CONFIDENTIAL TREATMENT REQUESTED. Confidential portions of this document have been redacted and separately filed with the U.S. Securities and Exchange Commission. LICENSE AGREEMENT
Exhibit
10.32
CONFIDENTIAL
TREATMENT REQUESTED.
Confidential
portions of this document have been redacted and separately filed with the
U.S.
Securities and Exchange Commission.
LICENSE
AGREEMENT
This
License Agreement (this “Agreement”),
dated
January 15, 2007 (the “Effective
Date”),
is
made by and between DOV Pharmaceutical, Inc., a Delaware corporation
(“DOV”),
and
XTL Development, Inc., a Delaware corporation (“XTL”).
DOV
and XTL are sometimes hereinafter referred to each as a “Party” and collectively
as the “Parties.”
WHEREAS,
the Parties desire to enter into an agreement pursuant to which DOV will grant
a
sole and exclusive license to XTL under the DOV Patent Rights and DOV Know-How
for XTL to develop and commercialize the Licensed Compound and Licensed Product
as defined below, and
WHEREAS,
DOV and Wyeth Holdings Corporation (“Wyeth”) entered into that certain Amended
and Restated License Agreement dated December 7, 2006 (the “Wyeth
Agreement”),
relating, among other things, to Bicifadine (as defined below).
NOW,
THEREFORE, the Parties hereby agree as follows:
Section
1. Definitions.
For
the
purpose of this Agreement, the following words and phrases shall have the
meanings set forth below:
1.1 “Affiliate”
means with respect to a party, any other business entity that directly controls,
is controlled by, or is under common control with, such party. A business entity
or party shall be regarded as in control of another business entity if it owns,
or controls, more than fifty percent (50%) of the voting stock or other voting
ownership interest of the other business entity, or if it directly or indirectly
possesses the power to direct or cause the direction of the management and
policies of the other business entity by any means whatsoever.
1.2 “Annual”
means from January 1 to December 31 of any given calendar year.
1.3 “Approval”
means, with respect to any Licensed Product in any regulatory jurisdiction,
approval from the applicable Regulatory Authority sufficient for the
manufacture, offer for sale, sale, distribution, importation or use of the
Licensed Product in such jurisdiction in accordance with applicable Laws.
1.4 “Bicifadine”
means the compound CL 220,075 as listed in Schedule 1 to the Wyeth Agreement.
1.5 “Clinical
Data” means the information with respect to the Licensed Product or the Licensed
Compound made, collected or otherwise generated under or in connection with
pre-clinical, clinical, or the post-Approval studies for the Licensed Compound
or Licensed Product, including any data, reports and results with respect to
any
of the foregoing.
1.6 “Commercially
Reasonable Efforts” means, with respect to Licensed Products, the carrying out
of development and commercialization activities in a manner comparable to that
which a company within the pharmaceutical industry that is similarly situated
to
XTL and its Affiliates, taken collectively, would reasonably devote to a product
of similar market potential based on conditions then prevailing and taking
into
account, without limitation, issues of safety and efficacy, product profile,
the
proprietary position, the then current competitive environment for such product
and the timing of such product’s entry into the market, the regulatory
environment and status of such product, and other relevant scientific, technical
and commercial factors.
1.7 “Confidential
Information” means all data or information received by a Party or its Affiliates
(“Receiving Party”) that is of value to the Party or its Affiliates disclosing
or providing such data or information (“Disclosing Party”) including, but not
limited to, Technology; marketing plans or strategies; formulas; methods;
techniques; drawings; processes; financial data; financial plans; product plans;
lists of actual or potential customers, vendors and/or employees; potential
packaging; advertising materials; trademarks, service marks and trade dress;
price lists; pricing policies; and competitive strategies. Confidential
Information also includes any compilation or organization of information which,
divided into individually segregated segments, may not be deemed confidential
but in its organized completed format is unique, proprietary and confidential
to
the Disclosing Party. Additionally, Confidential Information includes any
information described in this provision which the Disclosing Party obtains
from
another party and which the Disclosing Party treats as proprietary or designates
as confidential information, whether or not owned or developed by the Disclosing
Party. Confidential Information shall be treated as such regardless of whether
it is marked “confidential” or “proprietary” or communicated by the
Disclosing Party or its Affiliates in oral, written, graphic, or electronic
form.
1.8 “Confidentiality
Agreement” means that certain Confidentiality and Nondisclosure Agreement, dated
October 17, 2006, by and between the Parties.
1.9 “Controlled”
or “Controls”, means, when used in reference to intellectual property
(including, but not limited to, patents, trademarks, know-how or Technology),
the legal authority or right of a person or entity to license or sublicense
such
intellectual property to another person or entity, or to provide or disclose
such intellectual property to such other person or entity, in each case, without
breaching any contractual or fiduciary obligations.
1.10 “DOV
Bicifadine Patent Rights” means the DOV Patent Rights that relate only to the
Licensed Compound and not to any other compounds.
1.11 “DOV
Commingled Patent Rights” means all DOV Patent Rights other than the DOV
Bicifadine Patent Rights.
1.12 “DOV
Know-How” means all Technology owned, licensed or otherwise Controlled by DOV or
any of its Affiliates as of the Effective Date, that is related to the Licensed
Compound or Licensed Product, or that is essential, necessary or useful for
the
manufacture, use, sale, offer for sale, importation, research, development,
commercialization or other exploitation of the Licensed Compound or Licensed
Product.
1.13 “DOV
Patent Rights” means the patents and patent applications listed in Exhibit B
attached
hereto, as amended from time to time during the term of this Agreement by mutual
agreement of the Parties, and (a) any foreign counterparts thereof,
(b) all divisionals, continuations, continuations-in-part thereof or any
other patent application claiming priority directly or indirectly to
(i) any of the patents or patent applications identified in Exhibit B
or
(ii) any patent or patent application from which the patents or patent
applications identified in Exhibit B
claim
direct or indirect priority, and (c) all patents issuing on any of the
foregoing, and any foreign counterparts thereof, together with all
registrations, reissues, re-examinations, renewals, supplemental protection
certificates, or extensions of any of the foregoing, and any foreign
counterparts thereof. The parties shall update Exhibit
B
from
time to time during the term of this Agreement as may be required.
2
1.14 “EMEA”
means the European Agency for the Evaluation of Medicinal Products, or any
successor agency thereto.
1.15 “EU”
means the European Union, as its membership may be altered from time to time,
and any successor thereto, and which, as of the Effective Date, consists of
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden
and the United Kingdom, and that certain portion of Cyprus included in such
organization.
1.16 “Europe”
means the countries comprising the EU as it may be constituted from time to
time, together with those additional countries included in the European Economic
Area as it may be constituted from time to time.
1.17 “FDA”
means the United States Food and Drug Administration or any successor agency
thereto.
1.18 “Field”
means the treatment of any diseases, disorders and conditions in humans, other
than the treatment or amelioration of vasomotor symptoms caused by or occurring
in relation to or connection with menopause or other female hormonal
fluctuations in a patient undergoing treatment.
1.19 “First
Commercial Sale” means, with respect to any Licensed Product on a
country-by-country basis, the first sale for use by the general public of such
Licensed Product in such country after Approval of such Licensed Product has
been granted, or marketing and sale of such Licensed Product is otherwise
permitted, by the applicable Regulatory Authority of such country.
1.20 “FTE”
means full-time equivalent.
1.21 “Governmental
Authority” means any supranational, national, federal, state or local judicial,
legislative, executive or regulatory authority or any arbitrator or arbitration
tribunal.
1.22 “IND”
means an investigational new drug application filed with the FDA for
authorization to commence clinical studies or post-Approval studies and its
equivalent in other countries or regulatory jurisdictions.
1.23 “JNDA”
means a New Drug Application filed with the Koseisho required for marketing
approval for the applicable Licensed Product in Japan.
1.24 “Koseisho”
means the Japanese Ministry of Health and Welfare, or any successor agency
thereto.
1.25 “Laws”
means all laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law of any federal, national, multinational,
state, provincial, county, city or other political subdivision, domestic or
foreign.
1.26 “Licensed
Compound” means (a) Bicifadine and (b) any prodrugs, optical isomers, hydrates,
solvates, salt forms and polymorphs of Bicifadine.
1.27 “Licensed
Product” means any pharmaceutical product in all forms, presentations,
formulations and dosage forms containing a Licensed Compound, either alone
or in
combination with one or more other active ingredients (“Combination Product”).
3
1.28 “NDA”
means a New Drug Application filed with the FDA seeking approval to market
a
Licensed Product in the United States.
1.29 “NDA
Filing” means an NDA for a Licensed Product that has been accepted for filing by
the FDA.
1.30 “Net
Sales” means the gross amount invoiced for Licensed Product sold, distributed or
otherwise disposed of by XTL, its Affiliates and/or Sublicensees (collectively,
the “Selling
Party”),
in an
arm’s length transaction to an end user (“Gross
Sales”),
less:
(i) trade,
quantity or cash discounts (other than early payment discounts);
(ii) credits
or allowances, if any, given or made on account of price adjustments, returns,
bad debts, rebates, and any all Federal, state or local government rebates
whether in existence now or enacted at any time during the term of this
Agreement (e.g.,
HCFA
or Medicaid rebates), rejections, recalls or destruction requested or made
by an
appropriate government agency; and
(iii) any
tax,
excise or governmental charge upon or measured by the sale, transportation,
delivery or use of the Licensed Product;
provided
that Net Sales shall in no event be less than eighty percent (80%) of Gross
Sales.
In the
case
of discounts on “bundles” of products which include the Licensed Product, XTL
and its Affiliates may, subject to notice to DOV, calculate Net Sales as set
forth above discounting the bona fide list price of the Licensed Product by
the
average percentage discount of all products of the Selling Party in a particular
“bundle”, calculated as follows:
Average
percentage
discount
on a =
(1-A/B)
x
100
particular
“bundle”
where
A
equals the total discounted price of a bundle, and B equals the sum of the
undiscounted bona fide list prices of each unit of every product in such bundle.
XTL shall, and shall cause its Affiliates and Sublicensees (directly or through
XTL) to, provide DOV documentation, reasonably acceptable to DOV, establishing
such average discount with respect to each bundle. Where the Licensed Product
is
also sold other than in a bundle, the average discount as calculated above
shall
be applied to the undiscounted list price of the Licensed Product in the bundle.
If the Licensed Product is not sold separately and no bona fide list price
exists for the Licensed Product, the Parties shall negotiate in good faith
an
imputed list price for the Licensed Product, and the average discount as
calculated above with respect thereto shall be applied to such imputed list
price.
For
the
sake of clarity, sales of Licensed Product among XTL, its Affiliates or
permitted Sublicensees, where such Licensed Product is being transferred to
such
Affiliate or permitted Sublicensee for purposes of resale or further
distribution, shall not be included in the calculation of Net Sales, it being
understood that Net Sales shall be calculated based on the gross amount invoiced
in connection with such resale or further distribution. Notwithstanding, the
foregoing, if Licensed Product is sold or otherwise transferred among XTL,
its
Affiliates or permitted Sublicensees and XTL, such Affiliate or such permitted
Sublicensee is the end user of such Licensed Product, then the Net Sales for
such units of Licensed Product shall be calculated based on the gross amount
invoiced in connection with such sale or transfer.
4
*****Confidential
material redacted and filed separately with the Commission.
1.31 “Phase
IIB Trial” means a double-blind, placebo-controlled, dose finding study in a
specific chronic pain indication designed so as to achieve the first Milestone
Event set forth in Section 6.3.
