OPTION & LICENSE AGREEMENT by and between INTELLECT NEUROSCIENCES, INC. and
Exhibit
10.1
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.
|
CONFIDENTIAL
|
EXECUTION
COPY
|
OPTION
& LICENSE AGREEMENT
by
and between
and
[***]
dated
as of
October
3, 2008
|
CONFIDENTIAL
|
EXECUTION
COPY
|
OPTION & LICENSE
AGREEMENT
THIS AGREEMENT is made as of October 3,
2008 (the “Effective Date”) by and between INTELLECT NEUROSCIENCES, INC. having
a place of business at 0 Xxxx 00xx Xx. 0xx Xx. Xxx Xxxx 00000 (“Intellect”, and
following exercise of the Option (as defined below), “Licensor”), and [***],
having a place of business at [***] (“[***]”, and following exercise of the
Option, “Licensee”).
Intellect
is the owner of the Licensed Patents, as defined below.
[***] wishes to purchase an
option to obtain a license under the Licensed Patents, to practice the
technology included or claimed in the Licensed Patents and to make, have made,
use, sell, offer to sell and import Licensed Products, as defined
below.
Intellect
is willing to grant such an option, and following exercise of the option, a
license to [***] on the
terms and conditions of this Agreement.
Intellect
and [***] have therefore
agreed as follows:
1. DEFINITIONS
The
following terms shall have the meanings indicated in this
Agreement:
1.1. “Agreement” means this
Agreement, including all schedules hereto.
1.2. “Affiliate” means any
Person controlled by, controlling, or under common control with either Licensee
or Licensor. For this purpose, “control” means direct or indirect
beneficial ownership of at least fifty percent (50%) interest in the voting
stock (or the equivalent) of such Person or having the right to direct, appoint
or remove a majority or more of the members of its board of directors (or their
equivalent), or having the power to control the general management of such
Person, by contract, law or otherwise.
1.3.
“Control” or
“Controlled”
shall mean with respect to intellectual property, the right to grant a license
or sublicense with respect thereto, whether by ownership, license or
otherwise.
1.4.
“Effective
Date” has the meaning given to it in the Preamble.
1.5. “Exercise Fee: is
defined in Section 3.1.2.
1.6. “Field” shall mean the
treatment, prevention and/or control of all diseases and/or conditions in
humans, including but not limited to Alzheimer’s Disease and Mild Cognitive
Impairment.
1.7. “Governmental
Authority” means any court, agency, department, authority or other
instrumentality of any national, state, county, city or other political
subdivision.
-1-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
1.8.
"Law" or “Laws” means all laws,
statutes, rules, regulations, orders, judgments and/or ordinances of any
Governmental Authority.
1.9. “Lead Compound” means
Licensee’s antibody directed toward Amyloid Beta, commonly referred to within
Licensee as [***].
1.10. “Licensed Patents”
means any U.S. and ex-U.S. patents and patent applications listed on Schedule 1 having
claims that encompass [***] Compounds, and any divisional, continuation or
continuation-in-part thereof or substitute therefor, any foreign patent
applications corresponding to any such patent applications, and any U.S. or
foreign patent or the equivalent thereof issuing therefrom, and any reissue,
re-examination, renewal, supplementary protection certificate or extension
thereof, all to the extent within the Control of Licensor as of the Effective
Date.
1.11. “Licensed Product”
means any product in any dosage form containing the [***] Compound, the
development, manufacture, use, sale or importation of which product would,
absent the license granted by Licensor to Licensee herein, infringe any Valid
Claim in any Licensed Patent.
1.12. “Net Sales” means with
respect to Licensed Products, the gross amount invoiced by Licensee, its
Affiliates and its sublicensees of such Licensed Products to Third Parties, less
(a) bad debts related to such Licensed Products and (b) sales returns and
allowances actually paid, granted or accrued, including, trade, quantity and
cash discounts and any other adjustments, including, those granted on account of
price adjustments, billing errors, rejected goods, damaged or defective goods,
recalls, returns, rebates, chargeback rebates, reimbursements or similar
payments granted or given to wholesalers or other distributors, buying groups,
health care insurance carriers or other institutions, adjustments arising from
consumer discount programs or other similar programs, customs or excise duties,
sales tax, consumption tax, value added tax, and other taxes (except income
taxes) or duties relating to sales, any payment in respect of sales to the
United States government, any state government or any foreign government, or to
any other Governmental Authority, or with respect to any government-subsidized
program or managed care organization, and freight and insurance (to the extent
that Licensee bears the cost of freight and insurance for a Licensed
Product). Net Sales shall be determined from books and records
maintained in accordance with generally acceptable accounting principles in the
United States, as consistently applied by Licensee with respect to sales of all
its pharmaceutical products.
1.13. “Party” means each
party to this Agreement and their respective successors and permitted
assigns.
1.14. “Person” means any
natural person or legal entity.
1.15. “[***] Compound” means
any antibody owned or licensed by Licensee or an Affiliate directed towards
Amyloid Beta, including the Lead Compound.
1.16. [***]
1.17. “Royalty Payments” is
defined in Section 3.1.4.
-2-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
1.18. “Territory” means
worldwide.
1.19. ”Third Party” means
any Person or entity other than Licensee, Licensor or any of their respective
Affiliates.
1.20. “Valid Claim” means
any claim of any issued and unexpired patent that has not been rejected,
revoked, or held unenforceable or invalid by a decision of a court or other
government agency of competent jurisdiction which decision is unappealable or
unappealed within the time allowed for appeal, or that has not been dedicated to
the public, disclaimed, withdrawn, abandoned or admitted by Licensor to be
invalid or unenforceable through reissue, disclaimer or otherwise.
2.1 Option. Intelllect
hereby grants to [***] and its Affiliates an irrevocable option (the “Option”), to be
exercised at [***]’s sole unfettered discretion, to acquire the license
described in Section 2.2 below. The Option may be exercised any time
from the Effective Date until March 31, 2009 (the “Option
Period”). [***] (or an Affiliate of [***]) shall notify
Intellect whether or not it wishes to exercise the Option as promptly as
practicable after [***] has made its decision whether to exercise or not to
exercise the Option, but in no event no later than the last day of the Option
Period.
2.2
Grant of
License. Subject to the terms of this Agreement, if [***]
exercises the Option pursuant to Section 2.1, Intellect hereby grants to [***]
and its Affiliates, commencing immediately upon exercise of the Option and for
the term of this Agreement, a non-exclusive, royalty bearing license under the
Licensed Patents, with the right to grant sublicenses, to develop, have
developed, make, have made, use, offer to sell, sell, import and have imported
Licensed Products in the Territory in the Field. Upon exercise of the
Option, Intellect will be referred to as “Licensor” and [***] will be referred
to as “Licensee”, provided, that use of such names in describing the parties is
for ease of reference only, and will not have any legal effect.
2.3
Compliance and
Approvals. Licensee shall comply with all applicable
Laws. Licensee shall be responsible for obtaining all regulatory
approvals required for the manufacture and sale of Licensed
Products.
2.3
Authority. Licensee
has sole authority in all matters related to the research, development,
manufacture and commercialization of the Licensed Products, whether conducted
using its own or its Affiliates’ resources or through one or more Third Parties
of its choosing.
3. PAYMENTS
3.1
Payments. [***]
shall make the following payments to Intellect:
3.1.1 Upfront
Payment. Within ten (10) business days after execution of this
Agreement, [***] shall pay Intellect a non-refundable fee of [***] for the
Option, of which [***] is creditable against the Exercise Fee.
-3-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
3.1.2 Exercise
Fee. Within ten (10) business days following exercise of the
Option, Licensee will pay a [***] exercise fee (the “Exercise Fee”), such
Exercise Fee to be reduced by [***] as a credit in respect of the upfront
payment made pursuant to Section 3.1.1 above.
3.1.3 Milestone
Payments. Licensee shall pay to Licensor the following
non-refundable milestone payments, to be paid only once, at the time when a
Licensed Patent or Licensed Product reaches, as the case may be, a milestone
described below:
|
|
a.
|
Upon
the later of (1) exercise of the Option, and (2) grant in the United
States of a Licensed Patent with at least one Valid Claim that covers a
Licensed Product in the Territory in the Field,
[***].
|
|
|
b.
|
After
Licensee reaches aggregate annual Net Sales in excess of [***] for any
Licensed Product in countries in which there are then existing one or more
Valid Claims covering the Licensed Product (“Covered Countries”), Licensee
would 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 and the number of times such milestone
is reached.
|
|
|
c.
|
For
the avoidance of doubt: (i) each milestone payment shall be
payable only on the first occurrence of the corresponding event milestone;
and (ii) none of the event milestone payments shall be payable more than
once. In the event that a Party has given the other Party any
notice of termination of this Agreement under Article 7, no further
payments under Section 3.1.3(a) shall become due following the date of
such notice, but all payments due with respect to milestones achieved
prior to such date shall remain payable in accordance with their
terms.
|
Each such
milestone payment shall be due upon the achievement of such milestone and
payable to Licensor within thirty (30) business days after the date such
milestone is achieved (whether achieved by or on behalf of Licensee or any of
its Affiliates or sublicensees).
3.1.4 Royalties. In
addition to the payments provided in Sections 3.1.1, 3.1.2 and Section 3.1.3, in
consideration of the rights granted hereunder, and subject to the terms and
conditions of this Agreement, Licensee shall pay or cause to be paid to Licensor
a royalty on all Net Sales of all Licensed Products by Licensee or any of its
Affiliates or permitted sublicensees (“Royalty Payments”) in
an amount equal to:
|
a.
|
[***]
of Net Sales for the portion of aggregate Net Sales of such Licensed
Products in a calendar year in the Territory below or equal to [***];
plus
|
|
|
b.
|
[***]
of Net Sales for the portion of aggregate Net Sales of
such Licensed Products in a calendar year in the Territory greater than
[***] and less than or equal to [***]; plus
|
-4-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
|
|
c.
|
[***]
Net Sales for the portion of aggregate Net Sales of
such Licensed Products in a calendar year in the Territory greater than
[***] and less than or equal to [***]; plus
|
|
|
d.
|
[***]
of Net Sales for the portion of aggregate Net Sales of such Licensed
Products in a calendar year in the Territory in excess of
[***].
|
Royalty
Payments shall be made in accordance with Sections 4, for the period commencing
upon launch of a Licensed Product in a country (or upon issuance of a Valid
Claim, whichever is later) and ending upon the date on which such Licensed
Product is no longer covered by a Valid Claim in such country.
