LICENSE AGREEMENT
Exhibit
10.6
Portions
herein identified by [***] have been omitted pursuant to a request for
confidential treatment under Rule 406 of the Securities Act of 1933. A complete
copy of this document has been filed separately with the Securities and Exchange
Commission.
This
License Agreement (hereinafter referred to as this "Agreement"), effective
as of
October
15, 2004 2004, (the “Effective Date”), is entered into by and between DEKK-TEK,
Inc., having an address at 0000 Xxxxx Xxxxxx, Xxxxx X, Xxx Xxxxxxx, XX, 00000
(the “Licensor”) and ZIOPHARM, Inc., having an address at 000 Xxxxxx Xx., Xxxxx
0, Xxx Xxxxx, XX 00000 (the "Company").
WHEREAS,
the
Licensor has certain proprietary rights and intellectual property with respect
to Technology; and
WHEREAS,
the
Company desires to obtain from the Licensor, and the Licensor desires to
grant
to the Company, an exclusive, world-wide, royalty bearing license to develop
and
commercialize the Technology on the terms and conditions set forth herein;
and
NOW,
THEREFORE, in
consideration of the foregoing premises, the mutual promises and covenants
of
the Parties contained herein, and other good and valuable consideration,
the
receipt and sufficiency of which are hereby acknowledged, the Parties hereto,
intending to be legally bound, do hereby agree as follows:
ARTICLE
1 - DEFINITIONS
For
the
purposes of this License Agreement, the following words and phrases shall
have
the following meanings:
1.1 "Affiliate"
shall mean, with respect to any Entity (as hereinafter defined), any Entity
that
directly or indirectly Controls, is Controlled by, or is under common Control
with such Entity.
1.1.1 “Control”
shall mean, for this purpose, direct or indirect control of more than fifty
percent (50%) of the voting securities of an Entity or, if such Entity does
not
have outstanding voting securities, more than 50% of the directorships or
similar positions with respect to such Entity.
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1.1.2 “Entity”
shall mean any corporation, association, joint venture, partnership, trust,
university, business, individual, government or political subdivision thereof,
including an agency, or any other organization that can exercise independent
legal standing.
1.2 “FDA”
shall mean the United States Food and Drug Administration
1.3 “Improvements”
shall mean any inventions (whether patentable or not), information
and data that are developed by or on behalf of the Licensor during the term
of
this Agreement, the manufacture, use or sale of which would infringe an issued
or pending claim within the existing Patent Rights.
1.4 “IND”
shall mean Investigational New Drug Application as defined by the rules and
regulations of the FDA.
1.5 “Know-how”
shall mean all tangible information (other than those contained in the Patent
Rights) whether patentable or not and all physical objects related to the
Patent
Rights or the Licensed Product, including but not limited to formulations,
materials, data, drawings and sketches, designs, testing and test result,
regulatory information of a like nature, owned or controlled by
Licensor.
1.6 “Licensed
Product(s)” shall mean any product, the manufacture, use, lease or sale of which
is covered in whole or in part by a Valid Claim contained in the Patent Rights
in the country in which the product is made, used, leased or sold.
1.7 “NDA”
shall mean New Drug Application as defined by the rules and regulations of
the
FDA.
1.8 “Net
Sales” shall mean the total gross receipts for sales of Licensed Products by or
on behalf of the Company of any of its Affiliates or any sublicensee, less
the
sum of the following: (a) usual trade discounts to customers; (b) sales,
tariff
duties and/or use taxes directly imposed and with reference to particular
sales;
(c) outbound transportation prepaid or allowed and transportation insurance;
(d)
amounts allowed or credited on returns; (e) bad debt deductions actually
written
off during the accounting period; (f) sales commissions; and (g) packaging
and
freight charges. For purposes of determining Net Sales, a Licensed Product
shall
not include transfers, uses or dispositions for charitable, promotional,
pre-clinical, clinical, regulatory or governmental purposes. For purposes
of
calculating Net Sales, sales between or among the Company or its Affiliates
shall be excluded from the computation of Net Sales, but sales by the Company
or
its Affiliates to third parties shall be included in the computation of Net
Sales.
