LICENSE AGREEMENT
THIS
LICENSE AGREEMENT (the “Agreement”) is made as of March 24, 2010 (the “Effective
Date”) between Panacea Pharmaceuticals, Inc., a corporation organized under the
laws of Maryland (“Pharmaceuticals”), having its principal place of business at
000 Xxxxx Xxxxxxx, Xxxxx 00, Xxxxxxxxxxxx, XX, and Panacea Global, Inc.
(“Global”), a corporation organized under the laws of Delaware, having its
principal place of business at Xxxxx 00, 000 Xxxxxxx Xxxx., Xxxxxxx, XX X0X
0X0.
RECITALS
WHEREAS,
Pharmaceuticals has developed various cancer diagnostic products used for
screening, monitoring, surveillance, and recurrence as well as for drug
sensitivity and as companion diagnostics for patient management;
WHEREAS,
Pharmaceuticals owns or has acquired proprietary rights related to such
technology;
WHEREAS,
Global has expertise in the development, marketing, and sales of
laboratory-based diagnostics; and
WHEREAS,
Global desires to receive and Pharmaceuticals desires to grant, certain licenses
to Global with respect to the development, use, and marketing of Licensed
Products (as defined below) within the Territory (as defined below), subject to
the terms and conditions of this Agreement.
NOW,
THEREFORE, in consideration of the foregoing premises and the mutual covenants
herein contained, Pharmaceuticals and Global agree as follows:
SECTION
1
DEFINITIONS
For the
purposes of this Agreement, the following terms, whether used in their singular
or plural form, shall have the respective meanings set forth below:
1.1 “Acquiring Entity”
means any entity that acquires all or substantially all of the stock, assets, or
business of Pharmaceuticals (or all or substantially all of the assets or
business thereof related, in either case, to this Agreement) or otherwise
obtains control of Pharmaceuticals (with “control”, for purposes of this Section
1.1, having the meaning set forth in Section 1.2 below), or any affiliate of
such an entity.
1.2 “Affiliate” means, in
the case of either Party, a corporation or other entity which, directly or
indirectly, controls, is controlled by or is under common control with, that
Party. A corporation or other entity shall be regarded as in control of another
corporation or entity if it owns or directly or indirectly controls more than
fifty (50) percent of the voting stock or other ownership interest of the other
corporation or entity, or if it possesses, directly or indirectly, the power to
direct or cause the direction of the management and policies of the corporation
or other entity.
1.3 “Confidential
Information” means any confidential or proprietary information, technical
data, or know-how of a Disclosing Party (as defined in Section 9.1), provided,
however, that Confidential Information does not include information that (i) is
in the possession of the Receiving Party (as defined in Section 9.1) at the time
of disclosure as shown by the Receiving Party's files and records immediately
prior to the time of disclosure, (ii) prior or after the time of disclosure
becomes part of the public knowledge or literature, not as a result of any
inaction or action of the Receiving Party; (iii) is received by the Receiving
Party on a non-confidential basis from a Third Party who is not subject to an
obligation of confidentiality to the Disclosing Party, or (iv) is independently
developed by the Receiving Party, as shown by the Receiving Party’s records.
Without limiting the generality of the foregoing, Global acknowledges that
Pharmaceuticals Know-How shall be considered Confidential Information of
Pharmaceuticals.
1.4 “Controlled” means,
with respect to any intellectual property or right therein, the possession by a
Party of the ability to grant a license or sublicense as provided for herein
without violating the terms of any arrangement or agreements between such Party
and any Third Party.
1.5 “Cover” means that the
use, manufacture, sale, offer for sale, development, commercialization or
importation of the subject matter in question by an unlicensed entity would
infringe a Valid Claim of a Patent.
1.6 “Customers” means
Third Parties that are physicians, hospitals, or other health care providers or
health care facilities.
1.7 “Effective Date” has
the meaning set forth in the preamble.
1.8 “Field” means the
performance of central laboratory-based diagnostic testing for cancer in humans
based on the detection of HAAH levels in blood.
1.9 “HAAH” means human
aspartyl beta-hydroxylase.
1.10 “Licensed Product”
means the technology, method, process, Pharmaceuticals Patent Rights, and
Pharmaceuticals Know-How related to a HAAH-based laboratory test to be provided
by Pharmaceuticals pursuant to the licenses granted in this
Agreement.
1.11 “Licensed Service”
means any service that is provided by Licensee to a Customer involving the use
of the Licensed Product in the Field.
1.12 “Party” means either
Pharmaceuticals or Global as the context requires, and “Parties” means,
collectively, Pharmaceuticals and Global.
1.13 “Patent(s)” means any
granted patents and pending patent applications, together with all additions,
divisionals, continuations, continuations-in-part, substitutions, reissues,
re-examinations, extensions, registrations, patent term extensions,
revalidations, supplementary protection certificates, and renewals of any of the
foregoing, and all foreign applications and patents corresponding to or claiming
priority from any of the foregoing.
1.14 “Pharmaceuticals
Know-How” means all unpatented inventions, technology, methods,
materials, know-how, studies, pre-clinical and clinical data (including
toxicology and safety data), tests and
assays, reports, manufacturing processes, regulatory filings (including drafts)
and other information Controlled by Pharmaceuticals or its Affiliates as of the
Effective Date or during the term of the Agreement, to the extent directly
relating to the commercialization of Licensed Products under this Agreement.
Notwithstanding anything to the contrary, Pharmaceuticals Know-How shall not
include any of the foregoing that is owned, licensed, or otherwise controlled by
any Acquiring Entity prior to the date of the transaction by which such
Acquiring Entity first became an Acquiring Entity, including any modifications
or extensions thereto (the “Acquiring Entity Know-How”), provided that such
Acquiring Entity Know-How was not already included within the Pharmaceuticals
Know-How prior to the date of the transaction by which such Acquiring Entity
first became an Acquiring Entity
1.15 “Pharmaceuticals Patent
Rights” means the Patents Controlled by Pharmaceuticals covering the
Licensed Product in the Territory, including, to the extent Controlled by
Pharmaceuticals, the Patents set forth on Schedule A hereto. Notwithstanding
anything to the contrary, Pharmaceuticals Patent Rights shall not include any
Patents that are owned, licensed, or otherwise controlled by any Acquiring
Entity prior to the date of the transaction by which such Acquiring Entity first
became an Acquiring Entity (the “Acquiring Entity Patents”), provided that such
Acquiring Entity Patents were not already included within the Pharmaceuticals
Patent Rights prior to the date of the transaction by which such Acquiring
Entity first became an Acquiring Entity.
1.16 “Pharmaceuticals
Territory” means United States and its territories and
protectorates.
1.17 “Regulatory Approval”
means any and all approvals (including supplements, amendments, pre- and
post-approvals, pricing and reimbursement approvals), licenses, registrations or
authorizations of any national, supra-national (e.g., the European Commission or
the Council of the European Union), regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity, that are
necessary for the marketing, sale and provision of Licensed Services to
Customers in the Territory, and the use of the Licensed Products in connection
therewith, in a regulatory jurisdiction.
1.18 “Regulatory
Documentation” means, with respect to the Licensed Product, all material
regulatory filings and supporting documents created or submitted to any
regulatory agency or government authority (including any supra-national agency
such as in the European Union) and all data contained therein including, without
limitation, the contents of any Regulatory Approvals, correspondence to and from
the any regulatory agency or governmental authority, minutes from meetings
(whether in person or by audioconference or videoconference) with regulatory
authorities, registrations and licenses, regulatory drug lists, advertising and
promotion documents shared with regulatory authorities, adverse event files,
complaint files and manufacturing records.
1.19 “Regulatory Filing”
means any filings required by regulatory authorities relating to the for the
marketing, sale and provision of Licensed Services to Customers in the
Territory, and the use of the Licensed Products in connection
therewith.
