** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
EXHIBIT 10.1
EXECUTION COPY
DISTRIBUTION AND LICENSE AGREEMENT
BY AND AMONG
BARRIER THERAPEUTICS, INC.,
BARRIER THERAPEUTICS, N.V.
AND
GRUPO XXXXXX INTERNACIONAL, S.A.
NOVEMBER 4, 2004
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
DISTRIBUTION AND LICENSE AGREEMENT
THIS DISTRIBUTION AND LICENSE AGREEMENT (this "Agreement") is made and entered
into as of this 4th day of November, 2004 (the "Effective Date"),
BY AND AMONG:
BARRIER THERAPEUTICS, INC., a company
incorporated under the laws of the State of
Delaware, having its principal place of
business at 000 Xxxxxxx Xxxx Xxxx, Xxxxx
0000, Xxxxxxxxx, Xxx Xxxxxx 00000
(hereinafter referred to as: "BARRIER");
BARRIER THERAPEUTICS, N.V., a company duly
constituted under the laws of Belgium, having
its principal place of business at Xxxxxxxx
0, X-0000, Xxxx, Xxxxxxx and wholly-owned
subsidiary of BARRIER
(hereinafter referred to as: "BARRIER NV");
AND:
GRUPO XXXXXX INTERNACIONAL, S.A., a
corporation duly constituted under the laws
of Spain, having its principal place of
business at Gran Xxx Xxxxxx XXX, 00, 00000,
Xxxxxxxxx, Xxxxx
(hereinafter referred to as: "XXXXXX").
BARRIER NV is a party to this Agreement for the sole purpose of granting to
XXXXXX certain rights as described herein to (i) the Products in Belgium and
(ii) the Regulatory Approvals held in the name of BARRIER NV pursuant to the
provisions of Sections 2.2.1, 8.2 and 8.3.
PREAMBLE
WHEREAS BARRIER controls, through ownership or license, the rights to the
Products, the Trademarks, the Know-how and the Patents in the Territory;
WHEREAS XXXXXX and BARRIER desire to enter into an Agreement pursuant to which
(i) XXXXXX will undertake responsibility for the marketing, distribution and
sale of the Products on an exclusive basis throughout the Territory, and (ii)
XXXXXX will obtain, in the name, or for the benefit, of BARRIER, or assist
BARRIER to obtain, the Regulatory Approvals required to market, distribute and
sell the Products within the Territory; and
WHEREAS XXXXXX, to the extent necessary to carry out the provisions of this
Agreement, needs to become a licensee of certain Product IP Rights.
2
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
NOW, THEREFORE, in consideration of the mutual representations, warranties,
covenants and agreements herein contained, the Parties hereto, intending to be
legally bound, agree as follows:
1. DEFINITION AND SCHEDULES
1.1 DEFINITIONS
As used in this Agreement, the following terms shall have the following
respective meanings:
1.1.1 "AFRICAN REGION" means the following countries: Benin, Burkina Faso,
Burundi, Cameroon, Central African Republic, Chad, Comoros, Morocco,
Algeria, Congo, Gabon, Togo, Ghana, Senegal, Gambia, Guinea Bissau,
Guinea, Egypt, Madagascar, Ivory Coast, Djibouti, Niger, Rwanda, Mali,
Tunisia, Reunion, Zaire, and Nigeria.
1.1.2 "AFFILIATE" means, with respect to any Party, any Person that at
such time directly or indirectly, through one or more intermediaries,
controls or is controlled by or under common control with such Party. As
used in this definition, "control" means (i) in the case of a Person that
is a corporate entity, direct or indirect ownership of fifty percent (50%)
or more of the stock or shares having the right to vote (or such lesser
percentage which is the maximum allowed to be owned by a foreign
corporation in a particular jurisdiction) for the election of directors of
such Person or (ii) in the case of a Person that is an entity, but is not
a corporate entity, the possession, directly or indirectly, of the power
to direct, or cause the direction of, the management or policies of such
Person, whether through the ownership of voting securities, by contract or
otherwise.
1.1.3 "APPLICABLE PERCENTAGE" with respect to a Product has the meaning
set forth in Section 4.2 for such Product.
1.1.4 "BARRIER HOUSEMARKS" mean the trade/service xxxx(s), logo(s), trade
dress, trade names or other symbols or designations exclusively identified
with Barrier or its products.
1.1.5 "COMMERCIALLY REASONABLE EFFORTS" mean, with respect to a Party,
[**].
1.1.6 "COMPETING PRODUCT" has the meaning set forth in Section 2.3.4.
1.1.7 "COUNTRY GROUP" means any two or more countries within a Region
which XXXXXX and BARRIER have combined for purposes of determining a
Minimum Purchase Quota pursuant to Section 8.1 below. For clarity, no
individual country for which XXXXXX and BARRIER have agreed upon a Minimum
Purchase Quota shall be included in any Country Group.
1.1.8 "EFFECTIVE DATE" has the meaning set forth in the introduction of
this Agreement.
1.1.9 "EUROPEAN REGION" means the following countries: Austria, Belgium,
France, Germany, Greece, Italy, Luxemburg, the Netherlands, Portugal and
Spain.
3
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
1.1.10 "EXCLUDED COUNTRIES" means with respect to the Ketanserin Product
only: Mexico, Central America (i.e., Belize, Costa Rica, El Salvador,
Guatemala, Honduras, Nicaragua and Panama) and Dominica, Dominican
Republic, and Haiti.
1.1.11 "EXW" has the meaning set out in the Incoterms of 2000 published by
the International Chamber of Commerce ("ICC") as modified from time to
time.
1.1.12 "FIELD OF USE" means the use of Products for applications for
treatment or prevention of diseases of the human skin, hair, nails and /or
the oral or genital mucosa customarily diagnosed and treated by
dermatologists, excluding skin cancer, but including without limitation,
actinic keratosis. With respect to the Ketanserin Product in the Latin
American Region, the Field of Use shall not include anal fissures.
1.1.13 "FIRST COMMERCIAL SALE" means with respect to any country in the
Territory, the first bona fide commercial sale of the Product to a Third
Party by XXXXXX or an Affiliate or other permitted sub-distributor of
XXXXXX in such country.
1.1.14 "GOVERNMENTAL BODY" means any national, supra-national (e.g., the
European Commission or the European Medicines Agency), regional, state or
local regulatory agency, department, bureau, commission, council or other
governmental entity involved in the granting of Regulatory Approval.
1.1.15 "IMPROVEMENTS" means, with respect to a particular Product, any new
formulation, way of administration, dosage, of such Product and also any
new indication for such Product to which BARRIER may obtain rights during
the Term of this Agreement, including any of the foregoing that constitute
a Distributor Invention.
1.1.16 "INTELLECTUAL PROPERTY" means, any intellectual property rights
including, without limitation, any rights under any patent, Trademark,
trade secret, copyright or Know-How.
1.1.17 "J&J AGREEMENTS" means collectively (i) that certain Intellectual
Property Transfer and License Agreement, dated as of May 6, 2002, by and
between BARRIER and Xxxxxxx and Xxxxxxx Consumer Companies, Inc., and (ii)
that certain Intellectual Property Transfer and License Agreement, dated
as of May 6, 2002, by and among BARRIER, Xxxxxxx Pharmaceutica Products,
L.P., and Ortho-XxXxxx Pharmaceutical, Inc., each as amended.
1.1.18 "KETANSERIN PRODUCT" means the pharmaceutical product currently
identified as "Ketanserin" containing a serotonin 2 antagonist and all
Improvements thereto.
1.1.19 "KNOW-HOW" means the skill or ingenuity based upon the body of
knowledge which comprises all of the methods, processes, designs,
information, data, formulas, manuals, guidelines and trade secrets
relating to the Product including, without limitation, all information
necessary for obtaining the Regulatory Approvals.
1.1.20 "LATIN AMERICAN REGION" means the following countries, except to
the extent any such country constitutes an "Excluded Country" for the
Ketanserin Product: Argentina, Belize, Bolivia, Brazil, Chile, Colombia,
Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala,
Haiti, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay, and
Venezuela.
4
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
1.1.21 "LIABILITIES" means losses, damages, fines, costs, liabilities and
expenses (including the reasonable fees, costs and expenses of attorneys
and other professionals and court costs), awarded to or otherwise required
to be paid to Third Parties in connection with any civil, criminal,
statutory or regulatory claims of liability.
1.1.22 "LIAROZOLE PRODUCT" means the pharmaceutical product currently
identified as "Liarozole" containing a retinoic acid metabolism blocking
agent and all Improvements thereto. For clarity, "Liarozole Product" shall
not include the pharmaceutical product currently identified as Rambazole
or any other product with asole active ingredient other than Liarozole.
1.1.23 "MAA" means an application filed with the relevant Governmental
Body seeking Regulatory Approval to market and sell a Product in the
Territory.
