Exhibit 10.38
ARDANA BIOSCIENCE LIMITED
and
COLUMBIA LABORATORIES (BERMUDA), LTD.
and
COLUMBIA LABORATORIES, INC.
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DEVELOPMENT AND LICENSE AGREEMENT
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DEVELOPMENT AND LICENSE AGREEMENT, dated as of 26 December 2002, between ARDANA
BIOSCIENCE LIMITED, a company incorporated in England, with its registered
office c/o Dundas & Wilson CS, Bush House, Aldwych, London WC2B 4PA, England
("Ardana") and COLUMBIA LABORATORIES (BERMUDA), LTD., a Bermuda corporation,
having its office at Rosebank Center, 14 Bermudiana Road, Pembroke, HM08 Bermuda
("Bermuda") and COLUMBIA LABORATORIES, INC., a US corporation incorporated in
Delaware having its principal place of business at 354 Eisenhower Parkway, Plaza
1, Second Floor, Livingston, NJ 07039 ("COB") (jointly, "Columbia", which shall
be used to refer to either or both Bermuda and COB as appropriate -- COB
generally with regard to US activities, rights, and obligations, and Bermuda
generally with regard to activities, rights, and obligations outside the US).
RECITALS:
(A) COB owns certain Patent Rights in the USA relating to a bioadhesive
delivery technology and in relation to certain uterine pass technology and
is also the owner of certain Know How in relation to their use in
conjunction with a treatment agent in a clinical setting. Bermuda owns
certain corresponding Patent Rights which exist outside the USA.
(B) Ardana is a specialty pharmaceutical company specialising in the research,
development, marketing and sale of products in the field of reproductive
health.
(C) The parties are interested in co-developing the bioadhesive delivery and
uterine pass technologies in conjunction with the compound known as
terbutaline in North America and Europe with a view to obtaining marketing
authorisations for and subsequently selling the resultant product in North
America and Europe, and arranging for the sale of such product in the rest
of the world.
(D) This Agreement sets out the terms upon which such co-development is to be
conducted and provides for the subsequent rights and obligations of the
Parties.
NOW THEREFORE, the Parties hereto agree as follows:
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1. DEFINITIONS
1.1 As used in this Agreement, the following definitions (in addition to
other definitions set forth in this Agreement) shall apply:
1.1.1 "Affiliate" shall mean any entity controlling, controlled by
or under the common control of Columbia or Ardana, as the
case may be. For the purpose of this Agreement, "control"
shall mean the direct or indirect ownership of more than
(50%) percent of the outstanding shares or other voting
rights of the subject entity or possession, directly or
indirectly, of the power to direct or cause the direction of
management and policies of such entity.
1.1.2 "Agreement" shall mean this development and license
agreement (which expression shall be deemed to include the
Recitals and Exhibits hereto).
1.1.3 "Allocable Overhead" - either a standard percentage rate
agreed to by the Parties for each of them to be added to an
item of cost, failing which means the addition to an item of
cost of other relevant pro-rated costs incurred by a party
or for its account which are attributable to the operation
by such party of its service departments including human
relations, information systems, payroll, purchasing,
supervisory and other internal groups or which are
attributable to its occupancy provided that such party
normally allocates such service department costs to its
departments or project groups based on space occupied or
headcount or other activity-based method in a manner
consistently applied by such party. Allocable Overhead shall
not include any costs attributable to corporate activities
of an exceptional nature including, by way of example of
each, costs relating to acquisitions or disposals or other
corporate transactions, or to routine corporate activities
not related directly to the subject of this Agreement
including, for example, public and investor relations
activities, and CEO functions.
1.1.4 "Applicable Laws" means all applicable laws, rules,
regulations, directives and guidelines (including any
amendments, extensions or replacements thereto) (i) in any
country that apply to the development or to the
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Commercialization of the Product in such country; and (ii)
in any country that apply to the performance of either
Party's obligations or covenants under this Agreement.
1.1.5 "Ardana Negative Election" - an election by Ardana pursuant
to Clause 4.1 that it wishes to discontinue the
co-development and Commercialisation of Candidate Product
and resultant Product.
1.1.6 "Ardana Positive Election" - an election by Ardana pursuant
to Clause 4.1 that it wishes to continue with the
co-development and Commercialisation of Candidate Product
and resultant Product.
1.1.7 "Ardana Territory" - Europe, together with (with the
exception of the use of this definition in the provisions of
Clause 8) any territory allocated to Ardana under the
provisions of Clause 8.1.
1.1.8 "Business Days" shall mean 9.30 am to 5.30 pm local time on
a day other than a Saturday, Sunday, or public holiday in
the UK (or any part thereof) or the USA (or any part
thereof).
1.1.9 "cGMP" shall mean manufacture in accordance with:
(a) EC Directive 91/356/EEC as may be amended from time to
time;
(b) the current guide to good manufacturing practice for
medicinal products published by the European
Commission;
(c) U.S. Code of Federal Regulations Title 21, Parts 210
and 211, as may be amended from time to time; and
(d) the equivalent law or regulation in any country .
1.1.10 "Candidate Product" - the compound known as Terbutaline
delivered utilising the Columbia Technology as a vaginal gel
in a finished pharmaceutical dosage form, for the
indications determined by the DC for so long as the DC
exists.
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1.1.11 "Certificate of Analysis" shall mean a document of that name
as described in detail in the current guide to good
manufacturing practice for medicinal products published by
the European Commission.
1.1.12 "Clinical Trial Material" or "CTM" - Candidate Product
manufactured in compliance with cGMP in a form suitable for
administration and dosing to humans in Clinical Trials.
1.1.13 "Clinical Trials" - means any or all of the Phase I Clinical
Trials, Phase II Clinical Trials or Phase III Clinical
Trials.
1.1.14 "Columbia IP" - all intellectual property or other rights
relating to or comprised in the Columbia Technology,
including without limitation all Patent Rights (including
the Patent Rights listed in Exhibit A), Know How, trade
secrets, technology, disclosures, inventions, discoveries,
and other information whether patentable or not, owned or
licensed by Columbia or a Columbia Affiliate at the
Commencement Date, or thereafter.
1.1.15 "Columbia Negative Election" - an election by Columbia
pursuant to Clause 4.1 that it wishes to discontinue the
co-development and commercialisation of Candidate Product
and resultant Product.
1.1.16 "Columbia Patent Rights" - the Patent Rights relating to or
comprised in the Columbia Technology, at or after the
Commencement Date.
1.1.17 "Columbia Positive Election" - an election by Columbia
pursuant to Clause 4.1 that it wishes to continue with the
co-development and Commercialisation of Candidate Product
and resultant Product.
1.1.18 "Columbia Technology" - Columbia's proprietary delivery,
bioadhesive delivery, and uterine pass technologies,
disclosed to Ardana for the purposes of carrying out the
Development Program in relation to Candidate Product and
which shall include without limitation the inventions
claimed or disclosed in the Patent Rights listed in Exhibit
A, and all related Know How owned or licensed to Columbia as
of the Commencement Date including,
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without limitation, any pre-clinical or clinical data
relating to the use thereof with or without Terbutaline, as
well as any and all Improvements that arise during the term
of this Agreement.
1.1.19 "Columbia Territory" - North America together with (with the
exception of the use of this definition in the provisions of
Clause 8) any territory allocated to Columbia under the
provisions of Clause 8.1.
1.1.20 "Commencement Date" means the date of execution of this
Agreement.
1.1.21 "Commercialization", "Commercializing", or "Commercialize"
shall mean all activities in the Territory relating to the
import, export, promotion, marketing, detail, distribution,
storage, handling, offering for sale and sale of the
Finished Product including:
(1) determining the pricing of Product in a country
and, if relevant, obtaining the pricing or
reimbursement approval for Product in such
country;
(2) establishing the Trade Marks to be used for
Product in a country;
(3) establishing the Trade Dress, Packaging and
Labelling for Product in a country;
(4) establishing the commercial launch program and the
distribution chain for Product in a country.
1.1.22 "Commercialization Committee" - the joint committee of the
Parties established pursuant to Clause 5.6.6 for the
co-ordination of Commercialization and liaison between the
Parties in respect of the same.
1.1.23 "Commercialisation Costs" - any costs and expenses incurred
by either Party in relation to commercialisation.
1.1.24 "Commercialisation Know How" - any and all Know How relating
to Commercialisation.
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1.1.25 "Common Technical Document" or "CTD" - the common technical
document relating to the Candidate Product which shall be
generated pursuant to the Development Program and which is
sufficient to fulfill the requirements for filing an
application for Regulatory Approval with the FDA and for
Marketing Authorisation with the EMEA.
1.1.26 "Confidential Information" - means all materials, trade
secrets, or other commercially sensitive information,
including without limitation, proprietary information, that
the Disclosing Party reasonably deems and treats as
confidential when disclosed or made available to, or
otherwise coming into the possession of, the other Party in
relation to the performance of this Agreement which for the
avoidance of doubt shall in the case of obligations on
Ardana in relation to Confidential Information, include
without limitation Know How forming part of Columbia IP and,
in the case of both Ardana and Columbia, shall include
without limitation Joint Program Know How and
Commercialisation Know How.
1.1.27 "Co-ordination Committee" or "CC" - the committee to be
established pursuant to Clause 8.4 for the management by the
Parties of the clinical development and Commercialisation by
a ROW Partner.
1.1.28 "Development Budget" - a budget for a particular Year of the
Development Program being an estimate of Development Costs
to third parties to be incurred by the Parties in relation
to the Development Program during such year.
1.1.29 "Development Committee" or "DC" - the joint committee of the
Parties established pursuant to Clause 2 to manage the
Development Program subject to referral to the Chief
Executive Officers of the Parties as specified in Clause 2.
1.1.30 "Development Costs" - means:
(a) all reasonable costs and expenses (priced on a
competitive basis) paid by either of the Parties
to third parties in connection with the Second
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Development Program (including, for the avoidance
of doubt, the preparation of the CTD) conducted
externally (whether through a direct relationship
with a consultant or a clinical investigator or
through a contract research organisation) and in
all cases including the costs and expenses
incurred to such third party for data management,
statistical designs and studies, report
preparation and other administrative expenses of
such third party associated with the Second
Development Program;
(b) all costs and expenses paid by either of the
Parties to third parties including to outside
patent attorneys, legal counsel and experts for
the preparation, filing, prosecution and
maintenance of Joint Program Patent Rights
including costs of patent interference,
opposition, re-examination, reissue, and
revocation proceedings or requests for patent term
or SPC extensions relating thereto to the extent
the same occurs during the period of the
Development Program; and
(c) the Fully Burdened Manufacturing Costs incurred in
connection with supply of CTM for the Second
Development Program.
For the avoidance of doubt it is stated that Development
Costs shall not include related Allocable Overhead nor shall
they include Commercialisation Costs (the treatment of which
is governed by Clause 5.6).
1.1.31 "Development Program" - the First Development Program and
the Second Development Program.
1.1.32 "Documents" - reports, research notes, charts, graphs,
comments, computations, analyses, recordings, photographs,
paper, notebooks, books, files, ledgers, records, tapes,
discs, diskettes, CD-ROM, computer information storage means
and any other media on which Know How can be permanently
stored.
1.1.33 "EMEA" - European Medicines Evaluation Agency or any
successor group thereto.
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1.1.34 "Europe" - shall mean Austria, Belgium, Denmark, Finland,
France, Germany, Luxembourg, Netherlands, Spain, Sweden,
United Kingdom, Norway, Switzerland, Liechtenstein, Monaco,
Bulgaria, Czech Republic, Estonia, Hungary, Latvia,
Lithuania, Poland, Romania, Slovak Republic, Slovenia,
Malta, Cyprus, Turkey, Albania, Bosnia and Herzegovina,
Croatia, Kosovo, The Former Yugoslav Republic Of Macedonia,
Serbia, and Montenegro. For the avoidance of doubt, Europe,
for purposes of this Agreement, shall not mean Greece,
Ireland, Italy (including San Marino and Vatican City), and
Portugal, unless and until the conditions of Clause 21.2
shall have been met.
1.1.35 "FDA" means the Governmental Authority in the USA with the
name "Food and Drug Administration" or any successor agency
thereof.
1.1.36 "Finished Product" - Product Packaged and Labelled and ready
for ultimate commercial sale or use.
1.1.37 "First Commercial Sale" - the first invoiced commercial sale
by a Party, its Affiliates, agents or sublicensees in any
country after grant of Regulatory Approval or Marketing
Authorisation and pricing approval for Product (if required
in that country) in such country by the appropriate
Governmental Authority.
1.1.38 "First Development Program" - the detailed program of work
commencing upon the Commencement Date to be conducted by the
Parties comprising Formulation Work and the clinical
development of Candidate Product up to the Point of Proof of
Principle which is set out in Exhibit B hereto.
1.1.39 "Force Majeure" means in relation to either Party, any event
or circumstance which is beyond the reasonable control of
that Party and without the fault or negligence of that Party
so affected which results in or causes the failure of that
Party to perform any or all of its obligations under this
Agreement, including, without limitation, inevitable
accidents, perils of navigation, floods, fire, storms,
drought, or other weather-related conditions,
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earthquakes, asteroid or meteor activity, explosion,
hostilities, sabotage, act of vandalism, war (whether
declared or undeclared), civil disturbances, order or act of
any government, whether de jure or de facto or any official
purporting to act under authority of any such government,
illegality arising from domestic or foreign laws or
regulations, insurrections, quarantine or custom
restrictions, damage in factories or warehouses, strikes,
lockouts, other labor difficulty or other disturbance at the
Parties or the suppliers of Product, raw materials and/or
excipients, energy or other supplies, breakdown of machinery
or instruments or acts of God or other similar events beyond
the reasonable control of the Party so affected resulting in
hindrance of the performance by either Party of its
obligations hereunder.
1.1.40 "Formal Presentation" - in relation to the results of any
preclinical study or any Clinical Trial means an oral
presentation of the results of such preclinical study or
Clinical Trial following its conclusion with supporting
written evidence but does not mean the final formal written
report of the results of the preclinical study or Clinical
Trial containing the final assessment of the results
properly quality assured.
1.1.41 "Formulation Work" - the work to be conducted by Columbia
under the First Development Program as set out in the First
Development Program in relation to the formulation of the
Candidate Product.
1.1.42 "FTE" - a period of time equivalent to the number of hours
that an employee in the full time employment of either Party
shall be obliged to spend at work in any twelve (12) month
period of continuous employment.
1.1.43 "Fully Burdened Manufacturing Cost" - means: the cost of
producing the CTM or Finished Product including raw material
costs, direct labour costs, direct utilities and other
energy costs and direct product quality assurance/control
costs and including any applicable Allocable Overhead. For
the avoidance of doubt such Fully Burdened
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Manufacturing Costs chargeable under this Agreement the
Parties will apply GAAP in a consistent manner.
1.1.44 "Good Clinical Practice" or "GCP" shall mean clinical
practice as set out in:
(a) ICH Harmonised Tripartite Guideline for Good Clinical
Practice (CPMP/ICH/135/95) and any amendment thereof;
and
(b) any guidelines concerning good clinical practice
published from time to time by the European Commission
pursuant to Directive 2001/20/EC or any amendment
thereof; and
(c) US Code of Federal Regulations Title 21, Parts 50
(Protection of Human Subjects) and 56 (Institutional
Review Boards), as may be amended from time to time;
and
(d) the Declaration of Helsinki as last amended at the 52nd
World Medical Association October 2000 and any further
amendments thereto; and
(e) National Institute of Health Standards for the
protection of human subjects as may be amended from
time to time; and
the equivalent law or regulation in any relevant territory.
1.1.45 "Good Industry Practice" shall mean in relation to any
undertaking and any circumstance, the exercise of that
degree of skill, diligence, prudence and foresight which
would reasonably and ordinarily be expected from a skilled
and experienced person engaged in the same type of
undertaking under the same or similar circumstances.
1.1.46 "Good Laboratory Practice" or "GLP" - laboratory practice as
set out in:
(a) Directive 87/18/EEC as may be amended from time to
time; and
(b) US Code of Federal Regulations, Title 21, Part 58 (Good
Laboratory Practice for Nonclinical Laboratory Studies)
as may be amended from time to time; and
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(c) the equivalent law or regulation in any territory.
