LICENSE AGREEMENT By and Between PRESIDIO PHARMACEUTICALS, INC. and XTL BIOPHARMACEUTICALS LTD.
Confidential
Treatment Requested. Confidential portions of this document have
been
omitted
and have been separately filed with the Commission.
Execution
Version
By
and Between
PRESIDIO
PHARMACEUTICALS, INC.
and
Confidential
material omitted and filed separately with the
Commission.
TABLE
OF
CONTENTS
Page
|
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Article
I Definitions
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2
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Section 1.1
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“Additional
Third Party Licenses”
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2
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|
Section 1.2
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“Affiliate”
|
2
|
|
Section 1.3
|
“Assigned
Contracts”
|
2
|
|
Section 1.4
|
“Bankruptcy
Code”
|
3
|
|
Section 1.5
|
“Commercialization”
or “Commercialize”
|
3
|
|
Section 1.6
|
“Commercially
Reasonable Efforts”
|
3
|
|
Section 1.7
|
“Competing
Product”
|
3
|
|
Section 1.8
|
“Confidential
Information”
|
3
|
|
Section 1.9
|
“Control”
or “Controlled”
|
3
|
|
Section 1.10
|
“Cover”,
“Covering” or “Covered”
|
3
|
|
Section 1.11
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“Derivative
Compounds”
|
3
|
|
Section 1.12
|
“Development”
or “Develop”
|
4
|
|
Section 1.13
|
“EMEA”
|
4
|
|
Section 1.14
|
“EU”
|
4
|
|
Section 1.15
|
“FDA”
|
4
|
|
Section 1.16
|
“Field”
|
4
|
|
Section 1.17
|
“Fiscal
Year”
|
4
|
|
Section 1.18
|
“HCV”
|
4
|
|
Section 1.19
|
“HCV
Field”
|
4
|
|
Section 1.20
|
“IND”
|
4
|
|
Section 1.21
|
“Know-How”
|
4
|
|
Section 1.22
|
“Licensed
Compounds”
|
5
|
|
Section 1.23
|
“Licensed
Patent Rights”
|
5
|
|
Section 1.24
|
“Licensed
Product”
|
5
|
|
Section 1.25
|
“Licensed
Technology”
|
5
|
|
Section 1.26
|
“Major
EU Countries”
|
5
|
|
Section 1.27
|
“NDA”
|
5
|
|
Section 1.28
|
“Net
Sales”
|
5
|
|
Section 1.29
|
“NS5A”
|
7
|
|
Section 1.30
|
“Party”
or “Parties”
|
7
|
|
Section 1.31
|
“Pass-Through
Costs”
|
7
|
|
Section 1.32
|
“Patent
Rights”
|
7
|
|
Section 1.33
|
“Person”
|
7
|
|
Section 1.34
|
“Phase
I Trial”
|
7
|
|
Section 1.35
|
“Phase
II Trial”
|
7
|
|
Section 1.36
|
“Phase
III Trial”
|
7
|
|
Section 1.37
|
“Regulatory
Approval”
|
7
|
|
Section 1.38
|
“Regulatory
Authority”
|
7
|
|
Section 1.39
|
“Regulatory
Filings”
|
7
|
|
Section 1.40
|
“Royalty
Term”
|
8
|
|
Section 1.41
|
“Senior
Executives”
|
8
|
|
Section 1.42
|
“Series
1 Compounds”
|
8
|
|
Section 1.43
|
“Series
1 Licensed Products”
|
8
|
-i-
Confidential
material omitted and filed separately with the
Commission.
Section 1.44
|
“Series
1 Patent Rights”
|
8
|
|
Section 1.45
|
“Series
2-4 Compounds”
|
8
|
|
Section 1.46
|
“Series
2-4 Licensed Products”
|
8
|
|
Section 1.47
|
“Series
2-4 Patent Rights”
|
8
|
|
Section 1.48
|
“Series
5-50 Compounds”
|
8
|
|
Section 1.49
|
“Sublicense
Income”
|
9
|
|
Section 1.50
|
“Successful
Completion”
|
9
|
|
Section 1.51
|
“Territory”
|
9
|
|
Section 1.52
|
“Third
Party”
|
10
|
|
Section 1.53
|
“Valid
Claim”
|
10
|
|
Section 1.54
|
“VivoQuest
Asset Purchase Agreement”
|
10
|
|
Section 1.55
|
*****
|
10
|
|
Section 1.56
|
“VivoQuest
License Agreement”
|
10
|
|
Section 1.57
|
“VivoQuest
Licensed Patents”
|
10
|
|
Section 1.58
|
Additional
Definitions
|
10
|
|
Article
II Grant of License; Assigned Contracts;
Exclusivity
|
11
|
||
Section 2.1
|
License
Grant
|
11
|
|
Section 2.2
|
Assigned
Contracts
|
11
|
|
Section 2.3
|
Exclusivity
|
11
|
|
Section 2.4
|
Retained
Rights; Other Limitations
|
12
|
|
Section 2.5
|
Section
365(n) of the Bankruptcy Code
|
12
|
|
Article
III Technology Transfer
|
12
|
||
Section 3.1
|
Technology
Transfer
|
12
|
|
Section 3.2
|
Technology
Transfer Committee; Decision-Making Authority.
|
13
|
|
Article
IV Reports and Meetings; Diligence; Certain Regulatory and
Manufacturing Activities
|
13
|
||
Section 4.1
|
Development
Reports; Meetings.
|
13
|
|
Section 4.2
|
Commercially
Reasonable Efforts
|
14
|
|
Section 4.3
|
Certain
Regulatory and Manufacturing Activities
|
14
|
|
Article
V Financial Provisions
|
14
|
||
Section 5.1
|
License
Payment
|
14
|
|
Section 5.2
|
Milestone
Payments for Series 1 Licensed Products
|
14
|
|
Section 5.3
|
Royalties
|
16
|
|
Section 5.4
|
Sublicense
Income for Series 1 Licensed Products
|
16
|
|
Section 5.5
|
Reduction
for Lack of Patent Coverage.
|
17
|
|
Section 5.6
|
Reduction
for Pass-Through Costs Under Assigned Contracts and Additional
Third Party
Licenses
|
17
|
|
Section 5.7
|
Priority
of Reduction
|
18
|
|
Section 5.8
|
Offset
for Payment of VivoQuest Pass-Through Costs
|
18
|
|
Section 5.9
|
Reports
and Accounting.
|
18
|
|
Section 5.10
|
Currency
and Method of Payments
|
00
|
|
Xxxxxxx 0.00
|
Xxxxxx
Xxxxxx Dollars
|
19
|
|
Section 5.12
|
Tax
Withholding
|
19
|
|
Section 5.13
|
Late
Payments
|
20
|
|
Section 5.14
|
Blocked
Payments
|
20
|
|
Section 5.15
|
Costs
and Expenses
|
20
|
|
Article
VI Intellectual Property Protection and Related
Matters
|
20
|
||
Section 6.1
|
Prosecution
and Maintenance of Licensed Patent Rights.
|
20
|
-ii-
Confidential
material omitted and filed separately with the
Commission.
Section 6.2
|
Third
Party Infringement.
|
21
|
|
Section 6.3
|
Recoveries
|
22
|
|
Section 6.4
|
Claimed
Infringement
|
22
|
|
Section 6.5
|
Patent
Invalidity Claim
|
22
|
|
Section 6.6
|
Patent
Marking
|
22
|
|
Section 6.7
|
Certain
Limitations
|
22
|
|
Article
VII Confidentiality
|
22
|
||
Section 7.1
|
Confidential
Information
|
22
|
|
Section 7.2
|
Employee,
Director, Consultant and Advisor Obligations
|
23
|
|
Section 7.3
|
Publicity.
|
23
|
|
Section 7.4
|
Term
|
24
|
|
Article VIII Representations and Warranties
|
24
|
||
Section 8.1
|
Representations
of Authority
|
24
|
|
Section 8.2
|
Consents
|
24
|
|
Section 8.3
|
No
Conflict
|
24
|
|
Section 8.4
|
Employee,
Director, Consultant and Advisor Obligations
|
24
|
|
Section 8.5
|
Intellectual
Property
|
24
|
|
Section 8.6
|
No
Warranties
|
27
|
|
Article
IX Term and Termination
|
27
|
||
Section 9.1
|
Term
|
27
|
|
Section 9.2
|
Termination
For Material Breach
|
27
|
|
Section 9.3
|
Termination
for Convenience
|
28
|
|
Section 9.4
|
Effect
of Material Breach or Patent Validity Challenge by XTL or its
Affiliates.
|
28
|
|
Section 9.5
|
Effects
of Termination.
|
29
|
|
Section 9.6
|
Survival
|
30
|
|
Article
X Dispute Resolution
|
31
|
||
Section 10.1
|
Referral
to Senior Executives
|
31
|
|
Section 10.2
|
Mediation
|
31
|
|
Section 10.3
|
Arbitration.
|
31
|
|
Section 10.4
|
No
Limitation
|
32
|
|
Article
XI Miscellaneous Provisions
|
32
|
||
Section 11.1
|
Indemnification.
|
32
|
|
Section 11.2
|
Governing
Law
|
34
|
|
Section 11.3
|
Assignment
|
34
|
|
Section 11.4
|
Entire
Agreement; Amendments
|
34
|
|
Section 11.5
|
Notices
|
34
|
|
Section 11.6
|
Force
Majeure
|
35
|
|
Section 11.7
|
Independent
Contractors
|
35
|
|
Section 11.8
|
No
Strict Construction
|
35
|
|
Section 11.9
|
Headings
|
36
|
|
Section 11.10
|
No
Implied Waivers; Rights Cumulative
|
36
|
|
Section 11.11
|
Severability
|
36
|
|
Section 11.12
|
Execution
in Counterparts
|
36
|
|
No
Third Party Beneficiaries
|
36
|
||
Section 11.14
|
No
Consequential Damages
|
36
|
-iii-
Confidential
material omitted and filed separately with the
Commission.
Exhibit
A – Assigned Contracts
Exhibit
B – VivoQuest Agreements
Exhibit
C – Series 1, 2, 3 and 4 Compounds in XTL Database and Other
Records
Exhibit
D – Series 1 Patent Rights as of the Effective Date
Exhibit
E – Series 2-4 Patent Rights as of the Effective Date
Exhibit
F – Press Releases
Exhibit
G – *****
-i-
This
License Agreement (this “Agreement”),
dated
the 19th
day of
March, 2008 (the “Effective
Date”),
is by
and between Presidio Pharmaceuticals, Inc., a Delaware corporation
(“PRESIDIO”),
and
XTL Biopharmaceuticals Ltd., a public company limited by shares organized under
the laws of Israel (“XTL”).
INTRODUCTION
1. XTL
owns
or controls rights to Licensed Compounds, Licensed Patent Rights and Licensed
Technology (each as hereinafter defined).
2. PRESIDIO
is in the business of discovering, developing and marketing pharmaceutical
products.
3. XTL
and
PRESIDIO are interested in establishing a licensing relationship pursuant to
which XTL shall grant PRESIDIO certain rights and licenses to the Licensed
Compounds, Licensed Patent Rights and Licensed Technology to develop and
commercialize certain products.
NOW,
THEREFORE, for good and valuable consideration, the receipt and sufficiency
of
which are hereby acknowledged, PRESIDIO and XTL agree as follows:
Article
I
Definitions
When
used
in this Agreement, each of the following terms shall have the meanings set
forth
in this Article I:
Section
1.1 “Additional
Third Party Licenses”.
Additional Third Party Licenses means licenses under any Patent Rights of a
Third Party (other than Licensed Patent Rights licensed or sublicensed to
PRESIDIO under the VivoQuest License Agreement or any Assigned Contracts) which
PRESIDIO and/or any of its Affiliates or Third Party sublicensees reasonably
determines are necessary for the Development and/or Commercialization of a
Licensed Compound or Licensed Product for use in the Field in any country of
the
Territory.
Section
1.2 “Affiliate”.
Affiliate means, with respect to a Party, any Person that controls, is
controlled by, or is under common control with such Party. For purposes of
this
Section 1.2, “control” shall refer to (a) in the case of a Person that is a
corporate entity, direct or indirect ownership of fifty percent (50%) or more
of
the stock or shares having the right to vote for the election of directors
of
such Person, and (b) in the case of a Person that is not a corporate entity,
the
possession, directly or indirectly, of the power to direct, or cause the
direction of, the management or policies of such Person, whether through the
ownership of voting securities, by contract or otherwise.
Section
1.3 “Assigned
Contracts”.
Assigned Contracts means the agreements listed on Exhibit
A.
-2-
Confidential
material omitted and filed separately with the
Commission.
Section
1.4 “Bankruptcy
Code”.
Bankruptcy Code means 11 U.S.C §§ 101-1330, as amended.
Section
1.5 “Commercialization”
or “Commercialize”.
Commercialization or Commercialize means any activities directed to producing
or
manufacturing for commercial distribution; marketing, promoting, detailing
or
commercially distributing; importing, having imported, exporting or having
exported for commercial distribution; or selling or offering to sell, a
product.
Section
1.6 “Commercially
Reasonable Efforts”.
Commercially Reasonable Efforts means the efforts normally used by a United
States biotechnology or pharmaceutical company with resources similar to those
of PRESIDIO to Develop or Commercialize a pharmaceutical product or compound
owned by it or to which it has rights, taking into account its market potential
and the stage in its development or product life, relevant issues of safety
and
efficacy, product profile and labeling, other medical and clinical
considerations, difficulty in developing the product or compound,
competitiveness of the marketplace for the applicable product(s) marketed or
to
be marketed, the proprietary position of the compound or product, the regulatory
structure involved, the potential profitability of the applicable product(s)
marketed or to be marketed, and other relevant factors affecting the cost,
risk
and timing of Development and the total potential reward to be obtained if
a
product is Commercialized. Such efforts and resources that are used by
PRESIDIO’s Affiliates and Third Party sublicensees shall be attributed to
PRESIDIO for purposes of this Agreement.
