LICENSE AGREEMENT
Exhibit
10.2
Portions
herein identified by [***] have been omitted pursuant to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934.
A complete copy of this document has been filed separately with the Securities
and Exchange Commission.
This
License Agreement is entered into as of the 3rd day of November, 2006
(“Effective Date”), by and among Xxxxxx Healthcare S.A. a Swiss corporation
having offices at Xxxxxxxxxxxx
0, XX-0000, Xxxxxxxxxxx
Xxxxxxxxxxx and Xxxxxx International, Inc. a Delaware Corporation, having
offices at Xxx Xxxxxx Xxxxxxx, Xxxxxxxxx, XX 00000 (collectively, “Baxter”) on
the one hand, and Ziopharm Oncology, Inc. a Delaware
corporation having offices at 000
Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxxxx, XX 00000
(“Licensee”) on the other hand.
WHEREAS,
Baxter possesses certain intellectual property rights related to the
use
of nanosuspension technology in the manufacture of a suspension formulation
of
Indibulin and compositions thereof (“Licensed
Patents,” as further defined below);
WHEREAS,
Licensee is engaged in the pharmaceutical business and, more particularly,
in
oncology;
WHEREAS,
Baxter and Licensee are, concurrently with this Agreement, entering into a
separate Asset Purchase Agreement providing
for, among other things,
the
transfer of certain assets
relative
to the Indibulin molecule and associated intellectual property (the “Asset
Purchase Agreement”);
WHEREAS,
Licensee desires to obtain certain rights in and to the Licensed
Patents;
WHEREAS,
Baxter has agreed to license to Licensee certain rights in and to the Licensed
Patents;
NOW,
THEREFORE, in consideration of the promises
and the
mutual covenants contained
in this Agreement, and for other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, the Parties
agree as
follows:
ARTICLE
1
DEFINITIONS
| 1.1 |
Defined
Terms.
As used in this Agreement, the following terms shall have the following
meanings:
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An
“Affiliate”
of
a
subject person or entity shall mean any corporation, firm, business organization
or legal entity that directly
or indirectly through one or more intermediaries controls,
is controlled by, or is under common control with the subject person or entity.
As used in this definition, “control” (including, with its correlative meanings,
“controlled by” and “under common control with”) means possession, directly or
indirectly, of power to direct or cause the direction of management and policies
(whether through ownership of securities, partnership or other ownership
interests, by contract or otherwise).
“Asset
Purchase Agreement”
shall
have the meaning ascribed in preamble of this Agreement.
“Assumed
Patent”
shall
have the meaning set forth in Section
5.1(a)(ii).
“Commercialize”
shall
mean the sale of a Licensed Product which has received Marketing
Approval.
“Composite
Product”
shall
mean a product combination encompassing one or more Licensed Products and one
or
more separate products, wherein the Composite Product is sold as a complete
package for purposes of selling the one or more Licensed Products.
“CTA”
shall
mean the European
EMEA
equivalent of IND.
“EMEA”
means
European Agency for the Evaluation of Medicinal Products, or any successor
agency thereto.
“FDA”
shall
mean the United States Food
and
Drug Administration.
“Governmental Authority”
means
any United States federal, state or local or any foreign government,
governmental, regulatory or administrative authority, agency or commission
or
any court, tribunal or arbitral body.
“IND”
shall
mean an investigational new drug application submitted to the FDA.
“Indibulin-related Nanosuspension”
shall
mean a compound as claimed in claim 1 of U.S. Patent Application No. 11/266,518,
filed on November 3, 2005, formulated as particles and, optionally, suspended
in
a composition.
“Intangible
Property Rights”
shall
mean intangible property rights (other than the Licensed Patents) to the extent
that such intangible property rights relate to Indibulin-related Nanosuspension,
whether or not patentable including, but not limited to, inventions,
discoveries, trade secrets, technical information, know-how, copyrights and
other confidential business information.
“Licensed
Patents” shall
mean all shall mean all U.S. and foreign patents, provisional and
non-provisional patent applications and invention records listed on Exhibit
A
and (i)
any continuations,
continuations-in-part, divisionals and
reissue patent applications and resulting patents, derived from such prior
filed
patents and patent applications, and any foreign counterparts and any issued
patents thereof and (ii) any patent applications, filed patents and any
continuations,
continuations-in-part, divisionals
and
reissue patent applications and resulting patents and any foreign counterparts
and any issued patents thereof embraced by the disclosures in such invention
records.
“Licensed
Product”
shall
mean an
Indibulin-related Nanosuspension,
the
use, manufacture, sale, offer for sale or importation of which falls within
the
scope of a Valid Claim.
“Management”
shall
have the meaning set forth in Section
5.1(a)(i).
“Marketing
Approval”
shall
mean regulatory
approval
of the
marketing of a Licensed Product by the FDA or the EMEA.