1.1.24 "MINIMUM PURCHASE QUOTA" has the meaning set forth in Section 8.1
1.1.25 "MINIMUM SUPPLY PRICE" means (i) for the Zimycan Product, [**]
Euros per [**] gram unit, (ii) for the Sebazole Product, [**] Euros per
[**] gram unit, (iii) with respect to the Ketanserin Product and the
Liarozole Product [a price equal to BARRIER's cost of manufacturing plus
10% of Net Sales], provided that such amount does not exceed the amount
that would have occurred by applying the corresponding Applicable
Percentage listed under clause 4.2.1, and (iv) with respect to the other
unit sizes for the Zimycan Product and the Sebazole Product, the price
established in good faith by mutual agreement by the Joint Steering
Committee within thirty (30) days following the first submission of the
first MAA for such Product, or, in the case of a different unit size,
within thirty (30) days following the first submission for Regulatory
Approval for such unit size.
1.1.26 "NET SALES" means with respect to each Product sold in the
Territory, the gross amounts invoiced by XXXXXX, its Affiliates and
sub-distributors, on account of sales of each Product to Third Parties,
less the following:
1.1.26.1 trade, quantity and cash discounts, rebates and allowances
actually allowed or given, which are not already reflected in the
amount invoiced;
1.1.26.2 freight, postage, shipping insurance and other
transportation expenses incurred in transporting the Products in
final form to such customers to the extent included in the invoice
price and separately identified on the invoice;
1.1.26.3 credits, or refunds actually allowed for recalls of
Products;;
1.1.26.4 sales, excise and other consumption taxes, and tariffs and
duties directly related to the sale (including VAT) to the extent
included in the invoice price and to the extent such taxes are
remitted to the applicable taxing authority (but not including taxes
assessed against the income derived from such sale); and
1.1.26.5 any mandatory discounts or rebates to the competent
governmental authorities and/or social security systems pursuant to
governmental regulations.
5
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
1.1.27 "NET SELLING PRICE" means, with respect to each Product sold in the
Territory, the Net Sales for the applicable period divided by the quantity
of such Product sold.
1.1.28 "PARTY" means BARRIER or XXXXXX, and "PARTIES" means BARRIER and
XXXXXX.
1.1.29 "PATENTS" mean the patents listed in Schedule 1.1.29 as well as all
continuations, continuations-in-parts, divisions, and renewals thereof,
all patents which may be granted thereon, and all reissues,
reexaminations, extensions, patents of additions, and patents of
importation thereof, together with any foreign counterparts of any of the
foregoing.
1.1.30 "PERSON" means and includes any individual, corporation,
partnership, firm, joint venture, syndicate, association, trust,
Government Body, and any other form of entity or organization.
1.1.31 "PHARMACOVIGILENCE AGREEMENT" has the meaning set forth in Section
11.1.
1.1.32 "PRODUCTS" mean the Zimycan Product, the Sebazole Product, the
Ketanserin Product and the Liarozole Product.
1.1.33 "PRODUCT IP RIGHTS" means to the extent necessary to carry out the
provisions of this Agreement, the Intellectual Property rights used in or
related to the Products and including, without limitation, registration
dossiers for the Products, Regulatory Approvals, Trademarks, BARRIER
Housemarks, Know-How and patents owned or controlled by BARRIER whether by
license or otherwise and licensed to XXXXXX as of the date hereof and
during the term of this Agreement, and shall mean all or each such IP
Rights individually as the case may be.
1.1.34 "QUOTA COMMENCEMENT DATE" means, with respect to a Product in a
given country, the first day of the first full calendar year following the
calendar year in which the First Commercial Sales occurs for such Product
in such country.
1.1.35 "REGION" means any of the European Region, African Region or Latin
American Region, as applicable.
1.1.36 "REGULATORY APPROVAL(S)" means the technical, medical and
scientific licenses, registrations, authorizations and approvals
(including, without limitation, approvals of XXXx, supplements, variations
and amendments, pre- and post- approvals, pricing and Third Party
reimbursement approvals, and labelling approvals) of a Governmental Body
necessary for the distribution, marketing, promotion, offer for sale,
supply use, import, export or sale of a Product in a regulatory
jurisdiction in the Territory.
1.1.37 "SEBAZOLE PRODUCT" means the pharmaceutical product currently
identified as "Sebazole" containing ketoconazole in an anhydrous gel and
all Improvements thereto.
1.1.38 "SEMI-EXCLUSIVE" means the right of BARRIER to sell or supply a
Product by itself or to appoint a second distributor in a Region of the
Territory to distribute a Product, including in each case, the right to
use the Trademark, on a co-exclusive basis along with XXXXXX, at BARRIER's
sole discretion according to clause 2.3, where such use is not prohibited
by law.
6
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
1.1.39 "SPECIFICATIONS" means, with respect to a Product, the quality
assurance and quality release specifications for the Product set forth in
the Regulatory Approval for the Product, as may be modified from time to
time in the discretion of Barrier.
1.1.40 "TERM" means the period set forth under Section 13.1.
1.1.41 "TERRITORY" means the European Region, African Region and Latin
American Region.
1.1.42 "THIRD PARTY" means any Person that is not a Party or an Affiliate
of a Party.
1.1.43 "TPM" means any Third Party manufacturer of a Product.
1.1.44 "TRADEMARKS" means any trademarks, trade names or trade dress used
and/or selected by BARRIER to designate a Product.
1.1.45 "TRANSFER PRICE" has the meaning set forth in Section 4.2.1.
1.1.46 "VALID CLAIM" means a claim in any unexpired, issued patent within
the Patents which has not been held invalid or unenforceable by a
non-appealed or unappealable decision by a court or other appropriate body
of competent jurisdiction, and which is not admitted to be invalid through
disclaimer or dedication to the public.
1.1.47 "ZIMYCAN PRODUCT" means the pharmaceutical product containing .25%
miconazole in a zinc oxide and petrolatum base, currently identified as
"Zimycan", and all Improvements thereto.
1.2 SCHEDULES
The Schedules which are attached to this Agreement are incorporated into
this Agreement by reference and are deemed to be part hereof.
1.3 CURRENCY
Unless otherwise indicated, all amounts payable under this Agreement shall
be in Euros.
1.4 CHOICE OF LAW
This Agreement shall be governed by and construed in accordance with the
laws of the United Kingdom without regard to principles of conflicts of
law.
1.5 INTERPRETATION NOT AFFECTED BY HEADINGS OR PARTY DRAFTING
1.5.1 The division of this Agreement into articles, sections, paragraphs,
subsections and clauses and the insertion of headings are for convenience
of reference only and shall not affect the construction or interpretation
of this Agreement. The terms "this Agreement", "hereof", "herein",
"hereunder" and similar expressions refer to this Agreement and the
schedules hereto and not to any particular article, section, paragraph,
clause or other portion hereof and include any Agreement or instrument
supplementary or ancillary hereto. Each Party acknowledges that it and its
legal counsel have reviewed and participated in drafting the terms of this
Agreement, and the Parties
7
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
agree that any rule of construction to the effect that any ambiguity is to
be resolved against the drafting Party shall not be applicable in the
interpretation of this Agreement.
1.5.2 The phrase "country by country basis" or "for a given country" or
words to similar effect, shall include "Country Group by Country Group
basis" and "for a given Country Group," as applicable.
1.6 NUMBER AND GENDER
In this Agreement, unless there is something in the subject-matter or
context inconsistent therewith, (i) words in the singular number include
the plural and such words shall be construed as if the plural had been
used, (ii) words in the plural include the singular and such words shall
be construed as if the singular had been used, and (iii) words importing
the use of any gender shall include all genders where the context or Party
referred to so requires, and the rest of the sentence shall be construed
as if the necessary grammatical and terminological changes had been made.
2. SUPPLY AND DISTRIBUTION OF PRODUCTS
2.1 SUPPLY OF THE PRODUCTS
Subject to the terms and conditions of this Agreement, during the Term,
BARRIER shall sell the Products ready for sale as finished, packaged,
labeled units to XXXXXX for the Transfer Prices set forth in Article 4.
2.2 DISTRIBUTION OF THE PRODUCTS
2.2.1 Subject to the terms and conditions of this Agreement, BARRIER
hereby grants to XXXXXX the exclusive right, within the Field of Use, to
market, distribute and sell the Products for its own account in the
Territory.
2.2.2 XXXXXX shall have the right to appoint its Affiliates as
sub-distributors; provided, however, that (i) XXXXXX shall notify BARRIER
thereof in writing and (ii) XXXXXX shall remain responsible to BARRIER for
the performance of its Affiliates.
2.2.3 XXXXXX may appoint as a sub-distributor any Third Party that is not
an Affiliate provided that (i) it obtains BARRIER's prior written consent,
which shall not be unreasonably withheld, and (ii) XXXXXX shall remain
responsible to BARRIER for the performance of such Third Party.
2.2.4 XXXXXX shall ensure that all Affiliates and other Third Party
sub-distributors appointed by XXXXXX shall abide by the terms and
conditions of this Agreement.
2.2.5 XXXXXX acknowledges and understands that with respect to the Zimycan
Product in Xxxxxxxxx, Xxxxxxx, Xxxxxxx, Xxxxxxxxx, Xxxxxx, Xxxx and
Venezuela, and with respect to the Ketanserin Product in the Latin
American Region, Barrier's rights under the J&J Agreements are
non-exclusive.
