Exhibit 10.62
AGREEMENT
THIS AGREEMENT (this "Agreement") is made and is effective as of
October 20, 2003, (the "Effective Date") between Xx. Xxxxxx X. Xxxxxx ("Xxxxxx")
and CytRx Corporation, a Delaware corporation ("CytRx") with reference to the
following facts:
A. CytRx has developed CytRx Know-How (as hereinafter defined)
and has CytRx Patent Rights (as hereinafter defined) in the fields of:
(i) The composition and use of surface-active copolymers
exemplified by poloxamer 188 to treat ischemic tissue, myocardial damage,
stroke, pathological hydrophobic interactions in biological fluids, tissue
damaged by reperfusion injury, sickle cell disease, and in performing
angioplasty procedures (with the CytRx Know-How and CytRx Patent Rights in this
field referred to collectively as the "FLOCOR Intellectual Property");
(ii) the composition and use of surface active copolymers
(exemplified by poloxamers, reverse poloxamers and diether fatty acid conjugates
of poloxyethylene) to treat infections caused by microorganisms, including
bacteria, fungi, and viruses and to treat tumors (with the CytRx Know-How and
CytRx Patent Rights in this field referred to collectively as the
"Anti-Infectives Intellectual Property"); and
(iii) conventional vaccine adjuvants exemplified by
poloxamer P1005 (with the CytRx Know-How and CytRx Patent Rights in this field
referred to collectively as the "OptiVax Intellectual Property").
B. CytRx has exclusively licensed to Merck & Co. ("Merck), Ivy
Animal Health, Inc. ("Ivy Animal Health"), TiterMax USA, Inc. ("TiterMax"), and
Vical Inc. ("Vical"), and has granted an option to acquire an exclusive license
to Progenics Pharmaceuticals, Inc. ("Progenics"), CytRx Know-How and CytRx
Patent Rights in certain fields under agreements collectively referred to as the
CytRx Licenses, copies of which are attached hereto as SCHEDULE X.
X. Xxxxxx has previously participated in the development of most
of the poloxamer technology that is the subject of the Licensed Intellectual
Property (as hereinafter defined) and has developed Hunter Know-How (as
hereinafter defined).
D. CytRx and Hunter wish to continue the development and
subsequent commercialization of the FLOCOR Intellectual Property, the
Anti-Infectives Intellectual Property and the Opti-Vax Intellectual Property
(collectively referred to as the "Licensed Intellectual Property") and other
potential technologies in the field of FLOCOR, Opti-Vax and Anti-Infectives (as
such terms are hereinafter defined) through a jointly owned new corporation to
be formed by them and named SynthRx Inc. ("SynthRx").
E. CytRx and Hunter wish to provide for the formation and
operation of SynthRx, for Hunter to provide the initial capital for SynthRx, for
SynthRx to obtain an exclusive license under the Licensed Intellectual Property
from CytRx and for both CytRx and Hunter to provide know how to SynthRx upon the
terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the parties hereby agree as follows:
ARTICLE I.
DEFINITIONS
Unless specifically set forth to the contrary herein, the following
terms, whether used in the singular or plural, shall have the respective
meanings set forth below:
1.1 The term "Affiliate" shall mean (i) any corporation or
business entity of which 50% or more of the securities or other ownership
interests representing the equity, the voting stock or general partnership
interest are owned, controlled or held, directly or indirectly, by SynthRx,
Hunter or CytRx; or (ii) any corporation or business entity which, directly or
indirectly, owns, controls or holds 50% or more of the securities or other
ownership interests representing the equity or the voting stock of SynthRx or
CytRx.
1.2 The term "Anti-Infectives" shall mean
polyoxypropylene/polyoxyethylene copolymers and other polyoxyethylene conjugates
having therapeutic activity or having the ability to enhance the therapeutic
activity of other agents against infective organisms, including bacteria,
viruses and fungi.
1.3 The term "CytRx Know-How" shall mean contracts, information
and materials, including but not limited to, discoveries, Improvements,
processes, formulas, data, know-how and trade secrets, patentable or otherwise,
which (i) are in CytRx's possession or control at the Effective Date or are
developed by CytRx during the term of this Agreement, if any, (ii) are not
generally known, (iii) are valuable to SynthRx in connection with the research,
development, marketing, use or sale of Licensed Products in the Field in the
Territory, and (iv) CytRx has the right to provide to SynthRx.
1.4 The term "CytRx Licenses" shall mean the previously entered
into exclusive license agreements between CytRx and Merck, Ivy Animal Health,
Titermax and Vical and the exclusive license agreement to be entered into
between CytRx and Progenics upon Progenics exercising the option previously
granted to it by CytRx for certain CytRx Know-How and CytRx Patent Rights for
certain fields as defined in each license agreement listed in SCHEDULE A.
1.5 The term "CytRx Patent Rights" shall mean (i) all United
States or foreign patents or patent applications, and patents to be issued
pursuant thereto, owned by or licensed to CytRx, related to Flocor, Opti-vax or
the Anti-Infectives, excluding the use in certain fields that are covered in the
CytRx Licenses listed in SCHEDULE A hereto; or (ii) are divisions,
continuations, reissues, renewals, extensions, supplementary protection
certificates, utility models and the like of any such United States patents and
patent applications and foreign equivalents thereof. Hunter and CytRx
acknowledge that the patent rights licensed from Rush-Presbyterian-St. Luke's
Medical Center have reverted to Rush, that they are no longer part of CytRx
Patent Rights and that SynthRx must negotiate directly with Rush if it is to
obtain rights to these parts of the Anti-Infectives Intellectual Property.
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1.6 The term "Field" shall mean the use of Licensed Intellectual
Property in all fields for FLOCOR, Anti-Infectives and Opti-Vax, set forth in
recital A to this Agreement except for those fields of use that are or will be
licensed under the CytRx Licenses.
1.7 The term "FLOCOR" shall mean surface-active copolymers of an
ethylene oxide-propylene oxide condensation product that have cytoprotective,
rheologic and antithrombotic activities exemplified by poloxamer 188.
1.8 The term "Opti-Vax" shall mean novel
polyoxyethylene/polyoxypropylene copolymers that are high molecular weight
molecules and are useful as vaccine adjuvants.
1.9 The term "Hunter Know-How" shall mean information and
materials, including but not limited to, discoveries, improvements, processes,
formulas, dates, know-how and trade secrets, patentable or otherwise, which are
in Hunter's possession or control at the Effective Date or are developed by
Hunter alone or with others during the term of this Agreement, if any, (i) are
not generally known, (ii) are valuable to SynthRx in connection with the
research, development, marketing, use or sale of the Licensed Products in the
Field in the Territory, and (iii) which Hunter has the right to provide to
SynthRx. Hunter's rights are subject to an employment agreement with the
University of Texas-Houston.
1.10 The term "Hunter Patent Rights" shall mean in the fields of
Flocor, the antiinfectives and OptiVax (i) all United States or foreign patents
or patent applications and patents to be issued pursuant thereto, owned by or
licensed to Hunter, including but not limited to those listed in SCHEDULE B
hereto; or (ii) are divisions, continuations, reissues, renewals, extensions,
supplementary protection certificates, utility models and the like of any such
United States patents and patent applications and foreign equivalents thereof.
1.11 The term "License Agreement" shall mean the License Agreement
between CytRx and SynthRx in the form set forth in SCHEDULE C hereto.
1.12 The term "Licensed Product" shall mean a Product for use in
the Field, which in the absence of this Agreement would infringe one or more
claims of the CytRx Patent Rights, or a Product that is made using a process or
method covered by one or more claims of the CytRx Patent Rights.
1.13 The term "Proprietary Information" shall mean all SynthRx
Know-How, Hunter Know-How and CytRx Know-How, and all other scientific,
clinical, regulatory, marketing, financial and commercial information or data,
whether communicated in writing or orally or by sensory detection, which is
provided by one party to the other party in connection with this Agreement.
1.14 The term "Product" shall mean any prescription or
over-the-counter prophylactic, diagnostic or therapeutic product, vaccine or
device for use in the Field in the Territory.
1.15 The term "Territory" shall mean all of the countries in the
world.
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ARTICLE II.
FORMATION AND OPERATION OF SYNTHRX
2.1 Formation and Initial Capitalization of SynthRx. Within 20
business days following the Effective Date (the "Closing Date"), Hunter and
CytRx shall form SynthRx and provide it with the CytRx Know How and Hunter Know
How components of their capital contributions (which shall be returned to them
by SynthRx in the event Hunter or CytRx fails to make the balance of his or its
capital contribution as set forth in this Section 2.1). Within 20 business days
following Hunter's completion of the sale of his CytRx shares (described below),
Hunter and CytRx shall provide the additional contributions of capital for
SynthRx described in this Section 2.1, with each of these contributions to be
conditioned upon the other and with the date on which such contributions are
made being referred to herein as the "Second Closing Date." The initial capital
to be provided by Hunter pursuant to this Section 2.1 (the "Hunter Capital
Contribution") shall be in the form of the foregoing Hunter Know-How and a cash
contribution to SynthRx in an amount equal to 85% of the net proceeds (after
brokerage commissions) from sale of 497,000 shares of CytRx common stock (the
"Hunter Shares") to a third party, which sale shall be effected by Hunter not
later than the 90th business day following the Effective Date. Hunter hereby
represents that, subject to applicable community property laws, he is the sole
owner of the Hunter Shares, free and clear of all liens, claims and
encumbrances, and has the right to sell and transfer all of the Hunter Shares
without the consent of any third party in a Rule 144(k) transaction under the
Securities Act of 1933. CytRx shall provide reasonable assistance to Hunter in
identifying and completing the sale of the Hunter Shares to a third party but
makes no representation or warranty as to the price per share that will be
received by Hunter or the amount of federal or state taxes that will be payable
by Hunter in connection with his sale of the Hunter Shares. CytRx will make its
capital contribution, which will be in the form of the foregoing CytRx Know-How
and a transfer of property in the form of the grant of the license described in
Section 2.2 hereof (the "CytRx Capital Contribution") with the license grant to
be made concurrently with Hunter making the cash portion of the Hunter Capital
Contribution. In consideration of the Hunter Capital Contribution and CytRx
Capital Contribution, SynthRx shall issue Hunter a number of shares of its
common stock equal to 80.1% of the total outstanding capital stock of SynthRx on
the Closing Date and shall issue CytRx a number of shares of its common stock
equal to 19.9% of the total outstanding capital stock of SynthRx on the Closing
Date.
