EXHIBIT 10.27
Portions of this Exhibit have
been omitted pursuant to a
request for confidential
treatment. The omitted portions
are marked ***** and have been
filed separately with the
Commission.
LICENSE AGREEMENT
dated as of November 13, 1998
by and between
PG-TXL COMPANY, L.P.
and
CELL THERAPEUTICS, INC.
TABLE OF CONTENTS
Page
ARTICLE I DEFINITIONS....................................... 2
SECTION 1.01. Definitions....................................... 2
ARTICLE II DEVELOPMENT....................................... 7
SECTION 2.01. Development....................................... 7
SECTION 2.02. Drug Approval Applications........................ 7
SECTION 2.03. Costs of Development.............................. 8
SECTION 2.04. Exclusivity....................................... 8
SECTION 2.05. CTI Portfolio..................................... 8
ARTICLE III PAYMENTS.......................................... 8
SECTION 3.01. License Fee Payments.............................. 8
SECTION 3.02. Milestone Payments................................ 9
SECTION 3.03. Donation to MD Xxxxxxxx........................... 10
SECTION 3.04. Facilities and Administrative Expenses............ 10
ARTICLE IV LICENSES.......................................... 11
SECTION 4.01. Patent License to CTI............................. 11
SECTION 4.02. Trademark Assignment to CTI....................... 11
SECTION 4.03. Third Party Technology............................ 11
ARTICLE V COMMERCIALIZATION................................. 12
SECTION 5.01. CTI as Sole Marketing Party....................... 12
SECTION 5.02. Commercialization Efforts......................... 12
SECTION 5.03. Tax Considerations................................ 12
ARTICLE VI ROYALTIES......................................... 12
SECTION 6.01. Royalties......................................... 12
SECTION 6.02. Royalty Reports and Payments...................... 13
SECTION 6.03. Payments; Interest................................ 13
SECTION 6.04. Taxes............................................. 14
SECTION 6.05. Payments to or Reports by Affiliates.............. 14
SECTION 6.06. Payment Currency.................................. 14
ARTICLE VII MANUFACTURE, SALES AND SUPPLY..................... 15
SECTION 7.01. Manufacture and Supply of Licensed Products by CTI 15
SECTION 7.02. Regulatory Approval for Manufacturing............. 15
ARTICLE VIII CONFIDENTIALITY................................... 15
SECTION 8.01. Confidentiality; Exceptions....................... 15
i.
SECTION 8.02. Authorized Disclosure 16
SECTION 8.03. Survival.......................................... 16
SECTION 8.04. Termination of Prior Agreement.................... 16
SECTION 8.05. Publications...................................... 16
SECTION 8.06. Publicity Review.................................. 17
ARTICLE IX OWNERSHIP OF INTELLECTUAL PROPERTY AND
PATENT RIGHTS..................................... 17
SECTION 9.01. Patent Prosecution................................ 17
SECTION 9.02. Third Party Patent Rights......................... 18
SECTION 9.03. Enforcement Rights................................ 18
SECTION 9.04. Defense and Settlement of Third Party Claims...... 19
SECTION 9.05. Patent Expenses................................... 19
SECTION 9.06. Trademarks........................................ 19
ARTICLE X REPRESENTATIONS AND WARRANTIES.................... 19
SECTION 10.01. Representations and Warranties.................... 19
SECTION 10.02. Performance by Affiliates of CTI.................. 20
ARTICLE XI INFORMATION AND REPORTS........................... 20
SECTION 11.01. Records of Revenues and Expenses.................. 20
SECTION 11.02. Use of Names...................................... 22
ARTICLE XII TERM AND TERMINATION.............................. 22
SECTION 12.01. Term.............................................. 22
SECTION 12.02. Termination....................................... 22
SECTION 12.03. Surviving Rights.................................. 24
ARTICLE XIII INDEMNIFICATION................................... 24
SECTION 13.01. Indemnification................................... 24
ARTICLE XIV APRIL 30 LICENSE; SECURITY INTEREST............... 26
SECTION 14.01. April 30 License.................................. 26
SECTION 14.02. Security Interest................................. 26
ARTICLE XV MISCELLANEOUS..................................... 27
SECTION 15.01. Assignment........................................ 27
SECTION 15.02. Retained Rights................................... 28
SECTION 15.03. Force Majeure..................................... 28
SECTION 15.04. Further Actions................................... 28
SECTION 15.05. No Trademark Rights............................... 28
SECTION 15.06. Notices........................................... 28
SECTION 15.07. Waiver............................................ 29
SECTION 15.08. Severability...................................... 29
ii.
SECTION 15.09. Ambiguities 29
SECTION 15.10. Governing Law..................................... 29
SECTION 15.11. Arbitration....................................... 29
SECTION 15.12. Headings.......................................... 30
SECTION 15.13. Counterparts...................................... 30
SECTION 15.14. Entire Agreement; Amendments...................... 30
SECTION 15.15. Expenses.......................................... 30
SECTION 15.16. Independent Contractors........................... 31
EXHIBITS
EXHIBIT A PG-TXL Patent Rights
EXHIBIT B Form of Financing Statement
iii.
LICENSE AGREEMENT
-----------------
LICENSE AGREEMENT (the "Agreement"), dated as of November 13, 1998
---------
(the "Effective Date"), by and between PG-TXL COMPANY, L.P., a Delaware limited
--------------
partnership having its principal place of business at 0000 Xxxxxxxxxx Xxxxxx,
Xxxxxxx, Xxxxx, 00000 (hereinafter referred to as "PG-TXL") and CELL
------
THERAPEUTICS, INC., a Washington corporation having its principal place of
business at 000 Xxxxxxx Xxxxxx Xxxx, Xxxxxxx, Xxxxxxxxxx, 00000 (hereinafter
referred to as "CTI"). PG-TXL and CTI are sometimes referred to herein
---
individually as a "Party" and collectively as the "Parties."
W I T N E S S E T H:
-------------------
WHEREAS, CTI focuses on the discovery, development, and
commercialization of drugs that are relevant to the treatment of cancer and
inflammatory and immune diseases;
WHEREAS, PG-TXL has acquired certain technology related to conjugates
of water soluble polymers and, secondarily, metal chelators and has the right to
grant rights and licenses and/or sublicenses under the PG-TXL Patent Rights
(hereinafter defined) and PG-TXL Know-How (hereinafter defined);
WHEREAS, CTI has, based on its evaluation, expressed to PG-TXL its
interest in obtaining from PG-TXL certain rights and licenses to the PG-TXL
Patent Rights and PG-TXL Know-How;
WHEREAS, PG-TXL is willing to grant such rights and licenses to CTI
under the terms and conditions hereinafter set forth;
WHEREAS, the Parties intend to record, characterize and report their
activities under this Agreement as separate activities of each of the Parties;
NOW, THEREFORE, in consideration of the foregoing recitals and the
mutual covenants and agreements contained herein, the Parties hereto, intending
to be legally bound, do hereby agree as follows:
1.
ARTICLE I
DEFINITIONS
-----------
SECTION 1.01. Definitions. The following terms, when capitalized,
-----------
shall have the following meanings (such meanings to be equally applicable to
both the singular and plural forms of the terms defined) as used in this
Agreement:
"Affiliate" means any person, corporation, partnership, firm, joint
---------
venture or other entity which, directly or indirectly, through one or more
intermediaries, controls, is controlled by, or is under common control with, PG-
TXL or CTI, as the case may be. As used in this definition, "control" means the
possession of the power to direct or cause the direction of the management and
policies of an entity, whether through the ownership of the outstanding voting
securities or by contract or otherwise.
"April 30 License" means the License Agreement, effective as of April
----------------
30, 1998 by and among the April 30 Licensors and PG-TXL.
"April 30 Licensors" means Xxxx Xx, Ph.D., Xxxxxx Xxxxxxx, M.D., Xxxxx
------------------
X. Xxxx, Ph.D. and Dong Xxxx Xx, M.S.
"Audit Disagreement" shall have the meaning set forth in Section
------------------
11.01(b).
"Bankruptcy Event" shall have the meaning set forth in Section
----------------
12.02(d).
"Clinical Work" means any work related to human trials to assess the
-------------
dosing, safety and/or efficacy of Licensed Products and/or to assess a dose and
treatment plan employing such Licensed Products, including, but not limited to,
Phase III and Phase IV Clinical Trials (in the event such Phase IV Clinical
Trials are required by the FDA).
"Commercialization" and "Commercialize" shall refer to all activities
----------------- -------------
undertaken relating to the manufacture, pre-marketing, marketing and sale of
Licensed Products.
"Confidential Information" shall have the meaning set forth in Section
------------------------
8.01.
"Control" or "Controlled" shall refer to possession of the ability to
------- ----------
grant a license or sublicense of patent rights, know-how or other intangible
rights as provided for herein without violating the terms of any agreement or
other arrangement with any Third Party.