2.3 EXCLUSIVITY
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** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
2.3.1 This Agreement is exclusive on a Product by Product, Region by
Region and country by country basis for the Term, so long as XXXXXX
continues to satisfy the Minimum Purchase Quota for such Product (i) in
the Territory in the aggregate, (ii) in each Region in the aggregate, and
(iii) in each country, in each case, pursuant to the provisions of Section
8.1.
2.3.2 Following the Quota Commencement Date for a given Product, BARRIER
shall have the right, as its sole remedy, upon simple notice to transform
the exclusivity of this Agreement into a Semi-exclusive agreement for that
Product on a country by country basis if XXXXXX is in default of the
conditions set forth in Section 2.3.1. If XXXXXX is in default of the
Minimum Purchase Quota with respect to a Product in the Territory in the
aggregate, [**]. BARRIER will have the right upon simple notice to
transform the exclusivity of this Agreement for that country or countries
in the Region for which the Minimum Purchase Quota is not met into a
Semi-exclusive Agreement for that Product in that country. For clarity,
BARRIER shall [**].
2.3.3 The exclusivity as referred to in this Agreement means that BARRIER,
provided all conditions are met by XXXXXX, will not enter into other
agreements for the distribution and sale of the Products in the Territory
nor sale the Products by itself in the Territory.
2.3.4 (A) During the term of this Agreement, on a Product by product
basis, in each country in the Territory in which XXXXXX has exclusive
rights to such Product under this Agreement, except as necessary to
perform its obligations under this Agreement and except as set forth in
subsection (B) below, XXXXXX shall not, and shall not permit its
Affiliates, to directly or indirectly, alone or in conjunction with a
Third Party market, promote, distribute, offer for sale or sell a
Competing Product. For purposes of this Agreement, each of the following
shall be considered a "Competing Product":
(i) [**], and
(ii) [**]; and
(iii) [**].
(B) [**].
2.3.5 Solely for the purpose of enabling XXXXXX to exercise its
rights pursuant to Sections 5.1.6 and 13.4(i), BARRIER hereby grants
XXXXXX a non-exclusive, royalty-free license under the Product IP
Rights to make and have made the Products for sale in the Field of
Use in the Territory.
2.3.6 Nothing in this Agreement shall be construed to xxxxx XXXXXX
any rights or license (i) with respect to any Product outside of the
Territory or (ii) with respect to any other products of BARRIER, or
(iii) to manufacture any Product, except as provided in Section
2.3.5 above.
2.4 SAMPLES
Provided Barrier can obtain sample sizes of the Products from its
manufacturer, sample sizes of the Products may be purchased by
XXXXXX from BARRIER at BARRIER's cost
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** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
of goods for such samples. In any event, XXXXXX may obtain trade size
samples of Products from BARRIER at BARRIER's cost of goods. All samples
must be labeled "Sample, Not for Resale."
2.5 RESTRICTION ON PURCHASE AND SALE OF PRODUCTS
2.5.1 XXXXXX shall not actively promote the distribution or sale of the
Products for delivery at any location outside the Territory. XXXXXX shall
refer to BARRIER any order or inquiry from outside the Territory.
2.5.2 XXXXXX shall not actively promote the distribution or sale of the
Products outside of the Field of Use or otherwise than in accordance with
their Regulatory Approvals.
2.5.3 Unless otherwise authorized in writing by BARRIER, XXXXXX shall not
purchase any Products from any person other than BARRIER.
3. FORECASTS AND ORDERS
3.1 ESTIMATED REQUIREMENTS; FIRM ORDERS
3.1.1 Within thirty (30) days following the Effective Date, XXXXXX shall
provide BARRIER with a forecast showing XXXXXX'x estimated requirements of
Products, within the Territory and identified for each Region, for the
first twelve (12) months following the Effective Date. Such forecast shall
be a non-binding forecast of XXXXXX'x purchases of Products for the first
twelve (12) months of sales within the Territory.
3.1.2 On the first day of every calendar quarter during the Term, XXXXXX
shall provide BARRIER with a good faith, forecast update of its estimated
requirements by month and for each Region, of Products for the twelve (12)
month period commencing on the first day of the immediately following
calendar month (each a "Forecast Update").
3.1.3 XXXXXX'x specified requirements for Product for the first three (3)
calendar months of each Forecast Update shall constitute a binding order
for the purchase of Products (each, a "Firm Order"). The remainder of any
Forecast Update shall be non-binding.
3.2 PURCHASE ORDERS
3.2.1 Each Forecast Update shall be accompanied by one or more purchase
orders for Products covered by that portion of the Forecast Update
constituting a Firm Order (each, a "Purchase Order"). For each Product,
XXXXXX shall specify, on a Purchase Order, the requested quantity of
Product, required delivery dates, shipment method and destination. All
Purchase Orders must be received by BARRIER at least ninety (90) days
prior to the delivery date specified in each respective order. All such
orders shall be in full lot quantities. Each Purchase Order shall be in a
form and contain terms previously agreed to by the Parties. The delivery
of Products shall be made within a maximum of twenty (20) days from the
delivery date specified on the Purchase Order.
3.2.2 Purchase Orders under Section 3.2.1, up to one hundred and twenty
per cent (120%) of the quantities ordered in the Forecast Updates, shall
be deemed accepted by
10
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
BARRIER. BARRIER shall use Commercially Reasonable Efforts to comply with
unplanned increases in Purchase Orders in excess of XXXXXX'x Forecast
Updates.
3.2.3 In the event of any conflict between the terms and conditions of
this Agreement and the terms and conditions of any Purchase Order or any
other document, the terms and conditions of this Agreement shall prevail.
4. ECONOMIC TERMS
4.1 UPFRONT AND MILESTONE PAYMENTS
In consideration for the rights granted, within five (5) working days
following the event or date specified below, XXXXXX will pay BARRIER the
following non-refundable, non-creditable amounts:
4.1.1 (euro)500,000 upon the Effective Date of this Agreement.
4.1.2 A one time payment of (euro) [**] upon receipt of the first
Regulatory Approval of the Liarozole Product in any of the following
countries in the European Region: [**].
4.1.3 A one time payment of (euro) [**] upon the First Commercial Sale of
the Liarozole Product in any of the following countries in the European
Region: [**].
4.2 SUPPLY PRICES
4.2.1 XXXXXX shall purchase all of the Products for which a Purchase Order
has been submitted to BARRIER at a "Transfer Price" (which includes
BARRIER's cost of goods) equal to the Applicable Percentage of XXXXXX'x
Net Selling Price for such Product [**].
The "Applicable Percentage" for each Product is as follows:
Product Applicable Percentage
---------- -----------------------------------
Zimycan [**]% of Xxxxxx'x Net Selling Price
Ketanserin [**]% of Xxxxxx'x Net Selling Price
Sebazole [**]% of Xxxxxx'x Net Selling Price
Liarozole [**]% of Xxxxxx'x Net Selling Price
4.2.2 BARRIER shall invoice XXXXXX for Products upon shipment at the
Forecasted Supply Price determined in accordance with Section 4.3.
4.2.3 The Transfer Price for the Product shall be calculated and set each
year in accordance with the methods set forth below. The Parties shall
establish a Forecasted Supply Price in accordance with Section 4.3. During
such year, the Transfer Price shall be the Forecasted Supply Price. At the
end of each year, the Transfer Price shall be calculated and reconciled
with the Forecasted Supply Price for the same time period in accordance
with Section 4.4.
4.2.4 In addition to the Transfer Prices and any [**] payable pursuant to
Section 4.2.5, within sixty (60) days following each calendar quarter,
XXXXXX shall pay to BARRIER
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** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
[**] percent ([**]%) of XXXXXX'x aggregate Net Sales of all Products sold
during such quarter, until such time as XXXXXX has paid an aggregate of
(euro) [**] pursuant to this Section 4.2.4.
4.2.5 [**].
4.2.6 The [**] shall be in addition to any amounts payable under Section
4.2.4.
4.3 FORECASTED SUPPLY PRICE
For each Product in each Region, for the year in which the First
Commercial Sale occurs, the Forecasted Supply Price shall be calculated
according to the Applicable Percentage taking into account the Minimum
Supply Prices as specified under clauses 1.1.25 and 4.2.1, and mutually
agreed upon by the Joint Steering committee at least sixty (60) days prior
to the anticipated date of the First Commercial Sale. At least sixty (60)
days prior to the beginning of each subsequent calendar year, the
Forecasted Supply Price shall be calculated for each unit of Product and
shall be equal to the Transfer Price for the immediately three (3)
preceding calendar quarters. All of the foregoing shall be referred to as
the "Forecasted Supply Price".
4.4 ANNUAL RECONCILIATION OF SUPPLY PRICE
Within forty-five (45) days following (i) the end of each calendar year
during the Term of this Agreement, and (ii) the expiration or earlier
termination of this Agreement, XXXXXX shall deliver to BARRIER a report
and calculation of the Net Selling Price for each of the Products sold in
the Territory during such calendar year. BARRIER shall then calculate an
amount determined by multiplying for each Product (a) the Net Selling
Price for the preceding calendar year less the Forecasted Supply Price for
the preceding calendar year by (b) the number of Products sold during the
preceding calendar year. If the result of the calculation in this Section
4.4 is positive, XXXXXX shall pay such amount to BARRIER. If the result of
the calculation in this Section 4.4 is negative, XXXXXX shall be entitled
to a credit for such amount which it may apply to future invoices.