2.2 Transfer of License for Stock and Cash Payment. On the Second
Closing Date, SynthRx shall, in consideration of the grant of the license to the
Licensed Intellectual Property set forth in Section 3.1 hereof, (i) issue CytRx
all of the shares of common stock described in Section 2.1 hereof and (ii) make
a cash payment to CytRx equal in amount to the Hunter Capital Contribution, less
$500,000 that will be retained by SynthRx for its initial working capital (the
"CytRx Cash License Payment"). The common shares issued to Hunter and CytRx
pursuant to Section 2.1 hereof shall be the only capital shares of SynthRx that
will be initially issued, and SynthRx shall as of the Closing and the Second
Closing Date have no other obligation to issue any of its securities or have any
other debt or financial obligations to Hunter other than reimbursement of actual
direct expenditures for the establishment of SynthRx, CytRx or any third party
(except for other obligations set forth in this Agreement).
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2.3 CytRx Data Transfer. CytRx will transfer to SynthRx all
regulatory filings (including, without limitation, all INDs), tangible materials
(including finished drug, work-in-progress, drug substance and drug product) and
records, notes, data and other information or know how pertaining to FLOCOR,
OptiVax and its Anti-Infectives patent portfolio. SynthRx acknowledges that
CytRx has agreed to permit TransForm Pharmaceuticals, Inc. ("TransForm") access
to and the right to reference certain existing FLOCOR data under an agreement
that has been provided to SynthRx (the "TransForm Agreement"). SynthRx agrees to
comply with the terms of the TransForm Agreement, and CytRx will be entitled to
retain any amounts payable by TransForm to CytRx under the terms of that
agreement. CytRx shall have the right to sublicense the rights to use Poloxamer
188 to TransForm Pharmaceuticals as an "excepient" in animal drug products and
with written permission from SynthRx for human drug products, and CytRx shall be
entitled to retain all license fees, royalties or other compensation generated
by such sublease. CytRx agrees to reimburse any SynthRx expenses associated with
the TransForm Agreement, including employee time.
2.4 CytRx Materials Transfer. CytRx will transfer all product and
data related to the product being stored and transferred pursuant to this
Section 2.4 covered by this Agreement to SynthRx on the Second Closing Date.
SynthRx will be assigned ownership by CytRx of all existing FLOCOR product
currently in storage and any existing polymer products related to any of the
licensed technologies, which will be held at their current storage sites at
SynthRx's expense or at SynthRx's election will be transferred to alternative
locations at SynthRx's expense. This includes FLOCOR at Xxxxxx Cold Storage, an
undetermined amount in storage at Quintiles that has been put into vials with a
buffer for clinical trial use, a small amount at HITEX in France, data and
samples in storage at Covance, and samples that are in the freezer at CytRx's
Atlanta office. The material at Xxxxxx and Quintiles will have to be retested by
SynthRx before use. SynthRx will reserve up to 2 kg of purified FLOCOR material
and will make that available at no charge to CytRx. CytRx makes no
representation or warranty as to the physical condition or usability in any
future clinical trials of any of these drug products or materials.
2.5 Hunter Know-How Transfer. Hunter will transfer to SynthRx all
information and materials related to Flocor, OptiVax and the Anti-Infectives,
including but not limited to, discoveries, improvements, processes, formulas,
dates, know-how and trade secrets, patentable or otherwise, which are in
Hunter's possession or control at the Effective Date or are developed by Hunter
alone or with others during the term of this Agreement, if any, that (i) are not
generally known, (ii) are necessary to SynthRx in connection with the research,
development, manufacture, marketing, use or sale of the Licensed Products in the
Field in the Territory, and (iii) which Hunter has the right to provide to
SynthRx.
2.6 Management of SynthRx. SynthRx shall have a Board of Directors
consisting of five members, who shall be Hunter, three additional directors
designated by Hunter and a fifth director designated by CytRx. At CytRx's sole
discretion, CytRx may, in lieu of designating a director to SynthRx Board of
Directors, designate an observer who shall be entitled to attend all SynthRx
Board of Director meetings. The Chief Executive Officer of SynthRx shall be
Hunter or an individual designated by Hunter or the SynthRx Board of Directors.
2.7 Additional Financings. CytRx shall have the right with respect
to any subsequent issuance of securities by SynthRx to maintain its then
percentage interest (19.9% on a fully
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diluted basis) in SynthRx's capital stock by purchasing up to its pro rata share
of the securities proposed to be issued so as to maintain CytRx's percentage
interest in SynthRx, upon the same financial terms as which SynthRx proposes to
issue these securities to any third party. CytRx shall be required to exercise
this pre-emptive right not later than 30 days following written notice from
SynthRx of the proposed issuance, and this pre-emptive right shall not apply to
any issuance of (i) securities offered to the public pursuant to an IPO by
SynthRx or (ii) securities issued or to be issued to officers, directors,
employees or consultants pursuant to a stock option plan, employee stock
purchase plan or other similar plan that is approved by SynthRx's Board of
Directors. SynthRx shall not initiate any action (such as the repurchase of
outstanding shares of its common stock) that would cause CytRx's ownership
percentage of SynthRx to increase to in excess of 19.9% if such increase, in the
opinion of CytRx's independent public accountants would require CytRx to
consolidate SynthRx's operating results with those of CytRx or have any other
materially adverse accounting impact on CytRx.
2.8 Right of First Refusal. In the event Hunter or his Affiliates
propose to sell or transfer any of their SynthRx securities to a third party in
a transaction not covered by Section 2.10, CytRx shall have a right of first
refusal to purchase all or any portion of those securities (the "Hunter Transfer
Shares") upon the same financial terms as proposed to be paid by the third
party. CytRx shall have 30 days from receipt of a written notice from Hunter or
his Affiliate identifying the proposed purchaser, the financial terms of the
proposed sale or transfer and all other material terms and conditions of the
proposed transaction in which to exercise this right of first refusal and to pay
for the Hunter Transfer Shares that it elects to purchase. Hunter or his
Affiliate thereafter will have 90 days to complete the sale or transfer of the
Hunter Transfer Shares not purchased by CytRx on financial and other terms no
less favorable to Hunter or his Affiliate than those set forth in the foregoing
notice.
2.9 Registration Rights. CytRx will have customary piggyback
registration rights with respect to all of its SynthRx securities. In addition,
CytRx shall have the right at any time commencing on or after 9 months from an
Initial Public Offering to require SynthRx to register on the appropriate SEC
form of registration statement any or all of CytRx's SynthRx securities for
resale or in connection with the distribution by CytRx of these securities to
its shareholders. SynthRx shall bear all of the expenses of any registration of
CytRx's SynthRx securities under this Section 2.9.
2.10 Strategic Transactions. In the event of a merger,
consolidation or sale of assets by SynthRx in which SynthRx's shareholders are
to receive any payments for or with respect to their SynthRx shares, CytRx shall
have the right to require its payment options be no less favorable than any
other shareholder. In the event SynthRx seeks to enter into any strategic
alliance, joint venture, merger or acquisition, financing, any in-licensing or
out-licensing of a technology or other similar transaction (a "Strategic
Transaction"), it may request the assistance of CytRx in structuring and
completing such Strategic Transaction. If CytRx provides this assistance,
SynthRx shall pay CytRx for this assistance an amount equal to 10% of all
consideration received or paid (including debt assumed) by SynthRx throughout
the term of the Strategic Transaction, including without limitation license
payments, milestone payments, or royalties, with any such payment to be deemed
to be an additional payment for the license granted to SynthRx under Article III
hereof. In the case of payments to CytRx for this assistance in connection with
any sublicensee of the license granted to SynthRx under Article III hereof, the
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total amount to be paid to CytRx under this Section 2.10 and under the license
shall not exceed 25% of the license fee, milestone payments and royalties paid
by the sublicensee to SynthRx.
ARTICLE III.
LICENSE
3.1 SynthRx License Grant. Subject to the payment set forth in
Section 2.2 hereof, CytRx shall grant to SynthRx effective as of the Second
Closing Date an exclusive license in the Territory, with the right to
sublicense, the Licensed Intellectual Property to research, develop, use,
manufacture, have manufactured, sell, offer to sell or have sold (i) Licensed
Products; and (ii) Opti-Vax as it relates to use in the Field. The license shall
be in the form of the License Agreement attached hereto as SCHEDULE C, which
shall be executed by SynthRx and CytRx effective as of the Closing Date.