“Net
Sales”
shall
mean the total amount invoiced in
U.S.
dollars (or, if in another currency, as converted by Licensee
in
accordance with Section 3.7 by
Licensee or its subsidiaries, Affiliates or Sublicensees for
the
sale of any Licensed Product after
deducting the following costs, provided and to the extent such costs are
attributable to such sale of the Licensed Product in accordance with U.S.
generally accepted accounting principles as consistently applied by Licensee
and
are actually borne by or on behalf of Licensee or its subsidiaries, Affiliates
or Sublicensees: (i) invoiced freight, shipping and shipping insurance charges,
(ii) discounts allowed and taken, in amounts customary in the trade, (iii)
taxes, including sales, use, turnover, excise, import and other taxes or duties,
separately billed or invoiced and borne by or on behalf of Licensee or its
subsidiaries, Affiliates or Sublicensees, imposed by a Governmental Authority
on
the production, sale, use or transfer of the Licensed Product, (iv) amounts
repaid or credited by reason of rejection or return of any previously sold
Licensed Products and uncollectible portions of invoiced amounts with respect
to
any previously sold Licensed Products, and (v) rebates, chargebacks, retroactive
price reductions, allowances and fees paid or credited to customers,
wholesalers, distributors, third party payors, governmental agencies,
administrators and contractees with respect to Licensed Products
sold.
If
a
Licensed Product is
sold
as
part of
a Composite Product, then Net Sales for such Composite Product will be adjusted
by
multiplying (x)
actual
Net Sales of the Composite Product for
the
calendar quarter in the country in which the Composite Product is being sold
by
(y) the
fraction A/(A+B) where A is the average
invoice
price of
the Licensed Product
in such
country during such period,
if sold
separately (i.e., without one or more products), and B is the average
invoice
price of the other products in the Composite Product
in such
country during such period,
if sold
separately.
If in a
given country
A and/or
B are not sold separately, the
related value of the Licensed Product and the other products in the Composite
Product shall be determined based on
a good
faith estimate by Licensee
based
upon
the respective fair
market
values
of the Licensed Product as if it were sold separately and the other product(s)
as if they were sold separately, which good faith estimate shall be subject
to
approval by Baxter, which approval shall not be unreasonably withheld. In the
event the Parties cannot agree on a fair market value of the Licensed Product
relative to Composite Product sales, upon the request of any one of the Parties,
the Parties shall submit the valuation matter to a mutually, agreed to
independent consultant. The Parties shall accept the fair market value as
determined by the independent consultant.
No
sales
shall result from any transfer between Licensee or any of its subsidiaries,
Affiliates or Sublicensees for resale, but shall result from the resale by
the
subsidiary, Affiliate or Sublicensee.
“Party”
shall
mean either Baxter or Licensee, or both, as the context dictates.
“Sublicensee”
shall
mean a third party other than an Affiliate who has received a sublicense from
Licensee or Licensee’s sublicensees pursuant to Section
2.3.
“Term”
shall
have the meaning set forth in Section
10.1.
“Territory”
shall
mean the entire world.
“Valid
Claim”
means
a
claim of an issued and unexpired patent within the Licensed Patents that has
not
been (i) held permanently revoked, unenforceable, unpatentable or invalid by
a
decision of a court or governmental body of competent jurisdiction, unappealable
or unappealed within the time allowed for appeal, (ii) rendered
unenforceable through written disclaimer (iii) lapsed or abandoned for
failure to pay maintenance fees with no further remedy available to reinstate,
or (iv) lost through an interference proceeding.
ARTICLE
2
LICENSE
| 2.1 |
Grant.
Subject to the conditions hereunder,
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(a)
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Baxter
hereby grants to Licensee a world-wide, royalty bearing (pursuant
to
Article
3)
exclusive right and license, with the right to grant sublicenses,
under
Licensed Patents to use, market, sell,
offer to sell and
import (except
where a product is manufactured in a country where a Valid Claim
relative
to such manufacture does not exist, and such product is imported
in a
country where a Valid Claim relative to the manufacture does exist)
Licensed
Products
in
the Territory; and
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(b)
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Baxter
hereby grants to Licensee a world-wide, non-royalty bearing exclusive
right and license, with the right to grant sublicenses, under the
Intangible Property Rights to use, market, sell, offer to sell and
import
Licensed Products in the Territory.
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Notwithstanding
this Section
2.1,
Baxter
does not and shall not license to Licensee hereunder the right and license
under
the Licensed Patents or the Intangible Property Rights to make or have made
Licensed Products or Indibulin-related Nanosuspension in the
Territory.
| 2.2 |
Limitation
on License Grants.
Except for the license expressly granted pursuant to Section
2.1,
all right, title and interest in all Licensed Patents, and other
rights
owned by Baxter or in which Baxter has an interest shall remain
the sole
property of Baxter, and nothing herein shall be construed to grant
or
establish any other rights to the contrary.
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| 2.3 |
Sublicenses
by Licensee.
Licensee shall notify
Baxter of any sublicense hereunder
and
the identity of each Sublicensee,
and provide Baxter with a copy of the executed agreement involving
such
sublicense
with such redactions of confidential terms as Licensee shall determine
to
be appropriate,
all within thirty (30) days of execution of the Agreement.
Sublicenses shall not contain any provision contrary to, or inconsistent
with, this Agreement and shall provide that all obligations of
Licensee
hereunder shall be binding upon each Sublicensee
as
if the Sublicensee
were a party to this Agreement. Additionally, Licensee shall be
responsible for and liable to Baxter for
Sublicensee’s
compliance with the provisions hereof.
