EXHIBIT 10.35
Confidential treatment requested.
Confidential portions indicated by "[*****]"
have been omitted and filed separately
with the Securities and Exchange Commission.
LICENSE AGREEMENT
This LICENSE AGREEMENT (the "Agreement") is made this 12th day of
September, 2003 (the "Effective Date"), by and between Vion Pharmaceuticals,
Inc., a corporation organized and existing under the laws of the State of
Delaware and having its principal place of business at 0 Xxxxxxx Xxxx, Xxx
Xxxxx, Xxxxxxxxxxx 00000 ("VION"), and Beijing Xxxxx Pharmaceuticals, Inc., a
corporation organized and existing under the laws of the People's Republic of
China and having its registered office at 0 Xx Xxx Xxx Xxx Xxxxxx, Xxxxxxx
000000, P R China ("XXXXX").
RECITALS
WHEREAS, VION has developed or licensed the Inventions and the Vion
Research (each as defined below) resulting in a number of issued patents and
pending patent applications with respect thereto throughout the world, as set
forth in Exhibit E hereto, and publications as set forth on Exhibit F hereto;
WHEREAS, XXXXX desires to obtain a license to the Inventions and Vion
Research for the purpose of further development and commercialization of the
Products (as defined below) for use in the Field (as defined below);
WHEREAS, XXXXX anticipates that it will engage in all development
activities hereunder itself, and may engage in commercialization activities
hereunder through its wholly-owned subsidiary, Maxwin Pason Pharmaceuticals,
Inc. ("MAXWIN"); and
WHEREAS, VION is willing to grant such a license to XXXXX.
NOW, THEREFORE, in consideration of the premises and the terms set
forth herein, and for other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties (as defined below)
hereto, intending to be legally bound, hereby covenant and agree as follows:
ARTICLE 1
DEFINITIONS
1.1 Definitions. In addition to the terms defined elsewhere in this
Agreement, the following terms have the meanings indicated.
(a) "Affiliate" of any specified Person means any other Person
directly or indirectly controlling or controlled by or under direct or indirect
common control with such specified Person. For purposes hereof, "control" when
used with respect to any specified Person means the power to direct the
management and policies of such Person, directly or indirectly, whether through
the ownership of voting securities, by contract or otherwise; and the terms
"controlling" and "controlled" have correlative meanings.
(b) "Business Day" shall mean any day other than a Saturday, a
Sunday or a day on which commercial banks in the City of New York or Beijing are
authorized or required by law to close.
(c) "Earned Royalties" shall mean the royalties paid or
payable by XXXXX pursuant to Article 4.
(d) "Effective Date" shall be the date set forth in the first
paragraph of this Agreement.
(e) "Field" shall mean the treatment and/or prevention of
cancer, as well as viral infections.
(f) "Inventions" shall mean the inventions, the titles of
which are listed on Exhibit A.
(g) "Market Exclusivity" shall mean, with respect to the
Territory, that at least one of the following conditions exists: (i) one or more
Vion Licensed Patents is being prosecuted; (ii) one or more Vion Licensed
Patents has been issued and a Patent Lapse has not occurred with respect to all
such issued Vion Licensed Patents; (iii) "orphan drug" status or a similar
designation has been granted within the Territory with respect to one or more
Products and has not expired; or (iv) trademark, trade name, trade secret or
other similar protection exists with respect to one or more Products within the
Territory.
(h) "Net Sales," for purposes of computing Earned Royalties,
shall mean the gross sales in local currencies of all Products sold in the
Territory by XXXXX, its Affiliates and/or sublicensees to any third party, less
(i) actual credited allowances to such third party for spoiled, damaged,
outdated and returned Products and for retroactive price reductions; and (ii)
all invoiced transportation and handling charges, sales taxes, excise taxes and
use taxes actually paid by XXXXX (other than such taxes, if any, that would be
imposed on VION in accordance with the tax laws of the Territory). Such
deductions shall not include any amount related to bad debt. Where (i) a Product
is sold as one of a number of items (i.e., in a bundled transaction) without a
separate price; or (ii) the consideration for the Products includes any non-cash
element; or (iii) the Products are transferred in any manner other than an
invoiced sale, the Net Sales applicable to the quantity of Products of any such
transaction shall be deemed to be the average Net Sales for all other
transactions of Products at that time in the Territory. If a Product is "given
away" for no cash consideration or for a price reflecting a discount, in each
case, without the prior consent of VION, which consent shall not be unreasonably
withheld for normal and customary practices, Net Sales shall include an amount
equal to the list price of such Products "given away" or discounted. In order to
ensure that VION receives the full amount of Earned
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Royalties contemplated in this Agreement, XXXXX agrees that in the event any
Products shall be sold for purposes of resale either (i) to a corporation, firm,
or association that, or individual who, owns a controlling interest in XXXXX by
stock ownership or otherwise, or (ii) to a corporation, firm, or association in
which XXXXX or its stockholders own a controlling interest by stock ownership or
otherwise, the Earned Royalties to be paid in respect to such Products shall be
computed on the net selling price at which the purchaser for resale sells such
Products rather than on the net selling price of XXXXX.
(i) "Party" or "Parties" shall mean VION and/or XXXXX as
appropriate.
(j) "Patent Lapse" shall mean, with respect to any Vion
Licensed Patent that has issued in the Territory, the lapse of such Vion
Licensed Patent in the Territory or the declaration by a final, non-appealable
decision of a court or other tribunal of competent jurisdiction of the Territory
that all of the claims of such Vion Licensed Patent are invalid, through no
fault or cause of XXXXX (the failure to initiate or continue legal action, as
contemplated by Section 10.1, shall not be the basis of fault or cause by
XXXXX).
(k) "Person" shall mean and include any individual,
corporation, partnership, joint venture, trust, unincorporated organization,
university, college, government or any agency or political subdivision thereof,
or any other entity.
(l) "Products" shall mean all products (whether anti-cancer or
anti-viral) that may derive from or are related to, or which result from, the
manufacture and production or use of Vion Research, Inventions or a claim of the
Vion Licensed Patents, including, any pro drugs, metabolites, salts and
derivatives, and pharmaceutical preparations thereof; for all present and future
uses and indications.
(m) "Quarter Year" shall mean the three month periods ending
March 31, June 30, September 30 and December 31 of each Royalty Year.
(n) "Regulatory Approval" shall mean the applicable technical,
medical and scientific licenses, registrations, authorizations or approvals
(including, without limitation, supplements, amendments, pre- and
post-approvals, pricing and third party reimbursement approvals; marketing
authorizations based upon such approvals, including any prerequisite
manufacturing approvals or authorizations related thereto and labeling
approval(s)), of any national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity, necessary
for, as the context requires, the use, development, manufacture, distribution,
marketing, promotion, offer for sale, or sale of the Products in the Territory
or any part thereof.
(o) "Royalty Year" shall mean each twelve (12) month period
commencing January 1 and ending December 31 during the term of this Agreement.
The first Royalty Year shall be the period of time between the Effective Date
and December 31, 2003.
(p) "Territory" shall mean the Mainland of the People's
Republic of China ("PRC"), Hong Kong, Macao and Taiwan.
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(q) "Vion Licensed Patents" shall mean the patent
application(s) filed, and patent(s) owned, in whole or in part, by VION in the
Territory, which are listed on Exhibit B, together with any divisionals thereof,
any patents issuing from such applications and any extensions of any patents
licensed to XXXXX hereunder.
(r) "Vion Research" shall mean the research described on
Exhibit C.
1.2 Interpretation. (a) Words in the singular shall be held to include
the plural and vice versa and words of one gender shall be held to include the
other genders as the context requires, (b) the terms "hereof", "herein" and
"herewith" and words of similar import shall, unless otherwise stated, be
construed to refer to this Agreement and not to any particular provision of this
Agreement, and Article, Section, paragraph, clause, Exhibit and Appendix
references are to the Articles, Sections, paragraphs, clauses, Exhibits and
Appendixes to this Agreement unless otherwise specified, and (c) the word
"including" and words of similar import when used in this Agreement shall mean
"including, without limitation", unless otherwise specified.
