LICENSE AGREEMENT
EXHIBIT 10.1
This License Agreement (this “Agreement”), executed as of October 20, 2006 (the
“Effective Date”), between ADVENTRX Pharmaceuticals, Inc., a Delaware corporation, through
its wholly-owned subsidiary SD Pharmaceuticals, Inc., Delaware corporation (“ADVENTRX”),
and Theragenex, LLC., a North Carolina limited liability company (“THERAGENEX”). ADVENTRX
and THERAGENEX may be referred to individually by name as a “Party” or collectively as the
“Parties.”
BACKGROUND
| A. | ADVENTRX holds certain patent rights, as described in more detail below, that may be useful in the prevention, treatment and/or mitigation of virus-mediated diseases, including but not limited to common cold, influenza and herpes; and | |
| B. | WHEREAS, THERAGENEX desires to acquire an exclusive license under such patent rights, all on the terms and conditions as set forth herein below. |
NOW, THEREFORE, in consideration of the mutual covenants and agreements provided herein
below, ADVENTRX and THERAGENEX hereby agree as follows:
Article 1. DEFINITIONS.
For purposes of this Agreement, the following definitions shall be applicable:
1.1 “Active Ingredient” means any chemical or biological entity that is a Cationic
Polymer, Cationic Surfactant, and/or a Multivalent Metal Component, whether or not such chemical or
biological entity is labeled as an active ingredient in a given Licensed Product.
(a) “Cationic Polymer” means any positively charged, pharmacologically acceptable
molecule formed of repeating units (including homopolymers, co-polymers, and heteropolymers), which
may be linear, branched or crosslinked.
(b) “Cationic Surfactant” means any positively charged compound capable of lowering
surface tension of a liquid.
(c) “Multivalent Metal Component” means any compound or composition that may release a
multivalent metal cation.
1.2 “Affiliate” means any entity directly or indirectly controlled by, controlling, or
under common control with, a Party, but only for so long as such control shall continue. For
purposes of this definition, “control” (including, with correlative meanings, “controlled
by”, “controlling” and “under common control with”) of an entity means possession, direct or
indirect, of (i) the power to direct or cause direction of the management and policies of such
entity (whether through ownership of securities or other ownership interests, by partnership,
contract or otherwise), or (ii) more than
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fifty percent (50)% of the voting securities (whether directly or beneficially) or other
comparable equity interests of such entity.
1.3 “ADVENTRX Patent Rights” means: (i) the patents and patent applications identified
on Exhibit A; and (ii) any continuation, continuation-in-part (but only to the extent such
continuation-in-part covers the subject matter of the patents and patent applications identified on
Exhibit A and does not cover any new subject matter), division, substitution, and patent of
addition of the patents and patent applications listed in part (i) above, together with all
registrations, reexaminations, extensions (including extensions under the United States Patent Term
Restoration Act) or reissues thereof.
1.4 “Business Day” means a day other than a Saturday, Sunday, bank or other public
holiday in New York, New York.
1.5 “Calendar Quarter” means each of the four (4) three (3)-month periods beginning on
January 1st, April 1st, July 1st and October 1st,
respectively.
1.6 “Control” means, with respect to particular Technology or a particular Patent,
possession by ADVENTRX of the ability, whether arising by ownership, license, or otherwise, to
disclose and deliver the particular Technology to THERAGENEX, and to grant and authorize under such
Technology or Patent the right or license, as applicable, of the scope granted to THERAGENEX in
this Agreement without, in the case of licensed Technology or Patents, violating the terms of any
written agreement between ADVENTRX and the owner or licensor thereof. “Controlled” and
“Controlling” shall have their correlative meanings.
1.7 “Cover” means, with respect to any subject matter, the development, manufacture,
use, sale, offering for sale, importation, exportation or other exploitation of such subject matter
would, but for the rights or licenses granted under this Agreement, infringe a Valid Claim of the
ADVENTRX Patent Rights. As used in this Section 1.7, “infringe” shall include contributorily
infringing or inducing the infringement of such Valid Claim. For clarity with respect to a Valid
Claim within a patent application, “Cover” includes infringing a Valid Claim in such patent
application assuming such application were an issued patent. “Covered” or
“Covering” shall have their correlative meanings.
1.8 “FDA” means the United States Food and Drug Administration and any successor
agency thereto.
1.9 “FDCA” means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the
regulations promulgated thereunder.
1.10 “Field” means any and all fields.
1.11 “Homeopathic Pharmacopoeia” means the Homeopathic Pharmacopoeia of the United
States (HPUS) as published by the Homeopathic Pharmacopoeia of the United States (HPCUS) and any
successor agency thereto, and that is approved under the FDCA.
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1.12 “Governmental Authority” means any court, agency, department, authority or other
instrumentality of any multi-national, national, state, county, city or other political
subdivision.
1.13 “Launch” means, with respect to a Licensed Product, the first shipment of such
Licensed Product for commercial sale anywhere in the Territory by THERAGENEX, its Affiliates or
Sublicensees to an unaffiliated Third Party.
1.14 “Law” or “Laws” means all applicable laws, statutes, rules, regulations,
orders, judgments and/or ordinances of any applicable Governmental Authority.
1.15 “Licensed Product” means any product which is Covered by the ADVENTRX Patent
Rights. One Licensed Product shall be deemed different from another Licensed Product, even if they
have substantially the same composition, if they differ in (a) the medical or disease condition(s)
for which they are labeled or (b) consumer accessibility. For purposes of clarification, Licensed
Products shall be deemed to differ in consumer accessibility if such Licensed Products differ in
any one or more of the following methods of accessibility by consumers (in which case each such
difference shall constitute a separate Licensed Product): (x) by the consumer directly (“off the
shelf” or “over the counter”), (y) with the assistance of personnel at the location at which such
product is purchased (“behind the counter”) or (z) by prescription.
1.16 “Marketing Approval” means with respect to a Licensed Product in a particular
jurisdiction, all approvals, licenses, registrations or authorizations necessary for the marketing
of such Licensed Product in such jurisdiction (e.g., approval in the United States by the FDA of a
NDA for a Licensed Product or satisfaction of the applicable conditions and requirements to market
a Licensed Product under an OTC Monograph or under the Homeopathic Pharmacopoeia).
1.17 “NDA” means a New Drug Application, as more fully defined in 21 C.F.R. §314.50
et. seq.
1.18 “Net Sales” means, with respect to each Licensed Product, the gross amount
invoiced for sales of THERAGENEX, its Affiliates and Sublicensees (each, a “Selling Party”)
of such Licensed Product to an unaffiliated Third Party, less (i) actual bad debts related to such
Licensed Product and (ii) credits for sales returns and allowances actually paid, granted or
accrued, (iii) normal and customary trade, quantity and cash discounts and any other adjustments
actually allowed and taken with respect to such invoiced amounts, including granted on account of
price adjustments, billing errors, damaged or defective goods, recalls, returns, rebates,
chargeback rebates, reimbursements or similar payments granted or given to wholesalers or other
distributors, (iv) customs or excise duties, sales tax, consumption tax, value added tax, and other
taxes (except income taxes) or duties relating to sales in each case invoiced as a specific line
item in an invoice (to the extent such taxes are actually incurred by the Selling Party, and are
not reimbursable, refundable or creditable to the Selling Party) and (v) freight and insurance
levied on the invoiced amount in each case invoiced as a specific line item in an invoice (to the
extent that the Selling Party actually incurs the cost of freight and insurance for a Licensed
Product and are not reimbursable, refundable or creditable to the Selling Party), in each case as
determined from books and records of the Selling
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Party maintained in accordance with generally acceptable accounting principles in the United
States, consistently applied.
1.19 “OTC Monograph” means an over-the counter drug monograph, as more fully described
in 21 C.F.R. §330 et. seq.