3.1.5. Most Favored
Nation. 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 Agreement, such lesser payments and royalties shall be substituted for
the payments and royalties payable by Licensee under this Agreement, and any
amounts paid by Licensee 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 Licensee to Licensor under the
Agreement.
3.1.6. Third Party Royalty
Obligations. If Licensee, its Affiliate or permitted
sublicensee determines in its reasonable discretion that it is necessary to
obtain intellectual property rights from a Third Party (or has obtained such a
license) in order to make, use, sell, offer for sale, supply, cause to be
supplied, or import a Licensed Product in a country in the Territory to pay a
royalty to a Third Party based on the sale of a Licensed Product in a country in
the Territory (including in connection with the settlement of a patent
infringement claim or as a result of Licensee being subject to a final court or
other binding order or ruling requiring such payments, to a Third Party patent
holder in respect of sales of any Licensed Product in a country in the
Territory), then (a) Licensee, its Affiliate or sublicensee may negotiate and
procure any such licensing agreements (but will not be under an obligation to
Licensor to do so), and (b) the amount of Licensee’s royalty payments under
Section 3.1.4 with respect to Net Sales for such Licensed Product in such
country shall be reduced by [***] of the
amount of such royalties payable by Licensee to such Third Party; provided,
however, that in no event will a deduction, or deductions, under this Section
3.1.5, in the aggregate, reduce any Royalty Payment made by Licensee
in respect of Net Sales of such Licensed Product pursuant to Section 3.1.4 by
more than [***]; and
provided further, that no deduction or deductions will be permitted in respect
of formulation claims of such Third Party patent holders.
-5-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
3.1.7 Payment of Fees Following
Opposition. In the event Licensee, its Affiliates or
sublicensees files or maintains the opposition proceeding described in Section
7.2.2, following which event (i) Licensor elects not to terminate this Agreement
within thirty (30) days of such filing, and (ii) any of the claims opposed in
such opposition proceeding that Licensee would infringe in the absence of this
Agreement is upheld by the EPO, Licensee shall pay Licensor its reasonable legal
fees in connection with such opposition proceeding; provided, however, if
Licensee, an Affiliate or sublicensee only becomes a party to the opposition
proceeding after a Third Party initiates such proceeding, Licensee would only be
liable for a portion of such legal fees, determined by dividing such fees by the
number of persons that became a party to such opposition.
3.2 Records. During
the term of this Agreement and for two (2) years thereafter, Licensee shall (and
shall cause its Affiliates, distributors and permitted sublicensees to) keep
complete and accurate records of sales of Licensed Products and such other
matters as may affect the determination of any amount payable to Licensor
hereunder in sufficient detail to enable certified public accountants engaged by
Licensor to determine any amounts payable to Licensor under this
Agreement. Licensee shall (and shall cause its Affiliates,
distributors and permitted sublicensees to) permit an independent certified
public accountants engaged by Licensor, at Licensor’s expense (except as
provided below), and reasonably acceptable to Licensee to examine not more than
once in any twelve-month period per Person its books, ledgers, and records
during regular business hours for the purpose of and to the extent necessary to
verify any report required under this Agreement or the accuracy of any amount
payable hereunder. In addition, Licensee shall (and shall cause its
Affiliates, distributors and permitted sublicensees to) permit Licensor or its
representatives to examine periodically any documents relating to its
sublicensing of the Licensed Patents during regular business
hours. Licensee may require such accountants to enter into a
reasonably acceptable confidentiality agreement, and in no event shall such
accountants disclose to Licensor any information, other than such as relates to
the accuracy of the corresponding royalty reports pursuant to Section
4.2. The opinion of said independent accountants regarding such
reports and related payments shall be binding on the parties, other than in the
case of manifest error. Should any examination conducted by Licensor
or its representatives pursuant to the provisions of this paragraph result in an
increase of more than 5% of any payment due Licensor hereunder,
Licensee, in addition to any amounts that may be due Licensor, shall be
obligated to reimburse any out of pocket expenses incurred by Licensor with
respect to such examination within thirty (30) days after receipt of an invoice
therefor from Licensor. Any overpayment of royalties by Licensee
revealed by an examination shall be fully-creditable against future royalty
payments under Section 3.1.4.
4. Payments.
4.1 Inter-Company
Sales. Sales between or among Licensee, its Affiliates or
sublicensees shall not be subject to royalties under Section 3, unless Licensee,
or such Affiliate or sublicensee is the end-user of the Licensed
Product. Licensee shall be responsible for the payment of royalties
on Net Sales by its Affiliates or sublicensees to Third Parties.
4.2 Royalty Reporting.
Licensee shall make royalty payments to Licensor with respect to each [***]
within sixty (60) days after the end of such [***], and each payment shall be
accompanied by a report identifying the Licensed Product, each applicable
country, Net Sales for each such country, and the amount payable to Licensor, as
well as the computation thereof. Said reports shall be kept
confidential by Licensor and not disclosed to any other party, other than
Licensor’s accountants which shall be obligated to keep such information
confidential, and such information and reports shall only be used for purposes
of this Agreement.
-6-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
4.3 Fund
Transfers. Each payment hereunder shall be made by electronic
transfer in immediately available funds via either a bank wire transfer, an ACH
(automated clearing house) mechanism, or any other means of electronic funds
transfer, at Licensee’s election, to Licensor’s account at [***], or to such
other bank account as Licensor shall designate in a notice at least five (5)
Business Days before the payment is due. All payments under this
Agreement shall bear interest from the fifteenth (15th) day
after the date due until paid at a rate equal to the thirty (30)-day United
States dollar LIBOR rate in effect on the date that payment was due, as
published by The Financial
Times. All payments made under this Agreement shall be
non-refundable.
4.4 Taxes.
4.4.1 VAT. It is
understood and agreed between the parties that any payments made by Licensee
under this Agreement are inclusive of any value added or similar tax imposed
upon such payments.
4.4.2 Withholding Tax
Matters. In addition, in the event any of the payments made by Licensee
pursuant to Section 3 become subject to withholding taxes under the Laws of any
jurisdiction, Licensee shall deduct and withhold the amount of such taxes for
the account of Licensor to the extent required by Law, such payment to Licensee
shall be reduced by the amount of taxes deducted and withheld, and Licensee
shall pay the amount of such taxes to the proper Governmental Authority in a
timely manner and promptly transmit to Licensor an official tax certificate or
other evidence of such tax obligations, together with proof of payment from the
relevant Governmental Authority of all amounts deducted and withheld sufficient
to enable Licensor to claim such payment of taxes. Any such withholding taxes
required under applicable Law to be paid or withheld shall be an expense of, and
borne solely by, Licensor. Licensee will provide Licensor with
reasonable assistance, at Licensee’s expense, to enable Licensee to recover such
taxes as permitted by Law.
5.1 Patent Prosecution/Patent
Costs. Licensor shall be responsible for the prosecution,
maintenance, renewal, extension and defense of all Licensed Patents in its sole
discretion and at its expense.
5.2 Patent
Enforcement. 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 Party and provide it with full
details.
-7-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
|
|
(b)
With respect to any Licensed Product made, used, sold, imported or
exported by a Third Party which Licensee reasonably believe infringes a
claim of one or more Licensed Patents, at the written request of Licensee
provided in Licensee’s sole discretion (“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. Licensee, at its 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
Licensee shall first be reimbursed for all costs associated with the
Enforcement or its settlement, including, without limitation, attorney
fees, after which Licensee shall be paid [***] and Licensor shall be paid
[***] 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 Licensee, then Licensee 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 Licensee, Licensee shall be entitled to receive and retain
any and all sums recovered in the Enforcement or its
settlement. Licensor shall control any Enforcement action but
shall consult with Licensee regarding Enforcement strategy and
tactics.
|
|
|
(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 one hundred and twenty (120) days 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 fifty
percent (50%) (“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 3.1.6.
|
|
|
(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 any products
Controlled by Licensor.
|
|
|
(e)
|
Anything
to the contrary herein notwithstanding, Licensor shall not be obligated to
initiate or undertake Enforcement (or to join in any action with Licensee
pursuant to Section 5.1(b)) against any product or third party against
which Licensor (either alone or together with another party that is a
licensee under the Licensed Patents) has previously initiated or
undertaken Enforcement, or other action intended to xxxxx any infringement
of Licensed Patents, by such product or third party prior to receipt of a
Written Request from Licensee (“Prior Enforcement”). In the
event that Licensor has initiated Prior Enforcement, the provisions of
Section 5.1(c) shall not apply and there shall be no reduction of the
royalties due to Licensor under Section 5.1(c) in respect of such Prior
Enforcement.
|
-8-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
6.1 Indemnification.
6.1.1 Licensee
shall indemnify, defend and hold harmless Licensor, its Affiliates, and their
respective directors, partners, officers, managers, employees and agents and
their respective successors, heirs and assigns (each an “Indemnitee”), against
any liability, damage, deficiency, loss, obligation or expense of any kind
(including reasonable attorneys’ fees and expenses of litigation) incurred by or
imposed upon any Indemnitee as a result of or relating to (a) any death,
illness, personal injury, property damage, improper business practices or other
loss, casualty or harm arising out of the development, manufacture, sale, use or
other disposition of any Licensed Product (whether based on negligence or other
tort, warranty, strict liability, or any other theory) or (b) any breach of this
Agreement by Licensee, its Affiliates or any of its permitted
sublicensees.
6.1.2 This
Section 6.1 shall survive expiration or termination of this
Agreement.
6.2 Warranty
Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,
LICENSOR MAKES NO EXPRESS OR IMPLIED WARRANTY INCLUDING, WITHOUT LIMITATION, ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR ANY IMPLIED WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO ANY OF THE LICENSED PATENTS OR ANY LICENSED
PRODUCTS OR OTHERWISE AND HEREBY DISCLAIMS THE SAME. EXCEPT AS
PROVIDED BELOW, LICENSOR MAKES NO EXPRESS OR IMPLIED WARRANTY THAT THE
MANUFACTURE, USE OR SALE OF ANY LICENSED PRODUCT WILL NOT INFRINGE ANY PATENT OR
OTHER RIGHT OF ANY PARTY OR THIRD PERSON AND HEREBY DISCLAIMS THE
SAME.