ARTICLE 2
LICENSE AND SUBLICENSE
2.1 Licensed Rights. Subject to all applicable laws of the Territory
and all of the terms and conditions of this Agreement and effective as of the
Effective Date, VION hereby grants to XXXXX a non-transferable, royalty-bearing,
exclusive (subject to the other provisions of this Article 2) license under the
Vion Licensed Patents and Vion Research, for the term set forth in Article 3, to
use, develop, make, have made, market, sell and distribute the Products in the
Territory for the use in the Field. During the term of this Agreement, VION
shall not authorize any third party to manufacture, offer to sell, sell, import
the Products, or prosecute the Inventions, Vion Licensed Patents, and Vion
Research, for production and business purposes, in the Territory in violation of
XXXXX'x rights hereunder.
2.2 Right to Sublicense. VION hereby grants XXXXX the right to
sublicense any or all of XXXXX'x rights granted hereunder to non-Affiliated
third parties in the Territory, subject to the general terms and conditions of
this Agreement, including those set forth in Article 15 below.
2.3 Retained Rights. VION retains all rights to grant licenses under
the Vion Licensed Patents and Vion Research for the use, development,
manufacture, sale, marketing and distribution of the Products for any use in all
countries and territories outside the Territory, and for any use outside the
Field in the Territory.
ARTICLE 3
TERM OF LICENSE
3.1 Term. Subject to earlier termination in accordance with the terms
hereof, the term of the license and sublicense granted hereunder shall commence
on the Effective Date and shall expire (and Earned Royalties will no longer be
payable, subject to Section 6.3), at the latest
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to occur of (i) December 31, 2025, (ii) the date when Market Exclusivity no
longer exists in the Territory, and (iii) twenty (20) years after the date of
the first sale of any Product under this Agreement which results in Net Sales
under which a Earned Royalties (as defined below) become due and owing.
ARTICLE 4
CONSIDERATION
4.1 Initial Payment. XXXXX shall make a non-refundable payment of five
hundred thousand dollars ($500,000)[*****] (the "Initial Payment"), to Vion upon
the execution and delivery of this Agreement in accordance with the terms of
Section 4.3.
4.2 Milestone Payments. XXXXX shall make non-refundable milestone
payments (the "Milestone Payments") to Vion in the amounts specified below upon
the successful completion of the corresponding milestone events (the "Milestone
Events") designated below; provided that each such Milestone Payment shall be
due only with respect to the first occurrence of the noted Milestone Event in
connection with the first Product for which the Milestone Event occurs, in
accordance with the terms of Section 4.3:
(a) [*****] dollars ($[*****])[*****] upon the receipt of
Regulatory Approval to conduct clinical trials of a Product in the Territory;
(b) [*****] dollars ($[*****])[*****] upon the receipt of
Regulatory Approval to manufacture a Product in the Territory relating to cancer
therapy; and
(c) [*****] dollars ($[*****])[*****] upon the one-year
anniversary of the date of the first sale of any Product relating to cancer
therapy under this Agreement which results in Net Sales under which Earned
Royalties become due and owing;
(d) [*****] dollars ($[*****])[*****] upon the receipt of
Regulatory Approval to conduct clinical trials of a Product related to antiviral
therapy in the Territory; and
(e) [*****] dollars ($[*****])[*****] upon the one-year
anniversary of the date of the first sale of any Product under this Agreement
relating to anti-viral therapy, which result in Net Sales under which Earned
Royalties become due and owing.
4.3 Payment Terms. All payments payable under Sections 4.1 and 4.2
above shall be paid in United States dollars by wire transfer to an account
designated by VION. XXXXX shall pay the Initial Payment simultaneously with the
execution and delivery of this Agreement and shall pay the Milestone Payments
within ten days after the occurrence of the relevant Milestone Event.
4.4 Earned Royalties. In addition to the Initial Payment and the
Milestone Payments set forth above, XXXXX will pay to VION during the term of
this Agreement a royalty of eleven percent (11%) of Net Sales of the Products in
the Territory ("Earned Royalties"). Vion shall be responsible for all taxes, if
any, imposed on VION with respect to Earned Royalties in
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accordance with the tax laws of the relevant country in the Territory where the
Earned Royalties were generated.
ARTICLE 5
PREVIOUS RESEARCH DATA AND TECHNICAL SUPPORT
5.1 Within 5 days after executing the license agreement, Vion will
transfer all material documents relevant to the Product and the matters
contemplated by this Agreement to XXXXX including pre-clinical and clinical
research data, results, references papers, etc., as set forth on Exhibit X.
XXXXX will acknowledge receiving these documents by signing and returning the
attached receipt to Vion.
5.2 Vion will provide reasonable technical support and consultation
during the term of this AGREEMENT (which is understood to mean advice and
provision of knowledge and information, but not preclinical or clinical research
or testing). Unless otherwise agreed by the parties, such technical support and
consultation shall not involve travel to the Territory more than once per year,
or two times per year during the period of preparing and filing new drug
applications in the Territory. Any such visits shall be at the request of XXXXX
and shall be subject to VION's agreement that such visit is necessary. Issues
regarding technical support relating to the AGREEMENT shall be discussed
annually at a meeting between VION and XXXXX, which will take place, unless
otherwise agreed by the parties, in alternate years, in the United States and
the Territory, with the first such annual meeting taking place in the United
States. Each party will be responsible for its own expenses in attending these
annual meetings.
ARTICLE 6
PAYMENTS AND REPORTS
6.1 Payments and Sales Reports. Within thirty (30) days after the end
of each Quarter Year during the term of this Agreement, XXXXX shall furnish to
VION a written report setting forth the Net Sales of the Products during such
Quarter Year, as well as year to date in the Royalty Year, and the Earned
Royalties paid or payable thereon, accompanied by full payment in United States
dollars of any unpaid Earned Royalties by wire transfer to an account designated
by VION. In the event that a foreign currency is required to be converted in
calculating a payment of Earned Royalties hereunder, the exchange rate used
shall be the rate in effect at the end of the last Business Day of the month
just prior to the date payment is required to be made hereunder, as published in
The Wall Street Journal, Eastern Edition. The final sales report and the
associated payment shall be made within sixty (60) days after the effective date
of the termination of this Agreement and shall include any Earned Royalties due
for sales of the Products through the date of termination. The reports required
by this Section 6.1 shall be certified by the chief financial officer of XXXXX
to be correct to the best of XXXXX'x knowledge and information.
6.2 Status Reports. XXXXX shall provide periodic status reports to
VION, at least once during each Quarter Year and at any time upon the reasonable
request of VION, indicating
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progress to date in development, commercialization and sale of the Products, and
a forecast and schedule of major events required to develop and commercialize
the Products.
6.3 Final Report. Data Sharing and Notification. During the term of
this Agreement, XXXXX shall (a) provide VION with written summaries of all
pre-clinical and clinical data generated by or for XXXXX with respect to the
Products, (b) provide VION with copies of all proposed filings with regulatory
agencies with respect to the Products and the Vion Licensed Patents, including
filings in connection with seeking Regulatory Approval, at least ten days prior
to the making of any such filing (c) provide VION with copies of all proposed
protocols for human clinical trials, and (d) notify VION within five days of
receipt of any Regulatory Approval. Further, upon VION's request, XXXXX shall
provide VION with its clinical and pre-clinical data with respect to the
Products in such detail, to the extent available, as shall be necessary to allow
VION to develop the Products for sale outside the Territory.
6.4 Regulatory Filing Review. VION shall have the right to review and
comment on, and the parties shall cooperate in good faith with respect to, the
contents of any proposed filing referred to in Section 6.3(b) above.
ARTICLE 7
BOOKS AND RECORDS
7.1 Maintenance of Books and Records. XXXXX and its sublicensees shall
keep and maintain complete and accurate records and books of account in
sufficient detail and form so as to enable verification of Earned Royalties
payable by XXXXX hereunder. Such records and books of account shall be
maintained for a period of no less than five (5) years following the Royalty
Year to which they pertain. XXXXX shall permit such records and books of account
to be examined by VION or VION's duly appointed agent, to the extent necessary
for VION to verify the amount of Earned Royalties payable. VION will advise
XXXXX of the background and business qualifications of any such agent. Such
examination shall be at VION's expense, during normal business hours, and upon
five (5) days' prior written notice to XXXXX; provided, that if any such
examination reveals an underpayment of Earned Royalties in excess of one and
one-half percent (1.5%) for any Quarter Year, XXXXX shall bear the reasonable
costs and expenses of the examination. XXXXX shall pay VION the amount of any
underpayment of Earned Royalties revealed by an examination of the books and
records, together with interest thereon from the date such payment should have
been made at a rate per annum equal to the prime rate in effect as of the date
such payment should have been made, as published in The Wall Street Journal,
Eastern Edition (together with the costs of such examination if required
pursuant to the preceding sentence), by wire transfer of United States dollars
within fifteen (15) days of VION's submission of an invoice therefor.