1.20 “Sublicensing Revenue”
means any revenue, income, financial, or other consideration received by Global
from a Third Party in the Territory except for Canada as a one-time fee in
consideration for the grant of a sublicense to such Third Party under any of the
rights granted under this Agreement.
1.21 “Territory” means all
other countries except for United States and its territories and
protectorates.
1.22 “Third Party” means
any person or entity, which is not a Party or an Affiliate of a Party to this
Agreement.
1.23 “Valid Claim” means a
claim of any pending patent application or any issued, unexpired patent that has
not been dedicated to the public, disclaimed, abandoned or held invalid or
unenforceable by a court or other body of competent jurisdiction from which no
further appeal can be taken, and that has not been explicitly disclaimed, or
admitted in writing to be invalid or unenforceable or of a scope not Covering a
particular product or service through reissue, disclaimer or
otherwise.
Any and
all other capitalized terms set forth in this Agreement not otherwise defined in
this Section 1 shall have the meaning set forth elsewhere in this
Agreement.
SECTION
2
SCOPE
OF LICENSE
2.1 LICENSE GRANT
Subject
to the terms and conditions of this Agreement, Pharmaceuticals hereby grants to
Global a license, with rights of sublicense (as further described below), under
the Pharmaceuticals Patents and Pharmaceuticals Know-How to provide Licensed
Services in the Territory.
2.2 SUBLICENSING
Global
shall have the right to sublicense its rights under Section 2.1 to one or more
Third Parties, provided that rights to Pharmaceuticals Know-How may only
sublicensed as part of a sublicense under all or some of the related
Pharmaceuticals Patents. Global shall provide Pharmaceuticals a written copy of
each proposed sublicense (and each amendment thereto, if any) reasonably (and at
least fifteen (15) business days in advance of its execution, and with a fully
executed copy within thirty (30) days following its execution. Each sublicense
shall (1) be subject to, and consistent with, the terms and conditions of this
Agreement, (2) be no less favorable to Pharmaceuticals than this Agreement, (3)
not conflict with the terms of this Agreement, (4) contain terms and conditions
reasonably sufficient to enable Global to comply with the terms of this
Agreement; and (5) include as a material term of such sublicense that such
sublicense shall terminate concurrent with any termination of this
Agreement.
2.3 COVENANT TO MAINTAIN CERTAIN PATENT
RIGHTS
Pharmaceuticals
covenants and agrees to at all times during the term of this Agreement to keep
and maintain in valid force and effect the certain Exclusive License Agreement
by and between Rhode Island Hospital (“Xxxxx University”) and Pharmaceuticals
dated November 29, 1999 (the “Xxxxx License”) for the grant of a worldwide,
exclusive license (with the right to sublicense) for the Patents set forth on
Schedule B to this Agreement (the “Licensed Patent Rights”). Promptly following
the Effective Date, Pharmaceuticals shall obtain the required consent to effect
a sublicense of the Licensed
Patent Rights in accordance with the Xxxxx License (the “Sublicense”). To
facilitate Pharmaceuticals efforts to obtain the Sublicense, Global agrees to
cooperate with Pharmaceuticals and to provide to Pharmaceuticals all information
requested of Pharmaceuticals by Xxxxx University regarding Global and its
operations as Xxxxx University may request to provide its consent to such
sublicense. Upon receipt by Pharmaceuticals of the consent of Xxxxx University
as required by the Xxxxx License to the Sublicense, the Pharmaceuticals Patent
Rights licensed under this Agreement shall be amended to include all of the
Licensed Patent Rights within the Field.
SECTION
3
FINANCIAL
TERMS
3.1 EQUITY.
Following the Effective Date, Global and Pharmaceuticals agree to negotiate in
good faith a mutually-acceptable Stock Purchase/Subscription Agreement or
similar definitive agreement for the acquisition by Pharmaceuticals of
40,000,000 shares of the common stock of Global (the “Stock
Agreement”).
3.2 LICENSE
FEE. As consideration for the licenses granted by Pharmaceuticals to Global in
this Agreement, Global shall pay Pharmaceuticals two million and five hundred
thousand dollars ($2,500,000.00) (the “License Fee”) no later than within the
thirty (30) days following Global’s receipt of aggregate of ten million dollars
($10,000,000) in equity investment (the “Minimum Capital”) (including but not
limited to, for purposes of such calculation, the principal and interest of any
debt converted into equity in any such financing) (the “Funding Period”). During
the Funding Period, upon receipt of any part or portion of the Minimum Capital,
Global shall provide notice to Pharmaceuticals of the amount of such part or
portion received, the form and nature of such part or portion of the Minimum
Capital, whether issuance of equity securities, issuance of debt securities,
conversion of debt to equity, or any other funding instrument, and shall
together with such notice, remit to Pharmaceuticals one-half of each such part
or portion of the Minimum Capital as and when received by Global until such time
as the Licensee Fee shall be paid in full.
3.3 SUBLICENSING
REVENUE. As consideration for the licenses granted by Pharmaceuticals to Global
in this Agreement, Global shall pay Pharmaceuticals twenty-five (25) percent of
all Sublicensing Revenue (the “Revenue Share”).
3.4 U.S.
FUNDS. Each payment pursuant to this Agreement shall be paid in U.S. currency by
wire transfer in immediately available funds to an account designated by the
receiving party, or by other mutually acceptable means. All amounts specified in
this Agreement are expressed in U.S. dollars.
3.5 PAYMENTS.
All Revenue Share and payments due under Section 3.3 shall be paid within thirty
(30) days of the end of each calendar quarter during which Sublicensing Revenue
is received. Each payment shall be accompanied by a statement stating the amount
of Sublicensing Revenue received from each sublicensee during the relevant
calendar quarter and detailing the calculation of Revenue Share due for such
calendar quarter.
3.6 WITHHOLDING
TAXES. Where any sum payable to Pharmaceuticals hereunder is subject to any
withholding or similar tax, Global shall pay such withholding or similar tax to
the appropriate government authority, deduct the amount paid from the amount due
Pharmaceuticals and
secure and send to Pharmaceuticals the best available evidence of such payment.
Global will provide Pharmaceuticals with reasonable assistance to enable
Pharmaceuticals to recover such taxes or amounts otherwise withheld as permitted
by law.
3.7 FOREIGN
EXCHANGE. With respect
to Sublicensing Revenue received in a currency other than United States dollars,
such Sublicensing Revenue will be converted into the United States dollar
equivalent using the rate published by the Wall Street Journal (U.S. edition)
for conversion of that foreign currency into United States dollars on the last
day of the quarter during which such Sublicensing Revenue was
received.
3.8 INTEREST. If Global fails to make any
payment when due to Pharmaceuticals under this Agreement, then interest shall
accrue on the balance due at a per annum rate of five percent (5%). Amounts due
shall be compounded monthly until Global meets the full financial obligation due
at the time of the next payment or invoice due date. The obligation to pay
interest on such late payments set forth herein shall not be construed to limit
or restrict Pharmaceuticals’ right to any other rights or remedies which may be
available to it, including any applicable right to terminate this Agreement in
accordance with the terms and conditions of this Agreement.
3.9 RECORDS;
AUDITS. Global shall
keep or cause to be kept such records as are reasonably required to determine,
in a manner, with respect to any financial records, consistent with generally
accepted accounting principles in the United States, the amounts due under this
Agreement and the Supply Agreement and whether or not Global is complying with
the terms of this Agreement and the Supply Agreement; such records must be kept
for a minimum of five (5) years following the calendar year to which such
records pertain. At the request (and expense) of Pharmaceuticals, Global, its
Affiliates, and sublicensees shall permit Pharmaceuticals or any designee
thereof, at reasonable times not more than once a year and upon reasonable
notice, to examine only those records as may be necessary to determine, with
respect to any calendar year ending not more than five (5) years prior to
Pharmaceuticals’ request, the correctness or completeness of any report or
payment made under this Agreement or the Supply Agreement or whether or not
Global has complied with the terms of this Agreement or the Supply Agreement.
