AMENDED & RESTATED EXCLUSIVE LICENSE AGREEMENT
Portions
herein identified by [***] have been omitted pursuant to a
request
for
confidential treatment and have been filed separately with
the
Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of
1934
Exhibit
10.2
AMENDED
& RESTATED EXCLUSIVE LICENSE AGREEMENT
This
Amended & Restated Exclusive License Agreement (hereinafter referred to as
this “Agreement”), effective as of December 29, 2006 (the “Effective Date”), is
entered into by and between Asymmetric Therapeutics, LLC, (“Licensor”) a limited
liability company duly organized under the laws of the State of Delaware and
having a place of business at 000 Xxxx Xxxxxx, Xxxxxxxx, Xxx Xxxx 00000, Onc
Res, Inc., a corporation duly incorporated under the laws of the State of New
York (“Onc Res”) and having a place of business at 000 Xxxx Xxxxxx, Xxxxxxxx,
Xxx Xxxx 00000, Fiordland Pharmaceuticals, Inc., a corporation duly organized
and existing under the laws of the State of Delaware and having a place of
business at 000 Xxxxxxx Xxxxxx, 00xx
Xxxxx,
Xxx Xxxx, XX 00000 (the “Company”), and, for purposes of certain provisions
hereof, Stason Pharmaceuticals, Inc., a corporation duly incorporated under
the
laws the State of California (“Stason”) and having a place of business at 00
Xxxxxx, Xxxxxx, Xxxxxxxxxx 00000.
WHEREAS,
Licensor
is the sole owner of all right, title and interest in the Technology (as defined
below), the Patent Rights (as defined below), and Know How (as defined below)
related thereto;
WHEREAS,
Onc Res
is the sole owner of certain regulatory filings relating to the Technology,
and
possibly has some right, title, and interest to the Technology or Patent
Rights;
WHEREAS,
the
Company is interested in obtaining exclusive license under the Patent Rights
and
Know How in the Field of Use (as defined below) to make, have made, use, have
used, lease, import and export, offer to sell, sell have sold, produce,
manufacture, distribute and market products derived from such technologies;
and
WHEREAS,
Licensor
wishes to grant to the Company an exclusive license under the Patent Rights
and
Know How, in the Field of Use (as defined below) to make, have made, use, have
used, lease, import and export, offer to sell, sell have sold, produce,
manufacture, distribute and market products derived from such technologies;
WHEREAS,
Stason
Pharmaceuticals, Inc., a party to the JV Agreement, is willing to execute this
Agreement relating to certain Articles to induce the Company to execute this
Agreement; and
WHEREAS,
on December 29, 2006, the parties hereto executed an Exclusive License Agreement
(the “Original Agreement”) concerning the Technology and Patent Rights and that
it is the intent of the parties hereto that this Agreement will supersede and
replace such agreement in its entirety.
NOW,
THEREFORE,
in
consideration of the foregoing recitals, the premises and the mutual covenants
contained herein, the parties hereto, intending to be legally bound, agree
as
follows:
Article
1 Definitions
For
the
purposes of this Agreement, the following words and phrases shall have the
following meanings:
1.1 “Affiliate”
means,
with respect to any Person, any other Person which directly or indirectly
controls, is controlled by, or is under common control with, such Person. A
Person shall be regarded as in control of another Person if it owns, or directly
or indirectly controls, at least fifty percent (50%) of the voting stock or
other ownership interest of the other Person, or if it directly or indirectly
possesses the power to direct or cause the direction of the management and
policies of the other Person by any means whatsoever.
1.2 “Applicable
Law(s)”
means,
with respect to the United States, the FDCA (as defined below), all regulations
promulgated thereunder, and all other applicable laws, rules, regulations and
guidelines within the Territory that apply to the import, export, research
and
development, manufacture, marketing, distribution, or sale of Licensed Products
in the Field of Use in the Territory or the performance of either party’s
obligations under this Agreement (including disclosure obligations as required
by the United States Securities and Exchange Commission or other comparable
exchange or securities commission having authority over a party) to the extent
applicable and relevant to such party.
1.3 “Competent
Authority(ies)”
means
collectively the entities in each country in the Territory responsible for
(a)
the regulation of medicinal products intended for human use or the
establishment, maintenance and/or protection of rights related to the Patent
Rights, including but not limited to the FDA, the European Agency for Evaluation
of Medicinal Products (“EMEA”), and the Ministry of Health, Labor and Welfare in
Japan, and any other applicable administrative agency in any country in the
Territory having the aforementioned responsibilities, and any successor entities
thereto, (b) the establishment, maintenance and/or protection of rights
related to the Patent Rights, including the United States Patent and Trademark
Office (“USPTO”), and (c) any other applicable regulatory or administrative
agency in any country in the Territory that is comparable to, or a counterpart
of, the foregoing.
1.4 “Development”
means
the
Company’s, its Affiliates’, or Sublicensees’ use of commercially reasonable
efforts to secure Marketing Authorizations for Licensed Products in the
Territory.
1.5 “DMF”
means
a
drug master file, as provided for in 21 CFR § 314.420, or similar submission to
or file maintained with the FDA or other Competent Authority that may be used
to
provide confidential detailed information about facilities, processes, or
articles used in the manufacturing, processing, packaging, and storing of one
or
more human drugs.
1.6 “FDCA”
means
the
United States’ Federal Food, Drug, and Cosmetic Act, as amended, and the
regulations promulgated with respect thereto.
1.7 “FDA”
means
the
United States Food and Drug Administration and any successor entity
thereto.
2
1.8 “Field
of Use”
means
the
(i) use of uracil, its analogs, prodrugs, derivatives, metabolites, degradents,
and intermediates, alone or in combination with any device, pharmaceutical
ingredient, chemical or biologic, for the prevention or treatment of any
disease, state or condition in humans or animals and (ii) the use of any
pharmaceutical compositions, chemicals or biologics to treat Palmar-Plantar
Erythrodysesthesia (a/k/a "Hand-Foot Syndrome").
1.9 “First
Commercial Sale”
means,
with respect to any Licensed Product, the first sale of such Licensed Product
after all applicable Marketing Authorizations (if any) have been granted by
the
applicable Competent Authority(ies).
1.10 “Governmental
Approval(s)”
means
any
and all permits, licenses, approvals, and authorizations required by any
Competent Authority as a prerequisite to the development, manufacturing,
packaging, marketing, and selling of a Licensed Product in the Field of Use
in
the Territory.
1.11 “IND(s)”
means
an
investigational new drug application as defined in 21
C.F.R. Part 312
et seq
in the United States (as may be amended, supplemented or replaced from time
to
time), or equivalent application to any Competent Authority of any other country
in the Territory, to commence clinical testing of a drug, including but not
limited to any amendments, supplements, or supporting correspondence with
respect thereto.
1.12 “Improvements”
shall
mean any modification, enhancement, or improvement of a Licensed Product, or any
inventions, discoveries, improvements (whether patentable or not), information,
and data, owned or controlled by Licensor or Onc Res at any time during the
Term, which would be useful or necessary in the manufacture, use, or sale of
any
Licensed Product, or the practice of which would infringe an issued or pending
claim within the Patent Rights.
1.13 “Know-how”
shall
mean all tangible or intangible information
and know-how (other than that which is the subject of a Valid Claim in the
Patent Rights), whether patentable or not (but which has not been patented),
related to the Technology, the Licensed Product, or any Improvement or which
is
useful to or necessary for the Company to develop or commercialize any Licensed
Product (including but not limited to: trade secrets, formulations, protocol,
results of experimentation, in vitro, preclinical or clinical design,
information or results, other proprietary materials, processes, including but
not limited to manufacturing processes, data, drawings and sketches, designs,
testing and test results, regulatory information of a like nature), owned or
controlled by Licensor or Onc Res as of the Effective Date or which Licensor
or
Onc Res obtains the right to disclose and license to the Company during the
Term.
3
1.14 “Licensed
Product(s)”
shall
mean any product, including but not limited to the Technology, that cannot
be
manufactured, used or sold, in whole or part, without infringing one or more
Valid Claims included within the Patent Rights in the country in which the
product is made, used, leased, imported, exported, offered for sale or
sold.
1.15 “Licensor
IND(s)”
means
the
INDs, whether now existing or previously submitted, described on Schedule 1.15,
and any filings, updates, material correspondence, or material communications
to
or from any applicable Competent Authority with respect thereto.
1.16 “Marketing
Authorization”
means
all
necessary and appropriate regulatory approvals, including but not limited to
NDAs and reimbursement and pricing approvals, to allow a Licensed Product to
be
marketed and sold in the Field of Use in a particular country in the
Territory.
1.17 “Milestone
Payment”
means
the
payments set out in Article 6.4.
1.18 “NDA”
means
a
New Drug Application as defined in 21
C.F.R. Part 314.50 et
seq.
in the United States (as may be amended, supplemented or replaced from time
to
time), or equivalent application to any Competent Authority of any other country
in the Territory, to commence commercial sale and marketing of a drug for human
use, including but not limited to any amendments, supplements, or supporting
correspondence with respect thereto.
1.19 “Net
Sales”
shall
have the meaning set out below:
| 1.19.1 |
“Net
Sales” shall mean the total gross receipts for sales of Licensed Products
to customers who are not Affiliates, or are Affiliates, but are end
users
of the Licensed Products, by or on behalf of the Company or any of
its
Affiliates or Sublicensees, whether invoiced or not, less only the
sum of
the following:
|
| (a) |
usual
trade discounts to customers, including but not limited to cash,
quantity
and trade discounts, rebates and other price reductions for such
Licensed
Product given to such customers;
|
| (b) |
sales,
tariff duties, value-added tax and/or use taxes directly imposed
and with
reference to particular sales;
|
| (c) |
amounts
allowed or credited on charge-backs and/or
returns;
|
| (d) |
bad
debt deductions and uncollectible amounts actually written off during
the
accounting period;
|
4
| (e) |
outbound
transportation prepaid or allowed and transportation insurance;
|
| (f) |
sales
commissions;
|
| (g) |
wholesaler
and distribution fees;
|
| (h) |
packaging,
freight, and insurance charges;
|
| (i) |
customs
duties, surcharges and other governmental charges incurred in exporting
or
importing such Licensed Product to such customers;
and
|
| (j) |
wholesaler
discounts and government
chargebacks.
|
| 1.19.2 |
Components
of Net Sales (and the deductions listed above) shall be determined
in the
ordinary course of business in accordance with
GAAP.
|
| 1.19.3 |
Notwithstanding
anything herein to the contrary, the transfer of a Licensed Product
to an
Affiliate, Sublicensee, or other Third Party in connection with the
research, development or testing of a Licensed Product or for purposes
of
resale shall not be considered a sale of a Licensed Product under
this
Agreement. Nor shall the transfer of Licensed Product solely for
indigent
or similar public support or compassionate use programs be considered
a
sale of Licensed Product under this
Agreement.
|
| 1.19.4 |
In
the case of discounts on “bundles” of separate products or services which
include Licensed Products, the Company may discount (or enable its
Affiliates and Sublicensees to discount) the bona fide list price
of a
Licensed Product by the average percentage discount of all products
of the
Company and/or its Affiliates and Sublicensees in a particular “bundle”,
calculated as follows:
|
Average
percentage
discount
on a = 1
- (X/Y) x
100
particular
“bundle”
where
X
equals the total discounted price of a particular “bundle” of products, and Y
equals the sum of the undiscounted bona fide list prices of each unit of every
product in such “bundle”. The Company shall provide Licensor documentation
reasonably supporting such average discount with respect to each “bundle.” If a
Licensed Product in a “bundle” is not sold separately, and no bona fide list
price exists for such Licensed Product, the Company shall determine in good
faith a reasonable imputed list price for such Licensed Product and Net Sales
with respect thereto shall be based on such imputed list price.