7.2 Confidentiality of Records. The Parties agree that all information
subject to review under this Article 7 or under any sublicense agreement is
"Confidential Information" (as defined below) and shall be subject to the
provisions of Article 14.
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ARTICLE 8
PATENT PROTECTION
8.1 Patents. VION, at its expense, shall file, prosecute and do all
such acts and things as it, in its sole discretion, deems reasonably necessary
or appropriate to obtain issued patents in the Territory with respect to the
patent applications which are included in the Vion Licensed Patents. Nothing
herein shall be construed as requiring VION to litigate against any third party
to obtain any patent rights. Without limiting the foregoing, VION shall have
substantive control of and responsibility for direct prosecution of such patent
applications, including the selection and engagement of patent counsel, and it
shall keep XXXXX fully informed of the progress of such patent applications, by
means of a written report delivered every six months, and shall give XXXXX a
reasonable opportunity to comment on the type and scope of useful claims and the
nature of supporting disclosure.
8.2 Improvements. If XXXXX (or any sublicensee) develops any inventions
or improvements relating to the Inventions ("Improvements"), XXXXX shall
immediately notify VION in writing describing the Improvements. If XXXXX (or any
sublicensee) determines not to seek patent protection for any such Improvement,
XXXXX shall advise VION of this in writing promptly, and shall offer VION the
right to seek patent protection therefor. The Party seeking patent protection
for any Improvements hereunder: (i) shall be responsible for all costs of
prosecution and maintenance thereof, including without limitation attorney's
fees, taxes, working fees, maintenance fees and renewal and extension charges,
and shall pay such costs directly, (ii) shall have substantive control of and
responsibility for direct prosecution of patent applications, including the
selection and engagement of patent counsel, and (iii) shall keep the other Party
fully informed of the progress of such patent applications and shall give the
other Party a reasonable opportunity to comment on the type and scope of useful
claims and the nature of supporting disclosure. Any Improvements shall remain
the property of XXXXX (or its sublicensee); provided, that VION shall have a
worldwide, exclusive (except for XXXXX or its sublicensee in the Territory),
perpetual license to such Improvements, with royalties under the license to be
negotiated by the Parties in good faith, but in no event shall such royalties
exceed five percent (5%) of Net Sales. If VION obtains patent protection for
any Improvements, Vion shall have a worldwide, exclusive (except for XXXXX or
its sublicensee in the Territory), royalty free, perpetual license to such
Improvements and such Improvements shall be deemed VION Licensed Patents
hereunder. In accordance with Section 19.5 hereof, XXXXX shall, and shall cause
its Affiliates to, execute such instruments of assignment and other documents as
shall be reasonably necessary to assign the Improvements in accordance with, and
accomplish the purposes of, the foregoing paragraph.
8.3 Liability. A Party directing prosecution pursuant to this Article 8
shall have no liability to the other Party for damages, whether direct,
indirect, incidental, consequential or otherwise, arising or allegedly arising
from its good faith decisions, actions and omissions in connection with
prosecution of a patent or patent application.
8.4 Notices. XXXXX shall apply, and shall require its sublicensees to
apply to the Products, the patent marking notices required by the law of the
Territory, to the extent feasible and practical, and in accordance with the
applicable patent laws of the Territory.
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ARTICLE 9
COMMERCIALIZATION
9.1 Responsibility and Costs. From and after the Effective Date except
as set forth in Sections 8.1 and 8.2, all development costs, including those
incurred in connection with obtaining Regulatory Approval, clinical trials,
manufacturing, supply and commercialization, with respect to the Products in the
Territory will be borne by XXXXX, which will have the right to decide, in its
sole discretion (but subject to Sections 9.2 and 11.1(b)) which of the ongoing
trials in the Territory should be completed or stopped.
9.2 Obligations. XXXXX (by itself or through its Affiliates or
sublicensees) shall, at its expense, plan and implement appropriate research and
development, testing and production efforts directed toward commercialization of
the Products at the earliest practicable date consistent with sound scientific
and business judgment, and shall provide VION with a copy of such plan within
forty-five (45) days after the date hereof and any updates to the plan at least
twice during each Royalty Year. VION shall be entitled to terminate this
Agreement in accordance with Article 11 hereof if XXXXX fails to (i) initiate
clinical trials of a Product within two (2) years of the Effective Date and (ii)
obtain Regulatory Approval to manufacture and market a Product for the use in
the Field in the Territory within five (5) years from the Effective Date. VION
shall provide to XXXXX, at XXXXX'x cost and expense, a reasonable amount of
TRIAPINE for use by XXXXX as samples in meeting XXXXX'x obligations to conduct
clinical trials under this Agreement. VION agrees to ship up to 1600 vials of
TRIAPINE, with 100 vials to be delivered as soon as practicable promptly after
the signing of this Agreement and the remaining vials to be delivered according
to a delivery schedule to be agreed upon by the Parties based on VION's
production schedule for additional product, and up to 300 TRIAPINE tablets to
XXXXX for use in preclinical studies, in each case free of charge.
9.3 Trademarks. VION is simultaneously herewith granting to XXXXX a
non-exclusive, royalty free, worldwide license to the trademark TRIAPINE for the
use in the commercialization of the Products in the Field in the Territory in
accordance with this Agreement. Such right and license shall terminate
immediately upon termination of this Agreement for any reason. Any use by XXXXX
of the trademark TRIAPINE, whether in press releases, marketing, advertising,
packaging or other materials, shall be subject to VION's prior review and
approval. XXXXX'x use of the trademark TRIAPINE shall be in accordance with this
Section 9.3 and with VION's policies regarding trademark usage as established
from time to time by VION at its discretion and communicated to XXXXX. XXXXX
understands and agrees that its use of the trademark TRIAPINE in connection with
this Agreement shall not create any right, title or interest in or to the
trademark TRIAPINE and that all such use and goodwill associated with the
trademark TRIAPINE will inure to the benefit of VION and its licensors. XXXXX
shall not make use of the trademark TRIAPINE except as specifically provided for
in this Agreement or as authorized in writing by VION prior to such use.
9.4 Registration. XXXXX shall be responsible to register this Agreement
with relevant governmental authorities in the Territory in accordance with the
laws and regulations of the Territory, including:
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(a) recording the trademark license granted under this
Agreement with the China Trademark Office within 3 months after the Effective
Date of this Agreement. The record fee shall be borne by XXXXX;
(b) recording this Agreement with the China Intellectual
Property Office within 3 months after the Effective Date of this Agreement. The
record fee shall be borne by XXXXX; and
(c) registering this Agreement with the Ministry of Foreign
Trade and Economic Co-operation ("MOFTEC") or its successor within 30 days after
Effective Date of this Agreement to obtain a valid Technology Import Contract
Registration Certificate. The registration fee shall be borne by XXXXX.
9.5 Taxes. All taxes in the Territory imposed on VION with respect to
the Initial Payment and the Milestone Payments in accordance with any tax laws
of the Territory shall be borne by XXXXX, and VION should pay the taxes imposed
on VION in the Territory with respect to its Earned Royalties. All other taxes
imposed on VION (i.e., outside the Territory) in connection with payments made
to VION under this Agreement shall be borne by VION.
9.6 Cooperation. The parties may, upon mutual agreement, co-operate
with each other with respect to the development of other products utilizing VION
technology, and XXXXX shall reasonably cooperate, and may collaborate, with VION
upon VION's reasonable request, with respect to pre-clinical and the clinical
trials for other VION products. To the extent necessary, the parties will
negotiate in good faith the terms of any such cooperation or collaboration.