Section
1.7 “Competing
Product”.
Competing Product means any prescription pharmaceutical product that is an
*****.
Section
1.8 “Confidential
Information”.
Confidential Information means all Know-How and other information (whether
or
not patentable) regarding a Party’s technology, products, business or
objectives, that is disclosed by such Party to the other Party in the course
of
such Party’s performance of this Agreement.
Section
1.9 “Control”
or “Controlled”.
Control
or Controlled means, with respect to any intellectual property right or other
intangible property, the possession by a Party or an Affiliate of a Party
(whether by ownership or license, other than a license granted pursuant to
this
Agreement) of the ability to grant access to, or a license or sublicense of,
such rights or property as contemplated under this Agreement.
Section
1.10 “Cover”,
“Covering” or “Covered”.
Cover,
Covering or Covered means, as to Patent Rights and a product, that, but for
a
license granted to a Party under a Valid Claim of such Patent Rights, the
Development or Commercialization of such product would infringe such Valid
Claim.
Section
1.11 “Derivative
Compounds”.
Derivative Compounds means, with respect to any Licensed Compound, any compounds
actually chemically derived, in one or more steps, by or on behalf of PRESIDIO,
its Affiliates and/or Third Party sublicensees from such Licensed Compound,
provided that,
compounds derived by Third Party sublicensees or Third Party acquirers of
PRESIDIO shall not constitute Derivative Compounds if such compounds are so
derived (i) prior to the effective date of the grant by PRESIDIO of the
sublicense to such sublicensee or the acquisition by such acquirer, as evidenced
by contemporaneously prepared written records of such sublicensee or
acquirer or (ii) without any use, direct or indirect, of
(A) proprietary know-how disclosed to such Third Party in connection with
the grant of the sublicense or the acquisition, or (B) Licensed Compounds
(including Derivative Compounds) on which Development had previously been
conducted by XTL or PRESIDIO, the results of which prior Development are
identified to such Third Party in connection with the grant of the
sublicense or the acquisition.
-3-
Section
1.12 “Development”
or “Develop”.
Development or Develop means any research, discovery, and preclinical and
clinical drug development activities, including without limitation test method
development and stability testing, toxicology, animal efficacy studies,
formulation, quality assurance/quality control development, statistical
analysis, clinical studies, regulatory affairs, product approval and
registration, chemical development and manufacturing development, packaging
development and manufacturing and development documentation efforts in support
of development activities anywhere in the world.
Section
1.13 “EMEA”.
EMEA
means the European Agency for the Evaluation of Medical Products, or any
successor agency thereof.
Section
1.14 “EU”.
EU
means the European Union, as it may be constituted from time to
time.
Section
1.15 “FDA”.
FDA
means the United States Food and Drug Administration, or any successor agency
thereof.
Section
1.16 “Field”.
Field
means the prevention, treatment, palliation and/or control of any and all human
diseases and conditions, including without limitation the HCV
Field.
Section
1.17 “Fiscal
Year”.
Fiscal
Year means, with respect to a Party or any Third Party sublicensee of a Party,
the fiscal year of such Party or Third Party sublicensee.
Section
1.18 “HCV”.
HCV
means hepatitis C virus.
Section
1.19 “HCV
Field”.
HCV
Field means the prevention, treatment, palliation and/or control of any and
all
HCV indications.
Section
1.20 “IND”.
IND
means an Investigational New Drug application filed with the FDA.
Section
1.21 “Know-How”.
Know-How means any know-how, expertise, discoveries, inventions, information,
trade secrets, data or materials, whether or not patentable, proprietary or
embodied in tangible form, including without limitation ideas, concepts,
formulas, methods, procedures, designs, technologies, compositions, plans,
applications, technical data, samples, biological or chemical materials,
laboratory notebooks, preclinical or clinical data, databases, designs, assays,
protocols, analytical systems, discovery tools, reports, Regulatory Filings
and
manufacturing documentation.
-4-
Section
1.22 “Licensed
Compounds”.
Licensed Compounds means (a) the Series 1 Compounds, and (b) the Series 2-4
Compounds.
Section
1.23 “Licensed
Patent Rights”.
Licensed Patent Rights means (a) the Series 1 Patent Rights, (b) the Series
2-4
Patent Rights, and (c) any other Patent Rights Controlled by XTL or any of
its
Affiliates, as of the Effective Date and/or during the term of this Agreement,
that Cover any Licensed Technology and/or the Development and/or
Commercialization of any Licensed Compounds or Licensed Products.
Section
1.24 “Licensed
Product”.
Licensed Product means any product that contains one or more Licensed Compounds
as an active ingredient.
Section
1.25 “Licensed
Technology”.
Licensed Technology means any Know-How Controlled by XTL or any of its
Affiliates, as of the Effective Date and/or during the term of this Agreement,
relating to the Development and/or Commercialization of Licensed Compounds
or
Licensed Products, and all intellectual property rights therein.
Section
1.26 “Major
EU Countries”.
Major
EU Countries means any of the United Kingdom, Germany, France, Italy and
Spain.
Section
1.27 “NDA”.
NDA
means an application submitted to a Regulatory Authority for marketing approval
of a product, including without limitation a New Drug Application filed with
the
FDA and any foreign equivalent thereof.
Section
1.28 “Net
Sales”.
Net
Sales means, with respect to a Licensed Product, the gross amount invoiced
by
PRESIDIO and/or its Affiliates, or by Third Party sublicensees, as the case
may
be, in respect of sales of such Licensed Product to unrelated Third Parties,
in
each case less the following deductions:
(a) Trade,
cash and/or quantity discounts actually allowed and taken with respect to such
sales;
(b) Discounts
paid under discount prescription programs and reductions for coupon and voucher
programs;
(c) Tariffs,
duties, excises, sales taxes, value-added taxes and other taxes imposed upon
and
paid by PRESIDIO and/or one of its Affiliates, or by Third Party sublicensees,
as the case may be, with respect to the use, sale or importation of the Licensed
Product, to the extent that neither PRESIDIO nor any of its Affiliates is
entitled to a rebate, refund or credit for such amounts;
(d) Amounts
repaid or credited by reason of rejections, defects, recalls or returns or
because of chargebacks, refunds, rebates or retroactive price
reductions;
(e) Negotiated
payments made to private sector and government third party payors (e.g., PBMs,
HMOs and PPOs) and purchasers/providers (e.g., staff model HMOs, hospitals
and
clinics), regardless of the payment mechanism, including without limitation
rebate, chargeback and credit mechanisms;
-5-
Confidential
material omitted and filed separately with the
Commission.
(f) Freight,
insurance and other transportation charges incurred by PRESIDIO and/or its
Affiliates, or by Third Party sublicensees, as the case may be, in shipping
a
Licensed Product to Third Parties;
(g) Sales
commissions and inventory management fees paid to wholesalers and distributors
to the extent allocable to Licensed Products;
(h) Amounts
that are written off as uncollectible and costs of collections; and
(i) Gross
amounts received in respect of sales for test marketing, sampling or promotional
use, clinical trial purposes or compassionate or similar use.
Such
amounts shall be determined from the books and records of PRESIDIO and/or its
Affiliates, or Third Party sublicensees, as the case may be, maintained in
accordance with generally accepted accounting principles applicable within
a
particular country, consistently applied, including periodic adjustments to
reflect amounts actually incurred.
In
the
event the Licensed Product is sold as part of a Combination Product (as defined
below), the Net Sales from the Combination Product, for the purposes of
determining royalty payments, shall be determined on a country-by-country basis
by multiplying the Net Sales (as determined above) of the Combination Product
in
each country, during the applicable royalty reporting period, by the fraction
A/(A+B), where A is the average net selling price of the Licensed Product when
sold separately in finished form in such country and B is the average net
selling price of the other active ingredient(s) included in the Combination
Product when sold separately in finished form in such country, in each case
during the applicable royalty reporting period or, if sales of both the Licensed
Product and the other active ingredient(s) did not occur in such country in
such
period, then in the most recent royalty reporting period in which sales of
both
occurred in such country. In the event that such average net selling price
cannot be determined for both the Licensed Product and all other active
ingredient(s) included in such Combination Product for a country, Net Sales
for
the purposes of determining royalty payments shall be calculated by multiplying
the Net Sales of the Combination Product in such country by the fraction of
C/(C+D) where C is the fair market value of the Licensed Product and D is the
fair market value of all other active ingredient(s) included in the Combination
Product. In such event, PRESIDIO shall in good faith make a determination of
the
respective fair market values of the Licensed Product and all other active
ingredient(s) included in the Combination Product, and shall notify XTL of
such
determination and provide XTL with data to support such determination. XTL
shall
have the right to review such determination of fair market values and, if XTL
disagrees with such determination, to notify PRESIDIO of such disagreement
within ***** days after PRESIDIO notifies XTL of such determination. If XTL
notifies PRESIDIO that XTL disagrees with such determination within such *****
day period and if thereafter the Parties are unable to agree in good faith
as to
such respective fair market values, then such matter shall be resolved as
provided in Article X. If XTL does not notify PRESIDIO that XTL disagrees with
such determination within such ***** day period, such determination shall be
conclusive and binding on the Parties.
As
used
above, the term “Combination
Product”
means
any pharmaceutical product that includes both (x) a Licensed Product and (y)
other active ingredient(s).
-6-
Section
1.29 “NS5A”.
NS5A
means the HCV non-structural protein 5A, including without limitation partial
and full-length proteins thereof.
Section
1.30 “Party”
or “Parties”.
Party
means PRESIDIO or XTL; Parties means PRESIDIO and XTL.
Section
1.31 “Pass-Through
Costs”.
Pass-Through Costs means amounts payable to Third Parties pursuant to (a) the
Assigned Contracts attached hereto as Exhibit
A,
(b) the
VivoQuest License Agreement attached hereto as Exhibit
B,
and/or
(c) Additional Third Party Licenses, including without limitation upfront
payments or similar acquisition costs to obtain such licenses; in the case
of
each of the foregoing clauses (a), (b) and (c), with respect to the Development
and/or Commercialization of Licensed Compounds or Licensed
Products.
Section
1.32 “Patent
Rights”.
Patent
Rights means the rights and interest in and to all issued patents and pending
patent applications in any country in the Territory, including without
limitation all utility models, utility model applications, provisionals,
divisionals, substitutions, continuations, continuations-in-part, continuing
prosecution applications, patents of addition, requests for continued
examination, reexaminations, supplementary protection certificates, extensions,
registrations or confirmation patents, and reissues thereof.
Section
1.33 “Person”.
Person
means any natural person or any corporation, company, partnership, joint
venture, firm or other entity, including without limitation a
Party.
Section
1.34 “Phase
I Trial”.
Phase I
Trial means a clinical study of a Licensed Product in human volunteers or
patients with the endpoint of determining initial tolerance, toxicity, safety
and/or pharmacokinetic information.
Section
1.35 “Phase
II Trial”.
Phase
II Trial means a dose exploration, dose response, duration of effect,
kinetic/dynamic relationship and preliminary efficacy and safety
clinical study of a Licensed Product in patients.
Section
1.36 “Phase
III Trial”.
Phase
III Trial means a pivotal clinical study of a Licensed Product in patients
designed to confirm with statistical significance the efficacy and safety of
a
Licensed Product performed to provide a sufficient basis for an application
for
Regulatory Approval of such Licensed Product.
Section
1.37 “Regulatory
Approval”.
Regulatory Approval means the approvals (including any applicable governmental
price and reimbursement approvals), licenses, registrations or authorizations
of
Regulatory Authorities necessary for the commercial manufacture and sale of
a
product in a country or territory.
Section
1.38 “Regulatory
Authority”.
Regulatory Authority means a federal, national, multinational, state, provincial
or local regulatory agency, department, bureau or other governmental entity
with
authority over the testing, manufacture, use, storage, import, promotion,
marketing or sale of a product in a country or territory.
Section
1.39 “Regulatory
Filings”.
Regulatory Filings means any filing or application with any Regulatory Authority
with respect to a Licensed Compound or Licensed Product, including
without limitation any INDs or its foreign equivalent, Regulatory Approvals,
and
correspondence with the relevant Regulatory Authorities, as well as minutes
of
any material meetings, telephone conferences or discussions with the relevant
Regulatory Authorities.
-7-
Confidential
material omitted and filed separately with the
Commission.
Section
1.40 “Royalty
Term”.
Royalty
Term means, with respect to each Licensed Product in each country of the
Territory, the period commencing upon first commercial sale of such Licensed
Product in such country and ending upon the later of (a) the expiration of
the
last-to-expire Valid Claim under the Licensed Patent Rights Covering such
Licensed Product in such country, or (b) ***** years following first commercial
sale of such Licensed Product in such country. For avoidance of doubt, the
Royalty Term shall be determined on a country-by-country and Licensed
Product-by-Licensed Product basis.
Section
1.41 “Senior
Executives”.
Senior
Executives means, with respect to PRESIDIO, the Chief Executive Officer (or
a
senior executive designated by such officer) and, with respect to XTL, the
Chief
Executive Officer (or a senior executive designated by such
officer).