Pharmaceuticals shall promptly provide a copy of the results of any such audit
or examination to Global. Pharmaceuticals shall bear the full cost of the
performance of any such audit or examination, unless such audit or examination
discloses an underpayment exceeding five percent (5%) of the amount actually due
hereunder with respect to any particular calendar quarter or any other material
breach of this Agreement or the Supply Agreement, in which case Global shall
bear the reasonable, documented cost of the performance of such audit or
examination. Global shall promptly pay to Pharmaceuticals the amount of any
underpayment of Revenue Share or for any amounts otherwise due under the Supply
Agreement revealed by such an examination and review plus interest (in
accordance with Section 3.8). Any overpayment by Global of Revenue Share or any
other amount paid to Pharmaceuticals (including, without limitation, amounts
paid under the Supply Agreement) revealed by an examination and review shall, in
Global’s sole discretion, (i) be fully-creditable against future payments under
this Agreement, or the Supply Agreement (as applicable) or (ii) refunded to
Global within thirty (30) days of its request.
SECTION
4
SUPPLY
Subject
to the terms of this Agreement and the Supply and Services Agreement attached
hereto as Schedule C (the “Supply Agreement”), Global shall purchase (and its
Affiliates and sublicensees shall purchase) all of their requirements for the
consumables needed for use of the Licensed Product in provision or delivery of
the Licensed Services solely from Pharmaceuticals, and shall not directly or
indirectly make any Licensed Products themselves or have Licensed Products
manufactured by any Third Party. Global shall make sure that any contracts it
enters into with any sublicensees of the rights granted hereunder or any Third
Party concerning the commercialization of Licensed Products shall include
provisions imposing such limitation on such Third Parties and language ensuring
that Global is a third party beneficiary entitled to enforce such provisions.
The Parties shall execute the Supply Agreement simultaneously with the execution
of this Agreement.
SECTION
5
DILIGENCE
5.1 Global
shall use commercially reasonable efforts to exploit the rights granted under
this Agreement for the Parties’ maximum economic benefit.
5.2 Global
shall have sole responsibility for, and shall bear the cost of preparing, all
Regulatory Filings and Regulatory Approvals. Except as set forth in Section
11.3.1, as between the Parties, Global will own and be fully responsible for all
Regulatory Approvals and Regulatory Filings for each country in the Territory.
Global shall maintain reasonably complete and accurate records of all work
conducted in furtherance of its efforts under this Agreement and all material
results, data and developments made in conducting such activities. Such records
shall be maintained in reasonably sufficient detail and in good scientific
manner reasonably appropriate for patent and regulatory purposes.
5.3 Global
shall provide Pharmaceuticals a quarterly update, within thirty (30) days of the
end of each calendar quarter, summarizing the progress and results of its, its
Affiliates’, and sublicensees’ efforts to exploit the rights granted under this
Agreement, and any ongoing plans with respect thereto. By February 15th of each
year that this Agreement is in effect, Global must provide Pharmaceuticals a
reasonably detailed report describing the status of Global’s, its Affiliates’,
and sublicensees’ efforts to exploit the rights granted under this Agreement,
and any ongoing plans with respect thereto. The report must, if and as requested
and specified by Pharmaceuticals in advance, provide information at least
sufficient to meet Pharmaceuticals’ and its licensors’ government reporting
requirements.
5.4 Global
shall comply, and shall ensure that its Affiliates and any sublicensees comply,
with all applicable laws, rules, and regulations in the exercise of the rights
granted under this Agreement and in any use of Licensed Products in any manner
whatsoever, including, without limitation, in the provision or delivery of the
Licensed Services.
SECTION
6
INTELLECTUAL
PROPERTY
6.1 ENFORCEMENT.
If any Pharmaceutical Patents Rights is infringed by a Third Party in the
Territory during the term of this Agreement, the Party to this Agreement first
having knowledge of such infringement shall have promptly notify the other Party
in writing. The notice shall set forth the perceived facts of such infringement
in reasonable detail. Pharmaceuticals shall have the sole right, but not the
obligation, to institute, prosecute, and control any action with respect to
infringement and misappropriation of such Pharmaceuticals Patents Rights in the
Territory.
6.2 INFRINGEMENT
ACTIONS BY THIRD PARTIES. If a Party, or to its knowledge, shall be sued by a
Third Party for infringement of a patent because of the use of Licensed Products
in the Territory, such Party shall promptly notify the other in writing of the
institution of such suit. The Party sued shall control the defense of such suit
at its own expense; provided, however, if the Party being sued is being
indemnified for such claim by the other Party, then the indemnifying Party shall
have the right to control the defense of the claim in accordance with Section 8.
Each Party shall cooperate fully in the defense of such suit and shall furnish
to the other Party all evidence and assistance in its control. The Party sued
shall make a preliminary decision to defend or not defend its interests in such
suit and shall so notify the other Party in writing of its decision within
thirty (30) days of the institution of such a suit. If a Party after electing to
defend a suit should at any time elect to drop such defense, said Party shall
immediately notify the other Party in writing and permit such other Party to
control the suit at such other Party’s expense, in the name of the Party
initiating the defense. If the Party sued notifies the other Party in writing
per the above that it shall not defend or continue the defense of such suit,
then the other Party shall have the right, but not the obligation, to defend its
interests in such a suit, and shall have the right to litigate, settle, or
otherwise dispose of such suit as it sees fit, provided, however, that Global
shall not settle such suit in a manner that would adversely affect the
Pharmaceuticals Patent Rights. Any judgments, settlements, or damages payable
with respect to legal proceedings covered by this Section 6.2 shall be paid by
the Party which controls the litigation, subject to any claims against the other
Party for breach of or indemnification under this Agreement or otherwise
available at law or in equity.
6.3 PATENT
TERM RESTORATION. The Parties hereto shall give reasonable cooperation to each
other in obtaining patent term restoration, extensions, supplemental protection
certificates, or their equivalents in any country in the Territory where
applicable to the Licensed Products.
6.4 TRADEMARKS.
Global shall not, without the written consent and authorization of
Pharmaceuticals, use the (a) trade name, trademark or service xxxx PANACEA or
colorable imitations thereof (collectively, the “Pharmaceuticals Marks”) in the
name of the License Service or for any other purpose; (b) Pharmaceuticals Marks
in any press release, advertising, marketing and/or promotional materials,
documentation or collateral related to the Licensed Product or Licensed Service.
Global has no power or right to, and shall not during the term of this Agreement
or thereafter:
6.4.1
attack
the title or any rights of Pharmaceuticals in and to the Pharmaceuticals
Marks;
6.4.2 claim
any right, title or interest in and to the Pharmaceuticals Marks or any other
trademarks or service marks of Licensor which is adverse to any of Licensor's
rights therein; or
6.4.3 register
or apply for registration anywhere in the world of the Pharmaceuticals Marks, or
any other trademark or service xxxx which is similar to or a colorable imitation
thereof.
SECTION
7
REPRESENTATIONS,
WARRANTIES, AND COVENANTS
7.1 REPRESENTATIONS
AND WARRANTIES. Each Party represents and warrants to the other
that:
7.1.1 CORPORATE
POWER: It is duly organized and validly existing under the laws of its state of
incorporation, and has full corporate power and authority to enter into this
Agreement and to carry out the provisions hereof.
7.1.2 DUE
AUTHORIZATION: It is duly authorized to execute and deliver this Agreement and
to perform its obligations hereunder, and any person executing this Agreement on
its behalf has been duly authorized to do so by all requisite corporate
action.