1.20 “Patent” means any of the following, whether existing now or in the future
anywhere in the world: (i) any issued patent, including without limitation inventor’s certificates,
utility model, substitutions, extensions, confirmations, reissues, re-examination, renewal or any
like governmental grant for protection of inventions; and (ii) any pending application for any of
the foregoing, including without limitation any continuation, divisional, substitution, additions,
continuations-in-part, provisional and converted provisional applications.
1.21 “Regulatory Authority” means any Governmental Authority with authority over the
discovery, development, commercialization or other use or exploitation (including the granting of
Marketing Approvals) of Licensed Products in any jurisdiction, including the FDA, the European
Medicines Evaluation Agency, and the Ministry of Health, Labor and Welfare in Japan.
1.22 “Regulatory Filing” shall mean any filing or application with any Regulatory
Authority, including Investigational New Drug Applications and NDAs and their equivalents in
jurisdictions other than the United States, and authorizations, approvals or clearances arising
from the foregoing, including Marketing Approvals, and all correspondence with the FDA or other
relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences
or discussions with the FDA or other Regulatory Authority, in each case with respect to Licensed
Products.
1.23 “Royalty Term” means, on a Licensed Product-by-Licensed Product basis, the period
commencing on the date of the first commercial sale of such Licensed Product by THERAGENEX, its
Affiliates, or Sublicensees and ending on the later of (i) latest date on which such Licensed
Product is Covered by a Valid Claim or (ii) twenty (20) years from the date of the first commercial
sale of such Licensed Product by THERAGENEX, its Affiliates, or Sublicensees.
1.24 “Sublicensee” means any Third Party to whom THERAGENEX has granted the right,
directly or indirectly, to (i) make and sell any Licensed Product or (ii) sell any Licensed
Product.
1.25 “Technology” means technical information and materials comprising (i) ideas,
discoveries, inventions (to the extent that disclosure thereof would not result in loss or waiver
of privilege or similar protection), improvements or trade secrets, (ii) research and development
data, such as preclinical data, pharmacology data, chemistry data (including analytical, product
characterization, manufacturing, and stability data), toxicology data, clinical data, statistical
analyses, expert opinions and reports, safety and other electronic databases), analytical and
quality control data and stability data, in each case together with supporting data, (iii)
practices, methods, techniques, specifications, formulations, formulae, knowledge, (iv) techniques,
processes, manufacturing information, (iv) research materials, reagents and compositions of matter,
including
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biological material and (v) compositions of matter. Technology shall not include any Patent
rights with respect thereto.
1.26 “Term” means the period commencing on the Effective Date and, unless earlier
terminated as herein provided, ending on the last to expire Royalty Term.
1.27 “Territory” means the United States of America (including its territories and
possessions).
1.28 “Third Party” means any entity other than ADVENTRX, THERAGENEX or their
respective Affiliates.
1.29 “Valid Claim” means a claim of any issued, unexpired patent or a claim of a
pending patent application within the ADVENTRX Patent Rights which has not been dedicated to the
public, disclaimed, abandoned or held invalid or unenforceable by a Governmental Authority of
competent jurisdiction in a decision from which no appeal can be taken or is otherwise not taken.
Article 2. LICENSE GRANT.
2.1 Exclusive Licenses. Subject to the terms and conditions of this Agreement,
ADVENTRX hereby grants to THERAGENEX an exclusive license under the ADVENTRX Patent Rights to
develop, make, have made, use, sell, offer for sale, and import Licensed Products in the Field in
the Territory (the “License”). THERAGENEX shall have the right to exercise such License
through its Affiliates solely for as long as such entity remains an Affiliate of THERAGENEX, and
THERAGENEX shall remain responsible for the compliance of such Affiliate with the applicable terms
of this Agreement.
2.2 Sublicenses.
(a) The License includes the right to sublicense (a “Sublicense”) within the scope
thereof; provided however that: (i) each sublicense agreement shall be subject to the prior written
approval of ADVENTRX, such approval not to be unreasonably withheld, (ii) each sublicense shall
include all of the applicable terms and conditions from this Agreement; and (iii) THERAGENEX shall
promptly provide ADVENTRX a copy of the final executed version of each such sublicense agreement,
redacted for information not pertinent to this Agreement.
(b) THERAGENEX shall be responsible for the failure by its Sublicensees to comply with, and
THERAGENEX guarantees the compliance by each of its Sublicensees with, all relevant restrictions,
limitations and obligations in this Agreement.
(c) In the event of a material default by any Sublicensee under a sublicense agreement,
THERAGENEX shall take such action that in THERAGENEX’s reasonable business judgment is required to
remedy such default.
(d) If this Agreement is terminated pursuant to Section 9.2, all Sublicenses shall survive
such termination to the extent provided in such Sublicenses; provided that such Sublicensees
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agree, in writing with ADVENTRX, to the same obligations of THERAGENEX hereunder, including
without limitation to the diligence obligations described in Section 3.2 and the milestone and
royalty payments described in Article 4.
2.3 No Further Rights. Each Party acknowledges that the rights and licenses granted
under this Article 2 and elsewhere in this Agreement are limited to the scope expressly granted.
Accordingly, except for the rights expressly granted under this Agreement, no right, title, or
interest of any nature whatsoever is granted whether by implication, estoppel, reliance, or
otherwise, by either Party to the other Party. All rights with respect to Technology, Patents or
other intellectual property rights that are not specifically granted herein are reserved to the
owner thereof.
2.4 Exclusivity of Efforts. Except for the conduct of activities directed toward the
development and commercialization of Licensed Products in accordance with this Agreement, during
the Term and for twelve (12) months thereafter THERAGENEX agrees on its behalf and on behalf of its
Affiliates (i) not to conduct, participate in or sponsor, directly or indirectly, inside or outside
of the Territory, any activities directed toward the development or commercialization of any
product containing an Active Ingredient, for an indication or market segment for which THERAGENEX
has already Launched a Licensed Product hereunder (collectively, such activities “Competing
Activities”) or (ii) appoint, license or otherwise authorize any Third Party, whether pursuant
to such license, appointment, or authorization or otherwise to perform any Competing Activities.
Article 3. THERAGENEX RESPONSIBILITIES AND DILIGENCE.
3.1 Responsibilities. Subject to Section 3.2, THERAGENEX shall fund, take the lead
and be solely responsible for conducting the development of Licensed Products, including clinical
trials, as may be reasonably necessary to expeditiously obtain Marketing Approvals for Licensed
Products for applications in the Field throughout the Territory. Further, THERAGENEX shall fund,
take the lead and be solely responsible for commercialization of Licensed Products in the Field
throughout the Territory. Without limiting the foregoing, THERAGENEX agrees to launch Licensed
Products in the Field in the Territory as soon as reasonably practicable, and thereafter to use
commercially reasonable efforts to market, promote and sell such Licensed Products for multiple
market segments and indications in the Field in the Territory so as to maximize Net Sales with
respect thereto. It is understood and agreed that all development and commercialization efforts
for the Licensed Products in the Field in the Territory shall be at the sole expense of THERAGENEX.
3.2 Diligence Milestones. THERAGENEX shall meet each of the following minimum
development and commercialization milestones (each, a “Diligence Milestone”):
(a) Launch a Licensed Product on or before December 31, 2007.
(b) Launch a second Licensed Product on or before December 31, 2008.
If THERAGENEX fails to meet either of the Diligence Milestones set forth above within the
applicable time period, as such time period may be extended pursuant to Section 3.2(c), such
failure
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shall be deemed a material breach of this Agreement and, accordingly, ADVENTRX may terminate this
Agreement pursuant to Section 9.2(a).