1.1.47 "Governmental Authority" shall mean all governmental and
regulatory bodies, agencies, departments or entities that
regulate, direct or control commercial and other related
activities the subject of this Agreement, including any
relevant government health authority (or successor agency
thereof) in any country or countries including the FDA and
the EMEA whose approval is necessary to market the Finished
Product in such country or countries in the Territory.
1.1.48 "Improvements" - all improvements, enhancements, or
modifications, whether or not patentable, to the Columbia
Technology, including without limitation any new
formulations, technologies, or other inventions either made,
obtained, or licensed by or on behalf of either of Columbia
or its Affiliates, during the term of this Agreement or made
or obtained by Ardana during the term of this Agreement
provided that in the case of Ardana all such improvements,
enhancements, or modifications were so made and obtained
utilising or derived from the Columbia Technology and such
improvements, enhancements, or modifications shall not
include any of the same independently developed by or on
behalf of Ardana without access to the Columbia Technology.
For the avoidance of doubt, at the request of Columbia,
Ardana shall establish by clear and convincing evidence that
any improvements, enhancements, or modifications to be
excluded from Improvements were made or obtained by or on
behalf of Ardana independently without access to the
Columbia Technology. Also for the avoidance of doubt it is
declared and agreed that Improvements:
1.1.48.1 includes, without limitation, the results of any
and all Formulation Work; and
1.1.48.2 excludes:
(a) all pre-clinical and clinical data generated
after the Commencement Date and during the
Term of this Agreement to the extent it
relates to the use of terbutaline with such
Columbia Technology; and
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(b) all discoveries unrelated to the subject
matters of the Columbia Technology, such as,
for example, a new indication for terbutaline
that is independent of the delivery
formulation or mechanism.
1.1.49 "Insolvency Event" shall mean, in relation to either Party,
any one of the following:
(a) a notice shall have been issued to convene a meeting
for the purpose of passing a resolution to wind up that
Party or such resolution shall have been passed other
than a resolution for the solvent reconstruction or
reorganisation of that Party or for the purpose of
inclusion of any part of the share capital of that
Party in the Official List of the London Stock Exchange
or in the list of the American Stock Exchange or
quotation of the same on the National Association of
Securities Dealers Automated Quotation System or any
other international stock exchange or an application by
that Party for registration as a public company in
accordance with the requirements of the Companies Act
1985; or
(b) a resolution shall have been passed by that Party's
directors to seek a winding up or an administration
order or a petition for a winding up or administration
order shall have been presented against that Party
which, in the case of a petition presented against a
Party, shall not have been appealed within 7 days of
having been lodged or such an order shall have been
made and shall have been dismissed within thirty (30)
days thereafter; or
(c) a receiver, administrative receiver, receiver and
manager, interim receiver, custodian, sequestrator or
similar officer is appointed in respect of that Party
or over a substantial part of its assets or any third
party takes steps to appoint such an officer in respect
of that Party or an encumbrancer takes steps to enforce
and enforces its security which shall not have been
dismissed by a court of competent jurisdiction within
thirty (30) days thereafter; or
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(d) a proposal for a voluntary arrangement shall have been
made in relation to that Party under Part I Insolvency
Act 1986; or
(e) a step or event shall have been taken or arisen outside
the United Kingdom which is similar or analogous to any
of the steps or events listed at (a) to (d) above in
the case of Bermuda under the laws of Bermuda and in
the case of COB under the laws of USA but for avoidance
of doubt including in the case of COB filing of a
petition under the US Bankruptcy Code including a
filing under Chapter 11 proceedings, which, in the case
of a filing made against a Party, shall not have been
appealed within 7 days of having been lodged or such an
order shall have been made and dismissed within thirty
(30) days thereafter; or
(f) that Party takes any step (including starting
negotiations) with a view to readjustment, rescheduling
or deferral of any part of that Party's indebtedness,
or proposes or makes any general assignment,
composition or arrangements with or for the benefit of
all or some of that Party's creditors or makes or
suspends or threatens to suspend making payments to all
or some of that Party's creditors or the Party submits
to any type of voluntary arrangement; or
(g) where that Party is resident in the United Kingdom it
is deemed to be unable to pay its debts within the
meaning of Section 123 Insolvency Act 1986.
1.1.50 "Joint Program IP" -Joint Program Patent Rights and any
other intellectual property or other rights relating to or
comprised in Joint Program Know How, including without
limitation all Patent Rights, trade secrets, technology,
disclosures, inventions, discoveries, and other information,
whether patentable or not, which for the avoidance of doubt
excludes any Columbia IP or any rights to Columbia
Technology.
1.1.51 "Joint Program Know How" - Know How conceived, generated or
developed by or on behalf of either Party during the
performance of the
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Development Program including in particular any Know How
comprising or relating to the CTD but which for the
avoidance of doubt excludes any Know How relating to the
Columbia Technology.
1.1.52 "Joint Program Patent Rights" - any Patent Rights claiming
or covering or otherwise based on inventions forming part of
Joint Program Know How, but which for the avoidance of doubt
excludes any Columbia Patent Rights.
1.1.53 "Know How" - technical and other information which is not in
the public domain, including information comprising or
relating to concepts, discoveries, data, designs, formulae,
ideas, inventions, methods, models, assays, research plans,
procedures, designs for experiments and tests and results of
experimentation and testing (including results of research
or development), processes (including manufacturing
processes, specifications and techniques), laboratory
records, chemical, pharmacological, toxicological, clinical,
analytical and quality control data, trial data, case report
forms, data analyses, reports, manufacturing data or
summaries and information contained in submissions to and
information from ethical committees and regulatory
authorities. Know How includes Documents containing Know
How. The fact that an item is known to the public shall not
be taken to preclude the possibility that a compilation
including the item, and/or a development relating to the
item, is not known to the public.
1.1.54 "Label", "Labelled" or "Labelling" shall mean all labels and
other written, printed or graphic matter upon (i) the
Product or any container or wrapper utilized with the
Product, or (ii) any written material accompanying the
Product, including, without limitation, package inserts and
patient information leaflet.
1.1.55 "Marketing Authorisation or MA" - the Regulatory Approval
required from a Governmental Authority in any country to
market and sell Product in such country, but not any form of
pricing or reimbursement approval.
1.1.56 "Net Revenues" - shall mean in the case where pursuant to
Clause 4.5 or 5.8 a Third Party is licensed to develop, use,
import, have imported, market,
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distribute and sell or have marketed, distributed or sold
Product on a worldwide basis or in the case where pursuant
to Clause 8 it has been decided to appoint a ROW Partner to
develop, use, import, have imported, market, distribute and
sell or have marketed, distributed or sold the Product in
any territory of ROW Net Revenues shall mean all sums
received by either Party in respect of such licence whether
signature fees, up-front payments, milestone payments,
royalty payments or any other payments whatsoever except for
Fully Burdened Manufacturing Costs paid to Columbia if
Columbia manufacture Product for such Third Party licensee
which shall be separately paid to Columbia.
1.1.57 "Net Sales" with respect to Finished Product shall mean the
gross amount received by a Party, its Affiliates or
sub-licensees for sale of Finished Product to unrelated
third parties less:
(a) quantity, trade and/or cash discounts actually granted;
(b) amounts repaid or credited and allowances including
cash, credit or free goods allowances, given by reason
of charge backs, retroactive price reductions or
billing errors and rebates (including
government-mandated rebates), actually allowed or paid;
(c) amounts refunded or credited for Finished Product which
was rejected, spoiled, damaged, outdated or returned;
(d) freight, shipment and insurance costs incurred
transporting Finished Product to a third party
purchaser;
(e) taxes, tariffs, customs duties and surcharges and other
governmental charges incurred in connection with the
sale, exportation or importation of Finished Product.
Subject to the foregoing provisions if there are any other
issues surrounding the calculation of Net Sales these shall
to the extent possible be determined in accordance with GAAP
or its successor in the UK in the case of Ardana and in the
US in the case of Columbia.
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The transfer of Finished Product by a Party or one of its
Affiliates to another Affiliate or sub-licensee shall not be
considered a sale. In such cases Net Sales shall be
determined based on the invoiced sale price by the Affiliate
or sub-licensee to the first third party trade purchasers,
less the deduction allowed under this Clause.
Upon the sale or other disposal of Finished Product other
than in a bona fide arms length transaction exclusively for
money or upon any use of Finished Product for the purposes
which do not result in a disposal of that Finished Product
in consideration of sales revenue customary in the country
of sale (including, without limitation, the sale of the
Finished Product as a "loss leader" or in conjunction with
the sale of another product in the transaction commonly
known as "bundling"), such sale, other disposal or use shall
be deemed to constitute a sale at the relevant open market
price in that country in which the sale, other disposal or
use occurs, or, if that price is not ascertainable, a
reasonable price assessed on an arm's length basis or the
goods or services provided in exchange of the supply.
Disposal of Finished Product for, or use of Finished
Product, in clinical or pre-clinical trials or as free
samples to be in quantities common in the industry for this
sort of Product shall not give rise to any deemed sale under
this Clause.
1.1.58 "North America" shall mean Antigua and Barbuda, The Bahamas,
Barbados, Belize, Bermuda, Canada, Costa Rica, Cuba,
Dominica, Domican Republic, El Salvador, Greenland, Grenada,
Guatemala, Haiti, Honduras, Jamaica, Mexico, Nicaragua,
Panama, Saint Kitts and Nevis, Saint Lucia, Saint Vincent
and the Grenadines, Trinidad and Tobago, and the USA.
1.1.59 "Parties" shall mean Columbia and Ardana and "Party" shall
mean either Columbia or Ardana, however in either instance
Columbia shall include, as appropriate in context, COB with
regard to US activities, rights, and obligations, and/or
Bermuda with regard to activities, rights, and obligations
outside the US.
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1.1.60 "Package", "Packaged" and "Packaging" shall mean all primary
and secondary packaging components, including, without
limitation, cartons, partitions, shippers, or any other like
matter used in packaging the Product.
1.1.61 "Patent Rights" shall mean patent applications and patents,
author certificates, inventor certificates, utility
certificates, improvement patents and models and
certificates of addition and all foreign counterparts of
them, including any divisional applications and patents,
refilings, renewals, continuations, continuations-in-part,
patents of addition, extensions (including patent term
extensions), reissues, substitutions, confirmations,
registrations, revalidations, pipeline and administrative
protections and additions, and any equivalents of the
foregoing, as well as any supplementary protection
certificates and equivalent protection rights in respect of
any of them.
1.1.62 "Phase I Clinical Trial" - shall mean a small scale human
clinical trial normally conducted in healthy volunteers or
patients with the aim of establishing the pharmacokinetic,
pharmacodynamic and early safety profile.
1.1.63 "Phase II Clinical Trial" - shall mean a human clinical
trial where a product is tested in a number of patients for
the purpose of establishing further safety data, dose
ranging and/or preliminary data on the efficacy of product.
1.1.64 "Phase III Clinical Trial" - shall mean a human clinical
trial conducted in a sufficient number of patients to
establish safety and efficacy for the particular indication
tested and required for the filing to obtain Marketing
Authorisation.
1.1.65 "Point of Proof of Principle" - completion of Phase II
Clinical Trials for Candidate Product as evidenced by the
provision by Ardana to Columbia of first a Formal
Presentation followed by the final formal written report of
the results of the Phase II Clinical Trials containing the
final assessment of the results properly quality assured.
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1.1.66 "Product" - a finished pharmaceutical product comprising the
Candidate Product in relation to which Marketing
Authorisation and pricing approval has been granted by the
appropriate Governmental Authority for any country for at
least one indication. For the avoidance of doubt it is
declared and agreed that if the product can be marketed and
sold without pricing approval nothing in this definition
requires pricing approval for it to be classified as Product
for the purposes of this Agreement.
1.1.67 "QA Tests" - the quality assurance tests and testing regimes
for CTM to be agreed by the DC.
1.1.68 "Qualified Person" means a person qualified in accordance
with Article 49 or 50 of EU Directive 2001/83, who is
responsible under Applicable Law in all or any part of the
Territory for ensuring compliance with such Applicable Law
and for carrying out certain specified actions required by
such Applicable Law.
1.1.69 "Quarter" shall mean each period of three months ending on
31 March, 30 June, 30 September or 31 December and
"Quarterly" shall be construed accordingly.
1.1.70 "Regulatory Application" shall mean a regulatory application
or other application (including any supplements or
amendments thereto) required to be filed or filed with a
Governmental Authority in a country in connection with the
marketing and sale of the Finished Product in such country.
1.1.71 "Regulatory Approval" shall mean any and all consents or
other authorisations or approvals required from a
Governmental Authority to market and sell Finished Product
in any country, but excluding any form of pricing or
reimbursement approval.
1.1.72 "Responsible Party" - shall mean the Party with
responsibility for a particular task or tasks in relation to
the filing, prosecution, maintenance, enforcement or defence
of any Joint Program Patent Rights or the Party responsible
for the development and Commercialisation of Candidate
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Product or resultant Product in a country or countries in
ROW as the case may be.
1.1.73 "Rest of the World" or "ROW" - all countries of the world
excluding the Ardana Territory and the Columbia Territory.
1.1.74 "ROW Partner" - any Third Party entity with whom either or
both of the Parties contract either to be an agent or
distributor of the Product in any territory of ROW or to be
a licensee in any such territory of ROW.
1.1.75 "ROW Partner IP" - Know How and Patent Rights conceived,
generated or otherwise developed, owned, or licensed by any
ROW Partner and not included in Columbia IP.
1.1.76 "Second Development Program" - the program of work to follow
the First Development Program in the event of an Ardana
Positive Election and a Columbia Positive Election and which
is to be conducted by Ardana and Columbia hereunder for the
clinical development of Candidate Product in the Ardana
Territory (in the case of Ardana) and the Columbia Territory
(in the case of Columbia) being all further development work
which may be required for the purpose of preparing a CTD and
for filing an application for Regulatory Approval with the
FDA and for Marketing Authorisation with the EMEA, an
outline for which is attached in Exhibit C hereto and the
detail of which and the Development Budget for each year of
which shall be determined by the Development Committee (in
the case of the Development Budget subject to the provisions
of Clause 2.2.3).
1.1.77 "SmPC" shall mean the summary of product characteristics
containing the information set out in Article 11 of EU
Directive 2001/83.
1.1.78 "Solely Owned IP" - Solely Owned Patent Rights and any other
intellectual property or other rights relating to or
comprised in Solely Owned Know How, including without
limitation all Patent Rights, trade secrets, technology,
disclosures, inventions, discoveries, and other information,
whether patentable or not, but which for the avoidance of
doubt excludes
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any Columbia IP, any rights to Columbia Technology, and any
Joint Program IP.
1.1.79 "Solely Owned Know How" - Know How conceived, generated or
developed by or on behalf of only one of the Parties during
the period when it is proceeding to develop the Product
alone under the provisions of Clauses 4.3, 4.4, 5.4.1,
18.4.1 or 18.5.1 including in particular any Know How
comprising or relating to the CTD, but which for the
avoidance of doubt excludes any Know How relating to the
Columbia Technology and any Joint Program Know How.
1.1.80 "Solely Owned Patent Rights" - any Patent Rights claiming or
covering or otherwise based on inventions forming part of
Solely Owned Know How, but which for the avoidance of doubt
excludes any Columbia Patent Rights and any Joint Program
Patent Rights.
1.1.81 "Specification" - the specification for CTM to be agreed by
the DC.
1.1.82 "Territory" shall mean the Ardana Territory or the Columbia
Territory as appropriate.
1.1.83 "Trade Dress" means those aspects of the Packaging of the
Finished Product involving the design, get up and trade
dress thereof which are not required or dictated by the
Regulatory Approval or Marketing Authorisation including the
style of printing.
1.1.84 "Trade Marks" - registered and unregistered trade or service
marks, and applications for registration of such marks,
including trade dress in each case with any and all
associated goodwill and all rights or forms of protection of
a similar or analogous nature including rights which protect
goodwill whether arising or granted under the law of any
jurisdiction.
1.1.85 "Year" - twelve (12) months commencing on 1 January and
ending on 31 December.