7.1.3 BINDING
AGREEMENT: This Agreement is legally binding upon such Party and enforceable in
accordance with its terms, subject to the effects of bankruptcy, insolvency, or
other laws of general application affecting the availability of specific
performance and general principles of equity whether enforceability is
considered a proceeding at law or equity. The execution, delivery, and
performance of this Agreement by it does not conflict with any material
agreement, instrument, or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any material law or regulation of any
court, governmental body or administrative or other agency having jurisdiction
over it.
7.2 REPRESENTATIONS
AND WARRANTIES OF PHARMACEUTICALS. Pharmaceuticals represents and warrants that:
(a) it holds all licenses, franchises, ordinances, authorizations, permits,
certificates, orders, and approvals required for or which are material to the
ownership of the Licensed Product, including Pharmaceutical Patents Rights; (b)
the Licensed Product has not been obtained through any fraudulent activity or
misrepresentation; (c) there are no suits, claims, or proceedings pending or
threatened against Pharmaceuticals or any of its Affiliates with respect to the
Licensed Product or the making, having made, using, selling, or offering for
sale, a the Licensed Product; (d) there are no Third Party patents that would
adversely effect Global’s ability to use the Licensed Product in the Field; and
(e) Pharmaceuticals has not taken any action to permit or neglected to take any
action required in order to prevent the exercise by the United States Government
of any rights it may have with respect to Pharmaceuticals Patents Rights or the
Licensed Patent Rights to the detriment of Global, and Pharmaceuticals will not
take any action to permit or neglect to take any action required in order to
prevent such exercise.
SECTION
8
INDEMNIFICATION
8.1 INDEMNIFICATION
BY GLOBAL. Global hereby agrees to defend, indemnify and hold harmless
Pharmaceuticals and its officers, directors, employees, consultants, and agents
from and against any and all suits, claims, actions, demands, liabilities,
expenses and or losses, including reasonable attorney’s fees and other costs of
defense (the “Claims”) (a) resulting directly or indirectly from the use,
handling, storage, or other disposition of the Licensed Products by Global, its
Affiliates, agents, or sublicensees, but only to the extent such Claims do not
result from the negligence or intentional misconduct of, or material breach of
this Agreement by Pharmaceuticals, (b)
resulting directly from a breach of this Agreement by Global, or (c) resulting
directly from the negligence or intentional misconduct of Global, its officers,
directors, employees, contractors, or agents.
8.2 INDEMNIFICATION
BY PHARMACEUTICALS. Pharmaceuticals hereby agrees to defend, indemnify and hold
harmless Global and its officers, directors, employees, consultants, and agents
from and against any and all Claims resulting directly from a breach of this
Agreement by Pharmaceuticals or resulting directly from the negligence or
intentional misconduct of Pharmaceuticals, its officers, directors, employees,
contractors, or agents, except to the extent such Claims arise out of (a) the
use, handling, storage, or other disposition of the Licensed Products by Global,
its Affiliates, agents, or sublicensees, (b) a breach of this Agreement by
Global or (c) the negligence or intentional misconduct of Global, its officers,
directors, employees, contractors, or agents.
8.3 NOTIFICATION
AND DEFENSE. In the event, a Party seeks indemnification under this Section 8,
it shall inform the indemnifying Party of a Claim as soon as reasonably
practicable after it becomes aware of any Third Party Claim, shall permit the
indemnifying Party to assume direction and control of the defense of the Claim
(including the right to settle the Claim solely for monetary consideration), and
shall cooperate as requested (at the expense of the indemnifying Party) in the
defense of the Claim. Except with the prior written consent of the indemnified
Party, which consent shall not be unreasonably withheld, the indemnifying Party
may not enter into any settlement of such litigation unless such settlement
includes an unqualified release of the indemnified Party.
SECTION
9
CONFIDENTIALITY
9.1 UNDERTAKING;
EXCEPTIONS. Each Party acknowledges that from time to time it may
come into possession of certain Confidential Information of the other Party.
Except to the extent expressly authorized by this Agreement or otherwise agreed
in writing by the Parties, the Parties agree that the receiving Party (the
“Receiving Party”) shall, with respect to Confidential Information of the other
Party (the “Disclosing Party”) (i) keep Confidential Information confidential,
(ii) not publish or otherwise disclose Confidential Information to any Third
Party, except that it may disclose Confidential Information to its and its
Affiliates’ directors, officers and employees who have need to know Confidential
Information for the purposes of this Agreement and who are bound by
confidentiality and nonuse obligations at least as restrictive as those provided
herein, and the Receiving Party will be responsible for ensuring that all its
directors, officers, and employees
to whom Confidential Information is disclosed will also observe such obligations
of confidentiality and non-use as provided herein, and (iii) not use
Confidential Information for any purpose other than as provided for in this
Agreement
9.2 AUTHORIZED
DISCLOSURE. Each Party may disclose Confidential Information belonging to the
other Party to the extent such disclosure is reasonably necessary in the
following instances:
(a) filing or
prosecuting patent applications under this Agreement;
(b) regulatory
fillings (including filings with the SEC);
(c) prosecuting
or defending litigation;
(d) complying
with applicable governmental regulations;
(e) complying
with the order of any other court or other governmental or regulatory body
having jurisdiction;
(f) conducting
preclinical or clinical trials of the Licensed Products; and
(g) disclosure
to Affiliates, sublicensees of Global, employees, consultants, or agents who are
bound by similar terms of confidentiality and non-use at least equivalent in
scope to those set for in this Section 9.
Notwithstanding
the foregoing, in the event a Party is required to make a disclosure of the
other Party’s Confidential Information pursuant to this Section 9.2 such Party
will, except where impracticable, give reasonable advance notice to the other
Party of any disclosure required above and provide the other Party a reasonable
opportunity to review and comment on any potential disclosure and use reasonable
and diligent efforts to secure confidential treatment of economic, trade secret,
and other confidential or proprietary information to the extent permitted by
applicable laws, rules, and regulations and the applicable governmental
agency(ies). In any event, the Parties agree to take all reasonable action to
avoid disclosure of Confidential Information hereunder.
9.3 EXISTENCE
AND TERMS OF AGREEMENT. The Parties agree that the fact of the existence of this
Agreement, the terms and conditions hereof and all activities contemplated or
performed hereunder are the Confidential Information of the other Party and
shall not be disclosed to any Third Party in any manner whatsoever, including
without limitation, by way of news articles, public announcements or
disclosures, except pursuant to an authorized disclosure under Section 9.2 or
9.4 and to investment bankers, counsel accountants, financial advisors,
potential or actual investors, potential or actual lenders, potential or actual
acquirers, acquisition targets, or merger targets, actual or potential
sublicensees, or actual or potential other strategic partners, provided that
they are bound by obligations of confidentiality and non-use at least as
protective as those set forth in this Section 9.
9.4 PUBLICITY.
The Parties will issue a joint press release announcing the execution of this
Agreement on or shortly following the Effective Date and may desire or be
required to issue subsequent press releases relating to the Agreement or
activities thereunder. The Parties shall consult
with each other reasonably and in good faith and agree with respect to the text
and timing of such press releases prior to the issuance thereof, provided that a
Party may not reasonably withhold consent to or delay of such
releases
SECTION
10
PUBLICATIONS
10.1 NOTICE
OF PUBLICATION. If Global intends to publish or present the results of any
activities hereunder regarding its use of the Licensed Product it shall provide
Pharmaceuticals a reasonable advance opportunity, but no less than thirty (30)
days prior to its intended submission for publication (the “Review Period”), to
(a) review and comment on such proposed publication prior to its submission and
(b) review the proposed publication for any of Pharmaceuticals’ Confidential
Information. During the Review Period, Pharmaceuticals may request in writing,
and Global shall agree to, (i) the deletion of any of Pharmaceuticals’
Confidential Information, (ii) any reasonable changes requested by
Pharmaceuticals, or (iii) a delay of such proposed submission for an additional
period, not to exceed ninety (90) days, in order to protect the potential
patentability of any patentable information of Pharmaceuticals.