ARTICLE 10
INFRINGEMENT AND LITIGATION
10.1 Obligation to Defend. (a) Each Party shall promptly notify the
other in writing of any alleged or threatened infringement of any Vion Licensed
Patent in the Territory of which such Party becomes aware. VION shall have the
right to defend the Vion Licensed Patents against infringement or interference
by other parties in the Territory, including by bringing any legal action for
infringement or defending any counterclaim of invalidity or action of a third
party for declaratory judgment of non-infringement or interference; provided,
however, that XXXXX shall be entitled in each instance to participate through
counsel of its selection and at its own expense. In the event VION determines
not to initiate and pursue or participate in such legal action, XXXXX may
initiate legal action to uphold the Vion Licensed Patents against third parties
in the Territory. The parties will cooperate in good faith with respect to any
such action. Any settlement of any such action shall require VION's prior
written approval which may be granted or withheld in VION's sole discretion. The
Parties shall be entitled to deduct their respective costs and expenses incurred
in connection with prosecuting or participating in such lawsuit from any damages
that are awarded. Any remaining damage award in litigation prosecuted by XXXXX
shall be considered Net Sales and shall be subject to the royalty obligation
under this Agreement and any remaining damage award in litigation prosecuted by
VION shall be retained by VION.
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(b) Each Party shall promptly notify the other in writing in
the event that a third party shall bring a claim or action of infringement
against XXXXX or VION in the Territory. VION shall have the right to defend, at
its own expense, any such third party claim or action and to settle or
compromise the same in such manner as it shall see fit, provided, that VION
shall consult with XXXXX as to any such settlement or compromise. XXXXX may
participate in such litigation or claim on its behalf at its own expense. If
VION elects not to defend against such claim and not to obtain a license to
permit XXXXX to exercise its license or sublicense free of such claim, then
XXXXX may, in its own name and at its sole expense, defend such claim and may
compromise, settle or otherwise pursue such defense in such a manner and on such
terms as XXXXX shall see fit.
ARTICLE 11
TERMINATION
11.1 Termination by VION. VION may terminate this Agreement:
(a) upon ten (10) days' written notice to XXXXX if XXXXX fails
to make any payment hereunder when due and such failure has not been cured
during such ten (10) day period; or
(b) upon thirty (30) days' written notice to XXXXX if XXXXX
materially breaches or fails to meet any of its obligations under this Agreement
(other than a breach covered by clause (a) above), including without limitation,
failure of XXXXX to meet any of its obligations under Section 9.2 hereof, and
such breach (or failure) has not been cured (if capable of being cured) during
such thirty (30) day period.
11.2 Termination by XXXXX. XXXXX may terminate this Agreement upon
thirty (30) days' written notice to VION if VION materially breaches any of its
obligations under this Agreement and such breach has not been cured (if capable
of being cured) during such thirty (30) day period.
11.3 Termination by Operation of Law. This Agreement shall terminate
automatically (a) upon declaration, if any, of a court or other tribunal of
competent jurisdiction of the Territory by a final, non-appealable decision that
the sale of Products contemplated by this Agreement infringes or violates any
patent rights of third parties, which would have a material adverse effect on
the license conveyed under this Agreement or (b) if, at any time during the term
of this Agreement, XXXXX becomes insolvent or a petition in bankruptcy is filed
against XXXXX and is consented to, acquiesced in or remains undismissed for
ninety (90) days; or makes a general assignment for the benefit of creditors, or
a receiver is appointed for XXXXX.
11.4 Effect of Termination. Upon the complete expiration or termination
of this Agreement, the rights and obligations of the Parties shall cease, except
as follows:
(a) The obligations of confidentiality set forth in Article 14
shall survive for the period provided therein.
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(b) XXXXX'x obligation to pay Earned Royalties and Milestone
Payments pursuant to Article 4 and its obligation to keep books and records and
to submit such books and records to an examination will survive.
(c) The rights provided in this Article 11 shall be in
addition and without prejudice to any other rights which the Parties may have
with respect to any breach or violation of the provisions hereof.
(d) The expiration or termination of this Agreement shall not
affect any rights or obligations accrued prior to the effective date of such
expiration or termination, specifically including XXXXX'x obligation to pay
Earned Royalties as specified in Article 4.
11.5 Inventory. If existing inventory of the Products which had been
manufactured but not sold up to the date of termination exceeds a thirty (30)
day supply (based on Product sales in the prior Royalty Year, or forecasted
sales if there were no Product sales in the prior Royalty Year), XXXXX shall
offer to sell the inventory to VION at cost (to be negotiated by the parties in
good faith). If such inventory of the Products does not exceed a thirty (30) day
supply and VION declines to purchase the inventory from XXXXX at cost or the
parties cannot agree on the cost of the inventory within thirty (30) days from
the effective date of the termination of this Agreement, XXXXX shall destroy all
such inventory at its own expense and certify to VION as to its destruction.
11.6 Return of All Data. XXXXX will return to VION all information,
data, know-how and improvements on the Products received from VION. Information,
data, know-how and Improvements on the Products which may have been developed
and/or acquired by XXXXX in the course of this Agreement shall belong to XXXXX
(subject to the licenses described in Section 8.2 hereof), except to the extent
that, in accordance with Section 8.2, VION seeks and obtains patent protection
for such Improvements, in which case the information, data and know-how relating
to such Improvements shall belong to VION.
ARTICLE 12
REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION; INSURANCE
12.1 Representations and Warranties of VION. VION represents to XXXXX
as follows:
(a) VION is duly organized, validly existing and in good
standing as a corporation in the State of Delaware;
(b) VION has full corporate power to execute, deliver and
perform its obligations under this Agreement;
(c) the execution, delivery and performance by VION of this
Agreement has been duly authorized by all necessary corporate action;
(d) the execution, delivery and performance by VION of this
Agreement will not breach, conflict with or result in a default under the terms
of (i) its certificate
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of incorporation or by-laws, (ii) any contract to which VION is a party or by
which it or its assets are bound; or (iii) any law, rule, regulation or other
requirement of any governmental entity having jurisdiction over VION or its
assets;
(e) to its knowledge, there is no action, suit, proceeding,
alternative dispute resolution, mediation or investigation pending against VION
relating to the Vion Licensed Patents, nor is Vion aware of any assertions made
by any party relating to the validity of its own or of Vion's infringement of
any patents issued to any third parties; and
(f) Vion makes NO representation or warranties that patents
will issue on the pending patent applications set forth on Exhibit B hereto.
12.2 Representations and Warranties of XXXXX. XXXXX represents to VION
as follows:
(a) XXXXX is duly organized and validly existing as a
corporation under the laws of the People's Republic of China;
(b) XXXXX has full corporate power to execute, deliver and
perform its obligations under this Agreement;
(c) the execution, delivery and performance by XXXXX of this
Agreement has been duly authorized by all necessary corporate action; and
(d) the execution, delivery and performance by XXXXX of this
Agreement will not breach, conflict with or result in a default under the terms
of (i) its certificate of incorporation, by-laws or similar organizational and
governing documents, (ii) any contract to which XXXXX is a party or by which it
or its assets are bound; or (iii) any law, rule, regulation or other requirement
of any governmental entity having jurisdiction over XXXXX or its assets.
12.3 Disclaimer.
(a) VION makes no representations or warranties that any Vion
Licensed Patent is valid, or that the manufacture, use, sale or other disposal
of the Products does not or will not infringe upon any patent or other rights
not vested in VION.
(b) EXCEPT AS EXPRESSLY SET FORTH IN SECTION 12.1, VION
DISCLAIMS ALL WARRANTIES WHATSOEVER WITH RESPECT TO THE VION LICENSED PATENTS,
INVENTIONS, VION RESEARCH AND THE PRODUCTS, EITHER EXPRESS OR IMPLIED, INCLUDING
WARRANTIES AS TO THE MERCHANTABILITY OR FITNESS OF THE PRODUCTS FOR A PARTICULAR
PURPOSE, VALIDITY OF PATENT RIGHTS, NON-INFRINGEMENT, SAFETY, EFFICIENCY OF
TECHNOLOGY OR COMMERCIAL VIABILITY OF TECHNOLOGY.
12.4 Prohibition Against Inconsistent Representations. XXXXX shall not,
and shall require that its sublicensees do not, make any statements,
representations or warranties or accept
-13-
any liabilities or responsibilities whatsoever to or with regard to any Person
which are inconsistent with any disclaimer or limitation included in this
Article 12.