3.2 Assignment of Hunter Intellectual Property. Hunter shall
assign to SynthRx without any further payment by SynthRx all of Hunter's rights,
title and interest in and to the Hunter Know-How effective as of the Closing
Date. Within 60 days of the Closing Date, Hunter shall make available to SynthRx
in English and in writing for its use, Hunter Know-How in Hunter's possession as
of the Closing Date, including but not limited to the embodiments of such Hunter
Know-How as set forth on the attached SCHEDULE X. Xxxxxx also warrants that he
has no pending patent applications. During the term of this Agreement Hunter
shall promptly disclose to SynthRx in writing on an ongoing basis all Hunter
Know-How not previously disclosed.
ARTICLE IV.
CONFIDENTIALITY AND PUBLICATION
4.1 Nondisclosure Obligation. All Proprietary Information
disclosed by a disclosing party to a receiving party hereunder shall be
maintained in confidence by the receiving party and shall not be disclosed to a
non-party or used for any purpose except as set forth herein without the prior
written consent of the disclosing party, except to the extent that such
Proprietary Information:
(a) is known by recipient at the time of its receipt, and
not through a prior disclosure by the disclosing party, as documented by
business records;
(b) is properly in the public domain;
(c) is subsequently disclosed to the receiving party by a
third party who may lawfully do so and is not under an obligation of
confidentiality to the disclosing party;
(d) is developed by the receiving party independently of
Proprietary Information received from the disclosing party as documented by
business records;
(e) is disclosed to governmental or other regulatory
agencies in order to obtain patents or to gain approval to conduct clinical
trials or to market Licensed Product, but such disclosure may be only to the
extent reasonably necessary to obtain patents or authorizations upon prior
review and consent of the disclosing party;
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(f) is deemed necessary by SynthRx to be disclosed to
sublicensees, agents, consultants, Affiliates, distributors and/or other third
parties for the research and development, manufacture, use sale or offer for
sale of Licensed Products (or for such parties to determine their interest in
performing such activities) in accordance with this Agreement on the condition
that such third parties agree to be bound by the confidentiality obligations
contained in this Agreement, provided the term of confidentiality for such third
parties shall be no less than ten (10) years; or
(g) is required to be disclosed by law or court order,
provided that notice is promptly delivered to the other party in order to
provide an opportunity to challenge or limit the disclosure obligations.
ARTICLE V.
TERM AND TERMINATION
5.1 Term and Expiration. This Agreement shall continue in effect
until the later of ten years from the Effective Date or expiration of all
royalty obligations under the License Agreement.
5.2 Termination for Cause. Either CytRx or Hunter may terminate
this Agreement by written notice to the other party prior to the Second Closing
Date in the event the other party fails to cure a breach of its obligations
under this Agreement within 10 days after receiving written notice of such
breach. After the Second Closing Date, either CytRx or SynthRx may terminate
this Agreement by written notice to the other party in the event the other party
fails to cure a breach of its obligations under this Agreement within 30 days
after receiving written notice of such breach. In addition to terminating this
Agreement and any other remedies that may be available to CytRx as a result of
any uncured breach by Hunter or SynthRx under this Agreement, CytRx shall be
entitled to terminate the license granted under the License Agreement.
ARTICLE VI.
MISCELLANEOUS
6.1 Assignment. This Agreement may not be assigned by Hunter or
CytRx prior to the Closing Date. After the Closing Date, CytRx or SynthRx may
assign this Agreement without the other party's consent in connection with a
merger into, a consolidation with, or a transfer of all or substantially all of
its corporate assets or the transfer of all or substantially all of the assets
related to the product line to which this Agreement pertains as an entirety or
to any corporation, partnership or other person or entity, so long as the
successor surviving person or entity in any such merger, consolidation,
partnership or other person or entity transfer or reorganization assumes in
writing the obligations of this Agreement. Such merger, consolidation, transfer
or reorganization shall not in any way be a breach of this Section 6.1, nor be a
default under this Agreement. Any permitted assignee shall assume all
obligations of its assignor under the Agreement.
6.2 Severability. In the event any one or more of the provisions
contained in this Agreement should be held invalid, illegal or unenforceable in
any respect, the validity, legality
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and enforceability of the remaining provisions contained herein shall not in any
way be affected or impaired thereby, unless the absence of the invalidated
provision(s) adversely affect the substantive rights of the parties. The parties
shall in such an instance use their best efforts to replace the invalid, illegal
or unenforceable provision(s) with valid, legal and enforceable provision(s)
which, insofar as practical, implement the purposes of this Agreement.
6.3 Notices. All notices or other communications which are
required or permitted hereunder shall be in writing and sufficient if delivered
personally, sent by telecopier (and promptly confirmed by personal delivery,
registered or certified mail or overnight courier), sent by
internationally-recognized overnight or second day courier or sent by registered
or certified mail, postage prepaid, return receipt requested, addressed as
follows:
if to CytRx, to: CytRx Corporation
00000 Xxx Xxxxxxx Xxxxxxxxx
Xxxxx 000
Xxx Xxxxxxx, Xxxxxxxxxx 00000
Attention: President & CEO
Facsimile No. (000) 000-0000
if to Hunter, to: Xxxxxx X. Xxxxxx
0000 Xxxxxx
Xxxxxxxx, XX 00000
Facsimile No.: (713) 500 - 0732
if to SynthRx, to: To be provided when SynthRx becomes
operational________________________
___________________________________
Facsimile No.: (_____)____________
or to such other address as the party to whom notice is to be given may have
furnished to the other party in writing in accordance herewith. Any such
communication shall be deemed to have been given when delivered if personally
delivered or sent by telecopier on a business day, on the business day after
dispatch if sent by nationally-recognized overnight courier and on the third
business day following the date of mailing if sent by mail.
6.4 Applicable Law. The Agreement shall be governed by and
construed in accordance with the laws of the State of Texas and the United
States without reference to any rules of conflict of laws.
6.5 Dispute Resolution. The parties shall negotiate in good faith
and use reasonable efforts to settle any dispute, controversy or claim arising
from or related to this Agreement or the breach thereof. If the parties do not
fully settle, and a party wishes to pursue the matter, each such dispute,
controversy or claim that is not an "Excluded Claim" shall be finally resolved
by binding arbitration in Las Vegas, Nevada in accordance with the Commercial
Arbitration Rules and Supplementary Procedures for Large Complex Disputes of the
American Arbitration Association ("AAA"), and judgment on the arbitration award
may be entered in any court having
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jurisdiction thereof. A panel of three persons experienced in the pharmaceutical
business shall conduct the arbitration. Within 30 days after initiation of
arbitration, each party shall select one person to act as arbitrator and the two
party-selected arbitrators shall select a third arbitrator within 30 days of
their appointment. If the arbitrators selected by the parties are unable or fail
to agree upon the third arbitrator, the AAA shall appoint the third arbitrator.
Any party may apply to the arbitrators for interim injunctive relief until the
arbitration award is rendered or the controversy is otherwise resolved. Any
party also may, without waiving any remedy under this Agreement, seek from any
court having jurisdiction any injunctive or provisional relief necessary to
protect the rights or property of that party pending the arbitration award. The
arbitrators shall have no authority to award punitive or any other type of
damages not measured by a party's compensatory damages. Each party shall bear
its own costs and expenses and attorneys' fees and an equal share of the
arbitrators' and any administrative fees of arbitration. Except to the extent
necessary to confirm an award or as may be required by law, neither a party nor
an arbitrator may disclose the existence, content, or results of an arbitration
without the prior written consent of both parties. In no event shall an
arbitration be initiated after the date when commencement of a legal or
equitable proceeding based on the dispute, controversy or claim would be barred
by the applicable Texas statute of limitations. As used in this Section, the
term "Excluded Claim" shall mean a dispute, controversy or claim that concerns
(a) the validity or infringement of a patent, trademark or copyright; or (b) any
antitrust, anti-monopoly or competition law or regulation, whether or not
statutory.
6.6 Entire Agreement. This Agreement contains the entire
understanding of the parties with respect to the subject matter hereof. All
express or implied agreements and understandings, either oral or written,
heretofore made are expressly merged in and made a part of the Agreement. The
Agreement may be amended, or any term hereof modified, only by a written
instrument duly executed by each of the parties hereto.
6.7 Headings. The captions to the several Articles and Sections
hereof are not a part of the Agreement, but are merely guides or labels to
assist in locating and reading the several Articles and Sections hereof.
6.8 Independent Contractors. It is expressly agreed that the
parties shall be independent contractors and that the relationship between the
parties shall not constitute a partnership, joint venture or agency. No 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 any other party,
without the prior consent of the other party.
6.9 Waiver. The waiver by either party hereto of any right
hereunder or the failure to perform or of a breach by the other party shall not
be deemed a waiver of any other right hereunder or of any other breach or
failure by said other party whether of a similar nature or otherwise.
6.10 Counterparts. The Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
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6.11 Waiver of Rule of Construction. Each party has had the
opportunity to consult with counsel in connection with the review, drafting and
negotiation of this Agreement. Accordingly, the parties agree that the rule of
construction that any ambiguity in this Agreement shall be construed against the
drafting party shall not apply.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first set forth above.