SECTION
11
TERM
AND TERMINATION
11.1 TERM.
This Agreement shall commence as of the Effective Date and shall continue on a
country-by-country basis within the Territory, until the expiration of the last
to expire Valid Claim included in the Pharmaceutical Patent Rights covering the
Licensed Product in a particular country, unless terminated earlier as provided
herein. Upon the expiration of the term of this Agreement in a particular
country, all licenses granted hereunder shall terminate.
11.2 TERMINATION
FOR CAUSE. Either Party may terminate this Agreement prior to the expiration of
the term of this Agreement upon the occurrence of any of the
following:
11.2.1 In
the event either Party is subject to (a) a petition by one or more creditors of
the Borrower seeking: (i) the entry of a decree or order for relief by a court
having jurisdiction against or with respect to such Party in an involuntary case
under applicable bankruptcy or insolvency laws or similar laws ordering the
liquidation of such party; or (ii) a reorganization of such Party or such
Party’s business and affairs or the appointment of a receiver, liquidator,
assignee, custodian, trustee, or similar official for such Party or any of such
Party’s property, and such petition is not unconditionally dismissed within
sixty (60) days from the date of filing; or (b) a voluntary case filed by any
such Party under applicable federal, state or provincial bankruptcy or
insolvency or similar laws or the consent by such party to the appointment of or
taking possession by a receiver, liquidator, assignee, trustee, custodian or
similar official for such Party or any of such party’s property, or the making
by such Party of a general assignment for the benefit of creditors, or the
failure by such Party to generally to pay such Party’s debts as they become
due;
11.2.2 Global
fails to become listed on any of the New York Stock Exchange or any NASDAQ
exchange (each, a “Stock Exchange”) within ninety (90) days of the Effective
Date;
11.2.3 Global
fails to pay or Global determines it is unable to pay, the License Fee within
one hundred eighty (180) days of the date Global becomes listed on any Stock
Exchange, provided however,
that if Pharmaceuticals intends to terminate this Agreement under
this Section
11.2.3, Pharmaceuticals shall first give notice to Global at least sixty (60)
days prior to the expiration of such 180-day period;
11.2.4 The
Parties fail to execute the Stock Agreement within 180 days of the Effective
Date, provided however,
that the Party intending to terminate this Agreement under this Section
11.2.4 shall
first give notice to Global at least sixty (60) days prior to the expiration of
such 180-day period; or
11.2.5 upon
the breach of any material provision of this Agreement or the Supply Agreement
by the other Party if the other Party has not cured such breach within 60 days
after written notice thereof by the non-breaching Party.
11.3 IMMEDIATE
TERMINATION. This Agreement shall immediately terminate upon the termination of
(but not the natural expiration of) the Xxxxx License.
11.4 EFFECT OF
EXPIRATION OR TERMINATION
11.4.1 Upon
the termination of this Agreement (i) all rights under the licenses granted
hereunder shall automatically terminate, Global shall cease the provision and
delivery of Licensed Services and shall cease and desist in any and all uses of
the Licensed Product; (ii) Global shall deliver, assign and transfer to
Pharmaceuticals all right, title, and interest in all Regulatory Filings,
Regulatory Documentation, Regulatory Approvals, and shall take all actions and
execute all documents reasonably necessary to effectuate such delivery,
assignment and transfer; and (iii) any sublicense agreement entered into by
Global in accordance with Section 2.2 that (a) does not impose any obligations
on Pharmaceuticals in excess of those contained in this Agreement, (b) contains
economic terms at least as favorable to Pharmaceuticals as those contained in
this Agreement and (c) provides for the assignment of such sublicense agreement
to Pharmaceuticals upon termination of this Agreement, shall be automatically
assigned to Pharmaceuticals if the sublicensee thereunder is not in material
breach of such sublicense agreement at the time of termination.
11.4.2 Within
thirty (30) days following the termination or expiration of this Agreement, each
Party shall deliver to the other Party any and all Confidential Information, and
any copies thereof, of the other Party in its possession, except that the Party
will be entitled to retain one (1) copy of all documents in its legal
archives.
SECTION
12
MISCELLANEOUS
12.1 DISPUTE
RESOLUTION PROCESS. The Parties recognize that disputes as to certain matters
may from time to time arise during the Term that relate to either Party’s rights
and/or obligations hereunder. It is the objective of the Parties to facilitate
the resolution of disputes arising under this Agreement in an expedient manner
by mutual cooperation and without resort to litigation or arbitration. To
accomplish this objective, the Parties agree that, in the event of any disputes,
controversies or differences that may arise between the Parties, out of or in
relation to or in connection with this Agreement, or for the breach thereof,
upon the request of either Party, the Parties agree to meet and discuss in good
faith a possible resolution thereof. If the matter is not resolved within thirty
(30) days following the request for discussions, either Party may refer the
matter to arbitration in accordance with Section 10.3 below. Notwithstanding
anything to the contrary, each Party shall be entitled to seek appropriate
injunctive relief in any court of competent jurisdiction (i) to preserve such
Party’s rights pending resolution of arbitration proceedings under this
Agreement, (ii) to avoid irreparable damages, or (iii) with respect to any
matters concerning intellectual property rights or confidentiality.
12.2 GOVERNING
LAW AND JURISDICTION. This Agreement shall be governed and construed in
accordance with the laws of the State of Delaware without regard to the
conflicts of laws provisions hereof and without regard to the United Nations
Convention on Contracts for the International Sale of Goods. The sole
jurisdiction and venue for actions to enforce compliance with, or any dispute
arising from or related to this Agreement shall be the state and federal courts
of in and for New Castle County, Delaware. Both Parties consent to the
jurisdiction of such courts and agree that process may be served in the manner
allowed under state or federal law. In any action or proceeding to enforce
rights under this Agreement, the prevailing Party shall be entitled to recover
costs and attorneys’ fees.
12.3 ASSIGNMENT.
Except as expressly provided hereunder, neither this Agreement nor any rights or
obligations hereunder may be assigned or otherwise transferred by either Party
without the prior written consent of the other Party (which consent shall not be
unreasonably withheld, condition, or delayed); provided, however, that either
Party may assign this Agreement and its rights and obligations hereunder without
the other Party’s consent in connection with the transfer or sale of all or
substantially all of that portion of the business of such Party to which this
Agreement relates to another Party, whether by merger, sale of stock, sale of
assets, or otherwise; provided, that, for purposes of clarity, intellectual
property rights of a party to such transaction other than one of the initial
Parties to this Agreement shall not be included in the Licensed Product licensed
hereunder. The rights and obligations of the Parties under this Agreement shall
be binding upon and inure to the benefit of the successors and permitted assigns
of the Parties. Any assignment not in accordance with this Agreement shall be
void.
12.4 FORCE
MAJEURE. Neither Party shall be held liable or responsible to the other Party
nor be deemed to have defaulted under or breached this Agreement for failure or
delay in fulfilling or performing any term of this Agreement (other than
non-payment) 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 labour
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority.
12.5 SEVERABILITY.
In case any provision of this Agreement shall be invalid, illegal, or
unenforceable, that provision shall be limited or eliminated to the minimum
extent necessary so that this Agreement shall otherwise remain in full force and
effect and enforceable.
12.6 NOTICE.
All notices and other communications provided for hereunder shall be in writing
and shall be delivered personally, by overnight delivery service or by
facsimile, with confirmation of receipt, addressed as follows:
If to
Pharmaceuticals, addressed to:
Xx.