1.20 “Patent
Rights”
means
| 1.20.1 |
all
U.S. and foreign patents and patent applications set forth in Schedule
1.20;
|
| 1.20.2 |
any
and all US or foreign patents, patent applications, or other rights
issuing from, or filed subsequent to the date of this Agreement,
based on
or claiming priority to or from the applications, patents, and rights
listed on Schedule 1.20, including but not limited to continuations,
continuations in part, divisionals, reexaminations, extensions, reissues,
substitutions, renewals, supplementary protection certificates,
registrations, and confirmations of any of the foregoing, and any
patents
resulting from any application or right included in Articles 1.20.1
or
1.20.2;
|
5
| 1.20.3 |
any
other intellectual property rights owned or controlled by the Licensor
or
Onc Res or that Licensor or Onc Res has the ability to license to
the
Company relating to the Technology as of the date of this Agreement,
or
which Licensor or Onc Res acquires, or acquires the right to license
to
the Company, after the Effective Date, and any and all US or foreign
patents, patent applications, or other rights, including continuations,
continuations in part, divisionals, reexaminations, extensions, reissues,
substitutions, renewals, supplementary protection certificates,
registrations, and confirmations of such rights claiming or relating
to,
in each case, Technology;
|
| 1.20.4 |
any
other intellectual property rights owned or controlled by the Licensor
or
Onc Res at any time during the Term of this Agreement relating to
or
claiming an Improvement or that Licensor or Onc Res has the ability
to
license or gains the ability to license to the Company or Onc Res
relating
to or claiming an Improvement; and any and all US or foreign patents,
patent applications, or other rights, including continuations,
continuations in part, divisionals, reexaminations, extensions, reissues,
substitutions, renewals, supplementary protection certificates,
registrations, and confirmations of such rights relating to or claiming,
in each case, an Improvement;
and
|
| 1.20.5 |
any
information useful or necessary to file and obtain issuance of valid
patent claims relating to the use, manufacture, development,
administration, delivery, formulation, dosing, packaging, and handling
of
the Technology, Know-how, and Licensed
Products.
|
The
parties shall use commercially reasonable efforts to ensure that Schedule 1.20
shall be amended in writing from time to time to reflect the foregoing, provided
that any failure to do so shall not limit the scope of the definition of Patent
Rights established above.
1.21 “Person”
means
an
individual, corporation, partnership, limited liability company, trust, business
trust, association, joint venture, non-profit organization, pool, syndicate,
sole proprietorship, unincorporated organization, university, governmental
authority or any other form of entity not specifically listed
herein
1.22 “Phase
I Trial”
means
a
clinical trial that generally provides for the first introduction into humans
of
a Licensed Product with the primary purpose of determining safety, metabolism
and pharmacokinetic properties and clinical pharmacology of the Licensed
Product, and generally consistent with 21 CFR § 312.21(a).
1.23 “Phase
II Trial”
means
a
clinical trial of a Licensed Product on patients, including possibly
pharmacokinetic studies, the principal purpose of which is to make a preliminary
determination that such Licensed Product is safe for its intended use and to
obtain sufficient information about such Licensed Product’s efficacy to permit
the design of further clinical trials, and generally consistent with 21 CFR
§
312.21(b).
6
1.24 “Phase
III Trial”
means
a
pivotal human clinical trial of a Licensed Product, which trial is designed
to:
(a) establish that a Licensed Product is safe and efficacious for its intended
use; (b) define warnings, precautions and adverse reactions that are associated
with the Licensed Product in the dosage range to be prescribed; (c) support
Marketing Authorization of such Licensed Product; and (d) generally consistent
with 21
CFR §
312.21(c).
1.25 “Pivotal
Trial”
means
a
Phase III Trial of a particular Licensed Product that is conducted subsequent
to
completion of the first Proof of Concept Trial for such Licensed
Product.
1.26 “Proof
of Concept Trial”
means
a
Phase I Trial or Phase II Trial the results of which indicate that the Licensed
Product which is the subject of such Phase I Trial or Phase II Trial will be
safe and effective in humans for treatment of the indication(s) which are the
subject of such Phase I Trial or Phase II Trial, as reasonably determined by
the
Company.
1.27 “Registration(s)”
means
any
and all permits, licenses, authorizations, registrations or regulatory approvals
(including, but not limited to, IND or NDA) required and/or granted by any
Competent Authority as a prerequisite to the development, manufacturing,
packaging, shipping, marketing and/or selling of any product.
1.28 “Royalty
Term”
means,
on
a country-by-country and Licensed Product-by-Licensed Product basis, the period
commencing on the Effective Date and ending on the date of the last to expire
Valid Claim contained in the Patent Rights covering a Licensed Product in such
country (such expiration including, for purposes hereof, the date upon which
no
Valid Claims remain with respect to a particular country, even if such date
occurs prior to patent issuance), provided that, for purposes of this
definition, any Valid Claim that has not issued but has been pending more than
five (5) years from filing shall be deemed expired (and not a Valid
Claim).
1.29 “Sublicensee”
means
a
Third Party that has entered into an agreement with the Company licensing to
such Third Party any of the rights granted to the Company by the Licensor
pursuant to Article 2.1, or a Third Party that has entered into a license
agreement with any such Sublicensee licensing such Third Party the rights
granted to the Company by the Licensor and granted to such subsequent Third
Party licensee by the Sublicensee.
1.30 “Successful
Completion”
means
achieving the primary endpoint in the Proof of Concept Trial, as defined in
the
protocol for such trial, which shall be designed by the Company.
7
1.31 “Technology”
means
all
technology related to the topical, external, epidermal, or mucosal
administration of uracil, or any analogs, derivatives, isomers, enantiomers,
prodrugs,
metabolites, esters, salts, hydrates, solvates, or polymorphs thereof, and
any
other technology described in the Patent Rights.
1.32 “Term
has
the
meaning set out in Article 11.1.
1.33 “Territory”
means
the
world.
1.34 “Third
Party”
mean
any
Person other than Licensor, Onc Res, Company, and their respective
Affiliates.
1.35 “Valid
Claim”
means
any
pending or issued claim included within the Patent Rights that has been filed
in
good faith and has not been withdrawn, permanently revoked, abandoned nor deemed
unenforceable, unpatentable, or invalid by a decision of a court or other
governmental agency of competent jurisdiction that is unappealable or unappealed
in the time allowed for appeal, and which has not been admitted to be invalid
or
unenforceable through reissue or disclaimer or otherwise.
Article
1A Termination of Joint Venture Agreement; Assignment
Prior
to
or concurrent with the execution of this Agreement, that certain Joint Venture
Agreement, dated February 19, 2005, between Licensor, Xxxx X. Xxxx, MD (“Ford”),
and Stason Pharmaceuticals, Inc. (“Stason”; such agreement, the “JV Agreement”),
shall terminate or have been terminated, as the case may be, in a manner
acceptable to Company, in its sole discretion, pursuant to the Termination
Agreement attached hereto as Exhibit 1A(1) (the “Termination Agreement”).
Additionally, Xxxx Xxxx shall assign all right and title to the Patent Rights,
Know-how or Improvements to Licensor in a form acceptable to the Company
attached hereto as Exhibit 1A(2) (the “Assignment”). This Agreement shall not be
effective until a Termination Agreement acceptable to the Company has been
executed by Ford, Onc Res, and Stason and is itself effective and the Assignment
executed by Xx. Xxxx. Licensor, Onc Res, and Stason agree that the Company
shall
be a third party beneficiary of the Termination Agreement, as provided for
therein, and Licensor and Onc Res shall, upon the request of the Company, take
such actions as may be necessary to enforce Licensor’s or Onc Res’ or the
Company’s rights thereunder or otherwise ensure that all right, title, and
interest to Technology, Know-how, and Patent Rights (including but not limited
to Improvements and any rights related thereto) are and remain the sole property
of Licensor, subject to the rights granted under this Agreement.
8
Article
2 License Grant
2.1 Grant
of License
Licensor
and Onc Res hereby grant to the Company an exclusive license, with rights to
grant sublicense as further described below, in the Field of Use to practice
under the Patent Rights and to utilize the Know-how in the Territory, including
to:
| 2.1.1 |
conduct
research, make, have made, use, have used, import, have imported,
export,
have exported, offer for sale, have sold, sell, produce, manufacture,
distribute and market Licensed Products to the full end of the Royalty
Term, unless sooner terminated as hereinafter provided;
and
|
| 2.1.2 |
sublicense
to third parties, through multiple tiers, in accordance with Article
2.2
below, the rights granted under
Article 2.1.1.
|
2.2 Sublicenses
| 2.2.1 |
The
Company shall have the right to sublicense rights granted in Article
2.1
in its sole discretion, and shall have the right to grant further
sublicenses in their sole discretion. All sublicenses granted under
this
Article 2.2.1 shall survive and be automatically assigned to Licensor
and
Onc Res upon termination of this Agreement, provided
however,
Licensor and Onc Res shall not be obligated to incur any obligations
in
excess of those of Licensor and Onc Res contained herein.
|
| 2.2.2 |
Notwithstanding
the foregoing, if the Company believes that Licensor has terminated
this
Agreement for the primary purpose of doing business directly with
the
Sublicensee, the termination may be disputed under the provisions
of
Article 10.
|
Article
3 Technology; Regulatory Transfer
3.1 Technology
and Regulatory Transfer
Upon
execution of this Agreement, (i) Licensor and Onc Res shall transfer to the
Company, at no additional cost, all Know-how, which shall include but not be
limited to all pre-clinical or clinical data, trade secrets, human safety data,
preliminary efficacy data, and other regulatory data related to any Licensed
Product in its possession, and (ii) Licensor and Onc Res hereby assign all
right, title, and interest in the Licensor IND(s) to the Company, free and
clear
of all liens, claims, and encumbrances.
Licensor
and Onc Res shall, at Company’s cost, take any and all actions requested by the
Company to effect the purposes of the foregoing as promptly as practicable
following the execution of this Agreement, which shall include but not be
limited to (i) preparing and filing whatever filings, requests or applications
are required or deemed advisable to be filed with any Regulatory Authority,
if
any, in connection with the assignment of the Licensor and Licensor IND(s)
(including but not limited to, if applicable with respect to the FDA, a
“transfer of ownership letter”) and (ii) taking all reasonable actions necessary
to enable the Company to undertake the manufacture, development and
commercialization of Licensed Products under this Agreement. Such actions shall
include providing the Company with:
| a. |
copies
of all regulatory submissions;
|
9
|
b.
|
any
communications with Competent Authorities and the minutes of any
meetings
with Competent Authorities relating to any Licensed
Product;
|
|
c.
|
DMFs
and any trial, drug, or other master files relating to any Licensed
Product, including copies of all case report
forms;
|
|
d.
|
copies
of all listings and tables of results from the clinical trials relating
to
any Licensed Product;
|
|
e.
|
copies
of all treatment-related serious adverse event reports from the clinical
trials relating to any Licensed
Product;
|
|
f.
|
storage
of and access permission to any retained samples of materials used
in
clinical trials relating to any Licensed
Product;
|
|
g.
|
access
to contract and clinical research organizations involved in the
preclinical studies and clinical trials relating to any Licensed
Product;
|
|
h.
|
the
data, files and results of any chemistry, manufacturing, or
control-related activities regarding any Licensed Product;
and
|
|
i.
|
all
other information that the Company may reasonably request that may
be
useful to the Company for the manufacturing of Licensed Products
or
conducting preclinical studies and clinical trials and other development
activities with respect to each Licensed Product, and the
commercialization of Licensed
Products.
|
3.2 Transfer
of Inventory
For
a
period of one (1) year following the date of this Agreement, Licensor and Onc
Res shall provide such technical assistance to Company as Company reasonably
requests regarding the Patent Rights, Know-how, Licensed Products and
Technology, including without limitation providing to Company, as requested
by
the Company, all or part of Licensor’s and Onc Res’ inventory of GMP and non-GMP
Technology and Licensed Products, described on Exhibit 3.2, as the parties
mutually agree.
3.3 Consulting
The
Company and Ford shall enter into a consulting agreement in the form attached
hereto as Exhibit 3.3 (the “Consulting Agreement”) concurrent with the execution
of this Agreement; Company shall not have any payment or other obligations
under
this Agreement unless and until the Consulting Agreement has been executed
by
both the Company and Ford.
Article
4 Regulatory Compliance
4.1 Ownership
and Maintenance of Governmental Approvals
| 4.1.1 |
The
Company will own all Marketing Authorizations for each country in
the
Territory for Licensed Products. Without limiting the generality
of the
foregoing, the Company shall prepare and submit in its own name and
at its
expense NDAs with the FDA in the U.S. and any other equivalent application
with the Competent Authorities in other countries in the
Territory.
|
10
| 4.1.2 |
The
Company shall secure and maintain in good standing, at its sole cost
and
expense, any and all Governmental Approvals (including, Marketing
Authorizations, licenses, permits and consents, facility licenses
and
permits required by Applicable Laws or by the applicable Competent
Authorities) necessary and/or required for the Company to perform
its
obligations under this Agreement and use commercially reasonable
efforts
at its cost and expense to secure and maintain any variations and
renewals
thereof.