6.3 Representations and
Warranties of Licensor. Licensor hereby represents, warrants
and covenants to Licensee that Licensor has the full right and authority to
execute and perform this Agreement and the execution and performance of this
agreement by Licensor will not conflict with, cause a default under or violate
any existing contractual obligation that may be owed by Licensor to any Third
Party. Licensor hereby represents, warrants and covenants that it has
the right to grant licenses described in Section 2.1 to all of the patents and
patent applications listed in Schedule 1 without violating or breaching any
obligations to Third Parties.
6.4
Representations and
Warranties of Licensee. Licensee hereby represents, warrants
and covenants to Licensor that Licensee has the full right and authority to
execute and perform this Agreement and the execution and performance of this
agreement by Licensee will not conflict with, cause a default under or violate
any existing contractual obligation that may be owed by Licensee to any Third
Party. Licensee is a wholly-owned subsidiary of [***].
7.1 Term. This
Agreement will be effective as of the Effective Date and will remain in effect,
unless terminated under Sections 7.2 or 7.3 below, on a country-by-country basis
until all Valid Claims in all Licensed Patents have expired in a
country. Licensee shall have no obligation to make Royalty Payments
with respect to the Net Sales of a Licensed Product if all Valid Claims in all
Licensed Patents applicable to the development, manufacture, use, sale or
importation of such Licensed Product have expired in a country in which such
Licensed Product is used, sold or imported.
-9-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
7.2.1 Termination for
Cause. Licensor shall have the right to terminate this
Agreement and the license granted hereunder upon the happening of any of the
following events:
|
|
(i)
|
Licensee
fails to pay or cause to be paid any payment which has become due and
payable to Licensor under this Agreement (other than amounts pursuant to
Section 3.1.2) within sixty (60) days after the payment date, following
which Licensor has not paid or caused to be paid such amount within thirty
(30) days of written notice from Licensor given in respect of such failure
to so pay; or
|
|
|
(ii)
|
Licensee
has commenced an action as described in
Section 7.2.2.
|
7.2.2 Termination after
Opposition. If Licensee or any of its Affiliates or sublicensees files or maintains an opposition
proceeding in the European Patent Office with respect to EP 0994728 in the
European Patent Office (either by itself or through an Affiliate or Third
Party), Licensor may, at its option and in its
sole discretion, terminate this Agreement with respect to the European
Patent Convention countries, by providing written
notice of termination to Licensee.
7.2.3 Termination following
Failure to Exercise Option. This Agreement shall
automatically terminate upon failure of [***] or an Affiliate to exercise the
Option prior to expiration of the Option Period.
7.3 Termination for
Breach. Licensor or Licensee may
terminate for material breach of or default under any provision of this
Agreement, other than in the case of a Licensee breach, payment obligation
referred to in Section 7.2.1(i) or any breach of or default under any provision of Section 7.2.2, and the breaching or
defaulting Party has not cured such breach or default within ninety (90) days
after written notice from the non-breaching Party specifying the nature of such
breach or default (if such breach or default is capable of being
cured).
7.4 Insolvency
Event. If Licensee makes a general assignment for the benefit
of its creditors, or there shall have been appointed a receiver, trustee or
other custodian for Licensee for all or a substantial part of its assets, or any
case or proceeding shall have been commenced or other action taken by or against
Licensee in bankruptcy or seeking the reorganization, liquidation, dissolution
or winding-up of Licensee or any other relief under any bankruptcy, insolvency,
reorganization or other similar act or Law, and any such event shall have
continued for sixty (60) days undismissed, unstayed, unbonded and undischarged,
then Licensor may, upon notice to Licensee, terminate this Agreement, such
termination to be effective upon Licensee’s receipt of such notice.
-10-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
7.5 Termination by
Licensee. Licensee shall have the right to terminate this
Agreement at its sole discretion upon sixty (60) days written notice to Licensor
at any time after the cessation of its and its Affiliates’ activities relating
to the development, manufacture, commercialization, marketing or sale of the
Lead Compound.
7.6.1 Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either Party from any obligation that matured prior to the effective
date of such termination, except as provided in Section 3.1.3(c).
7.6.2 Upon
termination of this Agreement for any reason, any sublicense granted hereunder
with respect to which the sublicensee is not then in breach or default shall
continue as a direct license between the sublicensee and the Licensor on the
terms of this Agreement, provided that the sublicensee agrees in writing, within
thirty (30) days after termination of this Agreement, to be bound by the terms
of this Agreement.
7.6.3 The
provisions of Sections 5.2 (Infringement by Third Parties) (but only with
respect to infringement occurring prior to termination), 6.1 (Indemnification),
6.2 (Warranty Disclaimer), and 8 (General) shall survive termination of this
Agreement for any reason.
7.6.4 Licensee
may, after termination of this Agreement, sell all Licensed Products which are
in inventory at the time of termination, and complete and sell Licensed Products
which Licensee can clearly demonstrate were in the process of manufacture at the
time of such termination, provided that Licensee shall pay to Licensor any
Royalty Payments due on the sale of such Licensed Products and shall submit
reports, in accordance with this Agreement.
8. GENERAL
8.1 Assignment. This
Agreement shall be binding upon and shall inure to the benefit of each Party and
each Party’s respective transferees, successors and
assigns. Licensee shall not have the right to assign this
Agreement or its rights or obligations hereunder to any other Person; provided, however, Licensee
may, without such consent, assign this Agreement
in whole or in part to any of its Affiliates, without the prior written
consent of the Licensor; provided, further, Upon prior written notice to
Licensor, Licensee may assign this Agreement and all of its rights and
obligations under this Agreement to such Persons or Person to which
Licensee transfers or licenses on an exclusive basis in a country all or
substantially all of the assets and other rights and interests of Licensee with
respect to such country, necessary for, involved in or related to the
development, manufacture, marketing, commercialization or importation of the
[***] and any product containing the [***]; provided that the transferee or
licensee of such assets, rights and interests must agree in writing with
Licensor to assume all obligations of Licensee hereunder and to be bound by all
of the terms and conditions of this Agreement.
-11-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
8.2 Publicity. The
Parties agree that except for the press release attached hereto as Schedule 2, neither
Party shall issue any news release or other public announcement relating to this
Agreement, including any of its terms, the names of the Licensee or its
Affiliates, without the prior written approval of the other Party, except as
subject to the requirements of applicable Law (including, without limitation,
requirements promulgated by the U.S. Securities and Exchange Commission (“SEC”)
regarding the disclosure of corporate information in periodic
reports). The Agreement and its terms, including the name of the
Licensee and its Affiliates, will remain confidential, except as subject to the
requirements of applicable Law (including, without limitation, requirements
promulgated by the SEC regarding the disclosure of corporate information in
periodic reports) and as otherwise disclosed under obligations of strict
confidentiality to potential investors, merger or acquisition candidates, and
advisors, consultants, employees, directors and other representatives of
Licensor or Licensee. If a Party determines that it is required by
Law to publicly file, register or notify this Agreement or portions thereof
(including the name of the licensee or any of its Affiliates) with a
Governmental Authority, such party shall (i) initially file a redacted copy of
this Agreement (the “Redacted Agreement”)
in the form of Schedule 3 attached
hereto and such corporate information contained in periodic reports pursuant to
the requirements of applicable Law as described in the previous sentence, (ii)
request, and use commercially reasonable efforts to obtain, confidential
treatment of all terms redacted from this Agreement, as reflected in the
Redacted Agreement (including the name of the Licensee and its Affiliates), for
a period of at least ten (10) years, (iii) permit the other party to review and
approve such request for confidential treatment and any subsequent
correspondence with respect thereto at least five (5) Business Days prior to its
submission to such Governmental Authority, (iv) promptly deliver to the other
Party any written correspondence received by it or its representatives from such
Governmental Authority with respect to such confidential treatment request and
promptly advise the other Party of any other communications between it or its
representatives with such Governmental Authority with respect to such
confidential treatment request, (v) upon the written request of the other Party,
request an appropriate extension of the term of the confidential treatment
period, and (vi) if such Governmental Authority requests any changes to the
redactions set forth in the Redacted Agreement or to the disclosure of corporate
information described above, use commercially reasonable efforts to support the
redactions in the Redacted Agreement as originally filed or changes to the
disclosure of corporate information, as the case may be, and shall not agree to
any changes to the Redacted Agreement or to changes to the disclosure of
corporate information, as the case may be, without first discussing such changes
with the other Party and taking the other Party’s comments into consideration
when deciding whether to agree to such changes. In no event shall
Licensor be deemed to have breached this Section 8.2 as a result of any decision
or directive by the SEC requiring the disclosure of the Agreement or any term
thereof, so long as Licensor shall have satisfied its obligation to use
commercially reasonable efforts to avoid such directive or decision and
otherwise complied with the sentence set forth above. Each Party
shall be responsible for its own legal and other external costs in connection
with any such filing, registration or notification. Any breach of this Section
8.2 will be considered a material breach, and shall survive termination of this
Agreement. The parties agree that in the event of a breach of this
Section 8.2, the non-breaching party’s sole remedies, at its option, is to (i)
terminate this Agreement and the licenses granted hereunder pursuant to Section
7.3 hereof, or (ii) recover monetary damages resulting from such a breach,
provided, however, that the maximum amount of damages recoverable by Licensee
shall not in any event exceed the amount of aggregate cash paid to Licensor
pursuant to Section 3.1, regardless of the type of damages awarded, be they
direct, indirect, special, consequential, incidental or exemplary in
nature.
-12-
|
CONFIDENTIAL
|
EXECUTION
COPY
|
8.3 Entire
Agreement/Amendments. This Agreement constitutes the entire
and only agreement between the Parties relating to Licensed Patents, and all
prior negotiations, representations, agreements and understandings are
superseded hereby. No agreements amending, altering or supplementing
the terms hereof may be made except by means of a written document signed by a
duly authorized representative of each Party.