12.5 XXXXX Indemnity.
(a) With the exception of infringement claims or actions
covered by Article 10, XXXXX shall defend, indemnify and hold harmless VION and
its fellows, trustees, officers, directors, stockholders, Affiliates, employees
and agents from and against any and all claims, demands, damages, losses and
expenses of any nature (including attorney's fees), including death, personal
injury, illness, property damage or products liability, arising from or in
connection with any of the following:
(i) the use or testing by XXXXX and/or its Affiliates
and sublicensees of any method or process related to the Vion Licensed Patents
or the Products;
(ii) any use, manufacture, testing, operation, sale
or other disposition of any of the Products by XXXXX and/or its Affiliates and
sublicensees or any statement, representation or warranty of XXXXX and/or its
Affiliates and sublicensees with respect thereto;
(iii) the use of the Products manufactured, marketed
and sold under the license under this Agreement;
(iv) any breach (or facts alleged by a third party
which, if true, would constitute a breach) of a representation, warranty or
covenant made by XXXXX hereunder; and
(v) any negligence by XXXXX and its licensees and
their respective employees, agents and Affiliates.
(b) VION shall reasonably cooperate with XXXXX in defending
any such claim. VION shall be entitled to receive information regarding the
status of any such matter and shall be entitled to retain counsel on its own
behalf and at its sole expense, in addition to counsel retained by XXXXX to
defend it, if either of them is a named party and is not satisfied with the
defense provided by XXXXX for any reason.
12.6 Vion Indemnity.
(a) With the exception of infringement claims or actions
covered by Article 10, VION shall defend, indemnify and hold harmless XXXXX and
its officers, directors, stockholders, Affiliates, employees and agents from and
against any and all claims, demands, damages, losses and expenses of any nature
(including attorney's fees), including death, personal injury, illness, property
damage or products liability, arising from or in connection with any breach (or
facts alleged by a third party which, if true, would constitute a breach) of a
representation, warranty or covenant made by VION hereunder.
(b) XXXXX shall reasonably cooperate with VION in defending
any such claim. XXXXX shall be entitled to receive information regarding the
status of any such
-14-
matter and shall be entitled to retain counsel on its own behalf and at its sole
expense, in addition to counsel retained by VION to defend it, if it is a named
party and is not satisfied with the defense provided by VION for any reason.
12.7 Procedures.
(a) Each Party will promptly notify the other in writing of
any claims or of the commencement of any action with respect to which a claim
for indemnity may be made under this Article 12; provided, however, that no
Party's delay in notifying the other Party shall relieve the other Party from
any obligation hereunder unless (and then solely to the extent) the other Party
is thereby prejudiced.
(b) A Party responsible for indemnifying the other Party shall
not consent to any judgment or enter into any settlement unless the same shall
provide for a full release of the other Party without liability or obligation.
If both Parties have retained counsel with respect to any claim or action,
neither Party shall consent to any judgment or enter into any settlement with
respect thereto without the prior written consent of the other Party (which
shall not be unreasonably withheld or delayed).
12.8 Insurance. XXXXX shall purchase and maintain in effect or shall
require its sublicensees to purchase and maintain in effect a policy of products
liability insurance covering all claims with respect to the Products
manufactured or sold within the term of the license granted hereunder, which
policy shall (a) be in such form and amount of coverage and written by such
company as VION shall reasonably approve, (b) provide that such policy is
primary and not excess or contributory with regard to other insurance that VION
may have, (c) provide at least thirty (30) days' prior written notice to VION of
cancellation, and (d) include VION and its directors, officers and employees as
additional named insureds. XXXXX shall furnish a certificate of such insurance
to VION on or before the date of first sale or use of any Products. The
insurance will be purchased and maintained according to the governmental
requirements and the regulations of the Territory.
12.9 No Other Patents. Nothing in this Agreement shall be construed as
granting by implication, estoppel or otherwise any licenses under patents of
VION other than the Vion Licensed Patents, regardless of whether such patents
are dominant or subordinate to any of the Vion Licensed Patents.
12.10 NO CONSEQUENTIAL DAMAGES. IT IS UNDERSTOOD AND AGREED THAT
NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR INDIRECT, SPECIAL, PUNITIVE,
EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING LOSS OF PROFITS OR
REVENUES, REGARDLESS OF WHETHER SUCH DAMAGES WERE FORESEEABLE OR NOT.
NOTWITHSTANDING THE FOREGOING, FOR PURPOSES OF THIS SECTION, ALL LOSSES INCURRED
BY EITHER PARTY TO A THIRD PARTY ARISING OUT OF SUCH THIRD PARTY'S CLAIM FOR
CONSEQUENTIAL DAMAGES, WHICH CLAIM IS OTHERWISE SUBJECT TO INDEMNIFICATION UNDER
SECTIONS 12.5 OR 12.6 HEREOF, SHALL BE DEEMED TO BE DIRECT DAMAGES AS BETWEEN
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THE PARTIES HERETO AND NEITHER PARTY SHALL ASSERT AGAINST THE OTHER PARTY THAT
ANY SUCH DAMAGES ARE CONSEQUENTIAL DAMAGES.
ARTICLE 13
USE OF NAMES
13.1 Vion Name. XXXXX shall not use the name "Vion" or "Vion
Pharmaceuticals" for any purpose without prior written consent obtained from
VION in each instance.
ARTICLE 14
CONFIDENTIALITY
14.1 Treatment of Confidential Information. Except as otherwise
provided in this Article 14, during the term of this Agreement and for a
period of five (5) years thereafter:
(a) XXXXX will retain in confidence and use only for purposes
of this Agreement any confidential information and data supplied by VION or on
behalf of VION to XXXXX in connection with this Agreement; and
(b) VION will retain in confidence and use only for purposes
of this Agreement any confidential information and data supplied by XXXXX or on
behalf of XXXXX to VION in connection with this Agreement.
For purposes of this Agreement, all such confidential information and
data which a Party is obligated to retain in confidence shall be called
"Confidential Information" and shall include any technology, data, know-how,
compounds, processes, formulae, materials, devices, systems, notes, records,
preparations, usage information, procedures, regulatory information,
manufacturing information, proprietary and secret ideas, technical information,
trade secrets, commercial information, techniques, data or other information,
whether in written or verbal form, useful or related to the Inventions, the Vion
Licensed Patents, the Vion Research, the Products or the manufacturing of the
Products.
14.2 Right to Disclose. To the extent it is reasonably necessary or
appropriate to fulfill XXXXX'x obligations or exercise its rights under this
Agreement or any rights which survive termination or expiration hereof, XXXXX
may disclose Confidential Information it obtains from VION to its Affiliates,
sublicensees, consultants, outside contractors and clinical investigators on the
condition that such Persons agree: (a) to keep the Confidential Information
confidential for at least the same time periods and to the same extent as each
Party is required to keep the Confidential Information confidential; and (b) to
use the Confidential Information only for such purposes as such Party is
entitled to use the Confidential Information. Each Party or its Affiliates or
sublicensees may disclose Confidential Information to government or other
regulatory authorities to the extent that such disclosure is reasonably
necessary to obtain patents or authorizations to conduct clinical trials and to
commercially market the Products, provided, that such party is otherwise
entitled to engage in such activities under this Agreement. Further, VION shall
be permitted to disclose the existence and terms of this Agreement and the
existence of the relationship between the parties, and VION shall be permitted
to show this Agreement to,
-16-
third parties in connection with VION seeking, negotiating or consummating any
financing or a strategic partnership or other similar transaction.
14.3 Release From Restrictions. The obligation not to disclose
Confidential Information shall not apply to any part of such Confidential
Information that: (a) is or becomes patented, published or otherwise part of the
public domain other than by acts of the Party obligated not to disclose such
Confidential Information (for purposes of this Article 14, the "Receiving
Party") or its Affiliates or sublicensees; or (b) is disclosed to the Receiving
Party or its Affiliates or sublicensees by a third party, provided, that such
Confidential Information was not obtained by such third party directly or
indirectly from the other Party under this Agreement; or (c) results from
research and development by the Receiving Party or its Affiliates or
sublicensees independent of disclosures from the other Party under this
Agreement; or (e) is required by law or court order to be disclosed, in which
case the Receiving Party will (i) take all reasonable steps available to
maintain the confidentiality of Confidential Information; (ii) provide the other
Party with prompt notice of any request for Confidential Information with
sufficient time so as to allow the other Party a reasonable opportunity to
object to such disclosure, to seek a protective order, or to take other
protective actions; and (iii) if required to release any Confidential
Information, release such Confidential Information only as and to the extent
required.