(c) In the event that THERAGENEX is not able to achieve a Diligence Milestone by the milestone
achievement date set forth above, it shall promptly inform ADVENTRX, and provided that THERAGENEX
has been and continues at all times working diligently toward the achievement of such Diligence
Milestone, THERAGENEX shall be entitled to require ADVENTRX to extend the milestone achievement
date by one additional six (6) month period for each Diligence Milestone. In this event, for each
milestone achievement date so extended, THERAGENEX shall pay to ADVENTRX within fifteen (15) days
of the original milestone achievement date a payment in the amount of Five Hundred Thousand Dollars
($500,000).
3.3 Conference Call Updates; Reports.
(a) THERAGENEX shall make reasonably available during normal business hours, on a quarterly
basis, its representatives responsible for the development and commercialization of Licensed
Products for conference calls with ADVENTRX’s representatives, during which THERAGENEX shall
describe, in reasonable detail, the progress made in the development and commercialization of
Licensed Products. In addition, THERAGENEX shall provide a written report to ADVENTRX in
reasonable detail on an annual basis regarding the development, commercialization and other
activities taken since the last such report and plans for the Licensed Products for the upcoming
twelve (12) months (each such report, an “Update Report”). The Update Reports shall be
deemed THERAGENEX Confidential Information provided it is marked “CONFIDENTIAL” or marked with
another similar legend.
(b) If within twenty (20) Business Days after receipt of an Update Report ADVENTRX would like
to request a meeting with representatives of THERAGENEX to discuss such report, then ADVENTRX may
notify THERAGENEX of such request, and the Parties shall meet at the offices of ADVENTRX, or such
other mutually agreed upon location, within thirty (30) days of THERAGENEX’s receipt of such
request from ADVENTRX. At such meeting THERAGENEX shall make reasonably available its
representatives responsible for the applicable activities and plans in the Update Report for
discussion and to answer questions from ADVENTRX’s representatives regarding the Licensed Products.
In no event may THERAGENEX be required to attend more than one (1) such meeting for any Update
Report.
Article 4. PAYMENTS AND ROYALTIES.
4.1 Upfront Payment. In partial consideration of the License and other rights granted
hereunder, THERAGENEX shall make a non-creditable, non-refundable upfront payment to ADVENTRX of
One Million Dollars ($1,000,000). The first half payment of $500,000 is due 70 days after closing
of the agreement (December 31, 2006), the second half payment is due 6 months thereafter (June 30
2007).
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4.2 Milestone Payments. In further consideration of the License and other rights
granted hereunder, THERAGENEX shall make a non-creditable, non-refundable milestone payment of One
Million Dollars ($1,000,000) to ADVENTRX upon the Launch of each Licensed Product within forty-five
(45) days after such Launch.
4.3 Royalty Payments.
(a) In addition to the payments under Sections 4.1 and 4.2, THERAGENEX shall pay to ADVENTRX
each Calendar Quarter, in consideration of the License and other rights granted herein, the
following royalty payments on the aggregate Net Sales of Licensed Products made during such
Calendar Quarter (the “Royalty Payments”):
| Quarterly Net Sales | Royalty on Net Sales | |||
That portion of aggregate Net Sales of all Licensed
Products up to and including Two Million Five
Hundred Thousand Dollars ($2,500,000) |
15 | % | ||
That portion of aggregate Net Sales of all Licensed
Products in excess of Two Million Five Hundred
Thousand Dollars ($2,500,000)and up to and including
Three Million Seven Hundred Fifty Thousand Dollars
($3,750,000) |
18 | % | ||
That portion of aggregate Net Sales of all Licensed
Product in excess of Three Million Seven Hundred
Fifty Thousand Dollars ($3,750,000) |
20 | % | ||
For purposes of the foregoing, “aggregate Net Sales” of all Licensed Products shall mean the
aggregate Net Sales of all types and formulations of Licensed Products made within the particular
Calendar Quarter. In the event THERAGENEX and ADVENTRX determine that Patent rights or Technology
of a Third Party is necessary to make or sell a Licensed Product in the Territory, the Parties will
discuss a reduction in the royalty rates set forth above, if any.
(b) The Royalty Payments for a Licensed Product shall continue until the expiration of the
Royalty Term, and thereafter the License shall become, royalty-free, non-exclusive and perpetual
for such Licensed Product.
Article 5. ACCOUNTING AND PROCEDURES FOR PAYMENT.
5.1 Inter-Company Sales. Sales between or among THERAGENEX, its Affiliates or
Sublicensees shall not be subject to Royalty Payments; Royalty Payments shall only be calculated
upon Net Sales to an unaffiliated Third Party. THERAGENEX shall be responsible for payments on Net
Sales by its Affiliates and Sublicensees.
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5.2 Currency. All Royalty Payments shall be computed and paid in United States
dollars. For the purposes of determining the amount of Royalty Payments due for the relevant
Calendar Quarter, the amount of Net Sales in any foreign currency shall be converted into United
States dollars at the spot rate of exchange published by The Board of Governors of the Federal
Reserve System in Statistical Release H.10 (xxxx://xxx.xxxxxxxxxxxxxx.xxx/xxxxxxxx/X00) for the
date that is five (5) Business Days before the date payment is due.
5.3 Royalty Payments. Royalty Payments by THERAGENEX are due and payable by the 45th
day after the end of each Calendar Quarter, and each payment shall be accompanied by a report
identifying in the aggregate and on a Licensed Product-by-Licensed Product basis: (i) total gross
amount invoiced for sales of Licensed Products by THERAGENEX and its Affiliates and Sublicensees;
(ii) amounts deducted by category (e.g., normal and customary trade, quantity and cash discounts
actually allowed and taken with respect to such invoiced amounts) from gross amounts invoiced to
calculate Net Sales; (iii) Net Sales and (iv) royalties payable. Said reports shall be deemed
THERAGENEX Confidential Information.
5.4 Method of Payments. All payments hereunder shall be made by electronic transfer
in immediately available funds via a bank wire transfer, or any other means of electronic funds
transfer, at THERAGENEX’S election, to such bank accounts as ADVENTRX shall designate in writing at
least five (5) Business Days before the payment is due. All payments under this Agreement shall
bear interest from the date due until paid at a rate equal to the thirty (30) day U.S. Dollar LIBOR
rate effective for the date that payment was due, as published by The Wall Street Journal,
Eastern U.S. Edition, on the date such payment was due, plus two percent (2%).
5.5 Inspection of Records. THERAGENEX shall, and shall cause its Affiliates and
Sublicensees to, keep full and accurate books and records setting forth gross amounts invoiced for
each Licensed Product, Net Sales of each Licensed Product, itemized deductions from gross amounts
invoiced to calculate Net Sales and amounts payable hereunder to ADVENTRX for each such Licensed
Product. THERAGENEX shall permit ADVENTRX, by independent certified public accountants retained by
ADVENTRX and reasonably acceptable to THERAGENEX, to examine such books and records at THERAGENEX
at any reasonable time upon prior written request, but not later than three (3) years following the
rendering of any corresponding reports, accountings and payments pursuant to Section 5.3. The
foregoing right of review may be exercised only once during each twelve (12) month period;
provided, however, that if a review uncovers an underpayment by THERAGENEX of Royalty Payments of
more than five percent (5%) such review shall not count as an exercise of such right of review.
Such accountants may be required by THERAGENEX to enter into a reasonably acceptable
confidentiality agreement, and in no event shall such accountants disclose to ADVENTRX any
information other than such as relates to the accuracy of reports and payments made or due
hereunder. The opinion of said independent accountants regarding such reports, accountings and
payments shall be binding on the Parties other than in the case of clear error. ADVENTRX shall
bear the cost of any such review; provided that if the review shows an underpayment of Royalty
Payments of more than five percent (5%) of the amount due for the applicable period, then
THERAGENEX shall promptly reimburse ADVENTRX for all costs incurred in connection with such review.