1.32 “Publicly
Traded Stock” means:
A. ordinary
shares of XTL Biopharmaceuticals Ltd. (“XTL Ltd.”), a public company limited by
shares organized under the laws of the State of Israel which have been duly
authorized for issuance by all appropriate corporate action, and which
are:
(i) freely
tradable without restriction on the London Stock Exchange as of the date of
issuance; or
(ii) issued
off of a shelf registration statement filed by XTL Ltd. under the Securities
Act
of 1933, as amended (the “Securities
Act”),
such
that following such issuance they are freely tradable without restriction on
the
Nasdaq Global Market; and which carry a value equal to:
a. in
the
case of (i) above, the lesser of (x) the closing sales price of an ordinary
share as reported by the London Stock Exchange (or another authoritative source)
as of the close of business on the day prior to the date of issuance, and (y)
the average of the closing sales price of an ordinary share as reported by
the
London Stock Exchange (or another authoritative source) for the ***** trading
days beginning on the trading day ***** prior to the day the milestone giving
rise to the payment is publicly announced and ending with the close of business
on the ***** day following public announcement of such milestone;
or
b. in
the
case of (ii) above, the lesser of (A) the quotient of (w) the average of the
closing sales price of an American Depositary Shares of XTL Ltd. as reported
by
the Nasdaq Global Market (or another authoritative source), as of the close
of
business on the day prior to the date of issuance, and (x) the number of
ordinary shares of XTL Ltd. represented by each American Depositary Share of
XTL
Ltd., and (B) the quotient of (y) the average of the closing sales price of
an
American Depositary Shares of XTL Ltd. as reported by the Nasdaq Global Market
(or another authoritative source) for the ***** trading days beginning on the
trading day ***** prior to the day the milestone giving rise to the payment
is
publicly announced and ending with the close of business on the ***** day
following public announcement of such milestone, and (z) the number of ordinary
shares of XTL Ltd. represented by each American Depositary Share of XTL Ltd.;
or
B. shares
of
capital stock of XTL or XTL Biopharmaceuticals, Inc., a Delaware corporation
and
the parent corporation for XTL (“Parent”), in each case that have been
registered under the Securities Act and are freely tradable without restriction
on a stock exchange in the United States; and which carry a value equal to
the
lesser of (i) the closing sales price of such shares as reported by the stock
exchange on which such shares are listed (or another authoritative source),
on
the day prior to the date of issuance, and (ii) the average of the closing
sales
price of such shares as reported by the stock exchange on which such shares
are
listed (or another authoritative source), for the ***** trading days beginning
on the trading day ***** prior to the day the milestone giving rise to the
payment is publicly announced and ending with the close of business on the
*****
day following public announcement of the milestone giving rise to the payment.
5
*****Confidential
material redacted and filed separately with the Commission.
1.33 “Regulatory
Authority” means any national or supranational governmental authority,
including, without limitation, the FDA, EMEA or Koseisho, that has
responsibility in countries in the Territory over the development and/or
commercialization of the Licensed Compound and Licensed
Product.
1.34 “Regulatory
Documentation” means all applications, registrations, licenses, authorizations
and approvals (including all Approvals), all correspondence submitted to or
received from Regulatory Authorities (including minutes and official contact
reports relating to any communications with any Regulatory Authority) and all
supporting documents and all preclinical and clinical studies and tests,
relating to the Licensed Compound or the Licensed Product and all data contained
in any of the foregoing, including all NDAs, regulatory drug lists, advertising
and promotion documents, manufacturing data, Clinical Data, adverse event files
and complaint files.
1.35 “Technology”
means know-how, trade secrets, chemical and biological materials, formulations,
information, documents, studies, results, data and regulatory approvals, filings
and correspondence (including drug master files), including biological,
chemical, pharmacological, toxicological, pre-clinical, clinical and assay
data,
manufacturing processes and data, specifications, sourcing information, assays,
and quality control and testing procedures, whether or not patented or
patentable, in each case, to the extent related to the Licensed Compound or
Licensed Product.
1.36 “Territory”
means all countries of the world.
1.37 “Third
Party” means
any
person or entity other than XTL or DOV or any of their Affiliates.
1.38 “Trademark”
means any word, name, symbol, color, designation or device or any combination
thereof, including any trademark, trade dress, brand xxxx, service xxxx, trade
name, brand name, logo or business symbol, whether or not registered.
Section
2. License
and Assignment Grants by DOV.
2.1 Exclusive
License.
DOV,
for itself and on behalf of its Affiliates, hereby grants to XTL and its
Affiliates a non-transferable (except in accordance with
Section 12.2),
sole
and exclusive (even as to DOV and its Affiliates), worldwide license, with
the
right to sublicense in accordance with Section 2.1(a),
under
the DOV Patent Rights and DOV Know-How, to make, have made, use, sell, offer
to
sell, import, research, develop, commercialize and otherwise exploit the
Licensed Compound and Licensed Product in the Field in the
Territory.
The
foregoing license grant includes the right to make reference to all regulatory
approvals, filings and correspondence (including drug master files) contained
within the DOV Know-How.
Each
Affiliate of XTL performing any obligations or exercising any rights hereunder
shall be bound by the terms and conditions of this Agreement as and to the
same
extent as XTL, and XTL shall remain fully responsible for the performance of
its
Affiliates hereunder.
(a) Right
to Sublicense.
The
licenses granted in Section 2.1
include
the right to grant sublicenses (through multiple tiers) to Third Parties (each
such Third Party sublicensee, a “Sublicensee”),
provided that: (1) each such sublicense shall be subordinate to this Agreement,
(2) no such sublicense shall impair XTL (directly or with and through its
Sublicensees) to perform its obligations hereunder, (3) no such sublicense
shall
limit or impair DOV’s rights hereunder and (4) XTL
shall
remain responsible for its, its Affiliates and its Sublicensees conformity
to
the terms and conditions set forth herein, including without
limitation, the obligation to use Commercially Reasonable Efforts to develop
and
commercialize the Licensed Compound and Licensed Product throughout the
Territory, the obligation to make payments as and when due hereunder, and the
obligation to keep records and make reports hereunder.
XTL
shall provide DOV with a true, accurate and complete copy of each sublicense
agreement with its Sublicensees promptly after execution.
6
(i) Each
sublicense granted to a Sublicensee by XTL to any rights licensed to it
hereunder shall terminate immediately upon the termination of the license from
DOV to XTL with respect to such rights as of the effective date of such
termination by DOV pursuant to Section 11.2(b),
provided however, that if a Sublicensee is not in material default of its
obligations to XTL under its sublicense agreement, and within sixty (60) days
of
such termination the
Sublicensee agrees in writing to be bound directly to DOV under a license
agreement substantially similar to this Agreement with respect to the rights
sublicensed hereunder, substituting such Sublicensee for XTL, then such
sublicense shall not so terminate.
(b) Restrictions
on DOV.
DOV
and
its Affiliates shall not grant or provide to any Third Party any Technology,
patent or other intellectual property rights or Confidential Information
inconsistent with the terms of this Agreement. For as long as the license grant
set forth in Section 2.1
is in
effect, DOV Know-How shall be treated as Confidential Information of both XTL
and DOV, and DOV and its Affiliates shall neither use DOV Know-How, nor shall
DOV or its Affiliates disclose DOV Know-How, except as permitted by
Section 8.1(b)
or 8.2.
2.2 Assignment
of INDs.
DOV, for
itself and its Affiliates, hereby assigns and transfers to XTL all of DOV’s
right, title, and interest in and to any and all INDs relating to the Licensed
Compound in the Field in the Territory.
2.3 Use
of
Trademarks.
As
between the Parties, XTL shall have the sole right to determine and own the
Trademarks to be used with respect to the commercialization of the Licensed
Product in the Field in the Territory. XTL and its Affiliates shall make
reasonable efforts to avoid using in their Development and Commercialization
activities any Trademark that is confusingly similar to, misleading or deceptive
with respect to any trademark owned by DOV.
2.4 License
Limitations.
All
licenses and other rights are or shall be granted only as expressly provided
in
this Agreement, and no other licenses or other rights are or shall be created
or
granted hereunder by implication, estoppel or otherwise.
Section
3. Regulatory
Matters in the Territory.
3.1 Regulatory
Responsibilities.
As
between the Parties, XTL shall have sole responsibility for preparing and
maintaining all Regulatory Documentation with respect to (i) Approvals for
the Licensed Product in the Field in the Territory and (ii) Development and
Commercialization activities, as set forth in Section
5,
for the
Licensed Product in the Field in the Territory. To the extent possible, DOV
shall provide, at XTL’s expense, reasonable assistance to XTL with respect to
this Section 3.1.
3.2 [Reserved]
3.3 Ownership.
All
Approvals and related Regulatory Documentation for the Licensed Product in
the
Field in the Territory shall be the sole and exclusive property of XTL and
held
in the name of XTL (or in each such case XTL’s Affiliate or Sublicensee). DOV
shall not be entitled to receive copies of XTL’s Clinical Data, provided,
however, that upon written request by DOV, XTL shall, at its sole discretion,
provide such copies to DOV subject to the confidentiality provisions of
Section
8.
7
*****Confidential
material redacted and filed separately with the Commission.
3.4 Communications
with Regulatory Authorities.
As
between the Parties, XTL shall be responsible for all communications with any
Regulatory Authority relating to the Licensed Product or Licensed Compound
in
the Territory during the term of this Agreement. Subject to Section 3.3, as
relating to the Licensed Product or Licensed Compound, XTL (or its Affiliates
or
Sublicensees) shall promptly provide DOV with copies of all (i) material written
communications to or from any Regulatory Authority, and (ii) written meeting
minutes or summaries of material meetings, conferences and discussions with
Regulatory Authorities. Except as necessary to comply with the Laws, DOV shall
not initiate any communications with any Regulatory Authority concerning the
Licensed Compound or the Licensed Product without first obtaining XTL’s
approval.
(a) XTL
shall
promptly inform DOV of any action, correspondence or reports to or from
Governmental Authorities (other than Regulatory Authorities) that would
reasonably be expected to materially affect the current or anticipated
development or commercialization of the Licensed Product or Licensed Compound,
and shall furnish DOV with copies of any relevant documents relating
thereto.
3.5 Regulatory
Records.
XTL
shall maintain, or cause to be maintained, records of the development and
commercialization activities performed by XTL, its Affiliates and Sublicensees
with respect to the Licensed Product in sufficient detail and in good scientific
manner appropriate for patent and regulatory purposes, which shall be reasonably
complete and accurate and shall properly reflect all work done and results
achieved in the performance of such development activities, and which shall
be
retained by or for XTL for at least five (5) years after the termination of
this
Agreement, or for such longer period as may be required by Law.
Section
4. Performance
of Duties.
4.1 Transition.
Within
thirty (30) days following the Effective Date, DOV shall transfer or cause
to have transferred to XTL, or shall perform or cause to have performed, each
item scheduled in Exhibit
D
hereto;
provided that any copies of documents, data and other information shall be
made
available to XTL and may be copied at XTL’s expense. DOV shall cause its
Affiliates to provide XTL with access to their facilities, during normal
business hours for the purpose of reviewing such data or other information
in
DOV’s or its Affiliates’ possession as of the Effective Date. Such access shall
be granted on two (2) days written notice from XTL to DOV specifying the date
and time of access.
4.2 Studies
Completion.
