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.
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OPTION
& LICENSE AGREEMENT
by and
between
INTELLECT
NEUROSCIENCES, INC.
and
[***]
dated
as of
October
3, 2008
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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 7 West 18th St. 9th Fl. New York 10011
(“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:
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.
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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.
1.17. “
Royalty Payments ” is defined in Section
3.1.4.
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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.
3.1
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.
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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:
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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,
[***].
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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.
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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.
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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:
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[***]
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
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[***]
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
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[***]
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
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[***]
of Net Sales for the portion of aggregate Net Sales of such
Licensed Products in a calendar year in the Territory in excess of
[***].
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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.
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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.
4.1
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.
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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 (15 th
) 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.
4.4.1
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.
PROTECTION OF INTELLECTUAL PROPERTY RIGHTS
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.
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(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 abate 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.
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With
respect to any infringing activity set forth in clause (b) above,
and any other infringement of Licensed Patents by a Third Party, if
Licensor fails to commence any suit or proceeding or otherwise
abate such infringement within 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.
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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.
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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 abate 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.
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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.
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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:
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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
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Licensee
has commenced an action as described in Section 7.2.2.
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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.
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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.
8.1
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.
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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.
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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 a
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