Exhibit 10.37
Dated October 16th, 2002
ARDANA BIOSCIENCE LIMITED
and
COLUMBIA LABORATORIES (BERMUDA), LTD.
and
COLUMBIA LABORATORIES, INC.
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LICENSE AND SUPPLY AGREEMENT
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LICENSE AND SUPPLY AGREEMENT, dated as of October 16th, 2002, between ARDANA
BIOSCIENCE LIMITED, a company incorporated in England, with its registered
office c/o Dundas & ▇▇▇▇▇▇ ▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇
("Ardana") and COLUMBIA LABORATORIES (BERMUDA), LTD., a Bermuda corporation,
having its office at Rosebank Center, ▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇▇
("Columbia") and COLUMBIA LABORATORIES, INC., a US corporation incorporated in
Delaware having its principal place of business at ▇▇▇ ▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ("Inc").
RECITALS:
A. Columbia and its Affiliates (as hereafter defined) are engaged in, among
other things, the research, development, manufacture, marketing,
distribution and sale of drug products in Europe, the United States, and
throughout the world.
B. Ardana is engaged in, among other things, the research, development,
marketing, distribution and sale of drug products in the Territory (as
hereafter defined).
C. Columbia is the owner of certain Patent Rights, Trademarks and Regulatory
Applications (as hereafter defined) relating to the Product (as hereafter
defined).
D. It is intended that Columbia UK (as hereafter defined) shall file the
European Regulatory Application (as hereinafter defined) relating to the
Product and shall transfer the MAs (as hereafter defined) resulting from
the same to Ardana upon receiving Regulatory Approval.
E. Columbia is willing to grant to Ardana a license in the Territory and to
supply Ardana with its requirements of Finished Product (as hereafter
defined) for this purpose and Ardana desires to acquire such license and to
buy such Finished Products upon and subject to the terms and conditions set
forth hereunder.
F. Inc has been made a party to this Agreement solely for the purposes of
Clause 19.10
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 license and supply agreement (which
expression shall be deemed to include the Recitals and Exhibits
hereto);
1.1.3 "Applicable Laws" means all applicable laws, rules, regulations,
directives and guidelines (including any amendments, extensions or
replacements thereto) (i) in the Territory that apply to the
Commercialization of the Product in the Territory; and (ii) in or
outside the Territory that apply to the performance of either Party's
obligations or covenants under this Agreement;
1.1.4 "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;
1.1.5 "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; and
(c) the equivalent law or regulation in any country in the Territory;
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1.1.6 "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;
1.1.7 "CMC Data " means that part of a Regulatory Application or Regulatory
Approval containing the data and other know how relating to the
chemistry and manufacturing controls and other manufacturing processes
for the Product, including relating to the Packaging and Labelling;
1.1.8 "Columbia Patent Rights" means all Patent Rights owned by or licensed
to Columbia containing claims reciting or covering Product as more
particularly set out in Exhibit A;
1.1.9 "Columbia UK" means a company registered in England and Wales under
company number 02425939 with the name Columbia Laboratories (UK)
Limited;
1.1.10 "Commencement Date" means the date of execution of this Agreement;
1.1.11 "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;
1.1.12 "European Regulatory Application" means the Regulatory Application
to be filed by Columbia UK with the Medicines Control Agency in the UK
seeking Regulatory Approval for the Product in the UK and to be used
by Columbia UK as the basis for mutual recognition Regulatory
Applications in the Territory, as the same is modified or amended from
time to time during the Regulatory Application process;
1.1.13 "Expert's Decision" means the procedure set out in Exhibit E;
1.1.14 "FDA" means the Governmental Authority in the USA with the name
"Food and Drug Administration";
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1.1.15 "Finished Product" means Product in final Packaged and Labelled form
ready for ultimate commercial sale or use
1.1.16 "First Commercial Sale" means the first invoiced commercial sale by
Ardana, its Affiliates, agents or sublicensees in any country in the
Territory after grant of Regulatory Approval and pricing approval (if
required) for Finished Product in such country;
1.1.17 "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, 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;
1.1.18 "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
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(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.
1.1.19 "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;
1.1.20 "Governmental Authority" shall mean all governmental and regulatory
bodies, agencies, departments or entities that regulate, direct or
control commercial and other related activities in the Territory,
including any relevant government health authority (or successor
agency thereof) in any country or countries in the Territory whose
approval is necessary to market the Finished Product in such country
or countries in the Territory;
1.1.21 "Indication" shall mean all indications in men, including
hypogonadism;
1.1.22 "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
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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 ▇▇▇ ▇▇▇▇; 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
(d) a proposal for a voluntary arrangement shall have been made in
relation to that Party under Part I Insolvency ▇▇▇ ▇▇▇▇; 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 Columbia
under the laws of Bermuda and in the case of Columbia
Laboratories Inc under the laws of USA but for avoidance of doubt
including in the case of Columbia Laboratories, Inc. 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
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(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 ▇▇▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇;
1.1.23 "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;
1.1.24 "Major Markets" shall mean [***];
1.1.25 "Marketing Authorisation" or "MA" means any Regulatory Approval for
Finished Product granted by the Governmental Authority of any country
of the Territory as the same may be varied from time to time during
the Term of this Agreement;
1.1.26 "Minimum Purchase Requirements" means the minimum purchase
requirements set out in Exhibit D as the same may be amended from time
to time during the term of this Agreement under the provisions of
Clause 7.5;
1.1.27 "NDA Filing" means the Regulatory Application for Product which is a
new drug application submitted by Columbia Laboratories, Inc. with the
FDA on August 19 2002;
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1.1.28 "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 chargebacks,
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 UK GAAP or its successor.
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
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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;
1.1.29 "Option Countries" shall mean the countries listed in Exhibit C;
1.1.30 "Parties" shall mean Columbia and Ardana and "Party" shall mean
either Columbia or Ardana;
1.1.31 "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;
1.1.32 "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 in any and all countries of the Territory
or to any of them, as well as any supplementary protection
certificates and equivalent protection rights in respect of any of
them;
1.1.33 "Product" shall mean the testosterone buccal bioadhesive product for
men that contains 30 mg testosterone as described in the NDA filing
and once the European Regulatory Application is first filed as
described in the same (and then no longer described in the NDA filing)
and once the UK MA is issued as described in such MA as the same may
be varied from time to time;
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1.1.34 "QA Tests" shall mean the quality assurance tests and testing
regimes for Finished Product as set out in the MA;
1.1.35 "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;
1.1.36 "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;
1.1.37 "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;
1.1.38 "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;
1.1.39 "SmPC" shall mean the summary of product characteristics containing
the information set out in Article 11 of EU Directive 2001/83;
1.1.40 "Specifications" shall mean the specifications for Finished Product
set forth in each MA in the Territory;
1.1.41 "Technical Agreement" shall mean the agreement to be made between
the Parties as specified in Clause 11.4;
1.1.42 "Territory" shall mean those European countries listed in Exhibit B;
1.1.43 "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 MA including the style of printing;
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1.1.44 "Trademark(s)" shall mean one or more trademarks or trade names that
are owned or licensed by or on behalf of Columbia or its Affiliates
that the Parties identify pursuant to Clause 4.1 for use in connection
with the sale or promotion of the Finished Product by Ardana in the
Territory provided that such trademark or trade name is approved by
any relevant Governmental Authority in the Territory in relation to
the European Regulatory Application and any subsequent MA. As at the
Commencement Date, the trademark "STRIANT(TM)" shall be deemed to be
the nominated trademark of Columbia hereunder as the First Trademark
(as defined in Clause 4.1) but it remains subject to the approval of
the Governmental Authorities in the Territory.
1.2 Further Definitions.
In addition to the definitions set forth under Clause 1.1 above, the following
definitions have the meanings in the Clauses corresponding thereto, as set forth
below:
Definition Clause
---------- ------
MiPharm Agreement 2.3
First Trademark 4.1
New Trademark 4.1
Trademark Usage Manual 4.5
FCPA 6.14
Purchase Price 7.1
Assessing Party 7.2
Assessed Party 7.2
Committee 8.1
Members 8.1
Chairman 8.1
Initiating Party 9.1
Additional Studies 9.5
Forecasts 10.1
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Purchase Order 10.2
Visual Inspection 10.6
Recall Costs 11.3
Indemnified Party 13.3
Indemnified Party 13.4
Term 15
Assessing Party 16.5.6
Assessed Party 16.5.6
Assignee 19.4
Remaining Party 19.4
Expert Exhibit E
2. license/appointment
2.1 Subject to the provisions of Clause 2.2 and 2.3 Columbia hereby grants to
Ardana for the Term an exclusive license for and in the Territory to and
under Columbia Patent Rights and the Trademarks to develop, manufacture,
have manufactured, use, import, have imported, market, distribute and sell
or have marketed, distributed and sold the Product and Finished Product.
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 [***] 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 and Columbia's prior
written approval (which approval may be withheld by Columbia in its sole
discretion).
2.2 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 Clause 16.5 of this Agreement it shall not utilise the
license granted to it under Clause 2.1 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 Clauses 5, 7 and 10
of this Agreement.
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2.3 Ardana acknowledges that Columbia has granted to MiPharm S.p.A. a
non-exclusive license under the Columbia Patent Rights for the sole purpose
of manufacturing the Product in accordance with an agreement made between
Columbia and MiPharm dated 7 May 2002 ("MiPharm Agreement"). Columbia
agrees during the term of this Agreement not to extend the scope of the
grant of license rights under the Columbia Patent Rights granted in the
Territory to MiPharm beyond the manufacturing rights set out in the MiPharm
Agreement but for the avoidance of doubt it is declared that as this
Agreement does not include Italy in the Territory, Columbia shall be free
to grant MiPharm marketing and distribution rights under the Columbia
Patent Rights for Italy (and after taking into consideration Clause 3 for
anywhere else outside the Territory if Columbia so chooses).
2.4 Columbia shall forthwith following the Commencement Date supply to Ardana a
copy of the CMC Data forming part of the NDA Filing. As and when any
variation to such CMC Data is made Columbia shall supply a copy thereof to
Ardana.
2.5 As soon as Columbia UK has made the first European Regulatory Application
Columbia shall supply to Ardana a copy of the European Regulatory
Application. As and when any variation to the European Regulatory
Application is made Columbia shall supply a copy thereof to Ardana.