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| 2.4 |
Rights
in Bankruptcy.
All rights and licenses granted under or pursuant to this Agreement
by
Baxter are, and will otherwise be deemed to be, for purposes of Section
365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual
property” as defined under Section 101 of the U.S. Bankruptcy
Code.
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ARTICLE
3
PAYMENTS
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3.1
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Milestone
Fees.
As part of the consideration for the rights granted by Baxter to
Licensee hereunder,
Licensee shall pay to Baxter five hundred thousand United States
dollars
($500,000) within thirty (30) days of the first effectiveness of
an IND
submitted to the FDA or a CTA submitted to the EMEA permitting Licensee
to
initiate human clinical trials of an Indibulin-related Nanosuspension
in
the United States or Europe, whichever comes
first.
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3.2
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License
Royalties.
As part of the consideration for the rights granted by Baxter to
Licensee,
Licensee shall pay,
or cause to be paid to Baxter,
the following royalties
based on Net Sales of Licensed Products:
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| a) |
[****]
percent ([****]%) of worldwide calendar year annual Net Sales of
less than
[**********] Dollars
($[**********]);
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| b) |
[****]
percent ([****]%) of worldwide calendar year annual Net Sales from
[**********] Dollars ($[**********]) up to [**********] Dollars
($[**********]); and
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| c) |
[****]
percent ([****]%) of worldwide calendar year annual Net Sales in
excess of
[**********] U.S. Dollars
($[**********]).
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With
respect to each Licensed Product, royalties will be payable on a
country-by-country basis, so long as the importing, using or selling of the
Licensed Product was covered by a Valid Claim in the country in which such
Licensed Product was imported, used or sold.
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3.3
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Reports,
Audit and Payment Schedule. Licensee
shall keep and maintain detailed records of all sales of Licensed
Product
worldwide; and
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| a) |
Licensee
shall make quarterly payments to Baxter within forty-five
(45)
days of the close of each calendar quarter (March 31, June 30, September
30 and December 31) based
on Net
Sales in
such quarter, and shall additionally provide,
together with such payment,
a
sales report detailing Net
Sales of
Licensed Products sold per country and the royalty calculation, pursuant
to Section
3.2;
and
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| b) |
Baxter
shall have the right annually, at Xxxxxx’x expense, to audit
Licensee’s
records, or Licensee’s subsidiaries, Affiliates or Sublicensees in order
to verify the calculation of Net Sales of Licensed Products. Licensee
shall reasonably cooperate with Baxter to provide Licensee access
to such
records; provided that:
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(i)
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Such
audit shall be conducted by Xxxxxx’x independent
auditors;
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(ii)
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Such
audit shall be conducted during normal business hours, upon reasonable
advance notice and in a manner that does not cause unreasonable disruption
to the conduct of the business of Licensee, its subsidiaries, Affiliates
or Sublicensees;
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| (iii) |
Baxter
shall treat all information reviewed or learned of in the course
of such
audit in accordance with Section
11.13;
and
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(iv)
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prior
to such audit, Baxter shall cause its auditors to enter into a reasonably
acceptable confidentiality agreement with Licensee obligating such
auditors to maintain confidentiality of all financial
statements.
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3.4
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No
Multiple Payments.
For payments pursuant to Section
3.2,
only one payment shall be paid for each Licensed Product sold, regardless
of the number of Licensed Patents or claims thereof that cover such
Licensed Product. Additionally, in the event Licensee has paid Baxter
a
sales-based
contingent payment
on
the Net Sales of a unit of Licensed Product pursuant to Section
2.4
of
the Asset Purchase Agreement, Licensee shall not pay Baxter a royalty,
pursuant to Section
3.2
of
this Agreement, on the Net Sales of that unit of Licensed Product.
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3.5
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Royalty
Reduction.
In the event Licensee or its subsidiaries, Affiliates or Sublicensees
licenses third party patent rights in order to have freedom to make,
have
made or sell Licensed Product without infringing such patent rights,
Licensee shall be allowed to deduct from the royalties due pursuant
to
Section
3.2,
fifty percent (50%) of any royalties or any other license fees paid
or
incurred in connection with such license up to a maximum of fifty
percent
(50%) of the royalties due pursuant to Section 3.2 (with any amount
not
deducted due to such deduction limitation carried forward to subsequent
calendar quarters for deduction, but subject to the fifty percent
(50%)
maximum deduction limitation provided by this Section
3.5
for such subsequent calendar quarters).
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3.6
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Royalty
Credits.
Licensee shall be allowed to deduct from the royalty payments due
to
Baxter under Section
3.2
any payments made by it to Baxter pursuant to Section 2.3
of
the Asset Purchase Agreement.
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3.7
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Currency
Exchange.
In the event sales are invoiced in a currency other than United States
dollars, Net Sales shall be calculated in the following manner: cumulative
non-United States dollars sales invoiced by month shall be converted
to
United States dollars by multiplying or dividing, whichever is applicable,
this amount by the simple average of the daily NY close rates for
each day
in the month as published by Bloomberg, Reuters or some other generally
accepted source for publishing NY close foreign currency rates. The
rate
source shall be reviewed with Baxter prior to commencing payment
of
royalty payments to Baxter.