THERAGENEX shall promptly pay to ADVENTRX the amount of any underpayment of Royalty Payments
revealed by a review. ADVENTRX’s review
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rights under this Section 5.5 shall survive for a period of three (3) years after any
termination or expiration of this Agreement.
5.6 No Withholding Taxes. Unless reimbursable to ADVENTRX as a reduction in U.S. tax
liability, all payments required to be made pursuant to this Agreement shall be without deduction
or withholding for or on account of any taxes or similar governmental charge. Such taxes are
referred to herein as “Withholding Taxes” and such Withholding Taxes shall be the sole
responsibility of THERAGENEX. THERAGENEX shall provide a certificate evidencing payment of any
Withholding Taxes under this Agreement. It is understood and agreed that all payment obligations
rest solely on THERAGENEX, a North Carolina limited liability company, and that all payments due
under this Agreement shall be made by THERAGENEX, a North Carolina limited liability company to
ADVENTRX, a Delaware corporation. As a result, the Parties anticipate that no Withholding Taxes
will be assessed against THERAGENEX on ADVENTRX’s behalf.
Article 6. PATENTS AND INFRINGEMENT.
6.1 Prosecution and Maintenance. As between the Parties, ADVENTRX shall have the
right to control the Prosecution and Maintenance of the ADVENTRX Patent Rights using counsel of its
choice, such counsel to be reasonably acceptable to THERAGENEX, and THERAGENEX agrees to reimburse
ADVENTRX for its out-of-pocket expenses in connection with such activities as they are incurred,
not to exceed ten thousand dollars ($10,000) per calendar quarter. ADVENTRX agrees to: (i) keep
THERAGENEX reasonably informed with respect to such activities by providing THERAGENEX with an
opportunity to review and comment reasonably before the filing of all Prosecution and Maintenance
documents (but in no event less than ten (10) days before such filing) and ADVENTRX shall
incorporate all such reasonable comments to the extent that they are compatible with the
development of Licensed Products hereunder; and (ii) consult in good faith with THERAGENEX
regarding such matters, including the abandonment of any claim thereof covering a Licensed Product.
Following the filing or mailing thereof, ADVENTRX shall provide THERAGENEX with a copy of each
patent application within the ADVENTRX Patent Rights filed or mailed after the Effective Date,
together with notice of its filing date and serial number, and a copy of such other patent
prosecution document or any correspondence related to patent prosecution, as filed or sent, as
applicable. If ADVENTRX determines to abandon any patent or patent application within the ADVENTRX
Patent Rights, then ADVENTRX shall provide THERAGENEX with notice of such determination at least
sixty (60) days prior to the date such abandonment would become effective. In such event,
THERAGENEX shall have the right, at its option, to assume control of the Prosecution and
Maintenance of such patent or patent application at its own expense in ADVENTRX’s name. For
purposes of this Section 6.1, “Prosecution and Maintenance” means the preparing and filing of
documents pertaining to the prosecution and maintenance of a patent or patent application, as well
as filing for re-examinations, reissues, requests for patent term extensions and the like, together
with the conduct of interferences, the defense of oppositions and other similar proceedings; and
“Prosecute and Maintain” has the correlative meaning.
6.2 Enforcement.
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(a) Notice. Subject to the provisions of this Section 6.2, in the event that either
Party reasonably believes that any ADVENTRX Patent Right is being infringed or may be subject to a
declaratory judgment action as a result of the development, manufacture, use, sale, offer for sale
or importation of a product in the Territory (an “Infringing Product”), such Party shall promptly
notify the other Party in writing and shall provide the other Party with any evidence available
pertaining thereto. In such event, THERAGENEX shall have the initial right (but not the
obligation) to enforce such ADVENTRX Patent Right with respect to such infringement, or to defend
any declaratory judgment action with respect thereto (an “Enforcement Action”), at THERAGENEX’s
expense. At ADVENTRX’s request, THERAGENEX shall allow ADVENTRX to actively participate at its
expense in the planning and conduct of any such action, and THERAGENEX shall not, without the
express prior written consent of ADVENTRX, (i) make any substantive decision regarding strategy
related to such action or (ii) settle such action.
(b) Commencing Enforcement Actions. In the event that THERAGENEX fails to commence an
Enforcement Action to enforce such ADVENTRX Patent Right against an Infringing Product within sixty
(60) days of a request by ADVENTRX to do so, and if ADVENTRX reasonably believes that the
infringing activity may have a material adverse effect on the value, validity or enforceability of
the ADVENTRX Patent Rights or the financial interests of ADVENTRX hereunder, ADVENTRX may commence
an Enforcement Action against such infringement at its own expense.
(c) Cooperation. The Party commencing or defending any Enforcement Action (the
“Enforcing Party”) shall keep the other Party reasonably informed of the progress of any such
Enforcement Action, and such other Party shall have the right to participate with counsel of its
own choice at its own expense. In any event, the other Party shall reasonably cooperate with the
Enforcing Party, including providing information and materials, at the Enforcing Party’s request
and expense.
(d) Recoveries. Any recovery received as a result of any Enforcement Action to
enforce ADVENTRX Patent Rights pursuant to this Section 6.2 shall be used first to reimburse the
Parties for the costs and expenses (including attorneys’ and professional fees) incurred in
connection with such Enforcement Action (and not previously reimbursed), and the remainder of the
recovery shall be shared (to the extent the same represents damages from sales of Infringing
Products within the Field in the Territory) seventy-five percent (75%) to the Enforcing Party and
twenty-five percent (25%) to the other Party.
6.3 Defense. If the manufacture, sale or use of Licensed Products under this
Agreement by THERAGENEX, its Affiliates, Sublicensees, manufacturers, distributors or customers
results in any claim, suit or proceeding for patent infringement solely against THEREGENEX and/or
its Affiliates, THERAGENEX shall promptly notify ADVENTRX thereof in writing, setting forth the
facts of such claim in reasonable detail. As between the parties to this Agreement, THERAGENEX
shall have the first and primary right and responsibility, at its own expense and after
consultation with ADVENTRX, to defend and control the defense of any such claim, suit or proceeding
by counsel of its own choice, which counsel shall be reasonably acceptable to ADVENTRX. If
ADVENTRX, and not THERAGENEX, or ADVENTRX in addition to THERAGENIX, is named as
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a party to such claim, suit or proceeding, ADVENTRX shall tender its defense to THERAGENEX in
writing, and THERAGENEX shall defend ADVENTRX in such claim, suit or proceeding, at THERAGENEX’s
own expense and through counsel of its own choice, which counsel shall be reasonably acceptable to
ADVENTRX; provided, however, that ADVENTRX may, at its election and expense, actively participate
in the planning and conduct of such claim, suit or proceeding and THERAGENEX shall not, without the
express prior written consent of ADVENTRX (a) make any substantive decision regarding strategy
related to such claim, suit or proceeding or (b) settle such claim, suit or proceeding. In
connection with such claim, suit or proceeding, in no event shall either Party enter into any
agreement with any Third Party, with respect to the ADVENTRX Patent Rights, that (x) contemplates
payment or other action by the other Party (y) has a material adverse effect on the other Party’s
business or (z) makes any admission regarding (i) wrongdoing on the part of the other Party, or
(ii) the invalidity, unenforceability or absence of infringement of ADVENTRX Patent Rights, in each
case without the prior written consent of the other Party. The Parties shall cooperate with each
other in connection with any such claim, suit or proceeding and shall keep each other reasonably
informed of all material developments in connection with any such claim, suit or proceeding
(including furnishing a copy of each communication relating to such claim, suit or proceeding). It
is understood that the terms of this Section 6.3 shall in no way limit ADVENTRX’s right to receive
indemnification under Article 10 below in connection with any Third-Party Claims described in
Section 10.1(b).