2.6 Columbia hereby assigns to Ardana any and all copyright, database rights or
other rights in data, know how and other intellectual property (but for the
avoidance of doubt excluding the Columbia Patent Rights and the Trademarks)
which subsist in or relate to the European Regulatory Application in any
country of the Territory.
2.7 It is acknowledged and agreed that under the provision of Clause 5.1.1
Columbia will procure that Columbia UK progresses the European Regulatory
Application using all commercially reasonable efforts to obtain an MA in
each country of the Territory. Forthwith following the grant of each MA in
the Territory, Columbia shall procure that Columbia UK provides Ardana with
a copy thereof and transfers to Ardana such MA. Forthwith following the
Commencement Date, Columbia shall procure that Columbia UK signs transfer
forms to be used for such purposes in such circumstances to the extent that
such transfer forms are used and are available from the relevant
Governmental Authorities. Until the MA is granted in each country of the
Territory,
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although Columbia UK shall be named in each European Regulatory
Application, it shall hold the same on trust for Ardana.
2.8 Once Ardana is the MA holder in any country of the Territory:
2.8.1 Ardana hereby grants to Columbia irrevocable permission to cross
refer to any MA when Columbia UK is continuing with the mutual
recognition procedure in relation to the Territory and, when Columbia
is making Regulatory Application for Product in any country outside
the Territory and upon Columbia's request, Ardana will, within 30 days
of such request, supply Columbia with a copy of the MA;
2.8.2 Ardana shall sign a transfer form to be used in the circumstances of
Clause 16.3.3. and only in such circumstances to the extent that such
transfer forms are used and are available from the relevant
Governmental Authorities; and
2.8.3 on or before the approval of the MA in the last of the Major Markets,
and from time to time thereafter, Columbia may identify a country in
the European Union (subject to the approval of Ardana which shall not
be unreasonably withheld) and Ardana shall forthwith supply to
Columbia a copy of the MA for such country. As and when any variation
to such MA is made Ardana shall supply a copy thereof to Columbia.
2.9 Columbia undertakes and agrees that during the Term it will not, and will
procure that its Affiliates do not, appoint any other licensee,
distributor, reseller or other person to market, distribute and sell the
Product or Finished Product in the Territory nor will it, and it will
procure that its Affiliates do not, directly supply for their own account
the Product or Finished Product to distributors, resellers or users located
within the Territory.
2.10 Columbia shall, and Columbia shall procure that its Affiliates shall,
during the Term promptly refer to Ardana (or as Ardana shall direct) all
enquiries they receive for Finished Product for sale or ultimate delivery
within the Territory.
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2.11 Ardana shall exercise its rights conferred under this Clause 2 as principal
and it shall not sell or otherwise dispose of Finished Product on behalf
of, or in the name of Columbia or any of its Affiliates.
2.12 Ardana shall not claim any agency or other relationship which indicates any
authority to bind Columbia or its Affiliates contractually or incur
liabilities on behalf of Columbia or its Affiliates.
2.13 Columbia shall at its own cost and expense be solely responsible for the
filing, prosecution and maintenance of the Columbia Patent Rights and the
Trademarks in the Territory, and shall use its reasonable efforts to
prosecute all patent applications forming part of Columbia Patent Rights
and all trademark applications forming part of Trademarks in all countries
of the Territory (including the conduct of any claims or proceedings
relating to them including any opposition reissue or re-examination or
proceedings). Columbia will take account of Ardana's interest hereunder
when making any submission to a patent or trademark office in relation to
the Columbia Patent Rights or Trademarks in the Territory.
2.13.1 In the event that Columbia declines to pay the official fee to
maintain any issued Columbia Patent Rights or Trademark in the
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 or Trademark in Columbia's own name and expense
and Columbia shall do so.
2.13.2 In the event that Columbia declines to file or, having filed,
declines to further prosecute and maintain any Columbia Patent Rights
or Trademarks in the 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
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Columbia should continue to file or prosecute such Columbia Patent
Rights or Trademarks. Columbia shall then have the option, with at
least twenty (20) Business Days notice to Ardana, to:
2.13.2.1 continue to file or prosecute such Columbia Patent Rights or
Trademarks in Columbia's own name and expense; or
2.13.2.2 allow Ardana to file or prosecute such Columbia Patent Rights
or Trademarks in Columbia's name and at Columbia's 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.
2.14 Ardana shall promptly notify Columbia in writing if it becomes aware of any
infringement or unauthorized use by a third party of the Columbia Patent
Rights or Trademarks in the Territory.
2.15 In the event of an infringement of the Columbia Patent Rights or Trademarks
by a third party in the Territory, Columbia 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 Territory in accordance with the following:
2.15.1 as an exclusive licensee in the 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
Territory, whether at trial or by way of settlement, in obtaining a
financial payment to Columbia and/or Ardana:
2.15.1.1 Columbia shall first deduct for itself all of its costs and
expenses incurred in relation to such proceedings; and
2.15.1.2 Ardana shall then be entitled for itself all of its costs and
expenses incurred in relation to such proceedings; and
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2.15.1.3 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 Territory subject to the
provisions of sub-clauses 2.15.1.1 and 2.15.1.2 or, if in such
proceedings a court has not so allocated damages within the
Territory the Parties shall share such damages [***], subject to
the provisions of sub-clauses 2.15.1.1 and 2.15.1.2;
2.15.2 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 Territory. If Columbia succeeds
in any such proceedings in relation to an infringement in the
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 Territory, and, in the event of any balance remaining in
relation to the Territory, [***] shall be allocated to Columbia and
[***] to Ardana;
2.15.3 If Columbia fails to institute an action or proceeding in relation
to an infringement in the Territory for more than [***] from becoming
aware of the infringement pursuant to this Clause 2.15 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 Territory, and shall be entitled to retain any
financial payment awarded in such proceedings or agreed in any such
settlement for its own account. 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 2.15.4.
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2.16 If during the Term, either Party receives any notice, claim or proceedings
from any third party alleging infringement of that third party's Patent
Rights or trademarks by reason of any Party's activities in relation to
this Agreement, then the Party receiving that notice shall:
2.16.1 forthwith notify the other Party of the notice, claim or proceeding;
2.16.2 neither Party shall make any admission of liability;
2.16.3 the Parties shall consult with each other, taking advice from their
patent or trademark attorneys as to whether they consider the third
party intellectual property infringed and if so whether the claim of
infringement is valid;
2.16.4 in the event that the Parties consider that there is infringement of
such third party's intellectual property rights in relation to the
Territory, 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
Parties shall do so using a single counsel to be jointly appointed by
them at their joint cost and expense. Alternatively, the Parties may
agree to seek a license from such third party in which case Columbia
shall be responsible for doing so. If the 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.
3. EXTENSION OF THE TERRITORY
3.1 [***]
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4. TRADEMARKS
4.1 The Parties agree that, subject to consultation through the Committee, it
shall be Columbia's responsibility and expense to provide a single
Trademark (the "First Trademark") for Finished Product satisfactory to the
Governmental Authorities in the Territory which can be used for launch of
such Finished Product in the Territory. For the avoidance of doubt it is
declared and agreed that subject to the views of such Governmental
Authorities, this may or may not be the Trademark STRIANT. If at any time
thereafter Columbia or Ardana desires Ardana to sell the Product in the
Territory under a trademark other than the First Trademark, Columbia or
Ardana, as the case may be, shall send written notice to the other
requesting a Committee meeting to consider the selection of a different
Trademark. In the event a different Trademark is proposed by a Party: (i)
the different Trademark (the "New Trademark") must be acceptable to
Columbia (acting reasonably) having regard to Columbia's desire to have a
global Trademark, (ii) the New Trademark must be acceptable to the
Government Authority in each jurisdiction where a use of the New Trademark
would require making the change to the applicable Regulatory Application or
Regulatory Approval, (iii) all costs (including reasonable attorneys' fees)
for filing and prosecuting applications to register, and maintaining
registration of such New Trademark in the Territory will be paid by (A)
Ardana, if Ardana requested the New Trademark, or (B) Columbia, if Columbia
requested the New Trademark, and (iv) any New Trademarks shall be
registered in the name of, be owned by and be the sole
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property of Columbia and subject to the terms and conditions set forth in
this Clause 4.
4.2 In relation to any Trademark other than the First Trademark, if any
Governmental Authority in any country of the Territory insists on the use
of a trademark other than such Trademark in such country, Columbia or
Ardana, as the case may be, shall send written notice to the other
requesting a Committee meeting to consider the issue. At such Committee
meeting the Parties shall agree either (i) that the country in question is
sufficiently significant that the Trademark should be changed in all
countries of the Territory (in which case the terms set out in Clause
4.1(i) (ii) and (iv) shall apply) or (ii) that the preferable course is to
adopt a different trademark only in such country (in which case the term
set out in Clause 4.1(iv) shall apply). In either case all costs (including
reasonable attorneys' fees) for filing and prosecution any new trademark
applications will be shared equally by the Parties.
4.3 Ardana agrees to Commercialize Finished Product solely under the Trademark.
Ardana shall ensure that each reference to and use of the Trademark by
Ardana in any marketing material related to the Finished Product is
acceptable to Columbia as specified in Clause 4.6 and is accompanied by an
acknowledgement that the Trademark is a trademark or registered trademark
owned by Columbia and used by Ardana under license.
4.4 The initial Trade Dress for the Finished Product shall be as set out in the
European Regulatory Application. Once Ardana is the MA holder it may
request Columbia to modify or alter the Trade Dress for the Finished
Product. In such a case Columbia shall implement such modifications or
alterations on the following terms:
4.4.1 Ardana shall supply Columbia with full details of such new Trade
Dress and if the cost and expense of printing Packaging with such new
Trade Dress is greater than the cost and expense of the [***] used by
or on behalf of Columbia for the Trade Dress set out in the European
Regulatory Application, Columbia shall, within 60 days of receipt of
details of such new Trade Dress, advise Ardana in writing of such
additional cost and expense relating to preparing and printing such
new Trade Dress specified as a price
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in Euros per 60 tablet package (or other package volumes as agreed
between the Parties);
4.4.2 if Ardana decides to proceed, Ardana shall be responsible for
commissioning and acquiring all related artwork, plates and other
materials necessary to print the Packaging in the new Trade Dress; and
4.4.3 if Ardana decides to proceed, the additional price of Product
identified by Columbia under Clause 4.4.1 shall be added to the
purchase price under Clause 7.1.