Section
1.42 “Series
1 Compounds”.
Series
1 Compounds means (a) the compounds claimed or disclosed in the Series 1 Patent
Rights, (b) the compounds identified as “Series 1 Compounds” on Exhibit
C,
and (c)
Derivative Compounds of any compound set forth in either of the foregoing
clauses (a) and (b); in the case of each of clauses (a), (b) and (c) above,
regardless of whether or not any such compound has been synthesized by XTL
and/or its Affiliates.
Section
1.43 “Series
1 Licensed Products”.
Series
1 Licensed Products means Licensed Products that contain any Series 1
Compound(s).
Section
1.44 “Series
1 Patent Rights”.
Series
1 Patent Rights means (a) the Patent Rights set forth on Exhibit
D,
(b)
counterparts of the Patent Rights set forth on Exhibit
D
in any
country of the Territory, and (c) all Patent Rights claiming priority from
the
Patent Rights described in either of the foregoing clauses (a) and (b) in any
country of the Territory.
Section
1.45 “Series
2-4 Compounds”.
Series
2-4 Compounds means (a) any and all compounds claimed or disclosed in any Series
2-4 Patent Right, (b) the compounds identified as “Series 2, 3 or 4 Compounds”
on Exhibit
C,
and (c)
Derivative Compounds of any compound set forth in either of the foregoing
clauses (a) and (b); in the case of each of clauses (a), (b) and (c) above,
regardless of whether or not any such compound has been synthesized by XTL
and/or its Affiliates.
Section
1.46 “Series
2-4 Licensed Products”.
Series
2-4 Licensed Products means Licensed Products that contain any Series 2-4
Compound(s).
Section
1.47 “Series
2-4 Patent Rights”.
Series
2-4 Patent Rights means (a) the Patent Rights set forth on Exhibit
E,
(b)
counterparts of the Patent Rights set forth on Exhibit
E
in any
country of the Territory, and (c) all Patent Rights claiming priority from
the
Patent Rights described in either of the foregoing clauses (a) and (b) in any
country of the Territory.
Section
1.48 “Series
5-50 Compounds”.
Series
5-50 Compounds means any and all compounds claimed or disclosed in any Patent
Rights licensed or acquired by XTL from VivoQuest under the VivoQuest Asset
Purchase Agreement or VivoQuest License Agreement, excluding the Series 1
Compounds and the Series 2-4 Compounds.
-8-
Section
1.49 “Sublicense
Income”.
Sublicense Income means, subject to Section 5.4, all amounts received by
PRESIDIO and/or its Affiliates from Third Parties in connection with the
sublicensing or licensing to such Third Parties of rights under Licensed Patent
Rights and/or Licensed Technology to Develop and/or Commercialize any Series
1
Licensed Products, including without limitation all license fees, milestone
payments and royalties, but excluding any of the following amounts received
by
PRESIDIO and/or its Affiliates from such Third Parties:
(a) Amounts
received as the purchase price for PRESIDIO’s and/or its Affiliates’ debt or
equity securities, except to the extent such amounts exceed the fair market
value of such debt or equity securities;
(b) Amounts
received for bona fide research and development activities undertaken for,
or in
collaboration with, such Third Parties, except to the extent such amounts exceed
reasonable and customary funding amounts for such activities (e.g., cost
reimbursement or reasonable FTE-based funding);
(c) Amounts
received for bona fide co-promotion and other commercial activities undertaken
for, or in collaboration with, such Third Parties, except to the extent such
amounts exceed reasonable and customary funding amounts for such activities
(e.g., fees calculated and paid as cost reimbursement, reasonable per-detail
fees or reasonable FTE-based funding);
(d) In
the
event such license or sublicense is structured as a profit-sharing arrangement,
PRESIDIO’s and its Affiliates’ share of revenue amounts that are offset by
PRESIDIO’s and its Affiliates’ share of costs in the profit-share calculation
(i.e., only PRESIDIO’s and its Affiliates’ share of net profits, as opposed to
gross revenues, shall constitute Sublicense Income hereunder); and
(e) Amounts
received to cover Pass-Through Costs payable by PRESIDIO and/or its Affiliates
under this Agreement, including without limitation any Pass-Through Costs owed
by XTL to VivoQuest which are payable by PRESIDIO under Section 5.8 and any
Pass-Through Costs payable by PRESIDIO pursuant to any Assigned Contracts and
Additional Third Party Licenses.
Section
1.50 “Successful
Completion”.
Successful Completion means (a) with respect to a Phase I Trial for a Licensed
Product, the completion of such Phase I Trial with data that PRESIDIO determines
is satisfactory to progress such Licensed Product to a Phase II Trial, and
(b)
with respect to a Phase III Trial for a Licensed Product, the completion of
such
Phase III Trial with data that (i) achieves the primary endpoint of such Phase
III Trial or (ii) that PRESIDIO reasonably determines is suitable for inclusion
as a pivotal trial in an NDA for such Licensed Product to a Regulatory
Authority.
Section
1.51 “Territory”.
Territory means all countries of the world.
-9-
Confidential
material omitted and filed separately with the
Commission.
Section
1.52 “Third
Party”.
Third
Party means any person or entity other than a Party or any of its
Affiliates.
Section
1.53 “Valid
Claim”.
Valid
Claim means, on a country-by-country basis, a claim of (a) an issued patent
that
(i) has not expired; (ii) has not been disclaimed; (iii) has not been cancelled
or superseded, or if cancelled or superseded, has not been reinstated; and
(iv)
has not been revoked, held invalid, or otherwise declared unenforceable or
not
allowable by a tribunal or patent authority of competent jurisdiction over
such
claim in such country from which no further appeal has or may be taken; or
(b) a
patent application that has been pending less than ***** years from the earliest
date from which such patent application claims priority and which claim has
not
been cancelled, withdrawn or abandoned or finally rejected by an administrative
agency action from which no appeal can be taken.
Section
1.54 “VivoQuest
Asset Purchase Agreement”.
VivoQuest Asset Purchase Agreement means the asset purchase agreement, dated
as
of August 11, 2005, between XTL Biopharmaceuticals Inc. and VivoQuest Inc.
(including any successor-in-interest, “VivoQuest”).
Section
1.55 *****
Section
1.56 “VivoQuest
License Agreement”.
VivoQuest License Agreement means the license agreement, dated as of August
11,
2005, between XTL and VivoQuest.
Section
1.57 “VivoQuest
Licensed Patents”.
VivoQuest Licensed Patents means the “Licensed Patents” as defined in the
VivoQuest License Agreement.
Section
1.58 Additional
Definitions.
Each of
the following definitions is set forth in the section of this Agreement
indicated below:
Definitions
|
Section
|
|
Agreement
|
Preamble
|
|
Apath
License Agreement
|
Exhibit
A
|
|
Breaching
Party
|
9.2
|
|
Combination
Product
|
1.28
|
|
CPR
|
10.2
|
|
Effective
Date
|
Preamble
|
|
ICDR
|
10.3(a)
|
|
Indemnified
Party
|
11.1(c)
|
|
Indemnifying
Party
|
11.1(c)
|
|
Invalidity
Claim
|
6.4
|
|
Knowledge
|
8.5
|
|
PRESIDIO
|
Preamble
|
|
Retained
Liabilities
|
11.1(b)
|
|
Severed
Clause
|
11.11
|
|
Technology
Transfer Period
|
3.1
|
|
TTC
|
3.2
|
|
Validity
Challenge
|
9.4(b)
|
|
VivoQuest
|
1.54
|
|
XTL
|
Preamble
|
-10-
Article
II
Grant
of License; Assigned Contracts; Exclusivity
Section
2.1 License
Grant.
Subject
to the terms and conditions of this Agreement, XTL hereby grants to PRESIDIO
an
exclusive (even as to XTL), royalty-bearing right and license under the Licensed
Patent Rights and Licensed Technology, with the right to grant sublicenses,
to
Develop and Commercialize Licensed Compounds and Licensed Products in the Field
in the Territory. Each sublicense granted hereunder shall be pursuant to a
written agreement that is consistent with the terms and conditions of this
Agreement, provided that
further
sublicenses granted by any Third Party sublicensee to any of its affiliates
shall not be required to be pursuant to written agreements (the term
“affiliates” as used in this sentence shall mean, with respect to a Third Party
sublicensee, any Person that controls, is controlled by, or is under common
control with such Third Party sublicensee, with “control” having the meaning
provided in Section 1.2). PRESIDIO shall provide a copy of each such sublicense
agreement entered into by PRESIDIO promptly following its execution;
provided that,
PRESIDIO shall be entitled to redact from the copy of such sublicense agreement
provided to XTL terms that are not related to the determination of payments
due
to XTL under this Agreement or the consistency of such sublicense agreement
with
the terms and conditions of this Agreement; provided further that,
such
copies of sublicense agreements provided by PRESIDIO to XTL shall constitute
Confidential Information of PRESIDIO hereunder.
Section
2.2 Assigned
Contracts.
As of
the Effective Date, XTL shall, and shall cause its Affiliates to, assign to
PRESIDIO, and PRESIDIO shall assume, all of XTL’s or the applicable Affiliate’s
rights and obligations under the Assigned Contracts, provided,
that
XTL
shall remain responsible for the Retained Liabilities. XTL shall, and shall
cause its Affiliates to, take all reasonable further actions and execute all
assignments or other documents requested by PRESIDIO as may be necessary or
desirable to accomplish the foregoing assignments to PRESIDIO and to vest in
PRESIDIO the rights set forth in this Section 2.2.
Section
2.3 Exclusivity
(a) During
the term of this Agreement, neither XTL nor any of its Affiliates shall, or
shall license, permit or assist any Third Party to, use any of the Series 1
Compounds, the Series 2-4 Compounds, the Series 5-50 Compounds, any Derivative
Compounds of the foregoing, or any other materials or Know-How
licensed
or acquired by XTL from VivoQuest, for any Development or Commercialization
purpose relating or directed to the HCV Field in the Territory.
(b) During
the term of this Agreement, neither XTL nor any of its Affiliates shall, or
shall license, permit or assist any Third Party to, Develop or Commercialize
any
Competing Product in the Territory; provided,
however,
that
in the
event that, after the Effective Date, a Third Party acquires XTL, then such
Third Party shall not be bound by the restrictions provided in this Section
2.3(b), and no Patents or Know-How owned or Controlled by such Third Party
shall
be or become subject to the licenses granted herein, provided,
that
such
Third Party acquirer
does not access or use any Licensed Compounds or Licensed Technology, or
practice any invention Covered by any Licensed Patent Rights, in connection
with
such activities.
-11-
Confidential
material omitted and filed separately with the Commission.
Section
2.4 Retained
Rights; Other Limitations.
Without
limiting Section 8.5(a), the rights granted to PRESIDIO herein, including
without limitation the license granted to PRESIDIO in Section 2.1, as pertaining
to Licensed Patent Rights and Licensed Technology that are Controlled, but
are
not owned, by XTL, shall be limited by any rights retained by Third Parties,
or
other limitations or conditions on XTL’s sublicensee’s rights to such Licensed
Patent Rights and Licensed Technology. As of the Effective Date, such retained
rights and limitations consist solely of the rights retained by the U.S.
government pursuant to Section 2 of the VivoQuest License Agreement.
Section
2.5 Section
365(n) of the Bankruptcy Code.
All
rights and licenses granted to PRESIDIO under or pursuant to this Agreement
are,
and shall otherwise be, deemed to be, for purposes of Section 365(n) of the
Bankruptcy Code, licenses of rights to “intellectual property” as defined under
Section 101(35A) of the Bankruptcy Code. The Parties shall retain and may fully
exercise all of their respective rights and elections under the Bankruptcy
Code.
Article
III
Technology
Transfer
Section
3.1 Technology
Transfer.
Without
limiting the license granted to PRESIDIO pursuant to Section 2.1, XTL shall
deliver, and shall cause XTL’s Affiliates to deliver, to PRESIDIO, commencing
promptly following the Effective Date and for no additional consideration,
(a)
all Licensed Compounds and all other chemical or biological materials owned
or
Controlled by XTL or any of its Affiliates, that are necessary or useful for
producing the Licensed Compounds or otherwise practicing the Licensed Patent
Rights or Licensed Technology, (b) all patent files associated with the Licensed
Patent Rights, including without limitation the complete texts of all patents
and patent applications and copies of all office actions, office action
responses and other official communications received from, or filed with, all
relevant patent offices, in each case, in the possession or Control of XTL
or
any of its Affiliates, and (c) all Licensed Technology, including without
limitation all laboratory notebooks, preclinical or clinical data, databases,
designs, assays, protocols, analytical systems, discovery tools, reports and
manufacturing documentation relating to the Development and/or Commercialization
of any Licensed Compounds or Licensed Products, in each case, in the possession
or Control of XTL or any of its Affiliates. XTL shall complete, and shall cause
XTL’s Affiliates to complete, the delivery to PRESIDIO of all of the items
listed in each of the foregoing clauses (a), (b) and (c) within a period of
three (3) months following the Effective Date (the “Technology
Transfer Period”).
XTL
shall make ***** and ***** reasonably available to PRESIDIO *****, and *****
reasonably available to PRESIDIO until *****, in each case to answer any
questions or provide instruction concerning the Licensed Compounds, Licensed
Patent Rights, Licensed Technology and/or any of the other items delivered
to
PRESIDIO pursuant to this Section 3.1. During the Technology Transfer Period,
XTL and its Affiliates shall take all such further reasonable actions as may
be
necessary or desirable to accomplish the foregoing transfers to PRESIDIO and
to
put PRESIDIO in actual possession of the foregoing information and
materials.
-12-
Confidential
material omitted and filed separately with the Commission.
Section
3.2 Technology
Transfer Committee; Decision-Making Authority.
