Exhibit 4.5
COLLABORATIVE RESEARCH AND LICENCE AGREEMENT
THIS COLLABORATIVE RESEARCH AND LICENCE AGREEMENT (this "Agreement")' is entered
into on November 30, 2000 (the "Effective Date"), by and between Nortran
Pharmaceuticals Inc, a British Columbia corporation. having offices at 0000
Xxxxxxxxx Xxxx, Xxxxxxxxx, XX, Xxxxxx, X0X 0X0 ("Nortran") and Antalium Inc., a
Quebec corporation, having offices at 0000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx,
XX, Xxxxxx, X0X 0X0 ("Antalium"). Nortran and Antalium may be referred herein as
a "Party" or, collectively, as "Parties".
WHEREAS, Nortran is engaged in discovery research for a variety of biologically
active compounds and has patented Know-How for generating chemical compounds
having ion channel modulatory properties;
WHEREAS, Antalium is engaged in discovery research for a variety of therapeutic
targets and the development of technologies to facilitate such research, and
Antalium has patented technologies making use of proprietary ion channels:
WHEREAS, in exchange for payment by Antalium of research funds, Nortran is
willing to perform certain research and proceed together with Antalium with a
medicinal chemistry program to develop drug candidates for Antalium, from which
pharmaceutical products may be derived (the "Research Collaboration"); and
WHEREAS, Antalium wishes to acquire an exclusive license to develop and
commercialize Agreement Compounds (as defined below) and Nortran wishes to grant
to Antalium such license, all in accordance with the terms and conditions set
forth herein:
NOW, THEREFORE, for and in consideration of the covenants, conditions and
undertakings hereinafter set forth, it is agreed by and between the Parties as
follows:
ARTICLE 1
DEFINITIONS
As used herein, the following terms shall have the following meanings:
1.1 "Affiliate" of either Nortran or Antalium shall mean any corporation or
other business entity which, during the term of this Agreement, controls,
is controlled by or is under common control with such Party but only for
so long as such entity controls, is controlled by, or is under common
control with such Party. For this purpose, "control" shall mean the
possession of the power to direct or cause the direction of the management
and the policies of an entity whether through ownership directly or
indirectly of fifty percent (50%) or more of the stock entitled to vote,
and for nonstock organizations, the right to receive over fifty percent
(50%) of the profits by contract or otherwise, or if not meeting the
preceding requirement, any company owned or controlled by or owning or
controlling such Party at the maximum control or ownership right
permitted in the country where such entity exists.
1.2 "Antalium Technology" shall mean any patent application or patent owned
or controlled, in whole or in part, by Antalium or its Affiliates or
Sublicensees at any time during the term of this Agreement, that claims an
Agreement Compound, or method of use or process for the synthesis thereof,
or composition-of-matter containing such Agreement Compound.
1.3 "Antalium Research" shall mean all research activities performed solely by
Antalium pursuant to the Research Collaboration and any and all
information derived from such activities, including without limitation all
biological, chemical, pharmacological, toxicological pharmaceutical,
physical and analytical, clinical, safety, manufacturing and quality
control data and information.
1.4 "Agreement" shall mean the present agreement together with all appendices,
exhibits and schedules.
1.5 "Agreement Compound" Shall mean a Test Compound, Lead Compound, Clinical
Candidate, or Derivative, according to the terms and conditions set forth
herein.
1.6 "Biological Criteria.' shall mean the criteria for selection and
acceptance of an Active Compound, Lead Compound, Optimized Lead Compound
or any Derivative of the foregoing, as determined using in vitro and/or in
vivo screening procedures against selected molecular targets or animal
models.
1.7 "Clinical Candidate" shall mean a Test Compound, Lead Compound or
Derivative that has successfully passed a complete toxicological screen in
two animal models and that Antalium intends to enter into Phase I clinical
trials.
1.8 "Confidential Information" shall mean information' or material disclosed
hereunder by one Party (the "Disclosing Party") to the other Party (the
"Receiving Party") and as further defined in Article 8.
1.9 "Derivative" shall mean any compound derived from a Lead Compound. It is
understood that "Derivative" shall include any compound derived from
another Derivative.
1.10 "Effective Date" shall have the meaning as set forth in the opening
paragraph.
1.11 "FDA'" shall mean the U.S. Food and Drug Administration, and any successor
thereto, or any corresponding foreign registration or regulatory
authority.
1.12 "Field" or "Field of Interest' shall mean the area of Pain, Pain
Management, and all therapeutic, diagnostic or prophylactic uses of
Agreement Compounds or any Derivatives thereof as Pain modulators,
including but not limited to, local, topical and/or systemic analgesics
and/or anesthetics.
1.13 "First Commercial Sale" means, with respect to a given Product, the first
sale for use or consumption by the public of such Product in a country
after all required approvals, including marketing and pricing approvals,
have been granted by the applicable governmental drug regulatory agency of
such country, "First Commercial Sale" shall not include the sale of any
Product for use in clinical trials or for compassionate use prior to the
grant of an NDA.
1.14 "IND" shall mean an Investigational New Drug application, as defined in
the U.S. Food, Drug and Cosmetic Act and the regulations promulgated
thereunder for initiating clinical trials in the United States, or any
corresponding foreign application, registration or certification.
1.15 "Initial Term' shall mean the period commencing on the Effective Date and
terminating on the first anniversary thereof.
1.16 "Initial Screening Program" shall mean the panel of in vitro and/or in
vivo experimental procedures that Antalium will use to screen Test
Compounds to select Active Compounds.
1.17 "Know-How" shall mean all data, technical information, know-how,
experience, inventions, discoveries, trade secrets, compositions of matter
and methods. and whether or not patentable or confidential, to the extent
that such Know-How is Controlled by a Party or its Affiliates.
1.18 "Lead Compound" shall mean a Test Compound that has been chosen by
Antalium for further development.
1.19 "Licensed Technology" shall mean any Patent Rights or Know-How owned or
controlled in whole or in part, by Nortran, or developed in the course of
and in connection with the Research Collaboration, For the purpose of this
Section 1.19 the following definitions shall apply:
(a) "Patent Rights" shall mean (i) all patents and patent applications
existing as of the Effective Date, or covering inventions conceived
and reduced to practice by Nortran alone or jointly with Antalium
during the term of this Agreement, that claim an Agreement Compound
or any Derivative thereof, or method of use or process for the
synthesis thereof or composition-of-matter containing such Active
Compound, Other Compound or Derivative Compound thereof, and (ii)
any divisions, continuations, continuations-in part, reissues,
reexaminations, extensions or other governmental actions which
extend any of the subject matter of the patent applications or
patents in (i) above, and any substitutions, confirmations,
registrations or revalidations of any of the foregoing, in each
case, which is owned or controlled, in whole or part, by license,
assignment or otherwise by Nortran, to the extent Nortran has the
right to license or sublicense the same, and subject to any
limitations and prohibitions of such license or sublicense.
(b) "Know-How" shall mean all ideas, inventions, trade secrets, data,
instructions, processes, formulas, expert opinions and information,
including, without limitation, biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and
analytical, clinical, safety, manufacturing and quality control data
and information, existing as of the Effective Date, or developed by
Nortran alone or jointly with Antalium during the term of this
Agreement, whether or not patentable, in each case, which is
necessary for the synthesis, development and use of Agreement
Compounds or any Derivative thereof and/or for the development,
manufacture, use or sale or commercialization of Products, to the
extent Nortran has the right to license or sublicense the same,
and subject to any limitations and prohibitions of such license or
sublicense. Know-How does not include any inventions otherwise
included in the Patent Rights.
1.20 "Medicinal Chemistry Program" shall mean a program for the chemical
synthesis of structural analogs (the "Derivatives") of an Agreement
Compound(s) in order to improve the biological properties of such
compound(s) towards a target or an animal model, pursuant to the Screening
Programs conducted by Antalium.