1.2 In this Agreement:
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1.2.1 Unless the context otherwise requires all references to a
particular Clause, Schedule or paragraph shall be a
reference to that Clause, Schedule or paragraph, in or to
this Agreement as it may be amended from time to time
pursuant to this Agreement;
1.2.2 The table of contents and headings are inserted for
convenience only and shall be ignored in construing this
Agreement;
1.2.3 Unless the contrary intention appears words importing the
masculine gender shall include the feminine and vice versa
and words in the singular include the plural and vice versa;
1.2.4 Unless the contrary intention appears words denoting persons
shall include any individual, partnership, company,
corporation, joint venture, trust, association (incorporated
or incorporated), organisation or other entity, in each case
whether or not having legal personality;
1.2.5 Reference to any statute, directive or regulation includes
any modification or re-enactment of that statute or
regulation; and
1.2.6 Reference to the word "include" or "including" are to be
construed without limitation to the generality of the
preceding words.
2. DEVELOPMENT COMMITTEE
2.1 With effect from the Commencement Date the Parties shall establish and
run a Development Committee ("DC") as follows:
2.1.1 the DC shall comprise two (2) persons as voting members
("Members") and Ardana and Columbia respectively shall be
entitled to appoint one (1) Member and to replace the Member
appointed by it. The initial Members shall be appointed by
each Party prior to the first DC meeting. Ardana and
Columbia respectively shall each notify the other of any
change in the identities of their Member from time to time.
Both sides shall use reasonable endeavours to keep an
appropriate level of continuity in representation. Members
may be represented at any meeting by another person
designated
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by the absent Member. Meetings of the DC shall be co-chaired
by the two Members and such co-chairpersons shall only be
entitled to exercise one (1) vote each as Members at the DC
and shall not have any right to a veto or casting vote;
2.1.2 the quorum for meetings of the DC shall be the two (2)
Members. Conclusions and decisions of the DC shall be made
by unanimous agreement of the Members present wherever
possible and shall be minuted by or upon behalf of the
Chairpersons. Both Parties will use their reasonable efforts
to build consensus. If the DC does not reach unanimous
agreement regarding any matter such matter shall be referred
for resolution to the Chief Executive Officer of each Party;
2.1.3 the venue for meetings not held by teleconference shall
alternate between the offices of Ardana in Edinburgh,
Scotland and the offices of COB in Livingston, New Jersey or
such other venue as may be agreed. Each Party shall be
responsible for its own expenses including travel and
accommodation costs incurred in connection with DC meetings;
2.1.4 notwithstanding that each Party shall have only one Member
of the DC the Parties acknowledge that other individuals may
attend from either Party which additional attendees may
change according to the subject matter of DC meeting. Each
Party shall give the other reasonable advance notice of the
identity of any such additional attendees which it intends
to participate in the DC meeting in question. For the
avoidance of doubt it is agreed that such persons shall not
be Members and shall not have a right to vote or participate
in the decision making process of the DC; and
2.1.5 the DC Members shall take alternate responsibility for
promptly preparing the minutes of any DC meeting, receiving
approval of those minutes from the other DC Member who
participated in the meeting, signing and dating the approved
minutes and promptly distributing a copy of the signed
minutes to each Party. It is only such signed and dated
minutes which shall constitute a decision of the DC.
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2.2 The DC will be the key management decision making and liaison body in
control of the Development Program and:
2.2.1 shall hold meetings in person or by teleconference as
frequently as the members of the DC may agree shall be
necessary during the term of this Agreement or more
frequently upon the reasonable request of either Party, but
in any event no less frequently than once a Quarter. Dates
of meetings requested by the DC to be held in person shall
be agreed by the Parties not less than thirty (30) days
beforehand; responsibility for arranging the meetings,
including, at least, providing notice and an agenda, shall
alternate between the Parties; the first meeting will take
place as soon as practicable after the Commencement Date,
but in no event later than twenty (20) Business Days after
the Commencement Date and will be organised by Ardana;
2.2.2 to the extent that any details of the work to be conducted
under the First Development Program and the Second
Development Program have not been agreed by the Parties and
set out in the Development Program at the Commencement Date
the DC shall as necessary from time to time agree such
details (subject to the provisions of Clause 5.1) including
the indications to be pursued and the design of all Clinical
Trials and the timescales therefor;
2.2.3 shall agree the Development Budget for each Year of the
Second Development Program which Development Budget shall
require ratification by the Chief Executive Officer of each
Party;
2.2.4 shall agree the number of FTEs to be engaged by each Party
(for the avoidance of doubt FTEs in this context means
employees of a Party and not employees of a third party) on
the Development Program at such Party's cost and expense
which FTE commitment shall require ratification by the Chief
Executive Officer of each Party;
2.2.5 if the DC whether on its own initiative or whether as a
result of a decision of the Co-ordination Committee requests
modification or changes to the
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Development Program which would result in the total
Development Costs for any Year exceeding the Development
Budget for that Year then such modifications or changes
shall not be implemented by the DC (notwithstanding the
agreement of the DC Members) unless and until a
corresponding increase to the Development Budget is ratified
by the Chief Executive Officer of each Party;
2.2.6 shall prioritise all work programs being conducted pursuant
to the Development Program;
2.2.7 shall develop a global clinical development and regulatory
strategy for the Product;
2.2.8 shall determine when all regulatory filings should be made
for Regulatory Approval and Marketing Authorisation;
2.2.9 shall establish a mechanism for the representation of each
Party at all meetings or calls with Governmental Authorities
attended or made by Ardana or Columbia in relation to the
Candidate Product provided always that such attendees shall
have observer status only in meetings in the other Party's
territory;
2.2.10 shall establish a mechanism for the co-ordination of the
registration and mutual exchange of regulatory dossiers,
summaries and expert reports for Regulatory Approval and
Marketing Authorisation with the respective Governmental
Authorities;
2.2.11 shall review the Members' Quarterly progress reports
provided pursuant to Clause and monitor the progress of the
Development Program by the Parties, their Affiliates, agents
and/or their sub-contractors;
2.2.12 shall provide a Quarterly report to the respective
management of each Party detailing the progress of the
Development Program;
2.2.13 shall determine in conjunction with the Party's patent
attorneys when patent application filings for Joint Program
Patent Rights should be made which
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decision shall require ratification by the Chief Executive
Officer of each Party;
2.2.14 shall agree the Specifications for CTM and the QA Tests
therefor;
2.2.15 shall devise the pharmacovigilance procedures to apply
during the Development Program which meets all Legal
Requirements;
2.2.16 shall perform such other functions and responsibilities as
are given to it under the express provisions of this
Agreement or as it shall determine but for the avoidance of
doubt it is declared and agreed that the DC shall have no
authority to amend the terms of this Agreement. For the
avoidance of doubt it is declared and agreed that the DC has
no powers or responsibilities in relation to
Commercialisation nor the appointment of the ROW Partner.
3. THE FIRST DEVELOPMENT PROGRAM
3.1 Ardana shall at its own cost and expense but within the limit set out
in the Development Budget carry out, control and be responsible for
the conduct of all clinical studies up to the Point of Proof of
Principle the subject of the First Development Program as established
by the DC and shall as soon as practicable following completion of the
same provide Columbia with a Formal Presentation and subsequently a
final formal written report of the results of the Phase II Clinical
Trials containing the final assessment of the results properly quality
assured.
3.2 Columbia shall at its own cost and expense but within the limit set
out in the Development Budget carry out, control and be responsible
for the conduct of the Formulation Work as established by the DC and
shall keep Ardana informed in writing of the progress and results of
such Formulation Work.
3.3 During the First Development Program the provisions of Clause 5.3
shall apply in relation to those Development Costs described in
subsection (b) of the definition of Development Costs.
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3.4 The general obligations with regard to the conduct of the Development
Program set out in Clause 6 shall apply in relation to the Parties
conduct of the First Development Program.
3.5 During the period of the First Development Program each Party agrees
that it shall not without the other Party's prior written approval
(not to be unreasonably withheld) seek to develop, distribute or sell
anywhere in the World a 'B'-adrenergic agonist based product that
would compete with the Product.
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4. POINT OF PROOF OF PRINCIPLE ELECTIONS
4.1 Following the Point of Proof of Principle each Party shall have [***]
to decide whether it wishes to continue with the co-development and
Commercialisation of the Candidate Product and resultant Product in
the Ardana Territory or the Columbia Territory as the case may be and
each Party shall give written notice of its decision to the other
Party on such [***] or the day agreed by the Parties, under seal,
following which on the [***] day the Parties shall each break the seal
to reveal the election of the other Party and then the following
provisions of this Clause 4.1 shall apply as follows:
4.1.1 If Ardana or Columbia elects to continue with the
co-development and Commercialisation of Candidate Product
and resultant Product this shall be an Ardana Positive
Election or a Columbia Positive Election, respectively.
4.1.2 If Ardana or Columbia elects not to continue with the
co-development and Commercialisation of Candidate Product
and resultant Product this shall be an Ardana Negative
Election or a Columbia Negative Election, respectively.
4.2 In the event of an Ardana Positive Election and a Columbia Positive
Election the Parties shall proceed with the co-development and
Commercialisation of the Candidate Product and the resultant Product
pursuant to the terms of this Agreement on the following terms:
4.2.1 Ardana shall on the terms of Clauses 13.4 and the other
terms of this Agreement have the exclusive right to
Commercialise Candidate Product and resultant Product in the
Ardana Territory;
4.2.2 Columbia shall on the terms of Clause 13.2 and the other
terms of this Agreement have the exclusive right to
Commercialise Candidate Product and resultant Product in the
Columbia Territory;
4.2.3 the DC shall produce the detailed Second Development Program
and each Party shall carry out, control and be responsible
for their respective tasks under the Second Development
Program under the direction of the DC on the terms of Clause
5; and
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4.2.4 the Parties shall agree the approach to be taken for the
development and commercialisation of Candidate Product and
resultant Product in the ROW Territory pursuant to Clause 8.
4.3 In the event of an Ardana Positive Election and a Columbia Negative
Election, Columbia shall have [***] to elect to change its position to
a Positive Election, in which case Clause 4.2 shall apply. However, if
Columbia maintains its Negative Election, the DC shall be disbanded
and the Commercialisation Committee shall not be formed, Ardana shall
on the terms of Clause 13.6 have the exclusive fully paid up royalty
free right to continue with the worldwide development and
commercialisation of Candidate Product and resultant Product either
alone or in conjunction with a Third Party without further obligations
to Columbia. In such circumstances the provisions of Clause 14.1,
14.3, 14.4, 14.6, and 14.7 shall continue to apply and shall be deemed
expanded in scope to place similar obligations on Columbia in relation
to non-European Columbia IP as requested by Ardana, but shall be at
Ardana's sole reasonable expense: (1) for any additional filings
requested by Ardana with regard to any Columbia IP over and above
those filings which exist as of the Commencement Date, and (2) for any
filings of Columbia IP regarding Columbia Technology developed after
the Commencement Date requested by Ardana in countries other than
those listed in Exhibit E. So long as Columbia's election remains a
Negative Election, Ardana shall assume sole responsibility for the
prosecution, maintenance, defence and enforcement of Joint Program IP
at its own cost and expense, providing Columbia with at least 60 days
advance notice, with copies, of all proposed filings and proposed
correspondence, and prompt copies of all actual filings and
correspondence. Columbia shall retain joint ownership in the Joint
Program IP with rights to use or exploit the Joint Program IP other
than with regard to the Candidate Product and resultant Product (in
either case with any indication). If Ardana does not significantly
continue and forward the development and commercialization of the
Candidate Product and resulting Product consistent with Good Industry
Practice in [***], all of Ardana's exclusive rights to the Joint
Program IP regarding the Candidate Product and resultant Product shall
become non-exclusive as to Columbia.
4.4 In the event of a Columbia Positive Election and an Ardana Negative
Election, Ardana shall have [***] to elect to change its position to a
Positive Election, in which
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case Clause 4.2 shall apply. However, if Ardana maintains its Negative
Election, the DC shall be disbanded and the Commercialisation
Committee shall not be formed, Ardana shall lose all rights under, and
shall not use or exploit in any way the Columbia IP, and Columbia
shall on the terms of Clause 13.7 have the exclusive fully paid up
royalty free right to continue with the worldwide development and
commercialisation of Candidate Product and resultant Product either
alone or in conjunction with a Third Party without further obligation
to Ardana. In such circumstances the provisions of Clauses 14.3, 14.6
and 14.7 shall continue to apply. So long as Ardana's election remains
a Negative Election, Columbia shall assume sole responsibility for the
prosecution, maintenance, defence and enforcement of Joint Program IP
at its own cost and expense, providing Ardana with at least 60 days
advance notice, with copies, of all proposed filings and proposed
correspondence, and prompt copies of all actual filings and
correspondence. Ardana shall retain joint ownership in the Joint
Program IP with rights to use or exploit the Joint Program IP other
than with regard to the Candidate Product and resultant Product (in
either case with any indication). If Columbia does not significantly
continue and forward the worldwide development and commercialization
of the Candidate Product and resulting Product consistent with Good
Industry Practice in [***], all of Columbia's exclusive rights to the
Joint Program IP regarding the Candidate Product and resultant Product
shall become non-exclusive as to Ardana.
4.5 In the event of an Ardana Negative Election and a Columbia Negative
Election, the DC shall be disbanded and the Commercialisation
Committee shall not be formed. Ardana shall not use or exploit in any
way whatsoever the Columbia IP, and neither Party shall use or exploit
in any way whatsoever the Joint Program IP in relation to the
Candidate Product or resultant Product for any indication, without the
other Party's prior written consent. Each of the Parties shall use
their reasonable efforts to find and appoint a Third Party to continue
the worldwide development and commercialisation of the Candidate
Product and resultant Product. The Parties shall agree upon a
co-ordinated approach to this if this eventuality arises. The
appointment of such Third Party shall be on the basis that such Third
Party shall be granted an exclusive worldwide licence under the
Columbia IP and each Party's interest in the Joint Program IP to
develop, use, import, have imported, market, distribute and sell or
have marketed, distributed and sold Candidate Product and resultant
Product for all
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indications. The Net Revenues from any such Third Party appointment
shall be shared equally between the Parties on the terms of Clause 8.
Columbia agrees that it shall either manufacture and supply to such
Third Party its requirements of CTM and Finished Product for [***]
(which shall be paid separately to Columbia by such Third Party as a
term of the licensing agreement with such third party) or shall grant
such Third Party appropriate royalty-bearing licences under the
Columbia IP to permit such Third Party to manufacture or have
manufactured such CTM and Finished Product. The Net Revenues from any
such royalty-bearing licences shall be shared equally between the
Parties on the terms of Clause 8.
5. SECOND DEVELOPMENT PROGRAM
5.1 As soon as practicable following an Ardana Positive Election and a
Columbia Positive Election the Parties shall cause the DC to meet to
agree the detailed work program for the Second Development Program and
the Development Budget for the first Year of the Second Development
Program. The Parties agree that in relation to any Clinical Trials to
be carried out as part of the Second Development Program:
5.1.1 Ardana shall be the sole sponsor of and for organising any
such Clinical Trials to be carried out in the Ardana
Territory and for the Development Costs to be paid in
respect thereof (recouping the appropriate share of such
Development Costs under the provisions of Clause 5.3) and
Ardana shall make all Regulatory Applications in respect of
such Clinical Trials or in respect of any subsequent
Marketing Authorisation in the Ardana Territory in its own
name;
5.1.2 Columbia shall be the sole sponsor of and for organising any
such Clinical Trials to be carried out in the Columbia
Territory and for the Development Costs to be paid in
respect thereof (recouping the appropriate share of such
Development Costs under the provisions of Clause 5.3) and
Columbia shall make all Regulatory Applications in respect
of such Clinical Trials or in respect of any subsequent
Regulatory Approval in the Columbia Territory in its own
name.
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5.2 Subject to the provisions of Clause 5.1 each Party shall carry out
those tasks and parts of the work program for the Second Development
Program allocated to it by the DC provided always that neither Party
shall be obliged to commit more FTE to the Second Development Program
in any Year than determined under Clause 2.2.4.