6.4 Patent Marking. THERAGENEX shall xxxx (or cause to be marked) all Licensed
Products marketed and sold hereunder with appropriate ADVENTRX Patent Right numbers or indicia to
the extent permitted by Law in those countries in which such notices impact recoveries of damages
or remedies available with respect to infringements of Patents.
Article 7. CONFIDENTIALITY.
7.1 Confidentiality; Exceptions. Except to the extent expressly authorized by this
Agreement or otherwise agreed by the Parties in writing, the Parties agree that the Party receiving
confidential information (the “Receiving Party”) from the other Party shall keep
confidential and shall not publish or otherwise disclose or use for any purpose other than as
provided for in this Agreement any data, technical information, business information, or other
confidential or proprietary information furnished to it by the other Party pursuant to this
Agreement (collectively, “Confidential Information”). Confidential Information that is
disclosed in writing shall be marked, or disclosed under cover that is marked, with the legend
“CONFIDENTIAL” or another similar legend. Notwithstanding the foregoing, Confidential Information
shall not be deemed to include information to the extent that it can be established by written
documentation by the Receiving Party that such information or material:
(a) was already known to or possessed by the Receiving Party, other than under an obligation
of confidentiality (except to the extent such obligation has expired or an exception is applicable
under the relevant agreement pursuant to which such obligation was established), at the time of
disclosure;
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(b) was generally available to the public or otherwise part of the public domain at the time
of its disclosure to the Receiving Party;
(c) became generally available to the public or otherwise part of the public domain after its
disclosure and other than through any act or omission of the Receiving Party (or any person to whom
the Receiving Party made available Confidential Information) in breach of this Agreement;
(d) was independently developed by the Receiving Party without any reference to Confidential
Information as demonstrated by documented evidence prepared contemporaneously with such independent
development; or
(e) was disclosed to the Receiving Party, other than under an obligation of confidentiality,
by a Third Party who had no obligation not to disclose such information to others.
For purposes of the foregoing, information that is specific in nature shall not be deemed to
be within such provisions merely because it is embraced by more general information in the public
domain or in the possession of the receiving Party.
7.2 Authorized Use and Disclosure. Each Party may disclose Confidential Information
of the other Party as follows: (i) to employees and consultants on a need-to-know basis under
appropriate written confidentiality provisions substantially equivalent to those in this Agreement
and in connection with the performance of its obligations or exercise of rights granted to such
Party in this Agreement; (ii) to the extent such disclosure is reasonably necessary in filing for,
prosecuting or the maintenance of Patents (including applications therefor) in accordance with this
Agreement, prosecuting or defending litigation, complying with applicable governmental regulations,
Law or the rules of a recognized stock exchange, provided, however, that in each such case if a
Party is required to make any such disclosure of the other Party’s Confidential Information it will
give reasonable advance notice to the other Party of such disclosure requirement and, except to the
extent inappropriate in the case of patent applications, will use its reasonable efforts to secure
confidential treatment of such Confidential Information required to be disclosed; (iii) in
communication with existing and potential investors, consultants, advisors (including financial
advisors, lawyers and accountants) and its directors, officers, employees, and agents on a
need-to-know basis, in each case under appropriate written confidentiality provisions substantially
equivalent to those of this Agreement; or (iv) to the extent mutually agreed to by the Parties. The
Receiving Party shall not use Confidential Information for any purpose other than this Agreement.
7.3 Prior Confidentiality Agreement. This Agreement supersedes the Mutual
Confidential Disclosure Agreement between the Parties dated June 8, 2006 (the “Prior CDA”)
with respect to information disclosed thereunder. All information exchanged between the Parties
under the Prior Agreement shall be deemed Confidential Information of the disclosing Party and
shall be subject to the terms of this Article 7.
7.4 Publicity. Each of the Parties agrees not to disclose to any Third Party the
terms and conditions of this Agreement without the prior approval of the other Party, except to
advisors
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(including consultants, financial advisors, attorneys and accountants), potential and existing
investors, acquirors and partners, licensees, funding sources and similar individuals and entities
on a need-to-know basis, in each case under circumstances that reasonably protect the
confidentiality thereof, or to the extent required by applicable Law, including securities laws
and the rules of self-regulatory organizations, including stock exchanges. Notwithstanding the
foregoing, the Parties agree upon a joint press release to announce the execution of this
Agreement, which is attached hereto as Exhibit B; thereafter, the Parties may each disclose
to Third Parties the information contained in such press release without the need for further
approval by the other.
7.5 Use of Name. Other than in connection with a permitted use under Section 7.2 and
7.4, the use of the name of either Party, or any contraction thereof, by the other Party in any
manner in connection with this Agreement is expressly prohibited except with prior written consent
of the other Party or to the extent required by applicable law, including securities laws and the
rules of self-regulatory organizations, including stock exchanges.
7.6 Survival. The Parties’ obligations under this Article 7 shall survive for a
period of five (5) years following any termination or expiration of this Agreement.
Article 8. REPRESENTATIONS AND WARRANTIES.
8.1 General Representations and Warranties. Each Party represents and warrants to the
other that:
(a) it is duly organized and validly existing under the Laws of the jurisdiction of its
incorporation or organization, and has full corporate or similar power and authority to enter into
this Agreement and to carry out the provisions hereof;
(b) it is duly authorized to execute and deliver this Agreement and to perform its obligations
hereunder, and the person executing this Agreement on its behalf has been duly authorized to do so
by all requisite corporate or similar action;
(c) this Agreement is legally binding upon it and enforceable in accordance with its terms.
The execution, delivery and performance of this Agreement by it does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party or by which it may
be bound, nor violate any material applicable Law;
(d) it has not granted, and shall not grant during the Term, any right to any Third Party
which would conflict with the rights granted to the other Party hereunder; and
(e) it is not aware of any action, suit or inquiry or investigation instituted by any entity
which questions or threatens the validity of this Agreement.
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8.2 ADVENTRX’s Warranties. ADVENTRX represents and warrants that as of the Effective
Date:
(a) ADVENTRX Controls the ADVENTRX Patent Rights described on Exhibit A;
(b) ADVENTRX has not granted, and will not grant during the Term, rights to any Third Party
under the ADVENTRX Patent Rights that conflict with the rights granted to THERAGENEX hereunder;
(c) ADVENTRX has not received any written notice of any threatened claims or litigation
seeking to invalidate or otherwise challenge the ADVENTRX Patent Rights or ADVENTRX’s rights
therein;
(d) to its knowledge, none of the ADVENTRX Patent Rights are subject to any pending
re-examination, opposition, interference or litigation proceedings;
(e) it is not aware of any infringement of the ADVENTRX Patent Rights by a Third Party;
(f) it has prosecuted all patent applications within the ADVENTRX Patent Rights in good faith;
and
(g) though it has not conducted any search or investigation, it is not aware of any Third
Party patents that present any substantial risk of infringement with respect to the making, use,
sale, or importation of Licensed Products.
8.3 Disclaimer of Warranties. EXCEPT AS SET FORTH IN THIS ARTICLE 8, ADVENTRX AND
THERAGENEX EXPRESSLY DISCLAIM ANY WARRANTIES OR CONDITIONS, EXPRESS, IMPLIED, STATUTORY OR
OTHERWISE, WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT, INCLUDING ANY WARRANTY OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY
RIGHTS OF THIRD PARTIES.
Article 9. TERM AND TERMINATION.
9.1 This Agreement shall be effective as of the Effective Date and shall remain in effect
during the Term.
9.2 This Agreement shall terminate as follows:
(a) If either THERAGENEX or ADVENTRX materially breaches or materially defaults in the
performance or observance of any of the provisions of this Agreement, and such breach or default is
not cured within thirty (30) days after the receipt of notice by the other Party specifying such
breach or default, the other Party shall have the right to terminate this Agreement
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forthwith, such termination to be effective upon the expiration of such thirty (30)-day notice
period. For the purposes of this Section 9.2(a), a material breach or material default in the
performance of any of the provisions of this Agreement shall include a material inaccuracy in any
warranty or representation contained herein.