(a) DOV
shall
use reasonable efforts to complete, or to cause to have completed, each of
the
deliverables specified in Exhibit
E
within
the one hundred eighty (180) days immediately following the Effective Date.
XTL
shall reimburse DOV for direct FTE costs and vendor costs incurred in connection
with DOV’s efforts to complete such deliverables, upon completion of each such
deliverable, within thirty (30) days following receipt of an invoice from
DOV. The estimated cost for the deliverables indicated on
Exhibit
E
are not
binding; provided that unless the Parties agree otherwise in writing, XTL shall
not be required to reimburse DOV for costs incurred in connection with a
specific deliverable that are in excess of ***** percent (*****%) of the
estimated cost associated with such deliverable. In the event that DOV does
not
complete one or more such deliverables within one hundred eighty (180) days
following the Effective Date, then for each business day above and beyond the
one hundred eighty (180) day period and until DOV completes each
such
deliverable, XTL shall reduce the reimbursement for each such outstanding
deliverable at a rate of ***** percent (*****%) per month, calculated on the
total number of days; provided that no such reduction shall apply to delays
that
are beyond DOV’s reasonable control, including, without limitation, delays
caused by Regulatory Authorities or by XTL.
*****Confidential
material redacted and filed separately with the Commission.
(b) XTL
shall
close out the 021 and 022 clinical studies using Good Clinical Practices
required by Regulatory Authorities, including, but not limited to, drug
accountability procedures.
4.3 Database
Support.
For
a
period of two (2) months after the Effective Date, DOV shall provide XTL access
to DOV’s Vice President of Clinical Research and Development, or an employee
with similar knowledge, to provide support and training to XTL as may be
reasonably necessary to complete the close-out of the 021 and 022 clinical
studies, in any case not to exceed twenty percent (20%) of such person’s time.
XTL shall reimburse DOV at cost for the time provided by the Vice President
of
Clinical Research and Development or other employee pursuant to this Section
4.3.
4.4 Sales
of Licensed Compound.
(a) To
the
extent that such purchase is necessary for the Commercialization and Development
of the Licensed Product, during the term of this Agreement XTL shall purchase
the Licensed Compound (whether in the form of the active pharmaceutical
ingredient, intermediate, or finished product) from DOV’s existing inventory
(the “Inventory”),
at a
price equal to *****, as set forth in Exhibit
C,
prior
to offering to purchase or purchasing any such material from any other source;
provided however, that such requirement shall be waived with respect to any
such
material that is expired or otherwise not in compliance with XTL’s applicable
specifications at the time XTL requests such supply. Within seven (7) days
notice from XTL of XTL’s request to purchase a quantity of the Inventory (each
such request, a “Purchase
Request”),
DOV
shall take
all
actions that may be reasonably necessary or desirable to fulfill the Purchase
Request. For each such Purchase Request, XTL shall remit payment to DOV for
the
purchased quantity of Inventory within thirty (30) days of receipt of an invoice
from DOV. XTL
will
reimburse DOV for any direct storage and necessary stability testing costs
associated with the Inventory actually purchased pursuant to this Section
4.4(a),
such
costs calculated for the period beginning on the Effective Date and until the
date of fulfillment of the Purchase Request.
(b) For
a
period of ***** years following the Effective Date, DOV shall be responsible
for
and shall perform or cause to have performed the storage and any necessary
stability testing of the Inventory. In the event that XTL purchases Inventory
in
accordance with the provisions of Section 4.4(a),
at the
time of each such purchase XTL shall reimburse DOV for the costs incurred to
store and conduct stability testing of such Inventory from the Effective Date
to
the time of purchase. Further, if at the end of the ***** year period following
the Effective Date Inventory remains on-hand, XTL shall reimburse DOV for *****
percent (*****%) of the sum of the costs incurred by DOV (i) to store and
conduct stability testing of such Inventory for such ***** year period and
(ii)
to dispose of such Inventory (should DOV decide to dispose of same at such
time). To the extent that the purchase of all of the Inventory (as described
in
Section 4.4(a)) is not necessary for the Commercialization and Development
of
the Licensed Product, XTL may provide notice to DOV that XTL shall not purchase
such Inventory and XTL shall then reimburse DOV for ***** percent (*****%)
of
the sum of the costs incurred by DOV (i) to store and conduct stability testing
of such remaining Inventory from the Effective Date until the date of such
notice and (ii) to dispose of such remaining Inventory (should DOV decide to
dispose of same at such time). In the event that XTL purchases all the Inventory
during the ***** years following the Effective Date, XTL shall have the option,
upon thirty (30) days notice to DOV, to assume all contracts for the storage
and
testing of the Inventory (the “Inventory
Contracts”),
and
DOV shall take all actions that may be reasonably necessary or desirable in
connection with such option, including, but not limited to, assignment of the
Inventory Contracts to XTL pursuant to an assignment agreement in form and
substance reasonably acceptable to the Parties.
9
*****Confidential
material redacted and filed separately with the Commission.
Section
5. Development
and Commercialization.
5.1 Clinical
Trial.
XTL
shall use Commercially Reasonable Efforts to initiate (i.e., dosing of the
first
patient) a Phase IIB Trial of the Licensed Compound no later than ***** the
date
of DOV’s compliance with Section 4.1.
If XTL
fails to initiate a Phase IIB Trial of the Licensed Compound by such *****,
and
provided that such failure is not due to a delay that is beyond XTL’s reasonable
control, including, without limitation, delays caused by Regulatory Authorities
or by DOV, then XTL may obtain a *****, provided that if XTL fails to initiate
a
Phase IIB Trial of the Licensed Compound by the end of such *****, and provided
that such failure is not due to a delay that is beyond XTL’s reasonable control,
including, without limitation, delays caused by Regulatory Authorities or by
DOV, then XTL may obtain a *****. The ***** described in the previous sentence
are *****.
Notwithstanding the foregoing, if during the ***** immediately following the
Effective Date, XTL enters into a sublicense in accordance with Section
2.1(a)
or XTL
assigns this Agreement in connection with a change of control in accordance
with
Section 12.2,
then
the fee for each of the ***** permitted in accordance with this Section
5.1
shall be
***** U.S. dollars (US$*****). Failure to initiate a Phase IIB Trial of the
Licensed Compound within ***** the date of DOV’s compliance with Section
4.1
shall
constitute a material breach of this Agreement, unless such failure is due
to a
delay that is beyond XTL’s reasonable control, including, without limitation,
delays caused by Regulatory Authorities or by DOV.
5.2 Responsibilities
and Costs. XTL
shall
use Commercially Reasonable Efforts to develop and commercialize the Licensed
Compound and Licensed Product throughout the Territory. Without limiting the
foregoing requirement, XTL shall have sole responsibility for, and shall bear
all costs associated with, such commercialization and development activities.
5.3 [Reserved]
5.4 Markings.
All
promotional materials, packaging and product labeling for the Licensed Product
used by XTL, its Affiliates, Sublicensees or distributors in connection with
the
Licensed Product shall contain (i) the applicable Trademark selected by XTL
for use in commercialization of the Licensed Product, (ii) if required by
Law, the logo and corporate name of the manufacturer, and (iii) if
appropriate, the applicable patent numbers.
Section
6. XTL
Payments.
6.1 Initial
License Fee.
Within
seven (7) days after the Effective Date, XTL shall pay to (a) Wyeth five million
U.S. dollars (US$5,000,000) in cash and (b) DOV one million five hundred
thousand U.S. dollars (US$1,500,000) in cash; in each case, in accordance with
wire instructions provided by DOV to XTL. Notwithstanding anything else
contained herein, in the event that XTL does not pay Wyeth in strict accordance
with the terms of this Section 6.1,
this
Agreement shall be void ab initio.
6.2 Transition
Fee.
Within
seven (7) days after the Effective Date, XTL shall place one million U.S.
dollars (US$1,000,000) in an interest-bearing escrow account. XTL shall pay
to
DOV the balance of such account, including interest, in cash and in accordance
with wire instructions provided by DOV to XTL, within thirty (30) days of the
Effective Date, subject only to DOV’s compliance with Section 4.1,
and
provided that for each day above and beyond the thirty (30) day period specified
in Section 4.1
that DOV
takes to complete the Transition, XTL shall reduce such payment at a rate of
***** percent (*****%) per month, calculated on the total number of days,
provided further that no such reduction shall apply to delays that are beyond
DOV’s reasonable control, including, without limitation, delays caused by
Regulatory Authorities or by XTL.
10
*****Confidential
material redacted and filed separately with the Commission.
6.3 Milestone
Payments.
As set
forth in the following table, XTL shall owe Milestone Payments to DOV upon
achievement of each of the Milestones Events by XTL or an Affiliate or
Sublicensee of XTL. Each Milestone Payment shall be due and payable by XTL
to
DOV within twenty (20) days after the achievement of the corresponding Milestone
Event with respect to a Licensed Product. Only one set of Milestone Payments
are
payable hereunder no matter how many times any of the Milestone Events are
achieved.
“Milestone
Event”
|
“Milestone
Payment”
|
|
1. Receipt
of favorable results *****
|
US$*****
(in cash or Publicly Traded Stock)
|
|
2. NDA
***** for a Licensed Product containing a Licensed Compound in a
*****
indication
|
US$*****
(in cash or Publicly Traded Stock)
|
|
3. NDA
***** for a Licensed Product containing a Licensed Compound in a
*****
indication
|
US$*****
(in cash or Publicly Traded Stock)
|
|
4. First
FDA Approval of NDA for a Licensed Product containing a Licensed
Compound
|
US$*****
(at least US$***** in cash and up to US$***** in Publicly Traded
Stock)
|
|
5. EMEA
Approval of a Licensed Product containing a Licensed Compound in
a *****
indication
|
US$*****
(in cash or Publicly Traded Stock)
|
|
6. JNDA
Approval of a Licensed Product containing a Licensed Compound in
a *****
indication
|
US$*****
(in cash or Publicly Traded Stock)
|
|
7. Commercial
Launch of a Licensed Compound for a ***** indication
|
US$*****
(in cash or Publicly Traded Stock)
|
|
8. NDA
***** for a Combination Product
|
US$*****
(in cash or Publicly Traded Stock)
|
|
9. FDA
Approval of NDA for a Combination Product
|
US$*****
(in cash or Publicly Traded Stock)
|
|
10. Annual
worldwide sales of Licensed Compounds and Licensed Products equal
US$*****
|
US$*****
(in cash or Publicly Traded Stock)
|
|
11. Annual
worldwide sales of Licensed Compounds and Licensed Products equal
US$*****
|
US$*****
(in cash or Publicly Traded Stock)
|
|
12. Annual
worldwide sales of Licensed Compounds and Licensed Products equal
US$*****
|
US$*****
(in cash or Publicly Traded Stock)
|
6.4 Royalties.
(a) Royalties.
Subject
to the terms and conditions of this Agreement (including the remainder of this
Section
6),
XTL
shall pay to DOV royalties, on a country-by-country and product-by-product
basis
for the period of time specified in Section 6.4(b),
at the
graduated royalty rates specified in the following table with respect to Net
Sales of Licensed Products:
Aggregate
Net Sales
of
All Licensed Products in a Calendar Year
|
Royalty
Rate
|
|
On
such Net Sales up to ***** U.S. dollars (US$*****)
|
*****
percent (*****%)
|
|
On
such Net Sales above ***** U.S. dollars (US$*****) and up ***** U.S.
dollars (US$*****)
|
*****
percent (*****%)
|
|
On
such Net Sales above ***** U.S. dollars (US$*****)
|
*****
percent (*****%)
|
11
*****Confidential
material redacted and filed separately with the Commission.