(a) Within
***** days following the Effective Date, the Parties shall establish a
technology transfer committee (the “TTC”)
to
facilitate and oversee the technology transfer activities set forth in Section
3.1 during the Technology Transfer Period. The TTC shall consist of no more
than
two (2) representatives from each Party, each of whom shall be appointed by
the
Senior Executive of the applicable Party. Each Party shall designate one such
representative to serve as the co-chair of the TTC. Unless otherwise agreed
by
the Parties, the TTC shall remain in effect solely during the Technology
Transfer Period.
(b) The
TTC
shall have decision-making authority with respect to any technical matter
relating to the technology transfer activities under Section 3.1, but shall
have
no authority to amend the scope of the licenses granted to PRESIDIO hereunder
or
amend any other contractual rights or obligations of either Party under this
Agreement. All decisions of the TTC shall be made by consensus of the TTC
co-chairs. If the TTC co-chairs are unable to reach consensus with respect
to a
particular matter within its purview, the matter shall be referred to the Senior
Executives for resolution. If the Senior Executives are unable to resolve such
matter within ***** days following such referral, the matter shall be resolved
pursuant to Article X.
Article
IV
Reports
and Meetings; Diligence; Certain Regulatory and Manufacturing
Activities
Section
4.1 Development
Reports; Meetings.
(a) Within
***** prior to the first commercial launch of the first Licensed Product by
PRESIDIO and/or any of its Affiliates or Third Party sublicensees, PRESIDIO
shall provide to XTL a written report summarizing the activities undertaken
by
PRESIDIO, its Affiliates and Third Party sublicensees during the immediately
preceding ***** period (or such shorter period as may be applicable with respect
to the first and last such report) in connection with the Development and
Commercialization of Licensed Products.
(b) Prior
to
the first commercial launch of the first Licensed Product hereunder, PRESIDIO
shall, upon reasonable request by XTL, at no cost to PRESIDIO, meet with XTL,
no
more frequently than on a semi-annual basis and at PRESIDIO’s corporate
headquarters (or by telephone), to discuss generally the reports provided to
XTL
under the foregoing Section 4.1(a).
(c) After
the
first commercial launch of the first Licensed Product by PRESIDIO and/or any
of
its Affiliates or Third Party sublicensees, PRESIDIO’s reporting obligations
shall be limited to those set forth in Section 5.9(a) below.
(d) Notwithstanding
any of the foregoing, in the event that XTL is acquired by, or otherwise becomes
an Affiliate of, a Person that is engaged in Development and/or
Commercialization activities relating or directed to the HCV Field, PRESIDIO’s
obligations under Section 4.1(a), Section 4.1(b) and Section 6.1(c) shall
terminate.
-13-
Confidential
material omitted and filed separately with the Commission.
Section
4.2 Commercially
Reasonable Efforts.
PRESIDIO shall use Commercially Reasonable Efforts to Develop and Commercialize
at least one Licensed Product for the prevention,
treatment, palliation and/or control of any HCV indication in the United States,
the EU and Japan. For purposes of clarity, PRESIDIO shall be deemed to have
used
Commercially Reasonable Efforts hereunder with respect to its Development and
Commercialization activities in the EU if PRESIDIO Develops and Commercializes
at least one Licensed Product for the prevention, treatment, palliation and/or
control of any HCV indication in any ***** of the Major EU Countries.
Notwithstanding anything to the contrary in this Agreement, however, XTL’s sole
and exclusive remedy, and PRESIDIO’s sole and exclusive liability, for any
breach by PRESIDIO of such obligation to exercise Commercially Reasonable
Efforts shall be for XTL to exercise any right that XTL may have to terminate
this Agreement as provided in Section 9.2.
Section
4.3 Certain
Regulatory and Manufacturing Activities.
As
between the Parties, PRESIDIO shall be responsible, at its expense, for all
Development and Commercialization activities conducted by PRESIDIO and/or its
Affiliates or Third Party sublicensees, including without
limitation:
(a) Filing
applications for, and obtaining and maintaining, any necessary Regulatory
Approvals with respect to the Development and/or Commercialization of Licensed
Compounds or Licensed Products. As between the Parties, PRESIDIO shall own
all
Regulatory Filings with respect to Licensed Compounds and/or Licensed Products
filed by or on behalf of PRESIDIO and/or its Affiliates or Third Party
sublicensees; and
(b) Manufacturing,
or having manufactured by a Third Party manufacturer, all preclinical, clinical
and commercial supply of Licensed Products, including without limitation
Licensed Compounds and/or other components necessary for such Licensed
Products.
Article
V
Financial
Provisions
Section
5.1 License
Payment.
Within
fourteen (14) days after the Effective Date, PRESIDIO shall make a one-time,
non-refundable license payment to XTL of Three Million Nine Hundred Forty
Thousand Dollars ($3,940,000).
Section
5.2 Milestone
Payments for Series 1 Licensed Products.
Subject
to Sections 5.4, 5.5(a), 5.6, 5.7 and 5.8(b), within ***** days after
achievement of each of the following milestone events with respect to Series
1
Licensed Products by PRESIDIO or any of its Affiliates, PRESIDIO shall make
the
indicated one-time milestone payment to XTL; provided, however, that where
a
portion of a milestone payment is payable by XTL to VivoQuest as indicated
in
the parenthetical clauses included in the table below, such amount (that is,
such portion of the total milestone payment) shall be payable by PRESIDIO to
XTL
within ***** days after the achievement of the relevant milestone event, except
that the amount so payable upon the achievement of the milestone event indicated
in row (h) in the table below shall be payable by PRESIDIO to XTL within *****
days after the achievement of the relevant milestone event. *****:
-14-
Confidential
material omitted and filed separately with the Commission.
Milestone
Event
|
Column
A
*****
|
Column
B
*****
|
|||||
*****
|
*****
|
*****
|
|||||
*****
|
*****
|
*****
|
|||||
*****
|
*****
|
*****
|
|||||
*****
|
*****
|
*****
|
|||||
*****
|
*****
|
*****
|
|||||
*****
|
*****
|
*****
|
|||||
*****
|
*****
|
*****
|
|||||
*****
|
*****
|
*****
|
|||||
*****
|
*****
|
*****
|
Each
of
the milestone payments
payable
pursuant to this Section 5.2 upon achievement of the corresponding milestone
event shall be payable (x) only once, under either Column A or Column B above
(but not both), irrespective of how many Licensed Products are Developed or
Commercialized hereunder, (y) only upon achievement of the corresponding
milestone event by PRESIDIO and/or its Affiliates, and not by any Third Party
sublicensee of PRESIDIO or any of its Affiliates, except as and to the extent
required by Section 5.8(a) and (z) with respect to the milestone payments set
forth in clauses (a), (b), (c), (d), (e), (f) and (g) of the table above,
subject to the limitations set forth in Section 5.4. In addition to the
foregoing, the milestone payments above shall be reduced if PRESIDIO enters
into
an agreement with one or more Third Parties pursuant to which PRESIDIO grants
such Third Party(ies) a sublicense or license under the Licensed Patent Rights
and/or Licensed Technology to Develop and Commercialize any Series 1 Licensed
Product in any of the countries indicated immediately below. Such reduction
shall be given effect prior to any reduction of the above milestones payments
as
provided in Section 5.5 and Section 5.6 of this Agreement. Such reduction shall
be in an amount equal to the percentage of the applicable milestone payment
indicated below in connection with the grant of the foregoing rights in the
specified country: *****. *****. Such reductions shall only be applied to
milestone payments that are payable in connection with milestone events that
are
achieved after the execution and delivery of the relevant agreement(s) between
PRESIDIO and such Third Party(ies) and shall not be given retroactive
effect.
-15-
Confidential
material omitted and filed separately with the Commission.
Section
5.3 Royalties.
During
the Royalty Term applicable to sales of each Licensed Product in each country
of
the Territory, PRESIDIO shall pay to XTL the royalties set forth in Section
5.3(a) or 5.3(b) below, as applicable, with the amount of such royalties
calculated as a percentage of worldwide Net Sales of such Licensed Product
during each Fiscal Year of PRESIDIO.
(a) Royalties
for Series 1 Licensed Products.
Subject
to Sections 5.5(b), 5.6, 5.7 and 5.8(b), PRESIDIO shall pay XTL the following
royalty with respect to Net Sales, generated during the applicable Royalty
Term,
of each Series 1 Licensed Product (on a product-by-product basis) by PRESIDIO
and/or its Affiliates (but not by any Third Party sublicensee of PRESIDIO or
any
of its Affiliates) during each Fiscal Year of PRESIDIO:
Annual
Worldwide Net Sales of
Series
1 Licensed Product
|
Percentage
of
Incremental
Net Sales Amount
|
|
*****
|
*****
|
|
*****
|
*****
|
|
*****
|
*****
|
|
*****
|
*****
|
*****.
(b) Royalties
for Series 2-4 Licensed Products.
PRESIDIO shall pay XTL a royalty of (i) *****of Net Sales by PRESIDIO and/or
its
Affiliates of a Series 2-4 Licensed Product during any period that such Series
2-4 Licensed Product is Covered by a Valid Claim of any Licensed Patent Right,
and (ii) ***** of Net Sales by any Third Party sublicensee of PRESIDIO and/or
its Affiliates of a Series 2-4 Licensed Product during any period that such
Series 2-4 Licensed Product is Covered by a Valid Claim of any Licensed Patent
Right.
(c) Royalties
Payable Only Once.
The
obligation to pay royalties is imposed only once with respect to Net Sales
of
the same unit of a Licensed Product.
Section
5.4 Sublicense
Income for Series 1 Licensed Products.
Subject
to Section 5.8(a), PRESIDIO shall pay XTL the following percentage of Sublicense
Income, with respect to the Development and/or Commercialization of any Series
1
Licensed Product by a Third Party sublicensee, which Sublicense Income is
received by PRESIDIO and/or its Affiliates during Royalty Term applicable to
such Series 1 Licensed Product in the country(ies) in which the activities
giving rise to the Sublicense Income payment to PRESIDIO and/or its Affiliates
occur:
(a) *****;
(b) *****;
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Confidential
material omitted and filed separately with the Commission.
(c) *****;
(d) *****.
Notwithstanding
Section 5.2 and the foregoing provisions of this Section 5.4, and subject to
the
remaining provisions of this paragraph, PRESIDIO’s obligations to pay XTL (A)
milestone payments upon the achievement by PRESIDIO or its Affiliates of the
milestone events designated (a), (b), (c), (d), (e), (f) and (g) in the table
in
Section 5.2 and (B) payments pursuant to this Section 5.4 based on Sublicense
Income comprised of upfront payments (that is, payments due in connection with
the execution and delivery of a sublicense that are not contingent on the
occurrence of other events or achievements) or milestone payments other than
milestone payments based on the achievement by a Third Party sublicensee of
sales milestones (i.e., the achievement of specified levels of sales of Series
1
Licensed Products *****. Notwithstanding the limitation on PRESIDIO’s payment
obligations described in this Section, the amounts provided in Section 5.8
shall
remain due and payable in full in accordance with the terms set forth in Section
5.8.
Section
5.5 Reduction
for Lack of Patent Coverage.
(a) Each
of
the milestone payments payable by PRESIDIO pursuant to Section 5.2 above shall
be reduced by ***** (i.e., reduced to ***** of the amount otherwise payable)
in
the event that the first Series 1 Licensed Product with respect to which the
corresponding milestone event is achieved is not Covered by a Valid Claim of
any
Licensed Patent Rights at the time of such achievement; provided that if the
same milestone event is subsequently achieved with one or more Series 1 Licensed
Products that are Covered by a Valid Claim of a Licensed Patent Right at the
time of such achievement, then the remainder of such milestone payment (i.e.,
the ***** not previously paid) shall then become payable hereunder.
(b) The
royalty rate set forth in Section 5.3(a) above payable by PRESIDIO with respect
to Net Sales by PRESIDIO and/or its Affiliates of any Series 1 Licensed Product
for use in the Field in any country in the Territory shall be reduced to *****
of Net Sales during any portion of the Royalty Term for such Series 1 Licensed
Product in which such Series 1 Licensed Product in such country is not Covered
by a Valid Claim of any Licensed Patent Rights.
Section
5.6 Reduction
for Pass-Through Costs Under Assigned Contracts and Additional Third Party
Licenses.
As
between the Parties, PRESIDIO shall be responsible for paying all Pass-Through
Costs required to be paid under the Assigned Contracts and any Additional Third
Party Licenses; provided,
however,
that,
PRESIDIO shall have the right to reduce the milestone and royalty payments
payable by PRESIDIO under Sections 5.2 and 5.3(a) above ***** of all such
Pass-Through Costs payable by PRESIDIO hereunder, provided,
that,
in no
event shall any single milestone or royalty payment payable by PRESIDIO under
Section 5.2 or 5.3(a) with respect to any Series 1 Licensed Product be reduced
by more than ***** of the amount otherwise due to XTL under Section 5.2 or
5.3(a). For the avoidance of doubt, no reduction shall be applied by PRESIDIO
under this Section 5.6 with respect to the ***** required to be paid under
the
*****.
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Confidential
material omitted and filed separately with the Commission.
Section
5.7 Priority
of Reduction.
In the
event that the reductions provided for in Sections 5.5 and 5.6 would otherwise
both be applicable to a milestone or royalty payment payable by PRESIDIO under
Section 5.2 or 5.3(a), then only the reduction in Section 5.5 shall apply to
such milestone or royalty payment.
Section
5.8 Offset
for Payment of VivoQuest Pass-Through Costs.