"Development" and "Develop" shall refer to all activities relating to
----------- -------
obtaining Regulatory Approval of Licensed Products, and all activities relating
to developing the ability to manufacture the same. This includes preclinical
testing, toxicology, formulation, bulk
2.
production, fill/finish, manufacturing process development, manufacturing,
quality assurance and quality control technical support, clinical studies,
regulatory affairs and outside regulatory counsel legal services.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
"Development Expenses" means the expenses incurred in connection with
--------------------
the Development of Licensed Products. Development Expenses shall include, but
are not limited to *****.
"Drug Approval Application" means an application for Regulatory
-------------------------
Approval required to be approved before commercial sale or use of a Licensed
Product as a drug in a regulatory jurisdiction, including, for the purposes of
Regulatory Approval in the United States, a New Drug Application and all
supplements filed pursuant to the requirements of the FDA (including all
documents, data and other information concerning Licensed Products which are
necessary for, or included in, FDA approval to market the Licensed Products, as
more fully defined in 21 C.F.R. (S)(S)314.1 et seq.).
"Effective Date" shall have the meaning set forth in the Recitals to
--------------
this Agreement.
"Europe" means the countries which are members of the European Union
------
as such membership may change from time to time.
"FDA" means the United States Food and Drug Administration, or any
---
successor agency.
"First Commercial Sale" means the date CTI or its Affiliate or a
---------------------
sublicensee of CTI first sells commercially, pursuant to a Regulatory Approval,
Licensed Products in any country of the Territory, provided that where such a
--------
first commercial sale has occurred in a country for which pricing or
reimbursement approval is necessary for widespread sale, then such sales shall
not be deemed a First Commercial Sale until such pricing or reimbursement
approval has been obtained.
"Improvements" shall mean any additional composition which comprises
------------
an agent conjugated to water soluble polymers or metal chelators.
"IND" shall mean an investigational new drug application required to
---
be filed with the FDA pursuant to 21 C.F.R. (S) 312, as such regulations may be
amended from time to time, to test drug products in humans, or any foreign
equivalent of the FDA.
3.
"Information" means (i) techniques and data relating to the Licensed
-----------
Products, including, but not limited to, inventions, practices, methods,
knowledge, know-how, skill, trade secrets, experience, test data including
pharmacological, toxicological, preclinical and clinical test data, regulatory
submissions, adverse reactions, analytical and quality control data, marketing,
pricing, distribution, cost, sales and manufacturing data or descriptions and
(ii) compounds, compositions of matter, assays and biological materials relating
to the Licensed Products.
"June 30 Letter Agreement" shall mean that Letter Agreement dated June
------------------------
30, 1998, between PG-TXL and CTI.
"Licensed Products" means all products, devices, apparatuses,
-----------------
compositions of matter, kits or component parts, and/or any method, procedure,
or process, (or other subject matter disclosed or claimed in the PG-TXL Patent
Rights) the manufacture, promotion, sale, marketing, distribution or use of
which for any purpose by Licensee are covered by a validly issued and unexpired
patent claim under the PG-TXL Patent Rights, or which utilize the PG-TXL Know-
How, and any Improvements utilized by CTI or its licensees or assigns.
"Losses" shall have the meaning set forth in Section 13.01(a).
------
"Major Market Country" means each of Germany, France, Italy and the
--------------------
United Kingdom.
"Manufacturing Party" means the Party who is from time to time
-------------------
responsible for the (i) manufacturing and supply of the Licensed Products for
use during Development or (ii) commercial manufacture and supply of the Licensed
Products.
"MD Xxxxxxxx" shall mean the University of Texas/M.D. Xxxxxxxx Cancer
-----------
Center located in Houston, Texas.
"MD Xxxxxxxx Release" means the release by MD Xxxxxxxx of its rights
-------------------
and claims to the PG-TXL Patent Rights as set forth in the letter dated March
11, 1997, from Xxxxxxx X. Xxxxxxx, M.D. to Xxxx Xxxxxxxxxx, M.D., and to be
confirmed in a letter to be dated on or about November 16, 1998, from Xxxx
Xxxxxxxxxx, M.D. to the April 30 Licensors.
"Necessary Third Party Intellectual Property" shall mean Third Party
-------------------------------------------
intellectual property which CTI, in its good faith judgment and with prior
consultation with PG-TXL, determines to be necessary and required to make, use,
sell, offer for sale or import Licensed Products.
"Net Sales" means the amount invoiced by a Party, its Affiliates or
---------
its sublicensees from sales of the Licensed Products to Third Parties in the
Territory, less reasonable and customary deductions applicable to the Licensed
Products for
4.
(i) transportation charges and charges such as insurance for goods in transit,
relating thereto paid by the selling party; (ii) sales and excise taxes or
customs duties paid by the selling party and any other governmental charges
imposed upon the sales of Licensed Products and paid by the selling party; (iii)
distributors' fees, rebates or allowances actually granted, allowed or incurred;
(iv) quantity discounts, cash discounts or chargebacks actually granted, allowed
or incurred in the ordinary course of business in connection with the sale of
the Licensed Products; (v) allowances or credits to customers, not in excess of
the selling price of the Licensed Products, on account of governmental
requirements, rejection, outdating, recalls or return of the Licensed Products;
(vi) any amount required to be paid for Necessary Third Party Intellectual
Property, and (vii) amounts actually charged for bad debts in connection with
sales of Licensed Products. Sales of the Licensed Products between a Party and
its Affiliates or sublicensees solely for research or clinical testing purposes
shall be excluded from the computation of Net Sales. Net Sales will be
accounted for in accordance with U.S. accounting standards consistently applied.
If Necessary Third Party Intellectual Property is purchased, for the purposes of
subclause (vi) the purchase price thereof shall be amortized over the remaining
life of the PG-TXL Patent Rights and the amount thereof charged quarterly in
computing Net Sales over the amortization period. If Necessary Third Party
Intellectual Property is licensed, the royalties payable with regard thereto for
the relevant period shall be deducted in computing Net Sales.
"Patent" means (i) valid United States and foreign patents, re-
------
examinations, reissues, renewals, extensions, term restorations, divisionals,
continuations and continuations-in-part thereof, and foreign counterparts
thereof, and (ii) pending applications for United States and foreign patents and
foreign counterparts thereof.
"Patent Expenses" means the fees, expenses and disbursements and
---------------
outside counsel fees, and payments to Third Party agents incurred in connection
with the preparation, filing, prosecution and maintenance of the PG-TXL Patent
Rights covering the Licensed Products, including costs of patent interference
and opposition proceedings and actions at law and equity for patent infringement
and any sums paid to Third Parties on account of judgments or settlements
arising out of Third Party patent claims (other than such judgments or
settlements resulting in the payment of royalties).
"PG-TXL Know-How" means Information which is within the Control of PG-
---------------
TXL and relates to the research, development, manufacture, use, importation,
sale or offer for sale of Licensed Products or potential Licensed Products,
including the use of the PG-TXL Patent Rights for uses other than cancer
therapies. Notwithstanding anything herein to the contrary, PG-TXL Know-How
shall exclude the PG-TXL Patent Rights.
"PG-TXL Patent Rights" means collectively, all right, title and
--------------------
interest of PG-TXL in, to and under the April 30 License to the Invention and
Licensed Intellectual Property, as defined therein, including:
5.
(a) any Patent listed in Exhibit A hereto or added thereto by
written agreement of the Parties during the term of this Agreement;
(b) any Patent application listed in Exhibit A hereto or added
thereto by written agreement of the Parties during the term of this Agreement;
and any continuations, continuations-in-part, Improvements, additions,
modifications, divisions or substitutions, of any such application; and any
Patent which shall issue based on such application, continuations,
continuations-in-part, Improvements, additions, modifications, divisions or
substitutions;
(c) any Patent which is a reissue, reexamination or extension of
any Patent or any Patent application described in (a) or (b) above;
(d) any foreign counterpart Patent application or Patent
corresponding to any Patent or Patent Application identified in (a), (b), or
(c), above which is filed or issued in any country; and
(e) any Patent or Patent application related to or based on any
PG-TXL Know-How related to the Licensed Products or the manufacture thereof
developed or acquired by PG-TXL prior to or during the term of this Agreement
and which is necessary for the use, development, manufacture, market, sale or
distribution of any marketed Licensed Products and any division, continuation or
continuation-in-part of any such Patent or Patent application; and any Patent
which shall issue based on such application, division, continuation or
continuation-in-part; and any Patent which is a reissue, reexamination or
extension of any such Patent.
As used herein, "Patent" also includes a Supplementary Certificate of Protection
of a member state of the European Community and any other similar protective
rights in any other country.
"Phase I Clinical Trials" means those trials on sufficient numbers of
-----------------------
normal volunteers and patients that are designed to establish that a drug is
safe for its intended use, and to support its continued testing in Phase II
Clinical Trials.
"Phase II Clinical Trials" means those trials on sufficient numbers of
------------------------
patients that are designed to gain evidence that a drug is effective for its
intended use in the target population within the meaning of 21 C.F.R.
(S)312.21(b).
"Phase III Clinical Trials" has the meaning ascribed thereto in 21
-------------------------
C.F.R. (S) 312.21(c), as amended from time to time.
"Phase IV Clinical Trials" means product support clinical trials of
------------------------
Licensed Products commenced after receipt of Regulatory Approval in the United
States for such Licensed Products.