The
applicable royalty rate shall be determined by reference to all Net Sales on
which royalties are paid in a given calendar year. By way of example, in a
given
calendar year, if the aggregate annual worldwide Net Sales for all Licensed
Products for which royalties are due under this Section 6.4(a)
were
US$*****, the following royalty payment would be payable under this
Section 6.4(a)
(subject
to all reductions set forth in this Agreement): *****.
(b) Royalty
Term.
The
royalties due under Section 6.4(a)
shall be
payable on Net Sales from the First Commercial Sale of a particular Licensed
Product until the later of, on a country-by-country basis, (i) the
expiration of the last to expire patent in such country covering such Licensed
Product or its use for which regulatory approval has been obtained in such
country, or (ii) ten (10) years from such First Commercial Sale in each
such country.
Such
period during which royalties are payable with respect to a Licensed Product
in
a country is referred to herein as the “Royalty Term” in such country with
respect to such Licensed Product.
(c) Only
One Royalty.
Only
one royalty shall be due with respect to the sale of the same unit of Licensed
Product. Only one royalty shall be due hereunder on the sale of a Licensed
Product even if the manufacture, use, sale, offer for sale or importation of
such Licensed Product infringes more than one claim of the DOV Patent
Rights.
6.5 Payment
Terms.
(a) Manner
of Payment.
All
payments to be made by XTL hereunder shall be made in U.S. dollars by wire
transfer to such bank account as DOV may designate or in Publicly Traded Stock.
DOV may designate that some or all of the amounts due hereunder be paid to
third
part(ies), for example, in the event that XXX xxxxx or assigns its right to
receive some or all of the amounts due hereunder to one or more third parties
and XTL agrees that such third parties shall be entitled to receive reports
under Section 6.5(b)
and to
perform audits under Section 6.5(c)
as and
to the same extent as DOV and without limiting DOV’s rights hereunder. In the
event that XTL elects to pay any Milestone Payment due under Section
6.3
(in part
or in whole) in Publicly Traded Stock, the amount of such Milestone Payment
paid
in Publicly Traded Stock will not exceed ***** percent (*****%) of the average
aggregate market value of the equity securities of XTL Ltd. over the *****
trading days before such Milestone Payment was due, provided, however, that
in
the case of the Milestone Payment due to DOV upon FDA Approval of NDA for a
Licensed Product containing a Licensed Compound, XTL may pay such Milestone
Payment in Publicly Traded Stock in an amount up to ***** percent (*****%)
of
the average aggregate market value of the equity securities of XTL Ltd. over
the
***** trading days before such Milestone Payment was due. In addition, XTL
will
reimburse DOV for any *****, provided, that such reimbursement shall not exceed
***** percent (*****%) of the aggregate market value of Publicly Traded Stock
sold in such transaction.
(b) Reports
and Royalty Payments.
For as
long as royalties are due under Section 6.4(a),
XTL
shall furnish to DOV a written report, within forty-five (45) days after
the end of each calendar quarter, showing the amount of Net Sales of Licensed
Products and royalty
due for such calendar quarter. Royalty payments for each calendar quarter shall
be due at the same time as such written report for the calendar quarter. The
report shall include, at a minimum, the following information for the applicable
calendar quarter, each listed by product and by country of sale: (i) the
number of units of Licensed Products sold by XTL and its Affiliates and
Sublicensees on which royalties are owed DOV hereunder; (ii) the gross
amount received for such sales; (iii) deductions taken from Net Sales as
specified in the definition thereof; (iv) Net Sales; and (v) the
royalties and Milestone Payments owed to DOV, listed by category. In addition
to
the foregoing, XTL shall furnish to DOV a written report within ten (10)
business days after the end of each calendar quarter estimating the total Net
Sales for such calendar quarter by XTL, its Affiliates and
Sublicensees.
12
*****Confidential
material redacted and filed separately with the Commission.
(c) Records
and Audits.
XTL
shall keep, and shall cause each of its Affiliates and Sublicensees, as
applicable, to keep adequate books and records of accounting for the purpose
of
calculating all royalties payable to DOV hereunder. For the five (5) years
next
following the end of the calendar year to which each shall pertain, such books
and records of accounting (including those of XTL’s Affiliates and Sublicensees,
as applicable) shall be kept at each of their principal place of business and
shall be open for inspection at reasonable times and upon reasonable notice
by
an independent certified accountant selected by DOV or Wyeth and reasonably
acceptable to XTL, for the sole purpose of inspecting the royalties due to
DOV
under this Agreement. In no event shall such inspections be conducted more
frequently than once every twelve (12) months. For the sake of clarity, DOV
or Wyeth may conduct an annual inspection of the books and records of XTL and
XTL’s Affiliates and Sublicensees, and each such inspection shall be limited to
the records and accounts pertaining to the year in which the inspection is
conducted and the immediately preceding five (5) calendar years. Results of
each
such audit shall be shared by DOV and Wyeth. The accountant conducting the
inspection must have executed and delivered to XTL and its Affiliates and
Sublicensees, as applicable, a confidentiality agreement as reasonably requested
by XTL, which shall include provisions limiting such accountant’s disclosure to
DOV or Wyeth, as applicable, to only the results and basis for such results
of
such inspection. The results of such inspection, if any, shall be binding on
both Parties. Any underpayments shall be paid by XTL within thirty (30)
days of notification of the results of such inspection. Any overpayments shall
be fully creditable against amounts payable in subsequent payment periods.
DOV
shall pay for such inspections, except that in the event there is any upward
adjustment in aggregate royalties payable for any calendar year shown by such
inspection of more than ***** percent (*****%) of the amount paid, XTL shall
reimburse DOV for any reasonable out-of-pocket costs of such
accountant.
(d) Currency
Exchange.
Royalties shall accrue in the currency of the country in which the sale of
the
Licensed Product or Licensed Compound is made, and if different from U.S.
dollars, shall be converted into U.S. dollars using the exchange rate of such
domestic currency as quoted by the Wall Street Journal, for the last business
day of the calendar quarter during which the royalties accrued.
(e) Tax
Withholding.
The
withholding tax, duties, and other levies (if any) applied by any government
authority on payments made by XTL to DOV hereunder shall be borne by DOV. DOV
shall provide to XTL a signed Form W-9 with its certified tax identification
number within 30 days from the date hereof. XTL and its Affiliates shall use
commercially reasonable efforts to provide to DOV proper evidence of payments
of
withholding tax (if any) and assist DOV by obtaining or providing in as far
as possible the required documentation for the purpose of DOV’s tax
returns.
(f) Blocked
Payments.
In the
event that, by reason of applicable law in any country, it becomes impossible
or
illegal for XTL (or any of its Affiliates or Sublicensees) to transfer, or
have
transferred on its behalf, payments owed DOV hereunder, XTL shall promptly
notify DOV of the conditions preventing such transfer and such payments shall
be
deposited in local currency in the relevant country to the credit of DOV in
a
recognized banking institution designated by DOV or, if none is designated
by
DOV within a period of thirty (30) days, in a recognized banking
institution selected by XTL or its Affiliate or Sublicensee, as the case may
be,
and identified in a written notice given to DOV.
13
*****Confidential
material redacted and filed separately with the Commission.
(g) Interest
Due.
XTL
shall pay DOV interest on any payments that are not paid on or before the date
such payments are due under this Agreement at a rate of ***** percent (*****%)
per month or the maximum applicable legal rate, if less, calculated on the
total
number of days payment is delinquent.
Section
7. Patent
Prosecution, Infringement and Extensions.
7.1 Generally.
Anything
herein to the contrary notwithstanding, the Wyeth Patents (as such term is
defined under the Wyeth Agreement) shall not be subject to this Section
7
and all
rights and obligations set forth in this Section
7
are
subject to the rights held by Wyeth pursuant to Article 12.0 of the Wyeth
Agreement, provided, however, that in the event Wyeth gives notice to DOV of
any
desire to cease preparation, filing, prosecution or maintenance of any Wyeth
Primary Patent (as such term is defined under the Wyeth Agreement), then DOV
shall promptly notify XTL of such event and shall elect to continue preparation,
filing, prosecution, or maintenance of any Wyeth Primary Patent at XTL’s request
and expense.
7.2 Prosecution
and Maintenance of DOV Patent Rights.
(a) XTL
shall
be responsible for the preparation, prosecution (including any interferences,
oppositions, reissue proceedings and reexaminations) and maintenance of the
DOV
Bicifadine Patent Rights. XTL shall use Commercially Reasonable Efforts to
obtain appropriate patent protection for the Licensed Compound and Licensed
Product (including related compositions, formulations, methods of use, and
processes). XTL shall reasonably consult with DOV with respect to the
preparation, filing, prosecution and maintenance of the DOV Bicifadine Patent
Rights and DOV agrees to reasonably cooperate with XTL in such activities.
XTL
shall keep DOV advised of the status of such activities and shall also inform
DOV in a timely manner of any material communications XTL receives from the
relevant patent office with respect to such activities, including providing
DOV
with copies of any papers relating to the filing, prosecution or maintenance
of
DOV Bicifadine Patent Rights in sufficient time to allow DOV to review and
submit comments to XTL regarding responsive submissions to such papers. In
the
event DOV submits comments to XTL, XTL will reasonably consider DOV’s
substantive and/or strategic comments in preparing such responsive submissions.
DOV shall forward to XTL copies of any papers relating to the filing,
prosecution or maintenance of DOV Bicifadine Patent Rights promptly upon
receipt. As of the Effective Date, XTL shall be responsible for all its costs
incurred for such preparation, filing, prosecution and maintenance.
(b) Without
limiting the foregoing, XTL shall not knowingly permit any of the DOV Bicifadine
Patent Rights to be abandoned in any country without DOV first being given
an
opportunity to assume full responsibility and costs for the continued
prosecution and maintenance of same.
(c) DOV
shall
be responsible for the preparation, prosecution (including any interferences,
oppositions, reissue proceedings and reexaminations) and maintenance of all
DOV
Commingled Patent Rights, and all preparation, filing, prosecution, and
maintenance decisions with respect to the DOV Commingled Patent Rights shall
be
made by DOV with the goal and intention of obtaining appropriate patent
protection for the Licensed Compound and Licensed Product in the Territory.
DOV
shall reasonably consult with XTL with respect to the preparation, filing,
prosecution and maintenance of the DOV Commingled Patent Rights as they pertain
to the Licensed Product and Licensed Compound
and XTL agrees to reasonably cooperate with DOV in such activities. DOV shall
keep XTL advised of the status of such activities and shall also inform XTL
in a
timely manner of any material communications DOV receives from the relevant
patent office with respect to such activities, including providing XTL with
copies of any papers relating to the filing, prosecution or maintenance of
DOV
Commingled Patent Rights as they pertain to the Licensed Product and Licensed
Compound in sufficient time to allow XTL to review and submit comments to DOV
regarding responsive submissions to such papers. In the event XTL submits
comments to DOV, DOV will reasonably consider XTL’s substantive and/or strategic
comments in preparing such responsive submissions. XTL shall forward to DOV
copies of any papers relating to the filing, prosecution or maintenance of
DOV
Commingled Patent Rights promptly upon receipt. DOV shall be responsible for
all
its costs incurred for such preparation, filing, prosecution and maintenance.
14
(d) DOV’s
obligations and XTL’s rights relating to the DOV Commingled Patent Rights
pertain only to the Licensed
Compound and Licensed Product.