1.9 “Patent
Rights” shall mean all of Licensor’s interest in:
1.9.1 All
United States and foreign patents and patent applications and invention
disclosures set forth in Appendix A;
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1.9.2 All
United States and foreign patents and patent applications which cover an
invention included in the patents and/or patent applications or invention
disclosures set forth in Appendix A;
1.9.3 All
United States and foreign patents and patent applications which cover an
Improvement;
1.9.4 Any
continuations, divisionals, re-issue applications, continuation-in-part
applications, re-examinations or extensions or any other later filed
applications of any of the foregoing patent applications/patents set forth
in
1.9.1-1.9.3;
and
1.9.5
Any
United States and/or foreign patents issuing from any of the foregoing patent
applications/patents set forth in 1.9.1-1.9.4.
1.10 “Phase
II” shall mean a controlled clinical study in the United States conducted to
obtain preliminary data on effectiveness of an investigational new drug for
a
particular indication, as required in 21 C.F.R. Sec. 312.
1.11 “Phase
III” shall mean a controlled clinical study in the United States, the principal
purpose of which is to establish pivotal safety and pivotal efficacy in patients
with the disease target being studied, as required in 21 C.F.R.
Sec,312.
1.12 “Technology”
means Patent Rights, Improvements and Know-how.
1.13 “Valid
Claim” means an issued claim of any unexpired patent included in
Patent
Rights, which patent has not been held unenforceable, unpatentable or invalid
by
a decision of a court of a governmental body of competent jurisdiction,
unappealable or uanppealed within the time allowed for appeal, which has
not
been rendered unenforceable through disclaimer or otherwise, and which has
not
been lost through an interference proceeding or abandoned.
ARTICLE
2 - GRANT
2.1 The
Licensor hereby grants to the Company and the Company accepts, subject to
the
terms and conditions of this Agreement, an exclusive worldwide license in
all
fields of use to utilize the Technology, and to make, have made, use, have
used,
lease, import, offer to sell, sell, and/or have sold the Licensed Products,
to
the full end of the term for which the Patent Rights are granted, unless
sooner
terminated as hereinafter provided. Company may extend the license granted
herein to any Affiliate, provided that the Affiliate consents in writing
to be
bound by this Agreement to the same extent as Company.
2.2 To
the
best of Licensor’s knowledge and belief and upon due inquiry, the Licensor has
all right, title, and interest in and to the Patent Rights, including 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 and to best of Licensor’s knowledge and belief, and upon due inquiry,
there are no licenses, options, restrictions, liens, rights of third parties,
disputes, royalty obligations, proceedings or claims relating to, affecting,
or
limiting its rights or the rights of the Company under this Agreement with
respect to any part or all of the Patent Rights and their use as contemplated
in
the underlying patent applications as presently drafted.
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2.3 To
the
best of Licensor’s knowledge and belief and upon due inquiry, there is no claim,
pending or threatened, of infringement, interference or invalidity regarding,
any part or all of the Patent Rights and their use as contemplated in the
underlying patent applications as presently drafted. The validity or
enforceability of any of the Patent Rights or Technology has not been questioned
in any litigation, governmental inquiry or proceeding to which the Licensor
is a
party and, to the knowledge of the Licensor, not such litigation, governmental
inquiry or proceeding is threatened.
2.4 The
Licensor grants to the Company and its Affiliates the right to grant sublicenses
to third- parties under the license granted hereunder.
2.4.1 Within
thirty (30) days after execution or receipt thereof, as applicable, the Company
shall provide the Licensor with a confidential copy of each sublicense issued
hereunder.
2.4.2 Upon
the
termination of this Agreement, Licensor agrees to accept existing sublicensees
under the terms of such sublicense provided that such sublicensee is in good
standing, or restores its good standing within 90 days from the termination
of
this Agreement.
2.5 Upon
execution of this Agreement, Licensor shall promptly provide Know-how to
Company. Additionally, Licensor will promptly disclose to Company any
Improvements.