6.
"Preclinical Work" means any nonclinical in vivo or in vitro
----------------
biological work to assess the safety or efficacy of Licensed Products.
"Regulatory Approval" means any approvals, product and/or
-------------------
establishment licenses, registrations or authorizations of any federal, state or
local regulatory agency, department, bureau or other governmental entity,
necessary for the manufacture, use, storage, importation, export, transport or
sale of Licensed Products in a regulatory jurisdiction.
"Royalty Percentages" shall have the meaning set forth in Section
-------------------
6.01.
"Successful Completion" means, with respect to a Phase II or Phase III
---------------------
Clinical Trial, that such trial has achieved each of its primary endpoints at a
level that is statistically significant.
"Territory" means all the countries, territories and subdivisions of
---------
the world.
"Third Party" means any entity other than PG-TXL or CTI and their
-----------
respective Affiliates and sublicensees.
"Written Disclosure" shall have the meaning set forth in Section 8.06.
------------------
ARTICLE II
DEVELOPMENT
-----------
SECTION 2.01. Development. CTI will be the sole party responsible
-----------
for Development of Licensed Products and shall use commercially reasonable
efforts to develop, manufacture, promote, sell, market, distribute or use the
Licensed Products. Such efforts shall be consistent with commercially
reasonable practices in the biotechnology industry as well as the efforts used
by CTI with respect to its own pharmaceutical products.
SECTION 2.02. Drug Approval Applications. CTI, or its designee,
--------------------------
shall be responsible for preparing and filing Drug Approval Applications and
seeking Regulatory Approvals for Licensed Products in the Territory, including
preparing all reports necessary as part of a Drug Approval Application. All
such Drug Approval Applications shall be filed in the name of CTI or its
designee, and a copy of each such Drug Approval Application shall be provided to
PG-TXL within 180 days of such filing. CTI shall be responsible for prosecuting
such Drug Approval Applications. In the event that any regulatory agency
threatens or initiates any action to remove Licensed Products from the market,
CTI shall notify PG-TXL of such communication within ten (10) business days of
receipt by CTI. As between Parties, CTI shall be the legal and beneficial owner
of all Drug Approval Applications and related approvals in the Territory.
7.
SECTION 2.03. Costs of Development. Unless otherwise agreed all
--------------------
Development Expenses incurred for Licensed Products shall be borne by CTI. PG-
TXL shall not conduct any Development, nor incur Development Expenses, without
CTI's prior written consent.
SECTION 2.04. Exclusivity.
-----------
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
(a) The rights granted by PG-TXL to CTI under Section 4.01 shall
become non-exclusive at the option of PG-TXL, upon written notice to CTI,
effective ninety (90) days after receipt by CTI of such notice, if: *****.
(b) Neither PG-TXL nor any of its Affiliates shall use, Develop,
manufacture, have manufactured, market, sell, or distribute directly or
indirectly any Licensed Product in the Territory, nor aid in any of the
aforementioned activities, including through the licensing of any PG-TXL Patent
Rights or PG-TXL Know-How. If PG-TXL or any of its Affiliates makes, uses, or
sells a product competitive with a Licensed Product in a country, or aids in any
such activities with any of their respective licensees or sublicensees, and
after written notice of breach from CTI, PG-TXL or its Affiliates fails to cease
such making, using, or selling, CTI shall not be obligated to pay royalties on
the sale of Licensed Products in such country, and may seek damages for PG-TXL's
breach hereof
SECTION 2.05. CTI Portfolio. PG-TXL is aware of the fact that CTI
-------------
is, as of the Effective Date, engaged in the discovery, development and
commercialization of products which potentially may be competitive with Licensed
Products and will continue to be so engaged after the Effective Date. PG-TXL
agrees that nothing in this Agreement is intended to prevent or prevents CTI, in
its sole discretion, from continuing to engage in such drug discovery,
development or commercialization efforts.
ARTICLE III
PAYMENTS
--------
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
SECTION 3.01. License Fee Payments. On July 2, 1998, in
--------------------
consideration of the rights granted by PG-TXL to CTI under Section 3.0 of the
June 30 Letter Agreement, CTI paid to PG-TXL a nonrefundable initial license fee
payment of *****. In consideration of the rights granted by PG-TXL to CTI
under Section 4.01 of this Agreement, CTI shall make the following remaining
license fee payments:
8.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
Payment Due Date
------- ---------------
***** January 5, 1999
***** April 1, 1999
***** July 1, 1999
CTI shall have no obligation to make the license fee payments specified
above; however the failure to make any payment shall, at the option of either
Party upon written notice to the other Party, terminate this Agreement effective
five (5) days after receipt of such notice by such Party. Upon any termination,
the license granted pursuant to Section 4.01 shall terminate and CTI shall
comply with Section 12.02(e).
SECTION 3.02. Milestone Payments. CTI shall make the following
------------------
payments to PG-TXL within ten (10) business days after the first achievement of
each of the corresponding milestones (each milestone and corresponding payment
shall be a stand-alone event and shall in no way be dependent upon the
achievement of any other milestone):
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
PG-TXL
PG-TXL Milestone
Milestone Event Payment
--------------- -----------
Oncology/PG-TXL:
Upon the earlier to occur of: *****
1. 24 months from the execution of this
Agreement; or
2. Acceptance by the FDA for filing of the
first IND for a Licensed Product in
U.S.
The filing with the relevant regulatory agency or *****
authority of the first IND application (or its
counterpart) in the first Major Market Country
which accepts the filing
The filing with the relevant regulatory agency or *****
authority of the first IND application (or its
counterpart) in Japan
Successful Completion of a Phase II Clinical *****
Trial in the U.S.
Successful Completion of a Phase II Clinical *****
Trial in a Major Market Country
9.
PG-TXL
PG-TXL Milestone
Milestone Event Payment
--------------- -----------
Successful Completion of a Phase II Clinical Trial in *****
Japan
Successful Completion of a Phase III Clinical Trial in *****
the U.S.
Successful Completion of a Phase III Clinical Trial in *****
a Major Market Country
Successful Completion of a Phase III Clinical Trial in *****
Japan
Regulatory Approval for the first indication in the *****
U.S.
Regulatory Approval for the first indication in a Major *****
Market Country
Regulatory approval for the first indication in Japan *****
Additional Products:
Commencement of a Phase I Clinical Trial in the U.S. *****
for the second compound protected by the
PG-TXL Patent Rights
Commencement of a Phase I Clinical Trial in the U.S. *****
for the third compound protected by the
PG-TXL Patent Rights
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
SECTION 3.03. Donation to MD Xxxxxxxx. CTI shall make a
-----------------------
donation for research in the amount of ***** to the Division of Diagnostic
Imaging of MD Xxxxxxxx upon receipt by CTI of the first regulatory approval by
the FDA for the manufacture and sale of Licensed Products. Such donation shall
be made within ten (10) days of receipt of such regulatory approval by CTI.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
SECTION 3.04. Facilities and Administrative Expenses. For
--------------------------------------
a minimum three (3) year period, CTI shall reimburse PG-TXL for the cost of
reasonable office space and office support facilities in the Houston area for
use by PG-TXL and CTI personnel in an amount not to exceed ***** per year.
10.
ARTICLE IV
LICENSES
--------
SECTION 4.01. Patent License to CTI.
---------------------
(a) PG-TXL grants to CTI a worldwide exclusive (even as to PG-TXL)
license, with all rights to sublicense, under the PG-TXL Patent Rights and the
PG-TXL Know-How to use, develop, manufacture, have manufactured, market, sell,
offer to sell, import, export and distribute Licensed Products in the Territory.
(b) A list of the PG-TXL Patent Rights identified as of the Effective
Date is set forth on Exhibit A. Such list shall be modified from time to time
to reflect any changes to PG-TXL Patent Rights and shall be expanded from time
to time to include any Patents owned or Controlled by PG-TXL relevant to the
Development or Commercialization of Licensed Products.
SECTION 4.02. Trademark Assignment to CTI.
---------------------------
(a) PG-TXL hereby transfers and assigns to CTI all of its right, title
and interest in and to the trademark "PG-TXL" to be used by CTI in connection
with the development, commercialization, sales and marketing of Licensed
Products; provided that PG-TXL shall retain the right to use the trademark "PG-
TXL" in connection with its limited partnership name. Upon sixty (60) days
prior notice to PG-TXL by CTI, PG-TXL will change its partnership name to one
not containing "PG-TXL."
(b) PG-TXL makes no warranty regarding its right, title or interest in
or to the trademark "PG-TXL."
SECTION 4.03. Third Party Technology.
----------------------
(a) Existing Licenses. The licenses granted under Section 4.01
-----------------
include sublicenses of Third Party technology existing on the Effective Date and
licensed to PG-TXL to the extent that such sublicenses can be so granted,
subject to the terms and conditions of the license agreement pursuant to which
the sublicense is granted. As of the Effective Date hereof, the April 30
License is the only such agreement in place. PG-TXL shall be solely responsible
for any and all payments required to be made under the April 30 License.