(e) Upon
either DOV’s or XTL’s reasonable request, the Parties shall cooperate in good
faith to prepare and file separate patent application(s) designed to sever
the
DOV Commingled Patent Rights. All “divisional” patent applications that pertain
specifically and exclusively to the Licensed
Compound and Licensed Product shall be considered DOV
Bicifadine
Patent
Rights and XTL shall be
responsible for the preparation, prosecution (including any interferences,
oppositions, reissue proceedings
and reexaminations) and maintenance of such “divisional”
patent
applications in accordance with the terms of Section 7.2(a).
All
“divisional” patent applications that do not pertain specifically and
exclusively to the Licensed
Compound and Licensed Product shall
not
be subject to the terms of this License Agreement and DOV shall not have any
obligations under this Agreement with respect to such “divisional” patent
applications. Upon the filing of any “divisional” patent applications pursuant
to the terms of this Section 7.2(e),
the
Parties shall amend Exhibit
B
so as to
list the “divisional” patent application(s) that are DOV Patent Rights and
delete the parent or other patent application(s) claiming the residual DOV
Commingled Patent Rights. The Parties shall cooperate to ensure that any
“divisional” patent applications filed pursuant to the terms of this Section
7.2(e)
shall
not adversely affect the patentability, validity or enforceability of any of
the
other DOV Patent Rights or any other patent rights owned or controlled by DOV,
any of DOV’s Affiliates, Wyeth or any of Wyeth’s Affiliates. XTL shall be
responsible for any incremental out-of-pocket costs incurred by DOV for
preparing and filing such “divisional” patent application(s)
and
maintaining any patent that issues therefrom.
7.3 Enforcement
and Defense of DOV Patent Rights.
(a) Enforcement
by XTL.
In the
event that DOV or XTL becomes aware of a suspected infringement of any DOV
Patent Right exclusively licensed to XTL under this Agreement, or any such
DOV
Patent Right is challenged in any action or proceeding (other than any
interferences, oppositions, reissue proceedings or reexaminations, which are
addressed above), in each case, in the Field in the Territory, such Party shall
notify the other Party promptly, and following such notification, the Parties
shall confer. XTL shall have the right, but shall not be obligated, to bring
an
infringement action or defend any such action or proceeding at its own expense,
in its own name and entirely under its own direction and control, or to settle
any such action or proceeding by sublicense, subject to the following. DOV
shall
reasonably assist XTL (at XTL’s expense) in any action or proceeding being
defended or prosecuted if so requested, and shall lend its name to and join
as a
nominal party in such actions or proceedings if reasonably requested by XTL
or
required by applicable Laws. DOV shall have the right to participate and be
represented in any such suit by its own counsel at its own expense. No
settlement of any such action or proceeding which restricts the scope, or
adversely affects the enforceability, of a DOV Patent Right may be entered
into
by XTL without the prior written consent of DOV, which consent shall not be
unreasonably withheld, delayed or conditioned.
15
*****Confidential
material redacted and filed separately with the Commission.
(b) Enforcement
by DOV.
If XTL
elects not to bring any action for infringement described in Section
7.3(a)
and so
notifies DOV, then DOV may bring such action at its own expense, in its own
name
and entirely under its own direction and control, subject to the following.
XTL
shall reasonably assist DOV (at DOV’s expense) in any action or proceeding being
prosecuted if so requested, and shall lend its name to such actions or
proceedings if requested by DOV or required by applicable Laws. XTL shall have
the right to participate and be represented in any such suit by its own counsel
and at its own expense. No settlement of any such action or proceeding which
restricts the scope, or adversely affects the enforceability, of a DOV Patent
Right may be entered into by DOV without the prior written consent of XTL,
which
consent shall not be unreasonably withheld, delayed or conditioned.
(c) Damages.
In
the
event that either Party exercises its rights under this
Section 7.3
(the
“Exercising
Party”)
and
recovers any damages or other sums in such action or proceeding or in settlement
thereof (“Recovery”),
then
after deducting the costs and expenses borne by such Exercising Party in
prosecuting or defending such action, proceeding or settlement, and, in the
event the other Party participated in the action, proceeding or settlement,
after deducting the costs and expenses borne by such other Party in prosecuting
or defending such action, proceeding or settlement, the Exercising Party shall
be entitled to ***** percent (*****%) of the remainder of such Recovery and
the
other Party, regardless of whether such other Party participated in the action,
proceeding or settlement, shall be entitled to ***** percent (*****%) of the
remainder of such Recovery.
(d) Withdrawal.
If
either Party brings an action or proceeding under this Section 7.3 and
subsequently ceases to pursue or withdraws from such action or proceeding,
it
shall promptly notify the other Party and the other Party may substitute itself
for the withdrawing Party under the terms of this Section 7.3.
7.4 Patent
Extensions; Orange Book Listings; Patent Certifications.
(a) Patent
Term Extension.
XTL
shall have the sole right to make any elections with respect to obtaining patent
term extension or supplemental protection certificates or their equivalents
in
any country with respect to DOV Patent Rights. XTL shall notify DOV in the
event
XTL determines it will not make such elections or their equivalent. Upon such
notice from XTL, DOV may make elections with respect to obtaining patent term
extension or supplemental protection certificates or their equivalents in any
country with respect to DOV Patent Rights
(b) Data
Exclusivity.
With
respect to any data exclusivity periods, such as those periods listed in the
FDA’s Orange Book (including any available pediatric exclusivities) or other
exclusivity periods under national implementations of Article 10.1(a)(iii)
of
Directive 2001/EC/83 (and all equivalents in any country), XTL shall have the
sole right to seek and maintain all such data exclusivity periods available
for
the Licensed Compound or Licensed Product.
(c) Notification
of Patent Certification.
Each
Party shall notify and provide the other Party with copies of any allegations
of
alleged patent invalidity, unenforceability or non-infringement of a DOV Patent
Right pursuant to a Paragraph IV Patent Certification by a Third Party filing
an
Abbreviated New Drug Application, an application under §505(b)(2) or any other
similar patent certification by a Third Party, and any foreign equivalent
thereof. Such notification and copies shall be provided to the other Party
within five (5) business days after a Party receives such certification, and
shall be sent to the address set forth in Section 12.6.
16
*****Confidential
material redacted and filed separately with the Commission.
SECTION
8. Confidential
Information and Publicity.
8.1 Confidentiality.
(a) Confidential
Information.
Except
as expressly provided herein, each of the Parties agrees that, for itself and
its Affiliates, and for as long as this Agreement is in effect and for a period
of ***** years thereafter, a Receiving Party shall (i) not disclose such
Confidential Information to any Third Party without the prior written consent
of
the Disclosing Party, except for disclosures expressly permitted below, and
(ii) not use such Confidential Information for any purpose except those
licensed or otherwise authorized or permitted by this Agreement. For clarity,
all Confidential Information of XTL received by or disclosed to DOV hereunder
shall be used by DOV only for ensuring that XTL complies with its obligations
hereunder and that DOV complies with its obligations under the Wyeth Agreement
and for no other purposes.
(b) Exceptions.
The
obligations in Section 8.1(a)
shall
not apply with respect to any portion of the Confidential Information that
the
Receiving Party can show by competent proof:
(i) is
publicly disclosed by the Disclosing Party, either before or after it is
disclosed to the Receiving Party hereunder;
(ii) was
known
to the Receiving Party or any of its Affiliates, without any obligation to
keep
it confidential or any restriction on its use, prior to disclosure by the
Disclosing Party;
(iii) is
subsequently disclosed to the Receiving Party or any of its Affiliates by a
Third Party lawfully in possession thereof and without any obligation to keep
it
confidential or any restriction on its use;
(iv) is
published by a Third Party or otherwise becomes publicly available or enters
the
public domain, either before or after it is disclosed to the Receiving Party;
or
(v) has
been
independently developed by employees or contractors of the Receiving Party
or
any of its Affiliates without the aid, application or use of Confidential
Information of the Disclosing Party.
8.2 Authorized
Disclosures.
The
Parties may disclose Confidential Information belonging to either Party to
the
extent such disclosure is reasonably necessary,
in
order to comply with applicable Laws, in connection with prosecuting or
defending litigation, making regulatory filings, and filing, prosecuting and
enforcing patent applications and patents.
Other
than making a regulatory filing, prior to publishing any Clinical Data regarding
the Licensed Compound, XTL shall provide DOV with a reasonable opportunity
to
review and comment on the proposed publication (which notice shall be no less
than one business day under any circumstances). Prior to the Effective Date,
DOV
submitted certain articles for publication by various journals. The Parties
agree that the publication of such articles after the Effective Date shall
not
be a breach by DOV of its obligations under this Agreement. XTL shall, in
connection with all publications regarding the Licensed Compound, indicate
that
the Licensed Compound is licensed by XTL from DOV.
8.3 Terms
of this Agreement; Publicity.
The
Parties agree that the terms of this Agreement shall be treated as Confidential
Information of both Parties.
Each
Party agrees not to issue any press release or other public statement disclosing
information relating to this Agreement or the transactions contemplated hereby
or the terms hereof without the prior written consent of the other Party, except
that:
(a) DOV
shall
be permitted to disclose the terms hereof to Wyeth; and
17
*****Confidential
material redacted and filed separately with the Commission.
(b) The
Parties shall each be permitted to disclose the terms of this Agreement (i)
in
communication with investors, consultants, advisors or others on a need-to-know
basis, in each case under appropriate confidentiality provisions substantially
equivalent to those of this Agreement; (ii) as necessary to comply with
applicable governmental Laws and regulations (including, without limitation,
the
rules and regulations of the Securities and Exchange Commission or any national
securities exchange) and with judicial process; or (iii) to other parties under
a written confidentiality agreement.
8.4 Relationship
to the Confidentiality Agreement.
This
Agreement supersedes the Confidentiality Agreement, provided that all
“Confidential Information” disclosed or received by the Parties thereunder shall
be deemed “Confidential Information” hereunder and shall be subject to the terms
and conditions of this Agreement.
Section
9. *****.
9.1 As
stated
in Sections 9.2
and
9.3,
XTL
shall keep (and XTL shall cause its Sublicensees to keep under terms and
conditions equal to those set forth in this Section
9)
DOV,
during the term of this Agreement, promptly and fully informed of all
pharmaceutical, toxicological and clinical findings relating to ***** of the
Licensed Product or Licensed Compound. DOV shall be permitted to share with
Wyeth all data and information provided under this Section
9
by
XTL.
9.2 XTL
undertakes to notify DOV promptly with written confirmation by immediate
telecopy of any information concerning *****, reasonably associated with
clinical studies or attributed to the use or application of the Licensed Product
or Licensed Compound. In any event the above notification shall be made within
two (2) working days after Licensee first learns or is advised of relevant
information with respect to such *****.
9.3 XTL
shall
also forward regularly (and usually every six (6) months unless the Parties
agree on another period) to DOV any information on *****.
9.4 XTL
shall
provide upon request the information on *****.
9.5 XTL
shall
inform DOV, without delay, of any governmental action, correspondence or reports
to or from Governmental Authorities that may affect the situation of the
Licensed Product or Licensed Compound and furnish DOV with copies of any
relevant documents relating thereto.
Section
10. Warranties;
Limitations of Liability; Indemnification;
Covenants.
10.1 Representations
and Warranties of Both Parties.
Each
Party represents and warrants to the other Party, as of the Effective Date,
that:
(a) Such
Party is a corporation duly organized, validly existing and in good standing
under the Laws of the state in which it is incorporated, and it has full right
and authority to enter into this Agreement and to accept the rights
and licenses granted
as herein described.