(b) If either Party admits in writing that it is generally unable to meet its debts when due,
or makes a general assignment for the benefit of its creditors, or there shall have been appointed
a receiver, trustee or other custodian for such Party or for a substantial part of its assets, or
any case or proceeding shall have been commenced or other action taken by or against such Party in
bankruptcy or seeking the reorganization, liquidation, dissolution or winding-up of such Party or
any other relief under any bankruptcy, insolvency, reorganization or other similar act or Law, and
any such event shall have continued for sixty (60) days undismissed, unstayed, unbonded and
undischarged, then the other Party may, upon notice to such Party terminate this Agreement, such
termination to be effective upon such Party’s receipt of such notice.
(c) THERAGENEX shall have the right to terminate this Agreement at any time, upon ninety (90)
days’ written notice to ADVENTRX if THERAGENEX concludes in good faith, based on technical
information learned by it following the Effective Date, that there is no reasonable likelihood of a
commercially viable Licensed Product, such termination to be effective upon the expiration of such
ninety (90)-day notice period.
(d) THERAGENEX shall have the right in its sole discretion to terminate this Agreement upon
written notice to ADVENTRX prior to December 31, 2006, in the event that its review of the ADVENTRX
Patent Rights and any Third Party patents indicates that the making, use, sale, offer for sale, or
importation of a Licensed Product would likely infringe valid claims of a Third Party’s patent or
published patent application in the Territory.
9.3 General Effects of Expiration or Termination.
(a) Accrued Obligations. Expiration or termination of this Agreement for any reason
shall not release either Party of any obligation or liability which, at the time of such expiration
or termination, has already accrued to the other Party or which is attributable to a period prior
to such expiration or termination. For the avoidance of doubt, if THERAGENEX terminates this
Agreement (whether pursuant to Section 9.2(a) or 9.2 (d)), it shall be required to make the Upfront
Payments described in Section 4.1.
(b) Non-Exclusive Remedy. Notwithstanding anything herein to the contrary,
termination of this Agreement by a Party shall be without prejudice to other remedies such Party
may have at law or equity.
(c) General Survival. Articles 1, 7, 8 and 10-12, and Sections 2.2(d), 2.4, 4.1,
5.2-5.6, and 9.3-9.5 shall survive expiration or termination of this Agreement for any reason.
Except as otherwise provided in this Article 9, all rights and obligations of the Parties under
this Agreement shall terminate upon expiration or termination of this Agreement for any reason.
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9.4 Effects of Certain Terminations. If THERAGENEX electively terminates this
Agreement pursuant to Section 9.2(c) or ADVENTRX terminates this Agreement pursuant to Section
9.2(a) or (b), then upon such notice of termination:
(a) Ongoing Trials. If there are any ongoing clinical trials with respect to Licensed
Products being conducted by or on behalf of THERAGENEX (or its Affiliates) at the time of notice of
termination, THERAGENEX agrees to (i) promptly transition to ADVENTRX or its designee some or all
of such clinical trials and the activities related to or supporting such trials, (ii) continue to
conduct such clinical trials for a period requested by ADVENTRX up to a maximum of six (6) months
after the effective date of such termination or (iii) terminate such clinical trials; in each case
as requested by ADVENTRX. In such event, ADVENTRX shall be responsible for the costs of such
transition.
(b) Commercialization. Subject to ADVENTRX’s rights under Section 9.4(f), THERAGENEX
shall, and shall cause its Affiliates, immediately to terminate the manufacture (whether directly
by THERAGENEX or its Affiliates or through a third party), use, sale and importation of Licensed
Products, except that THERAGENEX and its Affiliates shall, for a period requested by ADVENTRX not
to exceed twelve (12) months following the effective date of the termination of this Agreement (or
such other period as is mutually agreed to by the Parties) (the “Agreement Wind-Down Period”)
continue to manufacture, promote, market, take orders for, distribute and sell the Licensed
Products for which it has received Marketing Approval in the Territory in accordance with the terms
and conditions of this Agreement (including that THERAGENEX shall continue to pay the royalty
thereon at the rate and at the time provided for herein); provided that ADVENTRX may terminate the
Agreement Wind-Down Period upon ninety (90) days notice to THERAGENEX. For clarification,
THERAGENEX’s and its Affiliates’ rights with respect to Licensed Products during the Wind-Down
Period (including the License granted under Section 2.1) shall be non-exclusive and ADVENTRX shall
have the right to engage one or more other promoter(s), marketer(s), partner(s) or distributor(s)
of Licensed Products in all or part of the Territory. Other than as set forth in this Section
9.4(b), THERAGENEX and its Affiliates and Sublicensees shall not manufacture, promote, market,
distribute or sell Licensed Products or make any representation regarding their status as a
licensee of or distributor for ADVENTRX for any Licensed Product.
(c) Regulatory Filings. THERAGENEX shall, at ADVENTRX’s expense, promptly assign and
transfer to ADVENTRX all Regulatory Filings for Licensed Products that are held or controlled by or
under authority of THERAGENEX or its Affiliates, and shall take such actions and execute such other
instruments, assignments and documents as may be necessary to effect the transfer of rights under
the Regulatory Filings to ADVENTRX. THERAGENEX shall cause each of its Affiliates to transfer any
such Regulatory Filings to ADVENTRX. If applicable Law prevents or delays the transfer of
ownership of a Regulatory Filing to ADVENTRX, THERAGENEX (for itself and its Affiliates) shall
grant, and does hereby grant, to ADVENTRX an exclusive and irrevocable right of access and
reference to such Regulatory Filing for Licensed Products, and shall cooperate fully to make the
benefits of such Regulatory Filings available to ADVENTRX and/or its designee(s). Within sixty
(60) days after notice of such termination, THERAGENEX shall provide to ADVENTRX copies of all such
Regulatory Filings, and of all
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preclinical and clinical data (including investigator reports, both preliminary and final,
statistical analyses, expert opinions and reports, safety and other electronic databases) and other
Technology pertaining to any Licensed Product, or the manufacture thereof. ADVENTRX shall be free
to use and disclose such Regulatory Filings and other items in connection with the exercise of its
rights and licenses under this Section 9.4.
(d) Technology Licenses. THERAGENEX hereby grants ADVENTRX, effective upon the notice
of termination under Section 9.2(c) or the effective date of such termination under Section 9.2(a)
or (b), a non-exclusive, worldwide, irrevocable, fully paid-up license in the Territory, with the
right to sublicense, under (i) any Patent controlled by THERAGENEX or its Affiliates covering
Licensed Products that were developed or commercialized by or under authority of THERAGENEX;
provided, however if any such Patent controlled by THERAGENEX is subject to payment obligations to
a Third Party, THERAGENEX shall promptly disclose such obligations to ADVENTRX in writing and such
Patents shall be deemed to be controlled by THERAGENEX only if ADVENTRX agrees in writing to
reimburse all amounts owed to such Third Party as a result of ADVENTRX’s exercise of such license,
and (ii) any Technology disclosed to ADVENTRX under this Agreement or developed or utilized by
THERAGENEX in connection with the Licensed Products; in each case to develop, make, have made, use,
sell, offer for sale and import Licensed Products.
(e) Trademarks. Effective upon the notice of termination under Section 9.2(c) or the
effective date of such termination under Section 9.2(a) or (b), THERAGENEX hereby assigns and shall
cause to be assigned to ADVENTRX all rights in and to any trademarks specific to one or more
Licensed Products that THERAGENEX used with such Licensed Product(s). It is understood such
assignment shall not include the THERAGENEX name or trademark for the THERAGENEX company itself.