ARTICLE
3 - DUE DILIGENCE
3.1 The
Company, by itself or through its affiliates or sublicensees shall use all
reasonable commercial efforts to bring a product incorporating the Technology
to
market through a thorough, vigorous and diligent program. Such program shall
include the preclinical and clinical development of the product, including
research and development, manufacturing, laboratory and clinical testing
and
marketing. On or before each anniversary of this Agreement until the Company
markets a product incorporating the Technology, Licensor may request in writing
that the Company submit a report covering the preceding year, regarding the
Technology development progress. Should Licensor believe the Company is not
using all reasonable commercial efforts to bring a product incorporating
the
Technology to market, the Licensor will notify the Company of such concern
and
the Company and the Licensor will meet to discuss such concerns. If as a
result
of such meeting the Licensor is not satisfied the Company is using all
reasonable commercial efforts to bring a product incorporating the Technology
to
market, the parties shall proceed to dispute resolution in accordance with
Section 8.1 of this Agreement.
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ARTICLE
4 - ROYALTIES AND OTHER CONSIDERATION
4.1 As
partial consideration for the rights granted by Licensor to Company,
Company will issue to the Licensor stock options (“Options”) to purchase a total
of 50,000 shares (the “Shares”) of the Company’s common stock (the “Common
Stock”) at an exercise price per share equal to $0.01 per share, equal to one
percent (1%) of the outstanding shares of Common Stock of the Company on
a fully
diluted basis as of the Effective Date. The Options will vest and become
exercisable in accordance with the following schedule:
(i)
12,500
Shares upon the Effective Date;
(ii)
[***]
Shares
[***] of Licensed Product in the United States [***]; and
(iii)
[***] Shares upon the final approval by the FDA of the first NDA submitted
by
the Company or its sublicensee for a Licensed Product.
(i) |
The
Options shall be granted under a Stock Option Agreement containing
such
terms and conditions as are customary for the Company.
|
(ii) |
Upon
the occurrence of a Change of Control as defined below, all unvested
Options shall be accelerated and deemed to have vested as of the
date of
such Change of Control. For purposes of this section, “Change of Control”
shall mean (a) the acquisition, directly or indirectly, following
the date
hereof by any person (as such term is defined in Section 13(d)
and
14(d)(2) of the Securities Exchange Act of 1934, as amended), in
one
transaction or a series of related transactions, of securities
of the
Company representing in excess of fifty percent (50%) or more of
the
combined voting power of the Company’s then outstanding securities if such
person or his or its affiliate(s) do not own in excess of 50% of
such
voting power on the date of this Agreement, or (b) the future disposition
by the Company (whether direct or indirect, by sale of assets or
stock,
merger, consolidation or otherwise) of all or substantially all
of its
business and/or assets in one transaction or series of related
transactions (other than a merger effected exclusively for the
purpose of
changing the domicile of the
Company).
|
4.2 The
Company agrees to pay to Licensor royalties in an amount equal to [***] percent
[***] of Net Sales by the Company, or any Affiliate of the Company, or any
sublicensee thereof, of Licensed Products. The royalty obligations under
this
Section 4.2 shall
terminate, on a country-by-country basis, with respect to each Licensed Product
upon the expiration date in such country of the last to expire of any patent
included in the Patent Rights covering the sale of such Licensed Product
in such
country. Any payments pursuant to this section shall be payable on an annual
basis within thirty (30) calendar days of the end of the prior
year.
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4.3 On
sales
of Licensed Products by the Company to Affiliates or related parties that
are
end users of such Licensed Products, the value of Net Sales attributed under
this Article 4 shall be that which would have been received in an arms-length
transaction, based on sales of like quantity and quality products at or about
the time of such transaction.
4.4 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 and unexpired
claim contained in the Patent Rights.
4.5 In
the
event that a Licensed Product is sold in the form of a combination product
containing one or more products or technologies which are themselves not
a
Licensed Product, 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 A is the invoice price of the Licensed Product or the Fair
Market
Value of the Licensed Product if sold to an Affiliate and B is the total
invoice
price of the other products or technologies or the Fair Market Value of the
other products or technologies if purchased from an Affiliate.
4.6 All
payments under this Agreement shall be paid in United States dollars. Royalty
payments shall be paid in United States dollars in New York, New York or
at such
other place as Licensor may reasonably designate consistent with the laws
and
regulations controlling in any foreign country. Any withholding taxes which
the
Company, its Affiliate or any sublicensee shall be required by law to withhold
on remittance of the royalty payments shall be deducted from such royalty
payment to Licensor. The Company shall furnish Licensor with the original
copies
of all official receipts for such taxes. 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.