/s/ XXXXXX X. XXXXXX
--------------------------------
Xx. Xxxxxx X. Xxxxxx
Date: October 21, 2003
--------------------------
CYTRX CORPORATION
By: /s/ XXXXXX X. XXXXXXXXX
---------------------------
Title:
------------------------
Date:
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SCHEDULE A
PATENTS & LICENSES
U.S. PATENT
5,554,372 (subject to U.S. government regulations)
5,990,241
6,086,899
RE 36,665
5,567,859
5,696,298
5,824,322
Pending application 90/104,088
RELATED FOREIGN PATENTS
WO96/04932
U.S. PATENT
5,234,683
5,114,708
5,824,322
RELATED FOREIGN PATENTS
596,986 Australia 000 Xxxxx
1,279,822 Canada 228,448 France
36,564 Chile 228,448 United Kingdom
96,104,742 China 176,179 Mexico
228,448 Germany 228,448 Netherlands
228,448 EPO 864,556 South Africa
A - 1
LICENSE AGREEMENTS
AGREEMENT DATE
--------- ----
TiterMax, USA, Inc. June 15, 2000
Merck & Co. November 1, 2000
Ivy Animal Health February 16, 2001
Vical Incorporated December 7, 2001
PSMA Development Co., LLC December 23, 2002
(option agreement)
TransForm Pharmaceuticals, Inc. April 22, 2003
A-2
SCHEDULE B
HUNTER PATENT RIGHTS
None
B - 1
SCHEDULE C
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this "Agreement") is made and is effective as
of ______ ___, 2003, (the "Effective Date") between SynthRx, Inc. a Texas
corporation ("SynthRx") and CytRx Corporation, a Delaware corporation ("CytRx")
with reference to the following facts:
A. CytRx has developed CytRx Know-How (as hereinafter defined)
and has CytRx Patent Rights (as hereinafter defined) in the fields of:
(i) the composition and use of surface-active copolymers
exemplified by poloxamer 188 to treat ischemic or damaged tissue, myocardial
damage, stroke, pathological hydrophobic interactions in biological fluids,
tissue damaged by reperfusion injury, sickle cell disease, cancer and in
performing angioplasty procedures (with the CytRx Know-How and CytRx Patent
Rights in this field referred to collectively as the "FLOCOR Intellectual
Property");
(ii) the composition and use of surface active copolymers
(exemplified by poloxamers, reverse poloxamers and diether, diester or diamide
fatty acid conjugates of poloxyethylene) to treat infections caused by
microorganisms, including bacteria, fungi, and viruses and to treat tumors (with
the CytRx Know-How and CytRx Patent Rights in this field referred to
collectively as the "Anti-Infectives Intellectual Property"); and
(iii) conventional vaccine adjuvants exemplified by
poloxamer P1005 (with the CytRx Know-How and CytRx Patent Rights in this field
referred to collectively as the "OptiVax Intellectual Property").
B. CytRx has exclusively licensed to Merck & Co. ("Merck), Ivy
Animal Health, Inc. ("Ivy Animal Health"), TiterMax USA, Inc. ("TiterMax") and
Vical Inc. ("Vical") and has granted an option to acquire an exclusive license
to Progenics Pharmaceuticals, Inc. ("Progenics"), CytRx Know-How and CytRx
Patent Rights in certain fields under agreements collectively referred to as the
CytRx Licenses, copies of which are attached hereto as SCHEDULE A.
C. Xx. Xxxxxx X. Xxxxxx ("Xxxxxx") has previously participated in
the development of most of the poloxamer technology that is the subject of the
Licensed Intellectual Property (as hereinafter defined) and has developed Hunter
Know-How (as hereinafter defined) and has no Hunter Patent Rights (as
hereinafter defined).
D. CytRx and SynthRx wish to continue the development and
subsequent commercialization of the FLOCOR Intellectual Property, the
Anti-Infectives Intellectual Property and the OptiVax Intellectual Property
(collectively referred to as the "Licensed Intellectual Property") pursuant to a
license to the Licensed Intellectual Property to be granted by CytRx to SynthRx
and upon the terms and conditions set forth herein.
C - 1
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the parties hereby agree as follows:
ARTICLE I.
DEFINITIONS
Unless specifically set forth to the contrary herein, the following
terms, whether used in the singular or plural, shall have the respective
meanings set forth below:
1.1 The term "Affiliate" shall mean (i) any corporation or
business entity of which 50% or more of the securities or other ownership
interests representing the equity, the voting stock or general partnership
interest are owned, controlled or held, directly or indirectly, by SynthRx,
Hunter or CytRx; or (ii) any corporation or business entity which, directly or
indirectly, owns, controls or holds 50% or more of the securities or other
ownership interests representing the equity or the voting stock of SynthRx or
CytRx.
1.2 The term "Anti-Infectives" shall mean
polyoxypropylene/polyoxyethylene copolymers and other polyoxyethylene conjugates
having therapeutic activity or having the ability to enhance the therapeutic
activity of other agents against infective organisms, including bacteria,
viruses and fungi.
1.3 The term "Calendar Quarter" shall mean the respective periods
of three consecutive calendar months ending on March 31, June 30, September 30
and December 31.
1.4 The term "Calendar Year" shall mean each successive period of
twelve consecutive calendar months commencing on January 1 and ending on
December 31.
1.5 The term "CytRx Know-How" shall mean information and
materials, including but not limited to, discoveries, Improvements, processes,
formulas, data, know-how and trade secrets, patentable or otherwise, which (i)
are in CytRx's possession or control at the Effective Date or are developed by
CytRx during the term of this Agreement, if any, (ii) are not generally known,
(iii) are necessary to SynthRx in connection with the research, development,
marketing, use or sale of Licensed Products in the Field in the Territory, and
(iv) CytRx has the right to provide to SynthRx.
1.6 The term "CytRx Licenses" shall mean the previously entered
into exclusive license agreements between CytRx and Merck, Ivy Animal Health,
TiterMax and Vical and the exclusive license agreement to be entered into
between CytRx and Progenics upon Progenics exercising the option granted to it
by CytRx for certain CytRx Know-How and CytRx Patent Rights for certain fields
as defined in each license agreement listed in SCHEDULE A.
1.7 The term "CytRx Patent Rights" shall mean (i) all United
States or foreign patents or patent applications, and patents to be issued
pursuant thereto, owned by or licensed to CytRx, pertaining to Flocor, the
Anti-Infectives or Optivax, excluding the use in certain fields that are covered
in the CytRx Licenses listed in SCHEDULE A hereto; or (ii) are divisions,
continuations, reissues, renewals, extensions, supplementary protection
certificates, utility models and the like of any such United States patents and
patent applications and foreign equivalents thereof.
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1.8 The term "Field" shall mean the use of Licensed Intellectual
Property in all fields for FLOCOR, Anti-Infectives and OptiVax Agreements,
except for those fields of use that are or will be licensed under the CytRx
Licenses set forth in recital A to this Agreement.
1.9 The term "FLOCOR" shall mean surface-active copolymers of an
ethylene oxide-propylene oxide condensation products that have cytoprotective,
rheologic and antithrombotic activities exemplified by poloxamer 188.
1.10 The term "Hunter Know-How" shall mean information and
materials, including but not limited to, discoveries, Improvements, processes,
formulas, dates, know-how and trade secrets, patentable or otherwise, which are
in Hunter's possession or control at the Effective Date or are developed by
Hunter alone or with others during the term of this Agreement, if any, (i) are
not generally known, (ii) are necessary to SynthRx in connection with the
research, development, marketing, use or sale of the Licensed Products in the
Field in the Territory, and (iii) which Hunter has the right to provide to
SynthRx.
1.11 The term "Hunter Patent Rights" shall mean (i) all United
States or foreign patents or patent applications and patents to be issued
pursuant thereto, owned by or licensed to Hunter, including but not limited to
those listed in Schedule B hereto; or (ii) are divisions, continuations,
reissues, renewals, extensions, supplementary protection certificates, utility
models and the like of any such United States patents and patent applications
and foreign equivalents thereof in the fields of FLOCOR, the Anti-Infectives and
OptiVax.
1.12 The term "Improvement" shall mean any improvement or
enhancement by SynthRx, CytRx or Hunter to any of the Licensed Intellectual
Property, including without limitation in the synthesis, purification or
manufacture of FLOCOR, OptiVax or the Anti-Infectives.
1.13 The term "Licensed Product" shall mean a Product for use in
the Field, that in the absence of this Agreement would infringe one or more
claims of the CytRx Patent Rights or Hunter Patent Rights, or a Product that is
made using a process or method covered by one or more claims of the CytRx Patent
Rights or Hunter Patent Rights.
1.14 The term "Major Market Country" shall mean the United States,
Japan or one half of the countries of the European Union.
1.15 The term "Net Sales" shall mean with respect to any Licensed
Product, the gross sales price of such Licensed Product invoiced by SynthRx or
Affiliates to customers who are not Affiliates (or are Affiliates but are end
users of such Licensed Product) less, to the extent actually paid or accrued by
SynthRx or Affiliates (as applicable), (a) normal and customary credits,
allowances, discounts and rebates to, and chargebacks from the account of, such
customers for spoiled, damaged, out-dated or returned Licensed Product; (b)
normal and customary outer packing, freight and insurance costs incurred in
transporting such Licensed Product to such customers; (c) normal and customary
cash, quantity and trade discounts, rebates and other price reductions for such
Licensed Product given to such customers; (d) sales, use, excise, value-added
and other taxes (but not income taxes of any kind) imposed upon the sale of such
Licensed Product in final form to such customers; and (e) customs duties,
surcharges and
C - 3
other governmental charges incurred in exporting or importing such Licensed
Product to such customers.
In the case of a Combination Product, as defined below, for which the
agent or ingredient constituting a Licensed Product and each of the other active
agents or active ingredients not constituting a Licensed Product have
established market prices when sold separately, Net Sales shall be determined by
multiplying the Net Sales for each such Combination Product by a fraction, the
numerator of which shall be the established market price for the Licensed
Product contained in the Combination Product and the denominator of which shall
be the sum of the established market prices for the Licensed Product plus the
other active agents or active ingredients contained in the Combination Product.