14.4 Confidentiality of Agreement. Except as otherwise required by law
or the terms of this Agreement or mutually agreed upon by the Parties hereto,
each Party shall treat as confidential the specific terms and conditions of this
Agreement (but the existence, scope and general terms of this Agreement shall
not be confidential). Subject to Section 14.5, neither Party shall make or
procure or permit the making of any announcement or statement to the public with
respect to this Agreement, its subject matter or any ancillary matter without
the prior consent of the other Party, which consent shall not be unreasonably
withheld. Subject to Section 14.5, the wording and timing of any such
announcement or statement to the public (including any press release) shall be
agreed upon by the Parties in advance.
14.5 Certain Disclosures. Nothing herein shall prohibit VION from
disclosing information to the extent required by the United States Securities
and Exchange Commission (the "SEC"), Nasdaq or other similar authorities. It is,
however, understood and agreed that (a) with respect to the contents of any copy
of this Agreement, or of any other agreement between the Parties, which VION
must file with the SEC, the Parties shall reasonably agree on the portions for
which confidential treatment shall be requested under United States federal
securities laws, and (b) VION shall use its reasonable commercial efforts to
obtain authorization by the SEC to keep confidential any information which is
deemed to be confidential by the Parties or either of them or which may, in
either Party's reasonable opinion, give a competitive advantage to third
parties. Nothing herein shall prohibit either Party from disclosing information
to the extent required by governmental authorities of the Territory for the
purpose of compliance with applicable laws and regulations of the Territory.
-17-
ARTICLE 15
SUBLICENSING RIGHTS
15.1 Notification. XXXXX shall notify VION in writing of its intent to
enter into any sublicense agreement and/or amend any existing sublicense
agreement prior to the execution thereof, indicating the name of the intended
sublicensee, the intended territory of the sublicense and the scope of rights to
be conveyed under the sublicense. XXXXX shall further notify VION of any
executed sublicense or amendment thereto within thirty (30) days after execution
and shall provide a copy of the executed sublicense agreement or amendment.
Should the executed sublicense or agreement be in a language other than English,
XXXXX shall provide a certified translation of the executed sublicense or
agreement to VION.
15.2 Termination of Sublicense. Any sublicense granted by XXXXX under
this Article 15 shall automatically and simultaneously terminate, without action
by any party thereto, at the same time and to the same extent as any termination
of this Agreement.
15.3 Sublicense Terms and Conditions. Any sublicense agreement granted
by XXXXX shall be consistent with the terms of this Agreement and shall contain
(a) provisions requiring the payment of Earned Royalties to VION at the rates
and times and on the other terms set forth herein; (b) provisions requiring
indemnification as set forth in Section 12.5 hereof; and (c) acknowledgments by
the sublicensee of the disclaimers of warranty and limitation on liability, as
provided in Article 12 hereof. All sublicenses shall also contain provisions
under which the sublicensee accepts duties to keep records; to allow
examinations; to avoid improper representations or responsibilities; to hold
VION harmless; to restrict the use of VION's name; and to control export; which
duties shall be at least equivalent to those set forth in Articles 7, 12, 13 and
18 hereof.
ARTICLE 16
DISPUTE RESOLUTION
16.1 Arbitration. Subject to Section 16.2, any dispute between the
Parties (which does not involve a third party) arising out of or relating to
this Agreement or its breach or alleged breach (a "Dispute") shall be resolved
as follows:
(a) A Party shall submit written notice of the Dispute to the
other Party and request negotiations.
(b) The Parties shall promptly attempt in good faith to
resolve the Dispute by negotiations between representatives appointed by the
Parties who have power to settle the Dispute.
(c) If the Dispute has not been resolved within sixty (60)
days after a Party's request for negotiations, either Party may request that the
Dispute be submitted to binding arbitration for a final decision. Any such
arbitration shall be conducted in the English language. Any such Dispute shall
be resolved by arbitration in accordance with the Rules of the International
Chamber of Commerce International Court of Arbitration ("ICC Rules"). Within
-18-
ten days of the initiation of an arbitration hereunder, each Party will
designate an arbitrator pursuant to the ICC Rules. The appointed arbitrators
will appoint a neutral arbitrator from the panel in the manner prescribed in the
ICC Rules. The parties agree that the decision of the arbitrators selected
hereunder will be final and binding on both parties. If VION initiates an
arbitration procedure, the place of arbitration shall be Hong Kong. If XXXXX (or
MAXWIN) initiates an arbitration procedure, the place of arbitration shall be
New York, New York. Each Party shall pay its own expenses of arbitration, and
the expenses of the arbitrators shall be equally shared; provided, however, that
if in the opinion of the arbitrators any claim or any defense or objection
thereto was unreasonable, the arbitrators may assess, as part of their award,
all or any part of the arbitration expenses of the other Party (including
reasonable attorney's fees) and of the arbitrators against the Party raising
such unreasonable claim, defense or objection. The Parties regard the
obligations in this Article 16 to constitute an essential provision of this
Agreement and one that is legally binding on them. In case of a violation of the
obligations in this Article 16 by either Party, the other Party may bring an
action to seek enforcement of such obligations in any court of law having
jurisdiction.
16.2 Exceptions.
(a) Section 16.1 shall not apply to any Dispute where relief
of an equitable nature, such as injunctive relief, may be sought through the
courts (it being understood that only the equitable relief portion of a claim
may be sought through the courts).
ARTICLE 17
NOTICES
All notices, requests, demands and other communications under this
Agreement or in connection herewith shall be in writing in the English language
and shall be deemed to have been duly given or made: (a) on the date delivered
in person; (b) on the date received if sent by certified United States mail,
return receipt requested, or by Federal Express or other internationally
recognized airline courier service, with all charges prepaid; or (c) on the date
transmitted by facsimile if confirmation is sent in the manner set forth in (a)
or (b) within one (1) day; in each case, such notices, requests, demands or
other communications shall be sent to a Party at its address or facsimile number
as follows, or as otherwise designated by the Party by notice in accordance
herewith:
If to VION:
Vion Pharmaceuticals, Inc.
0 Xxxxxxx Xxxx
Xxx Xxxxx, XX 00000
XXX
Attn: Xxxxxx Xxxxxxx
Telephone: 000-000-0000
Facsimile: 000-000-0000
with a copy (which shall not constitute notice) to:
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Fulbright & Xxxxxxxx L.L.P.
000 Xxxxx Xxxxxx
Xxx Xxxx, XX 00000
XXX
Attn: Xxxxxxxx X. Xxxxxxx, Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
If to XXXXX:
Beijing Xxxxx Pharmaceuticals, Inc.
0 Xx Xxx Xxx Xxx Xxxxxx
Xxxxxxx 000000, P R China
Attn: Dr. Sen Liu
Telephone: +86-10-6834 1662
Facsimile: +86-10-6834 1665
ARTICLE 18
LAWS AND REGULATIONS
XXXXX shall comply with all national, state and local laws,
regulations, rules and orders applicable to the testing, production,
transportation, packaging, labeling, export, sale and use of the Products in the
Territory. In particular, XXXXX shall be responsible for assuring compliance
with all United States export laws and regulations applicable to this Agreement,
the license and sublicense granted hereby and XXXXX'x activities hereunder.
ARTICLE 19
MISCELLANEOUS
19.1 Force Majeure. Any delays in or failure by either Party in
performance of any obligations hereunder shall be excused if and to the extent
caused by occurrences beyond such Party's reasonable control, including such
occurrences as acts of God, strikes or other labor disturbances, war, and other
causes which cannot reasonably be controlled by the Party who failed to perform.
19.2 Amendment and Assignment. This Agreement may not be amended except
by written agreement signed by both of the Parties and shall not be assigned by
XXXXX except upon the advance written consent of VION; provided, that this
Agreement may be assigned by either Party to an entity that succeeds by
operation of law to, or otherwise acquires substantially all of the stock or
assets of such Party, or into which such Party is merged, and that assumes such
Party's obligations hereunder. Further, notwithstanding anything herein to the
contrary, XXXXX may assign any of its rights and obligations relating to
manufacture, marketing and commercialization of Products hereunder to MAXWIN so
long as (i) MAXWIN is a wholly-
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owned subsidiary of XXXXX, (ii) XXXXX remains primarily liable for all of its
(and MAXWIN's) obligations hereunder and (iii) MAXWIN agrees in writing to be
bound by all of the provisions applicable to XXXXX herein relevant to the
performance of such obligations and enjoyment of such rights.
19.3 Entire Agreement. This Agreement constitutes the entire agreement
of the Parties relating to the subject matter hereof, and all prior or
contemporaneous representations, agreements and understandings, whether written
or oral.