4.5 PAYMENT METHOD
All payments under this Agreement shall be made by bank wire transfer in
immediately available funds to an account designated by the Party to which
such payments are due. Any payments due under this Agreement which are not
paid by the date such payments are due under this Agreement shall bear
interest to the extent permitted by applicable law at a rate equal to the
thirty (30) day London inter-bank offering rate U.S. dollars as quoted in
The Financial Times on the first business day of the month on which the
payment was due. This Section 4.5 shall in no way limit any other remedies
available to the Parties.
4.6 EURO; CURRENCY EXCHANGE
All sums due under this Agreement shall be payable in Euros. With respect
to Net Sales invoiced in a currency other than Euros, the Net Sales shall
be expressed in the domestic currency of the entity making the sale or
incurring the expense, together with the Euro equivalent, calculated using
the arithmetic average of the spot rates on the last working day of each
month of the calendar quarter in which the Net Sales were made.
12
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
The "closing mid-point rates" published by The Financial Times, or any
other publication as agreed to by the Parties, shall be used as the source
of spot rates to calculate the average as defined in the preceding
sentence.
4.7 INVOICES; TIMING OF PAYMENTS
Barrier shall invoice XXXXXX for all Products supplied hereunder at the
Forecasted Supply Price on the date of shipment, which invoice shall
include any Shipping Costs paid by BARRIER and any applicable taxes, for
all amounts due to BARRIER hereunder monthly in arrears. Payment for the
Products shall be made by XXXXXX to BARRIER in Euros within sixty (60)
days of XXXXXX'x receipt of invoicing. Unless otherwise specified in this
Agreement, all other amounts due to BARRIER hereunder shall be paid by
XXXXXX within sixty (60) days following the date of XXXXXX'x receipt of
invoice.
4.8 TAXES
Where any sum due to be paid to a Party under this Article 4 is subject to
any withholding or similar tax, the Parties shall use their reasonable
efforts to do all such acts and to sign all such documents as will enable
them to take advantage of any applicable double taxation agreement or
treaty. In the event there is no applicable double taxation agreement or
treaty, or if an applicable double taxation agreement or treaty reduces
but does not eliminate such withholding or similar tax, the Party making a
payment shall pay such withholding or similar tax to the appropriate
government authority, deduct the amount paid from the amount due to the
other Party, and secure and send to the other Party the best available
evidence of such payment.
4.9 AUDIT RIGHTS
XXXXXX shall keep, and require its Affiliates and any Third Party
sub-distributors to keep, complete and accurate books of accounts and
records for the purpose of determining the amounts payable pursuant to
this Agreement. Such books and records shall be kept at the principal
place(s) of business of XXXXXX and its Affiliates for at least three (3)
years following the end of the calendar year to which they pertain. Such
records will be open for inspection during such three (3) year period by
an independent auditor chosen by BARRIER and reasonably acceptable to
XXXXXX for the purpose of verifying the amounts payable hereunder. Such
inspections may be made no more than once each calendar year, at
reasonable times and on reasonable notice and once the records for a
period are audited they shall not be subject to re-audit. Inspections
conducted under this Section 4.9 shall be at the expense of BARRIER,
unless a variation or error producing an underpayment in amounts payable
exceeding five percent (5%) of the amount paid for the entire period
covered by the inspection is established in the course of any such
inspection, whereupon all reasonable documented out-of-pocket costs
relating to the inspection for such period and any unpaid amounts that are
discovered shall be paid by XXXXXX, together with interest on such unpaid
amounts at the rate set forth in Section 4.5 above.
5. TERMS OF SALE
5.1 DELIVERY OF PRODUCTS, TRANSFER OF RISKS AND PROPERTY
13
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
5.1.1 The Products shall be sold and delivered EXW from BARRIER's
manufacturer's plant or BARRIER's warehouse prior to or within twenty (20)
days of the date specified in the applicable Purchase Order. In accordance
with EXW terms, XXXXXX shall bear all risk of loss and damage to the
Products from the time they have been placed at XXXXXX'x disposal. BARRIER
shall ship the Products on a carrier specified by XXXXXX at XXXXXX'x
expense.
5.1.2 Delivery of eighty percent (80%) or more of any Purchase Order shall
be considered a complete order, provided that the remaining quantities of
any Purchase Order are delivered within the ninety (90) day period
following the requested delivery date.
5.1.3 Products will be delivered ready for sale in the Territory.
5.1.4 XXXXXX shall pay all costs, expenses, taxes (including VAT), levies,
tariffs, brokerage fees, insurance premiums and other costs and charges
assessed or levied in connection with the transportation of Products from
the manufacturing facility at which final packaging of such Product is
completed (the "Shipping Costs"). If BARRIER pays any of the Shipping
Costs on behalf of XXXXXX, then BARRIER shall invoice such Shipping Costs
to XXXXXX and XXXXXX shall pay such costs in accordance with the
provisions of Section 4.7 above.
5.1.5 BARRIER shall use all Commercially Reasonable Efforts to supply
XXXXXX'x requirements of Products. If BARRIER is temporarily unable to
supply XXXXXX'x requirements for a particular Product, [**].
5.1.6 [**].
5.2 COMPLIANCE OF PRODUCTS
5.2.1 XXXXXX shall have the right to ensure that all Products comply with
the Specifications during the period of fifteen (15) working days
following the date of BARRIER's delivery of such Products. In the event
XXXXXX finds that the Products do not conform to the Specifications,
XXXXXX shall send a notice to BARRIER within the fifteen (15) working day
period following delivery. If BARRIER has not received any notice from
XXXXXX within such fifteen (15) working days following delivery, XXXXXX
shall be deemed to have accepted the Products as is. Such limitations
shall not apply as per latent defects. For clarity, XXXXXX shall not have
the right to return Products which conform to the applicable
Specifications .
5.2.2 If XXXXXX receives Products from BARRIER that do not comply with the
Specifications ("non-conforming"), BARRIER shall replace such
non-conforming Products with an equal quantity of Product that conforms to
the Specifications at no additional cost to XXXXXX. If a shortage exists
with respect to a shipment of Products, XXXXXX shall so inform BARRIER,
and BARRIER shall make-up such shortage at no additional cost to XXXXXX.
The remedies set forth in this Section 5.2.2 shall be the sole and
exclusive remedies of XXXXXX with regard to a shortage or non-conforming
Products.
5.2.3 If the analysis or assay of a sample of the Products performed by or
for XXXXXX indicates that the batch of Products does not meet
Specifications and
14
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
BARRIER's analysis or assay of its sample from the same batch indicates
that the batch does meet Specifications, BARRIER will so advise XXXXXX and
a joint investigation will be conducted to determine the cause of the
failure.
5.2.4 If the Products are proven to meet Specifications, then XXXXXX shall
be responsible for the cost of the joint investigation and any independent
Third Party testing of Products.
5.2.5 If the Products are proven not to meet Specifications in a material
way that is likely to affect the Products, BARRIER shall be responsible
for the cost of the joint investigation and any independent Third Party
testing of Products, and shall replace such Products at its own cost.
6. REPRESENTATIONS AND WARRANTIES
6.1 REPRESENTATIONS AND WARRANTIES OF BARRIER
BARRIER represents and warrants the following:
6.1.1 it has full power and authority to enter into and perform its
obligations pursuant to this Agreement and to consummate the transactions
contemplated herein;
6.1.2 the execution, delivery and performance of this Agreement have been
duly authorized by all necessary corporate action and constitute a legal,
valid and binding obligation of BARRIER;
6.1.3 it shall comply with the material Specifications and the applicable
current Good Manufacturing Practices (cGMPs) of Europe and each Region, as
applicable, and shall comply, with the assistance of XXXXXX in informing
BARRIER, with local, state, and federal laws and regulations applicable in
the Territory. BARRIER may however make modifications to the
Specifications if approved by the applicable Governmental Body and shall
thereafter inform XXXXXX of any such modifications and, other than with
respect to the Zimycan Product in the European Region, provide XXXXXX with
the corresponding documentation to be submitted to the Governmental Body;
6.1.4 its obligations under this Agreement are valid and binding and
enforceable against it in accordance with their terms, except as
enforcement may be affected by bankruptcy, insolvency, or other similar
laws and by general principles of equity; and
6.1.5 it has not previously granted any rights that are inconsistent with
the rights and licenses granted herein.
6.2 REPRESENTATION AND WARRANTIES OF XXXXXX
XXXXXX represents and warrants the following:
6.2.1 it has full power and authority to enter into and perform its
obligations pursuant to this Agreement and to consummate the transactions
contemplated herein;
15
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
6.2.2 the execution, delivery and performance of this Agreement have been
duly authorized by all necessary corporate action and constitute a legal,
valid and binding obligation of XXXXXX;
6.2.3 its obligations under this Agreement are valid and binding and
enforceable against it in accordance with their terms, except as
enforcement may be affected by bankruptcy, insolvency, or other similar
laws and by general principles of equity;
6.2.4 it shall perform its obligations hereunder in compliance with all
applicable laws and regulations whether it be local or otherwise;
6.2.5 it has the commercial capacity to distribute and sell the Product in
the Territory; and
6.2.6 there are no agreements or commitments to which it or any of its
Affiliates is a party that conflicts with its obligations hereunder.