When such separate market prices are not established, then the parties shall
negotiate in good faith to determine a fair and equitable method of calculating
Net Sales for the Combination Product in question. For purposes of the
foregoing, "Combination Product" shall mean any product containing both an agent
or ingredient, which constitutes a Licensed Product and one or more other active
agents which do not by themselves constitute Licensed Products, whether such
Combination Product is packaged separately but sold together or are both
packaged and sold together.
1.16 The term "OptiVax" shall mean novel
polyoxyethylene/polyoxypropylene copolymers that are high molecular weight
molecules and are useful as vaccine adjuvants.
1.17 The term "Organization Agreement", shall mean the Agreement
dated as of October 20, 2003, by and among CytRx, SynthRx and Hunter.
1.18 The term "Phase I Clinical Trial" shall mean that portion of
the clinical development program, which includes one or more trials of a
Licensed Product on human patients to estimate initial safety and tolerability
for the desired claims and indications.
1.19 The term "Phase II Clinical Trial" shall mean that portion of
the clinical development program conducted after the completion of the required
Phase I Clinical Trials and which includes one or more human clinical trials,
which trials are intended to evaluate the safety and effectiveness of a Licensed
Product for a particular indication or indications in patients with the disease
or indication under study or that would otherwise satisfy the requirements of 21
CFR 312.21(b), any future revisions thereof, any future substitutes therefor, or
foreign equivalents thereof.
1.20 The term "Phase III Clinical Trial" shall mean that portion of
the clinical development program which includes one or more human clinical
trials, the results of which could be used to establish the safety and efficacy
of a Licensed Product as a basis for a NDA or that would otherwise satisfy
requirements of 21 CFR 312.21(c), any future revisions thereof, any future
substitutes therefor, or foreign equivalents thereof.
1.21 The term "Product" shall mean any prescription or
over-the-counter prophylactic, diagnostic or therapeutic product, vaccine or
medical device for use in the Field in the Territory.
1.22 The term "Proprietary Information" shall mean all SynthRx
Know-How, Hunter Know-How and CytRx Know-How, and all other scientific,
clinical, regulatory, marketing, financial and commercial information or data,
whether communicated in writing or orally or by
C - 4
sensory detection, which is provided by one party to the other party in
connection with this Agreement.
1.23 The term "Regulatory Approval" shall mean notification from
the United States Food and Drug Administration or a comparable regulatory
authority in a country that all approvals for the marketing of a Licensed
Product, including pricing approvals, have been granted.
1.24 The term "SynthRx Know-How" shall mean any SynthRx information
and materials, including but not limited to, discoveries, Improvements,
processes, formulas, data, inventions, know-how and trade secrets, patentable or
otherwise, which during the term of this Agreement are not generally known.
1.25 The term "Territory" shall mean all of the countries in the
world.
1.26 The term "separately branded Licensed Products" shall mean two
or more Licensed Products that are not interchangeable. It does not include
different dosage forms, modified labeling or different names used in conjunction
with different languages.
ARTICLE II.
LICENSE; DEVELOPMENT AND COMMERCIALIZATION
2.1 SynthRx License Grant. CytRx hereby grants to SynthRx
effective as of the Effective Date an exclusive license to CytRx Patent Rights
in the Territory with the right to sublicense the Licensed Intellectual Property
to research, develop, use, manufacture, have manufactured, sell, offer to sell
or have sold (i) Licensed Products; and (ii) OptiVax as it relates to use in the
Field.
2.2 Exchange of Information; Supply of Material.
(a) Initial Data Transfer. CytRx shall make available to
SynthRx on or prior to the Closing Date in English and in writing for its use,
CytRx Know-How in CytRx's possession as of the Closing Date (as defined in the
Organization Agreement), including but not limited to the embodiments of such
CytRx Know-How as set forth on the attached SCHEDULE C. CytRx also agrees to
disclose to SynthRx, upon execution of this Agreement CytRx's pending United
States patent applications, if any. CytRx shall also transfer to SynthRx within
60 days of the Closing Date copies of all regulatory filings (including without
limitation IND's) and data pertaining to FLOCOR, OptiVax and CytRx's
Anti-Infectives patent portfolio.
(b) Additional Data Transfer. During the term of this
Agreement and so long as SynthRx continues to have an obligation to pay
royalties to CytRx under this Agreement, CytRx shall promptly disclose to
SynthRx in writing on an ongoing basis all CytRx Know-How not previously
disclosed.
(c) Reports. During the term of this Agreement, and upon
written request from CytRx, but not more than once per Calendar Year, SynthRx
agrees to provide CytRx with a written report summarizing research and
development activities related to the Licensed Intellectual Property over the
previous Calendar Year.
C - 5
(d) Sublicense Agreements. SynthRx shall provide to CytRx
a copy of all sublicense agreements pertaining to Licensed Intellectual Property
within 30 days of execution.
(e) Supply of Flocor and other drug product. CytRx shall
assign ownership to SynthRx on or before the Second Closing Date (as defined in
the Organization Agreement) of all of its drug product relating to OptiVax, the
Anti-Infectives and FLOCOR, including FLOCOR finished drug product, work in
progress drug product and drug substance in accordance with the provisions of
the Organization Agreement but makes no representation or warranty as to the
physical condition or usability in future clinical trials of any of these drug
materials. CytRx also agrees to sell to SynthRx all equipment owned by CytRx
that is located at the Organichem Corp. facility and to use its commercially
reasonable best efforts to negotiate on behalf of SynthRx a new supply agreement
for FLOCOR with Organichem Corp. If SynthRx accepts the equipment at Organichem
Corp., SynthRx will pay a one time payment to CytRx of $200,000. This amount
will be due at the time of first commercial sale of a product produced by the
Organichem facility for SynthRx.
2.3 Development and Commercialization. SynthRx shall use its
commercially reasonable best efforts at its own expense, to develop and
commercialize Licensed Products in the Territory and to maximize the sales of
Licensed Products. SynthRx shall provide CytRx with summaries of all of its
development plans for Licensed Products as well as copies of all material
correspondence with the FDA and other foreign regulatory authorities with
respect to the development, manufacture and sale of Licensed Products.
ARTICLE III.
CONFIDENTIALITY AND PUBLICATION
3.1 Nondisclosure Obligation. All Proprietary Information
disclosed by a disclosing party to a receiving party hereunder shall be
maintained in confidence by the receiving party and shall not be disclosed to a
non-party or used for any purpose except as set forth herein without the prior
written consent of the disclosing party, except to the extent that such
Proprietary Information:
(a) is known by recipient at the time of its receipt, and
not through a prior disclosure by the disclosing party, as documented by
business records;
(b) is properly in the public domain;
(c) is subsequently disclosed to the receiving party by a
third party who may lawfully do so and is not under an obligation of
confidentiality to the disclosing party;
(d) is developed by the receiving party independently of
Proprietary Information received from the disclosing party as documented by
business records;
(e) is disclosed to governmental or other regulatory
agencies in order to obtain patents or to gain approval to conduct clinical
trials or to market Licensed Product, but such disclosure may be only to the
extent reasonably necessary to obtain patents or authorizations upon prior
review and consent of the disclosing party;
C - 6
(f) is deemed necessary by SynthRx to be disclosed to
sublicensees, agents, consultants, Affiliates, distributors and/or other third
parties for the research and development, manufacture, use sale or offer for
sale of Licensed Products (or for such parties to determine their interest in
performing such activities) in accordance with this Agreement on the condition
that such third parties agree to be bound by the confidentiality obligations
contained in this Agreement, provided the term of confidentiality for such third
parties shall be no less than ten (10) years; or
(g) is required to be disclosed by law or court order,
provided that notice is promptly delivered to the other party in order to
provide an opportunity to challenge or limit the disclosure obligations.
ARTICLE IV.
PAYMENTS; ROYALTIES AND REPORTS
4.1 Initial Payment. In partial consideration for the license
granted pursuant to Section 2.1 hereof under the Licensed Intellectual Property,
upon the terms and conditions contained herein, SynthRx shall pay to CytRx on
the Effective Date the CytRx cash license payment provided for by Section 2.2 of
the Organization Agreement. This cash payment shall be non-refundable and not
creditable against the royalty or other payments called for by Section 4.2 or
Section 4.3 hereof
4.2 Milestone Payments. Subject to the terms and conditions in
this Agreement and as further consideration for the license granted herein,
SynthRx shall pay to CytRx the following milestone payments, which shall be
non-refundable and not creditable against the royalty called for under Section
4.3 hereof:
(a) With respect to the development of Licensed Products
being developed by SynthRx or an affiliate based on FLOCOR Intellectual
Property:
(i) A {***} payment for the first Major Market
Country upon obtaining Regulatory Approval and first commercial sale due to such
approval in that country.
(ii) For each additional separately branded
License Product:
A {***} payment for the first Major Market
Country in which a Regulatory Approval is obtained, upon the securing the first
commercial sale due to such approval.
(b) With respect to the development of Licensed Products
being developed by SynthRx or an affiliate based on Anti-Infectives Intellectual
Property:
(i) A {***} payment for the first Major Market
Country in which Regulatory Approval is obtained, upon the securing the first
commercial sale due to such approval.
C - 7
(ii) For each additional separately branded
Licensed Product:
A {***} payment for the first Major Market
Country in which a Regulatory Approval is obtained, upon the securing the first
commercial sale due to such approval.