19.4 Expenses. Each Party shall bear its own expenses in connection
with the negotiation, execution and delivery of this Agreement and the other
transactions contemplated hereby.
19.5 Cooperation. Each Party agrees to cooperate with the other and
take all reasonable actions as may be reasonably required to achieve the intent
of this Agreement, including, without limitation, the execution of all necessary
and appropriate instruments and documents.
19.6 Independent Contractors. It is expressly agreed that the Parties
shall be independent contractors and that the relationship between them shall
not constitute a partnership, joint venture or agency. Neither Party shall have
the authority to make any statements, representations or commitments of any
kind, or to take any action, which shall be binding on the other.
19.7 Governing Law. This Agreement shall be governed by and construed
in accordance with the laws of the State of New York, except where the federal
laws of the United States are applicable and have precedence. For purposes of
Section 16.2 hereof, the Parties hereby consent to the personal jurisdiction and
venue of state and federal courts in the State of New York and waive any
objection to the same.
19.8 Severability. The provisions of this Agreement shall be deemed
separable. If any part of this Agreement is rendered void, invalid or
unenforceable, such shall not affect the validity or enforceability of the
remainder of this Agreement unless the part or parts which are void, invalid or
unenforceable shall substantially impair the value of the entire Agreement as to
either Party.
19.9 Headings. The Article and Section headings of this Agreement are
used for convenience only and are not to be considered in construing or
interpreting this Agreement.
19.10 Counterparts. This Agreement may be executed in one or more
counterparts (including by facsimile), each of which shall be an original but
all of which together shall constitute one and the same instrument.
[Signature Page Follows]
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IN WITNESS WHEREOF, the Parties hereto have executed and delivered this
Agreement in multiple originals by their duly authorized officers and
representatives on the respective dates shown below but effective as of the
Effective Date.
Vion Pharmaceuticals, Inc.
By: /s/ Xxxxxx X. Xxxxxxx
-------------------------------------------
Title: Chief Financial Officer
----------------------------------------
Date: September 12, 2003
-----------------------------------------
Beijing Xxxxx Pharmaceuticals, Inc.
By: /s/ Sen Liu By: /s/ Xxxxxxxxx Xxxx
---------------------------------- -------------------------------
Name: Sen Liu Name: Xxxxxxxxx Xxxx
-------------------------------- -----------------------------
Title: President Title: Vice President/Director
------------------------------- ----------------------------
Date: September 12, 2003 Date: September 12, 2003
-------------------------------- -----------------------------
EXHIBIT A
INVENTIONS
o 3-Aminopyridine-2-carboxyaldehyde thiosemicarbazone or 3-AP
o 3-amino-4-methylpyridine-2-carbox aldehyde thiosemicarbazone or 3-AMP
o Prodrugs of 3-AP
o Prodrugs of 3-AMP
EXHIBIT B
PATENTS AND PATENT APPLICATIONS IN
THE TERRITORY
o Chinese Patent application [*****] Patent issued on August 13, 2003, Patent
No. ZL98805147.8
o Hong Kong Patent application [*****]
o Chinese Patent application [*****]
o Hong Kong Patent application [*****]
o Chinese Patent application [*****]
o [*****]
EXHIBIT C
VION RESEARCH
Vion Research shall include:
o All clinical data (bioanalytical) generated to which VION has rights that
relates to the Product (including anti-cancer and anti-viral data) in the
Field.
o All preclinical formulation, manufacturing information or know-how related
to proprietary formulations or manufacturing process for the Product in the
Field to which VION has rights.
o All IND or equivalent regulatory approvals for the Product in the Field to
which VION has rights.
o All know-how regarding product development by VION relating to the use of
the Product in combination with other anti-cancer and anti-viral agents in
the Field.
o Any invention disclosures regarding the Product in the Field, which lead to
patent applications by VION.
o Intellectual property to which VION has rights associated with the
development of the Product in the Field:
a. Bulk pharmaceutical manufacturing process
b. Stability data for bulk
c. Analytical methods for bulk
d. Finished product manufacturing process
e. Stability data for finished drug product
f. Analytical methods for finished drug product
g. Animal pharmacokinetic data
h. Preclinical data relevant to clinical development
i. Animal toxicology data
j. IND for U.S. regulatory submission and IND annual reports
k. CTX for U.K. regulatory submission
l. Clinical protocols and available data on all human clinical trials
m. Clinical investigator's brochure
n. Clinical development plan for NDA submission in the U.S.
o. List of all sites involved with the clinical trials
EXHIBIT D
MATERIAL DOCUMENTS
================================================================================
[VION LOGO]
DOCUMENT RECEIPT FORM FORM NO.: QA-F009-R0
Document Type: [ ] Standard Operating Procedure [x] Protocol
[ ] Standard Test Procedure [x] Report
[ ] Form [x] Other
--------------------------------------------------------------------------------
Binder Title
================================================================================
1-7 Triapine'r' IND: 7 Volumes
--------------------------------------------------------------------------------
8 CMC Amendment for Change in Drug Substance Manufacturer
--------------------------------------------------------------------------------
9 CMC Amendment for Change in Drug Product Manufacturer
--------------------------------------------------------------------------------
10 INFORMATION AMENDMENT FOR TRIAPINE'r' CAPSULE (INCLUDES STABILITY
DATA)
--------------------------------------------------------------------------------
11 2003 IND ANNUAL REPORT (INCLUDES STABILITY DATA)
--------------------------------------------------------------------------------
12 TRIAPINE'r' CTX
--------------------------------------------------------------------------------
13 TRIAPINE'r' CLINICAL PROTOCOLS AND INVESTIGATOR'S BROCHURE
(INCLUDES NCI PROTOCOL LIST)
--------------------------------------------------------------------------------
14 TRIAPINE'r' CLINICAL REPORT FOR CLI-001-1
--------------------------------------------------------------------------------
15 TRIAPINE'r' CLINICAL REPORT FOR CLI-001-2
--------------------------------------------------------------------------------
16 Triapine'r' Clinical Report for CLI-009
--------------------------------------------------------------------------------
17 Triapine'r' Clinical Report for CLI-019
--------------------------------------------------------------------------------
18 TRIAPINE'r' NONCLINICAL REPORTS
================================================================================
Document(s) issued by: Quality Assurance Date issued: September 10, 2003
--------------------- --------------------
Document(s) issued to: Xxxxx
----------------------------------------------------------
I acknowledge that I have received the document(s) described above.
--------------------------------- ------------------------ -------------------
Name (please print) Signature Date
UPON RECEIPT, PLEASE COMPLETE THIS FORM AND FAX THE COMPLETED FORM TO:
XXXXX XXXXXX
ASSOCIATE DIRECTOR, QUALITY ASSURANCE
VION PHARMACEUTICALS, INC.
FAX NUMBER: (000) 000-0000
EXHIBIT E
PATENTS AND PATENT APPLICATIONS
TRIAPINE PATENTS:
USP 5,281,715 2-Formylpyridine Thiosemicarbazone compounds, Issued 25 January
1994; International Patent Granted 30 July 1997 (Austria, Belgium, Denmark,
Europe, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands,
Spain, Sweden, Switzerland); Japanese Patent 0000000 Issued 25 May 2001;
Canadian Patent 2,095,881 Issued 23 January 2002. (Licensed from Yale
University)
USP 5,721,259 Method of using 2-Formylpyridine Thiosemicarbazone compounds,
Issued 24 February 1998. (Licensed from Yale University)
USP 5,767,134 Prodrug forms of ribonucleotide reductase inhibitors 3-AP and
3-AMP, Issued 16 June 1998; Canadian Patent 2,290,617 Issued 02 April 2001;
Australian Patent 727848 Granted 19 April 2001; Russian Patent 99127343 Granted
05 September 2002.
USP 5,869,676 Process for the synthesis of ribonucleotide reductase inhibitors
3-AP and 3-AMP, Issued 09 February 1999; Canadian Patent 2,289,970 Issued 02
April 2001; Chinese Patent 98805147.8 Issued 13 August 2003; Australian Patent
728165 Granted 19 April 2001; Russian Patent 99126808 Granted 14 August 2002.
USP 6,458,816 B1 Modified prodrug forms of AP/AMP, Issued 01 October 2002.
PCT WO 02/30424 A1 Modified prodrug forms of AP/AMP, Issued 18 April 2002.