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3.8
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Withholding
Taxes.
Licensee may withhold taxes in the event that revenue authorities
in any
country require the withholding of taxes on amounts paid hereunder
to
Baxter. Licensee will deduct such taxes from such payment and such
taxes
will be paid by Licensee to the proper taxing authority on behalf
of
Baxter. In the event such taxing authority routinely provides a tax
receipt upon payment, Licensee will procure such tax receipt and
forward
it to Baxter. Licensee agrees to assist Baxter in claiming exemption
from
such deductions or withholdings under any applicable double taxation
or
similar agreement or treaty.
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3.9
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Late
Penalty.
Milestone fees and royalties not received within the required timeframe
shall bear interest at the lesser of (a) the maximum rate permitted
by
law, and (b) 1.0%
per month on the outstanding balance compounded monthly. All applicable
sums due herein shall be paid in U.S. Dollars.
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ARTICLE
4
SUPPLY
OF LICENSED PRODUCT
| 4.1 |
Baxter
to Supply.
In the event that Licensee desires the supply of Licensed Products
or
Indibulin-related Nanosuspension, Baxter and Licensee shall negotiate
and
enter into a separate supply agreement governing the developmental
and
commercial supply by Baxter of Licensed Product or Indibulin-related
Nanosuspension to Licensee.
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ARTICLE
5
PATENT
PROSECUTION, ENFORCEMENT AND INFRINGEMENT
| 5.1 |
Prosecution
and Maintenance of Patents.
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| a) |
Patents.
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(i) Baxter
to Manage Patents.
Baxter
shall be
responsible for,
and use
reasonable discretion in,
the
filing, prosecution and maintenance (“Management”) of Licensed Patents.
At
a
minimum, Baxter shall file,
prosecute and maintain Licensed Patents
in the
U.S., Germany, France, United Kingdom, Belgium, Netherlands, Spain, Italy,
Australia, China, Mexico, Korea, Canada, Brazil and Japan. Each
Party agrees to cooperate with the other with respect to the preparation,
filing, prosecution and maintenance of patents and patent applications pursuant
to this Section
5.1.
(ii) Step-In
Rights by Licensee.
In the
event Baxter determines to abandon or not to continue with any Management of
a
Licensed Patent, it shall provide Licensee with at least sixty (60) days prior
written notice of such determination. Licensee, in its discretion, may elect
to
assume the Management of such Licensed Patent (an “Assumed Patent”), at
Licensee’s sole expense; provided, however, Assumed Patents shall remain the
sole property of Baxter, subject to the license of Section 2.1; and provided
further that Licensee shall be entitled to deduct 50% of the direct costs of
the
Management of the Assumed Patents from any amounts due under
Section 5.1(b).
b) Costs.
The
Parties have agreed to estimate the annual cost of filing,
prosecuting
and maintaining the Licensed Patents at thirty thousand dollars
($30,000)
and, as
a result, have agreed that for so long as Baxter is filing, prosecuting and
maintaining the Licensed Patents, with the exception of the Assumed Patents
or
Licensed Patents not elected pursuant to Section
5.1(a)(ii),
the
Licensee shall pay
to
Baxter fifteen thousand dollars ($15,000) on the Effective Date and every
anniversary thereafter during the Term.
| 5.2 |
Enforcement
of Intellectual Property Rights.
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| a) |
Each
Party shall promptly, but in no event later than thirty (30) days
after
receipt of notice thereof, notify the other Party (i) of any nullity
actions, oppositions, reexaminations, declaratory judgment actions
or any
alleged or threatened infringement affecting any Licensed Patent
or the
misappropriation or violation of any intellectual property rights
relating
to any Licensed Product or any Licensed Patent; or (ii) if it reasonably
believes that any Licensed Patent is being infringed, misappropriated
or
violated by a third party.
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| b) |
Litigation.
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(i)
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Except
as provided in Section 5.2(b)(ii), Baxter, in its discretion and
at its
expense, shall pursue all necessary actions,
including initiating a suit, against
any third party that Baxter reasonably believes is infringing,
misappropriating or violating a Licensed
Patent.
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(ii)
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Notwithstanding
Section
5.2(b)(i), Licensee,
in its discretion and its expense, shall have the first right and
option
to pursue all necessary actions, including initiating a suit, against
any
third party that Licensee reasonably believes is infringing,
misappropriating or violating or Licensed Patent, if such infringement,
misappropriation or violation relates to the development or
commercialization of a product or product candidate that is competitive
(i.e., the product or product candidate is a tubulin inhibitor particle
suspension) with a Licensed Product being developed or commercialized
by
Licensee. If Licensee fails to take any of the foregoing actions
within a
reasonable period of time after becoming aware of the claimed
infringement, misappropriation or violation (but in no event more
than
ninety (90) days), or otherwise notifies Baxter within such time
period
that it elects to not pursue any such action, then Baxter shall have
the
right to take any such action in accordance with Section
5.2(c).