(b) Necessary Third Party Intellectual Property. CTI shall have the
-------------------------------------------
right to obtain (whether by license or purchase from Third Parties) Necessary
Third Party Intellectual Property. CTI shall give PG-TXL, to the extent
practicable, at least thirty (30) days notice of its intention to obtain
Necessary Third Party Intellectual Property, and the terms upon which CTI
prepares to obtain such property. If PG-TXL does not agree that obtaining such
property is required to make, use, sell, offer for sale or import Licensed
11.
Products, PG-TXL shall, within ten (10) days after receipt of such notice,
inform CTI in writing of the basis for its disagreement, setting forth in
reasonable detail the reasons for its disagreement. Regardless of whether the
parties are in agreement, CTI shall be free to obtain such property. If PG-TXL
does not agree that such property is required for CTI to make, use, sell, offer
for sale or import Licensed Products, the issue shall be referred to arbitration
in accordance with Section 15.11 hereof. The question which the arbitrator(s)
shall decide is whether the property is required for CTI to make, use, sell,
offer for sale or import Licensed Products. If the arbitrator(s) decide in
CTI's favor, then the purchase price or royalty, as the case may be, shall be
deducted when computing Net Sales as set forth in the definition of Net Sales
under Section 1.01 hereof; otherwise such costs shall not be deducted when
computing Net Sales.
ARTICLE V
COMMERCIALIZATION
-----------------
SECTION 5.01. CTI as Sole Marketing Party. CTI, or its designees,
---------------------------
will be the sole marketing Party with respect to Licensed Products in the
Territory, and as a result, shall be responsible for carrying out
Commercialization in the Territory.
SECTION 5.02. Commercialization Efforts. CTI agrees to use
-------------------------
commercially reasonable efforts with respect to the Commercialization of
Licensed Products throughout the Territory provided for hereunder. Such
commercially reasonable efforts shall be consistent with the efforts used by CTI
in preparing commercialization plans and budgets and commercializing its own
pharmaceutical products.
SECTION 5.03. Tax Considerations. Either Party may take advantage of
------------------
tax considerations which benefit it and not the other Party. In the event that
a Party takes advantage of a tax consideration in connection with Licensed
Products which benefits it and not the other Party, no compensation to the other
Party shall be required, provided that no negative tax implication for the other
--------
Party may be an element of such tax benefit.
ARTICLE VI
ROYALTIES
---------
SECTION 6.01. Royalties. In further consideration of the rights and
---------
licenses granted to CTI under Article IV of this Agreement, CTI shall pay to PG-
TXL the following royalties based on the Net Sales of Licensed Products in the
Territory (the "Royalty Percentages"):
-------------------
12.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
Cumulative Net Sales Royalty Percentage
-------------------- ------------------
Less than $50 million *****
$50 million - $150 million *****
Greater than $150 million *****
If a Licensed Product is made and sold in any country in which CTI
does not have valid patent coverage which would prevent the sale of a generic
form of such Licensed Product, the Royalty Percentage set forth above with
respect to Net Sales attributable to the sale of such Licensed Product in such
country shall be reduced by ***** of the Royalty Percentage that would
otherwise be payable with respect to Net Sales attributable to the sale of
such Licensed Product in such country, until CTI is granted such valid and
enforceable patent coverage of such Licensed Product in such country.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
(a) Royalty Term. All royalties to a Party shall be paid, on a
------------
country-by-country basis, from the date of the First Commercial Sale of each
Licensed Product in a particular country until the later of *****.
(b) Discontinuance. Subject to the provisions of, and obligations of
--------------
CTI under, Article XII, CTI may discontinue Commercialization of Licensed
Products at any time.
(c) License Following Expiration. Upon expiration of the royalty term
----------------------------
for Licensed Products in the country as described above, CTI shall thereafter
have an exclusive (even as to PG-TXL), paid-up license to PG-TXL Know-How to
make, have made, use, sell, offer for sale, have sold and import that Licensed
Products in that country. In such event, CTI shall retain responsibility for,
and indemnify PG-TXL from, the payment of all applicable royalties and other
obligations owed to a Third Party with respect to Licensed Products.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
SECTION 6.02. Royalty Reports and Payments. CTI shall make royalty
----------------------------
payments to PG-TXL within ***** days after the end of each calendar quarter
in which Net Sales occurred. A report summarizing the Net Sales of Licensed
Products during the relevant quarter on a country-by-country basis shall be
delivered to PG-TXL within ***** days following the end of each calendar
quarter for which royalties are due. The final quarterly payment of every
calendar year will include any additional payment or relevant credit to account
for any difference in actual annual Net Sales for the applicable calendar year
and the prior year's annual Net Sales.
SECTION 6.03. Payments; Interest. Any payments due under this
------------------
Agreement shall be due on such date as specified in this Agreement and, in the
event such date is a day on which commercial banks are not authorized to conduct
business in either Houston, Texas,
13.
or Seattle, Washington, then the next succeeding business day, and shall be made
by wire transfer to a designated bank account of the receiving Party.
Any failure by a Party to make a payment within five (5) days after
the date when due shall obligate such Party to pay interest to the receiving
Party at a rate per annum equal to the prime rate as quoted in the Eastern
edition of the Wall Street Journal as of the date such payment is due and, in
the event such a rate is not quoted on such date then on the immediately
preceding date such rate is quoted, such interest due and payable upon the
payment of principal otherwise due and payable.
SECTION 6.04. Taxes. The Party receiving royalties shall pay any and
-----
all taxes levied on account of royalties it receives under this Agreement. If
laws or regulations require that taxes be withheld, the Party paying royalties
will (i) deduct those taxes from the remittable royalty, (ii) timely pay the
taxes to the proper taxing authority, and (iii) send proof of payment to the
other Party within thirty (30) days of receipt of confirmation of payment from
the relevant taxing authority. The Party paying royalties agrees to take all
lawful and reasonable efforts to minimize such taxes to the other Party.
SECTION 6.05. Payments to or Reports by Affiliates. Any payment
------------------------------------
required under any provision of this Agreement to be made to either Party or any
report required to be made by any Party shall be made to or by an Affiliate of
that Party if designated by that Party as the appropriate recipient or reporting
entity without relieving such party from responsibility for such payment or
report.
SECTION 6.06. Payment Currency. Payments by CTI under this Agreement
----------------
shall be paid to PG-TXL in U.S. dollars by wire transfer of immediately
available funds to an account at a commercial bank designated by PG-TXL pursuant
to this Article VI at least ten (10) business days before payment is due. Where
payments are based on Net Sales in countries other than the United States, the
amount of such Net Sales expressed in the currency of each country shall be
converted first into the then-applicable European currency, and then into U.S.
dollars at the average exchange rate (calculated at the average of the "bid" and
"asked" exchange rate) for the applicable quarter. In determining the average
exchange rate for any quarter, the standard shall be fifty percent (50%) of the
sum of (i) the rate quoted by Reuters (or a different independent wire service
providing international spot exchange rates as agreed to by the Parties) in New
York at 1:00 p.m. on the last business day of the applicable quarter; plus (ii)
the rate quoted by Reuters (or the approved successor service) in New York at
1:00 p.m. on the last business day of the quarter immediately preceding the
applicable quarter.
14.
ARTICLE VII
MANUFACTURE, SALES AND SUPPLY
-----------------------------
SECTION 7.01. Manufacture and Supply of Licensed Products by CTI.
--------------------------------------------------
CTI shall be the sole Party responsible for the manufacture, sale and supply of
Licensed Products and shall use commercially reasonable efforts to manufacture,
sell, market and supply Licensed Products (or arrange for such manufacture and
supply) to meet demand for Licensed Products throughout the Territory. PG-TXL
shall provide reasonable assistance to CTI with respect to the transfer of all
manufacturing capabilities from PG-TXL (or its subcontractors) to CTI.
SECTION 7.02. Regulatory Approval for Manufacturing. CTI will use
-------------------------------------
commercially reasonable efforts to make necessary filings to obtain, or to cause
a Third Party manufacturer to make necessary filings to obtain, Regulatory
Approval for the manufacture of each Licensed Product as part of the approval of
a Drug Approval Application for such Licensed Product.
ARTICLE VIII
CONFIDENTIALITY
---------------
SECTION 8.01. Confidentiality; Exceptions. Except to the extent
---------------------------
expressly authorized by this Agreement or otherwise agreed in writing, the
Parties agree that the receiving Party shall keep confidential and shall not
publish or otherwise disclose or use for any purpose other than as provided for
in this Agreement: (i) any Information or other information and materials
furnished to it by the other Party pursuant to this Agreement, (ii) any
Information developed during the course of the collaboration hereunder, or (iii)
any provisions of this Agreement that may become the subject of an effective
order of the Securities and Exchange Commission granting confidential treatment
pursuant to the Securities Act of 1934, as amended (collectively, "Confidential
------------
Information"), except to the extent that it can be established by the receiving
-----------
Party that such Confidential Information:
(a) was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by the other Party;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving Party;
(c) became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or omission of
the receiving Party in breach of this Agreement;
15.
(d) was disclosed to the receiving Party, other than under an
obligation of confidentiality, by a Third Party who had no obligation to the
disclosing Party not to disclose such information to others; or
(e) was independently discovered and/or developed by the receiving
Party as documented in its corporate records.