4.7 The
Company shall pay Licensor a nonrefundable licensee fee in the amount of
$50,000, which is due and payable within fifteen (15) calendar days after
the
Company has received an invoice of the amount from Licensor.
4.8 The
Company shall pay Licensor a fee in the amount of $[***] upon the issuance
of a United States patent included in Patent Rights which covers the use
of a
lysine salt of isophosphoramide mustard to treat cancer.
4.9 The
Company shall pay to Licensor the following milestone payments for the
particular milestone event achieved by the Company, its Affiliate or a
sublicensee, which shall be due and payable within thirty (30) calendar days
of
such milestone event:
4.9.1 [***]
Dollars ($[***]) upon [***]of Licensed Product in the United
States;
4.9.2 [***]
Dollars ($[***]) upon [***] of Licensed Product in the United
States;
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4.9.3 [***]
Dollars ($[***]) upon [***] Licensed Product; and
4.9.4 [***]
Dollars ($[***]) upon the final approval by the FDA of the first NDA for
a
Licensed Product, which milestone payment shall be fully creditable against
future royalties payments hereunder.
4.10 To
the
extent that the Company or any Affiliate of the Company or any sublicensee
thereof needs to obtain in any jurisdiction any license from a third party
in
order to practice the rights purported to be granted to the Company by Licensor
hereunder under issued patents in such jurisdiction, then up to [***] percent
([***]%) of the royalties payable under such license in such jurisdiction
may be
deducted from royalties otherwise payable to Licensor hereunder, provided
that
in no event shall the aggregate royalties payable to Licensor in any semi-annual
period in such jurisdiction be reduced by more than [***] percent ([***]%)
as a
result of any such deduction, provided further that any excess deduction
remaining as a result of such limitation may be carried forward to subsequent
periods.
4.11 From
and
after the termination of royalty obligations in accordance with Section 4.2
of
this Agreement, Company will have a paid up, royalty-free license under
Technology to make, have made, use, have used, sell and have sold products.
4.12 Upon
approval by Company of invoices attributable to the pharmacokinetic analysis
of
samples from a phase I study of Technology, Company shall reimburse Licensor
for
moneys paid by Licensor to conduct such analysis, in an amount not to exceed
[***] Dollars ($[***]).
ARTICLE
5 - REPORTS AND RECORDS
5.1 The
Company shall keep full, true and accurate books of account containing all
particulars that may be necessary for the purpose of showing the amounts
payable
to the Licensor by way of royalty and other payments as aforesaid. Said books
of
account shall be kept at the Company's principal place of business and the
supporting data shall be open up to twice per year upon reasonable notice
to the
Company, for two (2) years following the end of the calendar year to which
they
pertain, for inspection by the Licensors’ internal audit division and/or by
another designated auditor selected by the Licensor, except one to whom the
Company has reasonable objection, for the purpose of verifying the Company's
royalty statement and any other payment reports required under this License
Agreement. If an inspection shows an under reporting or underpayment in excess
of the greater of $[***] or [***] percent ([***]%) of royalties payable for
any
twelve (12) month period, then the Company shall reimburse the Licensor for
the
reasonable cost of the inspection at the time the Company pays the unreported
royalties, including any late charges as required by section 5.4 of this
Agreement. All payments required under this Article 5 shall be due within
sixty
(60) days of the date the Licensor provides the Company notice of the payment
due.
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5.2 Within
sixty (60) days from the end of each quarter of each calendar year for which
royalties are due hereunder, the Company shall deliver to the Licensor complete
and accurate reports, giving such particulars of the business conducted by
the
Company during the preceding quarter under this License Agreement as shall
be
pertinent to a royalty accounting hereunder. These shall include at least
the
following:
5.2.1 All
Licensed Products used, leased or sold, by or for the Company or its Affiliates
or sublicensees.
5.2.2 Total
amounts invoiced for Licensed Products used, leased or sold, by or for the
Company or its Affiliates or sublicensees.
5.2.3 Deductions
applicable in computed "Net Sales" as defined in Section 1.8.
5.2.4 Total
royalties due based on Net Sales by or for the Company or its Affiliates
or
sublicensees.
5.2.5 All
other
amounts due Licensor hereunder.