1.21 "NDA" shall mean a New Drug Application, as defined in the U.S. Food,
Drug, and Cosmetic Act and the regulations promulgated thereunder, or any
corresponding foreign application, registration or certification.
1.22 "Net Sales" shall mean the invoice price of Products sold by Antalium or
its Affiliates or Sublicensees to Third Parties, less, to the extent
included in such invoice price the total of: (i) ordinary and customary
trade, quantity and/or cash discounts actually allowed, including
government managed care and other contract rebates, pharmacy incentive
programs, including chargebacks of pharmacy or hospital performance
incentive programs or similar programs; (ii) credits, rebates and returns
(including, but not limited to, wholesaler and retailer returns), (iii)
freight, postage, shipping insurance, and other transportation expenses
paid for and separately identified on the invoice or other documentation
maintained in the ordinary course of business. Net Sales shall also
include the amount of fair market value of all other consideration
received by Antalium or its Affiliates or Sublicensees in respect of
Products, whether such consideration is in cash, payment in kind, exchange
or another form. With respect to Products sold in combination with other
products by Antalium or its Affiliates or Sublicensees in a capitation or
bundled transaction (each, a "Bundled Transaction"). Net Sales of such
Products shall be calculated in accordance with the following formula:
The Average Selling Price shall be based on the actual average selling
price of the applicable Product or product other than a Product, as the
case may be, determined for the applicable period.
If a Product is not sold separately and no bona tide list price exists for
such Product, the Parties shall negotiate in good faith an imputed bona
fide list price for such Product, and Net Sales with respect thereto shall
be based on such imputed list price.
1.23 "Nortran Research" shall mean all the research and development activities
concerning the Agreement compounds in the Field of Interest performed by
or on behalf of Nortran, or the results of which are lawfully in Nortran's
possession, and any and all information derived from such activities,
including without limitation all biological, chemical, pharmacological,
toxicological, pharmaceutical, physical and analytical, clinical, safety,
manufacturing and quality control data and information.
1.24 "Patent Rights" shall have the meaning as defined under Licensed
Technology above.
1.25 "Phase I", "Phase II", and "Phase III" shall mean Phase I (or Phase I/II),
Phase II (or Phase II/III). and Phase III clinical trials, respectively,
in each case as prescribed by applicable FDA regulations, or any
corresponding foreign statutes, rules or regulations.
1.26 "Product(s)" shall mean any pharmaceutical product in which a Lead
Compound or Derivative is an ingredient and which has been authorized for
sale in any regulatory jurisdiction.
1.27 "Research Collaboration" shall mean the research activities undertaken by
the Parties pursuant to Article 2 below.
1.28 "Research Term" shall mean the term of the Research Collaboration, as
provided in Section 2.5 below.
1.29 "Secondary Screening Program" shall mean the panel of in vitro and/or in
vivo experimental procedures that Antalium will use to screen Active
Compounds to select Lead Compounds.
1.30 "Screening Program(s)" shall mean the Initial Screening Program, Secondary
Screening Program or any other in vitro and/or in viva experimental
procedures that Antalium will use to screen Agreement Compounds.
1.31 "Sublicensee" shall mean, with respect to a particular Product, a Third
Party to whom Antalium has granted a license or sublicense under the
Licensed Technology to develop, make, have made, use and/or sell such
Product, as used in this Agreement, "Sublicensee" shall also include a
Third Party to whom Antalium has granted the right to distribute such
Product, provided that such Third Party has responsibility.
1.32 "Target(s)" shall mean any molecular target that Antalium believes to be a
valid therapeutic target for the identification and development of
pharmaceutical products.
1.33 "Territory" shall mean the entire world.
1.34 "Test Compound" shall mean any compound or chemical entity conceived,
identified, discovered, created or synthesized by Nortran and delivered to
Antalium under the Agreement.
1.35 "Third Party" shall mean any person or entity other than (i) Antalium and
any of its Affiliates, and (ii) Nortran and any of its Affiliates.
1.36 "Work" shall mean the research and development activities described in
Section 2.2
ARTICLE 2
RESEARCH COLLABORATION
2.1 Research Location.
The Parties acknowledge and agree that the Work shall be performed at such
location as may be agreed between the Parties.
2.2 Research Plan
2.2.1 Discovery of Test Compounds by Nortran.
Nortran shall deliver not less than 30 Test Compounds during a
period not to exceed 1 month from the Effective Date, according to
the schedule described in Exhibit A on all the Test Compounds,
Nortran shall perform preliminary testing of potential analgesic
properties using a well established in vivo pain model, the choice
of which shall be at Nortran's discretion Together with the Test
Compounds, Nortran shall provide Antalium upon request relevant data
and information about said Compounds, including but not limited to
physico-chemical properties and results and information derived from
Nortran Research, as further described in Section 2.4 hereinafter.
Nortran shall, at its expense, supply to Antalium the Test Compounds
in individual containers, in the quantities, described in Exhibit A.
Agreement Compounds delivered pursuant to the terms of this
Agreement shall be suitably packed for surface or air shipment, at
Nortran's discretion, and delivered to a shipping location
designated by Antalium and agreed to by Nortan, at which location
risk of loss shall pass to Antalium. All freight; insurance, and
other shipping expenses, and all applicable taxes, duties and
similar charges, as well as any special packing expenses shall be
paid by Nortran, unless incurred because of a special request of
Antalium.
2.2.2 Screening Program by Antalium.
Antalium shall have the right but not the obligation to use Test
Compounds in connection with an Initial Screening Program that shall
be elaborated and conducted solely by Antalium at its discretion and
expense, in compliance with Section 2.3. The objective of said
Screening Program shall be to identify the Test Compounds that
qualify as lead Compounds, as defined by their activity against
selected targets or selected in vivo animal models (the "Biological
Criteria"), and suitable for further development.
After the identification of such lead Compounds, Antalium shall
provide Nortran notice of such Lead Compounds selected by Antalium
(up to a total of 8 compounds). If additional quantities of selected
Test Compounds are required for any purpose subject to the terms and
conditions herein, the cost to produce the additional amounts of
such selected Lead Compounds shall be borne by Antalium, and may be
undertaken by either Nortran, if Nortran so agrees, or by a contract
synthesis laboratory acceptable to both Parties.
2.2.3 Medicinal Chemistry and Lead Optimization.
At any time during the term of the Agreement, Antalium may initiate
a Medicinal Chemistry Program to conceive, design and synthesize
Derivatives with improved or optimized biological properties for use
in the Field of Interest. Nortran shall promptly deliver to Antalium
the structures of all Lead Compounds and the synthesis procedures
used by Nortran to synthesize such Lead Compounds. Nortran shall use
reasonable efforts to assist Antalium, at the expense of Antalium,
in proceeding with the Medicinal Chemistry Program and agrees to
provide Antalium with reasonable technical and other support,
including access to Licensed Technology if required for future
efforts by Antalium to develop and commercialize Products based on
Agreement Compounds. It is understood by both Parties that any
Nortran assistance in this regard shall be provided in the context
of other demands and priorities which may be more urgent or
important than the needs of Antalium.
2.3 Limited Use and Exclusivity
2.3.1 Limited Use. Antalium may use any Test Compound or Derivative solely
to conduct identification and selection of compounds that may be
developed and commercialized by Antalium in the Field of Interest,
subject to the terms and conditions described herein. Antalium shall
not use any Agreement Compound or any other application or purpose
not contemplated herein without the prior written consent of
Nortran, such consent to be entirely at Nortran's discretion.
2.3.2 Exclusivity. Except as otherwise expressly permitted under this
Agreement, Nortran shall not conduct or fund, either by itself or at
a Third Party, any research or development activity specifically
intended to identify, discover, synthesize or develop compounds
using any of the Test Compounds during an 18 month period starting
on the Effective Date or any Lead Compounds or Derivative thereafter
as leads for, or as the basis for, chemical discovery for use in the
Field of Interest.