As
between the Parties, XTL shall be responsible for maintaining the VivoQuest
License Agreement in full force and effect and for paying all amounts due to
VivoQuest thereunder. Anything in this Agreement to the contrary
notwithstanding, in addition to (but subject to PRESIDIO’s offset rights as
provided below) any other amounts that may be payable hereunder:
(a) If,
at
any time, Pass-Through Costs are owed by XTL to VivoQuest under the VivoQuest
License Agreement as a result of the Development and/or Commercialization of
Series 1 Licensed Products by a Third Party sublicensee of PRESIDIO or any
of
its Affiliates (but not by PRESIDIO or any of its Affiliates), then PRESIDIO
shall pay XTL the amount of the Pass-Through Costs owed by XTL to VivoQuest;
provided,
however,
that,
PRESIDIO shall have the right to offset such amount paid by PRESIDIO against
any
amounts otherwise payable, concurrently or subsequently, by PRESIDIO to XTL
under Section 5.4.
(b) If
any
amount payable by PRESIDIO to XTL under Section 5.2 or Section 5.3(a) is less
than the corresponding Pass-Through Costs that are owed by XTL to VivoQuest
under the VivoQuest License Agreement as a result of the Development and/or
Commercialization of Series 1 Licensed Products by PRESIDIO and/or any of its
Affiliates (but not by a Third Party sublicensee of PRESIDIO or any of its
Affiliates), then PRESIDIO shall pay XTL the difference between (i) the amount
paid by PRESIDIO under Section 5.2 or Section 5.3(a), and (ii) the amount of
the
Pass-Through Costs owed by XTL to VivoQuest.
(c) PRESIDIO
shall be obligated to pay XTL any Pass-Through Costs that are owed by XTL to
VivoQuest under the VivoQuest License Agreement as a result of the Development
and/or Commercialization of Series 2-4 Licensed Products by PRESIDIO and/or
any
of its Affiliates or Third Party sublicensees.
(d) In
the
event that any Pass-Through Costs set forth in any of the foregoing clauses
(a)
through (c) are payable by PRESIDIO under such provisions, or any Pass-Through
Costs referenced in the parenthetical clauses in Column A of the table in
Section 5.2 are owed by XTL to VivoQuest, *****.
Section
5.9 Reports
and Accounting.
(a) Reports;
Payments.
PRESIDIO shall deliver to XTL, within ***** days after the end of each calendar
quarter, a good faith estimate of the royalties and Sublicense Income that
will
be paid to XTL for such calendar quarter (excluding any estimate of royalties
which may be payable by PRESIDIO under Section 5.3(b)(ii) with respect to Net
Sales of Series 2-4 Licensed Products by Third Party sublicensees of PRESIDIO
and/or its Affiliates), and, within ***** days after the end of each calendar
quarter, reasonably detailed written accountings of Net Sales and Sublicense
Income of Licensed Products that are subject to payment obligations to XTL
for
such calendar quarter. Such quarterly reports shall indicate (i) gross sales,
Net Sales, gross amounts received from Third Party sublicensees, and Sublicense
Income on a Licensed Product-by-Licensed Product and country-by-country basis,
and (ii) the calculation of payment amounts owed to XTL from such Net Sales
and
Sublicense Income. When PRESIDIO delivers such accounting to XTL, PRESIDIO
shall
also deliver all amounts due under Sections 5.3 and 5.4 to XTL for the
calendar quarter.
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Confidential
material omitted and filed separately with the Commission.
(b) Audits
by XTL.
PRESIDIO shall keep, and shall require its Affiliates and
Third
Party sublicensees to keep, records of the latest ***** years relating to gross
sales, Net Sales, gross amounts received from Third Party sublicensees, and
Sublicense Income, in each case as applicable, and all information relevant
under Sections 5.2, 5.3, 5.4, 5.6, 5.7 and 5.8. For the sole purpose of
verifying amounts payable to XTL, XTL shall have the right no more than once
each calendar year, at XTL’s expense, to have XTL’s independent certified public
accountants review such records in the location(s) where such records are
maintained by PRESIDIO and/or its Affiliates or, with respect to records of
Third Party sublicensees, either at PRESIDIO’s premises or the premises of such
Third Party sublicensees, in each case as may be designated by PRESIDIO, upon
***** days’ prior notice and during regular business hours. Results of such
review shall be made available to PRESIDIO. If the review reflects an
underpayment to XTL, such underpayment shall be promptly remitted to XTL,
together with interest calculated in the manner provided in Section 5.13. If
the
underpayment is equal to or greater than ***** of the aggregate amount that
was
otherwise due for any calendar year, PRESIDIO shall promptly reimburse XTL
for
the reasonable costs incurred in connection with such review. If the review
reflects an overpayment to XTL, such overpayment shall be promptly refunded
by
XTL to PRESIDIO.
Section
5.10 Currency
and Method of Payments.
All
payments under this Agreement shall be made in United States dollars by transfer
to such bank account as XTL may designate from time to time. Any royalties
or
portions of Sublicense Income due hereunder with respect to amounts in
currencies other than United States dollars shall be payable in their United
States dollar equivalents, calculated using the average applicable interbank
transfer rate determined by reference to the currency trading rates published
by
The
Wall Street Journal
(Western
U.S. edition) over all business days of the calendar quarter to which the report
under Section 5.9(a) relates.
Xxxxxxx
0.00 Xxxxxx
Xxxxxx Dollars.
All
dollar ($) amounts specified in this Agreement are United States dollar
amounts.
Section
5.12 Tax
Withholding.
If
withholding taxes are payable with respect to payments to XTL hereunder,
PRESIDIO may withhold the required amount and pay it to the appropriate
governmental authority. PRESIDIO
will withhold only such amounts as are required to be withheld by law in the
country from which payment is being made. PRESIDIO shall submit to XTL a copy
of
the remittance voucher and reasonably satisfactory evidence of payment of the
corresponding taxes with the applicable royalty report, if possible, or within
***** days thereafter. PRESIDIO will make reasonable efforts and will reasonably
cooperate with XTL and provide such information and records as XTL may
reasonably require in connection with XTL obtaining any applicable reduction
or
exemption from withholding tax from tax authorities in any country.
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Confidential
material omitted and filed separately with the Commission.
Section
5.13 Late
Payments.
PRESIDIO shall pay interest to XTL on the aggregate amount of any payment that
is not paid on or before the date such payment is due under this Agreement
at a
rate per annum equal to *****.
Section
5.14 Blocked
Payments.
In the
event that, by reason of applicable laws or regulations in any country, it
becomes impossible or illegal for PRESIDIO or its Affiliates to transfer, or
have transferred on its behalf, royalties or other payments to XTL, such
royalties or other payments shall be deposited in local currency in the relevant
country to the credit of XTL in a recognized banking institution designated
by
XTL or, if none is designated by XTL within a period of ***** days, in a
recognized banking institution selected by PRESIDIO or its
Affiliates.
Section
5.15 Costs
and Expenses.
Except
as otherwise expressly set forth herein, each Party shall bear its own costs
and
expenses incurred in connection with the performance of its obligations
hereunder.
Article
VI
Intellectual
Property Protection and Related Matters
Section
6.1 Prosecution
and Maintenance of Licensed Patent Rights.
(a) Right
to Prosecute and Maintain.
As
between the Parties, PRESIDIO shall have the first right to file and prosecute
patent applications and maintain patents within the Licensed Patent Rights.
Subject to Section 6.6 below, PRESIDIO shall use Commercially Reasonable Efforts
to file and prosecute patent applications and maintain patents within the
Licensed Patent Rights in the United States, Canada, the Major EU Countries
and
Japan in a manner that is intended to provide optimal protection for any
Licensed Products that PRESIDIO may Develop and/or Commercialize in such
countries, including without limitation seeking claims of reasonably broad
scope, to the extent permitted under applicable law. Notwithstanding the
foregoing, in the event that PRESIDIO decides to abandon or discontinue the
filing, prosecution or maintenance of any non-provisional patent application
or
patent within the Licensed Patent Rights in any such country, then PRESIDIO
shall notify XTL of such determination reasonably in advance of any loss of
rights by XTL with respect to such patent application or patent. Thereafter,
XTL
shall have the right, upon written notice to PRESIDIO, to file, prosecute and
maintain such non-provisional patent applications and patents, in its name
and
at its own expense, which patent applications and patents shall no longer be
deemed “Licensed Patent Rights” under this Agreement. Notwithstanding anything
in this Agreement to the contrary, XTL’s sole and exclusive remedy, and
PRESIDIO’s sole and exclusive liability, for any decision by PRESIDIO not to
file, prosecute and/or maintain any patent applications or patents hereunder
shall be for XTL to assume such filing, prosecution and maintenance activities
with respect to such patent applications or patents pursuant to this Section
6.1.
(b) Disclosure
of New Inventions.
XTL
shall, and shall cause its Affiliates to, disclose to PRESIDIO any and all
new
inventions or other Know-How that (i) would constitute subject matter with
respect to which a patent application within the Licensed Patent Rights may
be
filed hereunder or would otherwise constitute Licensed Technology hereunder,
and
(ii) becomes Controlled by XTL or any of its Affiliates during the term of
this
Agreement. XTL shall, and shall cause its Affiliates to, disclose such
inventions or other such Know-How to PRESIDIO within ***** days after such
Control exists, including without limitation reasonably detailed information
with respect to such inventions or other such Know-How to enable PRESIDIO to
obtain appropriate patent protection with respect to such inventions or other
Know-How.
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(c) Cooperation.
Subject
to Section 4.1(d), each Party agrees to cooperate with the other Party with
respect to the filing and prosecution of patent applications and maintenance
of
patents within the Licensed Patent Rights pursuant to this Section 6.1,
including without limitation:
(i) the
execution of all such documents and instruments and the performance of such
acts
as may be reasonably necessary in order to permit the other Party to file and
prosecute patent applications or maintain patents as provided for in Section
6.1(a);
(ii) making
its employees, agents and consultants reasonably available to the other Party
(or to the other Party’s authorized attorneys, agents or representatives), to
the extent reasonably necessary to enable such other Party to file and prosecute
patent applications or maintain patents as provided for in Section 6.1(a);
and
(iii) to
provide the other Party with copies of all material official communications
received from, or filed with, the relevant patent offices pertaining to the
filing and prosecution of patent applications and maintenance of patents as
provided for in Section 6.1(a).
Section
6.2 Third
Party Infringement.
(a) Notifications
of Third Party Infringement.
Each
Party agrees to notify the other Party when it becomes aware of any infringement
of the Licensed Patent Rights or misappropriation of Licensed Technology, or
the
reasonable probability of such infringement or misappropriation, arising from
or
relating to the development, manufacture, offer for sale, sale, import or other
use of any Third Party product.
(b) Infringement
Action.
PRESIDIO shall decide whether to institute an infringement suit or take other
appropriate action that it believes is reasonably required to protect the
Licensed Patent Rights or Licensed Technology from such infringement or
misappropriation. In the event that PRESIDIO brings an action pursuant to this
Section 6.2(b), XTL shall cooperate with PRESIDIO to the extent reasonably
requested by PRESIDIO, including without limitation joining the suit if
requested by PRESIDIO and necessary or desirable.
(c) Costs.
PRESIDIO shall assume and pay all of its own and XTL’s out-of-pocket costs
incurred in connection with any litigation or proceedings described in this
Section 6.2; provided,
however,
that
if XTL
elects to be represented in such litigation or proceedings by separate counsel,
XTL shall assume and pay for all of its own out-of-pocket costs incurred in
connection with such litigation or proceedings.
(d) Recoveries.
Any
recovery obtained by PRESIDIO as a result of any action or proceeding described
in this Section 6.2, or from any counterclaim or similar claim asserted in
a
proceeding described in Section 6.3, by settlement or otherwise, shall be
applied in the following order of priority:
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Confidential
material omitted and filed separately with the Commission.
(i) first,
to
reimburse PRESIDIO for all litigation costs in connection with such proceeding
paid by PRESIDIO and not otherwise recovered; and
(ii) second,
the remainder of the recovery shall be paid *****.
Section
6.3 Claimed
Infringement.
In the
event that a Party becomes aware of any claim that the Development or
Commercialization of Licensed Products infringes Patent Rights or
misappropriates the Know-How of any Third Party, such Party shall promptly
notify the other Party.
Section
6.4 Patent
Invalidity Claim.
If a
Third Party at any time asserts a claim that any Licensed Patent Right is
invalid, unenforceable and/or otherwise not infringed (an “Invalidity
Claim”),
whether as a defense in an infringement action brought by PRESIDIO pursuant
to
Section 6.2 or in an action brought against PRESIDIO or XTL referred to in
Section 6.3, PRESIDIO shall have the right to prepare and formulate all
responses to, and defend and settle, such Invalidity Claim. XTL shall cooperate
with PRESIDIO with respect to such activities upon reasonable request by
PRESIDIO.
Section
6.5 Patent
Marking.
PRESIDIO agrees to comply with any applicable patent marking statutes in each
country in which Licensed Products are sold by PRESIDIO and/or its
Affiliates.
Section
6.6 Certain
Limitations.
Without
limiting the representations, warranties and covenants provided by XTL pursuant
to Section 8.5, the Parties acknowledge that PRESIDIO may not be permitted
to
exercise all of the rights set forth in this Article VI with respect to Licensed
Patent Rights that are not owned by XTL. Under such circumstances, XTL shall
use
reasonable efforts to obtain such rights for PRESIDIO and XTL shall provide
prompt written notice to PRESIDIO of any such limitations on PRESIDIO’s rights
under this Article VI. The existence of any such limitations, or XTL’s inability
to avoid or eliminate any such limitations (provided XTL has used reasonable
efforts to do so and subject to Section 8.5), shall not constitute a breach
of
this Agreement by XTL.