The ninety (90) day time period in this sub-section shall be shortened
as
reasonably necessary to enable Baxter to initiate a suit or take
other
appropriate action if, in the absence of such shortening, a loss
of rights
with respect to such suit or other action would occur (e.g., if a
generic
pharmaceutical maker files an abbreviated new drug application for
which
the reference listed drug is a Licensed Product and, in order to
obtain an
automatic stay from the FDA with respect to the approval of such
abbreviated new drug application, a patent infringement suit must
be
brought within a shorter period of time). The Party filing any suit
or
taking any such action hereunder shall be responsible for all costs
in
connection therewith.
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| c) |
The
Party initiating suit or action under Section 5.2(b)(ii)
shall have the sole and exclusive right to select counsel for any
suit
initiated by it. If required under applicable law in order for the
initiating Party to initiate and/or maintain such suit or action,
the
other Party shall join as a party to the suit or action. Such other
Party
shall offer reasonable assistance to the initiating Party in connection
therewith at no charge to the initiating Party except for reimbursement
of
reasonable out-of-pocket expenses incurred in rendering such assistance.
The Party filing any such suit or taking any such action shall provide
the
other Party with an opportunity to make suggestions and comments
regarding
such suit or action. Thereafter, the Party filing any such suit or
taking
any such action shall, to the extent permitted by applicable law,
keep the
other Party promptly informed, and shall from time to time consult
with
such other Party regarding the status of any such suit or action
and shall
provide such other Party with copies of all material documents including
complaints, answers, counterclaims, material motions, orders of the
court,
memoranda of law and legal briefs, interrogatory responses, depositions,
material pre-trial filings, expert reports, affidavits filed in court,
transcripts of hearings and trial testimony, trial exhibits and notices
of
appeal filed in, or otherwise relating to, such suit or action. The
Party
not initiating such suit or action shall have the right to participate
and
be represented in any such suit by its own counsel at its own expense.
The
Parties shall not conduct or settle any such suit or action in a
manner
that deprives the non-initiating Party of material consideration
under
this Agreement or materially places at risk the scope or validity
of any
Licensed Patent without the prior written approval of the non-initiating
Party, which approval shall not be unreasonably withheld or
delayed.
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| d) |
With
respect to any suit or action referred to in Section
5.2(b)(ii),
any recovery obtained as a result of any such proceeding, by settlement
or
otherwise, shall be applied in the following order of
priority:
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(i) first,
the Party initiating
the
suit or action shall be reimbursed for all costs in connection with such
proceeding paid by such Party and not otherwise recovered; and
(ii) second,
any remainder shall be paid seventy-five percent (75%) to the Party initiating
such suit or action and twenty-five (25%) to the other Party.
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5.3
|
Defense
of Infringement Action.
With respect to any and all claims instituted by third parties for
patent
infringement involving the manufacture, use, offer for sale or sale
of a
Licensed Product during the Term (“Third Party Suit”), Licensee shall have
the right, at its sole discretion, to defend and control any action
or
proceeding with respect to such claim. Baxter agrees to be joined
as a
party if necessary to defend the action or proceeding and shall provide
all reasonable cooperation, including any necessary use of its name,
required to defend such litigation. In the event Baxter is joined
as a
party to any Third Party Suit, Baxter shall have the right to be
represented by its own counsel, at its own selection and expense.
Licensee
shall have sole control of any such suit and all negotiations for
its
settlement or compromise, provided that Licensee shall not conduct
or
settle any such suit in a manner that deprives Baxter of material
consideration under this Agreement or materially places at risk the
scope
or validity of any Licensed Patent without the prior written approval
of
Baxter, which approval shall not be unreasonably withheld or
delayed.
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ARTICLE
6
[Intentionally
Omitted]
ARTICLE
7
REPRESENTATIONS
AND WARRANTIES
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7.1
|
Licensee’s
Representations And Warranties. Licensee
hereby represents and warrants to Baxter as of the Effective Date
that:
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(a)
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Licensee
is duly authorized to enter into this Agreement;
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(b)
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no
consents or approvals which Licensee has not previously obtained
are
necessary for Licensee to enter into this Agreement and perform all
of
Licensee's obligations hereunder; and
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(c)
|
this
Agreement does not conflict with any other Licensee contractual,
statutory
or regulatory obligation.
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7.2
|
Licensee’s
Covenant.
Licensee hereby covenants during the Term that Licensee shall perform
its
obligations hereunder in accordance with all relevant material applicable
state and federal laws, rules and regulations as they apply.
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7.3
|
Xxxxxx’x
Representations and Warranties.
Baxter hereby represents and warrants to Licensee, as of the Effective
Date that:
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(a)
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Baxter
is duly authorized to enter into this
Agreement;
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(b)
|
no
consents or approvals which Baxter has not previously obtained are
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necessary
for Baxter to enter into this Agreement and perform all of Xxxxxx'x obligations
hereunder;
| (c) |
this
Agreement does not conflict with any other Baxter contractual, statutory
or regulatory obligation;
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| (d) |
Baxter
is the owner of the Licensed Patents and it is free and clear of
any
encumbrances, and that Baxter has the right to grant the license
hereunder, and such grant does not conflict with any other agreements,
documents or other materials;
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| (e) |
to
Xxxxxx’x knowledge,
the manufacture, sale, offer for sale, importation or use of a Licensed
Product would not infringe any existing, valid intellectual property
right
of any third party throughout the world. Baxter represents that it
has not
received any notice of any claimed infringement (including without
limitation patent infringement) in connection with the manufacture,
sale,
offer for sale, importation or use of a Licensed Product as of the
Effective Date;
|
| (f) |
Baxter
has not received and
does not have knowledge of any
information that would suggest the invalidity or unenforceability
of all
of the claims of the Licensed
Patents.
|
|
7.4
|
Xxxxxx’x
Covenant.