Licensor and Onc Res shall promptly notify Company of any written
or oral
notices received from, or inspections by, any Competent Authority
relating
to any such Governmental Approvals.
|
| 4.1.3 |
During
the time that Licensor or Onc Res is the holder of any Governmental
Approval referred to in Article 4.1.2 above, Licensor and Onc Res
shall
(i) promptly provide Company an advance draft of any proposed responses
to
such written notices or inspections and the resolution of any issue
raised
by such Competent Authority and (ii) make such reasonable changes
to such
proposed response as may be recommended by Company, and the Company
shall
be entitled to attend any and all meetings and participate in telephone
calls with the Competent Authorities, including without limitation
any
meeting preparation, meeting co-ordination and preparation of
minutes.
|
4.2 Rights
of Reference
Licensor
and Onc Res shall grant and hereby grants the Company a free-of-charge right
to
reference and use and have full access to all preclinical and clinical data,
information, and results, Governmental Approvals, and all other regulatory
documents relating to or useful for the Development of the Technology and
Licensed
Products,
including but not limited to any IND, NDA, DMF (whether as an independent
document or as part of any Governmental Approval), and all chemistry,
manufacturing and controls information, and any supplements, amendments or
updates to the foregoing, where such regulatory documents are owned, licensed,
or controlled by Licensor or Onc Res (for the purposes of this Article, the
“Right of Reference”). The Company may license the Right of Reference to
Affiliates and to Sublicensees.
4.3 Access
to Manufacturers
Licensor
and Onc Res grant to the Company a free of charge right to access any suppliers
of any form, component, or ingredient of or precursor to the Technology or
any
Licensed Product, and shall, if and as requested by the Company, reasonably
assist Company in establishing supply relationships with such suppliers on
commercially reasonable terms and/or assigning any relevant supply agreements
to
the Company.
4.4 Right
of First Negotiation To Market Licensed Products in Asia
Within
fifteen (15) days of receipt
by Stason from the Company (under appropriate confidentiality agreements) of
the
complete, final study report
from the
Proof of Concept Trial, Stason shall have the right to contact the Company
to
discuss the acquisition of commercial marketing rights for Licensed Products
in
the Asian Market. The Company hereby agrees to negotiate, in good faith, such
agreement with Stason for such rights provided Stason has the capabilities
and
resources to effectively market and commercialize such Licensed Product in
the
Asian Market. If the parties cannot agree on a definitive marketing agreement
relating to such Licensed Product within 90 days from the commencement of such
negotiations (such negotiations to commence within fifteen (15) days of receipt
of notification from Stason informing the Company that it wishes to commence
such negotiations), then the Company shall have the right to terminate such
negotiations and either market and commercialize Licensed Products in the Asian
Market by itself or license or otherwise grant such rights to a third party
or
parties. The Asian Market shall mean South Korea, China, Singapore, Taiwan,
Indonesia, Vietnam and Thailand.
11
Article
5 Development and Commercialization
5.1 Development
The
Company
shall
use commercially reasonable efforts, itself or through the activities of its
Sublicensees and Affiliates, to perform the Development
and
secure the Marketing Authorizations for Licensed Products.
5.2 Commercialization
The
Company shall, following receipt of the necessary Marketing Authorizations,
use
commercially reasonable efforts to, itself or through the activities of its
Sublicensees and Affiliates, commence marketing of, and to promote, market,
sell
and commercialize thereafter, Licensed Products in the Territory within Field
of
Use.
5.3 Diligence
Milestones
|
5.3.1
|
The
Company will use commercially reasonable efforts to achieve the
performance milestones set forth in Exhibit 5.3.1 (the “Diligence
Milestones”) by the dates indicated therefor. Each
of the Diligence Milestones shall only need to be satisfied once
under
this Agreement, regardless of the number of Licensed Products or
indications therefor.
|
|
5.3.2
|
Notwithstanding
anything to the contrary, the Company
shall be entitled to
extend the date specified for accomplishing any Diligence Milestone
by
6
month periods by paying an Extension Payment (any such payment, an
“Extension Payment”). The Extension Payment shall be $[***] for the first
6 month period, increasing at a rate of $[***] per 6 month period
thereafter, until achievement of any relevant Diligence Milestone.
As an
example by way of illustration only, a representative payment schedule
of
Extension Payments relating to the delay of each Diligence Milestone
is
attached as Exhibit 5.3.2. Upon the achievement of any Diligence
Milestone, the deadline of which has been extended pursuant to this
Article 5.3.2, the Company shall no longer have any obligation to
remit
Extension Payments to the Licensor relating to such Diligence Milestone
and the Company shall be deemed in good standing under this Agreement
as
it relates to the achievement of such Diligence Milestone and its
diligence obligations under Articles 5.1 and 5.2 (as
applicable).
|
|
5.3.3
|
If
the Company’s failure to accomplish any Diligence Milestone by the
applicable date set forth on Exhibit 5.3.1 (as such date may be extended
pursuant to Article 5.3.2 and this Article 5.3.3) is a result of
a
clinical hold or other delay caused by (i) the direction, guidance,
or
requirements of any Competent Authority, (ii) the inability of the
Company
to acquire GMP-grade Licensed Product on commercially reasonable
terms,
(iii) adverse events in clinical trials, or (iv) any other circumstances
beyond the Company’s reasonable control, then (1) this Agreement shall
remain in full force and effect, (2) the dates set forth on Exhibit
5.3.1
for the accomplishment of the Diligence Milestones shall be automatically
extended to the extent of any delay(s) resulting from the occurrence
of
the circumstances described in (i), (ii), (iii), and (iv) above,
and (3)
the Company shall not have any obligation to make any Extension Payments
with respect to such automatic extensions, provided however, the
Company
continues to use commercially reasonable efforts to progress the
development of a Licensed Product.
Licensor’s sole and exclusive remedy with respect to any failure of the
Company to achieve the Diligence Milestones on the dates required
by this
Article 5.3 (as they may be extended pursuant to Articles 5.3.2 and
5.3.3)
shall be its right to receive payments owed to it under Article 5.3.2
above.
|
12
5.4 Assumption
of Agreements
The
Licensor and Onc Res are parties to numerous clinical trial agreements with
physicians, care facilities, hospitals and contract research organizations
to
organize and carry out clinical trials that relate to Licensed Products (“CT
Agreements”). Attached as Schedule 5.4(a) is a list of those CT Agreements. The
Licensor and Onc Res hereby assign or otherwise transfer, as of the Effective
Date, and the Company hereby assumes, all of Licensor’s and Onc Res’ rights,
obligations and responsibilities under the CT Agreements listed on Schedule
5.4(b) (the “Transferred Agreements”) following the Effective Date.
Notwithstanding the foregoing, the parties acknowledge that, by this Agreement,
neither Licensor nor Onc Res is assigning, and the Company is not assuming,
any
indemnification or other liabilities or obligations under the CT Agreements
with
respect to any matters occurring prior to the Effective Date or that relate
to
the acts and omissions of Licensor or Onc Res, and that all liabilities and
obligations under the CT Agreements and all liabilities and obligations under
the Transferred Agreements that arose prior to the Effective Date or with
respect to the acts or omissions of Licensor or Onc Res shall be the sole
responsibility of the Licensor and Onc Res, unless otherwise specifically agreed
upon within this Agreement. The
Licensor and Onc Res have provided to the Company a copy of each written notice
of invention, if any, received by the Licensor, Onc Res, or their Affiliates
under any of the CT Agreements.
Article
6 Royalties and Other Consideration
6.1 Royalties
on Net Sales
During
the Royalty Term the Company shall pay Licensor royalties equal to:
|
a.
|
[***]
percent ([***]%)
of the first $[***] of Net Sales in a particular calendar
year;
|
|
b.
|
[***]
percent ([***]%) of all Net Sales in excess of $[***] but less than
$[***]
in a particular calendar year; and
|
|
c.
|
[***]
percent ([***]%) of all Net Sales in excess of $[***] in a particular
calendar year.
|
All
royalties described above shall, in each case, be subject to further adjustment
as described in this Article 6.
As
an
example of the royalty calculation contemplated above, if Net Sales in a
particular calendar year total $[***], Company’s royalty obligations to Licensor
with respect to such calendar year’s Net Sales would, without taking into
account any adjustments under this Article 6, equal $[***] under this Article
6.1 ([***]).
13
6.2 No
Multiple Royalties
No
multiple royalties shall be payable because the use, lease or sale of any
Licensed Product is, or shall be, covered by more than one Valid Claim contained
in the Patent Rights.
6.3 Combination
Products
In
the
event that a Licensed Product is sold in the form of a combination product
containing one or more technologies which, if incorporated into a product by
themselves, would not render a product a Licensed Product (i.e. the combination
product itself is not covered by the Patent Rights), the Net Sales for such
combination product shall be calculated by multiplying the sales price of such
combination product by the fraction A/(A+B) where (i) A is the invoice price
of
a Licensed Product incorporating solely the technology which renders such
product a Licensed Product, or, if such Licensed Product is not sold separately,
the fair market value of a Licensed Product incorporating solely such
technology, and (ii) B is the total invoice price of products incorporating
solely the other technologies or, if such products are not sold separately,
the
fair market value of such products. Notwithstanding the foregoing, for the
purposes of this Article 6.3, a combination product shall not include a Licensed
Product that is a combination of uracil and 5-FU, its prodrugs, derivatives,
precursors or analogues.
6.4 Milestone
Payments
As
further consideration for the license granted hereunder, the Company will make
the following one-time Milestone Payments to Licensor.
| 6.4.1 |
Three
Hundred Thousand Dollars ($300,000) on February 28, 2007, provided,
however, this Agreement is not terminated pursuant to Article
11.5.2;
|
| 6.4.2 |
[***]
Dollars ($[***]) upon Company’s receipt of the complete, final study
report following the Successful Completion of the first Proof of
Concept
Trial conducted
under a Company-sponsored (or Sublicensee-sponsored)
IND;
|
| 6.4.3 |
[***]
Dollars ($[***]) upon the first dosing of a patient in a Pivotal
Trial
conducted under a Company-sponsored (or Sublicensee-sponsored) IND;
|
| 6.4.4 |
[***]
Dollars ($[***]) upon the first acceptance for review by the FDA
of a
Company-sponsored (or Sublicensee-sponsored) NDA for a Licensed Product
in
the United States. Notwithstanding the forgoing, the Milestone Payment
in
this Article 6.4.4 shall equal [***] Dollars ($[***]) in the event
that
the Milestone Payment contained in this Article 6.4.4 becomes due
and
payable prior to the time the Milestone Payment in Article 6.4.3
becomes
due and payable (for instance, if the results of the Proof of Concept
Trial are used to file the NDA and the Company never conducts a Pivotal
Trial), provided, however, upon payment of such amount, the Company
shall
no longer have an obligation to remit the Licensor any payment pursuant
to
Article 6.4.3;
|
| 6.4.5 |
[***]
Dollars ($[***]) upon the final full approval by FDA of the first
Company-sponsored (or Sublicensee-sponsored) NDA for a Licensed Product
in
the United States;
|
14
| 6.4.6 |
[***]
Dollars ($[***]) upon the first commercial sale of a Licensed Product
for
human therapeutic use in the European Union by Licensee or any
Sublicensee;
|
| 6.4.7 |
[***]
Dollars ($[***]) upon the first commercial sale of a Licensed Product
for
human therapeutic use in Japan by Licensee or any
Sublicensee;
|
| 6.4.8 |
[***]
Dollars ($[***]) upon the last day of the first calendar year in
which Net
Sales during such calendar year exceed $[***];
and
|
| 6.4.9 |
[***]
Dollars ($[***]) upon the last day of the first calendar year in
which Net
Sales during such calendar year exceed
$[***].
|
Each
of
the
Milestone Payments described above shall only be paid once upon their respective
accomplishments, regardless of the number of times such milestones are achieved.
If the milestones described in Articles 6.4.8 and 6.4.9 occur in the same
calendar year, both payments will become due with respect to such calendar
year.
6.5 Place
of Payment, Taxes
and Conversions
All
payments under this Agreement shall be paid in United States dollars, unless
otherwise required by law, at such place as Licensor may reasonably designate
consistent with applicable laws and regulations. Any taxes, duties, or other
levies which the Company, its Affiliate or any Sublicensee shall, in its
reasonable discretion, be required by law to pay or withhold on remittance
of
any payment(s) due under this Agreement shall be deducted from such payment(s)
to Licensor. Any
such
taxes, levies, or duties required under applicable law to be paid or withheld
shall be an expense of, and borne solely by, Licensor. The
Company will use commercially reasonable efforts to secure and send to Licensor
proof of any such taxes, duties or other levies withheld and paid by the Company
for the benefit of Licensor, and cooperate, at Licensor’s expense, with any
reasonable request to help ensure that amounts withheld and/or paid are reduced
and/or recovered to the extent permitted by the relevant jurisdiction. If any
currency conversion shall be required in connection with the payment of
royalties hereunder, such conversion shall be made by using the exchange rate
prevailing at Citibank, N.A. in New York, New York on the last business day
of
the calendar quarterly reporting period to which such royalty payments relate.