8.4 Notices. Any
notice, communication or payment required or permitted to be given or made
hereunder shall be in writing and, except as otherwise expressly provided in
this agreement, shall be deemed given or made and effective (i) when delivered
personally; or (ii) upon confirmation of receipt if delivered by telex or
telecopy (if not a payment); or (iii) when received if sent by overnight
express; or (iv) upon confirmation of receipt if mailed by certified or
registered mail, postage prepaid and return receipt requested, in each case
addressed to Parties at their address stated below, or to such other address as
such Party may designate by written notice in accordance with the provisions of
this Section 8.4.
|
LICENSEE:
|
[***]
|
|
[***]
|
|
|
and
|
|
|
[***]
|
|
|
LICENSOR:
|
|
|
0
Xxxx 00xx Xxxxxx, 0xx Xxxxx
|
|
|
Xxx
Xxxx, XX 00000
|
|
|
Attention:
Chief Executive Officer
|
|
|
Fax
No.: 000-000-0000
|
8.5 Governing Law;
Jurisdiction. This Agreement shall be construed and enforced
in accordance with the domestic substantive laws of The State of New York and
the United States of America without regard to any choice or conflict of laws
rule or principle that would result in the application of the domestic
substantive law of any other jurisdiction other than, in regard to any question
affecting the construction or effect of any patent, the law of the jurisdiction
under which such patent is granted. This Agreement shall not be
subject to (a) the United Nations Conventions on Contracts for the International
Sale of Goods; (b) the 1974 Convention on the Limitation Period in the
International Sale of Goods (the “1974 Convention”); or (c) the Protocol
amending the 1974 Convention, done at Vienna April 11, 1980. Any
legal or other action hereunder shall be brought in the State and federal courts
of New York. The parties consent to the personal jurisdiction and
venue of such courts in the event of such action.
-13-
| CONFIDENTIAL |
EXECUTION
COPY
|
8.6 Limitation of
Liability. IN NO EVENT SHALL LICENSOR OR LICENSEE BE LIABLE
FOR ANY INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES
(INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR EXPECTED SAVINGS
OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS OR PROPERTY) ARISING OUT OF
OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS WHETHER
LICENSOR OR LICENSEE KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH
DAMAGES. LICENSOR’S AGGREGATE LIABILITY FOR ALL DAMAGES OF ANY KIND
RELATING TO THIS AGREEMENT OR ITS SUBJECT MATTER SHALL NOT EXCEED THE AMOUNT
PAID BY LICENSEE TO LICENSOR UNDER THIS AGREEMENT, EXCEPT FOR LICENSOR’S GROSS
NEGLIGENCE OR WILFULL MISCONDUCT. The foregoing exclusions and
limitations shall apply to all claims and actions of any kind, whether based on
contract, tort (including but not limited to negligence), or any other
grounds.
8.7 Headings. Headings
included herein are for convenience only, and shall not be used to construe this
Agreement.
8.8 Independent
Contractors. For the purposes of this Agreement and all
services to be provided hereunder, each Party shall be, and shall be deemed to
be, an independent contractor and not an agent, partner, fiduciary, joint
venturer or employee of the other Party. Neither Party shall have
authority to make any statements, representations or commitments of any kind, or
to take any action which shall be binding on the other Party, except as may be
explicitly provided for herein or authorized in writing.
8.9 Severability. If
any provision of this Agreement shall be found by a court of competent
jurisdiction to be void, invalid or unenforceable, the same shall either be
reformed to comply with applicable Law or stricken if not so conformable, so as
not to affect the validity or enforceability of this Agreement.
8.10 Force
Majeure. Neither Party shall be responsible or liable to the
other Party for nonperformance or delay in performance of any terms or
conditions of this Agreement due to acts or occurrences beyond the control of
the nonperforming or delayed Party, including, but not limited to, acts of God,
acts of government, wars, riots, strikes or other labor disputes, shortages of
labor or materials, fires, and floods, provided the nonperforming or delayed
Party provides to the other Party written notice of the existence of and the
reason for such nonperformance or delay.
8.11 No
Waiver. Failure of either Party to enforce a right under this
Agreement shall not act as a waiver of that right or the ability to later assert
that right relative to the particular situation involved or to terminate this
Agreement arising out of any subsequent default or breach.
8.12 Counterparts. This
Agreement may be executed in any number of counterparts, each of which shall
constitute an original document, but all of which shall constitute the same
agreement.
[the
remainder of this page is intentionally blank]
-14-
| CONFIDENTIAL |
EXECUTION
COPY
|
|
[***]
|
INTELLECT NEUROSCIENCES, INC. | |||
|
By:
|
|
|||
|
Name:
|
|
By:
|
|
|
| Title: |
|
Name:
|
|
|
|
Title:
|
|
|||
-15-
| CONFIDENTIAL |
|
Schedule
1
LICENSED
PATENTS
Intellect Neurosciences
Inc.
|
Patent
Report by Invention
|
Printed:
8/15/2008
|
||||||
|
COUNTRY
|
REFERENCE#
|
TYP
|
FILED
|
SERIAL#
|
ISSUED
|
PATENT
|
STATUS
|
DNA ENCODING RECOMBINANT ANTIBODY
MOLECULES END-SPECIFIC FOR AMYLOID – B PEPTIDES
PHARMACEUTICAL COMPOSITIONS THEREOF AND
METHOD OF PREVENTING OR INHIBITING
PROGRESSION OF ALZHEIMER'S
DISEASE
|
UNITED
STATES
|
0203301-US0
|
NEW
|
4/9/1997
|
60/041,850
|
EXPIRED
|
||
|
XXXXXXXXX
|
0000000-XX0
|
XXX
|
4/9/1998
|
71034/98
|
5/23/2002
|
743827
|
ISSUED
|
|
CANADA
|
2203301-CA0
|
DCA
|
4/9/1998
|
2,286,305
|
PENDING
|
||
|
CHINA
|
2203301-CN0
|
DCA
|
4/9/1998
|
98803546.4
|
12/1/2004
|
98803546.4
|
ISSUED
|
|
EUROPEAN
PATENT
|
2203301-EP0
|
DCA
|
4/9/1998
|
98918035.1
|
7/30/2008
|
0994728
|
ISSUED
|
|
EUROPEAN
PATENT
|
2203301-EP1
|
DIV
|
4/9/1998
|
08011798.9
|
PENDING
|
||
|
ISRAEL
|
2203301-IL0
|
DCA
|
4/9/1998
|
000000
|
XXXXXXX
|
||
|
XXXXX
|
0000000-XX0
|
XXX
|
4/9/1998
|
10-543043
|
6/16/2006
|
0000000
|
ISSUED
|
|
JAPAN
|
0000000-JP1
|
DIV
|
4/9/1998
|
2005-210196
|
XXXXXXX
|
||
|
XXX
XXXXXXX
|
0000000-XX0
|
XXX
|
4/9/1998
|
337765
|
1/10/2002
|
337765
|
ISSUED
|
|
WIPO
|
2203301-WO0
|
CEQ
|
4/9/1998
|
XXX/XX00/00000
|
XXX
XXXXX
|
||
|
XXXXXX
XXXXXX
|
0000000-XX0
|
XXX
|
10/12/1999
|
09/402,820
|
XXXXXXX
|
||
|
XXXXXX
XXXXXX
|
0000000-XX0
|
DIV
|
10/15/2001
|
09/975,932
|
ABANDONED
|
||
|
UNITED
STATES
|
1203301-US3
|
CIP
|
2/28/2002
|
10/084,380
|
PUBLISHED
|
||
|
AUSTRALIA
|
2203301-AU3
|
DCA
|
10/21/2002
|
2002367734
|
PENDING
|
||
|
CHINA
|
2203301-CN3
|
DCA
|
10/21/2002
|
02828857.2
|
PUBLISHED
|
||
|
EUROPEAN
PATENT
|
2203301-EP3
|
DCA
|
10/21/2002
|
02807019.1
|
ABANDONED
|
||
|
JAPAN
|
0000000-JP3
|
DCA
|
10/21/2002
|
2003-572597
|
PENDING
|
||
|
WIPO
|
2203301-WO3
|
CEQ
|
10/21/2002
|
XXX/XX00/00000
|
XXX
XXXXX
|
||
|
XXXXX
XXXXXX
|
0000000-XX0
|
XXX
|
10/21/2002
|
2004/9186
|
10/26/2005
|
2004/9186
|
ISSUED
|
|
HONG
KONG
|
2203301-HK3
|
CEQ
|
1/27/2006
|
06101278.5
|
PUBLISHED
|
||
|
UNITED
STATES
|
1203301-US4
|
DIV
|
5/8/2007
|
11/745,759
|
PENDING
|
| CONFIDENTIAL |
|
Schedule
2
Intellect
Neurosciences, Inc. Grants to Top Tier Global Pharmaceutical Company an Option
to License Certain Alzheimer’s Patents and Patent Applications
Agreement
Follows Recent Grant by Intellect of License to Wyeth (NYSE:WYE) and Elan Pharma
International Ltd.
New York,
NY, October , 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 an Option
Agreement with a top-tier global pharmaceutical company regarding the right to
purchase a license to certain of Intellect’s patents and patent
applications related to antibodies and methods of treatment for Alzheimer’s
disease.
Intellect
is entitled to an option fee upon execution of the Option Agreement. In
addition, Intellect will be entitled to fees, and may be entitled to milestone
payments and royalties from potential future drug sales upon exercise of the
Option by the licensee. Recently, Intellect received its first milestone payment
under its license agreement with Wyeth and Elan related to this patent family
and may be entitled to additional payments from Wyeth and Elan in the
future.
Xx.
Xxxxxx Chain, Intellect’s Chairman and CEO and inventor of the licensed patents
and patent applications, commented: “We are pleased to enter into
this second agreement with a top-tier global pharmaceutical company for our
patent estate relating to the use of antibodies to combat Alzheimer’s
disease. Alzheimer’s patients need strong and capable partners in
their fight to overcome this devastating disease. We believe that several
therapeutic agents may be necessary to fully treat the AD population and that
our licensing efforts, together with our internal program development, will
increase the likelihood of developing safe and effective therapies, as well as
provide us with financial rewards.”
About
Intellect’s Immunotherapy Platforms for Alzheimer’s disease
Intellect’s
immunotherapy platforms aim to prevent the accumulation of aggregated beta
amyloid protein fragments in the brain that are thought to be the root cause of
Alzheimer’s disease. In healthy people, beta amyloid does not aggregate but in
Alzheimer’s patients it clumps first to form long fibrils, like tentacles, that
eventually deposit on the surface of nerve cells as a spaghetti-like protein
mass called amyloid plaques. The beta amyloid fragments are generated as a
product of metabolism from the much larger Amyloid Precursor Protein which is
present in most tissues in the body and implicated in numerous important
physiological functions. Intellect’s immunotherapy approach for Alzheimer’s
disease involves making an antibody molecule available to bind to the
beta-amyloid toxin, thus promoting its clearance away from sites of damage the
brain. This therapeutic outcome can be potentially achieved either by
administering an externally generated monoclonal antibody (passive immunization)
or by provoking the patient’s immune system to generate such an antibody (active
immunization). Both approaches have the potential to slow or arrest disease
progression provided that key safety issues are addressed. Of particular
importance is the need to avoid interfering with the physiological roles of the
Amyloid Precursor Protein. Intellect’s has incorporated proprietary
safety features into its ANTISENILIN® monoclonal antibody and RECALL-VAXTM
technology platforms for both passive and active immunization, respectively to
minimize the potential for adverse side-effects by generating antibodies that
bind only the toxic beta amyloid and not the Amyloid Precursor Protein. These
features and supporting patent position provides the Company with a strong
competitive advantage in this field.