5.3 The Parties shall be jointly responsible on a 50:50 basis for all
Development Costs incurred by them in carrying out the Second
Development Program. Within thirty (30) days of the end of each
Quarter each party shall supply the other with a report of the
Development Costs paid by it during that Quarter which report shall
set out the tasks undertaken (which tasks shall be cross-referenced to
the Second Development Program) and the Development Costs paid in
relation to such task. Within forty-five (45) days of the end of each
Quarter there shall be a reconciliation prepared of the Development
Costs incurred during such Quarter by the Parties which reconciliation
shall be in the form of an invoice from one Party to the other Party
and a balancing payment as necessary by such Party to the other shall
be made so that each Party has borne 50% of the Development Cost for
that Quarter. For the avoidance of doubt it is declared and agreed
that the sharing of Development Costs shall commence from the point
that each Party makes a positive election pursuant to Clause 4 and the
Parties acknowledge and agree that subject to the provisions of Clause
3.3 any costs and expenses incurred prior to that date are not
chargeable to Development Costs.
5.4 If at the time that the DC seeks ratification of the Development
Budget for any Year during the Second Development Program or the FTE
commitment for any Year it is not so ratified by either Party's Chief
Executive Officer in writing within 3 months of the commencement of
the Year to which it relates (such Party's reasonable request for
changes to the Second Development Program and consequential changes to
the Development Budget or FTE commitment having been acceded to by the
other Party) this shall be deemed notice of withdrawal from the Second
Development Program by the Party refusing to ratify. Upon any such
notice of withdrawal:
5.4.1 the provisions of Clauses 4.3 and 4.4 shall be deemed to
apply such that the continuing Party shall have the fully
paid up royalty free worldwide right to continue alone with
development, commercialization, marketing, and sale of
Candidate Product and any resulting Product;
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5.4.2 the withdrawing Party shall upon the continuing Party's
written request deliver up to the continuing Party all
Documents containing any Know How (save for a single copy to
be retained for evidential purposes by the withdrawing
Party's lawyers), and any other Know How, held by the
withdrawing Party relating to the Candidate Product and/or
the resultant Product;
5.4.3 the withdrawing Party shall not use or otherwise exploit in
any way, either directly or indirectly the Joint Program IP
as it relates to the Candidate Product or any resulting
Product in either case for all indications;
5.4.4 only the continuing Party shall be free to use and exploit
all Joint Program IP as it relates to the Candidate Product
or any resulting Product in either case for all indications
as it sees fit with no obligation to the withdrawing Party
in respect thereof provided however that both Parties shall
be free to use and exploit all Joint Program IP, except as
it relates to the Candidate Product or any resulting Product
in either case for all indications, as each sees fit with no
obligation to the withdrawing Party in respect thereof;
5.4.5 if the withdrawing Party is Columbia the licences granted by
Columbia to Ardana pursuant to Clause 13.6 shall continue in
full force and effect and shall be extended to the Columbia
Territory and ROW and Columbia shall do all such acts and
things as may be necessary to perfect this obligation and
the provisions of Clauses 14.1, 14.3, 14.4, 14.6, and 14.7
shall continue to apply and shall be deemed expanded in
scope to place similar obligations on Columbia in relation
to non-European Columbia IP owned by Columbia at Ardana's
request and sole reasonable expense. In such circumstances
Ardana shall assume sole responsibility for the prosecution,
maintenance, defence and enforcement of Joint Program IP at
its own cost and expense, under the same terms, obligations,
and consequences, and the same standards for maintaining
exclusive rights, as set forth in Clause 4.3;
5.4.6 if the withdrawing Party is Ardana the licence granted by
Ardana to Columbia pursuant to Clause 13.7 shall continue in
full force and effect and shall be extended to the Ardana
Territory and ROW and Ardana shall do all
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such acts and things as may be necessary to perfect this
obligation and the provisions of Clauses 14.3, 14.6, and
14.7 shall continue to apply. In such circumstances Columbia
shall assume sole responsibility for the prosecution,
maintenance, defence and enforcement of Joint Program IP at
its own cost and expense, under the same terms, obligations,
and consequences, and the same standards for maintaining
exclusive rights, as set forth in Clause 4.4;
5.4.7 if the withdrawing Party is Columbia and it has obligations
to manufacture and supply CTM and Finished Product under the
terms of a Manufacturing and Supply Agreement entered into
pursuant to Clause 9 these shall continue;
5.4.8 the withdrawing Party shall commensurate with legislative
and regulatory requirements, transfer to the continuing
Party or its nominee all Regulatory Approvals, Marketing
Authorisations, Regulatory Applications and other regulatory
filings and approvals for Candidate Product or resultant
Product in all countries of the territory of the withdrawing
Party and any country in the ROW Territory in relation to
which the withdrawing Party has been appointed the
Responsible Party pursuant to Clause 8. In the event that in
any country such a transfer is not possible, the withdrawing
Party shall use reasonable endeavours to ensure that the
continuing Party has the benefit of the relevant Regulatory
Approvals, Marketing Authorisations, Regulatory applications
and other regulatory filings and approvals and, to this end,
consents to any Governmental Authority cross-referencing to
the data and information on file with any Governmental
Authority as may be necessary to facilitate the granting of
second Marketing Authorisations, applications, regulatory
filings and approvals to the continuing Party, and the
withdrawing Party agrees to complete whatever other
procedures are reasonably necessary in relation to the same
to enable the continuing Party (either itself or in
conjunction with a third party) freely to develop and sell
the Product in substitution for the withdrawing Party; and
5.4.9 the withdrawing Party shall use its reasonable endeavours to
assign to the continuing Party the benefit of any agreement
made between the
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withdrawing Party, and a sub- licensee in relation to
Product in ROW or any agreement between the withdrawing
Party and an agent or distributor in any country to which
Clause 8.1 relates.
5.5 In the event that during the course of the Development Program the DC
identifies a strategic, legal, commercial, safety, efficacy,
formulation, scientific or technical reason which means that both
Parties wish to abandon the development of the Candidate Product, then
this Agreement shall terminate by their mutual agreement to do so
(such mutual agreement being said decision of the DC ratified by both
the CEO of Ardana and the CEO of Columbia). Following any such
termination Ardana shall not use or exploit in any way whatsoever the
Columbia IP, and both Parties shall not use or exploit the Joint
Program IP in relation to the Candidate Product or resultant Product
in either case for any indication without the other Party's prior
written consent.
5.6 In the event that the Second Development Program continues to its
satisfactory conclusion and filings for Regulatory Approval are made
in the Columbia Territory and filings for Marketing Authorisation are
made in the Ardana Territory as specified in Clause 5.1 and
subsequently such Regulatory Approvals and/or Marketing Authorisations
are granted:
5.6.1 Columbia shall own and hold the Regulatory Approvals for the
Columbia Territory and thereafter shall be solely
responsible for ensuring that all Applicable Laws and other
regulatory or other obligations arising as a result thereof
or in relation thereto are met.
5.6.2 Ardana shall own and hold the Marketing Authorisations for
the Ardana Territory and thereafter shall be solely
responsible for ensuring that all Applicable Laws and other
regulatory or other obligations arising as a result thereof
or in relation thereto are met.
5.6.3 Columbia shall be solely responsible (as between Columbia
and Ardana) at its own cost and expense for the
Commercialisation of the Product in the Columbia Territory
and shall have the exclusive benefit of all revenues
generated in relation thereto. It is agreed that whilst the
final decision on
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Packaging and Labelling shall be Columbia's, the Packaging
and Labeling will be marked with all relevant patent numbers
in each country of the Territory, as may be required by
local patent law or practice or otherwise permitted under
Applicable Law and the MAs.
5.6.4 Ardana shall be solely responsible (as between Ardana and
Columbia) at its own cost and expense for the
Commercialisation of the Product in the Ardana Territory and
shall have the exclusive benefit of all revenues generated
in relation thereto. It is agreed that whilst the final
decision on Packaging and Labelling shall be Ardana's, the
Packaging and Labeling will be marked with all relevant
patent numbers in each country of the Territory, as may be
required by local patent law or practice or otherwise
permitted under Applicable Law and the MAs.
5.6.5 As and when any variation to any Regulatory Approval or
Marketing Authorisation is made each Party shall supply a
copy thereof to the other Party.
5.6.6 The Parties shall co-ordinate and liaise with each other in
connection with Commercialisation of the Product in the
Ardana Territory and Columbia Territory respectively and
shall establish a separate committee for this purpose. In
particular but not limiting the foregoing each party shall
supply details of its Commercialisation Know How to the
other. The Commercialisation Committee:
(a) shall be constituted as specified in Clause 2.1.1;
(b) shall be purely a co-ordination, liaison and
communication forum and shall not be a decision making
body (all decisions about Commercialisation being
reserved exclusively to Ardana in respect of the Ardana
Territory and Columbia in respect of the Columbia
Territory);
(c) shall meet as specified in Clauses 2.2.1 and 2.1.3; and
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(d) shall be a channel for communication between the
Parties requesting amendments to this Agreement (if any
such requests are made) so that Commercialisation by
such Party can occur in the most tax efficient manner
for such Party.
5.7 Each Party shall be responsible for acquiring any and all Trade Marks
for Product(s) in their respective territory and shall have sole
responsibility for selection, clearance and registration of said Trade
Marks in such territory provided always that the Parties shall liaise
with each other in relation thereto. The Parties agree that, for Trade
Marks owned jointly by the Parties or owned by one Party and used by
or on behalf of the other Party, the Party using the Mark will ensure
that the manner, form, and quality of all use of such Trade Marks will
be at the approval of at least one Party owner of the Marks, which
approval shall not be unreasonably withheld.
5.8 If at any time following First Commercial Sale by Columbia in the
Columbia Territory or by Ardana in the Ardana Territory either of them
should decide to withdraw the Product from such territory on a
permanent basis for whatever reason they shall give 90 days written
notice of the same to the other Party and this shall be deemed a
notice of withdrawal under Clause 5.4 and if the other Party so wishes
it shall have the exclusive 90 day right to run from the date of
receipt of such written notice and exercisable by notice in writing to
the withdrawing Party to take over such territory on the terms of
Clauses 5.4.1 to 5.4.9 respectively. If the other Party does not
exercise such right by issuing such a notice before the end of such 90
day period the withdrawing party shall be free to solicit interest
from other Third Party licensees in respect of such territory and if
any such Third Party is ultimately appointed the withdrawing Party
shall pay the other Party [***].
5.9 During the period of the Second Development Program neither Party
shall have any right to develop the Candidate Product for any
indication other than those indications determined by the DC.
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6. development obligations
6.1 Each Party shall carry out its part of the Development Program in the
following manner:
6.1.1 with all reasonable due diligence and using reasonable
efforts to ensure that appropriate levels of experience and
expertise and personnel are contributed to conduct the
Development Program in a timely and cost-effective manner;
6.1.2 in accordance with GLP, GCP and cGMP or other Applicable
Laws where so permitted (including obtaining any and all
ethics committee approvals required and utilising
investigator driven studies where appropriate) and during
the Second Development Program in accordance with the
pharmacovigilance procedures established by the DC; and
6.1.3 keeping or causing to be kept detailed written laboratory
notebooks and other records and reports of the progress of
its part of the Development Program in sufficient detail and
in good scientific manner for all purposes including patent
purposes, especially in accordance with practice within the
USA. Such notebooks and other records must properly reflect
all work done on the Development Program and the results
achieved thereunder.
6.2 Each Party shall have the right to sub-contract the whole of or part
of its part of the Development Program provided always that the
appointment of any sub-contractor shall be on the following terms:
6.2.1 the Party in question shall be responsible for all acts and
omissions of the sub-contractor as if performed by the
Party;
6.2.2 the Party in question shall pay the sub-contractor for work
carried out by the subcontractor (and for the avoidance of
doubt such payment shall form part of the Development
Costs);
6.2.3 that as between the Party and the sub-contractor, all
results emerging from such work and any related intellectual
property shall vest in such Party; and
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6.2.4 that the sub-contractor shall be obligated in terms the same
as Clause 16 (Confidentiality) of this Agreement.
7. OBLIGATIONS OF THE PARTIES
7.1 Upon and subject to the terms and conditions of this Agreement and
only in the circumstances of a Columbia Positive Election and an
Ardana Positive Election, each Party hereby agrees:
7.1.1 at its sole cost and expense, to be responsible for
obtaining all necessary permissions, consents and licences
(other than the MAs), required to Commercialize the Finished
Product in each country in its Territory under any
Applicable Law, including without limitation, any import
approvals, wholesale dealer's licenses and pricing and
reimbursement approvals. Each of the Parties agrees to
reasonably cooperate with the other in obtaining any such
additional necessary authorizations and approvals required
to launch the Finished Product in each country in the such
other Party's Territory;
7.1.2 to provide the other Party with reasonable assistance in
relation to any questions or issues raised by any
Governmental Authority in the other Party's Territory
relating to Finished Product or any application for
Marketing Authorisation;
7.1.3 to establish and maintain at its own cost and expense a
scientific service for scientific information relating to
the Product and to liaise with the other Party in relation
to any enquiries made to such service;
7.1.4 to maintain the MAs received in relation to its Territory,
including by filing variations to such MAs as necessary;
7.1.5 to provide the other Party with reasonable advance notice of
all material meetings or calls with Governmental Authorities
relating to the MAs. A maximum of 2 personnel from the other
Party may attend such meetings or calls at its own cost and
expense;
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7.1.6 the holder of the MA in each Territory to comply with the
content and terms of all MAs and any Applicable Law;
7.1.7 use its reasonable commercial efforts to promote, market and
sell the Finished Product, in each country within its
Territory launching the same in such country [***] of both
Marketing Authorisation and any relevant pricing and/or
reimbursements approvals being obtained in such country
(provided that it is acknowledged that the decision to
launch prior to such approvals shall be in the Party's sole
discretion) and use its reasonable commercial efforts to
obtain any relevant pricing approvals in the countries where
such approval is required;
7.1.8 to keep the Commercialization Committee informed of the
Commercialization of the Finished Product in the Territory
(including but not limited to sales of the Finished Product)
by way of a monthly written report detailing the level of
sales made during the previous month (as reasonably
available to the Party at the time of compiling such report)
and summarising any material developments relating to
Product during the previous month (for example obtaining
pricing and/or reimbursement approval in a particular
country in the Territory). Such report shall be submitted
within thirty (30) days of the end of each calendar month.
Each Party shall also promptly inform the Commercialization
Committee of any other information that it now has or which
it may receive in the future which in its opinion is likely
to be of interest, benefit, or use to the other Party in
relation to the sale of the Finished Products;
7.1.9 to investigate promptly all significant customer complaints
or reports of incidents relating to the Finished Product
affecting quality of which it has knowledge and co-operate
in the handling of such complaints and in accordance with
Clause 10.1;
7.1.10 to keep the other Party informed in a timely manner of any
information brought to its attention which in its reasonable
judgment could lead to a variation of the MA, SmPC,
Packaging or Labelling (subject to any
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overriding provisions of the pharmacovigilance procedures
agreed pursuant to Clause 2.2.15);
7.1.11 retain and archive all documentation relating to the
Product, including, in particular, documentation relating to
regulatory matters and to clinical trials of Product;
7.1.12 each Party shall be responsible for setting the sales price
of Finished Product in its Territory;
7.1.13 each Party shall during the Term of this Agreement fulfil
all of its obligations and covenants hereunder in a manner
that is consistent with Good Industry Practice;
7.1.14 a Party shall not:
7.1.14.1 advertise the Finished Product or canvass or
solicit orders for the Finished Product outside
its Territory; or
7.1.14.2 open branches for the sale of the Finished Product
outside its Territory; or
7.1.14.3 maintain distribution depots for the Finished
Product outside its Territory.
7.1.15 it shall not during the term of this Agreement without the
other Party's prior written approval (not to be unreasonably
withheld) seek to develop, distribute or sell anywhere in
the World outside its own Territory a 'B'-adrenergic
agonist based product that would compete with the Product.
7.2 Ardana affirms that it is familiar with the Foreign Corrupt Practices
Act of 1977 of the United States of America, as amended by the Foreign
Corrupt Practices Act Amendments of 1988 and as may be further amended
and supplemented from time to time ("FCPA"). Ardana warrants,
covenants, represents and agrees that, in connection with the
performance of this Agreement or with the sale of any Product, neither
Ardana nor any of its principals, employees or agents will perform any
act that may constitute a violation of the FCPA or that may cause a
violation under the FCPA by Ardana or Columbia. Ardana shall certify
the accuracy and veracity of the
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foregoing representation and warranty from time to time in writing, as
Columbia shall request.