In each country where the local currency is blocked and cannot be removed from
the country under such country’s applicable law, royalties accrued with respect
to that country shall be paid to Licensor in such country in local currency
by
deposit in a local bank designated by Licensor, unless the parties otherwise
agree. Notwithstanding the foregoing, until such time as Licensor instructs
the
Company otherwise (such instruction to be in writing), the Company shall remit
payments due to Licensor under this Agreement pursuant to the letter of
instruction attached hereto as Exhibit 6.5.
6.6 Time
for Payment
| 6.6.1 |
The
Company shall pay to Licensor the royalties due and payable under
this
Agreement on a quarterly basis, and shall provide the Royalty Statement
referred to in Article 7.2 along with such payment. Payments pursuant
to
this Article 6.6.1 are due with respect to a particular calendar
quarter’s
Net Sales ninety (90) days after the conclusion of such calendar
quarter.
|
| 6.6.2 |
Milestone
Payments payable to Licensor shall, notwithstanding the use of the
word
“upon” throughout Article 6.4, become due and payable within thirty (30)
days after achievement of the indicated milestone, provided that,
notwithstanding the foregoing, the Milestone Payments due pursuant
to
Articles 6.4.8 and 6.4.9 shall be due ninety (90) days after the
conclusion of the applicable calendar
year.
|
15
| 6.6.3 |
If
no royalties or other payments that may be due to Licensor under
this
Agreement shall be due, the Company shall not be required to make
a report
pursuant to Article 7.2.
|
6.7 Interest
Amounts
which are not paid when due shall accrue interest from the due date until paid,
at a rate equal to [***]%.
6.8 Royalty
Adjustments
| 6.8.1 |
Notwithstanding
anything to the contrary herein, if the Company or any Affiliate
or
Sublicensee obtains (or has obtained) one or more licenses under
patents
or patent applications owned by a Third Party to avoid infringement
thereof by the manufacture, use, or sale of any Licensed Product,
to
reasonably avoid infringement-related litigation regarding a Licensed
Product, or to make, use or sell any technology that could improve,
enhance, or modify a Licensed Product, as determined by the Company
in its
reasonable discretion, then the
Company may deduct [***] percent ([***]%) of any fees, milestones
or
royalties paid by the Company or any Affiliate or Sublicensee under
such
license(s) (even if paid in settlement or judgment of any claim for
infringement) from the payments otherwise due Licensor under this
Agreement; provided, however, that, notwithstanding the foregoing,
the
total amount due Licensor under this Agreement in any particular
calendar
quarter shall not be reduced by more than [***] percent ([***]%)
as a
result of any such deduction, and any amounts not deducted in a calendar
quarter shall be carried forward for deduction in the subsequent
calendar
quarter(s), subject to such [***]percent ([***]%) limitation in each
case.
|
| 6.8.2 |
Should
a compulsory license be granted, or be the subject of a possible
grant, to
a Third Party under the applicable laws of any country in the Territory
under the rights licensed under this Agreement, the Company shall
notify
Licensor, including any material information concerning such compulsory
license, and the running royalty rate payable under this Article
6 for
sales of Licensed Products in such country will be adjusted to equal
any
lower royalty rate granted to such Third Party for such country with
respect to the sales of such Licensed Products therein (the “Compulsory
Royalty”) during such periods such third parties sell or offer for sale
under the compulsory license articles that compete with the Licensed
Products then marketed and sold by the Company, its Affiliates, or
Sublicensees in that country, provided that such Compulsory Royalty
shall
remain subject to further adjustment consistent with this Article
6.
|
Article
7 Reports and Records
7.1 Records
and Audits
The
Company shall keep full, true and accurate books of account containing all
particulars that may be reasonably necessary for the purpose of showing the
amounts payable to Licensor under this Agreement. Said books of account shall
be
kept at the Company’s principal place of business and the supporting data shall
be opened up to Licensor once per year upon reasonable notice to the Company
for
inspection by Licensor’s internal audit division or by another designated
auditor selected by Licensor, except one to whom the Company has reasonable
objection, for the purpose of verifying the Company’s Royalty Statement (as
defined below) or compliance in other respects with this Agreement. If an
inspection shows an under reporting or underpayment in excess of the greater
of
[***] percent ([***]%) of remuneration payable, then the Company shall reimburse
Licensor for the reasonable, documented cost of the inspection at the time
the
Company pays the unreported royalties, including any late charges as required
by
Article 6.7 of this Agreement. Said books of account and the supporting data
shall be made available to Licensor for one (1) year following the expiration
of
the Term. All payments required under this Article 7.1 shall be due within
thirty (30) days of the date Licensor provides the Company notice of the payment
due. Licensor shall cause its accounting firm to retain all financial
information subject to review under this Article 7.1 in strict confidence;
provided, however, that Company shall have the right to require that such
accounting firm, prior to conducting such audit, enter into an appropriate
non-disclosure agreement with Company regarding such financial information.
The
accounting firm shall disclose to Licensor only whether the Company’s Royalty
Statement is correct or not and the amount of any discrepancy. No other
information shall be shared. Licensor shall treat all such financial information
as Company’s Confidential Information
16
7.2 Royalty
Statements
Within
90
days from the end of each calendar quarter of each calendar year, the Company
shall deliver to Licensor complete and accurate reports, giving such particulars
of the business conducted by the Company during the preceding quarter under
this
Agreement as shall be pertinent to an accounting of royalties and other payments
that may be due to Licensor under this Agreement (the “Royalty Statement”). The
Royalty Statement shall include at least the following:
| 7.2.1 |
Net
Sales for each Licensed Product by the Company, each Affiliate, and
each
Sublicensee;
|
| 7.2.2 |
cumulative
Net Sales for the applicable calendar
quarter;
|
| 7.2.3 |
a
breakdown of deductions applicable in computing Net Sales and taxes
paid
or withheld, if any;
|
| 7.2.4 |
a
breakdown of royalties due based on Net
Sales;
|
| 7.2.5 |
names
and addresses of all Sublicensees and Affiliates of the Company;
and
|
| 7.2.6 |
a
copy of each report from each Sublicensee as may be pertinent to
an
accounting of royalties and other payments that may be due to
Licensor.
|
7.3 Confidential
Treatment of Reports
Licensor
agrees to hold in confidence each Royalty Statement delivered by the Company
pursuant to this Article 7 for a period of five (5) years following termination
of this Agreement. Notwithstanding the foregoing, Licensor may disclose any
such
information required to be disclosed in its financial statements or as required
by any stock exchange or similar regulatory authority, or pursuant to any
Applicable Laws, provided that Licensor take reasonable steps to provide and
assist the Company with the opportunity, where reasonably appropriate, to (i)
contest such subpoena, requirement or order or (ii) seek protective or
confidential treatment thereof, including but not limited to reasonable advance
notice to the Company of any such required disclosure, to the extent reasonably
practicable. The Licensor understands that it is the intention of the Company
to
become publicly traded and that any information disclosed to Licensor under
this
Agreement, including the Royalty Statement, may be deemed “material non-public
information” under the state and federal securities laws.
17
Article
8 Patent Prosecution and Maintenance
8.1 Prosecution
and Maintenance
Following
the Effective Date, the Company shall, at its expense, diligently file, prepare,
prosecute and maintain the Patent Rights as set forth in Schedule 1.20 hereto
(as the same may be amended or supplemented in writing from time to time after
the date hereof), including, but not limited to, the filing of patent
applications, extensions, continuations, continuations in part, divisionals,
re-examinations, or re-issue applications that the Company determines may be
required to advance the purposes of this Agreement or otherwise to protect
the
rights and licenses granted hereunder. The Company shall control such
prosecution and maintenance, using counsel of its choosing, in the name of
Licensor and/or Onc Res, as appropriate, and agrees to keep Licensor and/or
Onc
Res, as appropriate, reasonably informed with respect to the status and progress
of any such applications, prosecutions and maintenance activities and to consult
in good faith with Licensor and/or Onc Res, as appropriate, and take into
account Licensor’s and/or Onc Res’, as appropriate, reasonable comments and
requests with respect thereto prior to the filing of any such documents.
Licensor and Onc Res shall notify Company in writing and reasonable detail
of
any Improvements and assist Company in filing, prosecuting, and maintaining
Patent Rights claiming the same. The parties agree to provide reasonable
cooperation to each other to facilitate the application and prosecution of
patents pursuant to this Agreement and the Licensor and Onc Res shall execute
all lawful papers and instruments and make all rightful oaths and declarations
as may be necessary in the preparation, prosecution and maintenance of all
patents and other filings referred to in this Article 8.
8.2 Patent
Term Extensions
The
Company shall promptly notify Licensor and Onc Res of the issuance of each
Governmental Approval and, where reasonably possible and reasonably useful
or
valuable in the commercialization of Licensed Products, use commercially
reasonable efforts to apply or enable Licensor and/or Onc Res, as appropriate,
to apply for a patent term extension, adjustment or restoration, supplementary
protection certificate, or other form of market exclusivity conferred by
Applicable Laws (collectively, “Patent
Term Extensions”)
in the
relevant country of the Territory. Licensor and Onc Res shall, to the extent
reasonably possible and reasonably useful or valuable in the commercialization
of Licensed Products, use commercially reasonable efforts to, if and as
requested by the Company, obtain (or assist the Company in obtaining) all
available Patent Term Extensions. The parties shall cooperate with each other
in
obtaining Patent Term Extensions wherever and whenever applicable, reasonably
possible to obtain, and reasonably useful or valuable in the commercialization
of Licensed Products.
8.3 Abandonment
The
Company may, in its discretion, elect to abandon any patent applications or
issued patent in the Patent Rights. Following such abandonment, Licensor and/or
Onc Res, as appropriate, shall have the right, but not the obligation, to
commence or continue such prosecution and to maintain any such patent or patent
application under its own control and at its own expense and such patent or
patent application shall thereafter be excluded from the definition of Patent
Rights for purposes of this Agreement. Prior to any such abandonment, the
Company shall give Licensor and/or Onc Res, as appropriate, at least sixty
(60)
days notice and a reasonable opportunity to take over prosecution of such patent
or patent application. The Company agrees to cooperate in such activities
including execution of any documents necessary to enable Licensor and/or Onc
Res, as appropriate, to retain ownership and control of such patent or patent
application.
18
Article
9 Infringement, Enforcement and Other Actions
9.1 Notice
of Infringement of Patent Rights
The
Company, Licensor, and Onc Res shall promptly provide written notice, to the
other party, of any alleged infringement or any challenge or threatened
challenge to the validity, enforceability or priority of any of the Patent
Rights, and provide each other with any available evidence of such infringement,
challenge or threatened challenge by a Third Party of the Patent Rights and
provide such other party with any available evidence of such
infringement.
9.2 Option
to Prosecute or Defend Patent Rights
During
the term of this Agreement, the Company shall have the first right, but not
the
obligation, to take (or refrain from taking) appropriate action to enforce
Patent Rights, to defend any declaratory judgments seeking to invalidate or
hold
the Patent Rights unenforceable, to control any litigation or other enforcement
action and to enter into, or permit, the settlement of any such litigation,
declaratory judgments or other enforcement action pertaining to Patent Rights,
with respect to any potential, threatened, alleged, or actual infringement
of,
or challenge, to, the Patent Rights, at its own expense and with counsel of
its
choosing. In furtherance of such right, Licensor and Onc Res hereby agree that
the Licensor and/or Onc Res may join Company as a party in any such suit (and
will join at the Company’s request), provided that the Company pay all of
Licensor’s and Onc Res’ reasonable, documented out-of-pocket expenses with
respect thereto. If, within twelve (12) months of the written notice above,
the
Company (i) shall have been unsuccessful in persuading the alleged infringer
to
desist, (ii) shall not have brought and shall not be diligently prosecuting
an
infringement action, or (iii) has not entered into settlement discussions with
respect to such infringement, or if the Company notifies Licensor or Onc Res
that it has decided not to undertake any of the foregoing against any such
alleged infringer, then Licensor and/or Onc Res, as appropriate, shall then
have
the right to bring suit to enforce such Patent Rights, at its own expense,
provided, however, that, within thirty (30) days after receipt of notice of
Licensor’s or Onc Res’ intent to file such suit, Company shall have the right to
jointly prosecute such suit and to fund up to one-half (½) the costs of such
suit in exchange for a commensurate share of the proceeds of such suit. Subject
to the effects of the foregoing in the event the Company exercises the
aforementioned right, any recovery of damages or amounts received in settlement
pursuant to this Article 9.2 shall be allocated pursuant to Article 9.5
below.