2.4 Research reports:
Nortran shall provide Antalium with a report on Nortran Research regarding
the Test Compounds and relevant to the Research Collaboration.
2.5 Term of the Research Collaboration
2.5.1 Research Term. The Research Collaboration shall commence on the
Effective Date and, unless terminated earlier as provided in Article
11 below, the Research Collaboration shall terminate on the day of
the first anniversary of the Effective Date (the "Initial Term"),
unless extended pursuant to Section 2.5.2 below, in which case the
Research Collaboration shall terminate on the last day of such
extension term.
2.5.2 Extension of Research Term. With the written agreement of both
Parties, the Research Term may be extended for up to two (2) years
following the Initial Term. If it wishes to extend the Research
Term, such Party must notify the other Party in writing at least
sixty (60) days prior to the then current expiration date for the
Research Term. The Parties shall negotiate in good faith the terms
of any such extension.
ARTICLE 3
DEVELOPMENT AND COMMERCIALIZATION
3.1 The selection of Lead Compound(s), Clinical Candidates, Derivative(s),
and Product(s) for development and commercialization shall be at the
discretion of Antalium. Unless otherwise mutually agreed, Antalium shall,
at no expense to Nortran, be responsible for conducting or arranging all
development and commercialization of Product(s).
ARTICLE 4
LICENSE RIGHTS
4.1 License to Agreement Compounds and Corresponding Products.
Subject to the terms and conditions of this Agreement, Nortran grants to
Antalium an exclusive, worldwide license under the applicable Licensed
Technology to develop, make, have made, and use all Lead Compounds and any
Derivative thereof in the Field of Interest, in the entire Territory, and
to develop, make, have made, use, import, have imported, sell, offer for
sale and engage in the commercialization of any Products containing such
Lead Compounds and Derivatives, in the Field of Interest, in the entire
Territory, during the term of this Agreement.
4.2 Sublicenses.
Antalium shall have the right to grant sublicenses, subject to and upon
terms consistent with this Agreement, under the license granted in Section
4.1. Within thirty (30) days following the execution of any such
sublicense, Antalium shall provide Nortran with at least the following
information with respect to each Sublicensee: (i) the identity of the
Sublicensee: (ii) a description of the Product, and the rights granted to
the Sublicensee; and (iii) the territory in which the Product will be
sold. Antalium shall remain responsible to Nortran for the compliance of
each such Sublicensee with the financial and other obligations due under
this Agreement.
4.3 Exclusivity in the Field of Interest.
Nortran agrees that Antalium shall have exclusive rights to use Lead
Compounds or Derivatives, in the Field of Interest during and in
accordance with the terms of this Agreement, and that Nortran may not
make, use, sell, promote, market, license or otherwise permit or authorize
any Third Party to make, use, sell, promote, or market Lead Compounds or
Derivatives, for any use in the Field of Interest during the term or this
Agreement. Nortran covenants that it shall expressly prohibit any
licensees of Nortran or its Affiliates who are licensed to make, use or
sell any Agreement Compounds from making, using, selling, promoting, or
marketing the Agreement Compounds for any use in the Field of Interest.
4.4 No Implied Licenses.
Only the licenses granted pursuant to the express terms of this Agreement
shall be of any legal force or effect, No other license rights shall be
created by implication, estoppel or otherwise, Notwithstanding the
provisions of this Article 4. Antalium's rights hereunder in respect of
Derivatives shall be limited to compounds which are not identical to or
close analogues of other Nortran owned molecules which are being
commercialized outside the Field of Interest.
4.5 Commercialization.
Except as otherwise agreed in writing or specifically provided in the
terms of this Agreement, neither Antalium nor its Affiliates nor
Sublicensees shall commercialize any Agreement Compound other than as a
Product in accordance with this Agreement.
4.6 Term of License.
The license granted to Antalium under this Article 4 snail expire in the
event:
(a) Antalium does not select a Lead Compound within eighteen (18) months
("First Expiration Period") of the Effective Date.
(b) Antalium does not select a Clinical Candidate within thirty-three
(33) months ("Second Expiration Period") starting from the Effective
Date.
4.7 Notwithstanding
Notwithstanding the provisions of Sections 4.1 through 4.6, the rights
granted to Antalium by Nortran under these Sections shall be subject to
the termination provisions in Article 11 "Term and Termination".
ARTICLE 5
INTELLECTUAL PROPERTY
5.1 Ownership of inventions and disclosure.
Title to all inventions and other intellectual property made solely by
employees of Antalium, but not Nortran, in the course of and in connection
with the Research Collaboration ("Antalium Inventions") shall be deemed
owned by Antalium. Title to all inventions and other intellectual property
made solely by employees of Nortran, but not Antalium, in the course of
and in connection with the Research Collaboration ("Nortran Inventions")
shall be deemed owned by Nortran. Title to all inventions and other
intellectual property made jointly by employees of Antalium and Nortran in
the course of and in connection with the Research Collaboration ("Joint
Inventions") shall be deemed owned jointly by Nortran and Antalium.
Inventorship of inventions and other intellectual property conceived and/
or reduced to practice pursuant to this Agreement shall be determined in
accordance with the laws of Canada. Each Party shall promptly disclose to
the other any inventions made in connection with this Agreement. It is
understood that both parties grant one another a worldwide, exclusive
(except as to each other), right and license, with the right to sub-
license, to develop, make, have made, use, sell, offer for sale, have
sold, import and have imported Products, under any Patent Rights and
Intellectual Property jointly owned by Nortran and Antalium.
5.2 Patent Filing and Prosecution.
5.2.1 Responsibilities
(a) Nortran Inventions. Nortran shall be responsible for
preparing, filing, prosecuting and maintaining, in such
countries in the Territory as it deems appropriate, patent
applications and patents directed to Nortran Inventions
included within the Licensed Technology and conducting any
interferences, re-examinations, reissues and oppositions
relating to such patent applications and patents.
(b) Antalium Inventions. Antalium shall be responsible for
preparing, filing, prosecuting and maintaining, in such
countries in the Territory as it deems appropriate, patent
applications and patents directed to all Antalium Inventions,
and conducting any interferences, re-examinations, reissues
and oppositions relating to such patent applications and
patents.
(c) Joint Inventions. Subject to Sections 5.3 and 5.4. Antalium
shall be responsible for preparing, filing, prosecuting and
maintaining in the Territory, or any countries agreed by
Antalium and Nortran, patent applications and patents directed
to all Joint Inventions, and conducting any interferences, re-
examinations, reissues and oppositions relating thereto.
5.2.2 Failure to Prosecute.
(a) Nortran Failure to Prosecute. Nortran may elect, upon ninety
(90) days prior notice, to discontinue prosecution of any
patent applications filed by Nortran pursuant to Section
5.2.1(a) or 5.2.1(c) above and/or not to file or conduct any
further activities with respect to the patent applications or
patents subject to such Sections. In the event Nortran
declines to file or, having filed, fails to further prosecute
or maintain any patent applications or patents described in
such Sections, or conduct any proceedings including, but not
limited to, interferences, re-examinations, reissues,
oppositions relating thereto, then Antalium shall have the
right to prepare, file, prosecute and maintain such patent
applications and patents in such countries as it deems
appropriate, and conduct such proceedings, at its sole expense
in such case, Nortran shall immediately execute all necessary
documents that may be required in order to enable Antalium to
file, prosecute and maintain such patent applications and to
conduct any such proceedings.
(b) Antalium Failure to Prosecute. Antalium may elect, upon ninety
(90) days prior notice, to discontinue prosecution of any
patent applications filed pursuant to Section 5.2.1 (b) or
5.21 (c) above and/or not to file or conduct any further
activities with respect to the patent applications or patents
subject to such Section. In the event Antalium declines to
tile or, having filed, fails to further prosecute or maintain
any patent applications or patents described in such Section,
or conduct any proceedings including, but not limited to,
interferences, re-examinations, reissues, oppositions relating
thereto, then Nortran shall have the right to prepare, file,
prosecute and maintain such patent applications and patents in
such countries as it deems appropriate, and conduct such
proceedings, at its sole expense. In such case, Antalium shall
immediately execute all necessary documents that may be
required in order to enable Nortran to file, prosecute and
maintain such patent applications and to conduct any such
proceedings.