PCT WO 98/51669 Prodrug forms of ribonucleotide reductase inhibitors 3-AP and
3-AMP, Issued 19 November 1998.
PCT WO 98/51670 Process for the synthesis of ribonucleotide reductase inhibitors
3-AP and 3-AMP, Issued 19 November 1998.
EXHIBIT F
PUBLICATIONS
Examination of the antiproliferative activity of iron chelators: multiple
cellular targets and the different mechanism of action of triapine compared with
desferrioxamine and the potent pyridoxal isonicotinoyl hydrazone analogue 311.
Clin Cancer Res 2003 Jan;9(1):402-14 Xxxxxxx XX, Xxxxxxx XX, Xxxxx XX,
Xxxxxxxxxx DR.
Therapeutic potential of iron chelators in cancer therapy. Adv Exp Med Biol
2002;509:231-49 Xxxxxxxxxx DR.
Iron chelators as therapeutic agents for the treatment of cancer. Crit Rev Oncol
Hematol 2002 Jun;42(3):267-81, Xxxxxxxxxx DR.
Phase I and pharmacokinetic study of 0-xxxxxxxxxxxxx-0-xxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxx (0-XX) using a single intravenous dose schedule. Cancer
Chemother Pharmacol 2002 Sep;50(3):223-9, Feun L, Modiano M, Xxx K, Mao J,
Xxxxxx A, Savaraj N, Xxxxxx P, Xxxxxxxxx B, Xxxxxxxx E, Xxxxxxx J, XxxXxxxxx S.
Modified Prodrugs Forms of AP/AMP. XXX Patent WO 02/30424, April 18, 2002; also
US Patent US 6,458,816, Oct. 1, 2002.DoyleTW, Karra S, Li Z, Lin X, Mao J, Qiao
Q, Xu Y Vion Pharmaceuticals Inc, Xxx Xxxxx, Xxxxxxxxxxx 00000, XXX.
Synthesis and Biological Evaluation of Novel Phosphate-bearing Prodrugs of
Triapine. 223rd ACS National Meeting, MEDI #161, Orlando, FL, April 7-11, 2002.
Almassian B, Xxxxxxx S, Xxxx XX, Xxxxxxxxx C, Xxxxx XX, Xxxx I, Xxxxx S, Li Z,
Lin X, Luo X, Mao J, Qiao Q, Xxxxxx J, Xxxx S, Trailsmith MD, Xu Y, Zheng L,
Vion Pharmaceuticals Inc, Xxx Xxxxx, Xxxxxxxxxxx 00000, XXX.
Syntheses and Antitumor Activities of Potent Inhibitors of Ribonucleotide
Reductase: 0-Xxxxx-0-Xxxxxx-xxxxxxxx-0-Xxxxxxxxxxxxxx-Xxxxxxxxxxxxxxxxx(0-XXX),
0-Xxxxx-Xxxxxxxx-0-Xxxxxxxxxxxxxx Xxxxxxxx-xxxxxxxxx (0-XX) and its
Water-Soluble Prodrugs, J Li, X-X Xxxxx, I Xxxx, XX Xxxxx and X-X Xxxx, Current
Medicinal Chemistry, 8, 121-133, 2001.
Enhancement of Antitumor Activity of Orthophosphate-3AP in Combination with
Chemotherapeutic Agents, XX Xxxxxx, X Luo, Z Li, X Lin, S Karra, S Shen, MD
Trailsmith, J Chen, L Zheng, XX Xxxxx and I Xxxx, 92nd AACR Meeting, New
Orleams, (Abst.427) March 2001.
In Vivo Evaluation of Thirteen 3-Aminopyridine-2-carboxaldehyde
Xxxxxxxxxxxxxxxxx Xxxxxxxx, X Xxxxx, X Xx , XX Xxxxxx, X Xxx, X Xxx, S Xxxxx, S
Xxxx, MD Trailsmith, J Chen, XX Xxxxx and I Xxxx, 92nd AACR Meeting, New
Orleams, (Abst.428) March 2001.
In Vitro Biological Stability and Pharmacokinetics of Novel Prodrugs of
3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone (Triapine) in Dogs, J Mao, Y
Xu, S Karra, X Lin, C Xxxxxxxxx, T Xxxxx and B Xxxxxxxxx, 92nd AACR Meeting, New
Orleams, (Abst. 446) March 2001.
Phase 1 and Pharmacokinetic Study of 3-Aminopyridine-2-Carboxaldehyde
Thiosemicarbazone (Triapine'r') Using a Single Intravenous Dose Schedule, L.
Feun, X. Xxxxxxx, X. Xxx, X. Xxx, X. Xxxxxx, X. Xxxxxxx, X. Xxxxxx, X.
Xxxxxxxxx, and X. XxxXxxxxx,. AACR Meeting , New Orleans, Mar. 24-28 2001.
A Phase 1 and Pharmacokinetic Study of Intravenous, Daily for 5 Days,
3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (Triapine'r') in Advanced
Cancer Patients X. Xxxxxxx, X. Xxxxxx, S, XxxXxxxxx, X. Xxx, X. Xxx, X.
Xxxxxxxxx, X. Xxxxxx, and X.Xxxxx,. AACR Meeting , New Orleans, Mar. 24-28 2001.
Triapine (3-aminopyridine-2-carboxaldehyde- thiosemicarbazone): A potent
inhibitor of ribonucleotide reductase activity with broad spectrum antitumor
activity. Xxxxx XX, Liu M, Grill SP, Xxxx XX, Xxxxxx R, Xxxxxxx XX, Xxxxx Y,
Xxxxxxxxxx XX., Biochem PharmacolApr 15;59(8):983-91, 2000.
Short term toxicological evaluation of Triapine'r'
(3-aminopyridine-2-carboxaldehyde thiosemicarbazone or 3-AP), a ribonucleotide
reductase inhibitor with potential anti-tumor activity, in dogs and rats, Xxx
XX, Xxxxxxxxx J, Xxxxxxxxx B. International Journal of Toxicology, 19:85-93,
2000.
Toxicological Evaluation in Dogs and Rats of a Ribonucleotide Reductase
Inhibitor (Triapine" or3-Amino-Pyridine-2-Carboxaldehyde Thiosemicarbazone) with
Anti-Tumor Activity .Xxx XX, Noverske JW, Almassian B. Society of Toxicological
Pathologist, 2000.
Triapine (3-aminopyridine-2-carboxaldehyde thiosemicarbazone; 3-AP): an
inhibitor of ribonucleotide reductase with antineoplastic activity. Xxxxx XX,
Xxx MC, Xxxx XX, Xxxx XX, Xxxxxxxxxx XX.
Adv Enzyme Regul.;39:3-12. Review. 1999.
Development of a Parenteral Formulation of an Investigational Anticancer Drug,
3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone Krishna, X. Xxx, J., and
Almassian, B. Pharm. Dev. And Tech 4(1), 71-80, 1999.
Antitumor activity of prodrugs of TriapineTM, an inhibitor of ribonucleotide
reductase, Li, Z., Luo, X., Chen, S.-H., Li, X.-Y., Li, J.,Niu, C., Karra, S.,
Wang, Q., Xxxxxxx, S., Mao, J., Xxxxx, T., King, I. And Zheng, L.-M., 90th AACR
Meeting, Philadelphia, Abstract No 1997, 1999.
Pharmacokinetics of 0-Xxxxxxxxxxxxx-0-Xxxxxxxxxxxxxx Xxxxxxxxxxxxxxxxx (0-XX), a
Ribonucleotide Reductase Inhibitor, in Rats and Dogs. X. Xxxx, X. Xxxx, G.
Krishna, X. Xxx, X. Xxx, and X. Xxxxxxxxx, Pharm. Res. 14:S357-358, 1997.
Altered efflux properties of mouse leukemia L1210 cells resistant to
4-methyl-5-amino-1-formylisoquinoline thiosemicarbazone. Xxxx XX, Cory AH,
Lorico A, Xxxxx G, Xxxxxxxxxx XX. Anticancer Res. Sep-Oct;17(5A):3185-93, 1997.
Overexpression of the multidrug resistance genes mdr1, mdr3, and mrp in L1210
leukemia cells resistant to inhibitors of ribonucleotide reductase. Xxxxx G,
Lorico A, Liu MC, Xxxx XX, Xxxx XX, Xxxx XX, Xxxxxxxxxx XX Biochem Pharmacol.
Sep 15;54(6):649-55, 1997.