Xxxxxxx Xxxxxxxx
Suite 13
– 000 Xxxxx Xxxxxxx
Xxxxxxxxxxxx,
XX 00000
If to
Global, addressed to:
Xx.
Xxxxxxx Xxxxxxx
Suite 11
– 000 Xxxxxxx Xxxx.
Xxxxxxx,
XX X0X 0X0
Either
Party may specify or change an address to which notices and communications shall
thereafter be sent. Notices sent by facsimile shall be effective upon
confirmation of receipt; notices sent by mail or overnight delivery service
shall be effective upon receipt; notices via email shall be effective if the
recipient confirms receipt from the sender; and notices given personally shall
be effective when delivered.
12.7 INDEPENDENT
CONTRACTORS. It is expressly agreed that Pharmaceuticals and Global shall be
independent contractors and that the relationship between the Parties shall not
mean that either has the authority to make any statement, representations, or
commitments of any kind on behalf of the other, or to take any action, which
shall be binding on the other Party, without the prior written consent of the
other Party.
12.8 ENTIRE
AGREEMENT; AMENDMENT. This Agreement (including the exhibits attached hereto)
sets forth all of the covenants, promises, agreements, warranties,
representations, conditions, and understandings between the Parties hereto with
respect to the subject matter hereof and supersedes and terminates all prior
agreements and understandings between the Parties; provided, however, that any
nondisclosure agreement entered into by the Parties shall remain in full force
and effect in accordance with its terms.
No
subsequent altercation, amendment, change, or addition to this Agreement shall
affect the rights of any Party hereto unless reduced to writing and signed by
the authorized officers of such Party, as applicable.
12.9 HEADINGS.
The captions to the several Sections hereof are not a part of this Agreement,
but are merely guides or labels to assist in locating and reading the several
Sections hereof.
12.10 WAIVER.
Except as specifically provided for herein, the waiver from time to time by
either of the Parties of any of their rights or their failure to exercise any
remedy shall not operate or be construed as a continuing waiver of same or of
any other of such Party’s rights or remedies provided in this
Agreement.
12.11 COUNTERPARTS.
This Agreement may be executed duplicate, each of which shall be deemed to be an
original but all of which shall constitute one and the same
Agreement.
[NEXT
PAGE IS SIGNATURE PAGE]
IN
WITNESS WHEREOF, the Parties have executed this Agreement effective as of the
Effective Date.
PANACEA
PHARMACEUTICALS, INC.
|
|||
By:
|
/s/ Xxxxxxx X.
Xxxxxxxx
|
||
Name:
|
Xxxxxxx
X. Xxxxxxxx
|
||
Title:
|
CEO/CSO
|
||
PANACEA
GLOBAL, INC.
|
|||
By:
|
/s/ Xxxxxxx Xxxxxxx | ||
Name:
|
Xxxxxxx
Xxxxxxx
|
||
Title:
|
Director
|
SCHEDULE
A
Panacea
Pharmaceuticals Patent Rights
US
11/668,421 Methods of
Diagnosing, Predicting Therapeutic Efficacy and Screening for New Therapeutic
Agents for Leukemia —Pending
US
12/175,451 Methods of
Diagnosing Lung Cancer—Pending
SCHEDULE
B
Licensed
Patent Rights under Xxxxx License
US
6,783,758
|
Diagnosis
and Treatment of Malignant Neoplasms—Issued
|
|
US
6,797,696
|
Diagnosis
and Treatment of Malignant Neoplasms—Issued
|
|
US
6,812,206
|
Diagnosis
and Treatment of Malignant Neoplasms—Issued
|
|
US
6,815,415
|
Diagnosis
and Treatment of Malignant Neoplasms—Issued
|
|
US
7,094,556
|
Diagnosis
and Treatment of Malignant Neoplasms—Issued
|
|
AUS
783327
|
Diagnosis
and Treatment of Malignant Neoplasms—Issued
|
|
EU
1259813
|
Diagnosis
and Treatment of Malignant Neoplasms—Pending
|
|
US
09/436,184
|
Diagnosis
and Treatment of Malignant Neoplasms—Pending
|
|
US
11/376,941
|
Diagnosis
and Treatment of Malignant Neoplasms—Pending
|
|
CA
2390374
|
Diagnosis
and Treatment of Malignant Neoplasms—Pending
|
|
EU
07008309.2
|
Diagnosis
and Treatment of Malignant Neoplasms—Pending
|
|
JP
2001-536582
|
Diagnosis
and Treatment of Malignant Neoplasms—Pending
|
|
US
6,835,370
|
Diagnosis
and Treatment of Malignant Neoplasms—Issued
|
|
US
11/020,965
|
Diagnosis
and Treatment of Malignant Neoplasms —Pending
|
|
AUS
2002303802
|
Diagnosis
and Treatment of Malignant Neoplasms —Pending
|
|
CA
2447367
|
Diagnosis
and Treatment of Malignant Neoplasms —Pending
|
|
EU
02731861.7
|
Diagnosis
and Treatment of Malignant Neoplasms —Pending
|
|
JP
2002-589650
|
Diagnosis
and Treatment of Malignant Neoplasms —Pending
|
|
AUS
2005/218044
|
Diagnosis
and Treatment of Malignant Neoplasms —Pending
|
|
US
11/974,076
|
Diagnosis
and Treatment of Malignant Neoplasms (2nd CIP)
- Pending
|
SCHEDULE
C
Supply
and Services Agreement
SUPPLY
AND SERVICES AGREEMENT
This
Supply and Services Agreement (“Agreement”)
is made and entered into effective as of March 24, 2010 (the “Effective
Date”), by and between Panacea Pharmaceuticals, Inc.,
a Maryland corporation (“Supplier”),
and PANACEA GLOBAL, INC. a Delaware
corporation (“Customer”).
Supplier and Customer each may be referred to
herein individually as a “Party”, or
collectively as the “Parties.”
Recitals
A. Supplier
and Customer are parties to a certain License Agreement dated as of the
Effective Date (the “License
Agreement”).
B. In
connection with the performance of diagnostic testing services pursuant to the
License Agreement, Customer desires to obtain from Supplier certain quantities
of a reagent described on Attachment A hereto (“Reagent”)
and certain technology transfer, training, and technical support services as
described on Attachment C hereto (“Services”),
and Supplier is willing to provide such Reagent and Services upon the terms and
conditions hereinafter set forth.
NOW,
THEREFORE, in consideration of the mutual covenants and agreements set forth
below and for other good and valuable consideration, the receipt and sufficiency
of which is hereby acknowledged by each of the parties hereto, the parties
hereto agree as follows:
Agreement
1.
|
Order and Sale of
Reagent.
|
1.1. Orders. From time to time
during the Term, Customer may submit written purchase orders
to Supplier for Reagent to be supplied hereunder. Each such purchase order will
set forth the quantity of Reagent desired and the delivery date for such
Reagent; provided, that the delivery date will be at least thirty (30) days
after the date of Supplier’s receipt of such purchase order. Supplier will
provide Customer with the quantities of Reagent set forth in each purchase order
that is submitted in compliance with the terms of this Section 1.1. Such Reagent
will meet the standards described on Attachment B hereto (the “Reagent
Specifications”); quantities of Reagent
meeting the Reagent Specifications are hereinafter referred to as “Conforming
Reagent.”
1.2. Purchase Price. The purchase
price of Conforming Reagent shall be lower of US $20/test or
10% of sale price of the individual test with $8.00/test as minimum base price.
The purchase price shall be paid as follows: (i) at the time of submitting a
purchase order for Reagent, Customer will remit 50% of the purchase price for
the amount of Reagent ordered pursuant to such purchase order, and (ii) within
thirty (30) days after the delivery of Reagent to Customer, Customer will remit
the remaining 50% of the purchase price for such Reagent, subject in each case
to the terms and conditions set forth in Section 2. Delivery shall be made when
Reagent is shipped FCA (Incoterms 2000) Supplier's facility, addressed as
Customer shall direct from time to time and
shipped at Customer’s expense via a common carrier designated by Customer. Title
and risk of loss shall pass to Customer upon delivery to such common
carrier.