5.3 Cooperation.
Antalium and Nortran shall consult together upon all matters relating to
the filing, prosecution, and maintenance of patents described in Article
4. This shall include giving the other Party the opportunity to review and
comment upon the text of any priority application before filing,
consultation about the decision whether or not to foreign file, and if so,
in which countries; and giving the other Party the opportunity, as far in
advance of filing dates as feasible, to fully review and comment on the
basic foreign filing text. Each Party shall provide to the other copies
of any search reports and official actions, including notice of all
interferences, reissues, re-examinations, and oppositions received from
the relevant patent offices promptly after receipt. Each Party, whether or
not involved in the filing, prosecution, defense or enforcement of any
Patent Rights hereunder or In the defense of any infringement claims by
Third Parties, shall reasonably cooperate with and assist the other in
connection with activities subject to Section 5.2,5.6,5.7, at the other's
request. Each Party shall execute and procure that its employee inventors
shall execute all documents reasonably required in connection with the
filing, prosecution, or maintenance of patents directed to all the Joint
Inventions.
5.4 Costs.
Responsibilities for costs incurred under this Articles shall be as
follows:
(a) Nortran shall pay all out-of-pocket costs incurred in
connection with the conduct of the activities described in
Sections 5.2.1(a)
(b) Antalium shall pay all out-of-pocket costs incurred in
connection with the conduct of the activities described in
Section 5.2.1(b).
(c) Subject to Section 5.2.2, the Parties shall reimburse each
other so as to equally share the out-of-pocket costs incurred
in connection with conduct of the activities described in
Section 5.2.1(c).
5.5 Copies
During the term of this Agreement Antalium shall promptly provide to
Nortran a copy of any patent applications filed by Antalium or its
Affiliates or Sublicensees, after the publication thereof, relating to any
Agreement Compounds. During the term of this Agreement, Nortran shall
promptly provide to Antalium a copy of any patent applications filed by
Nortran, after the publication thereof, relating to any Agreement
Compounds.
5.6 Enforcement and Defense.
5.6.1 Notice. Each Party shall promptly notify the other of any knowledge
it acquires of any potential infringement of the Licensed Technology
or the Antalium Technology by a Third Party.
5.6.2 Joint Inventions. In the event Nortran or Antalium becomes aware of
any actual or threatened infringement of any patent filed pursuant
to Section 5.2.1 (c), that Party shall promptly notify the other and
the Parties shall promptly discuss how to proceed in connection with
such actual or threatened infringement. Unless otherwise agreed by
the Parties, the terms of Sections 5.63 and 5.6.4 shall apply;
provided, the Parties may decide to jointly defend against any
patent infringement by Third Parties, in which case the Parties
shall also agree on allocation of costs and damages.
5.6.3 Antalium. Antalium shall have the initial right, but not the
obligation, to take reasonable legal action to enforce against
infringements by Third Parties or defend any declaratory judgment
action relating to any patent filed pursuant to Section 5.2.1 (c),
at its sole cost and expense. If, within six (6) months following
receipt of such notice from Nortran Antalium fails to take such
action to halt a commercially significant infringement, Nortran
shall, in its sole discretion, have the right, at its sole expense,
to take such action. Antalium shall have the right to enforce
patents filed pursuant to Section 5.2.1 (b), in its sole discretion,
unless Nortran has acquired a license to Antalium interest in such
patents.
5.6.4 Nortran. Nortran shall have the initial right, but not the
obligation, to take reasonable legal action to enforce against
patent infringement by Third Parties or defend any declaratory
judgment action relating to any patent filed pursuant to Section
5.2.1 (a), at its sole cost and expense. If, within six (6) months
following receipt of such notice from Antalium Nortran fails to take
such action to halt a commercially significant infringement,
Antalium shall, in its sole discretion, have the right, at its
expense, to take such action.
5.6.5 Cooperation; Costs and Recoveries. At the request and expense of
either Party, the other Party shall give the requesting Party all
reasonable assistance required to file and conduct any such
proceeding and shall be entitled to retain any and all awards or
damages obtained therefrom.
5.7 Infringement claims.
In the event the manufacture, sale, use, distribution or marketing of any
Product pursuant to this Agreement, because of the practice of the
Licensed Technology or the Antalium Technology, results in any claim, suit
or proceeding alleging patent infringement against Nortran or Antalium (or
its Affiliates or Sublicensees), such Party shall promptly notify the
other Party hereto in writing setting forth the facts of such claim in
reasonable detail. The defendant shall have the exclusive right and
obligation 10 defend and control the defense of any such claim, suit or
proceeding, at its own expense, using counsel of its own choice; provided,
however, it shall not enter into any settlement which admits or concedes
that any aspect of the Antalium Technology (in the case of Nortran) or the
Licensed Technology (in the case of Antalium) is invalid or unenforceable,
without the prior written consent of such other Party. The defendant shall
keep the other Party hereto reasonably informed of all material
developments in connection with any such claim, suit or proceeding. In the
event Antalium is the defendant, any costs and expenses of Antalium in
defending a suit, arising solely out of the use of Licensed Technology,
and any amounts that Antalium is required to pay to the Third Party in
order to settle or otherwise dispose of such suit or in damages or other
amounts finally awarded to such Third Parties in such suit, may be offset
by Antalium against any amounts that Antalium owes to Nortran under
Sections 6.2 and 6.3; provided that Antalium may not settle such suit
without Nortran's prior written approval, such approval to not be
unreasonably withheld or delayed.
ARTICLE 6
FINANCIAL TERMS
6.1 Research Funding
(a) In recognition of the research done by Nortran on Antalium's behalf
before the Effective Date, Antalium shall provide to Nortran a
research funding of five hundred thousand dollars ($500,000.00) to
enable Nortran to carry out Nortran's responsibilities in accordance
with Article 2.
(b) No withholding. The amounts paid to Nortran pursuant to this Section
6.1(a) are funding for the Research Collaboration and shall be made
without withholding for taxes or any other charge, unless required
by law.
6.2 Milestone Payments
In partial consideration of the rights granted to Antalium under this
Agreement, Antalium shall pay Nortran the following amounts within sixty
(60) days after each occurrence of the following milestones with respect
to an Agreement Compound or Product:
(a) $10,000 per compound selected as a Lead Compound regardless of the
number of Lead Compounds selected.
(b) $100,000 per compound selected as Clinical Candidate, regardless of
the number of Clinical Candidates selected.
(c) $3,000,000.00 upon the dosing of the first patient in a Phase III
clinical trial (as prescribed by applicable FDA regulations, or any
corresponding foreign statutes, rules or regulations).
(d) $5,000,000.00 upon the approval of a New Drug Application ("NDA")(or
its equivalent or non-U.S. counterpart in any jurisdiction).
(e) It is understood that Antalium shall have no obligation to pay any
of the milestone payments set forth above more than one (1) time
with respect to a particular molecular target within the Field,
regardless of how many Products are commercialized in respect of
such target and regardless of the number of jurisdictions involved.
The milestone payments shall be made on a target-by-target basis, so
that if Antalium ceases all development of a particular Lead
Compound or Derivative (or corresponding Product) after having made
payments with respect to such Lead Compound, Derivative or Product
under this Section 6.2 on the accomplishment of milestones specified
herein, there Shall be no payment due upon the accomplishment of
those same milestones with respect to a subsequent Agreement
Compound, or Product hereunder that is active against the same
molecular target.
For greater certainty, the amounts payable hereunder include any Lead
Compound Derivative or Product.
6.3 Royalties
Royalties shall be payable on any Product which contains a Lead Compound,
or Derivative.