8. REST OF THE WORLD TERRITORY
8.1 The Parties agree that no action shall be taken in relation to the
development and/or Commercialisation of Candidate Product or resultant
Product in ROW until after the Point of Proof of Principle and an
Ardana Positive Election and a Columbia Positive Election. For [***]
following the expiry of the [***] period to which Clause 4.1 provides
each Party shall have the right to bid by giving written advice to the
other for any country of ROW to be added to its Territory. In the
event of such a bid the Parties shall seek to negotiate and agree the
commercial and financial terms therefor within [***] following the
expiry of the second [***] period and assuming that such agreement is
reached the country or countries in question shall be added to the
relevant Territory on the basis of such agreed terms.
8.2 Either following such bidding and agreement procedure or following the
expiry of the ninety (90) day period to which Clause 4.1 refers in the
event that neither Party invokes the bidding procedure, as the case
may be, the Parties shall consult with each other and shall agree upon
and nominate one of the Parties as Responsible Party to seek a
licensee to develop, use, import, have imported, market, distribute
and sell or have marketed, distributed and sold Candidate Product and
resultant Product in all remaining territories of ROW.
8.3 Such Responsible Party shall use its reasonable endeavours to find an
appropriate Third Party and structure, negotiate and reach agreement
with such ROW Partner on the basis that:
8.3.1 each Party shall grant to the ROW Partner the necessary
licences under the Columbia IP and Joint Program IP which
the ROW Partner will require to develop and Commercialise
Candidate Product and resultant Product in the ROW Territory
(or part thereof);
8.3.2 the ROW Partner agrees to make available to Ardana and
Columbia all ROW Partner IP (especially Know How being
clinical data);
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8.3.3 the ROW Partner agrees to appropriate provisions envisioned
in Clause 8.4 relating to a Co-ordination Committee;
8.3.4 the ROW Partner shall be responsible for all
Commercialisation Costs in relation to ROW;
8.3.5 Columbia either itself or through a Third Party manufacturer
shall arrange for the manufacture of CTM and/or Finished
Product for the ROW Partner and shall supply to the ROW
Partner its requirements for such CTM and/or Finished
Product at a price equal to [***];
8.3.6 Ardana and Columbia share [***].
Notwithstanding that the Responsible Party seeks such ROW Partner and
negotiates such agreement both Parties shall enter into the agreement
appointing such ROW Partner.
8.4 Ardana and Columbia agree that in relation to the development and
Commercialisation of the Candidate Product in the Columbia Territory
and territories added under Clause 8.1 by Columbia, in the Ardana
Territory and territories added under Clause 8.1 by Ardana and in ROW
by the ROW Partner(s) co-ordination of their activities and sharing of
clinical data will be of paramount importance. As part of the
appointment of a ROW Partner (with appropriate terms being included in
the licensing agreement entered into with such ROW Partner) the
Parties shall cause to be established a Co-ordination Committee. The
Co-ordination Committee shall be a means of the Parties managing the
activities of the ROW Partner and linking these activities into the
global clinical development and regulatory strategy established by the
DC.
9. MANUFACTURE
9.1 Until the Point of Proof of Principle all quantities of CTM required
by Ardana shall be supplied by Columbia free of charge. In the event
of an Ardana Positive Election and a Columbia Positive Election, or an
Ardana Positive Election and a Columbia Negative Election, all
quantities of CTM required by DC or Ardana for Clinical Trials shall
be supplied by Columbia on the financial terms of Clause 9.3 or Clause
9.4,
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respectively until a full Manufacturing and Supply Agreement between
the Parties as contemplated in Clause 9.3 and 9.4 is executed.
Columbia shall manufacture such CTM to Specification and shall carry
out the QA Tests. The CTM shall be supplied to ARDANA Ex Works a site
in the European Union (Ex Works as defined in INCOTERMS 2000). Upon
taking delivery of each shipment of CTM Ardana may also carry out any
relevant parts of the QA Tests and any CTM found by Ardana not to meet
Specification shall upon reasonable evidence being furnished to
Columbia by Ardana shall be replaced as soon as reasonably practicable
by Columbia free of charge.
9.2 DC shall provide Columbia with a written forecast of DC's requirements
of CTM until the Point of Proof of Principle promptly following the
Commencement Date which forecast shall be reviewed and updated by DC
Quarterly.
9.3 In the event of an Ardana Positive Election and a Columbia Positive
Election Columbia within 60 days thereafter shall give written notice,
together with a draft Manufacturing and Supply Agreement, to Ardana
that Columbia or one of its Affiliates will manufacture and supply, or
arrange for the manufacture and supply of, all quantities of CTM
required by DC for Clinical Trials and will manufacture and supply all
quantities of Finished Product required by Ardana for sale for [***]
(or such additional time as required to qualify a second manufacturer
in accordance with Good Industry Practice) after First Commercial Sale
the financial terms of which Manufacturing and Supply Agreement shall
be that the supply shall be made at a price equal to [***] therefor on
terms of delivery Ex Works (INCOTERMS 2000) a site in European Union
(such price to be an element of Development Cost during the period of
the Second Development Program).
9.4 In the event of an Ardana Positive Election and a Columbia Negative
Election Columbia shall within 60 days thereafter give written notice,
together with a draft Manufacturing and Supply Agreement, to Ardana
that Columbia or one of its Affiliates will themselves manufacture and
supply all quantities of CTM required by Ardana for Clinical Trials at
a price equal to [***] therefor on terms of delivery Ex Works
(INCOTERMS 2000) a site in European Union and will manufacture and
supply, or arrange for the manufacture and supply of, all quantities
of Finished
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Product required by Ardana for sale for [***] (or such additional time
as required to qualify a second manufacturer in accordance with Good
Industry Practice) after First Commercial Sale the financial terms of
which Manufacturing and Supply Agreement shall be that the supply
shall be made at a price equal to [***] therefor on terms of delivery
Ex Works (INCOTERMS 2000) a site in European Union (such price to be
an element of Development Cost during the period of the Second
Development Program).
9.4 In the event of an Ardana Positive Election and a Columbia Negative
Election Columbia shall within 60 days thereafter give written notice,
together with a draft Manufacturing and Supply Agreement, to Ardana
that Columbia or one of its Affiliates will themselves manufacture and
supply all quantities of CTM required by Ardana for Clinical Trials at
a price equal to [***] therefor on terms of delivery Ex Works
(INCOTERMS 2000) a site in European Union and will manufacture and
supply, or arrange for the manufacture and supply of, all quantities
of Finished
Product required by Ardana for sale for [***] (or such additional time
as required to qualify a second manufacturer in accordance with Good
Industry Practice) after First Commercial Sale the financial terms of
which Manufacturing and Supply Agreement shall be that the supply
shall be made at a price equal to [***] such price to be based on
delivery terms Ex Works (INCOTERMS 2000) a site in the European Union.
9.5 If Columbia gives Ardana notice under Clause 9.3 or 9.4, the Parties
shall negotiate in good faith the terms of a manufacturing and supply
agreement that includes the financial terms set forth in Clause 9.3 or
9.4 ("Manufacturing and Supply Agreement"), respectively using their
commercially reasonable efforts to conclude and execute the same
within 90 days of the date of Columbia's written notice under Clause
9.3 or 9.4 respectively.
9.6 A term of any Manufacturing and Supply Agreement shall be that
Columbia shall use its commercially reasonable efforts to establish or
have established a second manufacturing site for the Finished Product.
10. REGULATORY AND OTHER MATTERS
10.1 In circumstances of a Columbia Positive Election and an Ardana
Positive Election:
10.1.1 each Party agrees to keep the other Party informed,
commencing within two (2) working days of notification of
any action by, or notification or other information which it
receives (directly or indirectly) from any Governmental
Authority, which (a) raises any material concerns regarding
the safety or efficacy of any Product, or (b) which
indicates or suggests a potential material liability for
either Party to third parties arising in connection with any
Product.
10.1.2 each Party agrees to keep the other Party regularly informed
of all material correspondence and communications with any
Governmental Authority in its Territory concerning the
manufacture, Specification, quality, Packaging or labeling
of the Finished Product.
10.2 If either Party is advised by its legal advisers that it must
communicate with any Governmental Authority in its Territory on any
matter the subject of Clause 10.1,
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such Party shall so advise the other Party immediately and, unless
prohibited by Applicable Law, such Party shall provide the other Party
in advance with a copy of any proposed written communication with any
such Governmental Authority and shall comply with any and all
reasonable directions of the other Party concerning any meeting or
written or oral communication with such Governmental Authority.
11. PAYMENTS AND AUDIT PROCEDURES
11.1 In consideration of Columbia entering into this Agreement Ardana shall
make the following payments to Columbia:
11.1.1 $250,000 within thirty days of the Commencement Date;
11.1.2 $250,000 within thirty days of the successful outcome of the
first Clinical Trial for Candidate Product as specified in
the First Development Program.
11.2 Each Party shall keep and shall procure that its Affiliates, agents,
distributors and sublicensees keep true and accurate records and books
of account containing all data necessary for the calculation of the
amounts payable by it to the other Party pursuant to this Agreement,
and in particular but without limitation data relating to the
calculation of Net Revenues and Development Costs. Those records and
books of account shall be kept for seven (7) years following the end
of the Year to which they relate. Upon a Party's (the "Assessing
Party") written request a firm of independent accountants appointed by
approval of the Parties which approval shall not be unreasonably
delayed or withheld, shall carry out an audit procedure in relation to
the other party (the "Assessed Party") and:
11.2.1 such firm of accountants shall be given access to and shall
be permitted to examine and copy such books and records upon
twenty (20) Business Days notice having been given by the
Assessing Party and at all reasonable times on Business Days
for the purpose of certifying to the Assessing Party that
the Net Revenues and Development Costs calculated by the
Assessed Party its Affiliates and/or agents, distributors or
licensees during any Year was calculated currently in
accordance with this Agreement and if such certification
cannot be given specifying the reasons why which will enable
the Parties to recalculate the relevant sums;
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11.2.2 prior to any such examination taking place, such firm of
accountants shall undertake to the Assessed Party in a deed
that they shall keep all information and data contained in
such books and records, strictly confidential and shall not
disclose such information or copies of such books and
records to any third person including the Assessing Party,
but shall only use the same for the purpose of the
calculations which they need to perform in order to issue
the certificate to the Assessing Party which this Clause
11.2 envisages;
11.2.3 any such access examination and certification shall occur no
more frequently than once per year and will not go back over
records more than two (2) years old unless a discrepancy is
found;
11.2.4 the Assessed Party shall make available personnel to answer
queries on all books and records required for the purpose of
that certification; and
11.2.5 if the certification shows that the Assessed Party has not
calculated the Net Revenues and Development Costs correctly
the Parties shall forthwith recalculate these sums and any
monies which such recalculation shows as being due and owing
by one Party to the other shall be paid by that Party. The
cost of the accountant shall be the responsibility of the
Assessed Party if the recalculation shows the Assessed
Party's previous figures supplied to the Assessing Party to
be inaccurate by more than five per cent (5%) and the
responsibility of the Assessing Party otherwise.
11.3 All payments under the terms of the Agreement are expressed to be
exclusive of value added tax howsoever arising.
11.4 Unless otherwise approved or reasonably directed in writing by the
Parties, all payments made by the Parties shall be made in United
States dollars. All cost of foreign currency conversion to United
States dollars shall be paid by the party making the payment without
deductions for taxes, assessments, fees or charges of any kind. All
payment amounts shall be converted to United States dollars on the
last business day of each calendar month. Any necessary currency
conversions shall be made using the United States dollar buying price
quoted for such conversion into United States
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dollars in the Wall Street Journal on the last business day of each
month wherein the conversion takes place.
11.5 All payments made to Ardana under the Agreement shall be made by
telegraphic transfer to the account of Ardana Bioscience Limited at:
[***]
Account Name: [***]
Account code: [***]
Sort Code: [***]
SWIFT Code: [***]
or any other bank account that may be notified by Ardana to Columbia
from time to time.
11.6 All payments made to Bermuda under the Agreement shall be made by
telegraphic transfer to the account of Bermuda at:
[***]
Account Name: [***]
Account Code: [***]
ABA Code: [***]
or any other bank account that may be notified by Bermuda to Ardana
from time to time.
11.7 All payments made to COB under the Agreement shall be made by
telegraphic transfer to the account of COB at:
[***]
Account Name: [***]
Account Code: [***]
ABA Code: [***]
or any other bank account that may be notified by COB to Ardana from
time to time.
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11.8 If either Party fails to make any payment to the other Party hereunder
on the due date for payment without prejudice to any other right or
remedy available to that Party, that Party expecting payment shall be
entitled to charge the other Party interest (both before and after
judgement) on the amount unpaid at the base rate of the Bank of
England from time to time or any successor rate thereto plus five per
cent (5%) calculated on a daily basis until payment in full is made
without prejudice to that Party's right to receive payment on the due
date.
12. INTELLECTUAL PROPERTY - OWNERSHIP
12.1 Columbia owns or shall own the Columbia IP and during the period of
this Agreement shall not assign, transfer, mortgage, charge or
otherwise dispose of the same in any manner that curtails the rights
and licenses granted in this Agreement to Ardana, without the prior
written consent of Ardana. Subject to the licences granted to Ardana
hereunder and the other provisions of this Agreement Columbia shall be
free to use, exploit, and dispose of the Columbia IP without
obligation to Ardana.
12.2 Any and all Joint Program IP shall vest in and be owned by Ardana and
Columbia jointly in equal undivided shares and neither Party shall
have the right to themselves use or to licence a Third Party the right
to use the Joint Program IP except as expressly set out in this
Agreement. Neither Party shall during the period of this Agreement
assign, transfer, mortgage, charge or otherwise dispose of or encumber
the same without the prior written consent of the other.
12.3 The Party proceeding to develop the Product alone under the provisions
of Clauses 4.3, 4.4, 5.4.1, 18.4.1 or 18.5.1 shall be the sole and
exclusive owner of all right, title and interest in and to the Solely
Owned IP.
12.4 Both Parties shall do all such acts and things and shall execute all
such deeds and documents as are necessary to give full effect to the
provisions of Clause 12.1, 12.2, or 12.3, as applicable.
13. INTELLECTUAL PROPERTY - LICENCES AND CONTRACTUAL EXCLUSIVITY
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13.1 Columbia hereby grants to Ardana a sole worldwide sub-licensable
licence under the Columbia IP only for the purposes of carrying out
the First Development Program. Columbia and Ardana hereby grant to
each other the sub-licensable right for each other and their
Affiliates to use the Joint Program IP for the purposes of carrying
out the First Development Program.
13.2 If Ardana makes an Ardana Positive Election and Columbia makes a
Columbia Positive Election pursuant to Clause 4 Ardana hereby grants
to Columbia an exclusive fully paid up royalty free licence with the
right to sub-license in accordance with Clause 13.3 in the Columbia
Territory under Ardana's interest in the Joint Program IP to use the
same as may be necessary in connection with the Second Development
Program and to develop, have developed, make, have made, anywhere in
the world, and to import, have imported, market, distribute and sell
and have marketed, distributed and sold the Product only in the
Columbia Territory.
13.3 Columbia shall be entitled to sublicense the rights granted to it
under Clause 13.2 to any Affiliate and to Third Parties provided that
Columbia has notified Ardana of the identity of any intended
sublicensee (including in circumstances where the sublicensee is an
Affiliate of Columbia, other than COB) and provides Ardana with a copy
of any such sublicence at the same time as it is made. Columbia shall
only have the right to sub-license any such rights on the basis that
Columbia shall notify Ardana of the identity of any proposed third
party licensee and Ardana shall have thirty (30) days to approve such
licensee (which approval shall not be unreasonably withheld) and
provided that the terms of appointment of such licensee shall prevent
the further appointment of sub-licensees without first obtaining
Ardana's prior written approval (which approval may be withheld by
Ardana in its sole discretion). Notwithstanding this permission to
sub-license Columbia shall remain responsible for all of its
obligations hereunder and if the acts or omissions of any such
sublicensee cause Columbia to be in breach of this Agreement Columbia
shall be responsible therefor (with all the express consequences
provided for under this Agreement and any implied consequences)
regardless of any remedy which Columbia may have against the
sublicensee for breach of the sublicence. In particular but without
limitation, Columbia shall ensure that any sublicensee performs its
financial obligations under that sublicence and Columbia indemnifies
Ardana against any and all loss, damage,
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cost or expense which Ardana may incur as a result of failure by a
sublicensee of Columbia to perform such obligations.