4.5 Columbia shall provide Ardana with a copy of Columbia's Trademark Usage
Manual relating to the manner of use of the Trademark, and may update the
Trademark Usage Manual from time to time as Columbia finds appropriate and
necessary. Ardana shall comply with the Trademark Usage Manual.
4.6 A copy of the marketing material (which the Parties agree may be in draft
layout) using or otherwise containing the Trademarks in the form to be
distributed, referenced or otherwise used by Ardana in connection with its
Commercialization of the Product shall be provided to Columbia not less
than thirty (30) days before Ardana intends to release, distribute,
reference or use such material and Columbia shall have fifteen (15)
Business Days from receipt of the same to provide Ardana with any comments
or suggested amendments in relation to the use of the Trademark. Ardana
shall take such reasonable comments or suggested amendments into account
subject always to Ardana's responsibilities as the holder or intended
holder of the MA relating to Product. If Columbia does not provide any
comments or suggested amendments within such fifteen (15) Business Day
period Columbia shall be deemed to have approved the use of the Trademarks
in such marketing material. The restrictions of this Clause 4.6 shall not
apply in relation to marketing or promotional material relating to Ardana
(as opposed to the Commercialization of Product) and Ardana shall be free
to use the Trademarks in Ardana's own promotional material and
presentations (for example, company presentations during fund raising
activities), provided, always, that it does so in accordance with the
Trademark Usage Manual.
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4.7 The final decision on Packaging, design and Labelling shall be Ardana's;
provided, however, that (i) with respect to all Finished Product
manufactured by Columbia's contract manufacturer Mipharm S.p.A., as far as
practicable, subject to Applicable Laws and the MAs, on the Packaging there
will be printed "Manufactured by Mipharm S.p.A., Milan, Italy" and (ii) the
Packaging and Labelling 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.
4.8 Columbia shall as directed by Ardana (acting in accordance with the
requirement of the relevant MA), ensure that the external Packaging of the
Finished Product includes Ardana's name and logo, which name and logo as
holder of the MA in the Territory shall be in as large a typeface and in as
prominent a position as is required and/or is permissible under the
Applicable Law of each country of the Territory. Save to the extent Ardana
may be required to do so by a Governmental Authority or pursuant to the
requirements of the MA, Ardana shall not alter the Packaging or Labelling
of the Product nor shall Ardana conceal or otherwise obscure, remove or
otherwise interfere with the Trademarks or other markings, which Columbia,
in its sole discretion, may include on the Packaging or Labelling of the
Product.
4.9 Ardana shall provide Columbia with information and examples as to Ardana's
use of the Trademarks, as Columbia may request, to permit Columbia's proper
maintenance and registrations of the Trademarks.
4.10 Ardana expressly acknowledges that Columbia owns the Trademarks, and the
considerable goodwill associated therewith. Ardana shall not attack,
dispute, or contest the validity of Columbia's ownership of the Trademarks
or any registrations issued or issuing with respect thereto, both during
the Term and/or thereafter. Ardana further agrees that any use of the
Trademarks by Ardana shall be for the benefit of Columbia and any goodwill
accrued in connection with the use and display of the Trademarks shall
accrue solely to the benefit of Columbia and not Ardana. In the event
Ardana acquires any rights relating to the Trademark for any reason, Ardana
agrees to assign to Columbia, at no cost to Columbia, all such rights,
together with any related goodwill. Ardana shall not do or perform any act
that may endanger,
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destroy, or similarly affect the value of the goodwill pertaining to the
Trademarks nor do any act that might support a petition to cancel or
otherwise invalidate any registration relating to the Trademarks or cause
the applicable registrar to require a disclaimer of exclusive rights in
such Trademarks nor assist any other person or other entity, directly or
indirectly, in so doing. Ardana will, at any time, upon the request of
Columbia, execute any documents reasonably required by Columbia to confirm
Columbia's ownership of all such rights in the Trademarks.
4.11 Ardana shall not sell or otherwise distribute any Finished Product under
any other trademark, logo or other indicia other than as contemplated under
the terms and conditions of this Agreement.
4.12 Ardana shall not use any trademarks or trade names (other than the
Trademarks) so resembling the Trademarks so as to be likely to cause
confusion, dilution, or deception. Ardana shall not register the Trademarks
in its own name nor attempt to register any trademarks, marks, or trade
names confusingly similar to the Trademarks.
5. COLUMBIA OBLIGATIONS
5.1 Upon and subject to the terms and conditions of this Agreement, Columbia
hereby agrees at its own cost and expense:
5.1.1 to procure that Columbia UK uses commercially reasonable efforts to
obtain an MA in each Major Market of the Territory by filing and
progressing the European Regulatory Application. In the event that any
Governmental Authority in a Major Market requests that any further
clinical trials, studies or investigations be conducted in the
Territory before such Governmental Authority grant an MA, Columbia
shall promptly conduct or have conducted such trials, studies or
investigations at Columbia's cost and expense.
5.1.2 to provide Ardana with reasonable advance notice of all material
meetings or calls with Governmental Authorities in the Territory
relating to the European Regulatory Applications and permit a maximum
of 2 Ardana personnel to attend such meetings or calls as an observer
at Ardana's sole cost and expense;
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5.1.3 to manufacture or have manufactured and to supply to Ardana such
amounts of the Finished Product for Ardana's Commercialization of the
Product in the Territory, as Ardana may order from time to time on
terms and otherwise in accordance with Clause 10 below and to
manufacture or have manufactured and supply the Finished Product in
the manner specified in the relevant MA of each country of the
Territory and in accordance with cGMP, the Specifications and the
Technical Agreement;
5.1.4 to use commercially reasonable efforts to obtain a manufacturing
authorisation for the purposes of manufacturing Finished Product in
relation to each and every site at which manufacture (or any part
thereof) of Finished Product shall occur, to provide Ardana with a
copy of such manufacturing authorisation(s) and to provide Ardana with
advance written notice of any proposed change to such manufacturing
authorisation(s) in order that Ardana may make any relevant variations
to the Regulatory Approval(s);
5.1.5 to ensure that Product is handled and stored by it in accordance with
all Applicable Laws and to ensure that it creates and retains
manufacturing, analytical and distribution records, testing and
releasing materials, undertakes production and quality controls,
including in-process controls and all necessary stability studies, and
analysis relating to the Product all in accordance with the
Specification and cGMP;
5.1.6 to have in place a Qualified Person, which Qualified Person shall be
responsible for batch release of Product in the Territory and to
supply Finished Product which has been released in the Territory for
sale in the Territory by a Qualified Person in accordance with
Applicable Laws;
5.1.7 to put in place and maintain a technical agreement with each of its
contract manufacturers from time to time (including in particular
Mipharm) as required by any Governmental Authority which technical
agreement shall be identical to the extent required by any
Governmental Authority in the Territory (save as to the parties) to
the Technical Agreement to be agreed pursuant to Clause 11.4;
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5.1.8 to procure that Ardana, or its duly appointed agent, shall have the
right to inspect the premises of Columbia or Columbia's contract
manufacturer(s) where the Finished Product is manufactured, Packaged
or Labelled, which inspections may take place no more often than once
per year upon advance notice at any reasonable time;
5.1.9 to ensure that no changes in chemistry and manufacturing controls
specified in the CMC Data in the MA for the Finished Product in the
Territory are made without Ardana's having obtained the prior approval
of each applicable Governmental Authority for such changes if such
approval is required;
5.1.10 to keep Ardana informed in a timely manner of any information
brought to Columbia's attention which in Columbia's reasonable
judgment could lead to a variation of the MA, SmPC, Packaging or
Labelling (subject to any overriding provisions of the
pharmacovigilance procedures agreed pursuant to Clause 11.3);
5.1.11 to provide Ardana with reasonable assistance in relation to any
questions or issues raised by any Governmental Authority relating to
Finished Product or the Regulatory Approvals, including, but not
limited to, the provision of any relevant background data relating to
Product in Columbia's possession or control;
5.1.12 to supply the Finished Product in Packaging as required by Ardana
which incorporates all information (including the patient information
leaflet) that may be required by the relevant MA, any Governmental
Authority or any Applicable Law from time to time;
5.1.13 to notify Ardana promptly of any proposed inspections by any
Governmental Authority (either in the Territory or outside of the
Territory) of the facilities at which Finished Product is manufactured
and procure that Ardana has a right to attend on such occasions if the
inspection is by a Governmental Authority in the Territory and in any
event Columbia shall inform Ardana of the outcome;
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5.1.14 to establish and maintain a scientific service for scientific
information relating to the Product and to liaise with Ardana in
relation to any enquiries made to such service;
5.1.15 to retain and archive all documentation relating to the Product
including, in particular, documentation relating to regulatory matters
and to clinical trials of Product; and
5.1.16 to investigate promptly and report to Ardana all significant
customer complaints or reports of incidents relating to the Finished
Product affecting quality of which it has knowledge and co-operate
with Ardana in the handling of such complaints and in accordance with
Clause 11.2 and to provide a copy of each investigation report under
this Clause 5.1.16 to Ardana.
6. ARDANA OBLIGATIONS
6.1 Upon and subject to the terms and conditions of this Agreement, Ardana
hereby agrees at its own cost and expense:
6.1.1 subject to provisions of Clause 2.7 to maintain the MAs received in
relation to the Territory, including by filing variations to such MAs
as necessary; and
6.1.2 to provide Columbia with reasonable advance notice of all material
meetings or calls with Governmental Authorities relating to the MAs. A
maximum of 2 Columbia personnel may attend such meetings or calls at
its own cost and expense.
6.2 Ardana, as the holder of the MAs in the Territory and without limiting its
obligations under this Agreement or under any Applicable Law, shall comply
with the content and terms of all MAs.