(b) This
Agreement has been duly authorized by all requisite corporate action, and when
executed and delivered will become a valid and binding contract of such Party
enforceable against it in
accordance with its terms, subject to applicable bankruptcy, insolvency,
reorganization, moratorium and other Laws affecting creditors’ rights generally
from time to time if effect, and to general principles of equity.
18
(c) The
execution, delivery and performance of this Agreement does not conflict with
any
other agreement, contract, instrument or understanding, oral or written, to
which such Party is bound, nor will it violate any law applicable to such
Party.
(d) All
necessary consents, approvals and authorizations of all regulatory and
Governmental Authorities and other persons or entities required to be obtained
by such Party in connection with the execution and delivery of this Agreement
and the performance of its obligations hereunder have been
obtained.
10.2 DOV
Representations and Warranties.
DOV
covenants, represents and warrants to XTL that as of the Effective
Date:
(a) DOV
Controls the patents and patent applications that are included within the DOV
Patent Rights as of the Effective Date and DOV Controls the DOV Know-How, in
both cases, for use with the Licensed Compound within the Field;
(b) To
the
best of its knowledge and belief, all of the issued patents within the DOV
Patent Rights are in good standing;
(c) To
the
best of its knowledge and belief, DOV is not aware of any notice from any Third
Party asserting any ownership rights to any DOV Know-How for use with the
Licensed Compound within the Field;
(d) To
the
best of its knowledge and belief, DOV is not aware of any pending or threatened
action, suit, proceeding or claim by a Third Party asserting that DOV is
infringing or has misappropriated or otherwise is violating any patent, trade
secret or other proprietary right of any Third Party as would reasonably be
expected to result in DOV being unable to grant the rights and licenses to
XTL
under this Agreement;
(e) DOV
has
not granted any right or license or other encumbrance of any kind to any Third
Party relating to the DOV Patent Rights and DOV Know-How that conflicts with
any
of the rights granted to XTL hereunder;
(f) Except
as
set forth on Schedule 10.2(f), there are no claims, actions, or proceedings
pending or, to DOV’s knowledge, threatened; nor are there any formal inquiries
or notices that may lead to the institution of such legal proceedings, against
DOV or its Affiliates or Wyeth or its Affiliates, which if adversely decided,
would, individually or in the aggregate, have a material adverse effect on,
or
prevent DOV’s ability to grant the licenses and assignments to XTL contemplated
hereunder; and
(g) Except
as
otherwise noted on Exhibit
C,
all
inventory of the Licensed Compound set forth on Exhibit
C,
whether
in the form of the active pharmaceutical ingredient, intermediate, or finished
product, has been manufactured in compliance with current Good Manufacturing
Practices as provided by the FDA (“cGMP”).
19
10.3 Disclaimer.
EXCEPT
AS
EXPRESSLY SET FORTH HEREIN, NEITHER DOV NOR XTL MAKES ANY REPRESENTATION OR
WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
10.4 Limitation
of Liability.
NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR OTHERWISE, NEITHER PARTY SHALL
BE
LIABLE TO THE OTHER OR ANY THIRD PARTY WITH RESPECT TO ANY SUBJECT MATTER OF
THIS AGREEMENT FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES; PROVIDED,
HOWEVER, THAT THIS SECTION 10.4
SHALL
NOT APPLY TO THE PARTIES’ INDEMNIFICATION RIGHTS AND OBLIGATIONS UNDER
SECTIONS 10.6(a)
AND
10.6(b).
10.5 Performance
by Affiliates.
The
Parties recognize that each Party may perform some or all of its obligations
under this Agreement through Affiliates and Third Party contractors provided,
however, that each Party shall remain responsible and liable for the performance
by its Affiliates and Third Party contractors and shall cause its Affiliates
and
Third Party contractors to comply with the provisions of this Agreement in
connection therewith.
10.6 Indemnification.
(a) XTL
Indemnity.
XTL
hereby agrees to indemnify and hold DOV and its Affiliates, and their respective
employees, directors, agents and contractors, and their respective successors,
heirs and assigns and
representatives (“DOV
Indemnitees”)
harmless from and against all claims, liability, threatened claims, damages,
expenses (including reasonable attorneys’ fees), suits, proceedings, losses or
judgments, whether for money or equitable relief, of any kind, including death,
personal injury, illness, product liability or property damage or the failure
to
comply with applicable law (collectively, “Losses”),
arising from any Third Party claim due to the use, manufacture, sale,
development or commercialization of any Licensed Compounds or Licensed Products
by or for XTL or any of its Affiliates, Sublicensees, agents and contractors,
except to the extent that such Losses arise from (a) the negligence,
recklessness or willful misconduct of any DOV Indemnitees or (b) any breach
of this Agreement by DOV.
(b) DOV
Indemnity.
DOV
hereby agrees to indemnify and hold XTL, its Affiliates and Sublicensees, and
their respective employees, directors, agents and contractors, and their
respective successors, heirs and assigns and
representatives (“XTL
Indemnitees”)
harmless from and against all Losses arising from any Third Party claim due
to
the
use,
manufacture, sale, development or commercialization of any Licensed Compounds
or
Licensed Products by or for DOV or any of its Affiliates, licensees (other
than
XTL and its Affiliates and Sublicensees), agents and contractors, except to
the
extent that such Losses arise from (a) the negligence, recklessness or
willful misconduct of any XTL Indemnitees or (b) any breach of this
Agreement by XTL.
(c) Indemnification
Procedure.
A claim
to which indemnification applies under Section 10.6(a)
or
Section 10.6(b)
shall be
referred to herein as a “Claim.” If any person or entity (each, an “Indemnitee”)
intends to claim indemnification under this Section 10.6,
the
Indemnitee shall notify the other Party (the “Indemnitor”)
in
writing promptly upon becoming aware of any claim that may be a Claim (it being
understood and agreed, however, that the failure by an Indemnitee to give such
notice shall not relieve the Indemnitor of its indemnification obligation under
this Agreement except and only to the extent that the Indemnitor is actually
prejudiced as a result of such failure to give notice). The Indemnitor shall
have the right to assume and control the defense of such Claim at its own
expense with counsel selected by the Indemnitor and reasonably acceptable to
the
Indemnitee; provided, however, that an Indemnitee shall have the right to retain
its own counsel, with the fees and expenses to be paid by the Indemnitee, if
representation of such Indemnitee by the counsel retained by the Indemnitor
would be inappropriate
due to actual or potential differing interests between such Indemnitee and
any
other party represented by such counsel in such proceedings. If the Indemnitor
does not assume the defense of such Claim as aforesaid, the Indemnitee may
defend such Claim but shall have no obligation to do so. The Indemnitee shall
not settle or compromise any Claim without the prior written consent of the
Indemnitor, and the Indemnitor shall not settle or compromise any Claim in
any
manner which would have an adverse effect on the Indemnitee’s interests, without
the prior written consent of the Indemnitee, which consent, in each case, shall
not be unreasonably withheld. The Indemnitee shall reasonably cooperate with
the
Indemnitor at the Indemnitor’s expense and shall make available to the
Indemnitor all pertinent information under the control of the Indemnitee, which
information shall be subject to Section 8.1.
20
10.7 Insurance.
XTL
and
its Sublicensees shall, beginning with the initiation of the first clinical
trial for a Licensed Product, maintain at all times during the development
and
commercialization of the Licensed Compound a comprehensive general liability
insurance from a recognized, creditworthy insurance company, on a claims-made
basis, with endorsements for contractual liability, product liability and
clinical trials, and with coverage limits at least equal to those that are
customary in the industry. DOV and Wyeth shall be named as additional insureds
on all such insurance policies. Within ten (10) days following written request
by DOV, XTL shall furnish to DOV a certificate of insurance evidencing such
coverage, and undertakes to communicate to DOV during the term of this Agreement
any modifications to such coverage.
10.8 Covenants.
(a) DOV
shall
not knowingly take any action, or omit to take any action, that it reasonably
expects would (i) encumber any of its right, title and interest in and to the
Licensed Compounds or the Licensed Products in any way that would have a
material adverse effect on the rights and licenses granted to XTL hereunder,
or
(ii) cause DOV to be in breach under the Wyeth Agreement.
(b) Neither
DOV, nor any of its Affiliates, will conduct research or development activities
with Wyeth, or any of its Affiliates, relating to the use of Bicifadine in
the
Retained Rights Field (as defined in the Wyeth Agreement).
(c) XTL
shall
only pay amounts due under this Agreement in shares of Publicly Traded Stock
if,
at the time of such payment, all material information regarding XTL Ltd. has
been disclosed to the public.
Section
11. Term
and Termination.
11.1 Term.
This
Agreement shall commence as of the Effective Date and, unless sooner terminated
in accordance with the terms hereof or by mutual written consent, shall continue
on a Licensed Product-by-Licensed Product and country-by-country basis until
the
end of the Royalty Term with respect to such Licensed Product in such country.
Upon the end of the Royalty Term for each country and each Licensed Product,
the
license grants contained in Section 2.1
shall
become non-exclusive, perpetual, irrevocable and fully paid up with respect
to
such Licensed Product in such country.
11.2 Termination
By DOV.
DOV
shall have the right to terminate this Agreement, in DOV’s sole discretion, as
follows:
(a) Insolvency.
DOV
shall have the right to terminate this Agreement upon delivery of written notice
to XTL in the event that: (i) XTL fails to or is unable to make payments to
DOV
or to any third parties as and when they become due and payable in the ordinary
course of business, (ii) a liquidation proceeding under any state or United
States bankruptcy Law, receivership Law, or the like, as they
now
exist, or as they may be amended, is commenced by XTL, (iii) if XTL is served
with an involuntary petition against it in any insolvency proceeding, upon
the
ninety-first (91st) day after such service if such involuntary petition has
not
previously been stayed or dismissed, or (iv) upon the making by XTL of an
assignment of substantially all of its assets for the benefit of its
creditors.
21
*****Confidential
material redacted and filed separately with the Commission.
(b) Breach.
Subject
to Section 11.2(c)
below,
DOV shall have the right to terminate this Agreement, at DOV’s sole discretion,
upon delivery of written notice to XTL in the event of any material breach
by
XTL of any terms and conditions of this Agreement, provided
that
such breach has not been cured within sixty (60) days after written notice
thereof is given by DOV to XTL specifying the nature of the alleged breach,
provided,
however,
that to
the extent such material breach involves the failure to make a payment when
due,
such breach must be cured within thirty (30) days after written notice thereof
is given by DOV to XTL.
(c) Disputed
Breach.
If XTL
disputes in good faith the existence or materiality of a breach specified in
a
notice provided by DOV pursuant to Section 11.2(b)
and XTL
provides notice to DOV of such dispute within the applicable thirty (30) day,
sixty (60) day or three (3) month period, DOV shall not have the right to
terminate this Agreement unless and until the existence of such material breach
or failure by XTL has been determined in accordance with
Section 12.7
and XTL
fails to cure such breach within sixty (60) days following such determination
(except to the extent such breach involves the failure to make a payment when
due, which breach must be cured within ten (10) business days following such
determination). It is understood and acknowledged that during the pendency
of
such a dispute, all of the terms and conditions of this Agreement shall remain
in effect and the Parties shall continue to perform all of their respective
obligations hereunder; provided, however, that any payments that are made by
one
Party to the other Party pursuant to this Agreement pending resolution of the
dispute shall be paid into escrow (such payments, the “Escrow
Funds”)
with
an escrow agent mutually selected by the Parties according to an escrow
agreement in form and substance reasonably satisfactory to the Parties. The
Parties further agree that any Escrow Funds shall be promptly refunded from
the
escrow if an arbitrator or court determines pursuant to
Section 12.7
that
such Escrow Funds are to be refunded by one Party to the other
Party.