-2-
| CONFIDENTIAL |
|
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 more
than 5 million Americans and about 30 million people suffering from Alzheimer’s
disease world wide with the number expected to increases dramatically 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 more than $6 billion in sales by 2010, indicating both the size of the
market and the demand for effective treatment beyond symptomatic
improvements.
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 completed Phase I clinical
trials for OXIGON™, which has potential to treat Alzheimer’s disease and other
serious disorders.
For
additional information, please visit xxxx://xxx.xxxxxxxxxxx.xxx, or
contact:
Xxxxxx
Xxxx, JD, CPA
President
& Chief Financial Officer
0 Xxxx
00xx Xxxxxx, 0xx Xxxxx Xxx Xxxx, XX 00000,
XXX Tel:
000-000-0000
-3-
| CONFIDENTIAL |
|
The
statements in this release and oral statements made by representatives of
Intellect relating to matters that are not historical facts (including without
limitation those regarding future performance or financial results, the timing
or potential outcomes of research collaborations or clinical trials, any market
that might develop for any of Intellect’s product candidates and the sufficiency
of Intellect’s cash and other capital resources) are forward-looking statements
that involve risks and uncertainties, including, but not limited to, the
likelihood that actual performance or results could materially differ, that
future research will prove successful, the likelihood that any product in the
research pipeline will receive regulatory approval in the United States or
abroad, or Intellect's ability to fund such efforts with or without partners.
Intellect undertakes no obligation to update any of these statements. Readers
are cautioned not to place undue reliance on these forward-looking statements,
which speak only as to the date hereof. Accordingly any forward-looking
statements should be read in conjunction with the additional risks and
uncertainties detailed in Intellect's filings with the Securities and Exchange
Commission, including those factors discussed under the caption "Risk Factors"
in Intellect's Annual Report on Form 10-KSBA (file no. 1-10615) filed on October
19, 2007,and our Quarterly Report on Form 10-QSB for the quarter ended September
30, 2007, filed on December 10, 2007 (file no. 1-10615), and for the quarter
ended December 31, 2007, filed on February 19, 2007.
-4-
CONFIDENTIAL
Schedule
3
OPTION
& LICENSE AGREEMENT
by
and between
and
[***]
dated
as of
October
3, 2008
-5-
CONFIDENTIAL
OPTION & LICENSE
AGREEMENT
THIS AGREEMENT is made as of October 3,
2008 (the “Effective Date”) by and between INTELLECT NEUROSCIENCES, INC. having
a place of business at 0 Xxxx 00xx Xx. 0xx Xx. Xxx Xxxx 00000 (“Intellect”, and
following exercise of the Option (as defined below), “Licensor”), and [***],
having a place of business at [***]
(“[***]”,
and following exercise of the Option, “Licensee”).
Intellect
is the owner of the Licensed Patents, as defined below.
[***]
wishes to purchase an option to obtain a license under the Licensed Patents, to
practice the technology included or claimed in the Licensed Patents and to make,
have made, use, sell, offer to sell and import Licensed Products, as defined
below.
Intellect
is willing to grant such an option, and following exercise of the option, a
license to [***]
on the terms and conditions of this Agreement.
Intellect
and [***]
have therefore agreed as follows:
2. DEFINITIONS
The
following terms shall have the meanings indicated in this
Agreement:
2.1. “Agreement” means this
Agreement, including all schedules hereto.
2.2. “Affiliate” means any
Person controlled by, controlling, or under common control with either Licensee
or Licensor. For this purpose, “control” means direct or indirect
beneficial ownership of at least fifty percent (50%) interest in the voting
stock (or the equivalent) of such Person or having the right to direct, appoint
or remove a majority or more of the members of its board of directors (or their
equivalent), or having the power to control the general management of such
Person, by contract, law or otherwise.
2.3.
“Control” or
“Controlled”
shall mean with respect to intellectual property, the right to grant a license
or sublicense with respect thereto, whether by ownership, license or
otherwise.
2.4.
“Effective
Date” has the meaning given to it in the Preamble.
2.5. “Exercise Fee: is
defined in Section 3.1.2.
2.6. “Field” shall mean the
treatment, prevention and/or control of all diseases and/or conditions in
humans, including but not limited to Alzheimer’s Disease and Mild Cognitive
Impairment.
2.7. “Governmental
Authority” means any court, agency, department, authority or other
instrumentality of any national, state, county, city or other political
subdivision.
-1-
CONFIDENTIAL
2.8.
"Law" or “Laws” means all laws,
statutes, rules, regulations, orders, judgments and/or ordinances of any
Governmental Authority.
2.9. “Lead Compound” means
Licensee’s antibody directed toward Amyloid Beta, commonly referred to within
Licensee as [***].
2.10. “Licensed Patents”
means any U.S. and ex-U.S. patents and patent applications listed on Schedule 1 having
claims that encompass [***]
Compounds, and any divisional, continuation or continuation-in-part thereof or
substitute therefor, any foreign patent applications corresponding to any such
patent applications, and any U.S. or foreign patent or the equivalent thereof
issuing therefrom, and any reissue,
re-examination, renewal, supplementary protection certificate or extension
thereof, all to the extent within the Control of Licensor as of the Effective
Date.
2.11. “Licensed Product”
means any product in any dosage form containing the [***]
Compound, the development, manufacture, use, sale or importation of which
product would, absent the license granted by Licensor to Licensee herein,
infringe any Valid Claim in any Licensed Patent.
2.12. “Net Sales” means with
respect to Licensed Products, the gross amount invoiced by Licensee, its
Affiliates and its sublicensees of such Licensed Products to Third Parties, less
(a) bad debts related to such Licensed Products and (b) sales returns and
allowances actually paid, granted or accrued, including, trade, quantity and
cash discounts and any other adjustments, including, those granted on account of
price adjustments, billing errors, rejected goods, damaged or defective goods,
recalls, returns, rebates, chargeback rebates, reimbursements or similar
payments granted or given to wholesalers or other distributors, buying groups,
health care insurance carriers or other institutions, adjustments arising from
consumer discount programs or other similar programs, customs or excise duties,
sales tax, consumption tax, value added tax, and other taxes (except income
taxes) or duties relating to sales, any payment in respect of sales to the
United States government, any state government or any foreign government, or to
any other Governmental Authority, or with respect to any government-subsidized
program or managed care organization, and freight and insurance (to the extent
that Licensee bears the cost of freight and insurance for a Licensed
Product). Net Sales shall be determined from books and records
maintained in accordance with generally acceptable accounting principles in the
United States, as consistently applied by Licensee with respect to sales of all
its pharmaceutical products.
2.13. “Party” means each
party to this Agreement and their respective successors and permitted
assigns.
2.14. “Person” means any
natural person or legal entity.
2.15. “[***] Compound” means any
antibody owned or licensed by Licensee or an Affiliate directed towards Amyloid
Beta, including the Lead Compound.
2.16. “[***]
2.17. “Royalty Payments” is
defined in Section 3.1.4.
-2-
CONFIDENTIAL
2.18. “Territory” means
worldwide.
2.19. ”Third Party” means
any Person or entity other than Licensee, Licensor or any of their respective
Affiliates.
2.20. “Valid Claim” means
any claim of any issued and unexpired patent that has not been rejected,
revoked, or held unenforceable or invalid by a decision of a court or other
government agency of competent jurisdiction which decision is unappealable or
unappealed within the time allowed for appeal, or that has not been dedicated to
the public, disclaimed, withdrawn, abandoned or admitted by Licensor to be
invalid or unenforceable through reissue, disclaimer or otherwise.
2.1 Option. Intelllect
hereby grants to [***]
and its Affiliates an irrevocable option (the “Option”), to be
exercised at [***]’s
sole unfettered discretion, to acquire the license described in Section 2.2
below. The Option may be exercised any time from the Effective Date
until March 31, 2009 (the “Option
Period”). [***]
(or an Affiliate of [***])
shall notify Intellect whether or not it wishes to exercise the Option as
promptly as practicable after [***]
has made its decision whether to exercise or not to exercise the Option, but in
no event no later than the last day of the Option Period.
2.2 Grant of
License. Subject to the terms of this Agreement, if [***]
exercises the Option pursuant to Section 2.1, Intellect hereby grants to [***]
and its Affiliates, commencing immediately upon exercise of the Option and for
the term of this Agreement, a non-exclusive, royalty bearing license under the
Licensed Patents, with the right to grant sublicenses, to develop, have
developed, make, have made, use, offer to sell, sell, import and have imported
Licensed Products in the Territory in the Field. Upon exercise of the
Option, Intellect will be referred to as “Licensor” and [***]
will be referred to as “Licensee”, provided, that use of such names in
describing the parties is for ease of reference only, and will not have any
legal effect.
2.3 Compliance and
Approvals. Licensee shall comply with all applicable
Laws. Licensee shall be responsible for obtaining all regulatory
approvals required for the manufacture and sale of Licensed
Products.
2.3 Authority. Licensee
has sole authority in all matters related to the research, development,
manufacture and commercialization of the Licensed Products, whether conducted
using its own or its Affiliates’ resources or through one or more Third Parties
of its choosing.
3. PAYMENTS
3.1 Payments. [***]
shall make the following payments to Intellect:
3.1.1 Upfront
Payment. Within ten (10) business days after execution of this
Agreement, [***]
shall pay Intellect a non-refundable fee of [***]
for the Option, of which [***]
is creditable against the Exercise Fee.
-3-
CONFIDENTIAL
3.1.3 Exercise
Fee. Within ten (10) business days following exercise of the
Option, Licensee will pay a [***]
exercise fee (the “Exercise Fee”), such Exercise Fee to be reduced by
[***]
as a credit in respect of the upfront payment made pursuant to Section
3.1.1 above.