6.3.1 Earned Royalties. In consideration for the licenses and rights
granted by Nortran to Antalium under this Agreement, Antalium shall
pay to Nortran during the applicable Royalty Period an earned
royalty of ten percent (10%) of Net Sales of Products.
6.3.2 Pass-through Royalties. In the case of sublicenses, Antalium shall
pay to Nortran, as royalty, twenty percent (20%) of all sub-
licensing revenues including all milestone payments, once collected.
Milestone payments to Nortran in accordance with Section 6.2, are
excluded from such pass-through royalties for greater certainty,
bulk sales of Product to a third party shall be considered as sub-
licenses and therefore subject to the 20% royalty rate.
6.3.3 Royalty Period. The royalty payments set forth above shall be
payable for each Product on a product-by-product and country-by-
country basis from the time of First Commercial Sale of Product in
such country until the last-to-expire or -lapse of Patent Rights
containing a Valid Claim with respect to the Agreement Compound
which is an ingredient of such Product in such country. At the end
of such period, Antalium shall have a fully paid-up, non-exclusive,
royalty-free license, with the right to sublicense, under any
unpatented Licensed Technology to make, have made, use and sell
products on a country-by-country and product-by product basis.
ARTICLE 7
PAYMENTS, BOOKS AND RECORDS
7.1 Royalty Reports and Payments.
After the First Commercial Sale of a Product on which royalties are
payable by Antalium or its Affiliates or Sublicensees hereunder, Antalium
shall make quarterly written reports to Nortran within ninety (90) days
after the end of each calendar quarter, stating in each such report,
separately for Antalium and each Affiliate and Sublicensee, the number,
description, and aggregate Net Sales, by country, of each Product sold
during the calendar quarter upon which a royalty is payable under Section
6.3.1 above. In the event that any Net Sales are based on Bundled
Transactions, such reports shall include a statement showing the
calculation of the Net Sales with respect to such Bundled Transactions.
Concurrently with the making of such reports, Antalium shall pay to
Nortran royalties due at the rates specified in such Sections.
7.2 Payment Method
All payments due under this Agreement shall be made by bank wire transfer
in immediately available funds to a bank account designated by Nortran.
All payments hereunder shall be made in Canadian dollars In the event that
the due date of any payment subject to Article 6 hereof is a Saturday,
Sunday or national holiday, such payment may be paid on the following
business day. Any payments that are not paid on the date such payments
are due under this Agreement shall bear interest to the extent permitted
by applicable law at the prime rate as reported by the Canadian Imperial
Bank of Commerce ("CIBC"), on the date such payment is due, plus an
additional one percent (1%), calculated on the number of days such payment
is delinquent.
7.3 Currency Conversion.
The royalty payments due shall be calculated at Antalium's customary
internal corporate monthly exchange rates for the last month of the
calendar quarter for which remittance is made for royalties for each month
and each currency, Antalium's customary internal corporate monthly
exchange rate shall equal the arithmetic average of the daily exchange
rates (obtained as described below) during the period from (i) the 20th
day of the preceding month (or, if such 20th day is not a business day,
the immediately preceding business day) through (ii) the 19th day of the
current month (or, if such 19th day is not a business day, the immediately
preceding business day); each daily exchange rate shall be obtained from
the Reuters Daily Rate Report or The Wall Street Journal, Eastern U.S.
Edition, or, if not so available, as furnished by Antalium's local
Affiliates.
7.4 Records' Inspection.
Antalium and its Affiliates and Sublicensees shall keep complete, true and
accurate books of account and records for the purpose of determining the
royalty amounts payable under this Agreement. Such books and records shall
be kept in the principal place of business of this Agreement. Such books
and records shall be kept at the principal place of business of such
Party, as the case may be, for at least three (3) years following the end
of the calendar quarter to which they pertain. Such records shall be open
for inspection during such three (3) year period by a public accounting
firm to whom Antalium has no reasonable objection, solely for the purpose
of verifying royalty statements hereunder. Such inspections may be made no
more than once each calendar year at reasonable times and on reasonable
notice. Inspections conducted under this Section 7.4 shall be at the
expense of Nortran, unless a variation or error producing an increase
exceeding five (5%) of the amount stated for any period covered by the
inspection is established in the course of any such inspection, whereupon
all reasonable costs relating to the inspection for such period and any
unpaid amounts that are discovered shall be paid promptly by Antalium
together with interest thereon from the date such payments were due at the
prime rate as reported by the CIBC plus an additional one percent (1%).
7.5 Tax Matters
7.5.1 Withholding Taxes. All milestone payments, royalty amounts and
license fees required to be paid to Nortran pursuant to this
Agreement shall be paid with deduction for withholding for or on
account of any taxes (other than taxes imposed on or measured by net
income) or similar governmental charge imposed by a jurisdiction
other than Canada ("Withholding Taxes") Antalium shall provide
Nortran a certificate evidencing payment of any Withholding Taxes
hereunder, and shall provide any further assistance reasonably
requested by Nortran to enable Nortran to obtain the benefit of any
such deduction.
7.5.2 Other Taxes. Nortran shall be responsible for any sales taxes, use
taxes, transfer taxes or similar governmental charges required to be
paid in connection with the transfer of the Agreement Compounds. In
the event that Antalium is required to pay any such amounts, and
reasonably documents payment, Nortran shall promptly reimburse
Nortran for such amounts.
ARTICLE 8
CONFIDENTIALITY
8.1 Confidential Information.
Except as expressly provided herein, the Parties agree that, for the Term
of this Agreement and for five (5) years thereafter, the Receiving Party,
except as expressly provided in this Article 8, shall not disclose to any
Third Party or use for any purpose any Confidential Information of the
Disclosing Party, howsoever acquired by the Receiving Party, except to the
extent that it can be established by the Receiving Party by competent
proof that such information:
(a) was already known to the Receiving Party, other than under an
obligation of confidentiality, at the time of disclosure:
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the Receiving Party;
(c) became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or
omission of the Receiving Party in breach of this Agreement;
(d) was independently developed by the Receiving Party as demonstrated
by documented evidence prepared contemporaneously with such
independent development;
(e) was, subsequently, lawfully disclosed to the Receiving Party by a
person other than the Disclosing Party; or
(f) was approved in writing by the Disclosing Party for public
disclosure by the Receiving Party.
8.2 Permitted Use and Disclosures.
Each Party hereto may use or disclose information disclosed to it by the
other Party to the extent such information is included in the Licensed
Technology or the Antalium Technology, as the case may be, and to the
extent such use or disclosure is reasonably necessary and permitted in the
exercise of such rights granted hereunder in filing or prosecuting patent
applications, prosecuting or defending litigation, complying with
applicable governmental regulations or court order or otherwise submitting
information to tax or other governmental authorities, conducting clinical
trials, or making a permitted sublicense or otherwise exercising license
rights expressly granted by the other Party to it pursuant to the terms of
this Agreement, provided that if a Party is required to make any such
disclosure, other than pursuant to a confidentiality agreement, it shall
give reasonable advance notice to the other Party of such disclosure and,
save to the extent inappropriate in the case of patent applications, shall
use its reasonable efforts to secure confidential treatment of such
information in consultation with the other Party prior to its disclosure
(whether through protective orders or otherwise) and disclose only the
minimum necessary to comply with such requirements.
8.3 Nondisclosure of Terms.
Each of the Parties hereto agrees not to disclose the terms of this
Agreement to any Third Party without the prior written consent of the
other Party hereto, which consent shall not be unreasonably withheld,
except to such Party's attorneys, advisors, investors and others on a need
to know basis under circumstances that reasonably ensure the
confidentiality thereof, or to the extent required by law. Notwithstanding
the foregoing, the Parties shall agree Upon Q press release and timing to
announce the execution of this Agreement, together with a corresponding
Q&A outline for use in responding to inquiries about the Agreement;
thereafter, Nortran and Antalium may each disclose to Third Parties the
information contained in such press release and Q&A without the need for
further approval by the other. In addition, Antalium and Nortran may make
public statements regarding the progress of the Research Collaboration and
the achievement of milestones and fees with respect thereto, following
consultation and mutual agreement, the consent of neither Party to be
unreasonably withheld.