5.3 With
each
such report submitted, the Company shall pay to the Licensor the royalties
due
and payable under this Agreement. If no royalties shall be due, the Company
shall not be required to make a report pursuant to this Article 5.
5.4 Amounts
which are not paid when due and which are not the subject of a bona fide
dispute
shall accrue interest from the due date until paid, at a rate equal to the
then
prevailing prime rate of Citibank, N.A., plus [***] percent
([***]%).
5.5 The
Licensor agrees to hold in confidence each report delivered by the Company
pursuant to this Article 5. Notwithstanding the foregoing, the Licensor may
disclose any such information required to be disclosed pursuant to any judicial,
administrative or governmental request, subpoena, requirement or order, provided
that the Licensor takes reasonable steps to provide the Company with the
opportunity to contest such request, subpoena, requirement or order.
ARTICLE
6 - PATENT PROSECUTION AND MAINTENANCE
6.1 The
Company shall be responsible for prosecution and maintenance of the intellectual
property included in the Patent Rights including, but not limited to, the
filing
of patent applications which may be required or desirable. The Company agrees
to
keep the Licensor reasonably well informed with respect to the status and
progress of any such applications, prosecutions and maintenance activities
and
to consult in good faith with the Licensor and use reasonable efforts to
incorporate Licensor’s reasonable suggestions regarding such prosecution. Both
parties agree to provide reasonable cooperation to each other to facilitate
the
application and prosecution of patents pursuant to this Agreement.
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6.2 The
Company may, in its discretion, elect to abandon any patent applications
or
issued patent in the Patent Rights or not file a patent application in any
national jurisdiction.
Prior to
any such abandonment or decisions not to file in certain countries, the Company
shall give Licensor at least sixty (60) days notice and a reasonable opportunity
to take over prosecution of such Patent Rights. In such event, Licensor shall
have the right, but not the obligation, to commence or continue such prosecution
and to maintain any such Patent Rights under its own control and at its expense
and the Company shall then have no further rights to such Patent Rights and
no
further royalty or other obligation to Licensor in connection therewith.
ARTICLE
7 - TERMINATION
7.1 Should
the Company fail to make payment to the Licensor of royalties due in accordance
with the terms of this Agreement which are not the subject of a bona fide
dispute between the Licensor and the Company, the Licensor shall have the
right
to terminate this License Agreement within sixty (60) days after giving said
notice of termination unless the Company shall pay to the Licensor, within
the
60-day period, all such royalties due and payable. Upon the expiration of
the
60-day period, if the Company shall not have paid all such royalties due
and
payable, the rights, privileges and license granted hereunder shall, at the
option of the Licensor, immediately terminate. In the event of a bona fide
dispute over royalties, the parties shall resolve such dispute in accordance
with Article 8.
7.2 Upon
any
material breach or default of this License Agreement by the Company, other
than
as set forth in Section 7.1 above, the Licensor shall have the right to
terminate this Agreement and the rights, privileges and license granted
hereunder upon giving sixty (60) days notice to the Company. Such termination
shall become effective immediately unless the Company shall have cured any
such
breach or default prior to the expiration of such sixty (60) day
period.
7.3 The
Company shall have the right at any time to terminate this Agreement in whole
or
as to any country by giving thirty (30) days notice thereof in writing to
the
Licensor.
7.4 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 obligations under Sections 2.4.2, 4.11 and Articles
5,8,9, 10 and 14. The Company, its Affiliates and/or any sublicensee thereof
may, however, after the effective date of such termination and continuing
for a
period not to exceed six (6) months thereafter, sell all completed Licensed
Products, and any Licensed Products in the process of manufacture at the
time of
such termination, provided that the Company shall pay or cause to be paid
to the
Licensor the royalties thereon as required by Article 4 of this License
Agreement and shall submit the reports required by Article 5 hereof on the
sales
of Licensed Products.
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ARTICLE
8 - DISPUTE RESOLUTION
8.1 Any
dispute or controversy arising out of or relating to this Agreement, its
construction or its actual or alleged breach will be decided by mediation.
If
the mediation does not result in a resolution of such dispute or controversy,
it
will be finally decided by an appropriate method of alternate dispute
resolution, including without limitation, arbitration, in accordance with
the
applicable, then current, procedures of the American Arbitration Association.