(f) Transition Assistance. THERAGENEX agrees to reasonably cooperate with ADVENTRX
and its designee(s) to facilitate a smooth, orderly and prompt transition of the development and
commercialization of Licensed Products to ADVENTRX and/or its designee(s) following notice of
termination of this Agreement. Without limiting the foregoing, THERAGENEX shall promptly provide
ADVENTRX (i) copies of customer lists, customer data and other customer information relating to
Licensed Products that THERAGENEX may properly disclose and (ii) manufacturing information
(including protocols for the production, packaging, testing and other manufacturing activities)
necessary or useful for the manufacture of Licensed Products in THERAGENEX’s control, which in
each case ADVENTRX shall, subject to Section 9.4(d), have the right to use and disclose for any
purpose during the Agreement Wind-Down Period and thereafter. Upon request by ADVENTRX, THERAGENEX
shall transfer to ADVENTRX some or all quantities of Licensed Products in its and its Affiliates
control (as requested by ADVENTRX), within thirty (30) days after the end of the Agreement
Wind-Down Period; provided, however, that ADVENTRX shall reimburse THERAGENEX for the out-of-pocket
costs that THERAGENEX actually incurred to manufacture or otherwise acquire the quantities so
provided. If any Licensed Product was manufactured by any Third Party for THERAGENEX, or
THERAGENEX had contracts with vendors which contracts are necessary or useful for ADVENTRX and/or
its designee to assume the promotion, marketing, distribution and sale/or of the Licensed Products
in the Field in
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the Territory, then THERAGENEX shall, to the extent possible and requested in writing by
ADVENTRX, assign such Third Party contracts to ADVENTRX.
9.5 Return of Materials. Within thirty (30) days after the end of the Agreement
Wind-Down Period, THERAGENEX shall destroy all tangible items comprising, bearing or containing any
Confidential Information of ADVENTRX (whether such Confidential Information is held by THERAGENEX
or its Affiliates), and provide written certification of such destruction, or prepare such tangible
items of Confidential Information for shipment to ADVENTRX, as ADVENTRX may direct, and at
ADVENTRX’s expense; provided that THERAGENEX may retain one (1) copy of ADVENTRX’s Confidential
Information solely for its legal archives.
Article 10. INDEMNIFICATION; INSURANCE.
10.1 Indemnification.
(a) Indemnification by ADVENTRX. ADVENTRX hereby agrees to defend, hold harmless and
indemnify (collectively, “Indemnify”) THERAGENEX and its Affiliates, and its and their
agents, representatives, consultants, directors, officers and employees (the “THERAGENEX
Indemnitees”) from and against any damages, liability or expense (including reasonable legal
expenses and attorneys’ fees) (collectively, “Losses”) resulting from suits, claims,
actions and demands, in each case brought by a Third Party (each, a “Third-Party Claim”)
arising out of a breach of any of ADVENTRX’s representations and warranties under Sections 8.1 or
8.2. ADVENTRX’s obligation to Indemnify the THERAGENEX Indemnitees pursuant to this Section 10.1(a)
shall not apply to the extent that any such Losses (A) arise from the gross negligence or
intentional misconduct of any THERAGENEX Indemnitee; (B) arise from any breach by THERAGENEX of
this Agreement; or (C) are Losses for which THERAGENEX is obligated to Indemnify the ADVENTRX
Indemnitees pursuant to Section 10.1(b) below.
(b) Indemnification by THERAGENEX. THERAGENEX hereby agrees to Indemnify ADVENTRX and
its Affiliates, and its and their agents, representatives, consultants, directors, officers and
employees (the “ADVENTRX Indemnitees”) from and against any and all Losses resulting from
Third-Party Claims arising out of: (i) a breach of any of THERAGENEX’s representations and
warranties under Section 8.1; (ii) the development, promotion, marketing, distribution, sale,
commercialization or other exploitation of Licensed Products or other exercise of the License
granted hereunder by or under authority of THERAGENEX (including, but not limited to, claims by
consumers or users of Licensed Products or claims relating to the labeling of Licensed Products
including, but not limited to, claims relating to inaccurate, incomplete, false or misleading
labeling); or (iii) a breach by a Sublicensee of its sublicense agreement. THERAGENEX’s obligation
to Indemnify the ADVENTRX Indemnitees pursuant to the foregoing sentence shall not apply to the
extent that any such Losses (A) arise from the gross negligence or intentional misconduct of any
ADVENTRX Indemnitee; (B) arise from any breach by ADVENTRX of this Agreement; or (C) are Losses for
which ADVENTRX is obligated to Indemnify the THERAGENEX Indemnitees pursuant to Section 10.1(a)
above.
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(c) Procedure. To be eligible to be Indemnified hereunder, the indemnified Party
shall provide the indemnifying Party with notice as soon as reasonably possible of the Third-Party
Claim giving rise to the indemnification obligation pursuant to this Section 10.1 and the exclusive
ability to defend (with the reasonable cooperation of the indemnified Party) or settle any such
claim; provided, however, that the indemnifying Party shall not enter into any settlement that
admits fault, wrongdoing or damages without the indemnified Party’s written consent, such consent
not to be unreasonably withheld or delayed. The indemnified Party shall have the right to
participate, at its own expense and with counsel of its choice, in the defense of any claim or suit
that has been assumed by the indemnifying Party.
10.2 Insurance. THERAGENEX shall obtain and maintain, prior to the earlier of (a) the
Launch of the first Licensed Product or (b) the first administration of the first Licensed Product
in humans (whether in a clinical trial or otherwise), and thereafter during the term of this
Agreement and for six (6) years thereafter, comprehensive general liability insurance and products
liability insurance (including human clinical trials coverage) with reputable and financially
secure insurance carriers at levels consistent with industry standards (subject to reasonable
deductibles) based upon THERAGENEX’s activities (including the conduct of clinical trials, if
applicable) and indemnification obligations hereunder, but in any event, for commercial general,
not less than $1,000,000 per occurrence and $3,000,000 in the aggregate and, for products
liability/human clinical trials, not less than $10,000,000 per occurrence and $10,000,000 in the
aggregate, with ADVENTRX named as an additional insured. Such liability insurance shall be
maintained on an occurrence basis to provide such protection after expiration or termination of the
policy itself or this Agreement. THERAGENEX shall furnish to ADVENTRX on request certificates
issued by the insurance company setting forth the amount of the liability insurance and a provision
THERAGENEX hereto shall receive thirty (30) days’ written notice prior to termination or material
reduction to the level of coverage.
Article 11. GOVERNING LAW AND ARBITRATION.
11.1 Governing Law. This Agreement shall be governed by and construed in accordance
with the substantive laws of the State of California, without reference to its conflicts of laws
provisions.
11.2 General Arbitration. In the event of any controversy, claim or counter-claim
arising out of or relating to this Agreement, the Parties shall first attempt to resolve such
controversy or claim through good-faith negotiations between the Chief Executive Officers (or their
senior level representatives) for a period of thirty (30) days, or such longer period as the
Parties may agree, following notification of such controversy or claim to the other Party. If such
controversy or claim cannot be resolved by means of such negotiations during such period, then such
controversy or claim shall be finally settled by binding arbitration in San Diego, California under
the then current Commercial Arbitration Rules of the American Arbitration Association by one (1)
arbitrator appointed in accordance with such rules. The arbitrator may grant injunctive or other
relief in such dispute or controversy. The decision of the arbitrator shall be final, conclusive
and binding on the Parties to the arbitration. Judgment may be entered on the arbitrator’s
decision in any court of competent jurisdiction. The Parties agree that, any provision of
applicable law notwithstanding, they
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will not request and the arbitrator shall have no authority to award, punitive or exemplary
damages against either Party. The costs of the arbitration, including administrative and
arbitrator’s fees, may be allocated between the Parties by the arbitrator, or if such award is not
made, shall be shared equally by the Parties. Each Party shall initially bear their respective
expenses of arbitration, including the cost of its own attorneys’ fees and expert witness fees
provided that the arbitrator has the right to allocate such expenses between the Parties. Nothing
in this Section 11.2 shall preclude either Party from seeking interim or provisional relief in the
form of a temporary restraining order, preliminary injunction, or other interim relief concerning a
dispute prior to or during an arbitration pursuant to this Section 11.2 necessary to protect the
interests of such Party.