Except as otherwise provided above, SynthRx shall notify CytRx in writing within
30 days upon the achievement of each milestone. Payment shall be divided and
spread over time, as follows: {***} will be due on market introduction; the
remaining {***} will be payable over time at a rate of 25% of net sales
quarterly as set forth in the reports described in Section 4.3.3 hereof until
the total amount specified is paid.
4.3 Royalties.
4.3.1 Royalties Payable By SynthRx. Subject to the terms
and conditions of this Agreement, SynthRx shall pay to CytRx royalties for sales
by SynthRx or an affiliate of Licensed Product on a country-by-country basis in
an amount equal to:
(a) Subject to Paragraph 4.3.1(b) below, for Net Sales by
SynthRx or Affiliates of Licensed Products sold:
(i) under the license to FLOCOR Intellectual
Property granted under Section 2.1(a) hereof, a royalty of {***}.
(ii) under the license for Anti-Infectives
Intellectual Property granted under Section 2.1(a) hereof, a royalty of {***};
and
(iii) under the license for OptiVax Intellectual
Property granted under Section 2.1(a) hereof, a royalty of {***}.
(b) If in any country, the total royalty payments on a
Licensed Product (including royalties payable to CytRx) being paid by SynthRx or
its Affiliates exceeds double the royalty obligation to CytRx, the royalty to
CytRx for such country shall be reduced by the formula set forth below, provided
that in no event shall the royalty payable to CytRx be reduced by more than 50%
on a country-by-country basis. It is understood that royalty reductions are
intended to be equitably applied to all of SynthRx's licensors of technology
related to Licensed Products. If SynthRx concludes that a royalty reduction
formula is applicable, SynthRx shall inform CytRx of the total amount of its
royalty burden on Licensed Product. SynthRx represents and warrants that as of
the Effective Date, it has no reason to know that total royalty payments on
Licensed Products will exceed 10%.
Formula. The amount payable to CytRx will be the larger of (1)
the contracted royalty to CytRx multiplied by the fraction that is double the
total royalty obligation of SynthRx or (2) 50% of the contracted royalty to
CytRx.
Example: CytRx royalty is {***} and total royalty burden on Licensed
Product is 30%. Royalty due CytRx would be as follows: {***} multiplied
by {***}. This is {***}.
C - 8
(c) Royalties on Licensed Product at the rates set forth
in this Section 4.3.1 shall be effective as of the date of first commercial sale
of Licensed Product in a country and shall continue for the longer of 7 years
from the first commercial sale of Licensed Product in that country or until the
expiration of the last applicable patent on Licensed Product in such country in
the case of sales under Subsection 4.3.1 (unless a generic equivalent for
Licensed Product is then being marketed in such country, in which case the
royalty rate will be reduced by 50%) subject to the following conditions.
(A) that only one royalty shall be due
under this Agreement with respect to the each unit of Licensed Product;
(B) that no royalties shall be due upon
the sale or other transfer among SynthRx or its Affiliates, but in such cases
the royalty shall be due and calculated upon SynthRx's or its Affiliate's Net
Sales; no royalties shall accrue on the disposition of Licensed Product by
SynthRx or its Affiliates as samples (promotion or otherwise) or as donations
(for example, to non-profit institutions, government agencies for a
non-commercial purpose); and
(C) sales of Licensed Product by
SynthRx, any Affiliate of SynthRx or any sublicensee or distributor of SynthRx
solely for research or clinical testing or for indigent or similar public
support or compassionate use programs, which sales are made at or below the cost
of goods of such Licensed Product or at or below the cost of purchasing such
Licensed Product from a third party manufacturer if such Licensed Product is so
purchased by SynthRx (plus, in each case, the costs of shipping and
administration of such clinical, indigent or compassionate use program) shall be
excluded from the computation of Net Sales.
4.3.2 Royalty Payable Under Managed Pharmaceutical
Contract. It is understood by the parties that SynthRx may sell Licensed Product
to an independent third party (such as a retailer or wholesaler) and may
subsequently perform services relating to Licensed Products under a managed
pharmaceutical benefits contract or other similar contract. In such cases, it is
agreed by the Parties that Net Sales shall be based on the invoice price to an
independent retailer or wholesaler, provided that such invoice price represents
a fair market price for such Licensed Products.
4.3.3 Reports; Payment of Royalty. During the term of this
Agreement following the first commercial sale of a Licensed Product, SynthRx
shall furnish to CytRx a quarterly written report for the Calendar Quarter
showing the sales of all Licensed Products subject to royalty payments sold by
SynthRx, its Affiliates and its sublicensees in the Territory during the
reporting period and the royalties payable under this Agreement. Reports shall
be due on the 45th day following the close of each Calendar Quarter. Royalties
shown to have accrued by each royalty report shall be due and payable on the
date such royalty report is due. SynthRx shall keep complete and accurate
records in sufficient detail to enable the royalties payable hereunder to be
determined.
4.3.4 Audits.
(a) Upon the written request of CytRx and not more than
once in each Calendar Year, SynthRx shall permit an independent certified public
accounting firm of
C - 9
nationally recognized standing selected by CytRx and reasonably acceptable to
SynthRx, at CytRx's expense, to have access during normal business hours to such
of the records of SynthRx as may be reasonably necessary to verify the accuracy
of the royalty reports hereunder for any year ending not more than 24 months
prior to the date of such request. The accounting firm shall disclose to CytRx
only whether the royalty reports are correct or incorrect and the specific
details concerning any discrepancies. No other information shall be provided to
CytRx.
(b) If such accounting firm correctly concludes that
additional royalties were owed during such period, SynthRx shall pay the
additional royalties within 30 days of the date CytRx delivers to SynthRx such
accounting firm's written report so correctly concluding, and will also pay the
fees charged by such accounting firm. In addition, if the additional royalties
found due exceed 5% of the amounts paid, the SynthRx will pay CytRx interest on
such additional royalties at the rate of prime rate plus 2% (as published in the
Wall Street Journal on the last Friday of the month) from the date such
additional royalties were due to the date such additional royalties are paid.
(c) SynthRx shall include in each sublicense granted by
it pursuant to this Agreement a provision requiring the sublicensee to make
reports to SynthRx, to keep and maintain records of sales made pursuant to such
sublicense and to grant access to such records by CytRx's independent accountant
to the same extent required of SynthRx under this Agreement. Upon the expiration
of 24 months following the end of any year, the calculation of royalties payable
with respect to such year shall be binding and conclusive upon CytRx, and
SynthRx and its sublicensees shall be released from any liability or
accountability with respect to royalties for such year.
(d) CytRx shall treat all financial information subject
to review under this Section 4.3.4 or under any sublicense agreement in
accordance with the confidentiality provisions of this Agreement, and shall
cause its accounting firm to enter into an acceptable confidentiality agreement
with SynthRx obligating it to retain all such financial information in
confidence pursuant to such confidentiality agreement.
4.3.5 Payment Exchange Rate. All payments to be made by
SynthRx to CytRx under this Agreement shall be made in United States dollars and
may be paid by check made to the order of CytRx or bank wire transfer in
immediately available funds to such bank account in the United States designated
in writing by CytRx from time to time. In the case of sales outside the United
States, the rate of exchange to be used in computing the amount of currency
equivalent in United States dollars shall be made according to the prevailing
rate of exchange on the last business day of the month in which such sales were
recorded as published in the Wall Street Journal.
4.3.6 Income Tax Withholding. If laws, rules or regulations
require withholding of income taxes or other taxes imposed upon payments set
forth in this Article IV, SynthRx shall make such withholding payments as
required and subtract such withholding payments from the payments set forth in
this Article IV. SynthRx shall submit appropriate proof of payment of the
withholding taxes to CytRx within a reasonable period of time.
C - 10
4.3.7 Sublicense Income. If SynthRx elects to sublicense
CytRx Patent Rights as provided for in Section 2.1, then after such sublicense
the milestone payments (Section 4.2) and royalties (Section 4.3) will not apply
to any Licensed Product sold by the sublicensee. Instead, SynthRx shall pay
CytRx an amount equal to {***} of any sublicensing income that it receives from
any third party within 30 days after receiving the sublicense payment from the
sub licensee. Sublicense income includes all payments received by SynthRx in
consideration of any sublicense of the rights granted to SynthRx by CytRx
pursuant to Section 2.1 hereof, including without limitation, license fees,
royalties, milestone payments, license maintenance fees and strategic alliance
payments, whether in cash, equity or other property, with the payment by SynthRx
to CytRx to be in the same form as the payment received by SynthRx.
ARTICLE V.
REPRESENTATIONS AND DISCLAIMER OF WARRANTIES
5.1 NOTHING IN THIS AGREEMENT SHALL BE DEEMED TO BE A
REPRESENTATION OR WARRANTY BY CYTRX OF THE VALIDITY OF ANY OF THE PATENTS OR THE
ACCURACY, SAFETY, OR USEFULNESS FOR ANY PURPOSE, OF ANY CYTRX KNOW-HOW AND ANY
OTHER TECHNICAL INFORMATION, TECHNIQUES, OR PRACTICES AT ANY TIME MADE AVAILABLE
BY CYTRX. CYTRX SHALL HAVE NO LIABILITY WHATSOEVER TO SYNTHRX OR ANY OTHER
PERSON FOR OR ON ACCOUNT OF ANY INJURY, LOSS, OR DAMAGE, OF ANY KIND OR NATURE,
SUSTAINED BY, OR ANY DAMAGE ASSESSED OR ASSERTED AGAINST, OR ANY OTHER LIABILITY
INCURRED BY OR IMPOSED UPON SYNTHRX OR ANY OTHER PERSON, ARISING OUT OF OR IN
CONNECTION WITH OR RESULTING FROM (a) THE PRODUCTION, USE, OR SALE OF ANY
PRODUCT, OR THE PRACTICE OF THE PATENT RIGHTS AND/OR CYTRX KNOW-HOW; (b) THE USE
OF ANY CYTRX KNOW-HOW OR ANY OTHER TECHNICAL INFORMATION, TECHNIQUES, OR
PRACTICES DISCLOSED BY CYTRX; OR (c) ANY ADVERTISING OR OTHER PROMOTIONAL
ACTIVITIES BY SYNTHRX WITH RESPECT TO ANY OF THE FOREGOING.