6.3 Ardana shall establish and maintain a scientific service for scientific
information relating to the Product and shall liaise with Columbia in
relation to any enquiries made to such service;
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6.4 Ardana shall use its reasonable commercial efforts to promote, market and
sell the Finished Product, in each country within the Territory launching
the same in such country within [***] of both Regulatory Approval 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 Ardana's sole discretion) and to establish a
sales force appointed and trained in accordance with Good Industry Practice
to promote the Finished Product in the Major Markets. Ardana shall use its
reasonable commercial efforts to obtain any relevant pricing approvals in
the countries where such approval is required. Additionally, Ardana shall:
6.4.1 comply at all times with all Applicable Laws pertaining to the
Commercialization of the Product, as applicable, including without
limitation, purchase, storage, handling, marketing, promotion,
distribution, offering for sale and sale of the Product in each
country of the Territory;
6.4.2 notify Columbia of the identity of any proposed third party
distributor and Columbia shall have [***] to approve such distributor
(which approval shall not be unreasonably withheld) and provided that
the terms of appointment of such distributor shall prevent the further
appointment of sub-distributors without first obtaining Ardana's and
Columbia's prior written approval (which approval may be withheld for
any or no reason);
6.4.3 either itself or through its agents or distributors maintain adequate
facilities for the efficient Commercialization of the Finished Product
throughout the Territory;
6.4.4 purchase from Columbia such quantities of the Finished Product as
will enable Ardana to maintain sufficient stocks to meet all
reasonably foreseeable demands for the Finished Product in the
Territory;
6.4.5 in dealing with or handling the Finished Product follow the
reasonable instructions of Columbia, and provide for or have provided
the storage of the Finished Product in a manner consistent with the
terms of the applicable MA and Applicable Law;
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6.4.6 in marketing and selling the Finished Product,
6.4.6.1 not make any statements, representations, warranties or
guarantees concerning the Finished Product which are contrary to
the MA for the Finished Product or Applicable Laws; and
6.4.6.2 avoid any misleading or deceptive marketing practices or any
other promotional activities that may harm or otherwise damage
Columbia's or its Affiliates image or reputation, whether within
the Territory or outside the Territory;
6.4.7 keep the Committee (as hereinafter defined) 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 Ardana 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. Ardana shall also promptly inform the Committee of any
other information that it now has or which it may receive in the
future which in Ardana's opinion is likely to be of interest, benefit,
or use to Columbia in relation to the sale of the Finished Products
outside the Territory;
6.4.8 maintain or have maintained the Finished Product, pending
distribution and sale to customers, in a facility that is properly
equipped (including temperature and humidity control) to store
pharmaceutical and other sensitive products. Columbia, or its duly
appointed agent, shall have the right to inspect the premises of
Ardana or sub-contractor where the Finished Product is held, stored,
and/or distributed, and Ardana shall permit such inspection or arrange
for such inspection no more often than once per year, upon advance
notice at any reasonable time, of the methods and procedures used in
the distribution, storage and sale of the Finished Product and provide
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to Columbia all government inspection reports and certificates
relating thereto promptly upon Ardana's or its sub-contractors'
receipt thereof;
6.4.9 investigate promptly and report to Columbia all significant customer
complaints or reports of incidents relating to the Finished Product
affecting quality of which it has knowledge and co-operate with
Columbia in the handling of such complaints and in accordance with
Clause 11.1. Ardana shall provide a copy of each investigation report
under this Clause 6.4.9 to Columbia.
6.4.10 keep Columbia informed in a timely manner of any information brought
to Ardana's attention which in Ardana's reasonable judgment could lead
to a variation of the MA, SmPC, Packaging or Labelling (subject to any
overriding provisions of the pharmacovigilance procedures agreed
pursuant to Clause 11.2); and
6.4.11 retain and archive all documentation relating to the Product,
including, in particular, documentation relating to regulatory matters
and to clinical trials of Product;
6.5 Ardana agrees that it shall not, without Columbia's prior written approval
(not to be unreasonably withheld), distribute or sell in the Territory a
testosterone product for the Indication other than the Product.
6.6 Ardana shall not Commercialize the Product in conjunction or otherwise
together with any other products as a loss leader without Columbia's prior
written approval, which approval may be withheld by Columbia for any
reason, provided always that Ardana shall be permitted to sell and promote
Finished Product with other products on an arms-length basis in accordance
with Good Industry Practice.
6.7 Ardana shall be responsible for all costs and expenses associated with its
Commercialization activities.
6.8 Ardana, at its sole cost and expense, shall be responsible for obtaining
all necessary permissions, consents and licences (other than the MAs),
required to Commercialize the Finished Product in each country in the
Territory under any Applicable Law,
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including without limitation, any import approvals, wholesale dealer's
licenses and pricing and reimbursement approvals. Columbia agrees to
reasonably cooperate with Ardana in obtaining any such additional necessary
authorizations and approvals required to launch the Finished Product in
each country in the Territory, including representatives of Columbia
attending meetings with the relevant Governmental Authorities if so
requested by Ardana together with Ardana at Columbia's own cost and expense
for such attendance.
6.9 Ardana shall be responsible for setting the sales price of Finished Product
in the Territory.
6.10 Ardana 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:
6.11 Ardana shall not:
6.11.1 advertise the Finished Product or canvass or solicit orders for the
Finished Product outside the Territory; or
6.11.2 open branches for the sale of the Finished Product outside the
Territory; or
6.11.3 maintain distribution depots for the Finished Product outside the
Territory.
6.12 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
foregoing representation and warranty from time to time in writing, as
Columbia shall request.
7. PRICE, PAYMENT TERMS AND SALES TARGETS
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7.1 Ardana shall purchase from Columbia all of its requirements for the
Finished Product at a fixed cost of Euro [***] for a package of 60 tablets
(the "Purchase Price") (or as otherwise agreed between the Parties in
respect of different package volumes). Such price shall apply before and
from First Commercial Sale subject to review at each anniversary of the
first of the month following First Commercial Sale as follows:
7.1.1 Columbia shall inform Ardana whether there has been any increase to
the cost of Columbia obtaining Finished Product from its contract
manufacturer;
7.1.2 Columbia shall use its reasonable efforts to avoid any such proposed
increase under its manufacturing agreement with its contract
manufacturer and to source Finished Product at a more competitive
price (in accordance with the provisions of such agreement); and
7.1.3 in the event that having fulfilled its obligations under Clause 7.1.2
the cost of supply of Finished Product to Columbia is increased then
the Purchase Price may be increased by Columbia provided that such
increase shall be no greater than the increase in [***] for the
previous 12 month period;
7.1.4 for the avoidance of doubt any increase in the Purchase Price
pursuant to this Clause 7.1 shall only apply to the extent of any
increase in the price of supply of Product to Columbia.
7.2 Columbia shall keep and shall procure that its Affiliates, agents,
distributors and subcontractors keep true and accurate records and books of
account containing all data necessary for the verification by Ardana under
sub-clauses 7.1.1 to 7.1.4. Those records and books of account shall be
kept for seven (7) years following the end of the year to which they
relate. Upon Ardana's (the "Assessing Party") written request a firm of
accountants appointed by agreement between the Parties (or, failing such
agreement within ten (10) Business Days of the initiation of discussions
between them on this point and at the request of either Party by the
President for the time being of the Institute of Chartered Accountants of
England and Wales in London) shall carry out a review procedure in relation
to Columbia's (the "Assessed Party") cost of obtaining Finished Product as
follows:
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7.2.1 such firm of accountants shall be given access to and shall be
permitted to examine 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 Columbia applied the provisions of sub-clauses
7.1.1 to 7.1.4;
7.2.2 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 7.2 envisages;
7.2.3 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;
7.2.4 the Assessed Party shall make available personnel to answer queries
on all books and records required for the purpose of the
certification;
7.2.5 if the certification shows that the Assessed Party has not applied
the provisions of sub-clauses 7.1.1 to 7.1.4 the Parties shall
forthwith recalculate the price which should have been paid by Ardana
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 that the Assessed Party has charged the Assessing
Party a price more than [***] in excess of the recalculated price and
the responsibility of the Assessing Party otherwise.
7.3 Upon shipment of Product to Ardana, Columbia shall submit invoices therefor
to Ardana. Ardana shall pay each invoice in full within thirty (30) days
after the date of invoice. All payments shall be made in Euros.
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7.4 It is acknowledged and agreed that the Minimum Purchase Requirements
operate as follows: if in any year following the date of First Commercial
Sale Ardana has not purchased from Columbia the volume of Product set out
in the Minimum Purchase Requirements for that year because of lack of
market demand or other reason. In such circumstances Ardana shall at its
option:
7.4.1 issue a Purchase Order or Purchase Orders to Columbia in accordance
with the procedures set out in Clause 10 for the outstanding
quantities for delivery during that year in which case there shall be
no breach of this Agreement by Ardana; or
7.4.2 fail to purchase the outstanding quantities during such year in which
case Ardana shall be in material breach of this Agreement and the
remedy provisions of Clause 16.1.1 shall not apply.
7.5 No later than 180 days before the end of the [***] period commencing on the
date of First Commercial Sale and covered by the Minimum Purchase
Requirements the Parties shall meet and shall seek to agree Minimum
Purchase Requirements for the [***] of this Agreement. If the Parties fail
to agree such new Minimum Purchase Requirements on or before 90 days before
the end of [***] the setting of the Minimum Purchase Requirements for the
[***] period shall be referred to the Expert's Decision. In making this
decision the expert shall:
7.5.1 invite written submissions from each of the Parties putting forward
justification for the Minimum Purchase Requirements which they are
proposing; and
7.5.2 invite oral submissions of no more than [***] utilising whatever
experts the Parties so choose putting forward justification for the
Minimum Purchase Requirements which they are proposing.
8. COMMERCIALISATION COMMITTEE
8.1 Ardana and Columbia shall create a Commercialisation Committee (the
"Committee") to consist initially of two persons as voting members
("Members"), one of whom shall be nominated by Ardana and one of whom shall
be nominated by Columbia. Each
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Member shall be entitled to exercise one (1) vote each on the Committee,
whether or not present at any Committee meeting. Columbia shall also be
entitled to appoint one of its nominees to be the chairman of the Committee
("Chairman"). In the event of a deadlock in relation to those issues set
out in Clauses 8.6, the Chairman shall be entitled to cast the deciding
vote. The Committee will meet no less frequently then [***].