The arbitration panel will include members knowledgeable in the evaluation
of
the Technology. Judgment upon the award rendered may be entered into the
highest
court or forum having jurisdiction, state or federal. The provisions of this
Section 8.1 will not apply to decisions on the validity of patent claims
or to
any dispute or controversy as to which any treaty or law prohibits such
arbitration. The decision of the arbitration must be sanctioned by a court
of
law having jurisdiction to be binding upon and enforceable by the parties.
ARTICLE
9 - INFRINGEMENT AND OTHER ACTIONS
9.1 During
the term of this Agreement, the Company and the Licensor shall promptly provide
written notice, to the other party, of any alleged infringement by a third
party
of the Patent Rights and provide such other party with any available evidence
of
such infringement. 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 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, subject to paragraph
9.2.
9.2 The
Company shall have the right, but not the obligation, to prosecute and/or
defend, at its own expense and utilizing counsel of its choice, any infringement
of, and/or challenge to, the Patent Rights occurring during the term of the
Agreement. In furtherance of such right, the Licensor hereby agrees that
the
Company may join the Licensor as a party in any such suit, without expense
to
the Licensor.
9.3 Any
recovery of damages by the Company, in any such suit, shall be applied first
in
satisfaction of any unreimbursed expenses and legal fees of the Company relating
to the suit and then to the Licensor for any royalties credited in accordance
with Section 9.4. The balance remaining from any such recovery shall be treated
as Net Sales and shared in accordance with Article 4 hereof.
9.4 The
Company may credit up to fifty percent (50%) of any litigation costs incurred
by
the Company in any country pursuant to this Article 9 and up to 50% of all
amounts paid in judgment or settlement of litigation within this Article
9 scope
against royalties thereafter payable to the Licensor hereunder for such country
and apply the same toward one-half of its actual, reasonable out-of-pocket
litigation costs. If one-half of such litigation costs in such country exceeds
50% of royalties payable to the Licensor in any year in which such costs
are
incurred than the amount of such costs, expenses and amounts paid in judgment
or
settlement, in excess of such 50% of the royalties payable shall be carried
over
and credited against royalty payments in future years for such country.
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9.5 If
within
six (6) months after receiving notice of any alleged infringement, the Company
shall have been unsuccessful in persuading the alleged infringer to desist,
or
shall not have brought and shall not be diligently prosecuting an infringement
action, or if the Company shall notify the Licensor, at any time prior thereto,
of its intention not to bring suit against the alleged infringer, then, and
in
those events only, the Licensor shall have the right, but not the obligation,
to
prosecute, at its own expense and utilizing counsel of its choice, any
infringement of the Patent Rights. The total cost of any such infringement
action commenced solely by the Licensor shall be borne by the Licensor and
the
Licensor shall keep any recovery or damages for infringement or otherwise
derived therefrom and such shall not be applicable to any royalty obligation
of
the Company.
9.7 In
any
suit to enforce and/or defend the Patent Rights pursuant to this License
Agreement, the party not in control of such suit shall, at the request and
reasonable 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 - INDEMNITY
10.1 The
Company agrees to defend, indemnify and hold the Licensor harmless from and
against all third party claims, demands or causes of action arising on account
of any injury or death of persons or damage to property (“Claims”) caused by or
arising out of or resulting from the exercise or practice of the rights granted
hereunder by Company or its Affiliates to the extent not due to the Licensor’s
negligence of willful misconduct and provided that prompt written notice
of such
Claim is provided to Company. The Company agrees that any sublicense agreement
it enters relative to the Licensed Products shall contain a covenant by such
sub-licensee providing for the indemnification of the Licensor as provided
in
this Article.
ARTICLE
11 - ASSIGNMENT
This
Agreement and the rights and duties appertaining hereto may not be assigned
by
either party without first obtaining the written consent of the other which
consent shall not be unreasonably withheld. Any such purported assignment,
without the written consent of the other party, shall be null and of no effect.
Notwithstanding the foregoing, the Company may assign this Agreement without
the
consent of the Licensor (i) to a purchaser, merging or consolidating
corporation, or acquiror of substantially all of the Company's assets or
business to which this Agreement pertains and/or pursuant to any reorganization
qualifying under section 368 of the Internal Revenue Code of 1986 as amended,
as
may be in effect at such time, or (ii) to an Affiliate of the Company,
provided
that such assignee consents in writing to be bound by this Agreement to the
same
extent as Company.