13.4 If Ardana makes an Ardana Positive Election and Columbia makes a
Columbia Positive Election pursuant to Clause 4 Columbia hereby grants
to Ardana an exclusive fully paid-up, royalty-free licence with the
right to sublicence in accordance with Clause 13.5 in the Ardana
Territory under the Columbia IP and under Columbia's interest in the
Joint Program IP in both cases such licence being to use the same as
may be necessary in connection with the Second Development Program and
to develop, have developed, make, have made, anywhere in the world,
and to import, have imported, market, distribute, sell and have
marketed, distributed and sold the Product only in the Ardana
Territory. Ardana undertakes and agrees that unless and until it
exercises its right to manufacture or have manufactured Product and/or
Finished Product under the provisions of or following the consequences
of Clauses 18.5.6 and 18.6 of this Agreement it shall not utilise the
license granted to it under this Clause 13.4 to manufacture or have
manufactured Product and/or Finished Product but instead shall obtain
all of its requirements for the same from Columbia on the terms of
Clause 9 of this Agreement.
13.5 Ardana shall be entitled to sublicense the rights granted to it under
Clause 13.4 to any Affiliate and to Third Parties provided that Ardana
has notified Columbia of the identity of any intended sublicensee
(including in circumstances where the sublicensee is an Affiliate of
Ardana) and provides Columbia with a copy of any such sublicence at
the same time as it is made. Ardana shall only have the right to
sub-license any such rights on the basis that Ardana shall notify
Columbia of the identity of any proposed third party licensee and
Columbia shall have thirty (30) days to approve such licensee (which
approval shall not be unreasonably withheld) and provided that the
terms of appointment of such licensee shall prevent the further
appointment of sub-licensees without first obtaining Columbia's prior
written approval (which approval may be withheld by Columbia in its
sole discretion). Notwithstanding this permission to sub-license
Ardana shall remain responsible for all of its obligations hereunder
and if the acts or omissions of any such sublicensee cause Ardana to
be in breach of this Agreement Ardana shall be responsible therefor
(with all the express consequences provided for under this Agreement
and any implied
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consequences) regardless of any remedy which Ardana may have against
the sublicensee for breach of the sublicence. In particular but
without limitation, Ardana shall ensure that any sublicensee performs
its financial obligations under that sublicence and Ardana indemnifies
Columbia against any and all loss, damage, cost or expense which
Columbia may incur as a result of failure by a sublicensee of Ardana
to perform such obligations.
13.6 If Ardana makes an Ardana Positive Election pursuant to Clause 4 but
Columbia makes and does not reverse a Columbia Negative Election
pursuant to Clause 4 Columbia hereby grants to Ardana a worldwide
exclusive fully paid-up, royalty-free, sub-licensable licence under
the Columbia IP and under Columbia's interest in the Joint Program IP
only to develop or have developed Candidate Product for all
indications and to make, have made, use, import, have imported,
market, distribute, sell and have marketed, distributed and sold the
Product for all indications. Ardana undertakes and agrees that unless
and until it exercises its right to manufacture or have manufactured
Product and/or Finished Product under the provisions of or following
the consequences of Clauses 18.5.6 and 18.6 of this Agreement it shall
not utilise the license granted to it under this Clause 13.6 to
manufacture or have manufactured Product and/or Finished Product but
instead shall obtain all of its requirements for the same from
Columbia on the terms of Clause 9 of this Agreement.
13.7 If Columbia makes a Columbia Positive Election pursuant to Clause 4
but Ardana makes and does not reverse an Ardana Negative Election
pursuant to Clause 4, Ardana hereby grants to Columbia a worldwide
exclusive, fully paid-up, royalty-free worldwide, sub-licensable
licence under Ardana's interest in the Joint Program IP only to
develop or have developed Candidate Product for all indications and to
make, have made, use, import, have imported, market, distribute and
sell and have marketed, distributed and sold Product for all
indications.
13.8 The Parties shall do all such acts and things and shall execute all
such deeds and documents as may be necessary or desirable to register
any of the foregoing licences at local patent offices.
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13.9 Each Party shall, and shall procure that its Affiliates shall, during
the Term promptly refer to the other Party (or as the other Party
shall direct) all enquiries they receive for Finished Product for sale
or ultimate delivery within the other Party's Territory.
13.10 Each Party shall exercise its rights conferred under this Clause 13 as
principal and it shall not sell or otherwise dispose of Finished
Product on behalf of, or in the name of the other Party or any of its
Affiliates.
13.11 Each Party shall not claim any agency or other relationship which
indicates any authority to bind the other Party or its Affiliates
contractually or incur liabilities on behalf of the other Party or its
Affiliates.
14. INTELLECTUAL PROPERTY - PROSECUTION, MAINTENANCE AND ENFORCEMENT
14.1 Columbia shall at its own cost and expense be solely responsible for
the filing, prosecution and maintenance of the Columbia Patent Rights
in the Ardana Territory, and shall use its reasonable efforts to
prosecute all patent applications forming part of Columbia Patent
Rights in all countries of the Ardana Territory, to the extent such
Patent Rights are subject to the licenses granted Ardana in this
Agreement (including the conduct of any disputes or proceedings
relating to them including any opposition, reissue, re-examination, or
proceedings). Columbia will take account of Ardana's interest
hereunder when making any submission to a patent in relation to the
Columbia Patent Rights in the Ardana Territory.
14.1.1 In the event that Columbia declines to pay the official fee
to maintain any issued Columbia Patent Rights necessary to
maintain the licenses granted Ardana in the Ardana
Territory, Columbia shall provide Ardana with written notice
thereof prior to the expiration of any deadline relating to
such activities, but in any event at least twenty (20)
Business Days prior notice. In such circumstances Ardana
shall have the right to decide, with reason and with written
notice thereof at least five (5) Business Days prior to the
deadline, to require Columbia to pay such fee to maintain
such Columbia Patent Rights in Columbia's own name and
expense and Columbia shall do so.
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14.1.2 In the event that Columbia declines to file or, having
filed, declines to further prosecute and maintain any
pending Columbia Patent Rights necessary to maintain the
licenses granted Ardana in the Ardana Territory, Columbia
shall provide Ardana with written notice thereof prior to
the expiration of any deadline relating to such activities,
but in any event at least thirty-five (35) Business Days
prior notice. In such circumstances Ardana shall have the
right to decide, with reason and with written notice at
least thirty (30) Business Days prior to the deadline, that
Columbia should continue to file or prosecute such Columbia
Patent Rights. Columbia shall then have the option to
decide, with at least twenty (20) Business Days notice to
Ardana, to:
14.1.2.1 continue to file or prosecute such Columbia Patent
Rights in Columbia's own name and expense; or
14.1.2.2 allow Ardana reasonably to file or prosecute such
Columbia Patent Rights in Columbia's name and at
Columbia's reasonable expense using counsel of
Ardana's own choice, in which instance Ardana
shall invoice Columbia for such expenses within 30
days of the end of each Quarter, such invoice to
be payable within 30 days.
14.2 Each Party shall disclose to the other Party any invention arising
pursuant to the Development Program, such disclosures to be provided
within twenty (20) Business Days after the Party determines that an
invention has been made. Such disclosures shall be treated as
Confidential Information. The DC shall confirm, subject, if needed, to
advice from each of Columbia's and Ardana's patent counsel, whether
the invention falls within Columbia IP or Joint Program IP. If the
invention falls within Columbia IP the provisions of Clause 14.1 shall
then apply. If the invention falls within Joint Program IP, the DC
shall decide, subject to advice from each of Columbia's and Ardana's
patent counsel, whether to file for Patent Rights applications
claiming such invention. In the event Patent Rights are not filed on
such invention disclosures by either Party, such invention disclosures
shall be considered Joint Program Know How. If the DC decides that a
filing for Joint Program Patent
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Rights should be made Ardana shall during the period of the
Development Program be the Responsible Party in relation to the
preparation, filing, prosecution and maintenance of such Joint Program
Patent Rights and for conducting any interferences, oppositions,
reexaminations, reissues, revocations or requests for patent term or
SPC extensions relating thereto, subject to Columbia's right to at
least 30 days advance notice, with copies, of all proposed filings and
proposed correspondence, as well as an opportunity for input regarding
all such matters, and prompt copies of all actual filings and
correspondence. Subject always to the provisions of Clause 8.3.4 all
costs and expenses associated with such Joint Program Patent Rights
incurred during the period of the Development Program shall be
considered part of Development Costs. Thereafter and subject always to
the provision of Clause 8.3.4 in the event of an Ardana Positive
Election and a Columbia Positive Election Ardana shall be the
Responsible Party in relation to the Ardana Territory and all costs
and expenses incurred in relation to the Ardana Territory shall be the
sole responsibility of Ardana and Columbia shall be the Responsible
Party in relation to the Columbia Territory and all costs and expenses
incurred in relation to the Columbia Territory shall be the sole
responsibility of Columbia. The Responsible Party promptly shall
provide copies of all correspondence with the respective patent office
to the other Party and shall use reasonable efforts to keep the other
Party informed of the progress of such prosecution. No filing for or
Joint Program Patent Rights shall be abandoned by the Responsible
Party unless both Parties have agreed to such action; otherwise, the
abandoning Responsible Party will transfer the filing or Joint Program
Patent Rights to the other Party, at the other Party's request.
14.3 If either Party learns of any infringement or threatened infringement
by a Third Party of Columbia IP or Joint Program IP then such Party
shall promptly notify the other Party and shall provide such other
Party with available evidence of such infringement. In the case of
Columbia learning of such infringement or threatened infringement of
Columbia IP the obligation set out in this Clause 14.3 shall only
apply where Columbia reasonably believes the infringement or
threatened infringement to be relevant to Ardana's licenses pursuant
to this Agreement.
14.4 In the event of an infringement of the Columbia Patent Rights (to the
extent licensed to Ardana) and/or Joint Program IP by a third party in
the Ardana Territory, Columbia
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shall have first right to bring any action or proceedings, and shall
have sole control of the conduct of any such proceedings, including,
the right to settle them, provided such settlement does not adversely
affect Ardana's rights and interests within the Ardana Territory in
accordance with the following:
14.4.1 as an exclusive licensee to the Joint Program IP and to
certain portions of the Columbia Patent Rights in the Ardana
Territory, Ardana at its election shall have the right to be
joined as a co-plaintiff and to be separately represented by
counsel of its own choice and at its own cost and expense.
In such a situation, if Columbia and Ardana succeed in any
such proceedings in relation to an infringement in the
Ardana Territory, whether at trial or by way of settlement,
in obtaining a financial payment to Columbia and/or Ardana
with respect to the Joint Program IP or to the portion of
the Columbia Patent Rights licensed to Ardana:
14.4.1.1 Columbia shall first deduct for itself all of its
costs and expenses incurred in relation to such
proceedings; and
14.4.1.2 Ardana shall then be entitled for itself all of
its costs and expenses incurred in relation to
such proceedings; and
14.4.1.3 either if in such proceedings a court has
allocated damages to Columbia and Ardana
respectively each shall be entitled to retain such
damages within the Ardana Territory subject to the
provisions of sub-clauses 14.4.1.1 and 14.4.1.2
or, if in such proceedings a court has not so
allocated damages within the Ardana Territory the
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Parties shall share such damages related to Ardana's
licenses [***], subject to the provisions of sub-clauses
14.4.1.1 and 14.4.1.2;
14.4.2 If Ardana elects not to be joined as a co-plaintiff and not
to be separately represented, Ardana shall, at Columbia's
reasonable request and expense, provide Columbia with
reasonable assistance in relation to such action or
proceedings in the Ardana Territory. If Columbia succeeds in
any such proceedings in relation to an infringement in the
Ardana Territory, whether at trial or by way of settlement,
in obtaining a financial payment to Columbia, Columbia shall
first deduct for itself all of its costs and expenses
incurred in relation to such proceedings in the Ardana
Territory, and, in the event of any balance remaining in
relation to the Ardana Territory, [***] shall be allocated
to Columbia and [***] to Ardana;
14.4.3 If Columbia fails to institute an action or proceeding in
relation to an infringement in the Ardana Territory for more
than ninety (90) days from becoming aware of the
infringement pursuant to this Clause 14.4 and if Ardana
wishes to do so, Ardana shall so notify Columbia and Ardana
shall have the right to do so and Columbia shall do all such
acts and things at Ardana's cost and expense as Ardana shall
reasonably request to assist Ardana in such proceedings,
including, lending its name to such proceedings. Ardana
shall have sole control of the conduct of any such
proceedings, including the right to settle them, provided
such settlement does not adversely affect Columbia's rights
and interests outside of the Ardana Territory, provided that
Columbia, at its election, shall have the right to be joined
as a co-plaintiff and to be separately represented by
counsel of its own choice and at its own cost and expense,
and the terms of Clauses 14.4.1 and 14.4.2 with regard to
Ardana shall be applicable to Columbia, provided that if
Columbia does not elect to join the proceeding as a
co-plaintiff, Ardana shall be entitled to retain [***] of
the damages in relation to the Ardana Territory. At Ardana's
reasonable request and expense, Columbia shall do all such
acts and things and sign all such documents as may be
necessary to give Ardana the full benefit of this Clause
14.4.3.
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14.5 As of and after the Commencement Date on an ongoing basis, each Party
shall have disclosed, and will promptly disclose to the other Party
any Patent Rights owned by or licensed to the disclosing Party, other
than Joint Program Patent Rights as well as any Third Party Patent
Rights that are or become known to it that claim or disclose Candidate
Product or Product, processes relating to the manufacture thereof or
methods for their use, or otherwise are relevant to the collaboration
established hereunder. In the event that any such Third Party Patent
Rights are identified the cost of any freedom to operate searches and
analyses with respect to Candidate Product and Products will be
chargeable to Development Costs and the Parties will agree through the
DC on an allocation of responsibilities between themselves regarding
such searches and analyses.
14.6 Each Party shall promptly take all necessary steps to facilitate the
other's application (made either on the other's own initiative or upon
request by the first Party ) for extensions to the term of Columbia
Patent Rights, and/or Joint Program IP in any country including
applications for supplementary protection certificates and patent term
extensions for the same in respect of Products. Each Party shall use
its best efforts to obtain any and all such extensions to the extent
permitted by law or regulation.
14.7 If during or after the Term of this Agreement, either Party receives
any notice, claim or proceedings from any third party alleging
infringement of that third party's intellectual property rights by
reason of any Party's activities in relation to this Agreement, then:
14.7.1 the Party receiving that notice shall forthwith notify the
other Party of the notice, claim or proceeding;
14.7.2 neither Party shall make any admission of liability;
14.7.3 the Parties shall consult with each other, taking advice
from their patent attorney as to whether they consider the
third party intellectual property infringed and if so
whether the claim of infringement is valid; and
14.7.4 in the event that the Parties whose activities are accused
(the Accused Parties) consider that there is a genuine issue
of infringement of such third
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party's intellectual property rights , the Parties shall
discuss in good faith whether to design around or to
challenge the same. If the Parties agree that it is not
possible or commercially reasonable to design around such
third party intellectual property, or cannot so agree, and,
nevertheless, agree to defend the incoming infringement
claim from the third party, the Accused Parties shall do so
using a single counsel to be jointly appointed by them at
their joint cost and expense, unless an Accused Party
reasonably believes that it is in its best interests to be
separately represented, in which case each Accused Party
shall be responsible for its own costs and expenses.
Alternatively, the Parties may agree to seek a license from
such third party in which case Columbia shall be responsible
for doing so. If Columbia does not itself require a license
to cover Columbia's activities, Columbia may choose to allow
Ardana to be responsible for seeking a license for itself.
If the Accused Parties can obtain a license upon terms
acceptable to each Party in its sole discretion, at that
time the Parties shall agree on any fees and royalties that
are necessary to obtain and maintain such a license which
shall be shared between the Parties in proportions which are
agreed between them in good faith which proportions are fair
and equitable between them reflecting the respective value
of the license to them, including without limitation whether
and the extent to which a Party's Territory is covered by
the license.