ARTICLE VI.
INVENTIONS AND PATENT PROVISIONS
6.1 Filing, Prosecution and Maintenance of Patents. SynthRx, at
its own expense shall have primary responsibility for filing, prosecuting, and
maintaining any and all CytRx Patent Rights, including any Improvements to the
CytRx Patent Rights. SynthRx shall have the right to determine whether or not,
and where to abandon the prosecution of any patent or patent application, to
discontinue the maintenance of any patent or patent application, or to seek
patent term restoration or supplemental protection certificates or their
equivalents in any country in the Territory where applicable to patents. SynthRx
shall provide CytRx with copies of all material correspondence and filings with
the U.S. Patent and Trademark Office and any foreign patent office. CytRx may,
at its own expense, file for or maintain any patent that SynthRx elects to not
pursue or to abandon, in which case such patent shall be excluded from the CytRx
Patent Rights that are licensed to SynthRx. However, some CytRx patents are
overlapping, providing multiple layers of protection. SynthRx may elect to
abandon such patents that are deemed not necessary for protection of the
technology. Consequently, if CytRx files for or maintains any patent that
C - 11
SynthRx elects to not pursue or to abandon, then CytRx agrees not to enforce
that patent against any activities of SynthRx permitted by this Agreement that
are protected by patents that SynthRx has elected to maintain.
6.2 Interference, Opposition, Reexamination and Reissue.
(a) CytRx and SynthRx shall, within ten 10 days of
learning of such event, inform the other party of any request for, or filing or
declaration of any interference, opposition, or reexamination relating to any of
the CytRx Patent Rights. SynthRx and CytRx shall thereafter consult and
cooperate fully to determine a course of action with respect to any such
proceeding, with SynthRx having primary responsibility, at its own expense, for
implementing such agreed upon action.
(b) SynthRx shall not institute any reexamination, or
reissue proceeding relating to any of the CytRx Patent Rights without the prior
written consent to CytRx, which consent shall not be unreasonably withheld.
(c) In connection with any interference, opposition,
reissue, or reexamination proceeding relating to any of the CytRx Patent Rights,
SynthRx and CytRx will cooperate fully and will provide each other with any
information or assistance that either may reasonably request. SynthRx shall keep
CytRx informed of developments in any such action or proceeding, including, to
the extent permissible, the status of any settlement negotiations and the terms
of any offer related thereto.
6.3 Enforcement Rights.
(a) CytRx and SynthRx shall give each other notice of
either (i) any infringement of any of the CytRx Patent Rights, or (ii) any
misappropriation or misuse of CytRx Know-How, that may come to CytRx's or
SynthRx's attention. SynthRx and CytRx shall thereafter consult and cooperate
fully to determine a course of action, including but not limited to the
commencement of legal action by SynthRx at its own expense to terminate any
infringement of any of the CytRx Patent Rights or any misappropriation or misuse
of CytRx Know-How. SynthRx shall promptly inform CytRx if SynthRx elects not to
exercise its right to commence legal action and CytRx shall thereafter have the
right, but not the obligation, to either initiate and prosecute such action.
(b) In the event that SynthRx elects not to initiate and
prosecute an action as provided in paragraph (a), and CytRx elects to do so, the
costs of any course of action to terminate infringement of any of the CytRx
Patent Rights or misappropriation or misuse of CytRx Know-How, including the
costs of any legal action commenced shall be shared equally by CytRx and
SynthRx.
(c) For any action to terminate any infringement of any
of the CytRx Patent Rights or any misappropriation or misuse of CytRx Know-How,
in the event that SynthRx is unable to initiate or prosecute such action solely
in its own name, CytRx will join such action voluntarily and will execute and
cause its Affiliates to execute all documents necessary for SynthRx to initiate
litigation to prosecute and maintain such action. In connection with any action,
SynthRx and CytRx will cooperate fully and will provide each other with any
information
C - 12
or assistance that either may reasonably request. Each party shall keep the
other informed of developments in any action or proceeding, including, to the
extent permissible by law, the status of any settlement negotiations and the
terms of any offer related thereto.
(d) Any recovery obtained by either SynthRx or CytRx in
connection with or as a result of any action contemplated by this section,
whether by settlement or otherwise, shall be shared in order as follows:
(i) the party which initiated and prosecuted the
action shall recoup all of its costs and expenses incurred in connection with
the action;
(ii) the other party or parties shall then, to
the extent possible, recover its costs and expenses incurred in connection with
the action; and
(iii) the amount of any recovery remaining shall
then be allocated between the parties on a pro rata basis under which CytRx
shall receive a proportion based on the royalties it lost and SynthRx shall
receive any remaining amounts.
(e) CytRx shall immediately give notice to SynthRx of any
certification regarding any Patent Rights it has received pursuant to the United
States "Drug Price Competition and Patent Term Restoration Act of 1984" under
either 21 U.S.C. Sections 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or equivalent
foreign provision and shall provide SynthRx with a copy of such certification
within 5 days of receipt. CytRx's and SynthRx's rights with respect to the
initiation and prosecution of any legal action as a result of such certification
or any recovery obtained as a result of such legal action shall be defined in
paragraphs (a)-(d) hereof; provided, however, if SynthRx decides not to bring
infringement proceedings against the entity making such a certification, SynthRx
shall give notice to CytRx of such decision not to bring suit within 30 days
after receipt of notice of such certification. CytRx may then, but is not
required to, bring suit against the party that filed the certification. Any such
suit by SynthRx or CytRx shall either be in the name of SynthRx or in the name
of CytRx, or jointly.
6.4 Patent Term Restoration. SynthRx and CytRx shall cooperate
with each other in obtaining patent term restoration or supplemental protection
certificates or their equivalents in any country in the Territory where
applicable to the CytRx Patent Rights. SynthRx shall have the opportunity to
make any election with respect to obtaining such patent term restoration to the
extent possible and shall bear the cost thereof, which shall be fully creditable
toward any future royalty payments owed by SynthRx pursuant to Section 5.3
hereof.
6.5 Patent Markings. SynthRx agrees to xxxx the Licensed Products
and OptiVax sold in the United States with all applicable United States patent
numbers. All Licensed Products and OptiVax shipped to or sold in other countries
shall be marked in such a manner as to conform with the patent laws and practice
of the country of manufacture or sale.
C - 13
ARTICLE VII.
TERM AND TERMINATION
7.1 Term and Expiration. This Agreement shall be effective as of
the Effective Date and the term of this Agreement shall continue in effect until
the expiration of all royalty obligations hereunder. Upon expiration of all
royalty obligations hereunder, SynthRx's license pursuant to Section 2.1 hereof
shall become a fully paid-up, perpetual license.
7.2 Termination Without Cause by SynthRx. Notwithstanding anything
contained herein to the contrary, SynthRx shall have the right to terminate the
license granted under this Agreement at any time in its sole discretion by
giving 90 days advance written notice to CytRx. In the event of such termination
under this Section 7.2, the rights and obligations under SynthRx's license
pursuant to Section 2.1 hereof and any payment obligations not due and owing as
of the termination date shall terminate, but the provisions of Article III shall
survive such termination.
7.3 Termination for Cause.
7.3.1 Termination for Non-Payment. The parties agree that
in the event that SynthRx fails to make any non-disputed payment due by virtue
of Article IV and such failure to make such non-disputed payment continues for
30 days after written notice of such breach is provided to SynthRx by CytRx,
then the license granted to SynthRx under Section 2.1 hereof shall automatically
terminate at the conclusion of the such 30-day period, unless otherwise mutually
agreed to in writing by SynthRx and CytRx.
7.3.2 Termination for Cause. This Agreement may be
terminated by notice by either SynthRx or CytRx at any time during the term of
this Agreement if the other party is in breach of its material obligations
hereunder by causes and reasons within its control and has not cured such breach
within 60 days after notice requesting cure of the breach. This Agreement may be
terminated by notice by CytRx upon the filing or institution of bankruptcy,
reorganization, liquidation or receivership proceedings by SynthRx, or upon a
general assignment of a substantial portion of all of SynthRx's assets for the
benefit of creditors; provided, however, in the case of any involuntary
bankruptcy proceeding such right to terminate shall only become effective if the
party consents to the involuntary bankruptcy or such proceeding is not dismissed
within 90 days after the filing thereof.
7.3.3 Effect of Termination for Cause on License.
(a) In the event that CytRx terminates this Agreement
under Section 7.3.1 hereof or 7.3.2 hereof, SynthRx's license pursuant to
Section 2.1 hereof shall terminate as of such termination date, but the
provisions of Article III shall survive such termination.