8.2 Each of Ardana and Columbia shall be entitled to remove their Member and
appoint a replacement therefor. The number of Members may be altered if
agreed to by Ardana and Columbia in writing; provided, however, that, each
of Ardana and Columbia shall be entitled to appoint an equal number of
Members.
8.3 The quorum for meetings of the Committee shall be two (2) Members. The
venue for meetings not held by teleconference shall alternate between the
offices of Ardana in Edinburgh, Scotland and the offices of Columbia's
Affiliate 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 Committee meetings.
8.4 The Committee shall have power to invite persons whose special skills or
influence might advance the Commercialisation of the Product, in confidence
and upon behalf of the Committee, to attend and address meetings of the
Committee. Each party shall give the other reasonable advance notice of the
identity of any such additional attendees which it intends to participate
in the Committee 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 Committee.
8.5 The Chairperson shall take responsibility for promptly preparing the
minutes of any Committee meeting, receiving approval of those minutes from
the other Committee Member who participated in the meeting, obtaining each
Member's signature on the approved minutes and promptly distributing a copy
of the signed minutes to each Party.
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8.6 The Committee shall be a co-ordination, liaison and communication forum in
relation to the global issues relating to Product and shall only be a
decision making forum in relation to strategic regulatory issues affecting
the Product, provided, always, that Ardana shall never be required to agree
to or implement any decision of the Committee which would be contrary to
Ardana's responsibilities as the holder of the MAs in the Territory or to
Applicable Laws.
9. CLINICAL STUDIES, TRIALS AND INVESTIGATIONS
9.1 Either Party (the "Initiating Party"), may from time to time, propose to
the other Party that additional clinical trials, studies or investigations
be initiated in relation to the Product including adding a further
indication to the European Regulatory Application or the MAs ("Additional
Studies"). The Parties shall meet and discuss the same in good faith and if
the Parties agree the plans and protocols for such Additional Studies
(including which Party shall be the sponsor of such Additional Studies) and
the cost of such Additional Studies will be shared equally between the
Parties. If the Parties do not agree to jointly fund such Additional
Studies then the provisions of Clause 9.2 and 9.3 shall apply.
9.2 If Ardana is the Initiating Party it shall obtain the prior written
approval of Columbia, which approval may be withheld by Columbia for any
reason or no reason, on the proposed Additional Studies prior to initiating
such Additional Studies and shall prepare, maintain and deliver to
Columbia, complete and accurate copies of records and reports, including
progress, safety and final reports. Columbia shall reasonably cooperate and
assist Ardana in obtaining any Regulatory Approvals required for additional
indications or other revised Labelling of Product in the Territory
justified by the outcome of such Additional Studies, including attendance
at meetings with relevant Governmental Authorities and Ardana shall file
(if applicable) variations to the MAs and use its reasonable efforts to
obtain such variations to the MAs relating to such Additional Studies at
its own cost and expense.
9.3 If Columbia is the Initiating party, Columbia shall give Ardana the
opportunity to comment upon such Additional Studies and shall keep Ardana
informed of the progress of such Additional Study and shall provide to
Ardana a written report of the outcome of such Additional Studies. Columbia
shall prepare, maintain and deliver to
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Ardana, complete and accurate copies of records and reports, including
progress, safety and final report. Columbia shall reasonably cooperate and
assist Ardana in obtaining any variations to the MAs required for
additional indications or other revised Labelling of Product in the
Territory justified by the outcome of such Additional Studies including
attendance at meetings with relevant Governmental Authorities and Ardana
shall file (if applicable) for such variations to the MAs and use its
reasonable efforts to obtain such variations to the MAs relating to such
Additional Studies at its own cost and expense.
9.4 Where Ardana is the Initiating Party a final report of the Additional Study
results from all Additional Study sites shall be prepared by Ardana and
reviewed by Columbia, and may thereafter be released or submitted for
publication by Ardana for use at conferences and publication in scientific
journals.
9.5 All rights in and to any data, results, information, inventions,
discoveries and/or improvements arising out of the performance of an
Additional Study, whether patentable or not, conceived, made, obtained or
developed ("the Data Package") pursuant to an Additional Study shall vest
in and remain the property of Columbia, provided always that the rights in
such Data Package shall be the subject of the license to Ardana under
Clause 2.1 and the assignment to Ardana under Clause 2.6. If Columbia uses
the Data Package outside the Territory by licensing or otherwise
authorising the use of the same by a third party (including the appointment
of a distributor):
9.5.1 if such Data Package has been generated pursuant to an Additional
Study funded by Ardana then notwithstanding that Columbia owns such
rights in such Data Package in the event that Columbia grants to a
third party any such rights to use such Data Package it shall pay to
Ardana one hundred percent (100%) of the consideration received from
such third party for the right to use such Data Package;
9.5.2 if such Data Package has been generated pursuant to an Additional
Study funded jointly between Ardana and Columbia then in the event
that Columbia grants to a third party any right to use such Data
Package it shall
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pay to Ardana fifty per cent (50%) of the consideration received from
such third party for the grant of the right to use such Data Package.
10. FORECASTS; ORDERS; DELIVERY AND ACCEPTANCE
10.1 No later than three months prior to the anticipated date of First
Commercial Sale of Finished Product in the Territory and each Quarter
thereafter, Ardana shall prepare and provide Columbia with a written
forecast by Quarter of its requirements for Product ("Forecasts") for the
immediately succeeding four full Quarters, including, with respect to the
first Forecast, the period between the anticipated date of First Commercial
Sale and the beginning of the first Quarter following First Commercial
Sale. The amounts set forth for the first Quarter in each Forecast shall
constitute a firm purchase order and shall be binding upon Ardana. The
amounts set forth in the following three (3) Quarters shall constitute
Ardana's non-binding, good faith estimate of the Product requirements of
Ardana for such periods; provided, however, that in relation to the amounts
set forth for the second Quarter when such Quarter becomes the first
Quarter of the next Forecast the amounts set forth in such first Quarter
shall not be less than eighty percent (80%) nor shall Columbia be obligated
to supply greater than one hundred twenty percent (120%) of the amounts set
forth in the immediately preceding Forecast for such Quarter, but Columbia
may agree to supply such greater amount in its sole discretion.
10.2 Each firm purchase order provided to Columbia by Ardana pursuant to Clause
10.1 above shall be in writing and shall specify the description of the
Finished Product ordered, the quantity ordered, the price and required
delivery date therefore ("Purchase Order"). In the event of a conflict
between the terms and conditions of any Purchase Order and this Agreement,
the terms and conditions of this Agreement shall prevail. Columbia shall
have no obligation to supply quantities of Finished Product (i) in the
event Ardana places orders for amounts of Product that are smaller than
Columbia or its contract manufacture standard manufacturing batch size for
the Product and the amount of Product remaining after filling orders from
other Columbia customers are not available in sufficient quantity to fill
the order placed by Ardana; or (ii) in relation to quantities of Finished
Product specified in the Purchase Order in excess of one hundred and twenty
percent (120%) the quantities specified in the previous Forecast for such
Quarter provided under Clause 10.1 above.
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10.3 Columbia shall within ten (10) days of the receipt of any Purchase Order
from Ardana made pursuant to Clause 10.2 give written notice to Ardana if
it cannot fulfil such Purchase Order and the provisions of Clause 16.1
shall apply.
10.4 All Finished Product supplied under this Agreement shall be delivered Ex
Works (INCOTERMS 2000) Columbia's or its nominee's manufacturing and/or
distribution facility in Europe and shall be accompanied by a written
certificate of analysis signed by the Qualified Person confirming that such
quantity of Finished Product meets the Specification. Ardana shall secure
transport and insurance with its own providers at its sole cost and
expense. Ardana shall pay all freight, insurance charges, taxes, import and
export duties, inspection fees and other charges applicable to the sale and
transport of Finished Product purchased by Ardana hereunder which amounts
shall be separately set forth on Columbia's invoices to Ardana. Title and
risk of loss and damages to Finished Product purchased by Ardana hereunder
shall pass to Ardana upon receipt of the Finished Product by the carrier
designated by Ardana at Columbia's facility. Columbia acknowledges that it
shall be obliged to supply Finished Product to Ardana from a manufacturing
and/or distribution facility in Europe. In the event that Columbia
manufactures or has manufactured the Finished Product outside Europe it
shall so notify Ardana and the delivery terms set out in this Clause 10.4
shall be amended such that Columbia shall supply Finished Product to Ardana
CIF (INCOTERMS 2000) to a delivery site in Europe and provided that such
Finished Product is released in the Territory by a Qualified Person in the
Territory. For the avoidance of doubt this shall not result in any change
to the Purchase Price.
10.5 Following receipt of a shipment of Finished Product from Columbia, Ardana
or its designated agent shall, within thirty (30) days, carry out a visual
inspection (as defined below) of such shipment to ensure that Packaging and
Labelling of Finished Product has taken place in accordance with the
Specification and is accompanied by an associated Certificate of Analysis
and if Ardana determines in its sole discretion (exercised reasonably) that
it has not so taken place it shall promptly notify rejection of shipment to
Columbia in writing. Subject to the provisions of Clause 10.7, if Ardana
does not notify Columbia of rejection of such shipment within such thirty
(30) days, such shipment of Finished Product shall be deemed to have been
accepted.
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10.6 For the purposes of this Agreement, "visual inspection" shall mean:
10.6.1 comparing the applicable order against the documentation
accompanying the shipment to verify that the delivery date, identity,
quantity and exterior shipment labelling comply with the order;
10.6.2 verifying that the Certificate of Analysis for the shipment states
that the Product conforms in all material respects to the applicable
Specifications; and
10.6.3 visually inspecting the exterior of the shipment of Finished
Products to verify that the shipment appears to be in good condition.
For the avoidance of doubt, visual inspection does not include laboratory
analysis.
10.7 Notwithstanding the foregoing, Columbia shall remain liable to Ardana to
the extent provided in Clause 10.8 or 10.9 as appropriate for any latent
defect that subsequently is discovered which renders the Finished Product
unsaleable, if such defect is due to the failure of the Finished Product to
meet Specification and/or cGMP and provided that Ardana immediately inform
Columbia by a notice in writing of such defect and rejection of the
relevant shipment not later than ten (10) days from the date of discovery
of such latent defect.