9.3 Infringement
by Licensed Product
In
the
event that a claim or suit is asserted or brought against the Company alleging
that the manufacture or sale of any Licensed Product by the Company, an
Affiliate of the Company, or any Sublicensee, or the use of such Licensed
Product by any customer of any of the foregoing, infringes proprietary rights
of
a Third Party, the Company shall give written notice thereof to Licensor and
Onc
Res. The Company may, in its sole discretion, modify such Licensed Product
to
avoid such infringement and/or may settle on terms that it deems advisable
in
its sole discretion, provided that any final disposition of the litigation
that
will restrict the claims in or admit any invalidity of any Patent Rights(s)
shall not be made without consultation with and approval by Licensor, such
approval not to be unreasonably withheld. Otherwise, the Company shall have
the
first right, but not the obligation, to defend any such claim or suit. If the
Company has not exercised such right to defend or entered into settlement
discussions concerning such alleged infringement within the sooner of (i) twelve
(12) months of the assertion of such a claim or (ii) thirty (30) days of the
filing of such a suit, or if the Company notifies Licensor and Onc Res that
it
has decided not to undertake such defense or enter into settlement discussions
with respect to its alleged infringement, then Licensor and/or Onc Res shall
then have the right to defend such alleged infringement, at their sole expense,
provided however that no settlement affecting Patent Rights will be agreed
upon
without Company’s written consent.
19
9.4 Control
of Infringement Action
The
party
controlling any action, suit, or defense under Article 9.2 or 9.3 (the
“Controlling Party”) shall be free to enter into a settlement, consent judgment,
or other voluntary disposition of any such action, provided, however, that
(i)
the Controlling Party shall consult with the other party (the “Secondary Party”)
prior to entering into any settlement thereof and (ii) any settlement, consent
judgment or other voluntary disposition of such actions which (1) materially
limits the scope, validity, or enforceability of any Patent Rights or, if the
Company is the Secondary Party, patents or patent applications owned or
controlled by the Company, (2) subjects the Secondary Party to any
non-indemnified liability, payment obligation, or injunction, or (3) admits
fault or wrongdoing on the part of Secondary Party must be approved in writing
by Secondary Party, such approval not to be unreasonably withheld. Secondary
Party shall provide the Controlling Party notice of its approval or denial
of
such approval within fifteen (15) business days of any request for such approval
by the Controlling Party, provided that (i) in the event Secondary Party wishes
to deny such approval, such notice shall include a written description of
Secondary Party’s reasonable objections to the proposed settlement, consent
judgment, or other voluntary disposition and (ii) Secondary Party shall be
deemed to have approved such proposed settlement, consent judgment, or other
voluntary disposition in the event it fails to provide such notice within such
fifteen (15) business day period.
9.5 Allocation
of Damages Recovered
Any
recovery of damages or amounts received in settlement by Company or its
Affiliates under Article 9.2 or 9.3 shall be applied first in satisfaction
of
any unreimbursed expenses and legal fees of the Company, Licensor, and Onc
Res
relating thereto, with the balance remaining from any such recovery or
settlement being allocated as follows: (i) amounts reasonably attributable
to
lost profits on Licensed Products shall be treated as Net Sales by the Company
and the Company shall pay to Licensor royalties thereon in accordance with
Article 6 and (ii) the balance shall be retained by the Company. Any recovery
of
damages or amounts received in settlement by Licensor or Onc Res under Article
9.2 or 9.3 shall be applied first in satisfaction of any unreimbursed expenses
and legal fees of the Company, Licensor, and Onc Res relating thereto, with
the
balance remaining from any such recovery being allocated as follows: (i) any
amounts reasonably attributable to any intellectual property rights of the
Company (other than those licensed to Company hereunder) being paid to Company
and (ii) the remaining balance shall be retained by the Licensor or Onc Res,
as
appropriate.
9.6 Credit
of Litigation Costs
To
the
extent there is no recovery of damages or amounts received in settlement by
Company, its Affiliates, or Licensor with respect to any matter contemplated
by
Article 9.2 or 9.3 above, or such amounts are insufficient to fully reimburse
the Company for any amounts incurred by the Company with respect to such matter
(including but not limited to attorneys’ fees, out-of-pocket costs, and all
amounts paid as judgments, damages, or in settlement) (such amounts,
“Infringement Costs”), the Company may, to the extent not deducted from amounts
due under this Agreement pursuant to Article 6.11.1, credit [***] percent
([***]%) of Infringement Costs (such [***] percent ([***]%), the “Infringement
Cost Credit”) against royalties or other fees thereafter payable to Licensor
under this Agreement. If the Infringement Cost Credit exceeds amounts payable
to
Licensor under this Agreement in any calendar quarter in which the relevant
Infringement Costs are incurred, then the amount of such Infringement Cost
Credit in excess of the amounts payable to Licensor shall be carried over and
credited against payments due in future calendar quarters.
20
9.7 Cooperation
In
any
suit to enforce and/or defend the Patent Rights pursuant to this Agreement,
or
defend any alleged infringement of Third Party intellectual property rights
by
the manufacture, use, sale, or import of a Licensed Product, the Secondary
Party
shall, at the request and expense of the Controlling Party, cooperate in all
respects and, to the extent possible, have its employees testify when requested
and make available relevant records, papers, information, samples, specimens,
and the like.
Article
10 Dispute Resolution
10.1 Disputes
| 10.1.1 |
The
parties recognize that disputes as to certain matters may from time
to
time arise during the Term which relate to either party’s rights and/or
obligations hereunder or to the interpretation, performance, breach,
or
termination of this Agreement, (a “Dispute”). It is the objective of the
parties to establish procedures to facilitate the resolution of a
Dispute
in an expedient manner by mutual cooperation and without resort to
litigation. To accomplish this objective, the parties agree to follow
the
procedures set forth in this Article 10 if and when a Dispute arises
under
this Agreement.
|
| 10.1.2 |
A
Dispute among the parties will be resolved as recited in this Article
10.
Any Disputes relating to this Agreement shall be promptly presented
to the
Chief Executive Officers of Licensor and the Company, or their respective
designees (who must be members of a party’s senior management) for
resolution. The Licensor shall have the obligation to represent Onc
Res in
any dispute under this Agreement under this Article 10 as if Onc
Res was
the Licensor. From the date of referral of a Dispute to the Chief
Executive Officers or their designees of the parties and until such
time
as any matter has been resolved by the parties or has been finally
settled
by arbitration hereunder, the running of the cure periods (if any)
as to
which a party must cure a breach that is part of the subject matter
of any
Dispute shall be suspended. In the event that the Chief Executive
Officers
of Licensor and the Company, or their respective designees, cannot
after
good faith negotiations resolve the Dispute within thirty (30) days
(or
such other period of time as mutually agreed to by the parties in
writing)
of being requested by a party to resolve a Dispute, the parties agree
that
such Dispute shall be resolved by binding arbitration in accordance
with
this Article 10.1.
|
| 10.1.3 |
If
a party intends to begin arbitration to resolve such Dispute, such
party
shall provide written notice (the “Arbitration Notice”) to the other party
informing such other party of such intention and the issues to be
resolved. Any arbitration hereunder shall be conducted pursuant to
the
Commercial Arbitration Rules of the American Arbitration Association
(“AAA”; such rules, the “AAA Rules”), except as modified herein. The
arbitration shall be conducted by a panel of three (3) independent,
neutral arbitrators that are industry experts experienced in the
issues
comprising the Dispute and have no past, present or reasonably anticipated
future affiliation with either party (the “Panel”). Company and Licensor
shall each be entitled to select one (1) such arbitrator, with the
two
such arbitrators so selected selecting the third such arbitrator.
In the
event either party fails to select its arbitrator within such ten
(10) day
period, the arbitrator selected by the other party within such ten
(10)
day period shall be entitled to select such arbitrator. The arbitration
shall take place in New York, New York and be conducted in English.
The
Panel shall apply the laws of the State of New York, without regard
to its
conflicts of laws provisions. The Panel shall issue appropriate protective
orders to protect each party’s Confidential Information. If a party can
demonstrate to the Panel that the complexity of the issue or other
reasons
warrant the extension of one or more timetables in the AAA Rules,
the
Panel may extend such timetables but in no event shall the proceeding
extend more than twelve (12) months from the date of filing of the
arbitration notice with the AAA. The Panel’s decision shall be in writing.
The Panel shall have the authority to award any remedy allowed by
law,
including but not limited to compensatory damages, pre-judgment interest,
but not punitive or other damages and each party shall be deemed
to have
waived any right to such excluded damages. Each party shall bear
its own
costs, fees and expenses in the arbitration and shall share equally
the
Panel’s fees, unless the Panel determines that its fees are to be paid
by
the non-prevailing party. Notwithstanding anything to the contrary,
without prejudice to the above procedures, either party may seek
injunctive relief or other provisional judicial relief if, in its
reasonable judgment, such action is necessary to avoid irreparable
damage
or otherwise enforce its rights
hereunder
|
21
10.2 Performance
to Continue
Each
party shall continue to perform its obligations, and shall be permitted to
continue to exercise its rights, under this Agreement pending final resolution
of any Dispute arising out of or related to this Agreement; provided, however,
that a party may suspend performance of its obligations during any period in
which the other party fails or refuses to perform its obligations.
10.3 Determination
of Patents and Other Intellectual Property
Notwithstanding
the foregoing, any dispute relating to the determination of validity of claims,
infringement or claim interpretation relating to Patent Rights shall
be
submitted exclusively to a federal court of competent jurisdiction.
10.4 Statute
of Limitation and Time-Based Defenses Tolled
All
applicable statutes of limitation and time-based defenses (such as estoppel
and
laches) shall be tolled while any arbitration proceedings are pending and during
any arbitration proceedings. The parties shall cooperate in taking any actions
necessary to achieve this result.
22
Article
11 Term and Termination
11.1 Term
This
Agreement shall become effective on the Effective Date and shall expire on
the
date of the expiration of the last to expire Royalty Term in any country in
the
Territory (the “Term”), unless earlier terminated as provided in Articles 11.2,
11.3, or 11.5.
11.2 Termination
for Insolvency
If
the
Company shall become bankrupt, or shall file a petition in bankruptcy, or if
the
business of the Company shall be placed in the hands of a receiver, assignee
or
trustee for the benefit of creditors, whether by the voluntary act of the
Company or otherwise, Company shall provide notice thereof to Licensor and
Licensor may, subject to the effects of and protections of any applicable
bankruptcy-related laws, rules, or regulations, terminate this Agreement upon
notice to Company given within thirty (30) business days of Licensor’s receipt
of such notice.
11.3 Termination
for Material
Breach
Upon
any
material breach or default of this Agreement by the Company, Licensor shall
have
the right to terminate this Agreement and the rights, privileges and license
granted hereunder by giving ninety (90) days prior written notice to the
Company. Upon the expiration of the ninety (90) day period, if the Company
shall
have not cured such breach or default, this Agreement shall, at the option
of
Licensor, terminate upon written notice of Licensor. In the event of a bona
fide
dispute over any material breach, the parties shall attempt to resolve such
dispute in good faith through negotiation, or if agreed to by the parties,
mediation, in each case to include the senior executive of both parties hereto.
Notwithstanding anything herein to the contrary, if the nature of the breach
is
such that additional time is reasonably needed to cure such breach, and Company
has commenced with good faith efforts to cure such breach, then Licensor shall
provide Company with additional time in which to cure such breach. If a dispute
regarding termination is addressed pursuant to Article 10, this license shall
remain in full force and effect until such dispute is resolved. All applicable
statutes of limitation and time-based defenses (such as estoppel and laches)
shall be tolled while any good faith negotiation or mediation procedures are
pending or ongoing. The parties shall reasonably cooperate in taking any actions
necessary to achieve this result.
11.4 Expiration
of Royalty Term on a Country-by-Country Basis
Upon
the
expiration of the Royalty Term in each country in the Territory, the Company
will have an irrevocable, perpetual, paid up, royalty-free exclusive license,
with rights of sublicense (through multiple tiers), under all rights granted
under this Agreement to make, have made, use, have used, lease, import and
export, offer to sell, sell have sold, produce, manufacture, distribute and
market Licensed Products in such country.