(b) In accordance with Section 365(n) of the United
States Bankruptcy Code, 11 USC 365(n), in the event an order for relief becomes
effective in any bankruptcy case under any chapter of the Bankruptcy Code, in
which CytRx is a debtor, SynthRx shall, as licensee from CytRx, upon the
rejection of such license by CytRx, have the right, without limitation and in
addition to all rights provided for by the Bankruptcy Code or otherwise, to
elect to retain its rights (including a right to enforce any exclusivity
provision of such license, but excluding any
C - 14
other right under applicable nonbankruptcy law to specific performance of such
license) under such license and under any agreement supplementary to such
license, to such intellectual property (including any embodiment of such
intellectual property to the extent protected by applicable nonbankruptcy law),
as such rights existed immediately before the bankruptcy case commenced, for:
(i) the duration of such license; and
(ii) any period for which such contract may be
extended by the licensee as of right under applicable nonbankruptcy law.
(c) In the event that CytRx materially breaches this
Agreement and fails to cure such breach as permitted by Section 7.3.1 hereof,
SynthRx may, in lieu of terminating this Agreement, recover the damages from
CytRx specifically resulting from such breach; provided, however, that SynthRx
will continue to be obligated to make and shall make all of the payments to
CytRx provided for by Article IV hereof or otherwise under this Agreement.
7.4 Effect of Termination. Expiration or termination of the
Agreement shall not relieve the parties of any obligation accruing prior to such
expiration or termination. Any expiration or early termination of this Agreement
shall be without prejudice to the rights of either party against the other
accrued or accruing under this Agreement prior to termination, including the
obligation to pay royalties for Licensed Products sold prior to such
termination. Notwithstanding the foregoing, any termination by either party
pursuant to Section 7.3.1 hereof or Section 7.3.2 hereof shall not limit any
other remedies that either party may have against the other arising out of or
related to such breach, including claims for damages. To the extent SynthRx's
license in CytRx Know-How is terminated, SynthRx shall promptly transfer to
CytRx all copies and materials containing CytRx Know-How in its possession and
control and in the possession and control of its Affiliates, sublicensees and
distributors and shall delete all CytRx Know-How, or any portion thereof, from
its and their computer data bases.
ARTICLE VIII.
MISCELLANEOUS
8.1 Force Majeure. Neither party shall be held liable or
responsible to the other party nor be deemed to have defaulted under or breached
the Agreement for failure or delay in fulfilling or performing any term of the
Agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected party including, but not limited to,
fire, floods, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other party. The affected party shall notify the
other party of such force majeure circumstances as soon as reasonably practical.
8.2 Assignment. This Agreement may not be assigned by SynthRx
without the consent of CytRx and may not be assigned by CytRx without the
consent of SynthRx. Notwithstanding the foregoing, either party hereto may
assign this Agreement without the other party's consent in connection with a
merger into, a consolidation with, or a transfer of all or substantially all of
its corporate assets or the transfer of all or substantially all of the assets
C - 15
related to the product line to which this Agreement pertains as an entirety or
to any corporation, partnership or other person or entity, so long as the
successor surviving person or entity in any such merger, consolidation,
partnership or other person or entity transfer or reorganization assumes in
writing the obligations of this Agreement. Such merger, consolidation, transfer
or reorganization shall not in any way be a breach of this Section 8.2, nor be a
default under this Agreement. Any permitted assignee shall assume all
obligations of its assignor under the Agreement.
8.3 Severability. In the event any one or more of the provisions
contained in this Agreement should be held invalid, illegal or unenforceable in
any respect, the validity, legality and enforceability of the remaining
provisions contained herein shall not in any way be affected or impaired
thereby, unless the absence of the invalidated provision(s) adversely affect the
substantive rights of the parties. The parties shall in such an instance use
their best efforts to replace the invalid, illegal or unenforceable provision(s)
with valid, legal and enforceable provision(s) which, insofar as practical,
implement the purposes of this Agreement.
8.4 Notices. All notices or other communications which are
required or permitted hereunder shall be in writing and sufficient if delivered
personally, sent by telecopier (and promptly confirmed by personal delivery,
registered or certified mail or overnight courier), sent by
internationally-recognized overnight or second day courier or sent by registered
or certified mail, postage prepaid, return receipt requested, addressed as
follows:
if to CytRx, to: CytRx Corporation
00000 Xxx Xxxxxxx Xxxxxxxxx
Xxxxx 000
Xxx Xxxxxxx, Xxxxxxxxxx 00000
Attention: President & CEO
Facsimile No. (000) 000-0000
if to SynthRx, to: _________________________________
_________________________________
_________________________________
Facsimile No.: (_____)___________
or to such other address as the party to whom notice is to be given may have
furnished to the other party in writing in accordance herewith. Any such
communication shall be deemed to have been given when delivered if personally
delivered or sent by telecopier on a business day, on the business day after
dispatch if sent by nationally-recognized overnight courier and on the third
business day following the date of mailing if sent by mail.
8.5 Applicable Law. The Agreement shall be governed by and
construed in accordance with the laws of the State of Texas and the United
States without reference to any rules of conflict of laws.
8.6 Dispute Resolution. The parties shall negotiate in good faith
and use reasonable efforts to settle any dispute, controversy or claim arising
from or related to this Agreement or the breach thereof. If the parties do not
fully settle, and a party wishes to pursue the matter, each
C - 16
such dispute, controversy or claim that is not an "Excluded Claim" shall be
finally resolved by binding arbitration in Las Vegas, Nevada in accordance with
the Commercial Arbitration Rules and Supplementary Procedures for Large Complex
Disputes of the American Arbitration Association ("AAA"), and judgment on the
arbitration award may be entered in any court having jurisdiction thereof. The
arbitration shall be conducted by a panel of three persons experienced in the
pharmaceutical business. Within 30 days after initiation of arbitration, each
party shall select one person to act as arbitrator and the two party-selected
arbitrators shall select a third arbitrator within 30 days of their appointment.
If the arbitrators selected by the parties are unable or fail to agree upon the
third arbitrator, the AAA shall appoint the third arbitrator. Either party may
apply to the arbitrators for interim injunctive relief until the arbitration
award is rendered or the controversy is otherwise resolved. Either party also
may, without waiving any remedy under this Agreement, seek from any court having
jurisdiction any injunctive or provisional relief necessary to protect the
rights or property of that party pending the arbitration award. The arbitrators
shall have no authority to award punitive or any other type of damages not
measured by a party's compensatory damages. Each party shall bear its own costs
and expenses and attorneys' fees and an equal share of the arbitrators' and any
administrative fees of arbitration. Except to the extent necessary to confirm an
award or as may be required by law, neither a party nor an arbitrator may
disclose the existence, content, or results of an arbitration without the prior
written consent of both parties. In no event shall an arbitration be initiated
after the date when commencement of a legal or equitable proceeding based on the
dispute, controversy or claim would be barred by the applicable Texas statute of
limitations. As used in this Section, the term "Excluded Claim" shall mean a
dispute, controversy or claim that concerns (a) the validity or infringement of
a patent, trademark or copyright; or (b) any antitrust, anti-monopoly or
competition law or regulation, whether or not statutory.
8.7 Entire Agreement. This Agreement, together with the
Organization Agreement, contains the entire understanding of the parties with
respect to the subject matter hereof. All express or implied agreements and
understandings, either oral or written, heretofore made are expressly merged in
and made a part of the Agreement. The Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by each of the
parties hereto.
8.8 Headings. The captions to the several Articles and Sections
hereof are not a part of the Agreement, but are merely guides or labels to
assist in locating and reading the several Articles and Sections hereof.
8.9 Independent Contractors. It is expressly agreed that the
parties shall be independent contractors and that the relationship between the
parties 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, without the prior consent of the other party.
8.10 Waiver. The waiver by either party hereto of any right
hereunder or the failure to perform or of a breach by the other party shall not
be deemed a waiver of any other right hereunder or of any other breach or
failure by said other party whether of a similar nature or otherwise.
C - 17
8.11 Counterparts. The Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
8.12 Waiver of Rule of Construction. Each party has had the
opportunity to consult with counsel in connection with the review, drafting and
negotiation of this Agreement. Accordingly, the parties agree that the rule of
construction that any ambiguity in this Agreement shall be construed against the
drafting party shall not apply.
8.13 Exportation of Technical Information. SynthRx agrees to comply
with the laws and rules of the United States Government regarding prohibition of
exportation of CytRx Know-How furnished to SynthRx either directly or indirectly
by CytRx.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first set forth above.
CYTRX CORPORATION
By:___________________________________
Title:________________________________
Date:_________________________________
SYNTHRX, INC.
By:___________________________________
Title:________________________________
Date:_________________________________
C - 18
SCHEDULE A
TO
LICENSE AGREEMENT
PATENTS & LICENSES
U.S. PATENT
5,554,372 (subject to U.S. government regulations)
5,990,241
6,086,899
RE 36,665
5,567,859
5,696,298
5,824,322
Pending application 90/104,088
RELATED FOREIGN PATENTS
WO96/04932
U.S. PATENT
5,234,683
5,114,708
5,824,322
RELATED FOREIGN PATENTS
596,986 Australia 000 Xxxxx
1,279,822 Canada 228,448 France
36,564 Chile 228,448 United Kingdom
96,104,742 China 176,179 Mexico
228,448 Germany 228,448 Netherlands
228,448 EPO 864,556 South Africa
C(A) - 1
LICENSE AGREEMENTS
AGREEMENT DATE
--------- ----
TiterMax, USA, Inc. June 15, 2000
Merck & Co. November 1, 2000
Ivy Animal Health February 16, 2001
Vical Incorporated December 7, 2001
PSMA Development Co., LLC (option agreement) December 23, 2002
TransForm Pharmaceuticals, Inc. April 22, 2003
C(A) - 2
SCHEDULE D
HUNTER KNOW HOW
None
D - 1
