in addition to, and shall in no way
limit, their respective obligations to Intellect pursuant to Section
2.5.
5.
ANNOUNCEMENTS.
No
Party
shall make any public announcement regarding this Agreement or otherwise
disclose this Agreement, any of its terms or any Exhibits or attachments hereto
or any negotiations or other discussions among the Parties relating to this
Agreement (collectively "Agreement Information") to any Third Party without
the
prior written consent of the other Parties. Notwithstanding the foregoing,
a
Party may disclose Agreement Information to the extent (a) such disclosure
is
required pursuant to applicable law, regulation or an order of a court of law
or
governmental agency, provided that the Party seeking to disclose such Agreement
Information shall (i) promptly provide written notice of such required
disclosure to the other Parties, (ii) consult with the other Parties with
respect to such required disclosure and (iii) provide the other Parties
sufficient opportunity to object to any such disclosure or to request that
the
Party seeking to make such disclosure seek confidential treatment thereof,
in
which event, the Party seeking to make such disclosure shall, at its sole
expense, use all reasonable efforts to accommodate such requests of the other
Parties.
34
6.
MISCELLANEOUS.
6.1
|
Assignment.
Grantors
may not assign any of their rights or obligations under this Agreement
without the prior written consent of Intellect, Wyeth and Elan. Intellect
may not assign any of its rights or obligations under this Agreement
without the prior written consent of Wyeth and Elan, which consent
shall
not be unreasonably withheld, provided, however, that Intellect may,
without such consent, assign its rights and obligations under this
Agreement to any purchaser of all or substantially all of the Intellect
Patents, or to any successor corporation resulting from any merger
or
consolidation of Intellect with or into such corporation. Recipients
may
not assign any of their rights or obligations under this Agreement
without
the prior written consent of Intellect, which consent shall not be
unreasonably withheld, provided, however, that each Recipient may,
without
such consent, assign its rights and obligations under this Agreement
to an
Affiliate, to the other Recipient, to any purchaser of all or
substantially all of its assets or research to which the subject
matter of
this Agreement relates, or to any successor corporation resulting
from any
merger or consolidation of either or both Grantor with or into such
corporation. This Agreement shall be binding upon and inure to the
benefit
of any permitted successors or assigns of the Parties. Any assignment
attempted to be made in contravention of this Section 6.1 shall be
void
and unenforceable.
|
6.2 | Entire Agreement. This Agreement constitutes the entire agreement between Grantors, on the one hand, and Intellect, Wyeth and Elan, on the other hand, with respect to the subject matter hereof and supersedes all previous agreements, except that the Patent Assignments and all other agreements assigning ownership of the Intellect Patents from Grantors to Intellect, either directly or indirectly, shall remain in full force and effect. |
6.3 | Amendments and Modifications. Any changes to this Agreement must be in writing and signed by authorized representatives of each Party. This Agreement shall not be changed or modified orally, but only by an instrument in writing signed by all Parties. |
6.4 | Severability. If any provision of this Agreement is declared invalid by a court of last resort or by any court, the decision of which appeal is not taken within the time provided by law, then and in such event, this Agreement will be deemed to have been terminated only in the relevant jurisdiction, but this Agreement, in all other respects and all other jurisdictions, will remain in force provided, however, that if the provision so invalidated is essential to the Agreement as a whole, then the Parties shall negotiate in good faith to amend the terms hereof as nearly as practical to carry out the original intent of the Parties and, failing such amendment, either Party may submit the matter to a court of competent jurisdiction for resolution. |
6.5 | Choice of Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, except for their conflict of laws principles. The Parties agree to exclusive jurisdiction and venue of any actions or proceedings relating to this agreement in the state and federal courts of New York, New York. |
35
6.6 | Headings. The captions used herein are inserted for convenience of reference only and shall not be construed to create obligations, benefits, or limitations. |
6.7
|
Waiver.
Any
delay in enforcing a Party's rights under this Agreement or any waiver
as
to a particular default or other matter shall not constitute a waiver
of
such Party's rights to the future enforcement of its rights under
this
Agreement, excepting only as to an express written and signed waiver
as to
a particular matter for a particular period of time.
|
6.8
|
Counterparts.
This
Agreement may be executed in any number of counterparts, each of
which
shall be deemed to be an original, and such counterparts together
shall
constitute one agreement. Execution and delivery of this Agreement
by
facsimile copies bearing the facsimile signatures of the Parties
shall
constitute a valid and binding execution and delivery of this Agreement
by
the signing Party, and such facsimile copies shall constitute original
documents.
|
[Signature
Page Follows]
36
IN
WITNESS WHEREOF,
the
Parties have duly executed this Agreement as of the Effective Date.
XX.
XXXXXX X.
CHAIN
MINDSET
BIOPHARMACEUTICALS, INC.
MINDSET,
LTD.
INTELLECT
NEUROSCIENCES, INC.
AHP
MANUFACTURING BV,
acting
acting through its Wyeth Medica Ireland Branch
ELAN
PHARMA INTERNATIONAL:
LIMITED
37
EXHIBIT
A
LICENSED
PATENTS EXISTING AS OF THE EFFECTIVE DATE
[*****]
EXHIBIT
B LICENSE AGREEMENT
See
Attached.