(d) Scope
of Termination.
Except
as otherwise expressly provided herein, termination of this Agreement shall
be
as to all countries in the Territory and all Licensed Products.
11.3 Termination
by XTL.
(a) At
XTL’s
discretion, effective upon ***** prior written notice in the case where NDA
Approval or other Approval has not been obtained for the applicable Licensed
Product or upon ***** prior written notice in the case where NDA Approval or
other Approval has been obtained for the applicable Licensed Product, XTL may
terminate this Agreement for any reason.
(b) In
addition, XTL may terminate this Agreement in the event of material breach
by
DOV, provided
that
such breach has not been cured within sixty (60) days after written notice
thereof is given by XTL to DOV. If
DOV
disputes in good faith the existence or materiality of such breach and provides
notice to XTL of such dispute within such sixty (60) day period, XTL shall
not
have the right to terminate this Agreement in accordance with this
Section 11.3(b)
unless
and until it has been determined in accordance with Section 12.7
that
this Agreement was materially breached by DOV and DOV fails to cure such breach
within sixty (60) days following such determination. It is understood and
acknowledged that during the pendency of such a dispute, all of the terms and
conditions of this Agreement shall remain in effect and the Parties shall
continue to perform all of their respective obligations hereunder. The Parties
further agree that any payments that are made by one Party to the other Party
pursuant to this Agreement pending resolution of the dispute shall be promptly
refunded if an arbitrator or court determines pursuant to
Section 12.7
that
such payments are to be refunded by one Party to the other Party.
22
*****Confidential
material redacted and filed separately with the Commission.
11.4 Effect
of Termination.
Upon
termination (or, in the case of clauses (c) below, expiration) of this Agreement
under Section 11.3(a)
or
Section 11.2,
either
in its entirety or with respect to one or more applicable country (each a
“Terminated
Country”;
the
rights and obligations of the Parties as to the remaining countries of the
Territory in which termination under Section 11.2
has not
occurred, being unaffected by such termination):
(a) All
rights and licenses granted to XTL in Section
2
shall
terminate with respect to each Terminated Country, all rights of XTL under
the
DOV Patent Rights and DOV Know-How shall revert to DOV, and XTL shall cease
all
use of the DOV Patent Rights, DOV Know-How and Trademarks and Corporate Names
of
DOV and its Affiliates with respect to each Terminated Country.
(b) With
respect to each Terminated Country, XTL shall assign to DOV XTL’s right, title
and interest in all regulatory filings (including, without limitation, all
NDAs)
and Approvals and other documents relating to or necessary to further develop
and commercialize Licensed Compounds and Licensed Products, as they exist as
of
the date of such termination, and XTL shall provide to DOV one (1) copy of
the
foregoing documents and filings and all documents and filings contained in
or
referenced in any such filings, together with the raw and summarized data for
any preclinical and clinical studies of the Licensed Compounds and such Licensed
Product (and where reasonably available, electronic copies thereof) at DOV’s
cost. In addition, upon request by DOV, XTL shall grant to DOV the right to
access and reference any other documents (including but not limited to
regulatory filings) that are available to XTL and reasonably necessary for
DOV
to further develop, manufacture and commercialize the Licensed Compounds and
Licensed Product for the Terminated Country. Without limiting the foregoing
in
this paragraph, to the extent applicable, XTL’s obligations under
Section 7.4
shall
continue with respect to the Terminated Country.
(c) All
amounts due or payable to DOV that were accrued, or that arise out of acts
or
events occurring, prior to the effective date of termination or expiration
shall
remain due and payable; but (except as otherwise expressly provided herein)
no
additional amounts shall be payable based on events occurring after the
effective date of termination or expiration.
(d) Should
XTL have any inventory of the Licensed Compound suitable for use in clinical
trials in each Terminated Country, XTL shall offer to sell such Licensed
Compound to DOV at ***** (but DOV shall be under no obligation to purchase
same
unless it agrees to do so in writing at such time).
(e) XTL
shall
assign (or, if applicable, cause its Affiliate to assign) to DOV all of XTL’s
(and such Affiliates’) right, title and interest in and to any registered or
unregistered trademark, trademark application, trade name or internet domain
name that is specific to a Licensed Product (it being understood that the
foregoing shall not include any trademarks or trade names that contain XTL’s
name) in each Terminated Country.
(f) XTL
shall
grant to DOV a license, which license shall be exclusive with respect to each
Terminated Country, with the right to grant sublicenses, under all patent rights
owned or Controlled by Licensee as of the Termination Date to make, use, import,
sell and offer for sale and otherwise develop and commercialize the Licensed
Product and Licensed Compound in the Terminated Country. In consideration of
the
license granted by XTL to DOV in accordance with this Section 11.4(f),
DOV
shall pay XTL a royalty on a product-by-product basis at a rate equal to *****
percent (***** %) of Net Sales (with the roles of DOV and XTL reversed for
purposes of the definition of Net Sales and for Section 6.5)
of the
Licensed Product in the Terminated Country. The maximum cumulative royalty
payments under this Section 11.4(f)
shall
not exceed ***** percent (*****%) of the payments due and payable by XTL to
DOV
under this Agreement
prior to
the time XTL grants DOV a license in accordance with this Section 11.4(f).
23
*****Confidential
material redacted and filed separately with the Commission.
(g) Neither
Party shall be relieved of any obligation that accrued prior to the effective
date of such termination or expiration.
(h) DOV
shall
have the right to retain all amounts previously paid to DOV by XTL, subject
to
any applicable determination of an arbitrator or court pursuant to
Section 11.6.
11.5 Survival.
The
following provisions shall survive termination or expiration of this Agreement,
as well as any other provision which by its terms or by the context thereof,
is
intended to survive such termination: Section
1
(as
applicable), Section 2.1(a)(i),
Section
5
(with
respect to obligations arising prior to expiration or termination of this
Agreement), Section
6
(with
respect to obligations arising prior to expiration or termination of this
Agreement). Section 7.3(c)
(with
respect to an action, suit or proceeding commenced prior to termination),
Section 7.4(c),
Section
8,
Section
10.3,
Section
10.4,
Section 10.6,
Section 11.4,
Section 11.5,
Section 11.6
and
Section
12.
Termination or expiration of this Agreement shall not relieve the Parties of
any
liability or obligation which accrued hereunder prior to the effective date
of
such termination or expiration nor preclude either Party from pursuing all
rights and remedies it may have hereunder or at law or in equity, subject to
Section 12.7,
with
respect to any breach of this Agreement nor prejudice either Party’s right to
obtain performance of any obligation. All other obligations shall terminate
upon
expiration of this Agreement.
11.6 Bankruptcy.
The
Parties agree that in the event a Party becomes a debtor under Title 11 of
the
U.S. Code (“Title
11”),
this
Agreement shall be deemed to be, for purposes of Section 365(n) of Title
11, a license to rights to “intellectual property” as defined therein. Each
Party hereunder shall have the rights and elections as specified in Title 11.
Any agreements supplemental hereto shall be deemed to be “agreements
supplementary to” this Agreement for purposes of Section 365(n) of Title
11.
Section
12. General
Provisions.
12.1 Efforts
to Consummate; Certain Governmental Matters.
Upon
the terms and subject to the conditions herein provided, each of the Parties
agrees to use its reasonable best efforts to provide or cause to be provided
promptly to each Governmental Authority with regulatory jurisdiction over
enforcement of any applicable Competition Laws (“Governmental
Antitrust Authority”)
information and documents requested by such Governmental Antitrust Authority
or
necessary, proper or advisable to permit consummation of the license of the
Licensed Compounds and Licensed Products and the other transactions contemplated
by this Agreement.
Subject
to appropriate confidentiality protections, each of the Parties hereto will
furnish to the other Party’s counsel such necessary information and reasonable
assistance as such other Party may reasonably request in connection with the
foregoing and will keep the other Party reasonably informed with respect to
any
consent, authorization, order or approval of, or exemption by, sought from
any
Governmental Authority in connection with this Agreement and the transactions
contemplated hereby.
For
purposes of this Section 12.1,
“Competition Laws” shall mean statutes, rules, regulations, orders, decrees,
administrative and judicial doctrines and other Laws of any jurisdiction that
are designed or intended to prohibit, restrict or regulate actions that may
have
the purpose or effect of creating a monopoly, lessening competition or
restraining trade.
12.2 Assignment.
Except
as
provided by Section 2.1,
6.5
or 10.5,
neither
Party may assign this Agreement, delegate its obligations or otherwise transfer
licenses or other rights created by this Agreement, without the prior written
consent of the other Party, which consent shall not be unreasonably withheld;
provided that each Party may assign this Agreement as a whole without such
consent to an Affiliate of such Party; provided, further, that DOV may assign
this Agreement as a whole without such consent in connection with the
acquisition (whether by merger, consolidation, sale or otherwise) of DOV or
of
that part of DOV’s business to which this Agreement relates. Any assignment or
transfer in violation of this Section 12.2
shall be
void. This Agreement shall inure to the benefit of, and be binding upon, the
legal representatives, successors and permitted assigns of the
Parties.
24
12.3 Force
Majeure.
Neither
Party shall be responsible for failure or delay in the performance of any of
its
obligations hereunder due to Force Majeure. Force Majeure shall mean any
circumstance that, due to an event or a legal position beyond the Party’s
reasonable control, renders impossible the fulfillment of any of the Party’s
obligations hereunder, such as, but not limited to, acts of God, acts,
regulations, or Laws of any government, war, civil commotion, destruction of
facilities or materials by fires, earthquakes, or storms, labor disturbances,
shortages of public utilities, common carriers, or raw materials, or any other
cause, or causes of similar effects, except, however, any economic occurrence.
During any such case of Force Majeure, this Agreement shall not be terminated,
but only suspended and the Party so affected shall continue to perform its
obligations as soon as such case of Force Majeure is removed or
alleviated.
12.4 Severability.
If any
one or more of the provisions contained in this Agreement is held invalid,
illegal or unenforceable in any respect, the validity, legality and
enforceability of the remaining provisions contained herein shall not in any
way
be affected or impaired thereby, unless the absence of the invalidated
provision(s) adversely affects the substantive rights of the Parties. The
Parties shall in such an instance use their reasonable best efforts to replace
the invalid, illegal or unenforceable provision(s) with valid, legal and
enforceable provision(s) which, insofar as practical, implement the purposes
of
this Agreement.
12.5 Amendment;
Waiver.
This
Agreement may not be modified, amended or rescinded, in whole or part, except
by
a written instrument signed by the Parties; provided that any unilateral
undertaking or waiver made by one Party in favor of the other shall be
enforceable if undertaken in a writing signed by the Party to be charged with
the undertaking or waiver. No delay or omission by either Party hereto in
exercising any right or power occurring upon any noncompliance or default by
the
other Party with respect to any of the terms of this Agreement shall impair
any
such right or power or be construed to be a waiver thereof. A waiver by either
of the Parties of any of the covenants, conditions or agreements to be performed
by the other shall not be construed to be a waiver of any succeeding breach
thereof or of any other covenant, condition or agreement herein
contained.