Article
VII
Confidentiality
Section
7.1 Confidential
Information.
All
Confidential Information disclosed by a Party to the other Party during the
term
of this Agreement shall not be used by the receiving Party except in connection
with the activities contemplated by this Agreement, shall be maintained in
confidence by the receiving Party (except to the extent disclosure is reasonably
necessary for Development and/or Commercialization of Licensed Products, for
the
filing, prosecution and maintenance of Patent Rights or to enforce the
provisions of this Agreement), and shall not otherwise be disclosed by the
receiving Party to any other person, firm, or agency, governmental or private
(except as set forth Sections 7.2 or 7.3), without the prior written consent
of
the disclosing Party, except to the extent that the Confidential
Information:
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(a) was
known
or used by the receiving Party prior to its date of disclosure to the receiving
Party; or
(b) either
before or after the date of the disclosure to the receiving Party is lawfully
disclosed to the receiving Party by sources other than the disclosing Party
rightfully in possession of the Confidential Information; or
(c) either
before or after the date of the disclosure to the receiving Party becomes
published or generally known to the public through no fault or omission on
the
part of the receiving Party; or
(d) is
independently developed by or for the receiving Party without reference to
or
reliance upon the Confidential Information; or
(e) is
required to be disclosed by the receiving Party to comply with applicable laws,
regulations or rules, to defend or prosecute litigation or to comply with legal
process, provided that
the
receiving Party provides prior written notice of such disclosure to the
disclosing Party and only discloses Confidential Information of the other Party
to the extent necessary for such legal compliance or litigation
purpose.
Section
7.2 Employee,
Director, Consultant and Advisor Obligations.
PRESIDIO and XTL each agrees that it and its Affiliates shall provide
Confidential Information received from the other Party only to the receiving
Party’s respective (a) employees, directors, consultants and advisors, and to
the employees, directors, consultants and advisors of the receiving Party’s
Affiliates, who have a need to know such Confidential Information to assist
the
receiving Party in fulfilling its obligations under this Agreement, and (b)
existing and prospective investors, acquirers, lenders, sublicensees,
collaborators and Third Party contractors engaged in the Development and/or
Commercialization of Licensed Compounds or Licensed Products, or in connection
with such Party’s financing activities; provided that
PRESIDIO
and XTL shall each remain responsible for any failure by any Person included
in
the foregoing clauses (a) and (b) to treat such Confidential Information as
required under Section 7.1.
Section
7.3 Publicity.
(a) Upon
execution of this Agreement, the Parties shall issue separate press releases,
in
form and substance mutually-agreed by the Parties, announcing the execution
of
this Agreement, a copy of each of which is attached hereto as Exhibit
F.
During
the term of this Agreement, neither Party nor its Affiliates shall disclose
this
Agreement or make any public announcement, press release, filing or other
disclosure concerning the existence, terms and conditions of this Agreement
without the other Party’s prior written consent (which consent shall not be
unreasonably withheld, conditioned or delayed), except (i) as set forth in
Section 7.3(b) below, (ii) as required to comply with applicable laws,
regulation or rules (including without limitation any rules of the United States
Securities and Exchange Commission or similar regulatory agency, stock exchange
or securities trading institution of such other jurisdictions whose laws may
apply to a Party), or (iii) to existing and prospective investors, acquirers,
lenders and other Third Parties in connection with such Party’s financing
activities, provided,
that
each
such Third Party is bound to treat such information as confidential. If a Party
is required to make any such disclosure under applicable law, regulation or
rule, such Party shall provide the other Party with a copy of the proposed
text
of any such written disclosure or the proposed content of any non-written
disclosure, sufficiently in advance (to the extent practicable or permitted
under applicable law, regulation or rule) of the scheduled release or disclosure
thereof to afford the other Party a reasonable opportunity to review and comment
upon such proposed disclosure and/or obtain confidential treatment with respect
to such proposed disclosure.
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Confidential
material omitted and filed separately with the
Commission.
(b) Notwithstanding
the foregoing, (i) PRESIDIO and/or any of its Affiliates and Third Party
sublicensees shall have the right to disclose, in private communications, public
announcements, press releases, filings or other disclosures, information
concerning or related to its or their Development and Commercialization
activities with respect to Licensed Products hereunder, and (ii) each Party
and/or any of such Party’s Affiliates and/or, with respect to PRESIDIO, Third
Party sublicensees, shall have the right to disclose information that is the
same or substantially similar to information that has previously been disclosed
under this Section 7.3; in the case of each of the foregoing clauses (i) and
(ii), without having to grant the other Party the opportunity to review and
comment on such proposed disclosure or obtain such other Party’s prior written
consent.
Section
7.4 Term.
All
obligations of confidentiality imposed under this Article VII shall expire
*****
following termination or expiration of this Agreement.
Article
VIII
Representations
and Warranties
Section
8.1 Representations
of Authority.
PRESIDIO and XTL each represents and warrants to the other that, as of the
Effective Date, it has full right, power and authority to enter into this
Agreement and to perform its respective obligations under this
Agreement.
Section
8.2 Consents.
PRESIDIO and XTL each represents and warrants that as of the Effective Date
all
necessary consents, approvals and authorizations of all government authorities
and other Persons required to be obtained by such Party in connection with
the
execution, delivery and performance of this Agreement have been
obtained.
Section
8.3 No
Conflict.
PRESIDIO and XTL each represents and warrants that, as of the Effective Date,
the execution and delivery of this Agreement and the performance of such Party’s
obligations hereunder (a) do not conflict with or violate any requirement of
applicable laws or regulations, and (b) do not conflict with, violate or breach
or constitute a default of, or require any consent under, any contractual
obligations of such Party, except such consents as have been obtained as of
the
Effective Date.
Section
8.4 Employee,
Director, Consultant and Advisor Obligations.
PRESIDIO and XTL each represents and warrants that, as of the Effective Date,
each of its and its Affiliates’ employees, directors, consultants and advisors
has executed an agreement or has an existing obligation under law obligating
such employee, director, consultant or advisor to maintain the confidentiality
of Confidential Information to the extent required under Article
VII.
Section
8.5 Intellectual
Property.
XTL
represents, warrants and covenants to PRESIDIO that:
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Confidential
material omitted and filed separately with the
Commission.
(a) VivoQuest
has assigned to XTL all right, title and interest in and to the VivoQuest
Licensed Patents, a complete and accurate list of which VivoQuest Licensed
Patents are included on Exhibit
D
and
Exhibit
E.
XTL is
the sole and exclusive owner (subject to Section 2.4) of all right, title and
interest in and to the VivoQuest Licensed Patents and the other Patent Rights
set forth on Exhibit
D
and
Exhibit
E,
and, as
of the Effective Date, is the sole and exclusive owner of all right, title
and
interest in and to, or has obtained exclusive rights to, the Licensed Compounds
and Licensed Technology;
(b) Each
of
XTL’s and its Affiliates’ current and former employees, directors, consultants
and contractors has executed an agreement assigning to XTL or XTL’s Affiliate
all of its or his or her right, title and interest in and to any inventions
developed in the course of its or his or her employment or engagement with
XTL
or XTL’s Affiliate, and such agreements are valid and binding on all such
current and former employees, directors, consultants and
contractors;
(c) To
the
Knowledge of XTL, each patent and patent application included within the
Licensed Patent Rights sets forth a complete and accurate list of all
inventors;
(d) XTL
has
the right to grant to PRESIDIO the rights and licenses to Licensed Compounds,
Licensed Patent Rights and Licensed Technology granted in this
Agreement;
(e) XTL
and
its Affiliates have not granted, and during the term of this Agreement XTL
will
not grant and will cause its Affiliates not to grant, any rights to any Third
Party (including without limitation VivoQuest or any of the counterparties
to
any Assigned Contracts) which would conflict with the rights granted to PRESIDIO
hereunder;
(f) None
of
the Licensed Patent Rights procured by XTL or its Affiliates and, to the
Knowledge of XTL, none of the Licensed Patent Rights procured by any Third
Party
was fraudulently procured from the relevant governmental patent granting
authority;
(g) To
the
Knowledge of XTL, the practice of the Licensed Patent Rights and Licensed
Technology as contemplated under this Agreement does not violate the
intellectual property rights of any Third Party, and, as of the Effective Date,
no claim, demand or suit has been made, or proceeding initiated, nor is any
such
claim, demand, suit or proceeding pending or threatened, that asserts the
invalidity, misuse or unenforceability of the Licensed Patent Rights or Licensed
Technology; *****;
(h) To
the
Knowledge of XTL, none of the Licensed Patent Rights are being infringed, nor
is
any Licensed Technology being misappropriated, by any Third Party;
(i) All
necessary registration, maintenance and renewal fees for Licensed Patent Rights
have been paid on time, *****;
(j) Exhibits
D and E
provide
a complete and accurate listing of the Licensed Patent Rights as of the
Effective Date, including without limitation the VivoQuest Licensed Patents,
and
XTL does not own or otherwise Control any Patent Rights other than the Patent
Rights listed on Exhibits
D and E
that
claim or disclose any Licensed Compounds or Licensed Technology;
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Confidential
material omitted and filed separately with the
Commission.
(k) Exhibit
C
provides
a complete and accurate listing of all Series 1 Compounds and Series 2-4
Compounds that are included in XTL’s and/or its Affiliates’ databases,
laboratory notebooks and/or other records, or that have otherwise been
identified, studied, screened or evaluated by XTL and/or its Affiliates,
regardless of whether or not such compounds have been synthesized by XTL or
any
of its Affiliates;
(l) *****;
(m) Attached
as Exhibits
A and B
are all
complete and accurate copies of all Third Party agreements to which XTL or
any
XTL Affiliate is a party as of (or, solely with respect to the Assigned
Contracts, immediately prior to) the Effective Date relating to the Licensed
Compounds, Licensed Patent Rights and/or Licensed Technology. Except for the
VivoQuest License Agreement, the VivoQuest Asset Purchase Agreement and Assigned
Contracts, neither XTL nor any XTL Affiliate, as of (or, except for the Assigned
Contracts, immediately prior to) the Effective Date, is a party to, or is
otherwise bound by, any agreement pursuant to which any Third Party has any
economic or other interest with respect to the Development and/or
Commercialization of the Licensed Compounds or Licensed Products, or any
ownership rights in any of the Licensed Compounds, Licensed Patent Rights and/or
Licensed Technology;
(n) The
VivoQuest License Agreement, the VivoQuest Asset Purchase Agreement and all
Assigned Contracts are in full force and effect, and XTL and/or its Affiliates
are in full compliance with the terms of such agreements, *****, no dispute
presently exists, nor has XTL received any notice of any such claim of breach
or
dispute nor, to the Knowledge of XTL, is any such claim pending or threatened,
between XTL and the counterparty to any such agreement that would jeopardize
any
of the rights or licenses granted to PRESIDIO under this Agreement, and, to
the
Knowledge of XTL, there is no basis for any such claim of breach or
dispute;
(o) During
the term of this Agreement, XTL shall, and shall cause its Affiliates to,
comply
with all terms and conditions of, and shall not, and shall cause its Affiliates
not to, without the prior written consent of PRESIDIO, amend, terminate,
or make
or waive any claims or rights under, or grant any rights to VivoQuest or
any
other Third Party in connection with, the VivoQuest License Agreement or
the
VivoQuest Asset Purchase Agreement, in any manner that would adversely affect
the rights granted to PRESIDIO under this Agreement, or take any action or
fail
to take any action that would give VivoQuest the right to amend or terminate
the
VivoQuest License Agreement or the VivoQuest Asset Purchase Agreement or
would
otherwise adversely affect the rights granted to PRESIDIO under this
Agreement;
(p) XTL
and
its Affiliates have obtained all necessary consents to assign the Assigned
Contracts to PRESIDIO hereunder;
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Confidential
material omitted and filed separately with the Commission.
(q) To
the
Knowledge of XTL, all written statements and other writings furnished by XTL
or
its Affiliates pursuant to or in connection with this Agreement or the
transactions contemplated hereby are complete and accurate in all material
respects. No representation or warranty by XTL in this Agreement contains any
untrue statement of a material fact or omits to state any material fact
necessary in order to make any statement contained herein not misleading. To
the
Knowledge of XTL, there is no fact, event or condition that would adversely
affect PRESIDIO’s rights under this Agreement that has not been set forth in
this Agreement or disclosed by XTL to PRESIDIO in writing; and
(r) *****.
The
term
“Knowledge” means the actual knowledge of ***** as of the Effective Date. For
avoidance of doubt, anything to the contrary herein notwithstanding, XTL makes
no representations or warranties with respect to any Derivative
Compounds.
Section
8.6 No
Warranties
. EXCEPT
AS OTHERWISE EXPRESSLY SET FORTH HEREIN, THE PARTIES MAKE NO REPRESENTATIONS
AND
EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. IN PARTICULAR, PRESIDIO EXPRESSLY DISCLAIMS ANY REPRESENTATION OR
WARRANTY THAT ANY LICENSED COMPOUND OR LICENSED PRODUCT WILL BE SUCCESSFULLY
DEVELOPED OR COMMERCIALIZED.
Article
IX
Term
and Termination
Section
9.1 Term
. This
Agreement shall become effective as of the Effective Date, may be terminated
as
set forth in this Article IX, and otherwise remains in effect until the
expiration of all of PRESIDIO’s payments obligations pursuant to Article V. Upon
expiration of this Agreement, on a Licensed Product-by-Licensed Product and
country-by-country basis, the license granted to PRESIDIO under Section 2.1
shall convert to a non-exclusive, perpetual, fully paid-up, non-royalty-bearing
license.