3.1.3 Milestone
Payments. Licensee shall pay to Licensor the following
non-refundable milestone payments, to be paid only once, at the time when a
Licensed Patent or Licensed Product reaches, as the case may be, a milestone
described below:
|
|
d.
|
Upon
the later of (1) exercise of the Option, and (2) grant in the United
States of a Licensed Patent with at least one Valid Claim that covers a
Licensed Product in the Territory in the Field, [***].
|
|
|
e.
|
After
Licensee reaches aggregate annual Net Sales in excess of [***]
for any Licensed Product in countries in which there are then existing one
or more Valid Claims covering the Licensed Product (“Covered Countries”),
Licensee would 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 and
the number of times such milestone is
reached.
|
|
|
f.
|
For
the avoidance of doubt: (i) each milestone payment shall be
payable only on the first occurrence of the corresponding event milestone;
and (ii) none of the event milestone payments shall be payable more than
once. In the event that a Party has given the other Party any
notice of termination of this Agreement under Article 7, no further
payments under Section 3.1.3(a) shall become due following the date of
such notice, but all payments due with respect to milestones achieved
prior to such date shall remain payable in accordance with their
terms.
|
Each such
milestone payment shall be due upon the achievement of such milestone and
payable to Licensor within thirty (30) business days after the date such
milestone is achieved (whether achieved by or on behalf of Licensee or any of
its Affiliates or sublicensees).
3.1.4 Royalties. In
addition to the payments provided in Sections 3.1.1, 3.1.2 and Section 3.1.3, in
consideration of the rights granted hereunder, and subject to the terms and
conditions of this Agreement, Licensee shall pay or cause to be paid to Licensor
a royalty on all Net Sales of all Licensed Products by Licensee or any of its
Affiliates or permitted sublicensees (“Royalty Payments”) in
an amount equal to:
|
a.
|
[***]
of Net Sales for the portion of aggregate Net Sales of such
Licensed Products in a calendar year in the Territory below or equal to
[***];
plus
|
|
|
e.
|
[***]
of Net Sales for the portion of aggregate Net Sales of
such Licensed Products in a calendar year in the Territory greater than
[***]
and less than or equal to [***];
plus
|
-4-
CONFIDENTIAL
|
|
f.
|
[***]
Net Sales for the portion of aggregate Net Sales of
such Licensed Products in a calendar year in the Territory greater than
[***]
and less than or equal to [***];
plus
|
|
|
g.
|
[***]
of Net Sales for the portion of aggregate Net Sales of such Licensed
Products in a calendar year in the Territory in excess of [***].
|
Royalty
Payments shall be made in accordance with Sections 4, for the period commencing
upon launch of a Licensed Product in a country (or upon issuance of a Valid
Claim, whichever is later) and ending upon the date on which such Licensed
Product is no longer covered by a Valid Claim in such country.
3.1.5. Most Favored
Nation. 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 Agreement, such lesser payments and royalties shall be substituted for
the payments and royalties payable by Licensee under this Agreement, and any
amounts paid by Licensee 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 Licensee to Licensor under the
Agreement.
3.1.6. Third Party Royalty
Obligations. If Licensee, its Affiliate or permitted
sublicensee determines in its reasonable discretion that it is necessary to
obtain intellectual property rights from a Third Party (or has obtained such a
license) in order to make, use, sell, offer for sale, supply, cause to be
supplied, or import a Licensed Product in a country in the Territory to pay a
royalty to a Third Party based on the sale of a Licensed Product in a country in
the Territory (including in connection with the settlement of a patent
infringement claim or as a result of Licensee being subject to a final court or
other binding order or ruling requiring such payments, to a Third Party patent
holder in respect of sales of any Licensed Product in a country in the
Territory), then (a) Licensee, its Affiliate or sublicensee may negotiate and
procure any such licensing agreements (but will not be under an obligation to
Licensor to do so), and (b) the amount of Licensee’s royalty payments under
Section 3.1.4 with respect to Net Sales for such Licensed Product in such
country shall be reduced by [***]
of the amount of such royalties payable by Licensee to such Third Party;
provided, however, that in no event will a deduction, or deductions, under this
Section 3.1.5, in the aggregate, reduce any Royalty Payment made by
Licensee in respect of Net Sales of such Licensed Product pursuant to Section
3.1.4 by more than [***];
and provided further, that no deduction or deductions will be permitted in
respect of formulation claims of such Third Party patent holders.
-5-
CONFIDENTIAL
3.1.7 Payment of Fees Following
Opposition. In the event Licensee, its Affiliates or
sublicensees files or maintains the opposition proceeding described in Section
7.2.2, following which event (i) Licensor elects not to terminate this Agreement
within thirty (30) days of such filing, and (ii) any of the claims opposed in
such opposition proceeding that Licensee would infringe in the absence of this
Agreement is upheld by the EPO, Licensee shall pay Licensor its reasonable legal
fees in connection with such opposition proceeding; provided, however, if
Licensee, an Affiliate or sublicensee only becomes a party to the opposition
proceeding after a Third Party initiates such proceeding, Licensee would only be
liable for a portion of such legal fees, determined by dividing such fees by the
number of persons that became a party to such opposition.
3.2 Records. During
the term of this Agreement and for two (2) years thereafter, Licensee shall (and
shall cause its Affiliates, distributors and permitted sublicensees to) keep
complete and accurate records of sales of Licensed Products and such other
matters as may affect the determination of any amount payable to Licensor
hereunder in sufficient detail to enable certified public accountants engaged by
Licensor to determine any amounts payable to Licensor under this
Agreement. Licensee shall (and shall cause its Affiliates,
distributors and permitted sublicensees to) permit an independent certified
public accountants engaged by Licensor, at Licensor’s expense (except as
provided below), and reasonably acceptable to Licensee to examine not more than
once in any twelve-month period per Person its books, ledgers, and records
during regular business hours for the purpose of and to the extent necessary to
verify any report required under this Agreement or the accuracy of any amount
payable hereunder. In addition, Licensee shall (and shall cause its
Affiliates, distributors and permitted sublicensees to) permit Licensor or its
representatives to examine periodically any documents relating to its
sublicensing of the Licensed Patents during regular business
hours. Licensee may require such accountants to enter into a
reasonably acceptable confidentiality agreement, and in no event shall such
accountants disclose to Licensor any information, other than such as relates to
the accuracy of the corresponding royalty reports pursuant to Section
4.2. The opinion of said independent accountants regarding such
reports and related payments shall be binding on the parties, other than in the
case of manifest error. Should any examination conducted by Licensor
or its representatives pursuant to the provisions of this paragraph result in an
increase of more than 5% of any payment due Licensor hereunder,
Licensee, in addition to any amounts that may be due Licensor, shall be
obligated to reimburse any out of pocket expenses incurred by Licensor with
respect to such examination within thirty (30) days after receipt of an invoice
therefor from Licensor. Any overpayment of royalties by Licensee
revealed by an examination shall be fully-creditable against future royalty
payments under Section 3.1.4.
4. Payments.
4.1 Inter-Company
Sales. Sales between or among Licensee, its Affiliates or
sublicensees shall not be subject to royalties under Section 3, unless Licensee,
or such Affiliate or sublicensee is the end-user of the Licensed
Product. Licensee shall be responsible for the payment of royalties
on Net Sales by its Affiliates or sublicensees to Third Parties.
4.2 Royalty Reporting.
Licensee shall make royalty payments to Licensor with respect to each [***]
within sixty (60) days after the end of such [***],
and each payment shall be accompanied by a report identifying the Licensed
Product, each applicable country, Net Sales for each such country, and the
amount payable to Licensor, as well as the computation thereof. Said
reports shall be kept confidential by Licensor and not disclosed to any other
party, other than Licensor’s accountants which shall be obligated to keep such
information confidential, and such information and reports shall only be used
for purposes of this Agreement.
-6-
CONFIDENTIAL
4.3 Fund
Transfers. Each payment hereunder shall be made by electronic
transfer in immediately available funds via either a bank wire transfer, an ACH
(automated clearing house) mechanism, or any other means of electronic funds
transfer, at Licensee’s election, to Licensor’s account at [***],
or to such other bank account as Licensor shall designate in a notice at least
five (5) Business Days before the payment is due. All payments under
this Agreement shall bear interest from the fifteenth (15th) day
after the date due until paid at a rate equal to the thirty (30)-day United
States dollar LIBOR rate in effect on the date that payment was due, as
published by The Financial
Times. All payments made under this Agreement shall be
non-refundable.
4.4 Taxes.
4.4.1 VAT. It is
understood and agreed between the parties that any payments made by Licensee
under this Agreement are inclusive of any value added or similar tax imposed
upon such payments.
4.4.2 Withholding Tax
Matters. In addition, in the event any of the payments made by Licensee
pursuant to Section 3 become subject to withholding taxes under the Laws of any
jurisdiction, Licensee shall deduct and withhold the amount of such taxes for
the account of Licensor to the extent required by Law, such payment to Licensee
shall be reduced by the amount of taxes deducted and withheld, and Licensee
shall pay the amount of such taxes to the proper Governmental Authority in a
timely manner and promptly transmit to Licensor an official tax certificate or
other evidence of such tax obligations, together with proof of payment from the
relevant Governmental Authority of all amounts deducted and withheld sufficient
to enable Licensor to claim such payment of taxes. Any such withholding taxes
required under applicable Law to be paid or withheld shall be an expense of, and
borne solely by, Licensor. Licensee will provide Licensor with
reasonable assistance, at Licensee’s expense, to enable Licensee to recover such
taxes as permitted by Law.
5.1 Patent Prosecution/Patent
Costs. Licensor shall be responsible for the prosecution,
maintenance, renewal, extension and defense of all Licensed Patents in its sole
discretion and at its expense.
5.2 Patent
Enforcement. 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 Party and provide it with full
details.