6.2.7 It has provided in writing to BARRIER a description of all products
as of the Effective Date [**], to which XXXXXX has obtained the rights to
market and/or distribute such products from a Third Party.
7. OBLIGATIONS OF BARRIER
7.1 FORM AND PROMOTION
7.1.1 During the Term of this Agreement, BARRIER shall use Commercially
Reasonable Efforts to assist XXXXXX in the preparation of sales promotion
material and shall, from time to time, provide XXXXXX with its sales
promotional material relating to the Products in order to facilitate
advertising of the Products, together with such information as BARRIER
deems appropriate in connection with any warranties relating to the
Products.
7.1.2 Prior to using any promotional materials for the Products for the
first time, XXXXXX shall submit a sample of such materials to BARRIER for
approval. BARRIER shall use Commercially Reasonable Efforts to approve
such materials within ten (10) days for materials in English and fifteen
(15) days for materials in a language other than English. Should XXXXXX
receive no response from BARRIER within that period the materials shall be
deemed approved.
7.1.3 XXXXXX shall provide to BARRIER with samples of all marketing and
promotion materials that XXXXXX uses for the Products for use by BARRIER
and BARRIER's other partners outside of the Territory, at BARRIER's cost
and expenses.
8. OBLIGATIONS OF XXXXXX
8.1 MINIMUM PURCHASE QUOTA
8.1.1 During the Term, XXXXXX covenants and agrees to purchase from
BARRIER for distribution within the Territory and independently for each
Region and each country or Country Group not less than the Minimum
Purchase Quota, as more specifically provided under clauses 2.3.1 and
2.3.2
16
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
8.1.2 On a Product by Product basis in the Territory, Region by Region and
country by country, XXXXXX shall not be deemed to be in default of the
requirement in Section 8.1.1 in any [**] for the year in question.
8.1.3 For purposes of this Agreement, the term "Minimum Purchase Quota"
with respect to each of the Zimycan Product and the Sebazole Product has
the meaning set forth on Schedule 8.1.3 with respect to each Region and
each country or Country Group therein. Upon the Effective Date, the
Minimum Purchase Quota for each Region set forth on Schedule 8.1.3 for the
Zimycan Product and the Sebazole Product shall be binding. During the
sixty (60) day period following the Effective Date, XXXXXX shall have an
opportunity to finalize the Minimum Purchase Quotas for each country or
Country Group. Within sixty (60) days following the Effective Date XXXXXX
shall deliver to BARRIER a revised Scheudule 8.1.3 containing the Minimum
Purchase Quotas for the Zimycan Product and the Sebazole Product for each
Region and each country or Country Group therein, which such revised
schedule shall be binding. For clarity, the Minimum Purchase Quota for
each Region on the revised schedule must be equal to the Minimum Purchase
Quota for each Region set forth on Schedule 8.1.3 on the Effective Date.
8.1.4 For purposes of this Agreement, the term "Minimum Purchase Quota"
with respect to the Liarozole Product [**] and the Ketanserin Product
[**], shall be those set forth of Schedule 8.1.4. The Minimum Purchase
Quotas set forth on Schedule 8.1.4 shall become binding unless, at least
ninety (90) days prior to the anticipated date of the first submission of
the first MAA for the applicable Product in such Region, XXXXXX shall
notify BARRIER in writing that due to the then proposed labeling or then
existing market conditions in the Region, XXXXXX believes in good faith
that such Minimum Purchase Quotas are commercially unfeasible. If XXXXXX
so notifies BARRIER, then the parties shall negotiate in good faith
revised Minimum Purchase Quotas for the applicable Product and Region and
for each country or Country Group in such Region. If XXXXXX does not so
notify BARRIER, then the Minimum Purchase Quotas on Schedule 8.1.4 shall
become binding and the Minimum Purchase Quota for each country or Country
Group within such Region shall be provided by XXXXXX during the thirty
(30) day period following the first submission of the first MAA for the
applicable Product in such Region. [**].
8.2 REGISTRATION OF PRODUCTS
Except for the Mutual Recognition Procedure which is in process as of the
Effective Date for the Zimycan Product in the European Region, XXXXXX,
based on the information provided by BARRIER, will use Commercially
Reasonable Efforts to obtain the necessary permits, licenses,
authorizations, registrations or approvals that may be required in
accordance with each Region's regulations, or under any other Governmental
Body, as may be required for the sale, distribution and promotion of the
Products in the Territory, unless BARRIER notifies XXXXXX that BARRIER
desires to take any such action. To this end, BARRIER shall provide all
reasonable assistance as XXXXXX shall request. With respect to such Mutual
Recognition Procedure and any other such regulatory action with respect to
Products in the Territory that BARRIER undertakes, XXXXXX shall provide
all reasonable assistance as BARRIER shall request.
17
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
8.3 REGULATORY APPROVALS
8.3.1 XXXXXX will seek such Regulatory Approval according to local
regulations on behalf of BARRIER and obtain and maintain any requisite
Regulatory Approval in the Territory in such name as BARRIER may require.
If the Products and the Regulatory Approvals are registered in the name of
XXXXXX, XXXXXX shall hold such Regulatory Approvals in trust for the
benefit of BARRIER. At BARRIER's request, whether or not this Agreement is
then in effect, XXXXXX shall take such action, including transferring the
Regulatory Approvals or assisting in the procuring of a new registration,
as BARRIER may request in order to vest the Regulatory Approvals of the
Products in BARRIER or its designee; provided however that no such
transfer shall be required prior to the valid termination of this
Agreement pursuant to provisions set forth in Section 13 if the rights of
XXXXXX are materially adversely affected thereby.
8.3.2 Each Party shall bear all costs and expenses actually incurred by it
in obtaining Regulatory Approvals and conducting its regulatory and
commercialization activities hereunder.
8.4 LABELLING
8.4.1 The inventory shall be shipped with appropriate labelling as
approved by the Governmental Body as per all standards, laws and
regulations applicable to each country of the Territory as notified by
XXXXXX to BARRIER from time to time.
8.4.2 Consistent and in accordance with Section 12.3.3, XXXXXX shall cause
BARRIER to be identified on the labels of the Products and on promotional
and educational materials as the manufacturer and holder of IP Rights
thereof, unless prohibited by applicable law or otherwise instructed by
BARRIER. XXXXXX shall represent itself as the distributor of the Products.
8.5 OTHER OBLIGATIONS
XXXXXX shall:
8.5.1 use Commercially Reasonable Efforts to promote, distribute, market
and sell the Product in the Territory;
8.5.2 properly carry out its obligations under this Agreement;
8.5.3 honor any warranty offered by BARRIER on the Products;
8.5.4 manage any consumers' complaints in a diligent and expeditious
manner, and inform BARRIER without delay of any abnormal increase in the
number of complaints in association with Products all pursuant to the
Pharmacovigilance Agreement; and
8.5.5 be responsible for complying with all local laws and regulations
including, without limitation, laws and regulations relating to the
importation and sale of the Products.
9. MUTUAL UNDERTAKINGS
18
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
9.1 MARKETING STRATEGY AND JOINT COMMERCIALIZATION COMMITTEE
As soon as practicable following the date of the Agreement, the Parties
will establish a Joint Commercialization Committee (JCC) to monitor [**].
BARRIER and XXXXXX shall each designate at least two (2) members to serve
on the JCC, one of whom must be the person [**]. The JCC shall meet at
least quarterly and at such other times as agreed to by the committee
members.
[**].
[**].
[**].
9.2 [**].
9.3 JOINT STEERING COMMITTEE
As soon as practicable following the Effective Date, the Parties shall
form a Joint Steering Committee. BARRIER and XXXXXX shall each designate
two (2) members to serve on the Joint Steering Committee and such members
shall be senior executives of the designating Party. Each member shall
serve until removed by the Party appointing the member. The initial
members of the Joint Steering Committee shall be Geert Cauwenbergh and Xx
Xxxxxxxx for BARRIER and Xxxxx Xxxxxxxx and Xxxxxx Xx Xxxxx for XXXXXX.
The Joint Steering Committee shall exist to (i) review the efforts of the
Joint Commercialization Committee, (ii) resolve disputes of the Joint
Commercialization Committee, (iii) establish the Minimum Supply Price and
the Forecasted Supply Price, and (iv) to perform such other duties to
facilitate the collaboration as the Parties deem necessary. Each Party
shall have one vote and both Parties must agree on all decisions of the
Joint Steering Committee.
10. INDEMNIFICATION
10.1 INDEMNIFICATION BY BARRIER
BARRIER shall indemnify, protect and hold XXXXXX and XXXXXX'x directors,
officers, and employees (the "XXXXXX Indemnified Parties") harmless from
and against any and all Liabilities, asserted at any time arising out of
(i) any breach or misstatement by BARRIER of its representations and
warranties made in this Agreement, or (ii) the Products themselves
(characteristics inherent to the Products), the manufacture, sale or use
of the Products produced by or for BARRIER or its designees (whether under
defective Product liability or otherwise) or (iii) any negligent act or
omission or gross negligence, recklessness or willful misconduct of
Barrier or any of its Affiliates; or (iv) any other breach by BARRIER of
its obligations under this Agreement except in each case, to the extent
caused by any negligent act or omission or gross negligence, recklessness
or willful misconduct of any of the XXXXXX Indemnified Parties.