15. WARRANTIES, INDEMNIFICATION; LIMITATION OF LIABILITY; AND INSURANCE
15.1 Each Party represents and warrants to the other Party that:
15.1.1 it has the corporate power and authority and the legal right
to enter into this Agreement, to grant the licenses granted
and to enter into its other obligations, that it has taken
any necessary corporate action with Affiliates, and that
this Agreement is a legal and valid obligation binding upon
such Party and enforceable in accordance with its terms. The
execution, delivery and performance of the Agreement by such
Party does not conflict with any agreement, instrument or
understanding, oral or written, to which it is or by
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which it is bound, nor violate any law or regulation of any
court, governmental body or administrative or other agency
having jurisdiction over it;
15.1.2 such Party has not, and during the term of the Agreement
will not, without the prior written consent of the other
Party grant any rights to any third party that would
conflict with the rights granted to the other Party
hereunder;
15.1.3 it is not aware that the exercise by either Party of its
respective rights and licenses hereunder would infringe the
Patent Rights or other intellectual property rights of any
third party;
15.1.4 it is a corporation duly organised, validly existing and in
good standing under the laws of the jurisdiction in which it
is incorporated; and
15.1.5 the execution and delivery of this agreement and the
performance of such Party's obligations do not constitute a
default or require any consent under any other contractual
obligation of such Party.
15.2 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT COLUMBIA MAKES NO
WARRANTIES OR REPRESENTATIONS, IMPLIED OR EXPRESS, WITH RESPECT TO THE
PRODUCT OR ANY OF THE RIGHTS, LICENSES, OR ACTIVITIES GRANTED OR
CONTEMPLATED HEREIN. SPECIFICALLY AND WITHOUT LIMITATION, COLUMBIA
MAKES NO EXPRESS OR IMPLIED WARRANTY OR REPRESENTATION OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, USE, PERFORMANCE,
NON-INFRINGEMENT, VALIDITY, OR PATENTABILITY AND ANY SUCH WARRANTIES
ARE HEREBY EXPRESSLY DISCLAIMED.
15.3 Subject to the provisions of Clause 15.4 and 15.5 Columbia shall be
responsible for and shall indemnify Ardana and its directors,
officers, servants and agents (collectively "the Indemnified Party")
against any and all liability, loss, damage, cost and expense
(including legal costs) incurred or suffered by the Indemnified Party
as a result of:
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15.3.1 any Columbia activity related to the Candidate Product or
resulting Product after Ardana gives up its rights and
relevant activity pursuant to Clause 4.4, 5.4, or 18.4.1;
15.3.2 that part of any claim brought against Ardana by a Third
Party which arises as a result of any activities of
Columbia, its Affiliates or contract manufacturers under or
in relation to this Agreement being a claim that use of any
Finished Product(s) has caused death or bodily injury; or
15.3.3 a breach of warranty by Columbia under Clause 15.1.
An Indemnified Party that intends to claim indemnification under this
Clause 15.3 shall promptly notify Columbia of any Third Party claim in
respect of which the Indemnified Party intends to claim that
indemnification. The Indemnified Party shall not compromise or settle
the claim prior to any such notice. Columbia may assume and control
the defence of any such Third Party claim, provided however, that an
Indemnified Party shall have the right to retain its own counsel at
its own cost and expense, if representation of that Indemnified Party
by the counsel retained by Columbia would be inappropriate due to
actual or potential differing interests between the Indemnified Party
and any other party represented by that counsel in the proceedings.
The Indemnified Party shall co-operate with Columbia and its legal
representatives in the investigation of any matter covered by this
indemnification.
15.4 Subject to the provisions of Clause 15.5, Ardana shall be responsible
for and shall indemnify Columbia and its Affiliates, directors,
officers, servants and agents (collectively "the Indemnified Party")
against any and all liability, loss, damage, cost and expense
(including legal costs) incurred or suffered by the Indemnified Party:
15.4.1 any Ardana activity related to the Candidate Product or
resulting Product after Columbia gives up its rights and
relevant activity pursuant to Clause 4.3, 5.4, or 18.5.1;
15.4.2 as a result of that part of any claim brought against
Columbia or its Affiliates by a Third Party which arises as
a result of the activities by Ardana or its affiliates,
sublicensees, distributors or agents under this Agreement
being a claim that use of any Finished Products has caused
death or bodily injury; or
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15.4.3 as a result of a breach of warranty by Ardana under Clause
15.1.
An Indemnified Party that intends to claim indemnification under this
Clause 15.4 shall promptly notify Ardana of any Third Party claim in
respect of which the Indemnified Party intends to claim the
indemnifications. The Indemnified Party shall not compromise or settle
the claim prior to any such notice. Ardana may assume and control the
defence of any such Third Party claim, provided however, that an
Indemnified Party shall have the right to retain its own counsel at
its own cost and expense, if representation of that Indemnified Party
by the counsel retained by Ardana would be inappropriate due to actual
or potential differing interests between the Indemnified Party and any
other party represented by that counsel in the proceedings. The
Indemnified Party shall co-operate with Ardana and its legal
representatives in the investigation of ay matter covered by this
indemnification.
15.5 Neither Party shall be liable to the other in contract, tort,
negligence, breach of statutory duty or otherwise for any loss,
damage, costs or expenses of any nature whatsoever incurred or
suffered by the other or its Affiliates:
15.5.1 of a direct nature where the same is a loss of turnover,
profits, business or goodwill; or
15.5.2 an indirect or consequential or punitive nature, including
any indirect or consequential economic loss or other
indirect or consequential loss of turnover, profits, loss of
enterprise value, business or goodwill or otherwise.
15.6 Columbia shall secure and maintain comprehensive general liability
insurance with insurers having an AM Best rating within the top 2
categories at the time (at the date of this Agreement known as
"superior" or "excellent"), including, product liability, contractual
liability, personal injury, and insurance against claims regarding the
development, manufacture, delivery, storage, handling and use of
Product under this Agreement, in such amounts as it customarily
maintains for similar products and activities in accordance with
prudent insurance practice, but in no event less than the US dollar
equivalent of [***] pounds sterling (GB(pound)[***]) per occurrence
and in the aggregate per year. Columbia shall use commercially
reasonable efforts following First Commercial Sale and at intervals
thereafter in accordance with Good Industry
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Practice to increase this cover to a level of [***] dollars (US$[***])
in the aggregate per year if this is achievable by Ardana.
15.7 Ardana shall secure and maintain comprehensive general liability
insurance with insurers having an AM Best rating within the top 2
categories at the time (at the date of this Agreement known as
"superior" or "excellent") including product liability, contractual
liability, personal injury, and insurance against claims regarding the
development, delivery, storage and handling and use of Product under
this Agreement, in such amounts as it customarily maintains for
similar products and activities in accordance with prudent insurance
practice, but in no event less than [***] pounds sterling
(GB(pound)[***]) per occurrence and in the aggregate per year. Ardana
shall use commercially reasonable efforts following First Commercial
Sale and at intervals thereafter in accordance with Good Industry
Practice to increase this cover to a level in pounds equal to
[***]dollars (US$[***]) in the aggregate per year if this is
achievable by Columbia.
15.8 Each Party shall maintain such insurance described in Clauses 15.6 and
15.7 during the term of this Agreement and thereafter for so long as
it customarily maintains insurance for itself for similar products and
activities. Each Party shall note the interest of the other Party on
such insurance and shall use commercially reasonable efforts to name
the other Party as an additional insured on such insurance if this is
also achievable by the other Party and shall provide the other Party
proof of such insurance upon request. Each Party shall cause such
insurance policies to provide that the other Party shall be given at
least thirty (30) days notice of any cancellation, termination or
change in such insurance.
15.9 Ardana shall have the control of and be responsible for the Clinical
Trials conducted under the First Development Program and the Phase III
Clinical Trials conducted in the Ardana Territory under the Second
Development Program and shall be the sponsor of such trials and in
such capacity, shall, notwithstanding its indemnity rights under
Clause 15.3 be responsible for the initial payment of any compensation
due to any participants in such trials who suffer death or bodily
injury pursuant to any legal rights or applicable industry guidelines.
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15.10 Columbia shall have the control of and be responsible for the
Formulation Work and the Phase III Clinical Trials conducted in the
Columbia Territory under the Second Development Program and shall be
the sponsor of such trials and in such capacity, shall,
notwithstanding its indemnity rights under Clause 15.4, be responsible
for the initial payment of any compensation due to any participants in
such trials who suffer death or bodily injury pursuant to any legal
rights or applicable industry guidelines.
16. CONFIDENTIALITY
16.1 The Parties agree not to disclose the Confidential Information to
third parties nor to use the Confidential Information except to the
extent necessary in connection with the transactions and business set
forth in this Agreement; provided, however, that such Confidential
Information shall not be subject to the restrictions and prohibitions
set forth in this Clause 16 to the extent that such Confidential
Information:
16.1.1 is available to the public in public literature or
otherwise, or after disclosure by one Party to the other
becomes public knowledge through no default of the Party
receiving such Confidential Information;
16.1.2 was (as evidenced in writing) known to the Party receiving
such confidential information prior to the receipt of such
Confidential Information by such Party, whether received
before or after the date of this Agreement;
16.1.3 is obtained by the Party receiving such confidential
information from a source free to disclose such information
other than the Party supplying such Confidential
Information;
16.1.4 is required to be disclosed pursuant to any order of a court
having jurisdiction or any lawful action of a Governmental
Authority having jurisdiction over the disclosing Party or
court of competent jurisdiction but only to the extent such
disclosure is so required; provided, however that in the
event of such an order or action, the Party ordered to
disclose such Confidential Information shall give the other
Party reasonably timely notice of the disclosure order in
order to allow such Party to seek a protective order or such
other appropriate relief with respect to the confidential
information; or
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16.1.5 in the case of Regulatory Applications is required to be
disclosed to the relevant Governmental Authorities.
16.2 Each Party shall take all precautions as it normally takes with its
own Confidential Information to prevent any improper disclosure of
such Confidential Information to any independent third party.
16.3 No public announcements or other disclosure to third parties
concerning the financial or other terms of this Agreement shall be
made, whether directly or indirectly, by either Party to this
Agreement, except as may be legally required or as may be required for
recording purposes, without first obtaining the approval of the other
Party and agreement upon the nature and text of such announcement or
disclosure, with the exception that:
16.3.1 a Party may disclose the full terms of this Agreement to its
investment bankers, lawyers, accountants and other
professional advisors or a third party seeking to invest in,
lend funds to acquire or merge with or be acquired by such
Party without the other Party's prior approval provided that
such disclosure is made under terms of confidentiality
whether express or implied; and
16.3.2 a Party may disclose the terms of this Agreement to any
securities exchange or regulatory authority or government
body to which either Party is subject or submits, wherever
situated, including (without limitation) the US Securities
Exchange Commission, the UK Stock Exchange or the Panel on
Take-overs and Mergers, whether or not the requirement has
the force of law provided that it takes advantage of all
provisions to keep confidential as many terms of this
Agreement as possible.
16.4 In respect of those public announcements and disclosures not permitted
by Clause 16.3 the Party desiring to make any such public announcement
or other disclosure shall inform the other Party of the proposed
announcements or disclosure in reasonably sufficient time prior to
public release, and shall provide the other Party with a written copy
thereof, in order to allow such Party to comment upon such
announcement or disclosure, which comments shall be provided by such
other Party
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within five (5) working days. The Parties shall jointly develop press
releases and information materials that can be used by either Party
for presentations to financial advisers and similar recipients.
17. TERM
17.1 This agreement shall commence on the commencement date and shall
continue in force until no payments are due hereunder or until
termination under Clause 18 whichever is the earlier.
18. TERMINATION
18.1 Ardana shall have the right at any time from the Commencement Date
until the Point of Proof of Principle to terminate this Agreement upon
30 days notice of termination in writing to Columbia.
18.2 This Agreement may be terminated immediately upon written notice of
termination given by either Ardana on the one hand (in circumstances
where either Bermuda or COB is in breach as specified in Clause 18.2.1
or Bermuda or COB satisfy the criteria of Clause 18.2.2) or Bermuda on
the other hand (where Ardana satisfies the criteria below):
18.2.1 in the event that during the period of the Development
Program the other Party commits a material breach or default
under this Agreement, which breach or default shall not be
remedied within sixty (60) days after the receipt of written
notice thereof by the person in breach or default provided
always that in the case of a breach by Ardana of Clause 11.1
in which case the remedy period shall be ten (10) days; or
18.2.2 in the event that at any time an Insolvency Event occurs in
relation to such person.
18.3 For the avoidance of doubt it is declared and agreed that following
completion of the Development Program neither Ardana on the one hand
nor Columbia on the other hand shall have the right to terminate this
Agreement for a material breach by the other but instead shall have a
remedy in damages against the other.
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18.4 Upon the termination of this Agreement by Ardana under Clause 18.1 or
by Columbia pursuant to Clause 18.2:
18.4.1 the provisions of Clause 4.4 apart from the first sentence
shall be deemed to apply such that Columbia shall have the
fully paid up royalty free right to continue alone;
18.4.2 Ardana shall upon Columbia's written request deliver up to
Columbia all Joint Program IP and all Documents containing
any Know How comprised in the Joint Program IP and all
copies made (save for a single copy to be retained for
evidential purposes by the Ardana's lawyers) and any other
Know How held by the Ardana relating to the Candidate
Product and/or the resultant Product;
18.4.3 Ardana shall not use or otherwise exploit in any way, either
directly or indirectly the Columbia IP in any manner, or the
Joint Program IP with regard to the Candidate Product or
resultant Product in either case in relation to all
indications, or directly or indirectly the Joint Program
Know How at all;
18.4.4 Columbia shall be free to use and exploit all Joint Program
IP as it sees fit with no obligation to Ardana in respect
thereof;
18.4.5 Columbia shall have the option, on a case by case basis, to
assume sole responsibility for the prosecution, maintenance,
defence and enforcement of Joint Program IP at its own cost
and expense, though Ardana shall retain joint ownership and
rights under the Joint Program IP other than as related to
the Candidate Product or resulting Product in either case in
relation to all indications;
18.4.6 Ardana shall commensurate with legislative and regulatory
requirements, transfer to Columbia or its nominee all
Regulatory Approvals, Marketing Authorisations, Regulatory
Applications and other regulatory filings and approvals for
Candidate Product or resultant Product in all countries of
the territory of the Ardana and any country in the ROW
Territory in relation to which the Ardana has been appointed
the Responsible Party pursuant to
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Clause 8. In the event that in any country such a transfer
is not possible, the Ardana shall use reasonable endeavours
to ensure that Columbia has the benefit of the relevant
Regulatory Approvals, Marketing Authorisations, Regulatory
applications and other regulatory filings and approvals and,
to this end, consents to any Governmental Authority
cross-referencing to the data and information on file with
any Governmental Authority as may be necessary to facilitate
the granting of second Marketing Authorisations,
applications, regulatory filings and approvals to Columbia,
and Ardana agrees to complete whatever other procedures are
reasonably necessary in relation to the same to enable
Columbia (either itself or in conjunction with a third
party) freely to develop and sell the Product in
substitution for Ardana;
18.4.7 Ardana shall use its reasonable endeavours to assign to
Columbia the benefit of any agreement made between Ardana,
and a sub-licensee in relation to Product in ROW or any
agreement between Ardana and an agent or distributor in any
country to which Clause 8.1 relates;
18.4.8 Ardana shall remit to Columbia any payments that are due and
payable as of the date of expiration or termination;
18.4.9 Columbia and Ardana shall return to each other all
confidential information supplied by one Party to the other,
including all copies and originals thereof;
18.4.10 as well as the other provisions of this Agreement which
survive its termination whether directly or indirectly by
virtue of the provisions of this Clause 18.4, the provisions
of Clauses 12, 15, 16, and 20, as applicable, shall continue
to apply.