- 1
-
2. Conforming Reagent. While it
is the intent that Supplier will provide Reagent which meets the Reagent
Specifications, it is acknowledged that Supplier does not so warrant and that
Customer will itself inspect all Reagent delivered to it and make an independent
and thorough determination as to whether the Reagent meets the Reagent
Specifications. Customer agrees that it will reject any Reagent which does not
meet the Reagent Specifications. The parties agree to the following protocol as
respects Customer's acceptance of Reagent delivered to it:
2.1. Determination. Customer agrees
to exercise commercially reasonable efforts to determine
whether Reagent is Conforming Reagent within 30 days of delivery. If Customer
has not given written notice that a particular shipment of Reagent is not
Conforming Reagent within 45 days of delivery thereof, such Reagent shall be
deemed to be Conforming Reagent for all purposes of this Agreement.
2.2. Return. If Customer determines
a quantity of Reagent is not Conforming Reagent, it shall
immediately notify Supplier in writing of its determination and the
particularities of non-conformance with the Reagent Specifications, and
promptly, at Supplier's request, return the subject Reagent, which return shall
be made FCA (Incoterms 2000) the site to which Supplier shipped such Reagent,
and which return shall be shipped via the same common carrier by which the
subject Reagent was shipped to Customer.
2.3. Dispute Resolution. If
Supplier disagrees with Customer's determination of non-conformance with
respect to any Reagent, and if the Parties cannot resolve the matter within
sixty (60) days of the issuance of the notice referenced in the preceding
Section 2.2, the Parties agree to immediately submit the matter to a mutually
acceptable independent laboratory for testing. The independent laboratory will
determine whether the Reagent in question conforms to the Reagent
Specifications. The determination of the independent laboratory will be final
and binding on the Parties. The costs of retaining the independent laboratory
will be borne by the Party whose determination regarding the conformance of the
Reagent was mistaken.
3. Provision of Services. From
time to time during the Term, Supplier will provide Customer with the
Services. During and following such initial period, Customer may request
additional Services to be provided on an a la carte basis at an hourly
billing rate of US$200 for Scientists and US$120 for Assistant Scientists.
Supplier will invoice Customer at the end of each calendar month for Services
provided during such month. Customer will pay all invoices for Services within
30 days of receipt thereof.
4. Payment Terms. All payments
under this Agreement shall be made in U.S. Dollars. Any amounts not
paid within 30 days after the date due under this Agreement are subject to
interest from the date due through and including the date upon which payment is
received. Interest is calculated, over the period between the date due and the
date paid, at a rate equal to five percent (5%) per annum. Supplier shall have
the right to audit all
books and records of Customer concerning orders and use of the Reagent for
compliance by Supplier with the financial terms of this Agreement and the terms
and conditions of the License Agreement otherwise in accordance with Section 3.9
of the License Agreement as if the references to the “Agreement” set forth in
such Section 3.9 refer to this Agreement.
- 2
-
5. Mutual Limits of Liability.
NEITHER SUPPLIER NOR CUSTOMER SHALL BE LIABLE FOR
INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXTRAORDINARY OR PUNITIVE DAMAGES OF ANY
DESCRIPTION, WHETHER FOR DAMAGE TO REPUTATION OR GOODWILL, LOST PROFITS, CLAIMS
OF THIRD PARTIES OR OTHERWISE, RESULTING FROM ANY CAUSE WHATSOEVER WHETHER SUCH
ASSERTED DAMAGE PURPORTS TO BE BASED ON WARRANTY OR GUARANTY, INDEMNITY OR OTHER
CONTRACT, CONTRIBUTION, NEGLIGENCE, OTHER TORT OR OTHERWISE.
5.1. Acknowledgement. Subject to
the provisions of Section 5 above, Customer acknowledges
that it is purchasing the Reagent from Supplier strictly on an "AS IS" basis
without any warranties or representations (expressed or implied) of any sort,
type or kind whatsoever.
5.2. Indemnity. Each Party (the
“Indemnifying Party”) agrees to indemnify, defend and hold harmless
the other Party (the “Indemnified Party”) and its officers, directors,
employees, members and agents from and against any and all claims, demands,
losses, damages, liabilities, settlement amounts, costs and expenses (including
without limitation, court costs and reasonable attorneys’ fees) (collectively,
the “Claims”) arising out of its and its employees’, agents’, contractors’,
vendors’ or service providers’ actual or alleged acts or omissions including,
but not limited to claims resulting directly or indirectly from (a) the
performance of its obligations hereunder or (b) breach of any representation and
warranty set forth herein. To the extent that Customer is the Indemnifying Party
for any Claim, Customer shall not be required to indemnify Supplier (as the
Indemnified Party) if such Claim results from any allegation that any particular
Reagent, at the time of shipment, was actually known to Supplier to be not
Conforming Reagent and with respect to which Supplier did not so notify Customer
in writing.
6.
|
Term and
Termination.
|
6.1. Term. The term of this
Agreement will commence as of the Effective Date and, unless earlier
terminated in accordance with this Section 6, will expire upon the expiration or
termination of the License Agreement (the “Term”).
6.2. Termination for Breach. Any
material failure by a Party (“Breaching Party”) to
comply with any of its material obligations contained in this Agreement
(such failure
a “Material
Breach”) will entitle the other Party (“Non-Breaching
Party”) to give to the Breaching Party written notice specifying the
nature of the Material Breach, requiring the defaulting Party to make good or
otherwise cure such Material Breach. If such Material Breach is not cured within
60 days after the receipt of such notice, the Non-Breaching Party will be
entitled to terminate this Agreement on written notice to the Breaching
Party and without prejudice to any of its other rights conferred on it by this
Agreement; provided, however, that if the Breaching Party disputes the existence
of a Material Breach, the matter will be submitted for resolution in accordance
with the terms set forth in the License Agreement, and this Agreement cannot be
terminated by the Non-Breaching Party until a court of competent jurisdiction in
a final decision from which no further appeal can be taken has found such
Material Breach to exist.
- 3
-
7.
|
Miscellaneous.
|
7.1. Confidentiality. The Parties
agree that any information disclosed in connection with the
performance of this Agreement, including ordering and pricing information, will
be treated as Confidential Information under the terms and conditions set forth
in Section 6 of the License Agreement, which Section is hereby incorporated
herein by reference.
7.2. Assignment. Neither Party will
sell, transfer, assign, delegate, pledge or otherwise dispose of,
whether voluntarily, involuntarily, by operation of law or otherwise, this
Agreement or any of its rights or duties under this Agreement; provided,
however, that either Party may assign or transfer this Agreement or any of its
rights or obligations under this Agreement to an Affiliate and to any Third
Party with which it merges or consolidates, or to which it transfers all or
substantially all of its assets to which this Agreement relates; and provided,
further, that the relevant assignee or surviving entity assumes in writing all
of the assigning Party’s obligations under this Agreement. The assigning Party
(except if it is not the surviving entity) will remain jointly and severally
liable with the relevant Third Party assignee under this Agreement. Any
purported assignment or transfer in violation of this Section will be void ab initio and of no force or
effect.