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ARTICLE
12 - USE OF NAMES
12.1 Except
as
required by law, the Company or its Affiliates shall not use in advertising,
publicity, or other promotional activities any name, trade name, trademark,
or
other designation of the Licensor or any of its units (including contraction,
abbreviation or simulation of any of the foregoing) without the prior, written
consent of the Licensor which shall not be unreasonably withheld; provided,
however,
that
the Licensor acknowledges and agrees that the Company may use the names of
the
Licensor in various documents used by the Company for capital raising and
financing without such prior written consent. Except as required by law,
neither
party shall disclose to a third party the terms of this Agreement, except
to the
extent that such other party is under confidence and needs to know the terms
of
this Agreement for business reasons.
ARTICLE
13 - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
13.1 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,
or by overnight courier, 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:
Name:
_______________________
Title:
________________________
Tel:
Fax:
In
the
case of the Company:
Dr.
Xxxxxxxx Xxxxx
Chief
Executive Officer
ZioPharm,
Inc.
000
Xxxxxx Xx.
Xxx
Xxxxx, XX 00000
Tel:
(000) 000-0000
Fax:
(000) 000-0000
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ARTICLE
14 - CONFIDENTIALITY AND PUBLICATION
14.1 Licensor
and Company each agree that all information related to this Agreement and
contained in documents marked “confidential” and forwarded to one by the other
(i) are to be received in strict confidence, (ii) are to be used only for
the
purposes of this Agreement, which may include disclosure of certain confidential
information to the FDA and foreign regulatory agencies and which disclosures
shall be expressly permitted hereunder and (iii) except as set forth in
14.1
(ii)
above, are not to be disclosed by the recipient party (except as required
by law
or court order and then only provided reasonable notice of the impending
disclosure is provided to the disclosing party), its agents or employees
without
the prior written consent of the other party, except to the extent that the
recipient party can establish that such information:
(a) |
was
in the public domain at the time of disclosure;
or
|
(b) |
later
became part of the public domain through no fault of the recipient
party,
its employees, agents, successors or assigns;
or
|
(c) |
was
lawfully disclosed to the recipient party by a third party having
the
right to disclose it and not under an obligation of confidence
to the
disclosing party; or
|
(d) |
was
already known by the recipient party at the time of disclosure;
or
|
(e) |
was
independently developed by the recipient without use of the other
party’s
confidential information.
|
14.2 Each
party’s obligation of confidence under this Article 14 will be fulfilled by
using at least the same degree of care with the other party’s confidential
information as it uses to protect its own confidential information, but always
a
reasonable degree of care. This obligation will exist while this Agreement
is in
force and for a period of three (3) years thereafter.
14.3 Licensor
reserves the right to publish the general scientific findings from research
related to Technology, with due regard to the protection of Company’s
confidential information. Licensor will submit the manuscript of any proposed
publication to Company at least thirty (30) calendar days before publication
in
order that Company have the right to delete its confidential information
review
and protect any potential inventions set forth therein. Upon Company’s request,
publication may be delayed up to sixty (60) additional days to enable Company
to
secure adequate intellectual property protection on inventions of Licensor
that
may be set forth in the publication and to which Company has rights under
this
Agreement.
ARTICLE
15 - REPRESENTATIONS AND WARRANTIES
15.1 The
Licensor represents and warrants to the Company, (i)
as
of the
date of this Agreement and (ii)
as
of the
date of each payment to be made by the Company to the Licensor under Article
4
hereof
solely
with respect to items under the control of Licensor,
that:
15.2 The
Licensor is a corporation
duly
organized, validly existing and in good standing under the laws of the
State
of
Delaware, the Licensor has the requisite corporate power and authority to
execute and deliver this Agreement and this Agreement is enforceable against
the
Licensor upon its terms.
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13
of 18
15.3 The
execution and delivery of this Agreement and the other agreements contemplated
hereby do not, and the consummation of the transactions contemplated hereby
and
thereby will not, (i) conflict
with, or result in any violation or breach of any provision of the certificate
of incorporation or bylaws of the Licensor, or (ii)
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 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.