11.5 Termination
for Convenience;
Due Diligence Termination
|
11.5.1
|
The
Company shall have the right at any time to terminate this Agreement
in
its entirety or on a country-by-country basis, for any reason or
no
reason, by giving thirty (30) days notice thereof in writing to Licensor.
|
|
11.5.2
|
Additionally,
the Company shall have the right at any time to terminate this Agreement
upon or before January 30, 2007, by giving written notice thereof
in
writing to Licensor. If the company so terminates, such termination
shall
be effective upon the Company giving notice thereof and the Company
will
have no further obligation to the Licensor or to Onc Res, including,
but
not limited to the obligation to remit payment under Article
6.4.1.
|
23
11.6 Consequences
of Termination
Upon
the
termination of this Agreement by either party pursuant to Article 11.2, 11.3,
or
11.5, the following shall occur:
| 11.6.1 |
Subject
to Article 11.6.2, the Company and its Affiliates (as the case may
be)
shall have no right to practice within the Patent Rights or use any
of the
Patent Rights and Know-how, and all rights, title or interest in,
or other
incidents of ownership under, the Patent Rights and Know-how shall
revert
to and become the sole property of Licensor, and the licenses granted
under Article 2.1 shall automatically
terminate.
|
| 11.6.2 |
Notwithstanding
Article 11.6.1, if this Agreement is terminated other than pursuant
to
Article 11.5, the Company and its Affiliates may, after the effective
date
of such termination and continuing for a period not to exceed twelve
(12)
months thereafter, sell all completed Licensed Products, and complete
(or
have completed) any Licensed Products in the process of manufacture
at the
time of such termination and sell the same, provided that the
Company:
|
| (a) |
notifies
Licensor of its decision within thirty (30) days after the date it
receives a notice of termination by Licensor or the date it provides
a
notice of termination to Licensor, as the case may
be;
|
| (b) |
pays
or cause to be paid to Licensor the royalties and other payments
thereon
as required by Article 6 of this Agreement;
and
|
| (c) |
submits
the reports required by Article 7
hereof.
|
| 11.6.3 |
If
the Company does not elect pursuant to Article 11.6.2 to sell-off
or
distribute, as applicable, any existing inventory of Licensed Product,
the
Company shall, at Licensor’s election,
either:
|
| (a) |
sell
all existing inventory of Licensed Product to Licensor at fair market
value; or
|
| (b) |
destroy
all remaining inventory of Licensed Product in accordance with Applicable
Laws and provide Licensor with written proof of destruction sufficient
to
comply with Applicable Laws.
|
| 11.6.4 |
Notwithstanding
anything to the contrary, each sublicense granted under this Agreement
by
the Company or its Affiliates to a Sublicensee shall, to the extent
not
imposing obligations on Licensor and Onc Res in excess of those contained
herein, survive such termination and be automatically assigned to
Licensor
and Onc Res as provided for in Article 2, in order to provide for
the
applicable Sublicensees’ continued enjoyment of their rights under such
sublicenses.
|
24
| 11.6.5 |
Upon
termination of this Agreement for any reason other than pursuant
to
Article 11.4, Stason shall have the right, for an exclusive period
of
ninety (90) days after the termination of this Agreement (the “Exclusive
Period”), to negotiate an agreement, on commercially reasonable terms for
both Stason and the Company, for the transfer, license and/or right
of
reference to the Company’s know-how, clinical and pre-clinical data,
regulatory filings and Marketing Authorizations. In the event of
such
termination, the Company agrees to negotiate with Stason in good
faith.
In
the event Stason and the Company fail to consummate such an agreement
by
the end of the Exclusive Period, the Company shall have the right
to
terminate such negotiations and license, assign, transfer or otherwise
grant such rights to a third party or
parties.
|
11.7 Partial
Termination
Upon
the
early termination of this Agreement by either party in respect of a country,
the
terms of Article 11.6 shall apply in respect of such country.
11.8 Survival
Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either party from any obligation that matured prior to the effective
date of such termination, or such party’s obligations under Articles 6 and 7,
and the following provisions shall survive such termination: Articles 7.3,
9
(with respect to infringement occurring prior to such termination), 10, 11,
13,
14, 15, and 16.
Article
12 Representations and Warranties
12.1 Licensor
Warranties
Licensor
and Onc Res represent and warrant, jointly and severally, that:
| 12.1.1 |
Licensor
owns all right, title, and interest in and to the Patent Rights and
Know-how, including the exclusive, absolute, irrevocable right, title
and
interest thereto, free and clear of all liens, charges, encumbrances
or
other restrictions or limitations of any kind
whatsoever.
|
| 12.1.2 |
There
are no licenses, options, restrictions, liens, rights of third parties,
disputes, royalty obligations, proceedings or claims relating to,
affecting, or limiting Licensor’s or Onc Res’ rights or the rights of the
Company under this Agreement, or which may lead to a claim of infringement
by or invalidity regarding, any part or all of the Patent Rights
or
Know-how or their use.
|
| 12.1.3 |
There
is no claim, pending or threatened, of infringement, interference,
invalidity or unenforceability regarding any part or all of the Patent
Rights or Know-how or their use.
|
| 12.1.4 |
The
US and foreign patent applications and patents itemized on Schedule
1.20
set forth all of the patents and patent applications necessary or
useful
for practicing the Technology in the Field of Use owned by or licensed
to
Licensor and Onc Res on the Effective
Date.
|
25
| 12.1.5 |
There
are no inventors of Patent Rights other than those listed as inventors
on
applications filed for such Patent
Rights.
|
| 12.1.6 |
The
development of the Technology, Patent Rights, and Know-how were not
supported in whole or part by funding or grants by any governmental
agency
or philanthropic or charitable organization.
|
| 12.1.7 |
The
Licensor is a limited liability company duly organized, validly existing
and in good standing under the laws of Delaware. Onc Res is a corporation
duly organized, validly existing and in good standing under the laws
of
New York. Both the Licensor and Onc Res have the requisite power
and
authority to execute and deliver this Agreement and to consummate
the
transactions contemplated hereby, including but not limited to the
execution of the Termination Agreement. The execution and delivery
of this
Agreement and the performance and consummation of the transactions
contemplated hereby, including but not limited to the execution of
the
Termination Agreement, by the Licensor and Onc Res and have been
duly
authorized by all necessary action on the part of the Licensor and
Onc
Res, as applicable. This Agreement has been duly executed and delivered
by
the Licensor and Onc Res and, subject to the due authorization, execution
and delivery of this Agreements by the Company, this Agreement constitutes
a valid and binding obligation of the Licensor and Onc Res, enforceable
against the Licensor and Onc Res in accordance with its terms, except
as
such enforcement may be affected by bankruptcy, reorganization,
insolvency, moratorium or similar laws affecting creditor’s rights
generally and except for general principles of equity.
|
| 12.1.8 |
The
Termination Agreement has been duly executed and delivered by Onc
Res and
Ford and the Termination Agreement constitutes a valid and binding
agreement, enforceable against Onc Res and Ford in accordance with
its
terms, except as such enforcement may be affected by bankruptcy,
reorganization, insolvency, moratorium or similar laws affecting
creditor’s rights generally and except for general principles of
equity.
|
| 12.1.9 |
The
execution and delivery of this Agreement does not, the consummation
of the
transactions contemplated hereby, and the performance of Licensor’s and
Onc Res’ obligations hereunder will not, (i) conflict with, or result
in any violation or breach of any provision of the organizational
documents of the Licensor or Onc Res, (ii) conflict with or violate
any applicable foreign, Federal, state and local statutes, judgments,
decrees, laws, ordinances, rules, regulations, injunctions and orders
(“Laws”) of any U.S. Federal, state, foreign or local government or any
court, tribunal, administrative agency or commission or other governmental
or regulatory authority, body or agency, including any self-regulatory
organization (“Governmental Authorities”) applicable to the Licensor or
Onc Res or any of their respective assets or operations or any permit
applicable to the Licensor or Onc Res or (iii) result in (x) any
violation or breach of, constitute (with or without notice or lapse
of
time or both) a default under or conflict with (or give rise to a
right of
termination, amendment, cancellation or acceleration of any material
obligation or loss of any benefit under) the provisions of any lease,
contract or other agreement to which the Licensor or Onc Res is a
party or
by which it or any of its properties or assets is otherwise bound
or
(y) the imposition of any lien, pledge, hypothecation, mortgage,
security interest, claim, lease, charge, option, right of first refusal
or
first offer, easement, servitude, transfer restriction, voting requirement
or any other encumbrance, restriction or limitation on any of the
properties or assets of the Licensor or Onc Res.
|
26
| 12.1.10 |
No
consent, approval or authorization of, or declaration or filing with,
any
Governmental Authority or other Third Party (a “Consent”) is required on
the part of the Licensor or Onc Res in connection with its execution,
delivery, and performance of this Agreement or the consummation of
the
transactions contemplated hereby.
|
| 12.1.11 |
No
written communication has been received by the Licensor or Onc Res,
and no
investigation, regulatory enforcement action (including seizure,
injunction, civil penalty or criminal action) or any related Governmental
Authority review is or, in respect of any Licensed Product, to the
knowledge of the Licensor or Onc Res, was at any time pending or
is
threatened by any Governmental Authority with respect to (i) any
alleged or actual violation by the Licensor or Onc Res of any permit,
Law
or other requirement of any Governmental Authority relating to the
operations conducted by the Licensor or Onc Res with respect to any
Licensed Product or the Technology or (ii) any alleged or actual
failure to have or maintain in effect all permits required in connection
with the operations conducted by the Licensor or Onc Res with respect
to
any Licensed Product or the Technology. Neither Onc Res nor the Licensor
has received from the FDA, the U.S. Drug Enforcement Administration
(“DEA”), or any similar state, local, federal, or foreign Governmental
Authority any written notice regarding the approvability or approval
of
any of the Licensed Products. No Licensed Product has been withdrawn,
suspended or discontinued by the Licensor or Onc Res as a result
of any
action by the FDA, the DEA or any similar state, local, federal,
or
foreign Governmental Authority, either within or outside the U.S.
(whether
voluntarily or otherwise). With respect to any Licensed Products,
no
officer, employee or, to the knowledge of the Licensor or Onc Res,
agent
of the Licensor or Onc Res has made any untrue statement of a material
fact or a fraudulent statement to the FDA, DEA or any similar state,
local, federal, or foreign Governmental Authority, failed to disclose
any
material fact required to be disclosed to the FDA, the DEA or any
similar
state, local, federal, or foreign Governmental Authority, or committed
an
act, made a statement or failed to make a statement that, at the
time such
act, statement or omission was made, could reasonably be expected
to
provide a basis for the FDA, the DEA or any similar state, local,
federal
or foreign Governmental Authority to invoke the FDA’s policy respecting
“Fraud, Untrue Statements of Material Facts, Bribery, and Illegal
Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991)
or any similar policy, nor has any director, officer, employee or,
to the
knowledge of the Licensor and Onc Res, agent of the Licensor or Onc
Res
been convicted of any crime or engaged in any conduct for which debarment
is mandated by 21 U.S.C. Article 335a(a) (or any similar Law) or
authorized by 21 U.S.C. Article 335a(b) (or any similar
Law).
|
| 12.1.12 |
There
are no suits or actions, administrative, arbitration or other proceedings,
or governmental investigations pending or, to the knowledge of
the
Licensor, threatened against or affecting the Licensor or Onc Res
with
respect to Licensed Products or the Patent Rights. No Entity has
notified
the Licensor or Onc Res in writing of any material claim against
the
Licensor or Onc Res alleging any personal property or economic
injury,
loss or damage incurred as a result of or relating to the use of
the
Technology or any Licensed Products. There is no judgment, order,
injunction, decree, writ or award against the Licensor or Onc Res
that is
not satisfied and remains outstanding with respect to the Technology,
Patent Rights, or any Licensed
Product.
|
27
| 12.1.13 |
Schedule
12.1.13 hereto sets forth a true and complete list of each material
license, contract or other agreements (together with certain other
agreements and any amendments to any of the foregoing) to which the
Licensor or Onc Res is a party or by or to which any property of
the
Licensor or Onc Res is otherwise bound or subject that relates to
the
Licensed Products or the Patent Rights, including but not limited
to the
CT Agreements (as defined below) (collectively, the “Material
Agreements”). True and complete copies of all Material Agreements have
been previously delivered to the Company. Each of the Material Agreements
is valid, binding and in full force and effect, and enforceable by
the
Licensor or Onc Res (as applicable), or has expired, in each case
in
accordance with its respective terms. No Person (other than the Licensor
or Onc Res, as applicable) that is a party to any Material Agreement
or is
otherwise bound thereby is, to the knowledge of the Licensor or Onc
Res,
in default or breach thereof and, to Onc Res’ and the Licensor’s
knowledge, no event, condition or act exists that, with the giving
of
notice or the lapse of time or both, would give rise to such a default
or
breach thereof or a right of cancellation by the Licensor or Onc
Res
thereunder. Neither Onc Res or the Licensor is in default or breach
in any
material respect of any of the Material Agreements and, to the knowledge
of the Licensor and Onc Res, no event, condition or act exists that,
with
the giving of notice or the lapse of time or both, would give rise
to a
default or breach by the Licensor or Onc Res (as applicable) thereof
or a
right of cancellation thereunder by any other party
thereto.