-7-
CONFIDENTIAL
|
(b)
|
With
respect to any Licensed Product made, used, sold, imported or exported by
a Third Party which Licensee reasonably believe infringes a claim of one
or more Licensed Patents, at the written request of Licensee provided in
Licensee’s sole discretion (“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. Licensee, at
its 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 Licensee shall first be reimbursed for all costs
associated with the Enforcement or its settlement, including, without
limitation, attorney fees, after which Licensee shall be paid[***]
and Licensor shall be paid [***]
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 Licensee, then Licensee 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 Licensee, Licensee shall be entitled to receive and retain
any and all sums recovered in the Enforcement or its
settlement. Licensor shall control any Enforcement action but
shall consult with Licensee regarding Enforcement strategy and
tactics.
|
|
|
(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 one hundred and twenty (120) days 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 fifty
percent (50%) (“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 3.1.6.
|
|
|
(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 any products
Controlled by Licensor.
|
|
|
(e)
|
Anything
to the contrary herein notwithstanding, Licensor shall not be obligated to
initiate or undertake Enforcement (or to join in any action with Licensee
pursuant to Section 5.1(b)) against any product or third party against
which Licensor (either alone or together with another party that is a
licensee under the Licensed Patents) has previously initiated or
undertaken Enforcement, or other action intended to xxxxx any infringement
of Licensed Patents, by such product or third party prior to receipt of a
Written Request from Licensee (“Prior Enforcement”). In the
event that Licensor has initiated Prior Enforcement, the provisions of
Section 5.1(c) shall not apply and there shall be no reduction of the
royalties due to Licensor under Section 5.1(c) in respect of such Prior
Enforcement.
|
-8-
CONFIDENTIAL
6.1 Indemnification.
6.1.1 Licensee
shall indemnify, defend and hold harmless Licensor, its Affiliates, and their
respective directors, partners, officers, managers, employees and agents and
their respective successors, heirs and assigns (each an “Indemnitee”), against
any liability, damage, deficiency, loss, obligation or expense of any kind
(including reasonable attorneys’ fees and expenses of litigation) incurred by or
imposed upon any Indemnitee as a result of or relating to (a) any death,
illness, personal injury, property damage, improper business practices or other
loss, casualty or harm arising out of the development, manufacture, sale, use or
other disposition of any Licensed Product (whether based on negligence or other
tort, warranty, strict liability, or any other theory) or (b) any breach of this
Agreement by Licensee, its Affiliates or any of its permitted
sublicensees.
6.1.2 This
Section 6.1 shall survive expiration or termination of this
Agreement.
6.2 Warranty
Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,
LICENSOR MAKES NO EXPRESS OR IMPLIED WARRANTY INCLUDING, WITHOUT LIMITATION, ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR ANY IMPLIED WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO ANY OF THE LICENSED PATENTS OR ANY LICENSED
PRODUCTS OR OTHERWISE AND HEREBY DISCLAIMS THE SAME. EXCEPT AS
PROVIDED BELOW, LICENSOR MAKES NO EXPRESS OR IMPLIED WARRANTY THAT THE
MANUFACTURE, USE OR SALE OF ANY LICENSED PRODUCT WILL NOT INFRINGE ANY PATENT OR
OTHER RIGHT OF ANY PARTY OR THIRD PERSON AND HEREBY DISCLAIMS THE
SAME.
6.3 Representations and
Warranties of Licensor. Licensor hereby represents, warrants
and covenants to Licensee that Licensor has the full right and authority to
execute and perform this Agreement and the execution and performance of this
agreement by Licensor will not conflict with, cause a default under or violate
any existing contractual obligation that may be owed by Licensor to any Third
Party. Licensor hereby represents, warrants and covenants that it has
the right to grant licenses described in Section 2.1 to all of the patents and
patent applications listed in Schedule 1 without violating or breaching any
obligations to Third Parties.
6.4
Representations and
Warranties of Licensee. Licensee hereby represents, warrants
and covenants to Licensor that Licensee has the full right and authority to
execute and perform this Agreement and the execution and performance of this
agreement by Licensee will not conflict with, cause a default under or violate
any existing contractual obligation that may be owed by Licensee to any Third
Party. Licensee is a wholly-owned subsidiary of [***].
7.1 Term. This
Agreement will be effective as of the Effective Date and will remain in effect,
unless terminated under Sections 7.2 or 7.3 below, on a country-by-country basis
until all Valid Claims in all Licensed Patents have expired in a
country. Licensee shall have no obligation to make Royalty Payments
with respect to the Net Sales of a Licensed Product if all Valid Claims in all
Licensed Patents applicable to the development, manufacture, use, sale or
importation of such Licensed Product have expired in a country in which such
Licensed Product is used, sold or imported.
-9-
CONFIDENTIAL
7.2 Termination by
Licensor.
7.2.1
Termination for
Cause. Licensor shall have the right to terminate this
Agreement and the license granted hereunder upon the happening of any of the
following events:
|
|
(i)
|
Licensee
fails to pay or cause to be paid any payment which has become due and
payable to Licensor under this Agreement (other than amounts pursuant to
Section 3.1.2) within sixty (60) days after the payment date, following
which Licensor has not paid or caused to be paid such amount within thirty
(30) days of written notice from Licensor given in respect of such failure
to so pay; or
|
|
|
(ii)
|
Licensee
has commenced an action as described in
Section 7.2.2.
|
7.3.2 Termination after
Opposition. If Licensee or any of its Affiliates or sublicensees files or maintains an opposition
proceeding in the European Patent Office with respect to EP 0994728 in the
European Patent Office (either by itself or through an Affiliate or Third
Party), Licensor may, at its option and in its
sole discretion, terminate this Agreement with respect to the European
Patent Convention countries, by providing written
notice of termination to Licensee.
7.3.3
Termination following
Failure to Exercise Option. This Agreement shall
automatically terminate upon failure of [***]
or an Affiliate to exercise the Option prior to expiration of the Option
Period.
7.4 Termination for
Breach. Licensor or Licensee may
terminate for material breach of or default under any provision of this
Agreement, other than in the case of a Licensee breach, payment obligation
referred to in Section 7.2.1(i) or any breach of or default under any provision of Section 7.2.2, and the breaching or
defaulting Party has not cured such breach or default within ninety (90) days
after written notice from the non-breaching Party specifying the nature of such
breach or default (if such breach or default is capable of being
cured).
7.4 Insolvency
Event. If Licensee makes a general assignment for the benefit
of its creditors, or there shall have been appointed a receiver, trustee or
other custodian for Licensee for all or a substantial part of its assets, or any
case or proceeding shall have been commenced or other action taken by or against
Licensee in bankruptcy or seeking the reorganization, liquidation, dissolution
or winding-up of Licensee or any other relief under any bankruptcy, insolvency,
reorganization or other similar act or Law, and any such event shall have
continued for sixty (60) days undismissed, unstayed, unbonded and undischarged,
then Licensor may, upon notice to Licensee, terminate this Agreement, such
termination to be effective upon Licensee’s receipt of such
notice.
-10-
CONFIDENTIAL
7.5 Termination by
Licensee. Licensee shall have the right to terminate this
Agreement at its sole discretion upon sixty (60) days written notice to Licensor
at any time after the cessation of its and its Affiliates’ activities relating
to the development, manufacture, commercialization, marketing or sale of the
Lead Compound.
7.6 Effect of
Termination.
7.6.1 Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either Party from any obligation that matured prior to the effective
date of such termination, except as provided in Section 3.1.3(c).
7.6.2 Upon
termination of this Agreement for any reason, any sublicense granted hereunder
with respect to which the sublicensee is not then in breach or default shall
continue as a direct license between the sublicensee and the Licensor on the
terms of this Agreement, provided that the sublicensee agrees in writing, within
thirty (30) days after termination of this Agreement, to be bound by the terms
of this Agreement.
7.6.3 The
provisions of Sections 5.2 (Infringement by Third Parties) (but only with
respect to infringement occurring prior to termination), 6.1 (Indemnification),
6.2 (Warranty Disclaimer), and 8 (General) shall survive termination of this
Agreement for any reason.
7.6.4 Licensee
may, after termination of this Agreement, sell all Licensed Products which are
in inventory at the time of termination, and complete and sell Licensed Products
which Licensee can clearly demonstrate were in the process of manufacture at the
time of such termination, provided that Licensee shall pay to Licensor any
Royalty Payments due on the sale of such Licensed Products and shall submit
reports, in accordance with this Agreement.
8. GENERAL
8.1 Assignment. This
Agreement shall be binding upon and shall inure to the benefit of each Party and
each Party’s respective transferees, successors and
assigns. Licensee shall not have the right to assign this
Agreement or its rights or obligations hereunder to any other Person; provided, however, Licensee
may, without such consent, assign this Agreement in whole or
in part to any of its Affiliates, without the prior written consent of
the Licensor; provided, further, Upon prior written notice to Licensor, Licensee
may assign this Agreement and all of its rights and obligations under this
Agreement to such Persons or Person to which Licensee transfers or
licenses on an exclusive basis in a country all or substantially all of the
assets and other rights and interests of Licensee with respect to such country,
necessary for, involved in or related to the development, manufacture,
marketing, commercialization or importation of the [***]
and any product containing the [***];
provided that the transferee or licensee of such assets, rights and interests
must agree in writing with Licensor to assume all obligations of Licensee
hereunder and to be bound by all of the terms and conditions of this
Agreement.
-11-
CONFIDENTIAL
8.2 Publicity. The
Parties agree that except for the press release attached hereto as Schedule 2, neither
Party shall issue any news release or other public announcement relating to this
Agreement, including any of its terms, the names of the Licensee or its
Affiliates, without the prior written approval of the other Party, except as
subject to the requirements of applicable Law (including, without limitation,
requirements promulgated by the U.S. Securities and Exchange Commission (“SEC”)
regarding the disclosure of corporate information in periodic
reports). The Agreement and its terms, including the name of the
Licensee and its Affiliates, will remain confidential, except as subject to the
requirements of applicable Law (including, without limitation, requirements
promulgated by the SEC regarding the disclosure of corporate information in
periodic reports) and as otherwise disclosed under obligations of strict
confidentiality to potential investors, merger or acquisition candidates, and
advisors, consultants, employees, directors and other representatives of
Licensor or Licensee. If a Party determines that it is required by
Law to publicly file, register or notify this Agreement or portions thereof
(including the name of the licensee or any of its Affiliates) with a
Governmental Authority, such party shall (i) initially file a redacted copy of
this Agreement (the “Redacted Agreement”)
in the form of Schedule 3 attached
hereto and such corporate information contained in periodic reports pursuant to
the requirements of applicable Law as described in the previous sentence, (ii)
request, and use commercially reasonable efforts to obtain, confidential
treatment of all terms redacted from this Agreement, as reflected in the
Redacted Agreement (including the name of the Licensee and its Affiliates), for
a period of at least ten (10) years, (iii) permit the other party to review and
approve such request for confidential treatment and any subsequent
correspondence with respect thereto at least five (5) Business Days prior to its
submission to such Governmental Authority, (iv) promptly deliver to the other
Party any written correspondence received by it or its representatives from such
Governmental Authority with respect to such confidential treatment request and
promptly advise the other Party of any other communications between it or its
representatives with such Governmental Authority with respect to such
confidential treatment request, (v) upon the written request of the other Party,
request an appropriate extension of the term of the confidential treatment
period, and (vi) if such Governmental Authority requests any changes to the
redactions set forth in the Redacted Agreement or to the disclosure of corporate
information described above, use commercially reasonable efforts to support the
redactions in the Redacted Agreement as originally filed or changes to the
disclosure of corporate information, as the case may be, and shall not agree to
any changes to the Redacted Agreement or to changes to the disclosure of
corporate information, as the case may be, without first discussing such changes
with the other Party and taking the other Party’s comments into consideration
when deciding whether to agree to such changes. In no event shall
Licensor be deemed to have breached this Section 8.2 as a result of any decision
or directive by the SEC requiring the disclosure of the Agreement or any term
thereof, so long as Licensor shall have satisfied its obligation to use
commercially reasonable efforts to avoid such directive or decision and
otherwise complied with the sentence set forth above. Each Party
shall be responsible for its own legal and other external costs in connection
with any such filing, registration or notification. Any breach of this Section
8.2 will be considered a material breach, and shall survive termination of this
Agreement. The parties agree that in the event of a breach of this
Section 8.2, the non-breaching party’s sole remedies, at its option, is to (i)
terminate this Agreement and the licenses granted hereunder pursuant to Section
7.3 hereof, or (ii) recover monetary damages resulting from such a breach,
provided, however, that the maximum amount of damages recoverable by Licensee
shall not in any event exceed the amount of aggregate cash paid to Licensor
pursuant to Section 3.1, regardless of the type of damages awarded, be they
direct, indirect, special, consequential, incidental or exemplary in
nature.