10.2 INDEMNIFICATION BY XXXXXX
XXXXXX shall indemnify, protect and hold BARRIER and BARRIER's directors,
officers, employees and agents harmless from and against any and all
Liabilities, asserted at any
19
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
time arising out of or involving (i) any breach or misstatement by XXXXXX
of its representations and warranties made in this Agreement or (ii) the
promotion, storage, sale and distribution of the Products by XXXXXX or its
designees, or (iii) any negligent act or omission or gross negligence,
recklessness or willful misconduct of XXXXXX or any of its Affiliates; or
(iv) any other breach by XXXXXX of its obligations under this Agreement
except in each case, to the extent caused by any negligent act or omission
or gross negligence, recklessness or willful misconduct of any of the
Barrier Indemnified Parties.
10.3 PROCEDURE
10.3.1 If any claim or action is asserted against a Party, or the
Affiliate of a Party, to this Agreement that would entitle such Party to
indemnification pursuant to either of the foregoing Sections 10.1 or 10.2
(a "Third Party Claim"), such Party who seeks indemnification (the
"Indemnitee") will give written notice thereof to the Party to this
Agreement from whom indemnification is sought (the "Indemnitor") promptly,
provided, however, that failure to give such notification will not affect
the indemnification provided hereunder except to the extent the Indemnitor
shall have been actually prejudiced as a result of such failure.
10.3.2 If a Third Party Claim is made against an Indemnitee and the
Indemnitor acknowledges in writing its obligation to indemnify the
Indemnitee therefore, the Indemnitor will be entitled, within one hundred
twenty (120) days after receipt of written notice from the Indemnitee of
the commencement or assertion of any such Third Party Claim to assume the
defense thereof (at the expense of the Indemnitor) with counsel selected
by the Indemnitor and reasonably satisfactory to the Indemnitee, for so
long as the Indemnitor is conducting a good faith and diligent defense.
Should the Indemnitor so elect to assume the defense of a Third Party
Claim, the Indemnitor will not be liable to the Indemnitee for any legal
or other expenses subsequently incurred by the Indemnitee in connection
with the defense thereof. If the Indemnitor assumes the defense of any
Third Party Claim, the Indemnitee shall have the right to participate in
the defense thereof and to employ counsel, at its own expense, separate
from the counsel employed by the Indemnitor. If the Indemnitor assumes the
defense of any Third Party Claim, the Indemnitor will promptly supply to
the Indemnitee copies of all correspondence and documents relating to or
in connection with such Third Party Claim and keep the Indemnitee informed
of developments relating to or in connection with such Third Party Claim,
as may be reasonably requested by the Indemnitee (including, without
limitation, providing to the Indemnitee on reasonable request updates and
summaries as to the status thereof). If the Indemnitor chooses to defend a
Third Party Claim, all Indemnitees shall reasonably cooperate with the
Indemnitor in the defense thereof (such cooperation to be at the expense,
including reasonable legal fees and expenses, of the Indemnitor). If the
Indemnitor does not elect to assume control of the defense of any Third
Party Claim within the 120-day period set forth above, or if such good
faith and diligent defense is not being or ceases to be conducted by the
Indemnitor, the Indemnitee shall have the right, at the expense of the
Indemnitor, after three (3) Business Days notice to the Indemnitor of its
intent to do so, to undertake the defense of the Third Party Claim for the
account of the Indemnitor (with counsel selected by the Indemnitee), and
to compromise or settle such Third Party Claim, exercising reasonable
business judgment.
10.3.3 If the Indemnitor acknowledges in writing its obligation to
indemnify the Indemnitee for a Third Party Claim, the Indemnitee will
agree to any settlement,
20
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
compromise or discharge of such Third Party Claim that the Indemnitor may
recommend that by its terms obligates the Indemnitor to pay the full
amount of losses (whether through settlement or otherwise) in connection
with such Third Party Claim and unconditionally and irrevocably releases
the Indemnitee completely from all liability in connection with such Third
Party Claim; provided, however, that, without the Indemnitee's prior
written consent, the Indemnitor shall not consent to any settlement,
compromise or discharge (including the consent to entry of any judgment),
and the Indemnitee may refuse to agree to any such settlement, compromise
or discharge, that provides for injunctive or other nonmonetary relief
affecting the Indemnitee. If the Indemnitor acknowledges in writing its
obligation to indemnify the Indemnitee for a Third Party Claim, the
Indemnitee shall not (unless required by law) admit any liability with
respect to, or settle, compromise or discharge, such Third Party Claim
without the Indemnitor's prior written consent (which consent shall not be
unreasonably withheld).
10.4 CONSEQUENTIAL DAMAGES
Other than amounts payable with respect to a Third Party Claim pursuant to
an indemnification obligation, neither Party hereto will be liable for
special, incidental or consequential damages arising out of this agreement
or the exercise of its rights hereunder, including without limitation lost
profits arising from or relating to any breach of this Agreement,
regardless of any notice of such damages.
10.5 INSURANCE
The Parties shall maintain, during the Term, commercial general liability
insurance, (including products liability, contractual liability, bodily
injury, property damage and personal injury) adequate enough to cover its
indemnification obligations under this Article 10. During the Term, the
Parties shall not permit such insurance to be expired or canceled without
reasonable prior written notice to the other Party. A Party's liability to
the other is in no way limited to the extent of the insurance coverage.
11. REGULATORY MATTERS
11.1 ADVERSE DRUG REACTIONS
Promptly following the Effective Date, but in no event later than 30
days prior to the anticipated First Commercial Sale of a Product, the
Parties shall negotiate in good faith and execute a pharmacovigilence
agreement containing terms customary for similar agreements (the
"Pharmacovigilence Agreement").
11.2 COMMUNICATIONS WITH GOVERNMENT BODIES; INQUIRIES
11.2.1 The Party to whom the MAA is granted shall be responsible for
communicating with Government Bodies on regulatory matters. Unless
otherwise determined pursuant to Section 8.3.1, it is anticipated that
BARRIER shall be responsible for communicating with Government Bodies in
the European Region and XXXXXX will be responsible for communicating with
Government Bodies in the African and Latin American Regions.
11.2.2 Upon being contacted by any Governmental Body in the Territory in
connection with a Product or any other matter which might reasonably be
expected to affect the rights or obligations of the other Party under this
Agreement, the Party so contacted
21
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
shall immediately notify the other Party. Each Party, as appropriate,
shall respond to all inquiries regarding the Products, from Governmental
Bodies throughout the Territory and the Parties shall provide one another
with reasonable assistance in this regard.
11.3 RECALLS
In the event that either Party determines that an event, incident or
circumstance has occurred which may result in the need for a recall or
other removal of the Products from the market, such Party shall advise and
consult with the other Party with respect thereto as to the appropriate
measures to be taken, as jointly agreed through the Joint
Commercialization Committee.
11.4 RECALL PROCEDURE
Prior to commencing any recall, the Parties shall review with one another
the manner in which the recall is to be carried out and any instructions
or suggestions of the applicable Regulatory Authority. BARRIER may decide
to assume control of any recall procedure and in such case XXXXXX shall
assist at BARRIER's reasonable cost in any action taken pursuant to such
recall.
11.5 COST OF RECALLS
Except as expressly otherwise provided below in this section 11.5, the
Parties shall share equally all costs of a recall, market withdrawal or
other corrective action with respect to any Product in the Territory.
Notwithstanding the foregoing, a Party shall bear any and all costs of a
recall, market withdrawal or other corrective action with respect to a
Product in the Territory to the extent such recall, market withdrawal or
other corrective action is attributable predominantly to the fault of such
Party and results from:
(A) in the case of BARRIER: (i) a grossly negligent or reckless act
or omission or intentional misconduct on the part of BARRIER or its
Affiliates, and not from a grossly negligent or reckless act or omission
or intentional misconduct on the part of XXXXXX or its Affiliates or
sub-distributors, (ii) characteristics inherent to the Products, (iii) the
failure of Product to be manufactured by BARRIER in compliance in all
material respects with all applicable laws, rules and regulations, and in
accordance with the Specifications; or (iv) material breach by BARRIER of
applicable laws, rules or regulations, or the provisions of this
Agreement; and
(B) in the case of XXXXXX: (i) a grossly negligent or reckless act
or omission or intentional misconduct on the part of XXXXXX or its
Affiliates or sub-distributors, and not from a grossly negligent or
reckless act or omission or intentional misconduct on the part of BARRIER
or its Affiliates; (ii) the failure of XXXXXX to handle, store or
distribute Product in compliance with all applicable laws, rules and
regulations from and after delivery of Product to XXXXXX; or (iii)
material breach by XXXXXX of applicable laws, rules or regulations, or the
provisions of this Agreement.
Notwithstanding the foregoing, neither Party shall have any obligation to
reimburse or otherwise compensate the other Party or its Affiliates for
any lost profits or income that may arise in connection with any recall,
market withdrawal or corrective action with respect to a Product.