7.3. Severability. If any provision
of this Agreement is held to be illegal, invalid or unenforceable
under any present or future law, and if the rights or obligations of either
Party under this Agreement will not be materially and adversely affected
thereby, (a) such provision will be fully severable, (b) this Agreement will be
construed and enforced as if such illegal, invalid or unenforceable provision
had never comprised a part hereof, (c) the remaining provisions of this
Agreement will remain in full force and effect and will not be affected by the
illegal, invalid or unenforceable provision or by its severance herefrom, and
(d) in lieu of such illegal, invalid or unenforceable provision, there will be
added automatically as a part of this Agreement a legal, valid and enforceable
provision as similar in terms to such illegal, invalid or unenforceable
provision as may be possible and reasonably acceptable to the Parties herein. To
the fullest extent permitted by applicable law, each Party hereby waives any
provision of law that would render any provision prohibited or unenforceable in
any respect.
7.4. Governing Law. This Agreement,
all disputes between the Parties related to or arising out of
this Agreement, the Parties’ relationship created hereby, or the negotiations
for and entry into this Agreement, including any dispute concerning its
conclusion, binding effect, amendment, coverage, or termination, will be
governed by the laws of
the State of Maryland without reference to any choice of law principles thereof
that would cause the application of the laws of a different
jurisdiction.
- 4
-
7.5.
Notices. All notices or other communications that are required or permitted hereunder will
be in writing and delivered personally, sent by facsimile (and promptly
confirmed by personal delivery or overnight courier as provided herein), or sent
by internationally-recognized overnight courier addressed as
follows:
If to
Supplier, to:
Chief
Executive Officer
Panacea
Pharmaceuticals, Inc.
000 Xxxxx
Xxxxxxx, Xxxxx 00
Xxxxxxxxxxxx,
XX 00000
Facsimile: 000-000-0000
If to
Customer, to:
Panacea
Global, Inc.
000
Xxxxxxx Xxxx., Xxxxx 00
Xxxxxxx,
XX X0X 0X0
Attention:
Xx. Xxxxxxx Xxxxxxx
Facsimile:
000-000-0000
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
will be deemed to have been given (i) when delivered, if personally delivered or
sent by facsimile on a business day, and (ii) on the second business day after
dispatch, if sent by internationally-recognized overnight courier. It is
understood and agreed that this Section is not intended to govern the day-to-day
business communications necessary between the Parties in performing their
duties, in due course, under the terms of this Agreement.
7.6.
Entire Agreement; Modifications. This Agreement sets forth and constitutes the entire
agreement and understanding between the Parties with respect to the subject
matter hereof and all prior agreements, understanding, promises and
representations, whether written or oral, with respect thereto. Each Party
confirms that it is not relying on any representations or warranties of the
other Party except as specifically set forth herein. No amendment or
modification of this Agreement will be binding upon the Parties unless in
writing and duly executed by authorized representatives of both
Parties.
7.7.
Relationship of the Parties. It is expressly agreed that the
Parties' relationship under this
Agreement is strictly one of supplier and customer, and that this Agreement does
not create or constitute a partnership, joint venture, or agency. Neither Party
will have the authority to make any statements, representations or commitments
of any kind, or to take any action, which will be binding (or purport to be
binding) on the other.
All persons employed by a Party will be employees of such Party and not of the
other Party and all costs and obligations incurred by reason of any such
employment will be for the account and expense of such Party.
- 5
-
7.8. Waiver. 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 will be effective unless
set forth in a written instrument duly executed by or on behalf of the Party
waiving such term or condition. The waiver by either Party hereto of any right
hereunder or of claims based on the failure to perform or a breach by the other
Party will 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.
7.9. Counterparts. This Agreement
may be executed in two or more counterparts, each of
which will be deemed an original, but all of which together will constitute one
and the same instrument.
7.10. No Benefit to Third Parties.
The representations, warranties, covenants and agreements set forth
in this Agreement are for the sole benefit of the Parties hereto and their
successors and permitted assigns, and they will not be construed as conferring
any rights on any other parties.
7.11. Further Assurance. Each Party
will duly execute and deliver, or cause to be duly executed and
delivered, such further instruments and do and cause to be done such further
acts and things, including the filing of such assignments, agreements, documents
and instruments, as may be necessary or as the other Party may reasonably
request in connection with this Agreement or to carry out more effectively the
provisions and purposes, or to better assure and confirm unto such other Party
its rights and remedies under this Agreement.
7.12. Construction. Except where the
context otherwise requires, wherever used, the singular will
include the plural, the plural the singular, and the use of any gender will be
applicable to all genders. Unless used in combination with the word “either,”
the word “or” is used throughout this Agreement in the inclusive sense (and/or).
Unless expressly provided otherwise, references to Sections are references to
Sections of this Agreement. The captions of this Agreement are for convenience
of reference only and in no way define, describe, extend or limit the scope or
intent of this Agreement or the intent of any provision contained in this
Agreement. The term “including” as used in this Agreement will mean including,
without limiting the generality of any description preceding such term. No rule
of strict construction will be applied against either Party.
[Signature
page follows.]
- 6
-
In
Witness Whereof, the Parties have executed this Supply and Services
Agreement by their respective authorized representatives as of the date first
written above.
Panacea
Pharmaceuticals, Inc.
|
Panacea
Global, Inc.
|
|||
By:
|
/s/ Xxxxxxx X.
Xxxxxxxx
|
By:
|
/s/ Xxxxxxx Xxxxxxx | |
Name:
Xxxxxxx X. Xxxxxxxx
|
Name:
Xxxxxxx Xxxxxxx
|
|||
Title:
CEO/CSO
|
Title:
Director
|
SCHEDULE
OF ATTACHMENTS
A.
|
Description
of Reagent
|
B.
|
Reagent
Specifications
|
C.
|
Description
of Services
|
- 7
-
ATTACHMENT
A
DESCRIPTION
OF REAGENT
1% BSA
Buffer
1%
NaN3
Artificial
Serum
Assay
Buffer
Block
Buffer
Calibrators
Coating
Buffer
Wash
Buffer
Negative
Control Serum
Positive
Control Serum
rHAAH
FB50
FB50b
Streptavidin-HRP
TMB
Substrate Kit
Sulfuric
Acid, 2.5N
ATTACHMENT
B
REAGENT
SPECIFICATIONS
List
of Solutions
|
Composition
|
|
Coating
Buffer
|
For
1liter volume:
1L
diH20,
two packets of Carbonate-Bicarbonate
|
|
Block
Buffer, pH 7.0
|
For
1 liter volume:
970mL
diH20, 2
packets of Tris Buffered Saline
(TBS),
10.00 g Bovine Serum Albumin (BSA),
20mL
of 1% NaN3
|
|
Assay
Buffer, pH 7.0
|
For
1 liter volume:
970mL
diH20, 2
TBS packets, 10.00 g BSA,
20mL
of 1% NaN3, 1mL
Tween-20,
|
|
1%
BSA Buffer, pH 7.2
|
For
1 liter volume:
980mL
diH20,
10.00 g BSA, 2 TBS packets
|
|
Wash
Buffer
|
For
2 liter volume:
2L
diH20, 4
TBS packets, 1mL Tween-20
|
|
Controls
and calibrators
|
Description
|
|
Negative
Control Serum
|
Pool
of serum samples with low HAAH levels
|
|
Positive
Control Serum
|
Pool
of serum samples with high HAAH levels
|
|
Calibrators
|
Negative
control serum, recombinant HAAH
|
|
(rHAAH)
|
||
FB50
|
Coating
antibody
|
|
FB50b
|
Detection
antibody
|
|
List
of Reagents
|
||
Streptavidin-HRP
|
||
TMB
Substrate Kit
|
||
Sulfuric
Acid, 2.5N
|
ATTACHMENT
C
DESCRIPTION
OF SERVICES
The
Services include:
|
1.
|
Laboratory
setup
|
|
2.
|
Technical
support
|
|
3.
|
Training
of personnel
|
|
4.
|
Design
and content of promotional material
|
|
5.
|
Participation
and presentation at technical
seminars
|
|
6.
|
Help
and support in regulatory
affairs
|