12.6 Notices.
Except
as
otherwise provided herein, all notices under this Agreement shall be sent by
certified mail or by overnight courier service, postage prepaid, to the
following addresses of the respective Parties:
If
to XTL, to:
|
XTL Biopharmaceuticals, Inc.
000
Xxxxxxxxx Xxxxxx, 00xx
Xxxxx
Xxx
Xxxx, Xxx Xxxx 00000
Attention:
Xxx Xxxxxxx
Facsimile:
(000) 000-0000
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With
a required copy to:
|
Xxxxxx & Bird LLP
00
Xxxx Xxxxxx
Xxx
Xxxx, Xxx Xxxx 00000
Attention:
Xxxx X. XxXxxxxxx
Facsimile:
(000) 000-0000
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25
If
to DOV, to:
|
DOV
Pharmaceutical, Inc.
000
Xxxxxx Xxxxxx
Xxxxxxxx,
Xxx Xxxxxx 00000
Attention:
President
Facsimile:
(000) 000-0000
|
|
With
a required
copy
to:
|
Xxxxxxx
Procter LLP
00
Xxxxx Xxxxxx
Xxxxxx,
XX 00000
Attention:
Xxxxxxxx X. Xxxx, Esq.
Facsimile:
(000) 000-0000
|
or
to
such address as each Party may hereafter designate by notice to the other Party.
A notice shall be deemed to have been given on the date it is received by all
required recipients for the noticed Party.
12.7 Dispute
Resolution.
Disputes arising under or in connection with this Agreement shall be resolved
pursuant to this Section 12.7;
provided,
however, that in the event a dispute cannot be resolved without an adjudication
of the rights or obligations of a Third Party (other than a DOV Indemnitee
or
XTL Indemnitee identified in Sections 10.6(a)
or
10.6(b),
as
applicable), the dispute procedures set forth in this Section 12.7
shall be
inapplicable as to such dispute.
(a) In
the
event of a dispute between the Parties, the Parties shall first attempt in
good
faith to resolve such dispute by negotiation and consultation between
themselves. In the event that such dispute is not resolved on an informal basis
within forty-five (45) days, any Party may, by written notice to the other,
have
such dispute referred to each of the Parties’ respective CEOs
or
his or her designee (who shall be a senior executive), who shall
attempt
in good faith to resolve such dispute by negotiation and consultation for a
thirty (30) day period following receipt of such written notice.
(b) In
the
event the Parties’ CEOs (or designees) are not able to resolve such dispute,
either Party may at any time after such 30-day period submit such dispute to
be
finally settled by arbitration administered in
accordance with the Commercial
Arbitration Rules
of the
American
Arbitration Association
(“AAA”)
in
effect at the time of submission. The arbitration shall be heard and determined
by three (3) arbitrators. XTL and DOV shall each appoint one (1) arbitrator
and the third arbitrator shall be selected by the two Party-appointed
arbitrators, or,
failing
agreement within sixty (60) days following the date of receipt by the respondent
of the claim, by
the
AAA. Such arbitration shall take place in New York, NY. The arbitration award
so
given shall be a final and binding determination of the dispute,
shall be
fully enforceable in any court of competent jurisdiction,
and
shall not include any damages expressly prohibited by Section 10.4.
(c) Costs
of
arbitration are to be divided by the Parties in the following manner: XTL shall
pay for the arbitrator it chooses, DOV shall pay for the arbitrator it chooses,
and the costs of the third arbitrator shall be divided equally between
the
Parties.
Except in a proceeding to enforce the results of the arbitration or as otherwise
required by law, neither Party nor any arbitrator may disclose the existence,
content or results of any arbitration hereunder without the prior written
consent of both
Parties.
12.8 Applicable
Law.
This
Agreement shall be governed by and construed in accordance with the Laws of
the
State of New York, without regard to its conflicts of law
provisions.
12.9 Further
Assurances.
Each
Party agrees to do and perform all such further acts and things and shall
execute and deliver such other agreements, certificates, instruments and
documents necessary or that the other Party may deem advisable in order to
carry
out the intent and accomplish the purposes of this Agreement and to evidence,
perfect or otherwise confirm its rights hereunder.
26
12.10 Relationship
of the Parties.
Each
Party is an independent contractor under this Agreement. Nothing contained
herein is intended or is to be construed so as to constitute DOV and XTL as
partners, agents or joint venturers. Neither Party shall have any express or
implied right or authority to assume or create any obligations on behalf of
or
in the name of the other Party or to bind the other Party to any contract,
agreement or undertaking with any Third Party. There are no express or implied
third party beneficiaries hereunder (except for XTL Indemnitees other than
XTL
and DOV Indemnitees other than DOV for purposes of Section 10.6).
12.11 Entire
Agreement.
This
Agreement (along with the Exhibits), together with the Wyeth Agreement, contains
the entire understanding of the Parties with respect to the subject matter
hereof and supersedes and replaces any and all previous arrangements and
understandings, including the Confidentiality Agreement, whether oral or
written, between the Parties with respect to the subject matter
hereof.
12.12 Headings.
The
captions to the several Sections hereof are not a part of this Agreement, but
are merely guides or labels to assist in locating and reading the several
Sections hereof.
12.13 Waiver
of Rule of Construction.
Each
Party has had the opportunity to consult with counsel in connection with the
review, drafting and negotiation of this Agreement. Accordingly, the rule of
construction that any ambiguity in this Agreement shall be construed against
the
drafting party shall not apply.
12.14 Interpretation.
Whenever
any provision of this Agreement uses the term “including” (or “includes”), such
term shall be deemed to mean “including without limitation” (or “includes
without limitations”). “Herein,”
“hereby,” “hereunder,” “hereof” and other equivalent words refer to this
Agreement as an entirety and not solely to the particular portion of this
Agreement in which any such word is used.
All
definitions set forth herein shall be deemed applicable whether the words
defined are used herein in the singular or the plural.
Unless
otherwise provided, all references to Sections and Exhibits in this Agreement
are to Sections and Exhibits of this Agreement. References
to any Sections include Sections and subsections that are part of the related
Section (e.g.,
a
section numbered “Section 2.1”
would
be part of “Section
2”,
and
references to “Section 2.1”
would
also refer to material contained in the subsection described as
“Section 2.1(a)”)
12.15 Counterparts;
Facsimiles.
This
Agreement may be executed in two or more counterparts, each of which shall
be
deemed an original and all of which together shall constitute one and the same
instrument. Facsimile
execution and delivery of this Agreement by either Party shall constitute a
legal, valid and binding execution and delivery of this Agreement by such
Party.
[Remainder
of this Page Intentionally Left Blank]
27
IN
WITNESS WHEREOF, the Parties have caused this License Agreement to be executed
by their respective duly authorized officers as of the Effective
Date.
DOV
PHARMACEUTICAL, INC.
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By: |
(Signature)
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Name: |
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Title: |
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Date: |
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XTL
DEVELOPMENT, INC.
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By:
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(Signature)
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Name:
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Title: |
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Date: |
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EXHIBIT
A
SPECIFIC
DOV KNOW-HOW
- |
All
Wyeth Know-How (as defined in the Wyeth Agreement) to which DOV has
a
license pursuant to the Wyeth
Agreement.
|
*****Confidential material redacted and filed separately
with
the Commission.
EXHIBIT
B
DOV
PATENT RIGHTS*
Dkt.
No.
|
Filing
date
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Filing
number
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Pub.
Date
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Grant
date
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Grant
number
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*****
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*
*****.
#
*****.
*****Confidential
material redacted and filed separately with the Commission.
EXHIBIT
C
INVENTORY
*****
INVENTORY
1 *****
*****
Manufacturer
|
Manufacturer
Batch Number
|
Manufacturing
Date
|
Quantity
(KG)
|
Current
Storage Location
|
Comment
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|||||
*****
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*****
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*****
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*****
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Footnote
1–
*****.
Footnote
2–
*****.
*****Confidential
material redacted and filed separately
with the Commission.
*****
INVENTORY
3 *****
Intermediate
Manufacturer
|
Manufacturer
Batch Number
|
Manufacturing
Date
|
Quantity
(KG)
|
Current
Storage Location
|
Comment
|
|||||
*****
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Various
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*****
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*****
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*****
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*****
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Footnote
3 –
*****.
*****
INVENTORY
4 *****
*****Manufacturer
|
Manufacturer
Batch Number
|
Manufacturing
Date
|
Quantity
(KG)
|
Current
Storage Location
|
Comment
|
|||||
*****
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Various
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*****
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*****
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*****
|
Footnote
4 –
*****.
*****Confidential
material redacted and filed separately
with the Commission.
*****
INVENTORY
5 *****
Drug
Product Manufacturer
|
Lot
Number
|
Manufacturing
Date
|
Quantity
6
|
Current
Storage Location
|
Comment
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|||||
*****
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Footnote
5 –
*****.
Footnote
6 –
*****.
*****
INVENTORY
7 *****
Drug
Product Manufacturer
|
Lot
Number
|
Manufacturing
Date
|
Quantity
|
Current
Storage Location
|
Comment
|
|||||
*****
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*****
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*****
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*****
|
Footnote
7 –
*****.
*****Confidential
material redacted and filed separately
with the Commission.
*****
INVENTORY
8 *****
Drug
Product Manufacturer
|
Lot
Number
|
Manufacturing
Date
|
Quantity
9
|
Current
Storage Location
|
Comment
|
|||||
*****
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*****
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Footnote
8–
*****.
Footnote
9–
*****.
*****Confidential
material redacted and filed separately with the Commission.
EXHIBIT
D
A.
Clinical Deliverables
1. |
*****.
|
2. |
*****.
|
3. |
*****.
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4. |
*****.
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5. |
*****.
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B.
CMC
Deliverables
1. |
*****.
|
2. |
*****.
|
3. |
*****.
|
4. |
*****.
|
5. |
*****.
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6. |
*****.
|
7. |
*****.
|
8. |
*****.
|
9. |
*****.
|
10. |
*****.
|
*****Confidential
material redacted and filed separately with the Commission.
EXHIBIT
E
1. Deliverables
and estimated completion dates for the following non clinical
studies:
Studies
|
Work
Remaining/Time and cost to Complete
(Refer
to Item 5.a below for a table of DOV hourly billing
rates.)
|
Estimated
Deliverable, Date and Cost
|
||
*****
|
*****
|
*****
|
||
*****
|
*****
|
*****
|
||
*****
|
*****
|
*****
|
*****Confidential
material redacted and filed
separately with the Commission.
2. Completion
dates and deliverables for the following clinical studies:
Type
of Study
|
Study
No.
|
Study
Objective
|
Analysis/TFLs
|
Reports
|
Estimated
Deliverable, Date and Cost
|
|||||
*****
|
*****
|
*****
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*****
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|||||
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*****
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*****
|
*****
|
*****Confidential
material redacted and filed separately with the Commission.
3.
Additional deliverables
a.
|
*****.
|
b.
|
*****.
|
c.
|
*****.
|
4.
|
Support
for providing the Exhibit F deliverables: *****.
|
5.
|
Explanatory
notes for cost estimates and
deliverables.
|
a.
|
DOV
billing rate table. The following table provides DOV hourly billing
rates:
|
Classification
|
Rate
|
|
*****
|
*****
|
|
*****
|
*****
|
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*****
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*****
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*****
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*****
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*****
|
*****
|
b.
|
*****.
|
SCHEDULE
10.2(f)
As
set
forth in Form 8-K filed by DOV on January 3, 2007, DOV is in default of that
certain Indenture dated December 22, 2004 (the “Indenture”). The trustee has
confirmed such default and made a demand for payment.