22
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
12. INTELLECTUAL PROPERTY
12.1 LIMITED KNOW-HOW AND PATENTS LICENSE
12.1.1 Subject to the terms and conditions of this Agreement, and only to
the extent required to perform its obligations and undertakings pursuant
to this Agreement, BARRIER hereby grants to XXXXXX an exclusive,
non-transferable license throughout the Territory to use the Know-How and
the Patents owned by BARRIER for the sole purpose of: (i) obtaining the
Regulatory Approvals in the Territory, and (ii) the sale, marketing and
distribution of the Product in the Territory in the Field of Use, as
provided herein.
12.1.2 BARRIER also grants to XXXXXX for the purpose provided for pursuant
to the provisions of sub-section 12.1.1, (i) an exclusive,
non-transferable right and license throughout the Territory to use such
Know-How and Patents of which BARRIER is an exclusive licensee, and (ii) a
non-exclusive, non-transferable right and license throughout the Territory
to use such Know-How and Patents of which BARRIER is a non-exclusive
licensee.
12.2 INVENTIONS
BARRIER shall retain sole ownership of and exclusive title in the Product
IP Rights. Any and all inventions relating to the Products resulting from
the activities conducted by XXXXXX'x directors, employees or agents under
this Agreement (each, a "Distributor Invention") shall be promptly
disclosed in writing to BARRIER. XXXXXX agrees to assign (or cause to be
assigned), and hereby does assign, to BARRIER all of XXXXXX'x right, title
and interest in and to any Distributor Invention (whether made solely by
employees and contractors of Distributor or jointly by employees or
contractors of BARRIER and employees or contractors of XXXXXX.
12.3 LIMITED LICENSE GRANT OF TRADEMARKS
12.3.1 Selection of Trademarks for the Product shall be at BARRIER's sole
discretion and BARRIER shall own all right, title and interest in and to
any and all such Trademarks.
12.3.2 BARRIER shall be responsible for maintaining and registering any
Trademarks. BARRIER shall be responsible for all costs relating to the
filing and renewal of Trademark applications for the Trademarks.
12.3.3 All packaging materials, package inserts, labels and promotional
materials relating to a Product distributed in the Territory shall display
the Trademark and such BARRIER Housemark(s) as may be determined by
BARRIER, in a form and style to be determined by BARRIER and in accordance
with local regulations. XXXXXX shall not use any other Trademark in
connection with the Product without obtaining BARRIER's prior consent in
writing; provided, however, this provision shall not be construed to
prohibit the continued use of XXXXXX'x company name and logo in connection
with its activities under this Agreement. In addition, if XXXXXX
reasonably believes that, in any given country, business conditions
justify that a Product should also be marketed as a generic, BARRIER shall
not unreasonably withhold its consent.
23
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
12.3.4 BARRIER hereby grants to XXXXXX a non-exclusive, royalty-free
license to use the Trademarks and the BARRIER Housemark(s) on and in
connection with the promotion, sale and distribution of Products in the
Territory during the Term of this Agreement. XXXXXX acknowledges that the
ownership and all goodwill from the use of the Trademarks and the BARRIER
Housemark(s) shall vest in and inure to the benefit of BARRIER. This
Agreement confers on XXXXXX no right or authority to use the Trademarks or
the BARRIER Housemark other than in connection with the Product marketed
pursuant to this Agreement. XXXXXX will not, at any time during the
continuance of this Agreement or thereafter, directly or indirectly, by
itself or through its employees, agents or related companies, contest or
assist any other company or person in contesting the validity of any of
the Trademarks of the BARRIER Housemark or the right, title and interest
of BARRIER to such Trademarks or the BARRIER Housemark.
12.3.5 XXXXXX agrees to notify BARRIER promptly in writing if it becomes
aware of any conflicting use of or application for registration of the
Trademarks, or of any trademark confusingly similar thereto, or of any
known or alleged infringements as well as of unfair competition involving
the Trademarks which shall come to its attention.
12.3.6 BARRIER shall be responsible for the defense of the Trademarks and
shall determine in its sole discretion as to whether it will bring any
actions in connection therewith. If BARRIER decides to do so, XXXXXX shall
cooperate with BARRIER and render BARRIER its reasonable assistance in the
defense of the Trademarks at BARRIER's expense. Any damages and costs
recovered shall be for BARRIER's sole benefit.
12.3.7 Other than as provided herein, XXXXXX shall not use or register at
any time, whether during the continuance of this Agreement or thereafter,
any business or tradename, company name, trademark, labeling or packaging
design that incorporates, is substantially identical with or is
deceptively or confusingly similar to any of the Trademarks or BARRIER
Housemark.
12.4 OTHER RIGHTS
During the term of this Agreement, BARRIER retains all rights not granted
or licensed hereunder including without limitation, the right to use the
IP Rights in connection with the manufacturing, labeling, marketing, sale
and distribution of the Products and the right to commercially exploit the
IP Rights and expand its activities in any way and in any country of the
world outside the Territory.
12.5 CONFIDENTIAL INFORMATION
The Parties shall not, at any time or under any circumstances, without the
consent of the other Party, directly or indirectly communicate or disclose
to any Person any confidential knowledge or information howsoever acquired
including without limitation information received by a Party relating to
or concerning the customers, Products, technology, Know-how, Patents,
Intellectual Property, trade secrets, systems, operations or other
confidential information regarding the other Party's business or that of
any of its Affiliates ("Confidential Information"), nor shall it utilize
or make available any such knowledge directly or indirectly in connection
with any business or activity in which it is or proposes to be involved,
or in connection with the solicitation or acceptance of employment with
24
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
any Person. For the purposes of this Article, shall be excluded from the
obligations of non-disclosure hereunder the confidential information
which:
12.5.1 is a part of the public domain through no act or omission of the
receiving Party or its officers, employees, agents, advisor or other
representatives;
12.5.2 was lawfully within its possession prior to its receipt thereof
from the other Party;
12.5.3 was received in good faith by the receiving Party from a Third
Party, who was lawfully in possession of, and had the right to disclose,
the same; or
12.5.4 is information which the receiving Party is required by law to
disclose, provided that the receiving Party first notifies the other Party
that it believes it is required to disclose such information and it allows
that Party a reasonable period of time to contest the disclosure of such
information.
13. TERM AND TERMINATION
13.1 TERM
Subject to termination as hereinafter provided, the term of this Agreement
shall commence on the Effective Date and shall expire on a Product by
Product basis and country by country basis on the later of (i) ten (10)
years from the date of the First Commercial Sale of such Product for each
country of the Territory and (ii) the date of expiration of the last Valid
Claim to expire of the Patents in such country.
13.2 RENEWAL
This Agreement shall be automatically renewed at the end of the Term for
consecutive periods of one (1) year upon the same terms and conditions,
unless the Parties mutually agree to modify such terms and conditions and
unless either Party gives a notice to the other Party, three months prior
to the expiry of the Agreement, that it does not intend to renew the
Agreement.
13.3 EARLIER TERMINATION
This Agreement may be terminated, prior to the expiration of the term
hereof by mutual written Agreement of the Parties or upon any of the
following:
13.3.1 TERMINATION UPON BUSINESS FAILURE. To the extent permitted by
applicable law, either Party shall have the option to terminate this
Agreement immediately upon notice to the other Party in the event that (i)
the other Party becomes insolvent, or subject to proceedings for its
adjudication as a bankrupt, (ii) a receiver, trustee, or custodian is
appointed for the other Party, or (iii) the other Party makes an
assignment for the benefit of creditors, or is liquidated or dissolved,
and (iv) in the event of the occurrence of any action or event which is,
the equivalent in law of one or more of the events described in this
subsection 13.3.1;
13.3.2 EITHER PARTY FOR CAUSE. This Agreement may be terminated by either
Party on a Product by Product and country by country basis in the event
that the other Party is in default of any of the material provisions,
terms and conditions herein with respect to
25
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
such Product in such country and fails to remedy (including payment of any
alleged damages) such default within sixty (60) days of a notice thereof
from the other Party.;
13.3.3 DEFAULT OF PAYMENT. This Agreement may be terminated in the event
that XXXXXX is in default of payment and XXXXXX fails to remedy such
default within ninety (90) days of a notice thereof from BARRIER;
13.3.4 TERMINATION BY XXXXXX. XXXXXX shall have the right to terminate
this Agreement on a Product by Product and country by country basis if:
(i) After [**] following the first submission of an MAA for a given
Product in a given country such Product is not approved by the
Governmental Body through no fault of XXXXXX, or
(ii) If for any other reason beyond the reasonable control of
XXXXXX, XXXXXX reasonably determines in good faith that commercialization
of a given Product is not feasible or is economically unreasonable in a
given country or countries of the Territory. Notwithstanding the above,
before XXXXXX exercises such right, both Parties shall meet and discuss in
good faith in order to try to find an alternative solution. In addition,
if XXXXXX and BARRIER are unable to arrive at an alternative solution with
respect to a country and XXXXXX has previously exercised its right to
terminate this Agreement with respect to another country in the same
Region, then BARRIER shall have the option, in its sole discretion, to
terminate this Agreement as to such Product for the entire Region, or
(iii) If a Product is withdrawn from the market due to safety
reasons by BARRIER.