Baxter hereby covenants during the Term that Baxter shall perform
its
obligations hereunder in accordance with all relevant material applicable
state and federal laws, rules and regulations as they
apply.
|
ARTICLE
8
INDEMNIFICATION
|
8.1
|
Indemnification.
Each Party’s rights to indemnification with respect to the provisions of
this Agreement and the performance thereof shall be governed by and
set
forth in Section 6.2
and 6.3
of
the Asset Purchase Agreement.
|
|
8.2
|
Exclusive
Remedy.
Except with respect to claims for fraud or for equitable relief,
and
claims for specific performance of the covenants and obligations
of the
other Party under this Agreement, claims for indemnification pursuant
to
Article VI
of
the Asset Purchase Agreement shall be the sole and exclusive remedy
for
claims and damages available to Baxter and Licensee and their respective
Affiliates arising out of or relating to this Agreement and the licenses
contemplated hereby.
|
| 8.3 |
Limitation
on Liability.
Notwithstanding Article VI
of
the Asset Purchase Agreement, or any other provision of this Agreement,
no
Party shall be liable under this Agreement for any special, indirect,
consequential or punitive damages except to the extent that the liability
for such damages arises out of a Third Party Action (as defined in
the
Asset Purchase Agreement).
|
ARTICLE
9
FORCE
MAJEURE
Neither
of the Parties shall be liable for failure of performing its obligation
hereunder to riot, act of God, war, fire, flood, invasion, earthquake,
epidemics, interruption of transportation, embargo, strike, lockout or any
other
causes similar to the foregoing which are beyond the reasonable control of
the
Party (“Events of Force Majeure”) and the performance of obligation hereunder
shall be suspended but not longer than the existence of such cause. The Party
so
affected shall: (a) give prompt written notice to the other Party of the nature
and date of commencement of the force majeure event and its expected duration;
and (b) use all reasonable commercial efforts to relieve the effect of such
cause as rapidly as possible. If the Events of Force Majeure do not xxxxx within
ninety (90) days such that the Party claiming such Force Majeure is still unable
to perform its obligations hereunder, the failure to perform shall be deemed
a
material breach and the other Party may terminate this Agreement pursuant to
Section
10.2.
ARTICLE
10
TERM
AND TERMINATION
|
10.1
|
Term.
The licenses granted under this Agreement shall come into effect
as of the
Effective Date and, subject to the provisions of this Article
10,
shall expire on the expiration of last to expire of the Licensed
Patents (the
“Term”). Upon expiration of the Term, (i) the licenses granted herein
shall terminate and (ii) no further obligation shall accrue under
Article
3.
|
|
10.2
|
Termination
of Certain Rights for Material Breach.
Either Party may terminate certain rights of the other Party under
this
Agreement, as more fully described in Section
10.4,
for any material breach by the other Party or if the other Party
has
failed to comply with all laws, regulations or treaties of the United
States of America applicable to its activities under this Agreement,
by
giving sixty (60) days written notice to the other Party specifying
the
nature of such breach or failure. Termination shall become effective
if
such breach or failure remains uncured at the end of such sixty (60)
day
period, provided, however, if such breach or failure is incapable
of cure
within a sixty (60) day period but is otherwise capable of cure,
and the
terminating Party will not be materially prejudiced if the cure is
effected in a reasonable time, and the curing Party is proceeding
to
effect the cure in good faith and with reasonable diligence, then
the
termination shall not become effective until the curing Party has
had a
reasonable time to effect the cure.
|
| 10.3 |
Licensee
Termination.
Licensee may terminate this Agreement at any time upon sixty (60)
days
prior written notice, at which time (i) the licenses granted herein
shall terminate and (ii) no further obligation shall accrue under
Article III.
|
|
10.4
|
Effect
of Termination Under Section 10.2.
In
the event Baxter exercises its right of termination pursuant to
Section
10.2,
the license pursuant to Section
2.1
shall, at Xxxxxx’x option, either (i) become non-exclusive, without the
right to sublicense; provided, however, that sublicenses granted
prior to
termination of the other Party’s licenses under this Agreement shall
continue unaffected by termination, except for the substitution of
Baxter
for Licensee as party to such sublicense or (ii) terminate.
|
ARTICLE
11
NOTICES
AND MISCELLANEOUS
| 11. |
1Notices.
All notices, requests, consents and other communications hereunder
shall
be in writing, shall be addressed to the receiving party’s address set
forth below or to such other address as a party may designate
by notice
hereunder, and shall be either (i) delivered by hand, (ii) made
by
telecopy or facsimile transmission, (iii) sent by recognized
overnight
courier, or (iv) sent by registered or certified mail, return
receipt
requested, postage
prepaid:
|
|
If
to the Sellers:
|
Xxxxxx
Healthcare S.A.