-12-
CONFIDENTIAL
8.3 Entire
Agreement/Amendments. This Agreement constitutes the entire
and only agreement between the Parties relating to Licensed Patents, and all
prior negotiations, representations, agreements and understandings are
superseded hereby. No agreements amending, altering or supplementing
the terms hereof may be made except by means of a written document signed by a
duly authorized representative of each Party.
8.4 Notices. Any
notice, communication or payment required or permitted to be given or made
hereunder shall be in writing and, except as otherwise expressly provided in
this agreement, shall be deemed given or made and effective (i) when delivered
personally; or (ii) upon confirmation of receipt if delivered by telex or
telecopy (if not a payment); or (iii) when received if sent by overnight
express; or (iv) upon confirmation of receipt if mailed by certified or
registered mail, postage prepaid and return receipt requested, in each case
addressed to Parties at their address stated below, or to such other address as
such Party may designate by written notice in accordance with the provisions of
this Section 8.4.
|
|
LICENSEE:
|
[***]
|
|
|
[***]
|
|
|
and
|
|
|
[***]
|
|
|
LICENSOR:
|
Intellect
Neurosciences, Inc.
|
|
|
7
Xxxx 00xx Xxxxxx, 0xx Xxxxx
|
|
|
Xxx
Xxxx, XX 00000
|
|
Attention:
Chief Executive Officer
|
|
| Fax No.: 000-000-0000 |
8.5 Governing Law;
Jurisdiction. This Agreement shall be construed and enforced
in accordance with the domestic substantive laws of The State of New York and
the United States of America without regard to any choice or conflict of laws
rule or principle that would result in the application of the domestic
substantive law of any other jurisdiction other than, in regard to any question
affecting the construction or effect of any patent, the law of the jurisdiction
under which such patent is granted. This Agreement shall not be
subject to (a) the United Nations Conventions on Contracts for the International
Sale of Goods; (b) the 1974 Convention on the Limitation Period in the
International Sale of Goods (the “1974 Convention”); or (c) the Protocol
amending the 1974 Convention, done at Vienna April 11, 1980. Any
legal or other action hereunder shall be brought in the State and federal courts
of New York. The parties consent to the personal jurisdiction and
venue of such courts in the event of such action.
-13-
CONFIDENTIAL
8.6 Limitation of
Liability. IN NO EVENT SHALL LICENSOR OR LICENSEE BE LIABLE
FOR ANY INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES
(INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR EXPECTED SAVINGS
OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS OR PROPERTY) ARISING OUT OF
OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS WHETHER
LICENSOR OR LICENSEE KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH
DAMAGES. LICENSOR’S AGGREGATE LIABILITY FOR ALL DAMAGES OF ANY KIND
RELATING TO THIS AGREEMENT OR ITS SUBJECT MATTER SHALL NOT EXCEED THE AMOUNT
PAID BY LICENSEE TO LICENSOR UNDER THIS AGREEMENT, EXCEPT FOR LICENSOR’S GROSS
NEGLIGENCE OR WILFULL MISCONDUCT. The foregoing exclusions and
limitations shall apply to all claims and actions of any kind, whether based on
contract, tort (including but not limited to negligence), or any other
grounds.
8.7 Headings. Headings
included herein are for convenience only, and shall not be used to construe this
Agreement.
8.8 Independent
Contractors. For the purposes of this Agreement and all
services to be provided hereunder, each Party shall be, and shall be deemed to
be, an independent contractor and not an agent, partner, fiduciary, joint
venturer or employee of the other Party. Neither Party shall have
authority to make any statements, representations or commitments of any kind, or
to take any action which shall be binding on the other Party, except as may be
explicitly provided for herein or authorized in writing.
8.9 Severability. If
any provision of this Agreement shall be found by a court of competent
jurisdiction to be void, invalid or unenforceable, the same shall either be
reformed to comply with applicable Law or stricken if not so conformable, so as
not to affect the validity or enforceability of this Agreement.
8.10 Force
Majeure. Neither Party shall be responsible or liable to the
other Party for nonperformance or delay in performance of any terms or
conditions of this Agreement due to acts or occurrences beyond the control of
the nonperforming or delayed Party, including, but not limited to, acts of God,
acts of government, wars, riots, strikes or other labor disputes, shortages of
labor or materials, fires, and floods, provided the nonperforming or delayed
Party provides to the other Party written notice of the existence of and the
reason for such nonperformance or delay.
8.11 No
Waiver. Failure of either Party to enforce a right under this
Agreement shall not act as a waiver of that right or the ability to later assert
that right relative to the particular situation involved or to terminate this
Agreement arising out of any subsequent default or breach.
8.12 Counterparts. This
Agreement may be executed in any number of counterparts, each of which shall
constitute an original document, but all of which shall constitute the same
agreement.
[the
remainder of this page is intentionally blank]
-14-
CONFIDENTIAL
|
[***]
|
INTELLECT
NEUROSCIENCES, INC.
|
|||
|
By:
|
By:
|
|||
|
Name:
|
Name:
|
|||
|
Title:
|
Title:
|
|||
-15-
Schedule
1
LICENSED
PATENTS
Intellect Neurosciences
Inc.
|
Patent Report by Invention
|
Printed: 8/15/2008
|
||||||
|
COUNTRY
|
REFERENCE#
|
TYP
|
FILED
|
SERIAL#
|
ISSUED
|
PATENT
|
STATUS
|
DNA ENCODING RECOMBINANT ANTIBODY
MOLECULES END-SPECIFIC FOR AMYLOID – B PEPTIDES
PHARMACEUTICAL
COMPOSITIONS THEREOF AND METHOD OF PREVENTING OR INHIBITING
PROGRESSION
OF ALZHEIMER'S DISEASE
|
UNITED
STATES
|
0203301-US0
|
NEW
|
4/9/1997
|
60/041,850
|
EXPIRED
|
||
|
AUXXXXXXX
|
0000000-XX0
|
XXX
|
0/9/1998
|
71034/98
|
5/23/2002
|
743827
|
ISSUED
|
|
CANADA
|
2203301-CA0
|
DCA
|
4/9/1998
|
2,286,305
|
PENDING
|
||
|
CHINA
|
2203301-CN0
|
DCA
|
4/9/1998
|
98803546.4
|
12/1/2004
|
98803546.4
|
ISSUED
|
|
EUROPEAN
PATENT
|
2203301-EP0
|
DCA
|
4/9/1998
|
98918035.1
|
7/30/2008
|
0994728
|
ISSUED
|
|
EUROPEAN
PATENT
|
2203301-EP1
|
DIV
|
4/9/1998
|
08011798.9
|
PENDING
|
||
|
ISRAEL
|
2203301-IL0
|
DCA
|
4/9/1998
|
130000
|
XXXXXXX
|
||
|
XXXXX
|
0000000-XX0
|
XXX
|
0/9/1998
|
10-543043
|
6/16/2006
|
0000000
|
ISSUED
|
|
JAPAN
|
0000000-JP1
|
DIV
|
4/9/1998
|
2005-210196
|
PEXXXXX
|
||
|
XXX
XXXXXXX
|
0000000-XX0
|
XXX
|
0/9/1998
|
337765
|
1/10/2002
|
337765
|
ISSUED
|
|
WIPO
|
2203301-WO0
|
CEQ
|
4/9/1998
|
PCX/XX00/00000
|
XXX
XXXXX
|
||
|
XXXXXX
XXXXXX
|
0000000-XX0
|
XXX
|
00/12/1999
|
09/402,820
|
PEXXXXX
|
||
|
XXXXXX
XXXXXX
|
0000000-XX0
|
XIV
|
10/15/2001
|
09/975,932
|
ABANDONED
|
||
|
UNITED
STATES
|
1203301-US3
|
CIP
|
2/28/2002
|
10/084,380
|
PUBLISHED
|
||
|
AUSTRALIA
|
2203301-AU3
|
DCA
|
10/21/2002
|
2002367734
|
PENDING
|
||
|
CHINA
|
2203301-CN3
|
DCA
|
10/21/2002
|
02828857.2
|
PUBLISHED
|
||
|
EUROPEAN
PATENT
|
2203301-EP3
|
DCA
|
10/21/2002
|
02807019.1
|
ABANDONED
|
||
|
JAPAN
|
0000000-JP3
|
DCA
|
10/21/2002
|
2003-572597
|
PENDING
|
||
|
WIPO
|
2203301-WO3
|
CEQ
|
10/21/2002
|
PCX/XX00/00000
|
XXX
XXXXX
|
||
|
XXXXX
XXXXXX
|
0000000-XX0
|
XXX
|
00/21/2002
|
2004/9186
|
10/26/2005
|
2004/9186
|
ISSUED
|
|
HONG
KONG
|
2203301-HK3
|
CEQ
|
1/27/2006
|
06101278.5
|
PUBLISHED
|
||
|
UNITED
STATES
|
1203301-US4
|
DIV
|
5/8/2007
|
11/745,759
|
PENDING
|