Section
9.2 Termination
For Material Breach
. Upon
any material breach of this Agreement by either Party (in such capacity, the
“Breaching
Party”),
the
other Party may terminate this Agreement by providing ***** days’ written notice
to the Breaching Party, specifying the material breach. The termination shall
become effective at the end of the ***** day period unless (a) the Breaching
Party cures such material breach during such ***** day period or (b) if the
material breach is not susceptible to cure within such ***** day period, the
Breaching Party is diligently pursuing a cure and effects such cure within
an
additional ***** days after the end of such initial ***** day period.
Notwithstanding any of the foregoing, (x) if the non-Breaching Party gives
the
Breaching Party notice pursuant to this Section 9.2 of a material breach by
such
Breaching Party, and the Breaching Party notifies the non-Breaching Party within
the applicable cure period set forth in the immediately preceding sentence
that
such Breaching Party disputes such basis for termination pursuant to this
Section 9.2, then this Agreement shall not terminate unless and until the
arbitrator issues a final award pursuant to Article X upholding such basis
for
termination (or unless and until the Breaching Party is no longer disputing
such
basis, if earlier) and within ***** days thereafter the Breaching Party fails
to
comply with the terms of such final award issued by the arbitrator, and (y)
if
any uncured material breach by PRESIDIO of its diligence obligations under
Section 4.2 is limited to only one or two of the following territories, then
XTL
may terminate this Agreement solely with respect to such territory or
territories: (i) the EU, (ii) the United States, and (iii) Japan. Both Parties
shall perform all of their respective obligations hereunder during the process
of conducting any dispute resolution hereunder, including without limitation,
the payment of all undisputed amounts as and when they become due and payable
hereunder.
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Confidential
material omitted and filed separately with the Commission.
Section
9.3 Termination
for Convenience
.
PRESIDIO may terminate this Agreement at any time upon ***** days prior written
notice to XTL for any or no reason.
Section
9.4 Effect
of Material Breach or Patent Validity Challenge by XTL or its
Affiliates.
(a) In
the
event that this Agreement is terminated by PRESIDIO pursuant to Section 9.2
above as a result of XTL’s uncured material breach (other than a material breach
by a Third Party acquirer of XTL, or by XTL or any of its Affiliates, following
an acquisition transaction resulting in a change of control of XTL or of all
or
substantially all of its business or assets), then PRESIDIO shall have the
option of (i) actually terminating this license, in which case the provisions
of
Section 9.5(c) shall apply and become effective, and pursuing any remedies
that
may be available to it hereunder or at law, or (ii) not exercising such
termination right and continuing the licenses and this Agreement, in accordance
with the terms and conditions set forth herein, provided that (A) the amounts
that become due under Article V shall, as of the date of such waiver and for
the
remainder of the term of this Agreement, be reduced by ***** (after application
of all other reductions and offsets that may be applicable); provided that
the
amounts provided in Section 5.8 shall remain due and payable in full in
accordance with the terms set forth in Section 5.8 and (B) PRESIDIO shall cease
to have any further obligation pursuant to Article IV as of the date of such
waiver and for the remainder of the term of this Agreement.
(b) If
(i)
XTL or any of its Affiliates intentionally initiates, or encourages or knowingly
provides assistance to any Third Party with respect to, any action seeking
a
determination that any of the Licensed Patent Rights in any country are invalid,
unenforceable and/or not infringed (including without limitation a request
for
reexamination of any Licensed Patent Rights or the institution of or
participation in any opposition, interference or similar administrative
proceeding adverse to the validity or enforceability of any Licensed Patent
Rights) (“Validity
Challenge”)
or
(ii) a Third Party acquirer of XTL, or XTL or any of its Affiliates, following
an acquisition transaction resulting in a change of control of XTL or of all
or
substantially all of its business or assets, materially breaches this Agreement
and fails to cure the breach such that PRESIDIO has the right to terminate
this
Agreement pursuant to Section 9.2 above, then (A) the license granted to
PRESIDIO under Section 2.1 shall automatically convert to a perpetual, fully
paid-up, non-royalty-bearing license; provided that the amounts provided in
Section 5.8 shall remain due and payable in full in accordance with the terms
set forth in Section 5.8 and (B) PRESIDIO shall cease to have any further
obligation pursuant to Article IV or Article V (other than Section 5.8 and,
to
the extent applicable to payments owed to VivoQuest, Sections 5.9, 5.10 and
5.11).
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Confidential
material omitted and filed separately with the Commission.
(c) The
reduction of payments in connection with PRESIDIO’s election not to exercise its
termination right referenced above in Section 9.4(a)(ii) and in connection
with
the license conversion referenced above in Section 9.4(b) is used for the
convenience of the Parties and is not intended to be a penalty to be paid by
XTL. The Parties acknowledge that there will be difficulties in proving the
amount and extent of PRESIDIO’s losses resulting from such uncured material
breach or Validity Challenge. The Parties also agree that the compensation
attributable to such reduction of payments is a reasonable pre-estimate of
the
probable losses which would be suffered by PRESIDIO.
Section
9.5 Effects
of Termination.
(a) If
this
Agreement is terminated in its entirety by XTL as a result of PRESIDIO’s uncured
material breach pursuant to Section 9.2 above, or on a territory-by-territory
basis as a result of PRESIDIO’s uncured material breach of its diligence
obligations with respect to a territory as described in Section 9.2(y) above,
then the following provisions shall be applicable:
(i) In
each
of the above instances of a termination of this Agreement, XTL shall have the
right to terminate the license granted by XTL to PRESIDIO under Section 2.1,
subject to Section 9.6 below and, in the case of an uncured material breach
by
PRESIDIO of its diligence obligations which breach is limited to only one or
two
of the territories identified in Section 9.2(y), the termination shall be
limited to such territory(ies); and
(ii) PRESIDIO
shall return to XTL all Licensed Technology and other items delivered by XTL
to
PRESIDIO pursuant to Section 3.1, to the extent such Licensed Technology and
other items remain in existence as of such termination; provided that PRESIDIO
shall not be required to return the Licensed Technology or other items delivered
by XTL to PRESIDIO pursuant to Section 3.1 if XTL terminates PRESIDIO’s rights
hereunder only in regard to certain territories and not the entire Territory
as
provided in Section 9.2(y) above; and
(iii) PRESIDIO
shall not, directly or with or through its Affiliates, and subject to Section
9.6 below, Third Party sublicensees or other Third Parties, continue the
Commercialization of any Licensed Compounds or Licensed Products for a period
of
***** following such termination, such restriction to apply to the entire
Territory if XTL
terminates the Agreement pursuant to Section 9.2, and, if such termination
is
only applicable to certain territories, then such restriction shall apply only
to the territories to which such termination applies; provided that
if, at
the time of such termination, PRESIDIO and/or any of its Affiliates and/or
Third
Party sublicensees is engaged in the Commercialization of Licensed Products
and
has commercial inventory (including work-in-process inventory) of Licensed
Products, PRESIDIO and/or such Affiliate(s) and/or Third Party sublicensee(s)
may complete the manufacture of any work-in-process inventory and continue
to
commercially distribute and sell all such existing inventory following
termination, subject to PRESIDIO continuing to pay XTL all amounts due under
this Agreement with respect to such continuing Commercialization.
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Confidential
material omitted and filed separately with the Commission.
(b) If
this
Agreement is terminated by PRESIDIO pursuant to Section 9.3, then the following
provisions shall be applicable:
(i) The
license granted by XTL to PRESIDIO under Section 2.1 shall terminate; and
(ii) PRESIDIO
shall return to XTL all Licensed Technology and other items delivered by XTL
to
PRESIDIO pursuant to Section 3.1, to the extent such Licensed Technology and
other items remain in existence as of such termination; and
(iii) PRESIDIO
shall not, directly or with or through its Affiliates, Third Party sublicensees
or other Third Parties, continue the Development and Commercialization of any
Licensed Compounds or Licensed Products for a period of ***** following such
termination.
(c) If
this
Agreement is terminated by PRESIDIO as described in Section 9.4(a)(i), then
the
following provisions shall be applicable:
(i) The
license granted by XTL to PRESIDIO under Section 2.1 shall terminate; and
(ii) PRESIDIO
shall return to XTL all Licensed Technology and other items delivered by XTL
to
PRESIDIO pursuant to Section 3.1, to the extent such Licensed Technology and
other items remain in existence as of such termination; and
(iii) PRESIDIO
shall not, directly or with or through its Affiliates, Third Party sublicensees
or other Third Parties, continue the Commercialization of any Licensed Compounds
or Licensed Products for a period of ***** following such
termination.
(d) The
license termination and other rights set forth in this Section 9.5 shall,
subject to Section 4.2, be in addition to any and all other remedies that XTL
may have in connection with such a termination of this Agreement.
Section
9.6 Survival
. Upon
expiration or termination of this Agreement for any reason, nothing in this
Agreement shall be construed to release either Party from any obligations that
accrue prior to the effective date of expiration or termination, and the
following provisions shall expressly survive any such expiration or termination:
Section 2.2, Section 2.5, Section 9.1, Section 9.4, Section 9.5, this Section
9.6 and Article V (solely as pertaining to payment obligations (a) that are
due
and payable as of the effective date of termination or expiration, (b) that
have
accrued prior to the date of termination or expiration but for which the payment
due date falls after the date of termination or expiration or (c) that become
payable after termination pursuant to Section 9.5(a)(iii)), Article VII, Article
X and Article XI. In addition, any sublicense granted by PRESIDIO and/or any
of
its Affiliates to a Third Party under the license granted by XTL to PRESIDIO
in
Section 2.1 shall survive expiration or termination of this Agreement,
provided that
such
termination did not arise out of the actions of such Third Party; provided further that
the
Third Party continues to comply in all material respects with the terms and
conditions of such sublicense.
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Confidential
material omitted and filed separately with the Commission.
Article
X
Dispute
Resolution
Section
10.1 Referral
to Senior Executives
. Except
as set forth in Section 3.2(b), any dispute arising out of or relating to this
Agreement shall first be referred to the Senior Executives of both Parties
for
resolution. Such Senior Executives shall attempt in good faith to resolve such
dispute within ***** days following such referral. If the Senior Executives
cannot resolve such dispute within such ***** day period, then either Party
may
make a written demand for formal dispute resolution pursuant to Section
10.2.
Section
10.2 Mediation
. If the
Senior Executives are unable to resolve any dispute referred to them as set
forth in Section 10.1, such dispute shall then be referred to non-binding
mediation upon either Party’s written demand for formal dispute resolution. Such
mediation shall be conducted by an impartial mediator in accordance with The
CPR
Mediation Procedure for Business Disputes (Revised 1998) of the CPR Institute
for Dispute Resolution (“CPR”).
The
Parties shall select, by mutual agreement, a mediator who has had both training
and experience as a mediator of general corporate and commercial matters in
the
biotechnology and/or pharmaceutical industry. If the Parties cannot agree upon
the selection of the mediator within ***** days after initiation thereof, the
mediator shall be appointed by the President of the CPR in accordance with
the
criteria set forth in the preceding sentence. Within ***** days after the
selection of the mediator, the Parties and their respective legal counsel will
meet with the mediator for one mediation session of at least four hours. If
any
dispute cannot be settled during such mediation session or during any mutually
agreed continuation of such session, either Party may give to the mediator
and
the other Party written notice declaring the mediation process at an end, and
such dispute will be resolved by binding arbitration pursuant to Section 10.3
below. The costs of any mediation pursuant to this Section 10.2 will be shared
equally by the Parties.
Section
10.3 Arbitration.
(a) If
any
dispute is not resolved by the Senior Executives pursuant to Section 10.1 or
through mediation pursuant to Section 10.2, either Party may submit such dispute
to arbitration upon written notice to the other Party. Within ***** days after
receipt of such notice, the Parties shall designate in writing a single
arbitrator to resolve the dispute; provided,
however,
that
if the
Parties cannot agree on an arbitrator within such ***** day period, the
arbitrator shall be selected by the International Centre for Dispute Resolution
(the “ICDR”).
The
arbitrator shall be a lawyer with biotechnology and/or pharmaceutical industry
legal experience, and shall not be an Affiliate, employee, consultant, officer,
director or stockholder of any Party.
(b) Within
***** days after the designation of the arbitrator, the arbitrator and the
Parties shall meet, at which time the Parties shall be required to set forth
in
writing all disputed issues and a proposed ruling on the merits of each such
issue.
(c) The
arbitrator shall set a date for a hearing, which shall be no later than *****
days after the submission of written proposals pursuant to Section 10.3(b),
to
discuss each of the issues identified by the Parties. The Parties shall have
the
right to be represented by counsel. Except as provided herein, the arbitration
shall be governed by the International Dispute Resolution Procedures of the
ICDR; provided,
however,
that
the United States Federal Rules of Evidence shall apply with regard to the
admissibility of evidence and the arbitration shall be conducted by a single
arbitrator.
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Confidential
material omitted and filed separately with the Commission.
(d) The
arbitrator shall use his or her best efforts to rule on each disputed issue
within ***** days after the completion of the hearings described in Section
10.3(c). The determination of the arbitrator as to the resolution of any dispute
shall be binding and conclusive upon all Parties. All rulings of the arbitrator
shall be in writing and shall be delivered to the Parties.
(e) The
(i)
attorneys’ fees of the Parties in any arbitration, (ii) fees of the arbitrator
and (iii) costs and expenses of the arbitration shall be borne by the Parties
as
determined by the arbitrator.