Xxxxxxxxxxxx
0, XX-0000
Xxxxxxxx,
Xxxxxxxxxxx
Attn: General
Manager
Fax:
x00 00 000 00 00
|
|
Xxxxxx
International Inc.
Xxx
Xxxxxx Xxxxxxx
Xxxxxxxxx,
XX 00000
Attn: Corporate
Vice President & General Counsel
Fax: 000.000.0000
|
|
|
If
to the Buyer:
|
ZIOPHARM
Oncology, Inc
0000
Xxxxxx xx xxx Xxxxxxxx
Xxx
Xxxx, XX 00000
Attn: Xxxxxxxx
Xxxxx, MD, PhD
Chief
Executive Officer and Executive Chairman
Fax: 000
000 0000
|
|
With
a copy to:
|
ZIOPHARM
Oncology, Inc
000
Xxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxxxxx,
XX 00000
Attn: Xxx
Xxxxxx, Senior Vice
President,
Business
and Development Operations
Fax: 000
000 0000
|
All
notices, requests, consents and other communications hereunder shall be deemed
to have been received (i) if by hand, at the time of the delivery thereof to
the
receiving party at the address of such party set forth above or as so
designated, (ii) if made by telecopy or facsimile transmission, at the time
that
receipt thereof has been acknowledged by electronic confirmation or otherwise,
(iii) if sent by overnight courier, on the next business day following the
day
such notice is delivered to the courier service, or (iv) if sent by registered
or certified mail, on the fifth business day following the day such mailing
is
made.
| 11.2 |
Entire
Agreement.
This Agreement, together with the Asset Purchase Agreement, collectively
embodies
the entire agreement and understanding among the Parties with respect
to
the subject matter hereof and supersedes
all prior oral or written agreements and understandings relating
to the
subject matter hereof. No statement, representation, warranty, covenant
or
agreement of any kind not expressly set forth in the Agreement shall
affect, or be used to interpret, change or restrict, the express
terms and
provisions of this Agreement.
|
| 11.3 |
Modifications
and Amendments.
The terms and provisions of this Agreement may be amended, modified,
supplemented or waived only by written agreement executed by all
Parties.
|
| 11.4 |
No
Waiver of Rights, Powers and Remedies.
No failure or delay by a Party in exercising any right, power or
remedy
under this Agreement, and no course of dealing between the Parties,
shall
operate as a waiver of any such right, power or remedy of the Party.
No
single or partial exercise of any right, power or remedy under this
Agreement by a Party, nor any abandonment or discontinuance of steps
to
enforce any such right, power or remedy, shall preclude such Party
from
any other or further exercise thereof or the exercise of any other
right,
power or remedy hereunder. The election of any remedy by a Party
shall not
constitute a waiver of the right of such Party to pursue other available
remedies. No notice to or demand on a Party not expressly required
under
this Agreement shall entitle the Party receiving such notice or demand
to
any other or further notice or demand in similar or other circumstances
or
constitute a wavier of the rights of the Party giving such notice
or
demand to any other or further action in any circumstances without
such
notice or demand. The terms and provisions of this Agreement may
be
waived, or consent for the departure therefrom granted, only by written
document executed by the Party entitled to the benefits of such terms
or
provisions. No such waiver or consent shall be deemed to be or shall
constitute a waiver or consent with respect to any other terms or
provisions of this Agreement, whether or not similar. Each such waiver
or
consent shall be effective only in the specific instance and for
the
purpose for which it was given, and shall not constitute a continuing
waiver or consent.
|
| 11.5 |
Assignment.
Neither Party may assign or transfer this Agreement or any rights
or
obligations hereunder without the prior written consent of the other,
except that a Party may make such an assignment without the other
Party’s
consent to one or more of its Affiliates
or
in connection with a sale or transfer of all or substantially all
of the
stock or assets of the Party or any merger, consolidation or similar
transaction involving the Party.
Any permitted successor or assignee of rights and/or obligations
hereunder
shall, in a writing to the other Party, expressly assume performance
of
such rights and/or obligations. Any permitted assignment shall be
binding
on the successors of the assigning Party. Any assignment or attempted
assignment by either Party in violation of the terms of this Section
shall
be null and void and of no legal
effect.
|
| 11.6 |
Parties
in Interest.
This Agreement shall be binding upon and inure solely to the benefit
of
each Party and their permitted
successors and
assigns, and nothing in this Agreement, express or implied, (i) is
intended to confer upon any other person or entity any rights or
remedies
of any nature whatsoever under or by reason of this Agreement, or
(ii)
shall be construed to create any rights or obligations except among
the
Parties, and no person or entity shall be regarded as a third-party
beneficiary of this Agreement.
|
| 11.7 |
Governing
Law.
This Agreement and the rights and obligations of the Parties hereunder
shall be construed in accordance with and governed by the internal
law of
the State of Illinois, without giving effect to the conflicts of
law
principles thereof.
|
| 11.8 |
Severability.
In the event that any court of competent jurisdiction shall finally
determine that any provision, or any portion thereof, contained in
this
Agreement shall be void or unenforceable in any respect, then such
provision shall be deemed limited to the extent that such court determines
it enforceable, and as so limited shall remain in full force and
effect.