8.4 Acknowledgement of Confidentiality.
Antalium acknowledges and confirms that all communications and information
relating to this Agreement received from Nortran prior to the date of this
Agreement shall be deemed to be Confidential Information under this
Agreement and shall be deemed to have been received under an obligation of
confidentiality from the time of its receipt on the terms as set out in
this Agreement.
ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 Representations and warranties of both Parties
Each Party hereby represents and warrants to the other Party as follows:
9.1.1 Existence. Such Party is duly organized and validly existing under
the laws of the province of its incorporation and has full corporate
power and authority to enter into this Agreement and to carry out
the provisions hereof.
9.1.2 Authorization and Enforcement of Obligations.
(a) Such Party has the requisite power and authority and the legal
right to enter into this Agreement and to perform its
obligations hereunder: and
(b) Such Party has taken all requisite action on its part to
authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder. This Agreement has
been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation enforceable
against such Party in accordance with its terms except as
enforcement may be limited by equitable remedies or defenses
and applicable bankruptcy laws.
9.1.3 No Consent. All necessary consents, approvals and authorizations
from all governmental authorities and other persons or Third Parties
required to be obtained by such Party in connection with the
execution and delivery of this Agreement have been obtained.
9.1.4 No Conflict. The execution, delivery and performance of this
Agreement by such Party do not conflict with any agreement,
instrument or understanding, oral or written, to which such Party is
a Party or by which such Party may be bound, nor violate any law or
regulation of any court, governmental body or administrative or
other agency having authority over such Party.
9.1.5 No Consequential Damages. In addition to the other limitations set
out in this Article 9, in no event shall either Party be liable to
the other for any indirect, consequential, special, incidental or
contingent damages of any nature whatsoever, including but not
limited to loss of revenue or profit, or loss of use of either, or
costs of capital.
9.2 Representations and Warranties of Nortran.
Nortran hereby represents and warrants to Antalium as follows:
(a) It has not previously granted, and during the term of this
Agreement shall not knowingly make, any commitment or grant
any rights which are in conflict in any material way with the
rights and licenses granted herein.
(b) To the best of its knowledge, it is the owner or licensee of
all of the Licensed Technology in existence on the Effective
Date, and has therefore the right to grant the licenses or
sublicenses granted under this Agreement, as the case may be.
(c) To the best of its knowledge as of the Effective Date, there
are no existing or threatened actions, suits or claims pending
against it with respect to the Licensed Technology.
(d) To the best of its knowledge as of the Effective Date, the
creation or synthesis of Agreement Compounds or any Derivative
thereof by Nortran does not infringe any patent rights of any
Third Party.
9.3 Disclaimer
Antalium and Nortran specifically disclaim any guarantee that the Research
Collaboration shall be successful, in whole or in part. The failure of the
Parties to successfully develop Agreement Compounds or Derivative thereof
or Products shall not constitute a breach of any representation or
warranty or other obligation under this Agreement, EXCEPT AS OTHERWISE
EXPRESSLY SET FORTH IN THIS AGREEMENT, NORTRAN AND ANTALIUM MAKE NO
REPRESENTATIONS AND EXTEND NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER
EXPRESS OR IMPLIED, WITH RESPECT TO THE TECHNOLOGY AND INFORMATION
DISCLOSED HEREUNDER OR PRODUCTS INCLUDING. BUT NOT LIMITED TO, WARRANTIES
OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF ANY
TECHNOLOGY. PATENTED OR UNPATENTED, OR NONINFRINGEMENT OF THE INTELLECTUAL
PROPERTY RIGHTS OF THIRD PARTIES. ALL TECHNOLOGY AND INFORMATION IS
PROVIDED "AS IS."
ARTICLE 10
INDEMNIFICATION
10.1 Antalium
Antalium agrees to indemnify, defend and hold Nortran and its Affiliates
and their respective directors, officers, employees, agents and their
respective successors, heirs and assigns (the "Nortran Indemnitees")
harmless from and against any losses, costs, claims, damages, liabilities
or expense (including reasonable attorneys' and professional fees and
other expenses of litigation) (collectively, "Liabilities") arising,
directly or indirectly out of or in connection with Third Party claims,
suits, actions, demands or judgments, relating to (i) any Products
developed, manufactured, used, sold or otherwise distributed by or on
behalf of Antalium, its Affiliates or Sublicensees or other designees
(including, without limitation. product liability and patent Infringement
claims), (ii) Antalium' performance of the Research Collaboration; and
(iii) any breach by Antalium of the representations and warranties made in
this Agreement, except, in each case, to the extent such Liabilities
result from a material breach of this Agreement by Nortran, gross
negligence or intentional misconduct of Nortran.
10.2 Nortran
Nortran agrees to indemnify. defend and hold Antalium, its Affiliates and
its Sublicensees and their respective directors, officers, employees,
agents and their respective heirs and assigns (the "Antalium Indemnitees")
harmless from and against any losses, costs, claims, damages, liabilities
or expense (including reasonable attorneys' and professional fees and
other expenses of litigation) (collectively, "liabilities") arising,
directly or indirectly out of or in connection with Third Party claims,
suits, actions, demands or judgments, relating to (i) any product based on
an Agreement Compound developed, manufactured, used, sold or otherwise
distributed by or on behalf of Nortran, its Affiliates, licensees or other
designees as permitted under this Agreement (including, without
limitation, product liability, patent infringement and other Intellectual
Property claims), (ii) the performance of the Research Collaboration by
Nortran, and (iii) any breach by Nortran of its representations and
warranties made in this Agreement, except, in each case, to the extent
such Liabilities result from a material breach of this Agreement by
Antalium, gross negligence or intentional misconduct of Antalium.
10.3 Procedure
In the event that any Indemnitee (either a Antalium Indemnitee or a
Nortran Indemnitee) intends to claim indemnification under this Article 10
it shall promptly notify the other Party in writing of such alleged
Liability. The indemnifying Party shall have the right to control the
defense thereof with counsel of its choice as long as such counsel is
reasonably acceptable to Indemnitee; provided, however, that any
Indemnitee shall have the right to retain its own counsel at its own
expense, for any reason, including if representation of any Indemnitee by
the counsel retained by the indemnifying Party would be inappropriate due
to actual or potential differing interests between such Indemnitee and any
other Party reasonably represented by such counsel in such proceeding. The
affected Indemnitee shall cooperate with the indemnifying Party and its
legal representatives in the investigation of any action, claim or
liability covered by this Article 10. The Indemnitee shall not, except at
its own cost, voluntarily make any payment or incur any expense with
respect to any claim or suit without the prior written consent of the
indemnifying Party, which such Party shall not be required to give.
ARTICLE 11
TERM AND TERMINATION
11.1 Term of Agreement
This Agreement shall commence on the Effective Date and shall remain. In
full force and effect until the expiration of the last to expire of the
applicable Patent Rights covering any royalty-bearing Licensed Product, on
a country-by-country basis, unless earlier terminated as provided in this
Article 11.
11.2 Early Termination.
Notwithstanding the provisions of Article 4 and Section 11.1, this
Agreement shall terminate if:
(a) after a period of more than 18 months starting from the Effective
Date, Antalium fails to select a Lead Compound.
(b) after a period of more than 33 months starting from the Effective
Date, Antalium fails to select a Clinical Candidate.
(c) If a Clinical Candidate is selected but a period of more than 12
months elapses between selection of Clinical Candidate and the
dosing of the first patient in a Phase I clinical trials and receipt
by Antalium of written notification from Nortran that such a gap has
occurred.