15.4 No
consent, approval or authorization of, or declaration or filing with, any
Governmental Authority or Person (a “Consent”) is required on the part of the
Licensor in connection with its execution, delivery and performance of this
Agreement or the consummation of the transactions contemplated hereby or
in
connection with the Technology.
15.5 No
oral
or written communication has been received by the Licensor, 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 Technology , was at any time pending or, to the
knowledge of the Licensor is threatened by any Governmental Authority with
respect to (i) any
alleged or actual violation by the Licensor of any permit, Law or other
requirement of any Governmental Authority relating to the operations conducted
by the Licensor with respect to any 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 with respect to
any
Technology. The Licensor has not received from the Federal Drug Administration
(“FDA”), the U.S. Drug Enforcement Administration (“DEA” or any similar state,
local or foreign Governmental Authority any written notice (i) regarding
the approvability or approval of any of the Technology , or (ii) alleging
any violation by the Licensor of any Law relating to any of the Technology.
No
product incorporating Technology has been withdrawn, suspended or discontinued
by the Licensor as a result of any action by the FDA, the DEA or any similar
state, local or foreign Governmental Authority, either within or outside
the
U.S. (whether voluntarily or otherwise.
15.6 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 with respect to the Technology.
No
Entity has notified the Licensor of any material claim against the Licensor
alleging any personal property or economic injury, loss or damage incurred
as a
result of or relating to the use of the Technology. There is no judgment,
order,
injunction, decree, writ or award against the Licensor that is not satisfied
and
remains outstanding with respect to any Technology.
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15.7 The
US
and foreign patent applications and patents and invention disclosures itemized
on Appendix A set forth all of the patents and patent applications and
inventions relating to isophosphoramide mustard compounds, owned
by,
or licensed to, the Licensor as of the date of this Agreement.
15.8 The
Licensor has taken all reasonable actions necessary or appropriate to preserve
the confidentiality of all trade secrets, proprietary and other confidential
information material to the business and operations of the
Licensor.
15.9 There
are
no licenses, options, restrictions, liens, rights of third parties, disputes,
royalty obligations, proceedings or claims relating to, affecting, or limiting
the Licensor’s rights or the rights of the Company under this Agreement after
giving effect to this Agreement, or which may lead to a claim of infringement
or
invalidity regarding, any part or all of the Technology or its use.
15.9 The
Technology was not supported in whole or part by funding or grants by any
federal or state agency. The Licensor has provided the Company with copies
of
all documents reflecting support or funding for all or part of the research
leading to the Technology, and has listed all funding agencies on Appendix
B.
ARTICLE
16 - MISCELLANEOUS PROVISIONS
16.1 This
License Agreement shall be construed, governed, interpreted and applied in
accordance with the laws of the State of Connecticut, without regard to
principles of conflicts of laws.
16.2 The
parties hereto acknowledge that this Agreement, including the Appendices
and
documents incorporated by reference, sets forth the entire agreement and
understanding of the parties hereto as to the subject matter hereof, supersedes
all previous communications, representations or understandings, either oral
or
written between the parties relating 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.
16.3 The
provisions of this License Agreement are severable, and in the event that
any
provision of this License 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.
16.4 The
failure of either party to assert a right hereunder or to insist upon compliance
with any term or condition of this License 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.
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16.5 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.
16.6 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 date
recited on page one.
16.7 Each
party hereto shall be excused from any breach of this Agreement which is
proximately caused by governmental regulation, act of war, strike, act of
God or
other similar circumstance normally deemed outside the control of the
parties.
IN
WITNESS WHEREOF,
the
parties hereto have executed this License Agreement, in triplicate by proper
persons thereunto duly authorized.
ZIOPHARM, INC. | DEKK-TEK | |||
By: | /s/ Xxxxxxxx Xxxxx | By: | /s/ Xxx Xxx Xxxxxx | |
|
|
|||
Name: | Xxxxxxxx Xxxxx | Name: | Xxx Xxx Xxxxxx | |
|
|
|||
Title: | CEO | Title: | CEO | |
|
|
|||
Date: | 11/9/04 | Date: | 10/15/04 | |
|
|
Page
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XXXXXXXX
X
(Xxx
Xxxxxx Xxxxxx and foreign patents and patent applications and invention
disclosures to be listed here)
Page
17
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APPENDIX
B
None
Page
18
of 18