|
| 12.1.14 |
To
the knowledge of the Licensor and Onc Res, none of the Patent Rights,
Licensed Products, or Technology, nor the practice, development,
use,
manufacture, sale, or import of any of the foregoing, infringes or
conflicts in any material respect with, and neither the Licensor
nor Onc
Res have received any notice of infringement of, or conflict with,
any
license, patent, copyright, trademark, service xxxx or other intellectual
property right of any Third Party and, to the knowledge of the Licensor
and Onc Res, there has not been and is not currently any infringement
or
unauthorized use by any Third Party of any of the Patent Rights,
Technology, Know-how, or Licensed Products. Except as provided herein,
the
validity or enforceability of any of the Patent Rights and or the
title of
the Licensor (or, if applicable, Onc Res) thereto has not been questioned
in any litigation, governmental inquiry or proceeding to which the
Licensor or Onc Res is a party and, to the knowledge of the Licensor
and
Onc Res, no such litigation, governmental inquiry or proceeding is
threatened.
|
| 12.1.15 |
To
the knowledge of the Licensor and Onc Res, the Licensor and Onc Res
(as
applicable) have taken all reasonable actions necessary or appropriate
to
preserve the confidentiality of all trade secrets, proprietary and
other
confidential information material to the Licensed Products, Know-how,
and
Patent Rights.
|
| 12.1.16 |
Licensor
and Onc Res are not aware of any Third Party activities which would
constitute misappropriation or infringement of the Patent
Rights.
|
| 12.1.17 |
Onc
Res owns all right, title, and interest to the Licensor IND(s) free
and
clear of all liens, claims, and encumbrances, Licensor IND(s) constitute
the only INDs or regulatory filings of any kind concerning any Licensed
Product, and there are no Governmental Approvals in place or effective
in
any jurisdiction with respect to any Licensed
Product.
|
28
| 12.1.18 |
Licensor
IND(s) are and have been filed, updated, and maintained in accordance
with
applicable Laws and pharmaceutical industry standards, and neither
Licensor nor Onc Res has received nor been the subject of, nor is
aware of
any information for which one would reasonably expect Onc Res or
Licensor
to receive or be the subject of, any correspondence or other action
on the
part of any Regulatory Authority which would or could reasonably
be
expected to have a material adverse effect on any study with respect
to
Licensor IND(s) or on the Company’s development or commercialization of
any Licensed Product.
|
| 12.1.19 |
Except
as provided in the Consulting Agreement, Ford is obligated by contract
to
assign all right, title, and interest in any modification, enhancement,
or
improvement of a Licensed Product, or any inventions, discoveries,
improvements (whether patentable or not), information, and data which
would be useful or necessary in the manufacture, use, or sale of
any
Licensed Product, or the practice of which would infringe an issued
or
pending claim within the Patent Rights, and any intellectual property
rights related to any of the foregoing (including but not limited
to
patent rights), owned, acquired, controlled, conceived, reduced to
practice, or otherwise developed by Ford at any time during the Term,
to
Licensor, free and clear of all liens, claims, and
encumbrances.
|
12.2 No
Impairment
Licensor
and Onc Res hereby covenant and agree that, during the Term, they will not
(either jointly or acting alone), by act or failure to act, impair or otherwise
adversely affect, or cause any occurrence which would reasonably anticipated
to
impair or otherwise adversely affect, the Company’s rights under this Agreement
or ability to freely exercise such rights.
|
12.3
|
Representations
by Stason.
Stason hereby represents and warrants
that:
|
| 12.3.1 |
Stason
has not conceived, reduced to practice, or otherwise developed any
inventions, improvements, data, information, or other intellectual
property related to, or useful or necessary with respect to, the
development, commercialization, or exploitation of the Technology,
Patent
Rights, Know-how, or Licensed Products, and Stason does not own,
control
(by license or otherwise), or have any rights to or interest in any
such
inventions, improvements, data, information, or other intellectual
property related to the Technology.
|
| 12.3.2 |
Both
this Agreement and the Termination Agreement have been duly executed
and
delivered by Stason and both such agreements constitute valid and
binding
agreements, enforceable against Stason in accordance with their terms
(as
limited by Article 16.13 herein), except as such enforcement may
be
affected by bankruptcy, reorganization, insolvency, moratorium or
similar
laws affecting creditor’s rights generally and except for general
principles of equity.
|
29
Article
13 Limitation of Liability, Indemnity
13.1 NO
IMPLIED WARRANTIES
| 13.1.1 |
EXCEPT
AS SET FORTH IN ARTICLE 12, LICENSOR DOES NOT MAKE AND EXPRESSLY
DISCLAIMS
ALL REPRESENTATIONS AND WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED,
INCLUDING, BUT NOT LIMITED TO, WARRANTY OF MERCHANTABILITY, FITNESS
FOR A
PARTICULAR PURPOSE, AND VALIDITY OF PATENTED RIGHTS CLAIMS, ISSUED
OR
PENDING.
|
| 13.1.2 |
EXCEPT
AS SET FORTH IN ARTICLE 12, NOTHING HEREIN SHALL BE CONSTRUED AS
A
REPRESENTATION OR WARRANTY BY LICENSOR TO THE COMPANY THAT THE PATENT
RIGHTS AND KNOW-HOW ARE NOT INFRINGED BY ANY THIRD PARTY, OR THAT
THE
PRACTICE OF SUCH RIGHTS DOES NOT INFRINGE ANY INTELLECTUAL PROPERTY
RIGHTS
OF ANY THIRD PARTY.
|
13.2 Indemnity
| 13.2.1 |
The
Company agrees to defend, indemnify and hold harmless Licensor, Onc
Res,
their Affiliates, directors, employees and officers (“Licensor
Indemnitees”) from and against all liability, demands, damages, including
without limitation reasonable legal fees and expenses, and losses
including death, personal injury, illness or property damage arising
directly out of the Company’s use, manufacture, sale, or other disposition
of Licensed Products under the terms of this Agreement, to the extent
not
resulting from any Licensor Indemnitee’s breach of this Agreement,
negligence, willful misconduct, or failure to comply with Applicable
Laws.
|
| 13.2.2 |
Licensor
and Onc Res agree to defend, indemnify and hold harmless the Company,
its
Affiliates, directors, employees, and officers (“Company Indemnitees”)
from and against all liability, demands, damages, including without
limitation reasonable legal fees and expenses, and losses including
but
not limited to death, personal injury, illness or property damage
arising
directly out of any Licensor Indemnitee’s breach of this Agreement,
negligence, willful misconduct, or failure to comply with Applicable
Laws.
|
| 13.2.3 |
In
the event that either party intends to seek indemnification for any
claim
under Article 13.2.1 or 13.2.2, it shall inform the other party of
the
claim promptly after receiving notice of the
claim.
|
In
the
case of a claim for which any Licensor Indemnitee seeks indemnification under
Article 13.2.1, such Licensor Indemnitee shall permit the Company to direct
and
control the defense of the claim and shall provide such reasonable assistance
as
is reasonably requested by the Company (at the Company’s cost) in the defense of
the claim, provided that nothing in this Article 13.2.3 shall permit the Company
to make any admission on behalf of Licensor or Onc Res, or to settle any claim
or litigation which would impose any financial obligations on Licensor or Onc
Res without the prior written consent of Licensor, such consent not to be
unreasonably withheld or delayed.
30
In
the
case of a claim for which the Company seeks indemnification under Article
13.2.2, the Company shall permit Licensor or Onc Res, whichever is indemnifying
the Company, to direct and control the defense of the claim and shall provide
such reasonable assistance as is reasonably requested by Licensor or Onc res
(at
Licensor’s or Onc Res’ cost) in the defense of the claim, provided that nothing
in this Article 13.2.3 shall permit Licensor or Onc Res to make any admission
on
behalf of the Company, or to settle any claim or litigation which would impose
any financial obligations on the Company without the prior written consent
of
the Company, such consent not to be unreasonably withheld or
delayed.
13.3 LIMITATION
OF LIABILITY
EXCEPT
WITH REGARD TO DAMAGES ARISING FOR INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS,
BREACHES
OF ARTICLE 14.3 OR 15, AND
ANY
DUTY TO INDEMNIFY FOR SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL
DAMAGES UNDER ARTICLE 13.2.1 OR 13.2.2, IN NO EVENT SHALL ANY PARTY OR THEIR
AFFILIATES BE LIABLE FOR
SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER BASED
ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY AND IRRESPECTIVE OF WHETHER SUCH
PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF ANY SUCH LOSS OR DAMAGE.
Article
14 Use of Names and Publication
14.1 Use
of Name
Nothing
contained in this Agreement shall be construed as granting any right to the
Company or its Affiliates to use in advertising, publicity, or other promotional
activities any name, trade name, trademark, or other designation of Licensor
or
Onc Res or any of its units (including contraction, abbreviation or simulation
of any of the foregoing) without the prior, written consent of Licensor;
provided that Company may identify Licensor and Onc Res as the licensors under
this Agreement without such consent to actual or potential investors, investment
bankers, acquirers, acquisition targets, and strategic partners, and where
the
use of such names may be required by Applicable Law.
14.2 No
Agency
Nothing
herein shall be deemed to establish a relationship of principal and agent
between Licensor and the Company, Onc Res and the Company, nor any of such
parties’ respective agents or employees for any purpose whatsoever. This
Agreement shall not be construed as creating a partnership between the Licensor
and the Company, or Onc Res and the Company, or as creating any other form
of
legal association or arrangement, which would impose liability upon one party
for the act or failure to act of the other party.
14.3 Publication
In
the
event that Licensor or Onc Res or any of their respective Affiliates, employees,
officers, directors, or shareholders thereof desires to publish or disclose,
by
written, oral or other presentation, any information included in the Patent
Rights, Know-how, or any material information related thereto, Licensor shall
provide the Company with a copy of the proposed publication, presentation,
or
disclosure at least sixty (60) days prior to its submission for presentation,
publication, or disclosure. The Company may request that Licensor or Onc Res,
no
later than sixty (60) days following the receipt of such proposed publication,
presentation, or disclosure, (i) delay such presentation, publication or
disclosure for up to an additional ninety (90) days in order to enable the
Company to file, or have filed on their behalf, a patent application, copyright
or other appropriate form of intellectual property protection related to the
information to be disclosed or request that Licensor or Onc Res do so, (ii)
remove the Company’s Confidential Information from such presentation,
publication or disclosure, and/or (iii) make any other reasonable changes to
such proposed publication, presentation, or disclosure, as applicable. Upon
receipt of such request, Licensor or Onc Res (as applicable) shall (i) arrange
for a delay of such presentation, publication or disclosure until such time
as
the Company or Licensor has filed, or had filed on its behalf, such patent
application, copyright or other appropriate form of intellectual property
protection in form and in substance reasonably satisfactory to the Company
and
Licensor, (ii) remove the Company’s Confidential Information from such
presentation, publication or disclosure, and/or (iii) reasonably consider any
other reasonable changes proposed by the Company. If Licensor or Onc Res (as
applicable) does not receive any request from the Company to delay such
presentation, publication or disclosure, Licensor or Onc Res (as applicable)
may
submit such material for presentation, publication or other form of disclosure,
subject to Licensor’s obligations under Article 15.
31
Article
15 Confidentiality
15.1 Confidentiality
and Non-Use
Any
proprietary or confidential information relating to the Technology, Patent
Rights, Know-how (including but not limited to patent prosecution documents
relating to Patent Rights), reports and records provided under Article 7, and
any other reasonably confidential or proprietary information concerning a
party’s business or technology disclosed to the other party under this Agreement
collectively constitute the “Confidential Information.” No party to this
Agreement will use the Confidential Information for any purpose unrelated to
the
exercise of their rights or fulfillment of their obligations under this
Agreement, and will hold it in confidence during the Term and for a period
of
five (5) years after the termination or expiration date of this Agreement.
Each
party shall exercise with respect to such the Confidential Information the
same
degree of care as the party exercises with respect to its own confidential
or
proprietary information of a similar nature, but in no event less than
reasonable care, and shall not disclose it or permit its disclosure to any
Third
Party (except to those of its employees, consultants, or agents who are bound
by
a substantially similar obligation of confidentiality of this Agreement).