(f) Any
arbitration pursuant to this Section 10.3 shall be conducted in New York, New
York. Any arbitration award may be entered in and enforced by any court of
competent jurisdiction.
Section
10.4 No
Limitation
.
Nothing in Section 10.1, Section 10.2 or Section 10.3 shall be construed as
limiting in any way the right of a Party to seek an injunction or other
equitable relief with respect to any actual or threatened breach of this
Agreement or to bring an action in aid of arbitration. Should any Party seek
an
injunction or other equitable relief, or bring an action in aid of arbitration,
then for purposes of determining whether to grant such injunction or other
equitable relief, or whether to issue any order in aid of arbitration, the
dispute underlying the request for such injunction or other equitable relief,
or
action in aid of arbitration, may be heard by the court in which such action
or
proceeding is brought.
Article
XI
Miscellaneous
Provisions
Section
11.1 Indemnification.
(a) PRESIDIO.
PRESIDIO agrees to defend XTL, its Affiliates and their respective directors,
officers, employees and agents at PRESIDIO’s cost and expense, and shall
indemnify and hold harmless XTL and its Affiliates and their respective
directors, officers, employees and agents from and against any liabilities,
losses, costs, damages, fees or expenses (including without limitation
reasonable attorneys’ fees) arising out of any Third Party claim relating to or
arising out of (i) any breach by PRESIDIO of any of its representations,
warranties or covenants pursuant to this Agreement, (ii) any failure by PRESIDIO
to make payment of any Pass-Through Costs which are payable by PRESIDIO under
this Agreement as a result of the Development and/or Commercialization of
Licensed Products by PRESIDIO or its Affiliates or Third Party sublicensees,
(iii) any liabilities and obligations of PRESIDIO under the Assigned Contracts
that arise after the date of assignment of such Assigned Contracts to PRESIDIO
hereunder, excluding the Retained Liabilities, (iv) any action by PRESIDIO
in
breach of this Agreement causing a breach of the VivoQuest License Agreement,
(v) any action by PRESIDIO causing a breach of any Additional Third Party
Agreements or any Assigned Contracts, or (vi) the Development and/or
Commercialization of a Licensed Product by PRESIDIO or its Affiliates or Third
Party sublicensees, in each case except to the extent that such claim relates
to
or arises out of any breach by XTL of any of its representations or warranties
pursuant to this Agreement or any breach by XTL or its Affiliates of the
VivoQuest License Agreement, the VivoQuest Asset Purchase Agreement or any
Assigned Contract.
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Confidential
material omitted and filed separately with the Commission.
(b) XTL.
XTL
agrees to defend PRESIDIO, its Affiliates and their respective directors,
officers, employees and agents at XTL’s cost and expense, and shall indemnify
and hold harmless PRESIDIO and its Affiliates and their respective directors,
officers, employees and agents from and against any liabilities, losses, costs,
damages, fees or expenses (including without limitation reasonable attorneys’
fees) arising out of (i) any Third Party claim relating to or arising out
of (A) any breach by XTL of any of its representations, warranties or covenants
pursuant to this Agreement, (B) any liabilities and obligations of XTL and/or
its Affiliates under the Assigned Contracts that have accrued prior to the
date
of assignment of such Assigned Contracts to PRESIDIO hereunder (the
“Retained
Liabilities”),
or
(C) without limiting the foregoing clauses (A) or (B), or any of XTL’s
representations, warranties or covenants in Section 8.5, any breach by XTL
or
its Affiliates of the VivoQuest License Agreement, the VivoQuest Asset Purchase
Agreement or any Assigned Contract; (ii) any claim by any existing or former
employee, director, shareholder or consultant of XTL or any of its Affiliates,
or of VivoQuest, to any right, title or interest in any of the Licensed Patent
Rights, Licensed Compounds or Licensed Technology which, if such claim were
successful, would limit or impair any of the rights granted hereunder to
PRESIDIO; *****.
(c) Claims
for Indemnification.
A
Person entitled to indemnification under this Section 11.1 (an “Indemnified
Party”)
shall
give prompt written notification to the Person from whom indemnification is
sought (the “Indemnifying
Party”)
of the
commencement of any action, suit or proceeding relating to a Third Party claim
for which indemnification may be sought or, if earlier, upon the assertion
of
any such claim by a Third Party (it being understood and agreed, however, that
the failure by an Indemnified Party to give notice of a third-party claim as
provided in this Section 11.1(c) shall not relieve the Indemnifying Party of
its
indemnification obligation under this Agreement except and only to the extent
that such Indemnifying Party is actually damaged as a result of such failure
to
give notice). Within ***** days after delivery of such notification, the
Indemnifying Party may, upon written notice thereof to the Indemnified Party,
assume control of the defense of such action, suit, proceeding or claim with
counsel reasonably satisfactory to the Indemnified Party. If the Indemnifying
Party does not assume control of such defense, the Indemnified Party shall
control such defense. The Party not controlling such defense may participate
therein at its own expense; provided that,
if the
Indemnifying Party assumes control of such defense and the Indemnified Party
reasonably concludes, based on advice from counsel, that the Indemnifying Party
and the Indemnified Party have conflicting interests with respect to such
action, suit, proceeding or claim, the Indemnifying Party shall be responsible
for the reasonable fees and expenses of counsel to the Indemnified Party solely
in connection therewith; provided,
however,
that
in no
event shall the Indemnifying Party be responsible for the fees and expenses
of
more than one counsel for all Indemnified Parties. The Party controlling such
defense shall keep the other Party advised of the status of such action, suit,
proceeding or claim and the defense thereof and shall consider recommendations
made by the other Party with respect thereto. The Indemnified Party shall not
agree to any settlement of such action, suit, proceeding or claim without the
prior written consent of the Indemnifying Party, which shall not be unreasonably
withheld, delayed or conditioned. The Indemnifying Party shall not agree to
any
settlement of such action, suit, proceeding or claim or consent to any judgment
in respect thereof that does not include a complete and unconditional release
of
the Indemnified Party from all liability with respect thereto or that imposes
any liability or obligation on the Indemnified Party without the prior written
consent of the Indemnified Party.
-33-
Section
11.2 Governing
Law
. This
Agreement shall be construed and the respective rights of the Parties determined
(including the validity and applicability of the arbitration provision set
forth
in Section 10.3, and the conduct of any arbitration, enforcement of any arbitral
award and any other questions of arbitration law or procedure arising
thereunder) according to the substantive laws of the State of New York, USA,
notwithstanding the provisions governing conflict of laws under such New York
law to the contrary.
Section
11.3 Assignment
.
Neither XTL nor PRESIDIO may assign this Agreement in whole or in part without
the consent of the other, except if such assignment occurs in connection with
the merger, sale or transfer of all or substantially all of the business and
assets of XTL, on the one hand, or PRESIDIO, on the other, to which the subject
matter of this Agreement pertains. Notwithstanding the foregoing, any Party
may
assign its rights (but not its obligations) pursuant to this Agreement in whole
or in part to an Affiliate of such Party, provided,
that
the
assigning Party shall remain primarily liable to the other Party for any breach
of this Agreement by such Affiliate.
Section
11.4 Entire
Agreement; Amendments
. This
Agreement (including all exhibits and attachments hereto) constitutes the entire
agreement between the Parties with respect to the subject matter hereof, and
supersedes all previous arrangements with respect to the subject matter hereof,
whether written or oral. Any amendment or modification to this Agreement shall
be made in writing signed by both Parties.
Section
11.5 Notices
. Any
notice required or provided for by the terms of this Agreement shall be in
writing and shall be (a) sent by registered or certified mail, return receipt
requested, postage prepaid, (b) sent via a reputable overnight or international
express courier service, (c) sent by facsimile transmission, or (d) personally
delivered, in each case properly addressed in accordance with the paragraph
below. The effective date of notice shall be the actual date of receipt by
the
Party receiving the same.
Notices
to XTL shall be addressed to:
000
Xxxxxxxxx Xxxx., Xxxxx X
Xxxxxx
Xxxxxxx, XX 00000
Attention:
Chief Executive Officer
Facsimile
No.:
000-000-0000
with
a
copy to:
Xxxxxxx
Procter
Exchange
Place
Boston,
MA 02109
Attention:
Xxxxxxxxxxx Xxxx
Facsimile
No.: 000-000-0000
Notices
to PRESIDIO shall be addressed to:
Presidio
Pharmaceuticals, Inc.
0000
Xxxxx Xxxxxx
Xxxxx
000
Xxx
Xxxxxxxxx, XX 00000
XXX
Attention:
President and Chief Executive Officer
Facsimile
No.: 415-986-2864
with
a
copy to:
WilmerHale
00
Xxxxx
Xxxxxx
Xxxxxx,
XX 00000
XXX
Attention:
Xxxxx X. Xxxxxxx, Esq.
Facsimile
No.: 000-000-0000
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Confidential
material omitted and filed separately with the Commission.
Any
Party
may change its address by giving notice to the other Party in the manner herein
provided.
Section
11.6 Force
Majeure
. No
failure or omission by a Party in the performance of any obligation of this
Agreement shall be deemed a breach of this Agreement or create any liability
if
the same shall arise from any cause or causes beyond the reasonable control
of
such Party, including, but not limited to, the following: acts of God; acts
or
omissions of any government; any rules, regulations or orders issued by any
governmental authority or by any officer, department, agency or instrumentality
thereof; fire; storm; flood; earthquake; accident; war; terrorism; rebellion;
insurrection; riot; and invasion. The Party claiming force majeure shall notify
the other Party with notice of the force majeure event as soon as practicable,
but in no event longer than ***** business days after its occurrence, which
notice shall reasonably identify such obligations under this Agreement and
the
extent to which performance thereof will be affected.
Section
11.7 Independent
Contractors
. It is
understood and agreed that the relationship between the Parties hereunder is
that of independent contractors and that nothing in this Agreement shall be
construed as authorization for either XTL or PRESIDIO to act as agent for the
other.
Section
11.8 No
Strict Construction
. This
Agreement has been prepared jointly and shall not be strictly construed against
any Party.
-35-
Section
11.9 Headings
. The
captions or headings of the sections or other subdivisions hereof are inserted
only as a matter of convenience or for reference and shall have no effect on
the
meaning of the provisions hereof.
Section
11.10 No
Implied Waivers; Rights Cumulative
. No
failure on the part of XTL or PRESIDIO to exercise, and no delay in exercising,
any right, power, remedy or privilege under this Agreement, or provided by
statute or at law or in equity or otherwise, shall impair, prejudice or
constitute a waiver of any such right, power, remedy or privilege or be
construed as a waiver of any breach of this Agreement or as an acquiescence
therein, nor shall any single or partial exercise of any such right, power,
remedy or privilege preclude any other or further exercise thereof or the
exercise of any other right, power, remedy or privilege.
Section
11.11 Severability
. If,
under applicable law or regulation, any provision of this Agreement is invalid
or unenforceable, or otherwise directly or indirectly affects the validity
of
any other material provision(s) of this Agreement (such invalid or unenforceable
provision, a “Severed
Clause”),
this
Agreement shall endure except for the Severed Clause. The Parties shall consult
one another and use reasonable efforts to agree upon a valid and enforceable
provision that is a reasonable substitute for the Severed Clause in view of
the
intent of this Agreement.
Section
11.12 Execution
in Counterparts
. This
Agreement may be executed in counterparts, each of which counterparts, when
so
executed and delivered, shall be deemed to be an original, and all of which
counterparts, taken together, shall constitute one and the same
instrument.
Section
11.13 No
Third Party Beneficiaries
. No
person or entity other than XTL, PRESIDIO and their respective Affiliates and
permitted assignees hereunder shall be deemed an intended beneficiary hereunder
or have any right to enforce any obligation of this Agreement.
Section
11.14 No
Consequential Damages
.
NEITHER PARTY HERETO WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL,
SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE
EXERCISE OF ITS RIGHTS HEREUNDER, OR FOR LOST PROFITS ARISING FROM OR RELATING
TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.
NOTHING IN THIS SECTION 11.14 IS INTENDED TO LIMIT OR RESTRICT THE
INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO THIRD
PARTY CLAIMS.
[Remainder
of This Page Intentionally Left Blank]
-36-
IN
WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective
Date.
PRESIDIO
PHARMACEUTICALS, INC.
|
|
By:
|
/s/
Xxxx X. Xxxxxx, Ph.D.
|
Name:
|
Xxxx
X. Xxxxxx, Ph.D.
|
Title:
|
President
and CEO
|
By:
|
/s/
Xxx Xxxxxxx
|
Name:
|
Xxx
Xxxxxxx
|
Title:
|
Chief
Executive Officer
|
-37-
Confidential
material omitted and filed separately with the Commission.
Exhibit
A
Assigned
Contracts
*****
*****
*****
Copies
of the foregoing contracts are attached hereto.
A-1
Exhibit
B
VivoQuest
Agreements
Copies
of the VivoQuest License Agreement and the VivoQuest Asset Purchase Agreement
are attached hereto.
B-1
Confidential
material omitted and filed separately with the Commission.
Exhibit
C
Series
1, 2, 3 and 4 Compounds in XTL Database and Other
Records
*****
C-1
Confidential
material omitted and filed separately with the Commission.
Exhibit
D
Series
1 Patent Rights as of the Effective Date
*****
D-1
Confidential
material omitted and filed separately with the Commission.
Exhibit
E
Series
2-4 Patent Rights as of the Effective Date
*****
E-1
Exhibit
F
Press
Releases
See
attached.
F-1
Confidential
material omitted and filed separately with the Commission.
Exhibit
G
*****
*****
*****
*****
*****
*****
G-1