In the event that such court shall determine that any such provision,
or
potion thereof, is wholly unenforceable, the remaining provisions
of this
Agreement shall nevertheless remain in full force and
effect.
|
| 11.9 |
Interpretation.
The Parties acknowledge and agree that: (i) each Party and its counsel
reviewed and negotiated the terms and provisions of this Agreement
and
have contributed to its revision; (ii) the rule of construction to
the
effect that any ambiguities are resolved against the drafting Party
shall
not be employed in the interpretation of this Agreement; and (iii)
the
terms and provisions of this Agreement shall be construed fairly
as to all
Parties and not in favor of or against any Party, regardless of which
Party was generally responsible for the preparation of this
Agreement.
|
| 11.10 |
Headings
and Captions.
The headings and captions of the various subdivisions of this Agreement
are for convenience of reference only and shall in no way modify,
or
affect, or be considered in construing or interpreting the meaning
or
construction of any of the terms or provisions
hereof.
|
| 11.11 |
Enforcement.
Each of the Parties acknowledges and agrees that the rights acquired
by
each Party hereunder are unique and that irreparable damage would
occur in
the event that any of the provisions of this Agreement to be performed
by
the other Party were not performed in accordance with their specific
terms
or were otherwise breached. Accordingly, in addition to any other
remedy
to which the Parties are entitled at law or in equity, each Party
shall be
entitled to an injunction or injunctions to prevent breaches of this
Agreement by the other Party and to enforce specifically the terms
and
provisions hereof in any federal or state court of competent
jurisdiction.
|
| 11.12 |
Publicity.
Neither Party shall make any public announcement concerning this
Agreement
without the prior written consent of the other Party, unless counsel
to
such Party advises that such announcement or statement is
required by law (including applicable stock exchange rule). In the
case of
an announcement required by law, the other Party shall be advised
in
advance and both Parties shall use good faith efforts to cause a
mutually
agreeable announcement to be issued in a timely basis,
subject to the disclosing party’s legal requirements.
|
| 11.13 |
Confidentiality.
The Parties acknowledge and agree that any information or data it
has
acquired from the other Parties, not otherwise properly in the public
domain, shall
be subject, in all respects, to Section
7.14
of
the Asset Purchase Agreement.
|
| 11.14 |
Confidentiality
of This Agreement.
Neither Party nor their representatives, will, without the prior
written
consent of the other Party, other than to its employees, their officers,
its Affiliates and/or its agents, disclose to any person any of the
terms
or conditions of this Agreement; provided, however, that notwithstanding
the foregoing, a Party may disclose the terms or conditions of this
Agreement to the extent such disclosure is reasonably necessary to
(a) comply with or enforce any of the provisions of this Agreement,
(b) comply with applicable laws, or (c) comply with applicable stock
exchange regulation, New York Stock Exchange regulation, Nasdaq regulation
or Securities and Exchange Commission rule or regulation. To the
extent
that either Party determines that it is required to file this Agreement
to
comply with the requirements of an applicable stock exchange regulation,
New York Stock Exchange regulation, Nasdaq regulation or SEC rule
or
regulation, such Party shall give at least three (3) days advance
written
notice of any such required disclosure to the other party, and to
the
extent the other party so requests it within such three (3) day period,
prior to making any such filing shall consult with the other Party
with
respect thereto regarding
confidentiality.
|
| 11.15 |
Interpretation.
Unless the context otherwise requires, words defined herein in the
singular include the plural and words defined herein in the plural
include
the singular. “Include,” “includes” or “including” shall in all places
mean including, but not limited to. The use of the masculine or any
other
pronoun herein when referring to any person or entity is for convenience
only and shall be deemed to refer to the particular person or entity
intended regardless of the actual gender of such person or whether
such
person is a corporation or other
entity.
|
| 11.16 |
Counterparts.
This Agreement may be executed in one or more counterparts, each
of which
deemed an original, but all of which together shall constitute one
and the
same instrument.
|
| 11.17 |
Facsimile/Scanned
Signatures.
For purposes of this Agreement and any other Transaction Documents
required to be delivered pursuant to this Agreement, facsimiles of,
or
scanned, signatures shall be deemed to be original signatures. In
addition, if any of the parties sign facsimile or scanned copies
of this
Agreement or any of the other Transaction Documents, such copies
shall be
deemed originals.
|
In
Witness Whereof, the Parties have executed this Agreement as of the day and
year
first above written.
| XXXXXX HEALTHCARE S.A. | ||
| By: |
/s/
Xxxxxx X. Xxxxxxx
|
|
| Name: |
Xxxxxx X. Xxxxxxx
|
|
| Title: | VP Finance Europe | |
|
XXXXXX
INTERNATIONAL INC.
|
||
| |
|
|
| By: | /s/ Xxx Xxxxx | |
| Name: |
Xxx Xxxxx |
|
| Title: | CVP, CFO | |
|
ZIOPHARM
ONCOLOGY, INC.
|
||
| |
|
|
| By: | /s/ Xxxxxxxx Xxxxx | |
| Name: |
Xxxxxxxx Xxxxx |
|
| Title: | Chief Executive Officer | |