10.8 Within 10 days of receipt by Columbia of a notice of rejection from Ardana
in accordance with Clauses 10.5 or 10.7 Columbia shall indicate in writing
to Ardana whether Columbia is issuing a return authorisation or not. In the
event that a return authorisation is so issued Ardana shall return to
Columbia at Columbia's expense the quantities of Finished Product in
question and Columbia shall replace such quantities within sixty (60) days
or as soon as reasonably practicable thereafter. If the payment in respect
of such quantities is outstanding, it shall be postponed until such
replacement quantities are received and accepted by Ardana in accordance
with this Clause 10.
10.9 After receipt of any rejection notice from Ardana pursuant to Clause 10.5
or Clause 10.7 if Columbia does not issue a return authorisation under
Clause 10.8, Columbia shall analyze any batch of Finished Product rejected
by Ardana for nonconformity
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with the Specifications within thirty (30) days of receipt of such notice,
and present its findings with respect to such Finished Product to Ardana.
If such tests confirm non-conformity with the Specification Columbia shall
promptly supply to Ardana (at Columbia's cost and expense) a conforming
batch in the same quantity as the rejected batch and shall reimburse Ardana
for any out of pocket costs or expenses incurred by Ardana including
shipping charges in relation to such non-conforming batch. If the Parties
cannot agree on whether the batch of Finished Product in question conforms
to the Specifications, an independent qualified laboratory reasonably
acceptable to both Parties, and at a cost equally shared by both Parties,
shall analyze both Ardana's and Columbia's samples of Product in question,
and the definitive results of such laboratory shall be binding on the
Parties. If the batch of Finished Product in question is determined to be
nonconforming, such nonconforming Finished Product shall be held for
Columbia's disposition, or shall be returned to Columbia, in each case at
Columbia's expense, as directed by Columbia no later than fifteen (15) days
following such determination. Columbia shall replace each nonconforming
batch of Finished Product, or the nonconforming portion thereof, with
conforming Finished Product within sixty (60) days or as soon as reasonably
practical after receipt of notice of rejection thereof. If the batch of
Finished Product in question is determined to be conforming and provided
that the Certificate of Analysis did not indicate it to be nonconforming,
such Finished Product shall be returned to Ardana at Ardana's cost and
expense.
10.10 Columbia shall use its commercially reasonable efforts to establish or
have established a second manufacturing site for of the Finished Product.
10.11 Columbia shall, at its own cost and expense hold for Ardana [***] stocks
of Finished Product for each of the Major Markets at levels commensurate
with the quantities ordered by Ardana in its previous Quarterly Purchase
Order for Finished Product in such country. In the event that Columbia is
forced to supply these safety stocks to Ardana in order to meet Ardana's
Purchase Order(s) in circumstances where Columbia cannot replenish these
safety stocks as a result of any failure of Columbia's contract
manufacturer to supply Columbia with Finished Product manufactured in
accordance with cGMP and to Specification for whatever reason, such failure
to replenish the safety stocks shall not constitute a breach of this Clause
10.11 by
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Columbia provided always that Columbia shall replenish such safety stocks
as soon reasonably practicable.
10.12 Columbia shall employ stock rotation methods and techniques consistent
with Good Industry Practice so as to ensure that Finished Product delivered
to Ardana has a minimum of [***] of its shelf life unexpired.
11. REGULATORY AND OTHER MATTERS
11.1 Except as may otherwise be agreed, Ardana shall refer any significant
complaints or reports of incidents which it or any of its Affiliates
receives concerning the Finished Product affecting quality to Columbia
within four (4) working days of Ardana's receipt of the same, provided,
that all complaints concerning suspected or actual Finished Product
tampering, contamination or mix-up shall be delivered within one (1)
working day of receipt of the same by Ardana or any Affiliate or
subcontractor of Ardana. For the avoidance of doubt, to the extent that any
such complaint amounts to or relates to an Adverse Reaction the terms of
the pharmacovigilance procedures to be agreed by the Parties pursuant to
Clause 11.2 shall apply in relation to such complaint: in the event of any
inconsistency between the application of this Clause 11.1 and such
pharmacovigilance procedures, the terms of such pharmacovigilance procedure
shall prevail.
11.2 The Parties agree that within nine months of the Commencement Date they
shall agree on a product recall procedure, subject always to the other
provisions of this Agreement, a Packaging and Labelling procedure, and a
pharmacovigilance procedure, all in accordance with Applicable Laws.
11.3 Notwithstanding that the Parties shall agree upon product recall procedure
pursuant to Clause 11.2, the Parties agree that the costs of recall shall
be met as follows: if a recall arises due to any act or omission by Ardana
the cost of goods sold, distribution expenses and third-party recall
expenses (collectively, the "Recall Costs") shall be borne by Ardana; if a
recall arises from any other reason then the Recall Costs shall be borne by
Columbia. Ardana shall maintain records of all sales of Product and
customers sufficient for Ardana (as appropriate) to adequately administer a
recall for the period required by Applicable Law.
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11.4 Within 9 months (or such other period as is agreed by the Parties) of the
Commencement Date the Parties shall agree upon a technical agreement as
required pursuant to Directive 2001/83.
11.5 In addition to the requirements of Clauses 11.1 and 11.3 and the items
agreed under Clause 11.2, 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, (b)
which indicates or suggests a potential material liability for either Party
to third parties arising in connection with any Product, or (c) which is
reasonably, likely to lead to a Recall of any Product, including in all
cases, but not limited to:
11.5.1 Governmental Authority inspections of manufacturing, distribution or
other related facilities, in which Product is manufactured, stored or
otherwise present;
11.5.2 receipt of a warning letter from any Governmental Authority relating
to any Product; or
11.5.3 initiation of any Governmental Authority investigations, detention,
seizure or injunction concerning any Product.
11.6 Columbia shall keep Ardana regularly informed of all material
correspondence and communications with any Governmental Authority in the
Territory concerning the manufacture, Specification, quality or Packaging
of the Finished Product by it or its contract manufacturer.
11.7 If Columbia is advised by its legal advisers that it must communicate with
any Governmental Authority in the Territory on any matter the subject of
Clauses 11.5 or 11.6, Columbia shall so advise Ardana immediately and,
unless prohibited by Applicable Law, Columbia shall provide Ardana 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 Ardana concerning any meeting or written or oral
communication with such Governmental Authority.
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12. SIGNATURE AND MILESTONE FEE
12.1 Signature Fee. In consideration of the obligations of Columbia under
Clauses 2.4 and 2.5 and in partial consideration of the rights assigned
hereunder under Clause 2.6 Ardana shall pay Columbia a non-refundable
signature fee of two million dollars (US$2,000,000) upon execution of this
Agreement or subsequent date agreed upon.
12.2 Milestone Fees.
12.2.1 Ardana shall pay to Columbia a non-refundable milestone payment of:
12.2.1.1 one million dollars (US$1,000,000) upon acceptance by the
Governmental Authority in the UK the Medicines Control Agency of
the European Regulatory Application being complete and sufficient
for the purpose of seeking Regulatory Approval in the UK in
further partial consideration of the rights assigned hereunder
under Clause 2.6;
12.2.1.2 one million dollars (US$1,000,000) on or before December 15,
2002,in further partial consideration of the rights assigned
hereunder under Clause 2.6;
12.2.1.3 eight hundred thousand dollars (US$800,000) upon receipt of
the MA for the Product in [***] in consideration of Columbia's
obligations under Clause 2.7 in relation thereto;
12.2.1.4 [***] dollars ($[***]) upon Marketing Authorisation for the
Product received in [***] for a total of US$1,200,000 and in
consideration of Columbia's obligations under Clause 2.7 in
relation thereto; and
12.2.1.5 in final partial consideration of the rights assigned
hereunder under Clause 2.6, two million dollars ($2,000,000)
within sixty (60) days of the end of the calendar month in which
cumulative Net Sales of the Product by Ardana, its Affiliates
and/or its licensees for all of the countries in the Territory
exceed US$[***]. Until this payment is
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made Ardana shall report to Columbia as specified in Clauses
16.5.5 and 16.5.6.
Columbia will invoice Ardana for the payment set out in 12.2.1.2 and,
provided that Ardana received such invoice, it shall pay to Columbia the
sum due under such clause on or before the 15th December 2002. Columbia
will invoice Ardana for each payment due under Clauses 12.2.1.3 to 12.2.1.5
on the occurrence of the event and, provided that Ardana receives such
invoice, Ardana shall pay such invoice within 15 Business Days of receipt
of invoice.
12.3 All payments under the terms of the Agreement are expressed to be exclusive
of value added tax howsoever arising.
12.4 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.
12.5 All payments made to Columbia under the Agreement shall be made by
telegraphic transfer to the account of Columbia at:
[***]
Account Name: [***]
Account Code: [***]
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ABA Code: [***]
or any other bank account that may be notified by Columbia to Ardana from
time to time.
12.6 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.
13. WARRANTIES, INDEMNIFICATION; LIMITATION OF LIABILITY; AND INSURANCE
13.1 Each Party represents and warrants to the other Party that:
13.1.1 it has the corporate power and authority and the legal right to
enter into this Agreement 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 which it is
bound, nor violate any law or regulation of any court, governmental
body or administrative or other agency having jurisdiction over it;
13.1.2 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;
13.1.3 in the case of Columbia it has the right to grant the licenses
granted under Clause 2.1 and to make the assignment under Clause 2.6
and to enter into its other obligations under this Agreement and that
it has taken any corporate
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action with Columbia Affiliates which is necessary for this to be the
case and that it has the authority to act as agent for Columbia UK in
the matters specified in this Agreement and the corporate power to
procure Columbia UK as specified in this Agreement. Columbia further
hereby warrants and undertakes that at the Commencement Date that save
as otherwise disclosed to Ardana in writing it has not assigned,
licensed, mortgaged, charged or otherwise disposed of or encumbered
the right, title or interest in the Columbia Patent Rights and that so
far as it is aware the exercise by Ardana of its rights hereunder
shall not infringe the Patent Rights or trademarks or other
intellectual property rights of any third party;
13.1.4 it is a corporation duly organised, validly existing and in good
standing under the laws of the jurisdiction in which it is
incorporated; and
13.1.5 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.