SECTION 8.02. Authorized Disclosure. Each Party may disclose
---------------------
Confidential Information hereunder to the extent such disclosure is reasonably
necessary in filing or prosecuting patent applications, prosecuting or defending
litigation, filing or updating any Drug Approval Application, complying with
applicable governmental regulations or conducting pre-clinical or clinical
trials, provided that if a Party is required by law or regulation to make any
such disclosures of the other Party's Confidential Information it will, except
where impracticable for necessary disclosures, for example in the event of
medical emergency, give reasonable advance notice to the other Party of such
disclosure requirement and, except to the extent inappropriate in the case of
patent applications, will use its reasonable efforts to secure confidential
treatment of such Confidential Information required to be disclosed. In
addition, and with prior notice to the other Party of each Third Party with whom
a confidential disclosure agreement is being entered into, each Party shall be
entitled to disclose, under a binder of confidentiality, Confidential
Information to any Third Party for the purpose of carrying out the purposes of
this Agreement. Nothing in this Article VIII shall restrict any Party from
using for any purpose any Confidential Information independently developed by it
during the course of the collaboration hereunder, or from using Confidential
Information that is specifically derived from pre-clinical or clinical trials to
carry out Regulatory Approval, marketing, sales or professional services support
functions as is customary in the pharmaceutical industry.
SECTION 8.03. Survival. This Article VIII shall survive the
--------
termination or expiration of this Agreement.
SECTION 8.04. Termination of Prior Agreement. This Agreement
------------------------------
supersedes the Secrecy Agreement between PG-TXL and CTI dated as of January 14,
1997, and the Letter Agreement between PG-TXL and CTI dated June 30, 1998.
SECTION 8.05. Publications. Prior to the launch of Licensed Products
------------
in the Territory, CTI will determine the overall strategy for publication in
support of Licensed Products in the Territory. Notwithstanding any term of
Section 8.06 below, the Parties recognize the need for scientific publications
pertaining to development of Licensed Products and the Parties will cooperate
with each other to provide for such publications. The Parties will use
reasonable efforts to obtain the voluntary consent of any Third Party granted
publication rights related to Licensed Products prior to the Effective Date to
comply with reasonable notice and timing requests and will promptly review any
publications delivered for review.
16.
SECTION 8.06. Publicity Review. Subject to Section 11.02 and the
----------------
further provisions of this Section 8.06, PG-TXL shall not originate any written
publicity, news release, or other announcement or statement relating to this
Agreement or to performance hereunder or the existence of an arrangement between
the Parties (collectively, "Written Disclosure"), without the prior prompt
------------------
review and written approval of CTI, which approval shall not be unreasonably
withheld or delayed. Notwithstanding the foregoing provisions of this Section
8.06, PG-TXL may make any public Written Disclosure it believes in good faith
based upon the advice of counsel is required by applicable law, provided that
prior to making such Written Disclosure, PG-TXL shall provide CTI with a copy of
the materials proposed to be disclosed at least thirty (30) days prior to (i)
submission for publication or (ii) disclosure to a Third Party. CTI shall, not
more than thirty (30) days after the receipt of any such proposed publication or
disclosure from PG-TXL, submit its suggestions, comments or objections, if any,
to PG-TXL. Any confidential matter as determined by CTI shall be deleted. In
the event CTI believes patentable subject matter is disclosed in such data or
information it shall, within twenty (20) days of its receipt thereof, notify PG-
TXL and publication or disclosure will thereupon be withheld until CTI files a
patent application thereon, or until CTI reasonably determines after sufficient
investigation that no patentable invention exists, whichever period is shorter.
The terms of this Agreement may also be disclosed by PG-TXL to (i) government
agencies where required by law, or (ii) Third Parties with the prior written
consent of CTI, which consent shall not be unreasonably withheld or delayed, so
long as such disclosure is made under a binder of confidentiality and so long as
highly sensitive terms and conditions such as financial terms are extracted from
the Agreement or not disclosed upon the request of CTI. All Written Disclosures
shall be factual and as brief as is reasonable under the circumstances. Upon
request by CTI, PG-TXL agrees to prepare a mutually agreed press release and
question and answer document with respect to this Agreement. PG-TXL agrees that
it will use reasonable efforts to cause all Written Disclosures and oral
statements relating hereto to be consistent with the answers specified in such
question and answer document.
ARTICLE IX
OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS
----------------------------------------------------
SECTION 9.01. Patent Prosecution.
------------------
(a) CTI shall be responsible for and have sole control over all Patent
prosecution hereunder.
(b) CTI shall file, prosecute and maintain all U.S. and foreign Patent
applications identified on Exhibit A and resulting Patents by counsel of its
choice on behalf of PG-TXL. CTI shall use its best efforts to ensure that the
PG-TXL Patent Rights are developed and maintained; CTI shall promptly provide
PG-TXL with copies of relevant documentation so that PG-TXL may be informed of
the continuing prosecution.
17.
(c) In the event PG-TXL, pursuant to Section 2.04(a), converts the
rights granted by PG-TXL to CTI under Section 4.01 from exclusive to non-
exclusive and, thereafter, grants additional licenses under the Patent Rights to
Third Parties, such prosecution and maintenance-related expenses going forward
will be shared equally between CTI and all such Third Party licensees.
(d) PG-TXL shall execute and deliver such documents and take such
other actions as CTI reasonably may request in connection with the preparation,
filing, prosecution and maintenance of any such Patent or Patent application
identified in Exhibit A.
SECTION 9.02. Third Party Patent Rights. Each Party agrees to bring
-------------------------
to the attention of the other Party any Third Party Patent it discovers, or has
discovered, and which relates to the subject matter of this Agreement.
SECTION 9.03. Enforcement Rights.
------------------
(a) Notification of Infringement. If either Party learns of any
----------------------------
infringement or threatened infringement by a Third Party of the PG-TXL Patent
Rights, such Party shall promptly notify the other Party and shall provide such
other Party with all available evidence of such infringement.
(b) Enforcement in the Territory. CTI shall have the right, but not
----------------------------
the obligation, to institute, prosecute and control at its own expense any
action or proceeding with respect to infringement of any PG-TXL Patent Rights
covering the manufacture, use, importation, sale or offer for sale of Licensed
Products being developed or marketed in the Territory, by counsel of its own
choice. PG-TXL shall have the right, at its own expense, to be represented in
any action by counsel of its own choice. If CTI fails to bring an action or
proceeding or otherwise take appropriate action to xxxxx such infringement
within a period of one hundred eighty (180) days of notice by PG-TXL to CTI
requesting action, PG-TXL will have the right to bring and control any such
action or proceeding relating to PG-TXL Patent Rights by counsel of its own
choice and CTI will have the right to be represented in any such action by
counsel of its own choice and at its own expense. If one Party brings any such
action or proceeding, the other Party agrees to be joined as a party plaintiff
if necessary to prosecute the action or proceeding and to give the first Party
reasonable assistance and authority to file and prosecute the suit. Any damages
or other monetary awards recovered pursuant to this Section 9.03(b) shall be
allocated first to the costs and expenses of the Party bringing suit, then to
the costs and expenses, if any, of the other Party. Such allocation of costs
and expenses shall be deducted first from compensatory damages and then from
punitive and exemplary damages. In the event that CTI brings such action, any
amounts remaining shall be distributed as follows: compensatory damages shall be
treated as Net Sales in the country and calendar quarter received and punitive
and exemplary damages shall be paid equally to CTI and PG-TXL. In the event
that PG-TXL brings such action, one hundred percent (100%) of any amounts
remaining shall be payable to PG-TXL.
18.
(c) Settlement with a Third Party. The Party that controls the
-----------------------------
prosecution of a given action shall also have the right to control settlement of
such action; provided, however, that if one Party controls, no settlement shall
-------- -------
be entered into without the written consent of the other Party (which consent
shall not be unreasonably withheld) if such settlement would materially and
adversely affect the interests of such other Party.
SECTION 9.04. Defense and Settlement of Third Party Claims. If a
--------------------------------------------
Third Party asserts that a patent, trademark or other intangible right owned by
it is infringed by any Licensed Products in the Territory, CTI will be solely
responsible for defending against any such assertions at its cost and expense.
The costs of any such settlement (including, without limitation, damages,
expense reimbursements, compliance, future royalties or other amounts) shall be
paid exclusively by CTI.
SECTION 9.05. Patent Expenses. CTI shall be obligated to pay all
---------------
worldwide Patent Expenses subject to the terms of this Agreement. CTI shall
promptly reimburse PG-TXL for all Patent Expenses undertaken by PG-TXL at CTI's
request subsequent to the execution of this Agreement.
SECTION 9.06. Trademarks. CTI shall be responsible for the
----------
selection, registration and maintenance of all trademarks which it employs in
connection with Licensed Products and shall own and control such trademarks (and
pay any costs in connection therewith). PG-TXL recognizes the exclusive
ownership by CTI of any proprietary CTI name, logotype or trademark furnished by
CTI (including CTI's Affiliates) for use in connection with Licensed Products.