18.5 Upon termination of this Agreement by Ardana pursuant to Clause 18.2:
18.5.1 the provisions of Clause 4.3 apart from the first sentence
shall be deemed to apply such that Ardana shall have the
fully paid up royalty free right to continue alone;
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18.5.2 Columbia shall upon Ardana's written request deliver up to
Ardana all Joint Program IP and all Documents containing any
Know How comprised in the Joint Program IP and all copies
made (save for a single copy to be retained for evidential
purposes by Columbia's lawyers) and any other Know How held
by Columbia relating to the Candidate Product and/or the
resultant Product;
18.5.3 Columbia shall not use or otherwise exploit in any way,
either directly or indirectly the Joint Program IP with
regard to the Candidate Product or resultant Product in
either case in relation to all indications, or directly or
indirectly the Joint Program Know How at all;
18.5.4 Ardana shall be free to use and exploit all Joint Program IP
as it sees fit with no obligation to Columbia in respect
thereof;
18.5.5 Ardana shall have the option, on a case by case basis, to
assume sole responsibility for the prosecution, maintenance,
defence and enforcement of Joint Program IP at its own cost
and expense, though Columbia shall retain joint ownership
and rights under the Joint Program IP other than as related
to the Candidate Product or resulting Product in either case
in relation to all indications;
18.5.6 if Columbia has entered into a Manufacturing and Supply
Agreement this may at Ardana's option exercisable on 90 days
written notice to Columbia be given within 30 days of the
date of termination either continue or be terminated and if
Ardana exercises its rights to terminate the Manufacturing
and Supply Agreement, Columbia will at its own cost and
expense provide such reasonable technical and other
assistance as may be required in order to ensure that Ardana
is able to manufacture or have manufactured Finished
Product. Ardana shall be free to contract for the
manufacture and supply of Product and/or Finished Product
with any contract manufacturer;
18.5.7 Columbia shall commensurate with legislative and regulatory
requirements, transfer to Ardana or its nominee all
Regulatory Approvals, Marketing Authorisations, Regulatory
Applications and other regulatory filings and
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approvals for Candidate Product or resultant Product in all
countries of the Columbia Territory and any country in the
ROW Territory in relation to which Columbia has been
appointed the Responsible Party pursuant to Clause 8. In the
event that in any country such a transfer is not possible,
Columbia shall use reasonable endeavours to ensure that
Ardana has the benefit of the relevant Regulatory Approvals,
Marketing Authorisations, Regulatory applications and other
regulatory filings and approvals and, to this end, consents
to any Governmental Authority cross-referencing to the data
and information on file with any Governmental Authority as
may be necessary to facilitate the granting of second
Regulatory Approvals, Marketing Authorisations, Regulatory
Applications, regulatory filings and approvals to Ardana,
and Columbia agrees to complete whatever other procedures
are reasonably necessary in relation to the same to enable
the continuing Party(either itself or in conjunction with a
third party) freely to develop and sell the Product in
substitution for the withdrawing Party;
18.5.8 Columbia shall use its reasonable endeavours to assign to
Ardana the benefit of any agreement made between Columbia,
and a sub- licensee in relation to Product in ROW or any
agreement between Columbia and an agent or distributor in
any country to which Clause 8.1 relates;
18.5.9 at its option, Columbia shall continue to prosecute,
maintain and defend the Columbia Patent Rights and
Trademarks as specified in Clause 2 or shall follow the
procedures set forth above at Clause 14.1.2;
18.5.10 as well as the other provisions of this Agreement which
survive its termination whether directly or indirectly by
virtue of the provisions of this Clause 18.5 the provisions
of Clauses 12, 15, 16, and 20, as applicable, shall continue
to apply.
18.6 Termination of this Agreement (whether under this Clause 18, upon
expiration of the Term, or otherwise) shall be without prejudice to
any rights of either Party against the other that may have accrued to
the date of such termination.
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19. FORCE MAJEURE
19.1 The obligations of the either Party hereunder shall be suspended
during the time and to the extent that such Party is prevented from
complying therewith due to Force Majeure.
19.2 As soon as possible after being affected by a Force Majeure
circumstance, the Party so affected shall furnish to the other Party
all particulars of the Force Majeure and the manner in which its
performance is thereby prevented or delayed. The Party whose
obligations hereunder have been suspended shall promptly and
diligently pursue appropriate action to enable it to lift the Force
Majeure situation, except that a Party shall not be obligated to
settle any strike, lockout or other labor difficulty on terms contrary
to its wishes.
20. GENERAL PROVISIONS
20.1 Independent Contractors. Ardana and Columbia are independent of each
other and nothing contained herein shall be construed to create a
joint venture, partnership or similar relationship. Neither Party is
authorized to, nor shall it, incur any liability whatsoever for which
the other may become directly, indirectly or contingently liable.
20.2 Dispute Resolution; Consent to Jurisdiction. This Agreement shall be
construed and interpreted in accordance with the law of the State of
Delaware without regard to principles related to conflicts of laws.
The parties expressly agree that the United Nations Convention on
Contracts for the International Sale of Goods shall not apply to the
interpretation and construction of this Agreement. In an effort to
resolve informally and amicably any claim, controversy or dispute
(whether such claim, sounds in contract, tort, or otherwise) arising
out of or relating to this Agreement, or the breach thereof (a
"Dispute"), each Party shall notify the other in writing of a Dispute
hereunder that requires resolution. Such notice shall set forth the
nature of the Dispute, the amount, if any, involved and the remedy
sought. Each Party shall designate a representative who shall be
empowered to investigate, discuss and seek to settle the Dispute. If
the two representatives are unable to settle the Dispute within thirty
(30) days after proper notification, the Dispute shall be submitted to
the Chief Executive Officer of each Party for consideration for an
additional thirty (30) days. If
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the Dispute remains unresolved after said sixty (60) day period,
either Party shall have a right to commence any action, suit or
proceeding with respect to such Dispute in a U.S. federal court of
competent jurisdiction in Delaware. The venue for such action, suit or
proceeding shall be in the U.S. federal Courts in Delaware. No
provision of, or the exercise of any rights under, this Agreement
shall limit the right of the parties to obtain, apply for, or resort
to court ordered injunctive relief. Ardana and Columbia each further
irrevocably consent to the service of any complaint, summons, notice
or other process by delivery thereof to it by any manner in which
notices may be given pursuant to this Agreement.
20.3 Notices.
20.3.1 Any notice or other communication given pursuant to or made
under or in connection with the matters contemplated by this
Agreement shall be in writing in the English language and
shall be delivered by hand or by courier or shall be sent by
recorded delivery to the address of the recipient set out in
Exhibit F or as specified by the recipient from time to time
in accordance with Clause 20.3.3. Notices sent by hand or by
courier shall require a written receipt of delivery. Notices
sent by fax or E-Mail shall not be valid of themselves and
must be confirmed in hard copy form by hand or by recorded
delivery.
20.3.2 Any notice given pursuant to this Clause shall be deemed to
have been received:
20.3.2.1 if delivered by hand or by courier, at the time of
delivery as evidenced in the receipt of delivery;
or
20.3.2.2 if sent by recorded delivery, at the time of
delivery.
20.3.3 A Party may notify the other Parties to this Agreement of a
change of its name, relevant addressee, address or facsimile
number for the purposes of Exhibit F provided that such
notification shall only be effective on:
20.3.3.1 the date specified in the notification as the date
on which the change is to take place; or
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20.3.3.2 if no date is specified or the date specified is
less than (five) clear Business Days after the
date on which the notice is given, the date
falling five clear Business Days after notice of
any such change has been given.
20.4 Assignment. Columbia shall not assign this Agreement without also
assigning to the same assignee the relevant portions of the Columbia
IP and its interest in the Joint Program IP and all related Regulatory
Application and Regulatory Approvals the subject matter of this
Agreement and conversely may not assign the rights in the relevant
portion of the Columbia IP and in its interest in the Joint Program IP
and all related Regulatory Applications and Regulatory Approvals the
subject matter of this Agreement and Trade Marks (other than to an
Affiliate) without also assigning to the same assignee this Agreement.
Ardana shall not assign this Agreement without also assigning to the
same assignee its rights in the Joint Program IP and all related
Regulatory Applications and Marketing Authorisations the subject
matter of this Agreement and conversely may not assign its rights in
the Joint Program IP and all related Regulatory Applications and
Marketing Authorizations the subject matter of this Agreement (other
than to an Affiliate) without also assigning to the same assignee this
Agreement. This Agreement shall not be assignable by either Ardana on
the one hand or by Columbia on the other hand ("Assignor") without the
written consent of the other ("Remaining Party") such consent not to
be unreasonably withheld, provided however that either Party may
assign this Agreement to any Affiliate or to a corporation with which
such Party may merge or consolidate, or to which it may transfer all
or substantially all of its assets to which this Agreement relates,
subject to obtaining a direct deed of undertaking from such
corporation addressed to the Remaining Party agreeing to be bound by
all the terms of this Agreement.
20.5 Amendment and Waiver. This Agreement (including the Exhibits hereto)
may be amended, modified, superseded or cancelled, and any other of
the terms or conditions hereof may be modified, only by a written
instrument executed by both parties hereto or, in the case of a
waiver, by the Party waiving compliance. Failure of any Party at any
time or times to require performance of any provision hereof shall in
no manner affect the right of such Party at a later time to enforce
the same, and no waiver of any nature, whether by conduct or
otherwise, in any one or more instances, shall be
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deemed to be or considered as a further or continuing waiver of any
other provision of this Agreement.
20.6 Severability. In the event that any one or more of the agreements,
provisions or terms contained herein shall be declared invalid,
illegal or unenforceable in any respect, the validity of the remaining
agreements, provisions of terms contained herein shall in no way be
affected, prejudiced or invalidated thereby.
20.7 Entire Agreement. This Agreement, together with the Exhibits hereto,
contains the entire agreement between the parties hereto and
supersedes any agreements between them with respect to the subject
matter hereof.
20.8 Section Headings. The section headings contained in this Agreement are
for reference purposes only and shall not affect in any way the
meaning or interpretation of this Agreement.
20.9 Counterparts. This Agreement may be executed in any number of separate
counterparts, each of which shall be deemed to be an original, but
which together shall constitute one and the same instrument.
21. MIPHARM AGREEMENT AND TESTOSTERONE FOR WOMEN
21.1 The Parties recognize the existence of, and that this Agreement is
subject to, a license and supply agreement made between Bermuda and
Mipharm SpA ("Mipharm") dated 5 March 1999 (the "Mipharm Agreement"),
a copy of which is attached hereto as Exhibit F.
21.2 From the Commencement Date and up to the elections by the Parties
under Clause 4.1, or such other date as the Parties may agree in
writing, Columbia shall, consistent with Good Industry Practice, take
all commercially reasonable acts to remove Chronodyne(R) (terbutaline
gel) from the grant of the license to Mipharm under the Mipharm
Agreement, such that the Mipharm Agreement does not affect the
Candidate Product or resultant Product. Upon the removal of
Chronodyne(R) (terbutaline gel) from the grant of the
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license to Mipharm under the Mipharm Agreement such that the Mipharm
Agreement does not affect the Candidate Product or resultant Product,
this Agreement shall be deemed to be amended to add Greece, Ireland,
Italy (including San Marino and Vatican City), and Portugal to the
definition of Europe. When undertaking its obligations under this
Clause 21.2 Columbia shall regularly liaise with Ardana and Ardana
shall, insofar as it communicates with Mipharm about the removal of
Chronodyne (terbutaline gel) from the grant of the license to MiPharm,
regularly liaise with Columbia. [***]
21.2.1 [***]
21.2.2 [***]
21.2.3 [***]
21.3 [***]
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
first above written.
ARDANA BIOSCIENCE COLUMBIA LABORATORIES
LIMITED (BERMUDA), LTD.
By: /S/ Maureen Lindsay By: /S/ Fred Wilkinson
----------------------------------- -----------------------------------
Maureen Lindsay Fred Wilkinson
Name Name
Chief Operating Officer President
Title Title
December 2002 December 2002
Date Date
/S/ Mike Piper /S/ Michael McGrane
----------------------------------- -----------------------------------
Witness (Signature) Witness (Signature)
Mike Piper Michael McGrane
Witness Name (Printed) Witness Name (Printed)
COLUMBIA LABORATORIES, INC.
By: /S/ Fred Wilkinson
-----------------------------------
Fred Wilkinson
Name
President & CEO
Title
December 2002
Date
/S/ Michael McGrane
-----------------------------------
Witness (Signature)
/S/ Michael McGrane
-----------------------------------
Witness Name (Printed)
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EXHIBIT A
WORLDWIDE PATENTS AND APPLICATIONS
"Basic Bioadhesive" Family
United States: Patent No. 4,615,697;
EPO (2) (Austria, Belgium, Switzerland/Liechtenstein, Germany, France,
Luxembourg, Netherlands, Sweden, United Kingdom): Patent No. 163 696; and Patent
No. 501 523;
Australia: Patent No. 565,354;
Hong Kong: Patent No. 1214/1997; and
Japan: Patent No. 2,113,953.
The Parties acknowledge that without SPC extensions the expiration date of the
EPO patents is in November 2004.
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"Uterine Pass" Family
United States (2): Patent No. 6,126,959; and Application No. 09/510,527;
EPO (Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Monaco, Netherlands, Portugal,
Spain, Sweden, Switzerland/Liechtenstein, United Kingdom): Application No.
98943548.2;
Argentina: App. No. P980104558; Malaysia: App. No. PI 9804131;
Australia: Patent No. 738,460; Mexico: App. No. 002448;
Brazil: App. No. PI 9812134-0; Morocco: App. No. 25.251;
Canada: App. No. 2,303,339; New Zealand: Patent No. 502,926;
Chile: App. No. 2185-98; Norway: App. No. 20001287;
China: App. No. 98808946.7; Peru: App. No. 867.98;
Colombia: App. No. 98 052.730; Philippines: App. No. 1998-02371;
Georgia: Patent No. P2645; Romania: App. No. A/00269;
Hong Kong: App. No. 00104419.5; Russia: App. No. 2000-108551;
Hungary: App. No. P0003784; South Africa: Patent No. 98/08328;
Israel: App. No. 134,564; Tangiers: App. No. 1653;
Japan: App. No. 2000511486; Ukraine: App. No. 2000042000/M; and
Korea (So.): App. No. 102000700261; Venezuela: App. No. 2026/98.
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"Treatment of Endometriosis/Infertility" Family
United States: Application No. 10/089,796;
EPO (Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece,
Ireland, Italy, Luxembourg, Monaco, Netherlands, Portugal, Spain, Sweden,
Switzerland/Liechtenstein, United Kingdom): Application No. 00964272.9;
Argentina: App. No. 000105228; Malaysia: App. No. 20004608;
Australia: App. No. 75250/00; Mexico: App. No. 2002/003453;
Brazil: App. No. PI0014548-3; Morocco: App. No. 26584;
Canada: App. No. 2,385,974; New Zealand: App. No. 518429;
Chile: App. No. 2679-2000; Norway: App. No. 2002 1591;
China: App. No. 00813807.9; Peru: App. No. 001044/2000;
Colombia: App. No. 00075387; Philippines: App. No. 2000-02714;
Georgia: App. No. 2000004769; Russia: App. No. 2002111682;
Hong Kong: App. No. 02105660.6; Singapore: App. No. 200201447-0;
Hungary: App. No. Not Yet Available; South Africa: App. No. 2002/2182;
India: App. No. 2002/00380; Taiwan: App. Nos. 89120706;
Israel: App. No. 148784; Tangiers: App. No. 2222;
Japan: App. No. 2001-527787; Turkey: App. No. 02/899;
Korea (So.): App. No. 2002-7004330; Ukraine: App. No. 2002043631/M; and
Venezuela: App. No. 2000-002213.
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EXHIBIT B
FIRST DEVELOPMENT PROGRAM
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EXHIBIT C
SECOND DEVELOPMENT PROGRAM
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EXHIBIT D
NAMES AND ADDRESSES FOR NOTICES
If to Columbia Laboratories (Bermuda), Ltd.:
Columbia Laboratories (Bermuda), Ltd.
P.O. Box HM 1179
Cedar House
41 Cedar Avenue
Hamilton HM 12
Bermuda
Attention: Secretary
Tel: (441) 295-2244
Fax: (441) 292-8666
(441) 295-5328
If to Columbia Laboratories, Inc.,
Columbia Laboratories, Inc.
354 Eisenhower Parkway
Plaza 1 Second Floor
Livingston, New Jersey 07039
Attention: President
Tel: (973) 994-3999
Fax: (973) 994-3001
With copy to:
Columbia Laboratories, Inc.
354 Eisenhower Parkway
Plaza 1 Second Floor
Livingston, New Jersey 07039
Attention: General Counsel
Tel: (973) 994-3999
Fax: (973) 994-3001
If to Ardana Biosciences Limited:
COO
Ardana Biosciences Limited
58 Queen Street
Edinburgh
EH2 3NS
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EXHIBIT E
DEFAULT PATENT COUNTRIES
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EXHIBIT F
THE "MIPHARM AGREEMENT"
(Attached separately.)
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