13.2 EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT COLUMBIA MAKES NO
WARRANTIES OR REPRESENTATIONS, IMPLIED OR EXPRESS, WITH RESPECT TO THE
PRODUCT, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, USE, PERFORMANCE,
NON-INFRINGEMENT OR PATENTABILITY AND ANY SUCH WARRANTIES ARE HEREBY
EXPRESSLY DISCLAIMED.
13.3 Subject to the provisions of Clause 13.4 and 13.5 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
13.3.1 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
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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
13.3.2 a breach of warranty by Columbia under Clauses 13.1.
An Indemnified Party that intends to claim indemnification under this
Clause 13.3 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.
13.4 Subject to the provisions of Clause 13.5, 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
13.4.1 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
13.4.2 as a result of a breach of warranty by Ardana under Clause 13.1.
An Indemnified Party that intends to claim indemnification under this
Clause 13.4 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
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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 any matter
covered by this indemnification.
13.5 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:
13.5.1 of a direct nature where the same is a loss of turnover, profits,
business or goodwill; or
13.5.2 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.
13.6 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 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 Practice to
increase this cover to a level of [***] dollars (US$[***]) in the aggregate
per year if this is achievable by Ardana.
13.7 Ardana shall secure and maintain comprehensive general liability insurance
with insurers having an AM Best rating within the top 2 categories at the
time (at the date of this Agreement known as "superior" or "excellent")
including product liability, contractual liability, personal injury, and
insurance against claims regarding the delivery, storage and handling and
use of Product under this Agreement, in such amounts as it customarily
maintains for similar products and activities in accordance
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with prudent insurance practice, but in no event less than [***] pounds
sterling (GB(pound)[***]) per occurrence and in the aggregate per year.
Ardana shall use commercially reasonable efforts following First Commercial
Sale and at intervals thereafter in accordance with Good Industry Practice
to increase this cover to a level in pounds equal to [***] dollars
(US$[***]) in the aggregate per year if this is achievable by Columbia.
13.8 Each Party shall maintain such insurance described in Clauses 13.6 and 13.7
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.
14. CONFIDENTIALITY
14.1 The content of the NDA Filing and the European Regulatory Applications and
any of the information pertaining to the Product or their respective
businesses that has been prior to the Commencement Date or will be
communicated by Ardana to Columbia, on the one hand, or by Columbia to
Ardana, on the other hand, including without limitation, trade secrets,
business methods and plans, and pricing, cost, manufacturing and customer
information shall be treated by Columbia and Ardana, respectively, and
their respective Affiliates, officers, directors, employees, agents and
representatives, as confidential information and shall not be disclosed to
third parties or be used except 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 14 to the extent that such
confidential information:
14.1.1 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;
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14.1.2 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;
14.1.3 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;
14.1.4 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
14.1.5 in the case of the European Regulatory Applications is required to
be disclosed to the relevant Governmental Authorities in the Territory
and thereafter once an MA is granted is contained in the Packaging,
Labelling or SmPC.
14.2 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.
14.3 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:
14.3.1 a Party may disclose the full terms of this Agreement to its
investment bankers, lawyers, accountants and other professional
advisors or a third
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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
14.3.2 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.
14.4 In respect of those public announcements and disclosures not permitted by
Clause 14.3 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 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.
15. TERM
The term of this Agreement (the "Term") shall commence on the date hereof
and shall continue for a period of the later of: (i) ten (10) years from
the First Commercial Sale of the Finished Product by Ardana; or (ii) the
date of expiration or lapse of the last to expire or lapse of rights under
any Columbia Patent Rights in the Territory on a country by country basis.
The Term shall automatically extend for successive periods of one (1) year
each unless either Party provides written notice to the other, at least
ninety (90) days prior to the end of the then existing Term, of its
intention not to renew this Agreement.
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16. TERMINATION
16.1 This Agreement may be terminated immediately upon written notice of
termination given by either Ardana on the one hand (in circumstances where
either Columbia is in breach as specified in Clause 16.1.1 or Columbia or
Columbia Laboratories, Inc. satisfy the criteria of Clause 16.1.2) or
Columbia on the other hand (where Ardana satisfies the criteria below):
16.1.1 in the event that 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:
16.1.1.1 in the case of a breach by Ardana of Clause 12.2 in which
case the remedy period shall be ten (10) days; and
16.1.1.2 in the case of a breach by Columbia under any of the
manufacturing and supply obligations of this Agreement the remedy
period shall be ninety (90) days; or
16.1.2 in the event that an Insolvency Event occurs in relation to such
person.
16.2 Termination of this Agreement (whether under this Clause 16, 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.
16.3 Upon the effective date of expiration or earlier termination of this
Agreement by Columbia pursuant to Clause 16.1 and subject always to the
provisions of Clause 6.6:
16.3.1 Ardana shall remit to Columbia any payments that are due and payable
as of the date of expiration or termination;
16.3.2 Ardana's rights and license under Clause 2.1 within the Territory
shall terminate and Ardana shall reassign to Columbia the subject
matter of Clause 2.6. At Columbia's request Ardana shall execute an
undated assignment to achieve this which Columbia shall only have the
right to date such that it is effective under the circumstances of
this Clause 16.3;
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16.3.3 Ardana shall supply to Columbia a copy of all MAs within 30 days of
the date of termination and commensurate with Applicable law Ardana
shall transfer to Columbia or its nominee all MAs in the Territory and
Ardana shall not following any such termination use such MA. In the
event that in any country of the Territory such a transfer is not
possible, Ardana shall ensure that Columbia has the benefit of the MA
and to this end hereby grants to Columbia irrevocable permission to
cross refer to any such MA when filing an MA for Finished Product in
its own name;
16.3.4 Columbia and Ardana shall return to each other all confidential
information supplied by one Party to the other, including all copies
and originals thereof;
16.3.5 At Columbia's option, (i) Ardana may have [***] from the
Commencement Date of expiration or termination to sell all existing
stocks of Product inventory (including, at Columbia's option, any
Product ordered by Ardana but not yet delivered by Columbia, which
Columbia may obligate Ardana to purchase), and/or (ii) Ardana shall
purchase any unused Packaging and Labelling held by Columbia or its
contract manufacturer bearing Ardana's name or trademark, and/or (iii)
Columbia may cancel any or all outstanding Product Orders; and/or (iv)
Columbia may repurchase all or some of the Product previously
delivered but not sold at a price equal to the price paid by Ardana
therefor less (a) any sums owed by Ardana to Columbia; and (b) any
sums attributable to any damage to Finished Product.
16.3.6 Ardana shall at Columbia's cost and expense promptly pack and ship
to such destination as Columbia may direct all Finished Product other
than that in relation to which Columbia exercises its option under
Clause 16.3.5;
16.3.7 The provisions of Clauses 13 and 14 shall continue to apply.
16.4 Upon termination of this Agreement as a result of a non-renewal notice by
Columbia pursuant to Clause 15:
16.4.1 the provisions of Clause 16.3.2, 16.3.3 and 16.3.4 shall apply;
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16.4.2 Columbia shall repurchase all of the Finished Product (other than
Finished Product which has become unsaleable due to any act or
omission of Ardana or any of its Affiliates) then owned by Ardana at a
price equal to the price paid by Ardana therefor less (a) any sums
owed by Ardana to Columbia; and (b) any sums attributable to any
damage to Finished Product; and Ardana shall have no obligation to
purchase Product ordered by Ardana but not yet delivered by Columbia;
16.4.3 [***]
16.4.4 the provisions of Clauses 13 and 14 shall continue to apply.
16.5 Upon termination of this Agreement by Ardana pursuant to Clause 16.1:
16.5.1 the license granted to Ardana under Clause 2.1 shall continue;
16.5.2 if at the date of termination any of the European Regulatory
Applications are still being progressed Columbia shall procure that
Columbia UK ceases such activity and shall procure that to the extent
possible under Applicable Law Columbia UK transfers the outstanding
European Regulatory Applications into the name of Ardana. In the event
that in any country of the Territory such a transfer is not possible
Columbia shall ensure that Ardana can proceed with the European
Regulatory Applications in Ardanas own name and to this end hereby
grants to Ardana (in so granting acting as duly authorized agent for
Columbia UK) irrevocable permission to cross refer to the European
Regulatory Applications in the name of Columbia UK when filing such
European Regulatory Applications in Ardana's own name;
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16.5.3 Thereafter Ardana shall have the right exercisable in its
discretion to terminate its obligation to obtain its requirements
of Finished Product from Columbia under Clause 2.2 and the
corresponding manufacturing and supply provisions of this
Agreement set out in Clauses 5, 7 and 10 on giving 30 days
written notice to Columbia.
16.5.4 Where Ardana terminates the manufacture and supply arrangements
under the provisions of Clause 16.5.3 Ardana shall pay to
Columbia a royalty equal to [***]. If Ardana exercises its rights
under Clause 16.5.3, Columbia will at its own cost and expense
procure that its contract manufacturer or contract manufacturers
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 previously
appointed by Columbia;
16.5.5 Ardana shall make the payments due to Columbia under Clause
16.5.4 at Quarterly intervals. Within 30 days of the end of each
Quarter Ardana shall prepare a statement which shall show on a
country by country basis in the Territory for the previous
Quarter all monies due to Columbia. That statement shall be
submitted to Columbia within 30 days of the end of the Quarter to
which it relates together with remittance of the monies due. The
following provisions shall also apply:
16.5.5.1 Ardana shall pay the sums due to Columbia from a single
source in Euros. Such payments shall be made free and clear
of and without deduction or deferment in respect of any
disputes or claims whatsoever and/or as far as is legally
possible in respect of any taxes imposed by or under the
authority of any government or public authority. Any tax
(other than VAT) which Ardana is required to pay or withhold
in respect of the payments to be made to Columbia hereunder
shall be deducted from the amount otherwise due provided
that, in regard to any such deduction, Ardana shall give
Columbia such assistance,
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which shall include the provision of such documentation as
may be required by any revenue authority and other revenue
services, as may reasonably be necessary to enable Columbia
to claim exemption therefrom or obtain a repayment thereof
or a reduction thereof and shall upon request provide such
additional documentation from time to time as is needed to
confirm the payment of tax. For the avoidance of doubt it is
declared and agreed that Ardana shall be liable to pay
Columbia the full amount of all sums due notwithstanding any
reason why monies in respect of any relevant sales cannot be
remitted to the country in which they are headquartered.