PG-TXL shall not, either while this Agreement is in effect, or at any time
thereafter, register, use or attempt to obtain any right in or to any such name,
logotype or trademark or in and to any name, logotype or trademark confusingly
similar thereto.
ARTICLE X
REPRESENTATIONS AND WARRANTIES
------------------------------
SECTION 10.01. Representations and Warranties.
------------------------------
(a) Each of the Parties hereby represents and warrants to the other
Party that this Agreement is a legal and valid obligation binding upon such
Party and enforceable in accordance with its terms. The execution, delivery and
performance of the Agreement by such Party does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a party or by which
it is bound, nor violate any law or regulation of any court, governmental body
or administrative or other agency having jurisdiction over it.
(b) PG-TXL hereby represents and warrants to CTI as follows:
19.
(i) PG-TXL has not, and during the term of the Agreement
neither Party will, (x) grant any right to any Third Party relating to the
PG-TXL Patent Rights and to PG-TXL Know-How which would conflict with the
rights granted to either Party hereunder, and (y) to the best of its
knowledge neither Party is employing (as an employee or consultant) any
person that has been debarred by the FDA.
(ii) To the best of its knowledge PG-TXL is not obligated
under any agreement as of the Effective Date to pay any Third Party
royalties with respect to Licensed Products other than (A) royalties owed
by PG-TXL to MD Xxxxxxxx in accordance with the terms of the MD Xxxxxxxx
Release and (B) royalties owed by PG-TXL to the Licensors under the April
30 License. As of the Effective Date there are no such agreements in place
other than the agreements comprising the MD Xxxxxxxx Release and the April
30 License.
(iii) PG-TXL has given CTI access to all of its laboratory,
pre-clinical and clinical records and all other data generated by Third
Parties on behalf of PG-TXL regarding Licensed Products in existence as of
the Effective Date.
(iv) As of the Effective Date, except as it may have
previously disclosed to CTI in writing or otherwise, PG-TXL has not
received any notices of infringement or any written communications relating
in any way to a possible infringement with respect to any PG-TXL Patent
Rights.
(v) Neither PG-TXL nor any of its employees have
misappropriated any trade secrets with respect to the PG-TXL Know-How or
PG-TXL Patent Rights.
SECTION 10.02. Performance by Affiliates of CTI. PG-TXL recognizes
--------------------------------
that CTI may perform some or all of its obligations under this Agreement through
Affiliates, provided, however, that CTI shall remain responsible for and be a
-------- -------
guarantor of the performance by its Affiliates and shall cause its Affiliates to
comply with the provisions of this Agreement in connection with such
performance.
ARTICLE XI
INFORMATION AND REPORTS
-----------------------
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
SECTION 11.01. Records of Revenues and Expenses.
--------------------------------
(a) CTI will maintain complete and accurate records which are relevant
to revenues, costs, expenses and payments on a country-by-country basis under
this Agreement and such records shall be open during reasonable business hours
for a period of *****
20.
years from creation of individual records for examination at PG-TXL's expense
and not more often than once each year by a certified public accountant selected
by PG-TXL, or PG-TXL's internal accountants unless CTI reasonably objects to the
use of such internal accountants, for the sole purpose of verifying for PG-TXL
the correctness of calculations and classifications of such revenues, costs,
expenses or payments made under this Agreement. Each Party shall bear its own
costs related to such audit; provided that, for any underpayments greater than
--------
***** by CTI, CTI shall pay PG-TXL the amount of underpayment, interest as
provided for in Section 6.03 from the time the amount was due and PG-TXL's out-
of-pocket expenses. For any underpayments less than ***** by CTI found under
this Section 11.01, CTI shall pay PG-TXL the amount of underpayment. Any
overpayments by CTI will be refunded to CTI or credited to future royalties, at
CTI's election. Any records or accounting information received from the other
Party shall be Confidential Information for purposes of Article VIII. Results of
any such audit shall be provided to both Parties, subject to Article VIII.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission).
(b) If there is a dispute between the Parties following any audit
performed pursuant to Section 11.01(a), either Party may refer the issue (an
"Audit Disagreement") to an independent certified public accountant for
-------------------
resolution. In the event an Audit Disagreement is submitted for resolution by
either Party, the Parties shall comply with the following procedures:
(i) The Party submitting the Audit Disagreement for
resolution shall provide written notice to the other Party that it is
invoking the procedures of this Section 11.01(b).
(ii) Within thirty (30) business days of the giving of such
notice, the Parties shall jointly select a recognized international
accounting firm to act as an independent expert to resolve such Audit
Disagreement.
(iii) The Audit Disagreement submitted for resolution shall be
described by the Parties to the independent expert, which description may
be in written or oral form, within ten (10) business days of the selection
of such independent expert.
(iv) The independent expert shall render a decision on the
matter as soon as practicable.
(v) The decision of the independent expert shall be final
and binding unless such Audit Disagreement involves alleged fraud, breach
of this Agreement or construction or interpretation of any of the terms and
conditions hereof.
(vi) All fees and expenses of the independent expert,
including any third party support staff or other costs incurred with
respect to carrying out the procedures specified at the direction of the
independent expert in connection with such
21.
Audit Disagreement, shall be borne by CTI in the event that a discrepancy
of more than ***** results from such decision, and by the Parties equally
in all other cases.
SECTION 11.02. Use of Names. Neither Party shall use the name of the
------------
other Party in relation to this transaction in any public announcement, press
release or other public document without the written consent of such other
Party, which consent shall not be unreasonably withheld or delayed; provided,
--------
however, that either Party may use the name of the other Party in any document
-------
filed with any regulatory agency or authority, including the FDA and the
Securities and Exchange Commission. PG-TXL agrees not to use the name "CTI" in
relation to this transaction in any press release, public announcement or other
public document without the approval of CTI, which approval shall not be
unreasonably withheld or delayed.
ARTICLE XII
TERM AND TERMINATION
--------------------
SECTION 12.01. Term. This Agreement shall commence as of the
----
Effective Date and, unless sooner terminated as provided herein shall continue
in effect until no royalties are payable under Article VI hereunder to PG-TXL.
SECTION 12.02. Termination.
-----------
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
(a) Notwithstanding any other provision herein, CTI may terminate this
Agreement on a country-by-country basis or in its entirety (i) upon *****
days advance written notice to PG-TXL in the event issues regarding the safety
of Licensed Products arise during Development or clinical data obtained reveal a
materially adverse tolerability profile for Licensed Products in humans; or (ii)
for any reason upon ***** days advance written notice.
(b) Notwithstanding any other provision herein, either Party may
terminate this Agreement pursuant to Section 3.01, on a country-by-country basis
or in its entirety, if CTI shall fail to make any license fee payment as set
forth in Section 3.01.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
(c) Failure by CTI or PG-TXL to comply with any other of the
respective material obligations and conditions contained in this Agreement shall
entitle the other Party to give the Party in default notice requiring it to cure
such default. If such default is not cured within ***** days after
receipt of such notice, the notifying Party shall be entitled (without prejudice
to any of its other rights conferred on it by this Agreement) to terminate this
Agreement or in the event of an uncured material breach by PG-TXL, effect the
rights of CTI set forth in Section 12.02(e) by giving a notice to take effect
immediately. Notwithstanding the foregoing, in the event of a non-monetary
default, if the default is not
22.
reasonably capable of being cured within the ***** day cure period by the
defaulting Party and such defaulting Party is making a good faith effort to cure
such default, the notifying Party may not terminate this Agreement, provided,
--------
however, that the notifying Party may terminate this Agreement if such default
-------
is not cured within ***** days of such original notice of
default. The right of either Party to terminate this Agreement as hereinabove
provided shall not be affected in any way by its waiver of, or failure to take
action with respect to any previous default.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
(d) In the event that one of the Parties hereto shall go into
liquidation, a receiver or a trustee be appointed for the property or estate of
that Party and said receiver or trustee is not removed within ***** days,
or the Party makes an assignment for the benefit of creditors (collectively, a
"Bankruptcy Event"), and whether any of the aforesaid Bankruptcy Events be the
-----------------
outcome of the voluntary act of that Party, or otherwise, the other Party shall
be entitled to terminate this Agreement (or in the event PG-TXL suffers such a
Bankruptcy Event, CTI may effect its rights described in Section 12.02(e)
forthwith by giving a written notice to PG-TXL).
(e) In the event that this Agreement is terminated by CTI in one or
more countries or in its entirety in accordance with Section 12.02(a), and in
the event that the Agreement is terminated by either Party in its entirety in
accordance with Sections 12.02(b) or (c) hereof, CTI will with respect to each
country for which the termination applies entirely:
(i) deliver to PG-TXL the PG-TXL Know-How and assign to PG-
TXL CTI's rights in said PG-TXL Know-How and PG-TXL Patent Rights if any,
in either case relating solely to the country that is the subject of the
termination;
(ii) not commercialize a product incorporating the PG-TXL
Know-How in such country;
(iii) not infringe any of the PG-TXL Patent Rights in such
country;
(iv) make all payments accrued under this Agreement with
respect to such country prior to the effective termination date;
(v) transfer all regulatory filings and approvals related to
Licensed Products in such country to PG-TXL upon PG-TXL's written request
for same;
(vi) transfer to PG-TXL responsibility for and control of
ongoing work of CTI related to Licensed Products, Affiliates and Third
Parties in an expeditious and orderly manner with the costs for such work
assumed by PG-TXL as of the date of notice;
23.