11.3 Termination for breach of payment obligations.
In the event that Antalium fails to make timely payment of any amounts due
to Nortran under this Agreement. Nortran may terminate the Research
Collaboration and/or this Agreement upon sixty (60) days written notice to
Antalium, unless Antalium pays all past-due amounts within such sixty-day
notice period.
11.4 Termination for Default.
If either Party breaches any material provision of this Agreement (other
than as provided in Sections 11.2 and 11.3) and if such breach is not
corrected within 90 days after the non-breaching Party gives notice of the
default to the breaching Party, the non-breaching Party may terminate the
Research Collaboration and/or this Agreement immediately by giving notice
of the termination, effective on the date of the notice; provided,
however, that if any such breach is not capable of being cured within the
aforesaid 90-day period, so long as the breaching Party (or any Third
Party on its behalf) commences to cure the breach promptly after receiving
notice of the breach from the non-breaching Party and thereafter
diligently prosecutes the cure to completion as soon as is practicable,
the non-breaching Party may not terminate this Agreement unless the
breaching Party (or any Third Party on its behalf), notwithstanding such
efforts, is unable to cure the breach within 80 days after the other
Party gives notice of the default, in which case the non-breaching Party
may terminate this Agreement immediately by giving notice of the
termination, effective on the date of the notice.
11.5 Termination for Insolvency.
If voluntary or involuntary proceedings by or against a Party are
instituted in bankruptcy under any insolvency law, or a receiver or
custodian is appointed for such Party, or proceedings are instituted by or
against such Party for corporate reorganization, dissolution, liquidation
or winding-up of such Party, which proceedings, if involuntary, shall not
have been dismissed within sixty (60) days after the date of filing, or if
such Party makes an assignment for the benefit of creditors, or
substantially all of the assets of such Party are seized or attached and
not released within sixty (60) days thereafter, the other Party may
immediately terminate the Research Collaboration and/or this Agreement,
effective upon notice of such termination.
11.6 Voluntary Termination of License Rights.
Antalium may terminate the license rights granted to it by Nortran under
Article 4 of this Agreement with respect to any particular country or
countries in the Territory or with respect to a particular Agreement
Compound or Product by giving Nortran at least thirty (30) days written
notice thereof.
11.7 Mutual Termination.
By written agreement, the Parties may at any time terminate this Agreement
on mutually acceptable terms.
11.8 Effect of termination
11.8.1 Accrued Rights and Obligations. Termination of this Agreement for
any reason shall not release either 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 preclude either Party from pursuing any rights and
remedies it may have hereunder or at law or in equity with respect
to any breach of this Agreement.
11.8.2 Return of Materials. Upon any termination of this Agreement or the
licenses granted to either Party pursuant to this Agreement, the
Parties shall promptly return to each other all Confidential
Information (including, without limitation, all Know-How) received
from the other Party, except one copy of which may be retained for
archival purposes.
11.8.3 Post-Termination Product Sales. In the event of the cancellation or
termination of any license rights with respect to a Product prior
to the expiration of this Agreement, inventory of such Product may
be sold for up 10 one year after date of termination or such longer
period as the Parties may agree, provided earned royalties are paid
thereon.
11.8.4 Licenses.
(a) Following expiration of the term of this Agreement with
respect to a Product in a country pursuant to Section 11.1,
Antalium shall have the royalty-free, perpetual right to make,
have made, use and sell such, Product in such country.
Following expiration of the term of this Agreement with
respect to every Product in every country pursuant to Section
11.1, Antalium shall have the royalty-free, perpetual right to
continue to make, have made, use and sell all Products
worldwide.
(b) The licenses granted to Antalium herein shall terminate in the
event of any termination of the Agreement by Nortran pursuant
to Sections 11.2, 11.3, 11.4, or 11.5. Notwithstanding the
foregoing, in the event of termination of this Agreement for
Insolvency of Nortran, pursuant to Section 11.5, all licenses
and rights granted to Antalium shall remain in full force and
effect, subject to the terms and conditions of this Agreement
applicable thereto.
(c) If more than one Product is being commercially developed or
exploited by Antalium or its Affiliates or Sublicensees
hereunder, and Nortran terminates this Agreement pursuant to
Section 11.3 or 11.4 due to a breach relating only to a single
Product, then Nortran shall be entitled to terminate this
Agreement only with respect to the applicable Product.
(d) Except as expressly provided in this Section 11.8.4, in the
event of any termination of this Agreement, the licenses
granted under this Agreement to either Party prior to the
effective date of such termination shall remain in effect,
subject to the terms and conditions of this Agreement
applicable thereto. In such event, the applicable provisions
of Articles 4, 6 and 9 shall survive and be applicable to such
licenses in addition to the provisions which survive pursuant
to Section 12.16.
ARTICLE 12
GENERAL PROVISIONS
12.1 Governing Law.
This Agreement and any dispute arising from the construction, performance
or breach hereof shall be governed, construed and enforced in accordance
with the laws of the Province of Quebec; and the laws of Canada applicable
in the Province of Quebec.
12.2 Compliance with Laws.
In exercising their rights under this Agreement, the Parties shall fully
comply in all material respects with the requirements of any and all
applicable laws, regulations, rules, and orders of any government body
having jurisdiction over the exercise of rights under this Agreement,
including, without limitation, those applicable to the discovery,
development, manufacture, distribution, import and export, and sale of
pharmaceutical products pursuant to this Agreement.
12.3 Notices.
All notices, reports, payments, requests, consents, demands and other
communications between Nortran and Antalium, pertaining to subjects
related to this Agreement, shall be in writing and shall be deemed duly
given and effective (A) when actually received by mail or personal
delivery, or (B) when mailed by prepaid registered or certified mail to
the receiving Party at the address set forth below, or to such other
address as may be later designated by written notice from either Party to
the other Party on the fifth (5th) day following the deposit thereof in
the mail, or (C) when transmitted by facsimile, at the facsimile of such
receiving Party set forth below, on the day of transmittal thereof:
Nortran's Notification Address:
Nortran Pharmaceuticals Inc.
0000 Xxxxxxxxx Xxxx Xxxxxxxxx, XX,
Xxxxxx, X0X 0X0
Facsimile: (000) 000-0000
Attention of: The Chief Executive Officer
Antalium's Notification Address:
Antalium Inc.
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, XX
Xxxxxx, X0X 0X0
Facsimile: (000) 000-0000
Attention of: The Chief Executive Officer
12.4 Entire Agreement.
This Agreement, constitutes the entire agreement, both written and oral,
between the Parties with respect to the subject matter hereof, and all
prior agreements respecting the subject matter hereof. either written or
oral, expressed or implied, shall be abrogated, canceled, and are null and
void and of no effect. No amendment or change hereof or addition hereto
shall be effective or binding on either of the Parties hereto unless
reduced to writing and executed by a duly authorized representative of
each, of Nortran and Antalium.
12.5 Amendment.
This Agreement may not be amended or modified except by written agreement
signed by both Parties.
12.6 Assignment.
This Agreement shall not be assignable by either Party to any Third Party
without the written consent of the other Party hereto; provided, however,
that either Party may assign this Agreement, without the other's consent,
to an entity that acquires all or substantially all of the business or
assets of such party to which this. Agreement pertains, whether by merger,
reorganization, operation of law, acquisition, sale, or otherwise. This
Agreement shall be binding upon and accrue to the benefit of any permitted
assignee, and any such assignee shall agree to perform the obligations of
the assignor.
12.7 Severability.
In the event that any provision of this Agreement becomes or is declared
by a court of competent jurisdiction to be illegal, unenforceable or void,
this Agreement shall continue in full force and effect to the fullest
extent permitted by law without said provision, and the Parties shall
amend the Agreement to the extent feasible to lawfully include the
substance of the excluded term to as fully as possible realize the intent
of the Parties and their commercial bargain.