16.5.5.2 Where Finished Product is sold in a currency other than
Euros the rate of exchange to be used for converting such
other currency into Euros shall be the midpoint rate at
which such other currency can be sold for Euros as listed in
the Financial Times published on the first working date
after the last working date for the period for which payment
is to be made.
16.5.6 Ardana 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 Columbia pursuant
to this Agreement, and in particular but without limitation data
relating to the calculation of Net Sales. Those records and books
of account shall be kept for seven (7) years following the end of
the Year to which they relate. Upon Columbia's (the "Assessing
Party") written request a firm of accountants appointed by
agreement between the Parties (or, failing such agreement within
ten (10) Business Days of the initiation of discussions between
them on this point and at the request of either Party by the
President for the time being of the Institute of Chartered
Accountants of England and Wales in London) shall carry out a
review procedure in relation to Ardana's (the "Assessed Party")
as follows:
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16.5.6.1 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
Sales calculated by the Assessed Party its Affiliates and/or
agents, distributors or licensees during any Year was calculated
in accordance with Clause 1.1.28 or, if this is not their
opinion, to indicate that this is the case and to specify in
detail why the Net Sales figures were not so calculated. The
Parties shall then recalculate the Net Sales in accordance with
such detailed guidance;
16.5.6.2 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 16.5.6 envisages;
16.5.6.3 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;
16.5.6.4 the Assessed Party shall make available personnel to answer
queries on all books and records required for the purpose of that
certification;
16.5.6.5 the cost of the accountant shall be the responsibility of the
Assessed Party if the Parties recalculation shows the Assessed
Party's previous figures supplied to the Assessing Party to be
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inaccurate by more than five per cent (5%) and the responsibility
of the Assessing Party otherwise. Within ten (10) Business Days
following any such recalculation any monies which such
recalculation shows as being due and owing by one Party to the
other shall be paid by that Party.
16.5.7 at its option, Columbia shall continue to prosecute, maintain and
defend the Columbia Patent Rights and Trademarks as specified in
Clause 2 or shall transfer to Ardana the files and papers necessary
for Ardana to do so, following which Ardana shall undertake such
prosecution, maintenance and defence using its reasonable commercial
judgement and deduct the cost and expense thereof from the royalties
payable by Ardana under Clause 16.5.4.
16.5.8 the provisions of Clauses 2.3 to 2.6 inclusive, 2.8 as appropriate,
2.9 to 2.16 inclusive, 3, 4, 9, 11, 13, 14, 18 and 19 shall continue
to apply.
17. FORCE MAJEURE
17.1 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.
17.2 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.
18. RECORDS INSPECTION; RECORD RETENTION
18.1 Columbia shall ensure that its contract manufacturer retains all production
records of the processing and manufacture of the Finished Product in
accordance with all relevant guidelines and applicable laws in the
Territory. Columbia will retain samples of the Product as are required in
all countries where Regulatory Approval has been obtained. Once during each
calendar year, Columbia shall ensure and/or Columbia
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shall permit Ardana or its duly authorized representatives, upon reasonable
written notice and at any reasonable time during normal business hours, can
visit and inspect the production, testing, packing, and shipping facilities
for the Product during normal business hours to verify compliance with this
Agreement.
18.2 Once during each calendar year, Ardana shall permit Columbia or its duly
authorized representatives, upon reasonable written notice and at any
reasonable time during normal business hours, to have access to, and to
inspect distribution, packaging and/or storage facilities relating to the
Product.
Any inspection shall be at the expense the Party conducting such
inspection.
18.3 Retention of Records. All documentation, records, raw data, and specimens
pertaining to this Agreement will be held for the length of time required
under Applicable Law.
19. GENERAL PROVISIONS
19.1 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.
19.2 Dispute Resolution; Consent to Jurisdiction. This Agreement shall be
construed and interpreted in accordance with English law 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 the Dispute remains
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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 court of competent jurisdiction. The venue for such action,
suit or proceeding shall be in the English Courts. 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.
19.3 Notices.
19.3.1 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 19.3.3. 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.
19.3.2 Any notice given pursuant to this Clause shall be deemed to have
been received:
19.3.2.1 if delivered by hand or by courier, at the time of delivery
as evidenced in the receipt of delivery; or
19.3.2.2 if sent by recorded delivery, at the time of delivery.
19.3.3 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:
19.3.3.1 the date specified in the notification as the date on which
the change is to take place; or
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19.3.3.2 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.
19.4 Assignment. Columbia shall not assign this Agreement without also assigning
to the same assignee the Columbia Patent Rights and Trademarks and
conversely may not assign the rights the Columbia Patent Rights 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 the rights the subject of Clause 2.6
and the MAs and conversely may not assign the rights the subject of Clause
2.6 and the MAs (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.
19.5 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 deemed to be or considered as a further or continuing waiver of
any other provision of this Agreement.
19.6 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
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validity of the remaining agreements, provisions of terms contained herein
shall in no way be affected, prejudiced or invalidated thereby.
19.7 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.
19.8 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.
19.9 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.
19.10 Columbia Laboratories, Inc. hereby agrees, by executing this Agreement in
the space provided below and subject to Ardana's full compliance with the
procedures set forth in Clause 13.3 to indemnify, defend and hold Ardana
harmless for all liability, loss, damage, cost and expense (including legal
costs) incurred or suffered by Ardana as a result of any breach of warranty
by Columbia under 13.1 in the event that Columbia fails to satisfy any
claim of Ardana for such breach under the provisions of Clause 13.3.
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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/ ▇▇▇▇▇ ▇. Best By: /S/ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
-------------------------------------- -------------------------------
▇▇▇▇▇ ▇. Best ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
Name Name
CEO President
Title Title
16th October 2002 16th October 2002
Date Date
AGREED TO SOLELY FOR
PURPOSES OF CLAUSE 19.10:
COLUMBIA LABORATORIES, INC.
By: /S/ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇
--------------------------------------
▇▇▇▇ ▇▇▇▇▇▇▇▇▇
Name
President & CEO
Title
16th October 2002
Date
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EXHIBIT A
EUROPEAN PATENTS AND APPLICATIONS
"Basic Bioadhesive" Family
Patent No:
EP 163 696 B1 and all corresponding national patents in the Territory
EP 501 523 B1 and all corresponding national patents in the Territory
The Parties acknowledge that without SPC extension these patents will expire in
November 2003.
"Buccal Tablet" Family
Published Patent Application No:
EP 1 105 104 A1 and any future corresponding nation patents in the Territory
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EXHIBIT B
TERRITORY
Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Luxembourg
Netherlands
Portugal
Spain
Sweden
United Kingdom
Norway
Switzerland
Liechtenstein
Monaco
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EXHIBIT C
OPTION COUNTRIES
[***]
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EXHIBIT D
MINIMUM PURCHASE REQUIREMENTS
----------------------------------- ------------------------------------------
YEAR UNITS
----------------------------------- ------------------------------------------
[***] [***]
----------------------------------- ------------------------------------------
Assumptions
1. Years start from the first of the month following First Commercial
Sale in a Major Market in the Territory
2. [***] assumes regulatory approval in UK occurs before [***]
3. [***] assumes regulatory and reimbursement approval in [***]
4. If either of these assumptions proves incorrect the Parties will
renegotiate the Minimum Purchase Requirements in this table under the
provisions of Clause 7.5.
5. A unit is one 60 tablet package or the equivalent number of tablets in
other package volumes.
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EXHIBIT E
EXPERT'S DECISION
1. Any matter or dispute to be determined by an expert under this Agreement.
("Expert") shall be referred to a person suitably qualified to determine
that particular matter or dispute who shall be nominated jointly by the
Parties or, failing agreement between the Parties within twenty (20)
Business Days of a written request by either Party to the other seeking to
initiate the Expert's decision procedure, either party may request the
President for the time being of the Association of the British
Pharmaceutical Industry or any successor body to it to nominate the Expert.
2. The Parties shall with fourteen (14) days of the appointment of the Expert
meet with him/her in order to agree the program for oral written and oral
submissions provided for in Clause 7.5.
3. In all cases the terms of appointment of the expert by whomsoever appointed
shall include:
3.1. a commitment by the Parties to share equally the expert's fee;
3.2. a requirement on the expert to act fairly as between the Parties and
according to the principles of natural justice;
3.3. a requirement on the expert to hold professional indemnity insurance
both then and for three years following the date of his/her
determination;
3.4. a commitment by the Parties to supply to the expert the submissions
the subject of Clause 7.5 all such assistance, documents and
information as he/she may require for the purpose of his or her
determination.
3.5. a commitment by the Parties that all negotiations connected with the
dispute shall be conducted in confidence and without prejudice to the
rights of the parties in any future proceedings.
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4. The expert shall give a written decision which shall contain a factual
analysis, his/her conclusions and the reasons for his conclusions.
5. The expert's decision shall be final and binding on the Parties (save in
the case of negligence or manifest error).
6. The parties expressly acknowledge and agree that they do not intend the
reference to the expert to constitute an arbitration within the scope of
any arbitration legislation, the expert's decision is not a quasi judicial
procedure and the parties shall have no right of appeal against the
expert's decision provided always that this shall not be construed as
waiving any rights the parties might have against the expert for breaching
his/her terms of appointment or otherwise being negligent.
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EXHIBIT F
NAMES AND ADDRESSES FOR NOTICES
If to Columbia Laboratories (Bermuda), Ltd.,
Columbia Laboratories (Bermuda), Ltd.
P.O. Box HM 1179
Cedar ▇▇▇▇▇
▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇ ▇▇
▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇: Secretary
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
(▇▇▇) ▇▇▇-▇▇▇▇
If to Columbia Laboratories, Inc.,
Columbia Laboratories, Inc.
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attention: President
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
With copy to:
Columbia Laboratories, Inc.
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attention: General Counsel
Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
If to Ardana Biosciences Limited:
COO
Ardana Biosciences Limited
▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇
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