(vii) reconvey to PG-TXL all rights to the trademark for
"PG-TXL" granted pursuant to Section 4.02; and
(viii) sell to PG-TXL, at any time within ninety (90) days of
such termination, at PG-TXL's election, all or any portion of the inventory
of Licensed Products owned by CTI or its Affiliates which are intended for
sale in such country at a price equal to CTI's or its Affiliate's cost
(which, if CTI is the manufacturing party, will be CTI's labor and material
cost without further markup) for such inventory. Such election shall be
made by PG-TXL in writing and within thirty (30) days of such election, CTI
shall ship at PG-TXL's cost and direction such inventory to PG-TXL. PG-TXL
shall pay for such inventory within forty-five (45) days of receipt of such
inventory.
(f) In the event of a Bankruptcy Event related to PG-TXL, CTI may
elect in lieu of terminating this Agreement to declare the license granted
pursuant to this Agreement to be irrevocable. From the date of receipt of
notice of such election, PG-TXL shall have no further rights or obligations
under this Agreement, except that PG-TXL may enforce any financial obligations
of CTI, including those arising under Articles III and VI herein before or after
such election.
(g) Except where expressly provided for otherwise in this Agreement,
termination of this Agreement shall not relieve the Parties hereto of any
liability, including any obligation to make payments hereunder, which accrued
hereunder prior to the effective date of such termination, nor preclude any
Party from pursuing all rights and remedies it may have hereunder or at law or
in equity with respect to any breach of this Agreement nor prejudice any Party's
right to obtain performance of any obligation.
SECTION 12.03. Surviving Rights. The rights and obligations set
----------------
forth in this Agreement shall extend beyond the term or termination of the
Agreement only to the extent expressly provided for herein, or the extent that
the survival of such rights or obligations are necessary to permit their
complete fulfillment or discharge.
ARTICLE XIII
INDEMNIFICATION
---------------
SECTION 13.01. Indemnification. With respect to Licensed Products
---------------
(determined on a country by country basis):
(a) Except as provided in Article 13.01(b), CTI hereby agrees to save,
defend and hold PG-TXL and its agents and employees harmless from and against
any and all suits, claims, actions, demands, liabilities, expenses and/or
losses, including reasonable legal expenses and attorneys' fees (collectively,
"Losses"), resulting from the commercial
-------
24.
sale of Licensed Products except to the extent such Losses result from the
negligence or willful misconduct of PG-TXL or the infringement by PG-TXL (due to
actions taken by PG-TXL prior to the Effective Date) of Third Party intellectual
property rights, in which case PG-TXL hereby agrees to save, defend and hold CTI
and its agents and employees harmless from any and all such Losses.
(b) Except as provided in Article 13.01(a), CTI and PG-TXL hereby
agree to save, defend and hold the other Party and its agents and employees
harmless from and against any and all Losses resulting directly from the
Development of Licensed Products to the extent such Development was performed by
such Party except to the extent such Losses result from the negligence or
willful misconduct of the other Party, in which case such Party hereby agrees to
save, defend and hold the other Party and its agents and employees harmless from
any and all such Losses.
(c) Each indemnified Party agrees to give the indemnifying Party
prompt written notice of any Loss or discovery of fact upon which such
indemnified Party intends to base a request for indemnification under Sections
13.01(a) or (b). Each Party shall furnish promptly to the other copies of all
papers and official documents received in respect of any Loss. With respect to
any Loss relating solely to the payment of money damages and which will not
result in the indemnified Party becoming subject to injunctive or other relief
or otherwise adversely affecting the business of the indemnified Party in any
manner, and as to which the indemnifying Party shall have acknowledged in
writing the obligation to indemnify the indemnified Party hereunder, the
indemnifying Party shall have the sole right to defend, settle or otherwise
dispose of such Loss, on such terms as the indemnifying Party, in its sole
discretion, shall deem appropriate. The indemnifying Party shall obtain the
written consent of the indemnified Party, which shall not be unreasonably
withheld or delayed, prior to ceasing to defend, settling or otherwise disposing
of any Loss if as a result thereof the indemnified Party would become subject to
injunctive or other equitable relief or any remedy other than the payment of
money, which payment would be the responsibility of the indemnifying Party. The
indemnifying Party shall not be liable for any settlement or other disposition
of a Loss by the indemnified Party which is reached without the written consent
of the indemnifying Party, which consent shall not be unreasonably withheld or
delayed. The reasonable costs and expenses, including reasonable fees and
disbursements of counsel incurred by any indemnified Party in connection with
any Loss, shall be reimbursed on a quarterly basis by the indemnifying Party,
without prejudice to the indemnifying Party's right to contest the indemnified
Party's right to indemnification and subject to refund in the event the
indemnifying Party is ultimately held not to be obligated to indemnify the
indemnified Party.
25.
ARTICLE XIV
APRIL 30 LICENSE; SECURITY INTEREST
SECTION 14.01. April 30 License.
----------------
(a) PG-TXL shall cause CTI to be added to Section 9.0(i)(ii) of the
April 30 License and thereby receive copies of all notices and communications
thereunder.
(b) PG-TXL shall not permit the April 30 License to be amended or
supplemented in any manner without CTI's prior written consent.
(c) At any time and from time to time, CTI, on behalf of PG-TXL may
make payments owed by PG-TXL to the April 30 Licensors under the April 30
License, directly to the April 30 Licensors.
(d) PG-TXL will comply in all respects with its obligations under the
April 30 License, and, in no event will PG-TXL make an election to reject the
April 30 License in connection with any bankruptcy, insolvency or similar
proceeding.
SECTION 14.02. Security Interest.
-----------------
(a) Grant of Security Interest. As security for the performance of
--------------------------
its obligations under this Agreement, PG-TXL hereby pledges, assigns, transfers,
hypothecates and sets over to CTI, and hereby grants to CTI a security interest
in, all of PG-TXL's right, title and interest in, to and under the April 30
License.
(b) PG-TXL Remains Liable. Anything herein to the contrary
---------------------
notwithstanding, (i) PG-TXL shall remain liable under the April 30 License, to
the extent set forth therein, to perform all of its duties and obligations
thereunder to the same extent as if this Agreement had not been executed, (ii)
the exercise by CTI of any of the rights hereunder shall not release PG-TXL from
any of its duties or obligations under the April 30 License, and (iii) CTI shall
not have any obligation or liability under the April 30 License by reason of
this Agreement, nor shall CTI be obligated to perform any of the obligations or
duties of PG-TXL thereunder or to take any action to collect or enforce the
April 30 License.
(c) Continuing PG-TXL Security Interest. PG-TXL agrees that this
-----------------------------------
Agreement shall create a continuing security interest in the April 30 License
which shall remain in effect until terminated in accordance with Article XII.
(d) Perfection. Within five (5) business days after execution of this
----------
Agreement, the parties shall file a financing statement covering this security
interest in the April 30 License substantially the form of Exhibit B hereto.
PG-TXL shall execute and deliver to CTI at any time and from time to time
thereafter, all continuation financing
26.
statements, termination statements, security agreements, documents of title,
affidavits, reports, notices, schedules of account, letters of authority and all
other documents and instruments, in form satisfactory to CTI, and take all other
action, as CTI may request, to perfect and continue perfected, maintain the
priority of or provide notice of the request, to perfect and continue perfected,
maintain the priority of or provide notice of CTI's security interest in the
April 30 License and to accomplish the purposes of this Agreement.
(e) Remedies. Under the terms of the security interest granted by PG-
--------
TXL to CTI pursuant to Section 14.02 and subject to Section 12.02(c), upon
default by PG-TXL in performance under this Agreement, CTI shall be entitled to
all of the rights and remedies (and be subject to the obligations of) a secured
creditor upon default as provided in Article 9 of the Texas Uniform Commercial
Code. Upon any foreclosure of such security interest, CTI shall owe no
fiduciary duties to the April 30 Licensors.
ARTICLE XV
MISCELLANEOUS
-------------
SECTION 15.01. Assignment.
----------
(a) CTI may assign any of its rights or obligations under this
Agreement in any country to any of its Affiliates or to any sublicensee as
provided in Section 4.01; provided, however, that such assignment shall not
-------- -------
relieve CTI of its responsibilities for performance of its obligations under
this Agreement.
(b) With the prior written consent of CTI, which shall not be
unreasonably withheld, PG-TXL may assign its right to receive license fee
payments under Section 3.01, milestone payments under Section 3.02, facilities
and administration expenses under Section 3.04 and royalty payments under
Section 6.01 to any of its Affiliates.