Article 12. MISCELLANEOUS.
12.1 Force Majeure. Neither Party hereto shall be liable to the other Party for any
losses or damages attributable to a default in or breach of this Agreement which is the result of
war (whether declared or undeclared), acts of God, revolution, acts of terror, fire, earthquake,
flood, pestilence, riot, enactment or change of Law, accident(s), labor trouble, or shortage of or
inability to obtain material, equipment or transport or any other cause beyond reasonable control
of such Party (in no event to include the obligation to pay money due hereunder).
12.2 Severability. If and solely to the extent that any provision of this Agreement
shall be invalid or unenforceable, or shall render this entire Agreement to be unenforceable or
invalid, such offending provision shall be of no effect and shall not affect the validity of the
remainder of this Agreement or any of its provisions; provided, however, the Parties shall use
their respective reasonable efforts to renegotiate the offending provisions to best accomplish the
original intentions of the Parties.
12.3 Accrued Obligation. Termination of this Agreement for any reason shall not
release any Party hereto from any liability which at the time of such termination has already
accrued to the other Party or which is attributable to a period prior to such termination, nor
shall it preclude either Party from pursuing all rights and remedies it may have hereunder or at
law or in equity with respect to any breach of this Agreement.
12.4 Waivers. Any term or condition of this Agreement may be waived at any time by
the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set
forth in a written instrument duly executed by or on behalf of the Party or Parties waiving such
term or condition. Neither the waiver by any Party of any term or condition of this Agreement nor
the failure on the part of any Party, in one or more instances, to enforce any of the provisions of
this Agreement or to exercise any right or privilege, shall be deemed or construed to be a waiver
of such term or condition for any similar instance in the future or of any subsequent breach
hereof. All rights, remedies, undertakings, obligations and agreements contained in this Agreement
shall be cumulative and none of them shall be a limitation of any other remedy, right, undertaking,
obligation or agreement.
12.5 Entire Agreement; Amendments. This Agreement sets forth the entire agreement and
understanding among the Parties as to the subject matter hereof and supercedes all agreements or
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understandings, verbal or written, made between ADVENTRX and THERAGENEX before the date hereof
with respect to the subject matter hereof. None of the terms or this Agreement shall be amended,
supplemented or modified except in writing signed by both Parties.
12.6 Assignment. This Agreement may not be assigned or otherwise transferred by
either Party without the prior written consent of the other Party; provided, however, either Party
may, without such consent, assign this Agreement, in whole or in part, to a party that succeeds to
all or substantially all of such Party’s business or assets relating to this Agreement whether by
sale, merger, operation of law or otherwise; provided that such assignee or transferee promptly
agrees in writing to be bound by the terms and conditions of this Agreement. Any purported
assignment in violation of this Section 12.6 shall be void. Any permitted assignee shall assume
all obligations of its assignor under this Agreement.
12.7 Independent Contractor. The relationship between ADVENTRX and THERAGENEX is that
of independent contractors. ADVENTRX and THERAGENEX are not joint venturers, partners, principal
and agent, employer and employee, and have no other relationship other than independent contracting
parties.
12.8 Notices. All notices, consents, approvals, or other communications required
hereunder given by one Party to the other hereunder shall be in writing and made by registered or
certified air mail, facsimile (and promptly confirmed by personal delivery or courier), express
overnight courier or delivered personally to the following addresses of the respective Parties:
| If to ADVENTRX: | ADVENTRX Pharmaceuticals, Inc. | |||
| Attn: Vice President, Business Development | ||||
| 0000 Xxxx Xxxxx Xxxx, Xxxxx 000 | ||||
| Xxx Xxxxx, Xxxxxxxxxx 00000 | ||||
| Tel: (000) 000-0000 | ||||
| Fax: (000) 000-0000 | ||||
| With copies to: | ADVENTRX Pharmaceuticals, Inc. | |||
| Attn: General Counsel | ||||
| 0000 Xxxx Xxxxx Xxxx, Xxxxx 000 | ||||
| Xxx Xxxxx, Xxxxxxxxxx 00000 | ||||
| Tel: (000) 000-0000 | ||||
| Fax: (000) 000-0000 | ||||
| Xxxxxx Xxxxxxx Xxxxxxxx & Xxxxxx, P.C. | ||||
| Attn: Xxx Xxxxxxxx, Esq. | ||||
| 000 Xxxx Xxxx Xxxx | ||||
| Xxxx Xxxx, Xxxxxxxxxx 00000 | ||||
| Tel: 000-000-0000 | ||||
| Fax: 000-000-0000 |
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| If to THERAGENEX: | Theragenex, LLC. | |||
| Suite 400, 0000 Xxxxxxx Xxxxxxxxx | ||||
| Xxxxxx, XX 00000 | ||||
| Attention: Chief Executive Officer | ||||
| Phone: 000-000-0000 | ||||
| Fax: 000-000-0000 | ||||
| with a copy to: | Xxxxxxxxx Law Group PLLC | |||
| 0000 Xxxxxxx Xxxx, Xxxxx 000 | ||||
| Xxxxxxx, XX 00000 | ||||
| Attention: J. Xxxxxx Xxxxx, III | ||||
| Fax: 000-000-0000 | ||||
| Phone: 000-000-0000 |
Notices hereunder shall be deemed to be effective (a) upon receipt if personally delivered, (b) on
the fifth Business Day following the date of mailing if sent by registered or certified air mail,
and (c) on the second Business Day following the date of transmission or delivery to the overnight
courier if sent by facsimile or overnight courier. A Party may change its address listed above by
sending notice to the other Party in accordance with this Section 12.8.
12.9 Third Party Beneficiaries. None of the provisions of this Agreement shall be for
the benefit of or enforceable by any Third Party, including, without limitation, any creditor of
either Party. No such Third Party shall obtain any right under any provision of this Agreement or
shall by reasons of any such provision make any claim in respect of any debt, liability or
obligation (or otherwise) against either Party.
12.10 Binding Effect. This Agreement shall be binding upon and inure to the benefit
of the Parties hereto and their respective heirs, successors and permitted assigns.
12.11 Counterparts. This Agreement may be executed in any two or more counterparts,
each of which, when executed, shall be deemed to be an original and all of which together shall
constitute one and the same document.
12.12 Headings. Headings in this Agreement are included herein for ease of reference
only and shall have no legal effect. References to Articles, Sections and Exhibits are to
Articles, Sections and Exhibits to this Agreement unless otherwise specified.
IN WITNESS WHEREOF the Parties hereto have caused this Agreement to be executed by their duly
authorized officers upon the Effective Date.
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| ADVENTRX PHARMACEUTICALS INC. | THERAGENEX, LLC. | |||||||||
By:
|
/s/ Xxxx X. Xxxxxx | By: | /s/ Xxxxx X. Xxxxxxx | |||||||
Name:
|
Xxxx X. Xxxxxx | Name: | Xxxxx X. Xxxxxxx | |||||||
Title:
|
Chief Executive Officer | Title: | Chairman | |||||||
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EXHIBIT A
ADVENTRX PATENT RIGHTS
U.S. 11/003,302 “Antiviral Pharmaceutical Compositions.”
1
EXHIBIT B
FORM OF PRESS RELEASE
[See Exhibit 99.1]
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