However, such undertaking of confidentiality shall not apply to any information
or data which:
| 15.1.1 |
The
receiving party receives without obligation of confidentiality at
any time
from a third-party lawfully in possession of same and having the
right to
disclose same;
|
| 15.1.2 |
is,
as of the date of this Agreement, in the public domain, or subsequently
enters the public domain through no fault of the receiving
party;
|
| 15.1.3 |
is
independently developed by the receiving party as demonstrated by
written
evidence without reference to or benefit of information disclosed
to the
receiving party by the disclosing
party;
|
| 15.1.4 |
is
disclosed pursuant to the prior written approval of the disclosing
party;
or
|
32
| 15.1.5 |
is
required to be disclosed pursuant to Applicable Law or legal process
(including, without limitation, to a governmental authority) provided
that
recipient will (i) give prior written notice of such required disclosure
to the other party, to the extent reasonably practicable, (ii) give
reasonable assistance to the other party, as requested thereby, seeking
confidential or protective treatment thereof, and (iii) only disclose
such
Confidential Information to the extent required by such Applicable
Law or
legal process.
|
15.2 Limited
Disclosure by Licensor
Licensor
and Onc Res acknowledge and agree that the Know-how licensed to the Company
has
value to the Company in being maintained as confidential. Therefore, neither
Licensor nor Onc Res shall disclose the Know-how to any Third Party without
the
Company’s prior written consent.
15.3 Material
Non-Public Information
Licensor,
Onc Res, and Stason understand that it is the intent of the Company to register
its capital stock on
a
national securities exchange, on the National Association of Securities Dealers,
Inc. Automated Quotation System (collectively “NASDAQ”), or the Over The Counter
Bulletin Board and accordingly, the Licensor understands that confidential
information provided to them by the Company pursuant to the terms of this
Agreement may constitute “material non-public information” concerning the
Company.
Article
16 Miscellaneous Provisions
16.1 Assignment
This
Agreement and the rights and duties appertaining hereto may not be assigned
by
any party without first obtaining the written consent of the other parties,
which consent shall not be unreasonably withheld. Any such purported assignment
without the written consent of the other parties shall be null and of no effect.
Notwithstanding the foregoing, the Company may assign this Agreement without
the
consent of any of the other parties (i) to a purchaser, merging, or
consolidating corporation, or acquirer of all or substantially all of the
Company’s (or its successors or assigns) assets or business (or that portion
thereof to which this Agreement relates) and/or pursuant to any reorganization
of the Company, (ii) to an Affiliate of the Company (or its successors or
assigns), or (iii) to VioQuest Pharmaceuticals, Inc.
16.2 Binding
Nature and Inurnment
This
Agreement will not be binding upon the parties until it has been signed below
on
behalf of each party, in which event, it shall be effective as of the Effective
Date. As of the Effective Date, this Agreement is binding upon and inures to
the
benefit of the parties and their respective permitted successors and
assigns.
16.3 Counterparts;
Facsimile
This
Agreement may be executed in two or more counterparts, each of which shall
be
deemed an original, but all of which together shall constitute one and the
same
instrument. This Agreement may be signed and delivered to the other party by
facsimile signature; such transmission will be deemed a valid
signature.
33
16.4 Entire
Agreement; Amendment
The
parties hereto acknowledge that this Agreement, including the Exhibits,
Schedules and documents incorporated by reference, sets forth the entire
agreement and understanding of the parties hereto as to the subject matter
hereof, and shall not be subject to any change of modification except by the
execution of a written instrument subscribed to by the parties hereto and shall
supersede all previous communications, agreements (including the Original
Agreement), representations or understandings, either oral or written, between
the parties relating to the subject matter hereof. No subsequent alteration,
amendment, change or addition to this Agreement shall be binding upon the
parties hereto unless reduced to writing and signed by the respective authorized
officers of the parties.
16.5 Force
Majeure
Neither
party is responsible for delays resulting from causes beyond its reasonable
control, including without limitation fire, explosion, flood, war, strike,
or
riot, provided that the nonperforming party uses commercially reasonable efforts
to avoid or remove those causes of nonperformance and continues performance
under this Agreement with reasonable dispatch whenever the causes are
removed.
16.6 Further
Assurances
From
time
to time during the Term, at the request of either party, the
other
party shall execute and deliver such
documents and take such other action as the requesting party may reasonably
request to consummate more effectively the transactions contemplated
hereby.
16.7 Headings
The
headings of the several articles are inserted for convenience of reference
only
and are not intended to be a part of or to affect the meaning or interpretation
of this Agreement.
16.8 Law
This
Agreement shall be construed, governed, interpreted and applied in accordance
with the laws of the State of New York, without regard to principles of
conflicts of laws.
16.9 Payments,
Notices and Other Communications
Any
payment, notice or other communication required or permitted to be given
pursuant to this Agreement shall be in writing and sent by certified first
class
mail, postage prepaid, by hand delivery or by facsimile if confirmed in writing,
in each case effective upon receipt, at the addresses below or as otherwise
designated by written notice given to the other party:
|
In
the case of Licensor:
|
Asymmetric
Therapeutics, LLC.
|
|
000
Xxxx Xx.
|
|
|
Xxxxxxxx,
XX 00000
|
|
In
the case of the Company:
|
Fiordland
Pharmaceuticals, Inc.
|
|
000
Xxxxxxx Xxx. 00xx
xxxxx
|
|
|
Xxx
Xxxx, XX 00000
|
34
16.10 Payment
of Own Fees and Expenses
Each
party shall be responsible for their own expenses relating to the preparation
and consummation of this Agreement and, except as specified herein, the
agreements and transactions contemplated hereby.
16.11 Severability
The
provisions of this Agreement are severable, and in the event that any provision
of this Agreement shall be determined to be invalid or unenforceable under
any
controlling body of law, such invalidity or unenforceability shall not in any
way affect the validity or enforceability of the remaining provisions
hereof.
16.12 Waiver
The
failure of either party to assert a right hereunder or to insist upon compliance
with any term or condition of this Agreement shall not constitute a waiver
of
that right or excuse a similar subsequent failure to perform any such term
or
condition by the other party. Any waiver of any rights or failure to act in
a
specific instance relates only to that instance and is not an agreement to
waive
any rights or fail to act in any other instance.
16.13b
No
Third Party Beneficiaries
No
third
party shall be a beneficiary to this Agreement. Stason agrees that it shall
have
no rights under this Agreement except to enforce its rights under Articles
4.4
and 11.6.5.
[Signature
page to follow.]
35
IN
WITNESS WHEREOF,
the
parties hereto have executed this Agreement, in triplicate by proper persons
thereunto duly authorized.
ONC
RES, INC. FIORDLAND
PHARMACEUTICALS, INC
|
ONC
RES, INC.
|
FIORDLAND
PHARMACEUTICALS, INC
|
|
|
|
|
By:
/s/ Xxxx X. Xxxx
|
By:
/s/ J. Xxx Xxxxxx
|
|
Name:
Xxxx X. Xxxx
|
Name:
J. Xxx Xxxxxx
|
|
Title:
Director
|
Title:
President
|
|
Date:
2/17/07
|
Date:
February 14, 2007
|
ASYMMETRIC
THERAPUETICS, LLC
By:
/s/
Xxxx
X. Xxxx
Name:
Xxxx X. Xxxx
Title:
Member Date:
2/17/07
SOLEY
AS TO ITS AGREEMENTS, REPRESENTATIONS AND WARRANTIES UNDER ARTICLE 1A, ARTICLE
12.3, ARTICLE 15, AND ARTICLE 16.13 AND TO ENFORCE ITS RIGHTS UNDER ARTICLES
4.4
AND 11.6.5
STASON
PHARMACEUTICALS, INC.
By:
/s/
Xxxxx
X. Fan
Name:
Xxxxx X. Fan
Title:
CEO Date:
2/21/07
36
Schedule
1.15: Licensor IND(s)
1.)
IND
66,845 filed February 28th,
2005
Schedule
1.20: Patent Rights
|
Docket
No.
|
|
Application
Serial No./Patent No. (if granted)
|
|
Filing
Date/Issue Date
|
|
Title
|
|
[***]
|
10/364,383
|
02/12/2003
|
Treatment,
Composition and Method using Uracil Against Side-Effects of
Chemotherapy
|
|||
|
[***]
|
10/684,203/
U.S.
Xxx. No. 6,979,688
|
10/10/2003/
12-27-2005
|
Treatment
Method Against Side-Effects of Chemotherapy
|
|||
|
[***]
|
11/146,883
|
06/06/2005
|
Treatment
Method Against Side-Effects of Chemotherapy
|
|||
|
[***]
|
10/918,199/
U.S.
Xxx. No. 6,995,165
|
08/13/2004/
02/07/2006
|
Methods,
Compositions and Kits for Organ Protection During Systemic Anticancer
Therapy
|
|||
|
[***]
|
11/196,921
|
08/03/2005
|
Methods,
Compositions and Kits for Organ Protection During Systemic Anticancer
Therapy
|
|||
|
[***]
|
60/697,910
|
07/08/2005
|
Systemic
Anticancer Therapy Safety and Compliance Packaging
|
|||
|
[***]
|
11/482,661
|
07/07/2006
|
Metered-Dose
and Safety and Compliance Packaging for Systemic Anticancer
Therapy
|
|||
|
[***]
|
2004283079
|
08/13/2004
|
Methods,
Compositions and Kits for Organ Protection During Systemic Anticancer
Therapy
|
|||
|
[***]
|
2,542,235
|
08/13/2004
|
Methods,
Compositions and Kits for Organ Protection During Systemic Anticancer
Therapy
|
|||
|
[***]
|
04781096.5
|
08/13/2004
|
Methods,
Compositions and Kits for Organ Protection During Systemic Anticancer
Therapy
|
|||
|
[***]
|
06112520.8
|
08/13/2004
|
Methods,
Compositions and Kits for Organ Protection During Systemic Anticancer
Therapy
|
|||
|
[***]
|
2006-533849
|
08/13/2004
|
Methods,
Compositions and Kits for Organ Protection During Systemic Anticancer
Therapy
|
|||
|
[***]
|
547045
|
08/13/2004
|
Methods,
Compositions and Kits for Organ Protection During Systemic Anticancer
Therapy
|
|||
|
[***]
|
200602330-3
|
08/13/2004
|
Methods,
Compositions and Kits for Organ Protection During Systemic Anticancer
Therapy
|
|||
|
[***]
|
2006/03458
|
08/13/2004
|
Methods,
Compositions and Kits for Organ Protection During Systemic Anticancer
Therapy
|
|||
|
[***]
|
PCT/US2004/026352
|
08/13/2004
|
Methods,
Compositions and Kits for Organ Protection During Systemic Anticancer
Therapy
|
Schedule
3.2: Existing Technology and Licensed Product Inventory
None.
Exhibit
5.3.1: Diligence Milestones
|
1.
|
Amend
a Licensor IND or file a Company-sponsored (or Sublicensee-sponsored)
IND
in the United States or Canada with respect to a Licensed Product
within
12 months of the Effective Date.
|
|
2.
|
Initiate
enrollment of patients for the first human clinical trial of a Licensed
Product to be conducted by or on behalf of the Company (or Sublicensee)
within 6 months after approval of an IND with respect
thereto.
|
|
3.
|
First
commercial sale of a Licensed Product no later than 6 months following
receipt by the Company of the initial Marketing Authorization obtained
with respect to a Licensed Product.
|
Exhibit
5.3.2: Example of Extension Payment Schedule
|
6
Month Period
|
Payment
|
Cumulative
|
Extension
Time
|
Cumulative
Extension Time
|
|||||||||
|
1
|
$
|
[***
|
]
|
$
|
[***
|
]
|
6
months
|
6
months
|
|||||
|
2
|
$
|
[***
|
]
|
$
|
[***
|
]
|
6
months
|
12
months
|
|||||
|
3
|
$
|
[***
|
]
|
$
|
[***
|
]
|
6
months
|
18
months
|
|||||
|
4
|
$
|
[***
|
]
|
$
|
[***
|
]
|
6
months
|
24
months
|
|||||
|
5
|
$
|
[***
|
]
|
$
|
[***
|
]
|
6
months
|
30
months
|
|||||
|
6
|
$
|
[***
|
]
|
$
|
[***
|
]
|
6
months
|
36
months
|
|||||
This
Exhibit is an example and illustration and is by no way intended create or
infer
any obligations on the parties except as specifically described in the
Agreement.
Exhibit
5.4(a): CT Agreements
None.
Schedule
5.4(b): Transferred Agreements
None.
Schedule
12.1.13: Material Agreements
|
1.
|
Joint
Venture Agreement, dated February 19, 2005, between Licensor, Xxxx
X.
Xxxx, MD, and Stason Pharmaceuticals,
Inc.
|
|
2.
|
Termination
Agreement dated December 29, 2006 between Onc Res, Xxxx X. Xxxx,
MD, and
Stason Pharmaceuticals, Inc.
|
|
3.
|
Assignment
Agreement dated December 29, 2006
|
|
4.
|
Supplemental
Assignment Agreement dated February __,
2007
|