(c) Either Party may assign its rights or obligations under this
Agreement in connection with a merger or similar reorganization or the sale of
all or substantially all of its assets, or otherwise with the prior written
consent of the other Party. This Agreement shall survive any such merger or
reorganization of either Party with or into, or such sale of assets to, another
party and no consent for such merger, reorganization or sale shall be required
hereunder; provided, that in the event of such merger, reorganization or sale,
no intellectual property rights of the acquiring corporation shall be included
in the technology licensed hereunder.
(d) This Agreement shall be binding upon and inure to the benefit of
the successors and permitted assigns of the Parties. Any assignment not in
accordance with this Agreement shall be void.
27.
SECTION 15.02. Retained Rights. Nothing in this Agreement shall
---------------
limit in any respect the right of either Party to conduct research and
development and to market products using such Party's technology other than as
herein expressly provided.
SECTION 15.03. Force Majeure. Neither Party shall lose any rights
-------------
hereunder or be liable to the other Party for damages or losses on account of
failure of performance by the defaulting Party if the failure is occasioned by
government action, war, fire, explosion, flood, strike, lockout, embargo, act of
God, or any other cause beyond the control of the defaulting Party, provided
--------
that the Party claiming force majeure has extended all reasonable efforts to
avoid or remedy such force majeure, continues to employ such efforts and
promptly notifies the other Party of such force majeure event.
SECTION 15.04. Further Actions. Each Party agrees to execute,
---------------
acknowledge and deliver such further instruments, and to do all such other acts,
as may be necessary or appropriate in order to carry out the purposes and intent
of this Agreement.
SECTION 15.05. No Trademark Rights. Except as otherwise provided
-------------------
herein, no right, express or implied, is granted by the Agreement to use in any
manner the name "CTI," or any other trade name or trademark of the other Party
or its Affiliates in connection with the performance of the Agreement.
SECTION 15.06. Notices. All notices hereunder shall be in writing
-------
and shall be deemed given if delivered personally or by facsimile transmission
(receipt confirmed in writing by the receiving Party), telexed, mailed by
registered or certified mail (return receipt requested), postage prepaid, or
sent by express courier service, to the Parties at the following addresses (or
at such other address for a Party as shall be specified by like notice; provided
--------
that notices of a change of address shall be effective only upon receipt
thereof).
(a) If to PG-TXL:
PG-TXL Company, L.P.
0000 Xxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxx 00000
Attention: Xxxxxx Xxxxxxx, M.D.
With a copy to:
Mayor, Day, Xxxxxxxx & Xxxxxx, LLP
000 Xxxxxxxxx, Xxxxx 0000
Xxxxxxx, XX 00000-0000
Attention: Xxxx Xxxxxx
Telecopy: (000) 000-0000
28.
(b) If to CTI:
Cell Therapeutics, Inc.
000 Xxxxxxx Xxxxxx Xxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attn: Xxxxx X. Xxxxxx, M.D.
President and Chief Executive Officer
With a copy to:
Xxxxxxx, Xxxxxxx & Xxxxxxxx LLP
Xxx Xxxxxx
Xxxxx Xxxxxx Xxxxx
Xxx Xxxxxxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxx
Telecopy: (000) 000-0000
SECTION 15.07. Waiver. Except as specifically provided for herein,
------
the waiver from time to time by either of the Parties of any of their rights or
their failure to exercise any remedy shall not operate or be construed as a
continuing waiver of same or any other of such Party's rights or remedies
provided in this Agreement.
SECTION 15.08. Severability. If any term, covenant or condition of
------------
this Agreement or the application thereof to any Party or circumstances shall,
to any extent or in any country, be held to be invalid or unenforceable, then
(i) the remainder of this Agreement, or the application of such term, covenant
or condition to Parties or circumstances other than those as to which it is held
invalid or unenforceable, shall not be affected thereby and each term, covenant
or condition of this Agreement shall be valid and be enforced to the fullest
extent permitted by law; and (ii) the Parties hereto covenant and agree to
renegotiate any such term, covenant or application thereof in good faith in
order to provide a reasonably acceptable alternative to the term, covenant or
condition of this Agreement or the application thereof that is invalid or
unenforceable, it being the intent of the Parties that the basic purposes of
this Agreement are to be effectuated.
SECTION 15.09. Ambiguities. Ambiguities, if any, in this Agreement
-----------
shall not be construed against any Party, irrespective of which Party may be
deemed to have authored the ambiguous provision.
SECTION 15.10. Governing Law. This Agreement shall be governed by
-------------
and interpreted under the laws of the State of New York as applied to contracts
entered into and performed entirely in New York by New York residents.
SECTION 15.11. Arbitration. The parties shall submit any dispute
-----------
concerning this interpretation of or the enforcement of rights and duties under
this Agreement to final
29.
and binding arbitration pursuant to the American Arbitration Association. At
the request of any party, the arbitrators, attorneys, parties to the
arbitration, witnesses, experts, court reports, or other persons present at the
arbitration shall agree in writing to maintain the strict confidentiality of the
arbitration proceedings. Arbitration shall be conducted by a single, neutral
arbitrator, or, at the election of any party, three neutral arbitrators,
appointed in accordance with the Commercial Arbitration Rules of the American
Arbitration Association in the City of Phoenix, Arizona. The award of the
arbitrator(s) shall be enforceable according to the applicable provisions of the
Arizona Code of Civil Procedure. The arbitrator(s) may award damages and/or
permanent injunctive relief, but in no event shall the arbitrator(s) have the
authority to award punitive or exemplary damages. Notwithstanding the
foregoing, a party may apply to a court of competent jurisdiction for relief in
the form of a temporary restraining order or preliminary injunction, or other
provisional remedy pending final determination of a claim through arbitration in
accordance with the paragraph. If proper notice of any hearing has been given,
the arbitrator(s) will have full power to proceed to take evidence or to perform
any other acts necessary to arbitrate the matter in the absence of any party who
fails to appear.
SECTION 15.12. Headings. The sections and paragraph headings
--------
contained herein are for the purposes of convenience only and are not intended
to define or limit the contents of said sections or paragraphs.
SECTION 15.13. Counterparts. This Agreement may be executed in one
------------
or more counterparts (and by facsimile), each of which shall be deemed an
original, but all of which together shall constitute one and the same
instrument.
SECTION 15.14. Entire Agreement; Amendments. This Agreement,
---------------- ----------
including all Exhibits attached hereto and thereto, and all documents delivered
concurrently herewith and therewith, set forth all the covenants, promises,
agreements, warranties, representations, conditions and understandings between
the Parties hereto and supersede and terminate all prior agreements and
understandings between the Parties. There are no covenants, promises,
agreements, warranties, representations, conditions or understandings, either
oral or written, between the Parties other than as set forth herein and therein.
No subsequent alteration, amendment, change or addition to this Agreement shall
be binding upon the Parties hereto unless reduced to writing and signed by the
respective authorized officers of the Parties. This Agreement, including
without limitation the exhibits, schedules and attachments thereto, are intended
to define the full extent of the legally enforceable undertakings of the Parties
hereto, and no promise or representation, written or oral, which is not set
forth explicitly is intended by either party to be legally binding. Both
Parties acknowledge that in deciding to enter into the Agreement and to
consummate the transaction contemplated thereby neither has relied upon any
statement or representations, written or oral, other than those explicitly set
forth therein.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
SECTION 15.15. Expenses. Except as otherwise specified in this
--------
Agreement, all costs and expenses, including, without limitation, fees and
disbursements of counsel,
30.
financial advisors and accountants, incurred in connection with this Agreement
and the transactions contemplated hereby shall be paid by the party incurring
such costs and expenses; provided, however, that upon execution of this
-------- -------
Agreement, CTI shall pay PG-TXL a one-time expense reimbursement in the amount
of ***** to cover historical legal expenses incurred by PG-TXL and the Initial
Royalty (as defined in the April 30 License) payable by PG-TXL under the April
30 License.
SECTION 15.16. Independent Contractors. The status of the Parties
-----------------------
under this Agreement shall be that of independent contractors. Neither Party
shall have the right to enter into any agreements on behalf of the other Party,
nor shall it represent to any person that it has any such right or authority.
Nothing in this Agreement shall be construed as establishing a partnership or
joint venture relationship between the Parties.
IN WITNESS WHEREOF, PG-TXL and CTI have caused this Agreement to be
executed as of the date first written above by their respective officers
thereunto duly authorized.
PG-TXL COMPANY, L.P.
By: Fem.CADeT Incorporated, its General
Partner
By:
------------------------------------------
Name: Xxxxxx Xxxxxxx, M.D.
Title: President
CELL THERAPEUTICS, INC.
By:
------------------------------------------
Name: Xxxxx X. Xxxxxx, M.D.
Title: President and Chief Executive Officer
31.
EXHIBIT A
PG-TXL PATENT RIGHTS
--------------------
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
(1) U.S. Patent Application No. *****, filed March 11, 1997 which is a
converted utility patent application from Provisional Application No. 60/013184,
filed with the United States Patent and Trademark Office on March 12, 1996;
(2) Intn'l Patent Application No. *****, filed March 11, 1997; and
(3) U.S. Patent Application No. *****, filed March 30, 1998.
32.
EXHIBIT B
FORM OF FINANCING STATEMENT FOR APRIL 30 LICENSE
------------------------------------------------
33.