12.8 Waiver of Rights.
In order to be effective, any waiver, by either Party, of any right under
this Agreement, must be in writing signed by an authorized representative
of the Party making the waiver No such waiver of failure of Nortran or
Antalium to enforce a right or strict performance under this Agreement
shall be deemed to be a waiver or forbearance which would in any way
prevent Nortran or Antalium from subsequently asserting or exercising any
such rights, making a claim not specifically waived, or requiring strict
performance of this Agreement. No such waiver or failure to enforce shall
affect the validity of this Agreement or be a continuing waiver excusing
compliance with any provision of this Agreement in the future.
12.9 Binding Effect.
This Agreement shall be binding upon and inure to the benefit of the
Parties and their respective legal representatives, successors and
permitted assigns.
12.10 Co-operation.
Each Party hereto agrees to co-operate with the other to insure that each
may have and enjoy to the fullest extent, all rights conveyed under this
Agreement. If at any time after the date hereof any Party, acting
reasonably, requests further documents, instruments or assurances in order
to carry out the provisions hereof, then the Party from which such
documents, instruments or assurances are requested shall promptly execute
and deliver any such documents, instruments and assurances and do all
things reasonably necessary to carry out the provisions hereof, all at the
cast and expense of the Party requesting such assurance.
12.11 Mediation.
Any dispute with respect to the present Agreement, and which cannot be
settle by negotiation between the Parties, shall firstly be submitted to
mediation by the Parties, who shall to this end appoint a mediator whose
expertise appears relevant to the matter in question, If the mediation
process does not resolve the disagreement within sixty (60) days, the
Parties shall have recourse to arbitration in accordance with subsection
12.12 hereafter, Mediator costs shall be equally shared by the Parties to
this Agreement.
12.12 Arbitration.
Any controversy which shall arise between the Ponies to this Agreement
concerning its construction or application, or the rights, duties or
obligations of any Party to this Agreement, shall be referred to an
arbitration, the award and determination of which shall be final and
binding upon the Par-ties hereto, the whole in accordance with the
provisions of the Code of Civil Procedure of the Province of Quebec. The
procedure of the arbitration shall be as follows:
(a) Upon the written demand of any of the Parties concerned, the Parties
shall meet and attempt to appoint a single arbitrator. If they are
unable to agree on a single arbitrator then upon the written demand
of any of them and within thirty (30) days of such demand, the
Person making the demand shall apply to any Judge of the Superior
Court of the Province of Quebec, to appoint such arbitrator that
meets the criteria set forth pursuant to the provisions of section
(b) of this Arbitration Schedule.
(b) The arbitrator selected to act hereunder shall be (i) affiliated
with a recognized national or international arbitration tribunal and
(ii) qualified by education and training to pass upon the particular
question or questions in dispute.
(c) The single arbitrator so chosen shall proceed immediately to hear
and determine the matter or matters in dispute. The decision of the
arbitrator shall be made within forty-five (45) days after his
appointment, subject to any reasonable delay due to unforeseen
circumstances. Notwithstanding the foregoing, in the event the
single arbitrator fails to make a decision within ninety (90) days
after his appointment then any of the Parties concerned may elect to
have a new single arbitrator chosen in like manner as if none had
previously been selected.
(d) The decision of the single arbitrator shall be in writing and signed
by the single arbitrator and shall be final and binding upon all of
the Parties hereto as to any matter or matters so submitted to
arbitration and the Parties shall perform the terms and conditions
thereof.
(e) The compensation and expenses of the single arbitrator (unless
otherwise determined by the arbitrator) shall be paid equally by the
Parties that are Party to the arbitration unless otherwise directed.
(f) None of the Parties concerned shall be deemed to be in default of
any matter being arbitrated until ten (10) days after the decision
of the arbitrator is delivered to all of them.
12.13 Injunctive Relief.
Notwithstanding Section 12.12, both Parties agree that any Party hereto
may be Irreparably damaged if any provision of this Agreement is not
performed by the other Party in accordance with its terms. Accordingly,
the Parties shall be entitled to apply for an injunction or injunctions to
prevent breaches of any of the provisions of this Agreement by the other
Party and may specifically enforce such provisions by an action instituted
in a court having jurisdiction. These specific remedies are in addition to
any other remedy to which either Party may be entitled at law or in
equity.
12.14 Force majeure.
A Party to this Agreement may not be held responsible to the other Party
and shall not lose any rights hereunder or be liable to the other Party
for damages or losses for any default or delay in execution caused by
circumstances beyond its control, which comprises, without however being
limited thereto, Acts of God, war, natural disasters, fire, trade
disputes, strikes, lockouts, embargo, governmental measures, including any
intervention by the Ministere du revenu du Quebec or Revenue Canada or any
regulatory body, failure of suppliers, or any other reason where failure
to perform is beyond the reasonable control and not caused by the
negligence or intentional conduct or misconduct of the non-performing
Party, provided however that the Party that is excused from performance
takes all the necessary measures to prevent, cease or terminate such
events, measures or facts making the execution impossible, provided,
however, that in no event shall a Party be required to settle any labor
dispute or disturbance.
12.15 Independent Contractors.
The relationship of the Parties hereto is that of independent contractors.
Neither Party hereto is to be deemed to be an agent, partner, or joint
venturer of the other Party for any purpose as a result of this Agreement
or the transactions contemplated thereby.
12.16 Survival of Articles.
The following Articles shall survive any termination or expiration of this
Agreement: Article 1 (Definitions), 5 (Intellectual Property), 8
(Confidential Information), 9 (Representations and Warranties), 10
(Indemnification), 11 (Term and Termination) and 12. (General Provisions).
12.17 Negotiation.
This Agreement has been negotiated by the Parties and shall be fairly
interpreted in accordance with its terms and without any rules of
construction relating to which Party drafted the Agreement being applied
in favor or against either Party.
12.18 Headings.
The section and subsection titles and headings contained in this Agreement
are for convenience and reference only. Such titles and headings do not
form a part of this Agreement, shall not define or limit the scope of the
sections or subsections, and shall not affect the construction or
interpretation of any of the sections or subsections.
12.19 Language.
The Parties hereto hereby acknowledge that they have agreed to this
Agreement being drawn up in the English language only. Les Parties
reconnaissent avoir consenti a ce que le present contrat de recherche
soit redige en langue anglaise seulement.
12.20 Counterparts.
This Agreement may be executed in counterparts, each of which shall be
deemed to be an original and all of which together shall be deemed to be
one and the same agreement.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly
executed by their authorized representatives and delivered in duplicate
originals as of the Effective Date.
Nortran Pharmaceuticals Inc. Antalium Inc.
Per: /s/ Xxxxxx Xxxxxx /s/ Xxxxxxxxx Xxxxxxxx
-------------------- ------------------------
Xxxxxx Xxxxxx Xxxxxxxxx Xxxxxxxx
Chief Executive Officer Chief Executive Officer
EXHIBIT A
In accordance with Section 2.2, Nortran shall deliver to Antalium a minimum of
30 different Agreement compounds according to the schedule set forth in Table 1
below:
TABLE 1
Compound Quantity Delivered By
-------- -------- ------------
RSD990 300 mg November 30, 2000
RSD1002 300 mg November 30, 2000
RSD1007 300 mg November 30, 2000
RSD1008 300 mg November 30, 2000
RSD1018 300 mg November 30, 2000
RSD1020 300 mg November 30, 2000
RSD1025 300 mg November 30, 2000
RSD1070 300 mg November 30, 2000
RSD1200 300 mg November 30, 2000
RSD1208 300 mg November 30, 2000
The remaining 20 compounds (100 mg quantity) to be selected by Antalium from the
following list and delivered by November 30. 2000.
RSD961 RSD1029
RSO962 RSD1034
RSD970 FSD1041
RSD971 RSD1044
RSD974 RSDI045
RSD981 RSDlO49
RSD983 RSDl171
RSD986 RSD1172
RSD994 RSD1174
RSD995 RSD1186
RSD998 RSD1197
RSD999 RSD1198
RSD1001 RSD1199
RSD1004