13.3.5 TERMINATION BY BARRIER. BARRIER may terminate this Agreement on a
Product by Product and country by country basis if:
(i) XXXXXX fails to use Commercially Reasonable Efforts to fulfill
its objectives to register the Products.
(ii) through fault of XXXXXX, XXXXXX fails to launch and actively
sell and promote a given Product in a given country of the Territory
within [**] after obtaining the Marketing Authorization, or
(iii) XXXXXX permanently ceases to sell a given Product in a given
country of the Territory for a period of [**], except in circumstances
where the Product has been withdrawn for safety reasons, or
(iv) During the Term of this Agreement, XXXXXX experiences a Change
of Control, or enters into any Agreement with respect to any such Change
of Control transaction, and as of the date of the closing of the Change of
Control transaction the surviving entity would be promoting, distributing,
marketing or selling a Competing Product in any country in the Territory.
However, before BARRIER exercises its right of Termination under this
clause 13.3.5 (iii), BARRIER shall allow XXXXXX and/or the surviving
entity a period of [**] to either divest or discontinue selling such
Competing Product. For purposes of this Agreement "Change of Control"
shall mean with respect to a Party (a) the merger or consolidation of such
Party and any Third Party which results
26
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
in the voting securities of such Party outstanding immediately prior
thereto ceasing to represent more than fifty percent (50%) of the combined
voting power of the surviving entity immediately after such merger or
consolidation, or (b) any Third Party, together with its affiliates,
becoming the beneficial owner of fifty percent (50%) or more of the
combined voting power of the outstanding securities of the Party, or (c)
the sale or other transfer to a Third Party of all or substantially all of
such Party's assets, or
(v) Xxxxxx contests the property rights of BARRIER in the IP Rights
or executes or causes to be executed at any time any act capable of
infringing the rights of BARRIER and/or the IP Rights.
13.4 RESULTS OF EXPIRY
Upon the scheduled expiration of the Term on a Product by Product and
country by country basis:
(i) XXXXXX'x license under Section 2.2.1 would become non-exclusive
and royalty free and would include the right to manufacture and have
manufactured the applicable Product for sale in the applicable country;
(ii) XXXXXX would transfer to BARRIER any marketing authorizations
or other regulatory approvals for Products held in XXXXXX'x name and
BARRIER would grant to XXXXXX the right of cross-reference in order to
enable XXXXXX to obtain a new marketing authorization in its own name;
(iii) BARRIER's obligation to supply the applicable Product shall
terminate; and
(iv) BARRIER shall grant to XXXXXX an exclusive license to continue
using the Trademarks in the applicable country in exchange for a royalty
equal to [**] percent ([**]%) of XXXXXX'x Net Sales, of Products bearing
such Trademark payable on a quarterly basis pursuant to the provisions of
Article 4 and XXXXXX and BARRIER shall execute and deliver any necessary
trademark license agreement that BARRIER reasonably believes to be
necessary in this regard.
13.5 RESULTS OF TERMINATION
13.5.1 Upon termination of this Agreement on a Product by Product and
country by country basis as applicable, by BARRIER pursuant to clauses
13.3.1 and 13.3.2 and/or 13.3.3, 13.3.4 and 13.3.5 all the rights, titles,
interests and privileges resulting from this Agreement shall automatically
revert to BARRIER, and subsequently:
13.5.1.1 XXXXXX shall cease all use, sale, distribution and
marketing of the Products and shall cease representing itself as the
authorized distributor of BARRIER;
13.5.1.2 XXXXXX shall return to BARRIER all information or materials
given to XXXXXX by BARRIER in whatever form or medium;
13.5.1.3 if requested by BARRIER, XXXXXX shall sell to BARRIER, at
the original net price paid by XXXXXX plus actual freight charges
for delivery to
27
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
BARRIER, all of the Products sold by BARRIER to XXXXXX and on hand in
XXXXXX'x place of business or in the possession or the control of XXXXXX
at the time of termination of this Agreement and deliver same to BARRIER
forthwith upon request;
13.5.1.4 in case BARRIER decides not to buy back all of the Products sold
by BARRIER to XXXXXX and on hand in XXXXXX'x place of business or in the
possession or the control of XXXXXX at the time of Termination of this
Agreement, then XXXXXX shall be entitled to sell it during a period of six
(6) months following termination;
13.5.1.5 XXXXXX shall transfer back to BARRIER the Regulatory Approvals in
accordance with the provisions of Section 8.3.
13.5.2 In the event that BARRIER commits a partial or total material
breach of this Agreement, XXXXXX shall give written notice to BARRIER and
BARRIER shall have ninety (90) days to cure each breach. If such breach
cannot reasonably be cured within such ninety (90) day period following
written notification from XXXXXX, then the Parties agree to negotiate in
good faith and/or follow the provisions provided under clause 14.1,
provided that, until a final decision is taken, this Agreement shall
continue in full force and effect allowing XXXXXX to continue its
commercial activities with the Products.
14. GENERAL
14.1 DISPUTE RESOLUTION; ARBITRATION
The Parties recognize that disputes may from time to time arise which
relate to either Party's rights and obligations hereunder. It is the
objective of the Parties to comply with the procedures set forth in this
Agreement to use all reasonable efforts to facilitate the resolution of
such disputes in an expedient manner by mutual agreement. The Parties
agree that, in the first instance, all disputes should be submitted to the
Joint Steering Committee for resolution. In the event the Joint Steering
Committee is unable to resolve any such dispute within thirty (30) days
after the matter is first submitted to the Joint Steering Committee,
either Party may submit the matter to arbitration pursuant to this Section
14.1.
Any dispute, controversy or claim between BARRIER and XXXXXX relating to
the breach, termination, construction, interpretation, application of (or
at the occasion of) this Agreement, which cannot be settled by the Joint
Steering Committee shall be settled, when permitted by law, by binding
arbitration under the following terms and conditions:
14.1.1 either BARRIER or XXXXXX may demand that a dispute, controversy, or
claim be submitted to arbitration. Such demand shall be made in writing to
the other Party at the notification address set forth in this Agreement;
14.1.2 all matters submitted by BARRIER and XXXXXX for settlement by
binding arbitration shall be decided by a single arbitrator agreeable to
both BARRIER and XXXXXX. If BARRIER and XXXXXX are unable to agree upon a
single arbitrator within a period of fifteen (15) business days following
the transmission by either Party of the notice referred to in section
14.1.1, an arbitrator shall be appointed in accordance with the then
existing Rules of Conciliation and Arbitration of the International
Chamber of
28
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
Commerce (the "Rules"), if for any reason an arbitrator cannot be
appointed in this manner, this section 14.1.2 shall cease to apply to the
dispute, controversy or claim in question and any Party may apply to a
court of competent jurisdiction for the settlement thereof;
14.1.3 all arbitration authorized by this Agreement shall be conducted in
accordance with the Rules, that are not inconsistent with the terms of
this Agreement;
14.1.4 decisions and awards rendered by arbitration authorized by this
Agreement may be entered and enforced by either BARRIER and XXXXXX in any
court having jurisdiction. BARRIER and XXXXXX hereby irrevocably consent
and submit to the jurisdiction of such court for purposes of such
enforcement;
14.1.5 in the event either BARRIER or XXXXXX does not reasonably comply
with a final decision or award made by the arbitrator, such non-complying
Party shall bear all costs and expenses, including attorney's fees,
incurred by the other Party in obtaining enforcement of the decision or
award;
14.1.6 during any period of arbitration concerning this Agreement or any
part thereof, this Agreement shall remain in full force and effect and all
terms shall be complied with by both BARRIER and XXXXXX;
14.1.7 the arbitrator shall not add to, subtract from, or modify any of
the terms or conditions of the Agreement;
14.1.8 the arbitrator shall use its best efforts (i) to complete the
process of arbitration including the arbitration hearing within one
hundred and twenty (120) days of his nomination and (ii) to render a
decision or an award within thirty (30) days after the close of
arbitration hearings;
14.1.9 the arbitrator, in his discretion, shall allocate all costs of the
arbitration between BARRIER and XXXXXX. However, neither BARRIER nor
XXXXXX shall be required to pay the costs of the other Party;
14.1.10 all arbitration proceedings authorized by this Agreement shall be
held in London, England and shall be conducted in the English language and
all documents referred to shall be in English;
14.1.11 this section 14.1 shall not apply in cases where a Party is
seeking, as a remedy to a dispute, controversy or claim, the issue of an
interlocutory injunction or another similar remedy and except for the
purpose of filing the award or obtaining an order of enforcement, as the
case may be, for the purpose of rendering the award executory;
14.1.12 EACH PARTY WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY;
14.1.13 EACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE, EXEMPLARY OR
MULTIPLIED DAMAGES FROM THE OTHER; AND
14.1.14 EACH PARTY HERETO WAIVES ANY CLAIM OF CONSEQUENTIAL DAMAGES FROM
THE OTHER.
29
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
14.2 ASSIGNABILITY
14.2.1 Except as expressly provided herein, neither this Agreement nor any
interest or rights hereunder shall be assignable by a Party without the
prior written consent of the other;
14.2.2 BARRIER may assign this Agreement to an Affiliate or the purchaser
of all or substantially all its business as it relates to the Products,
without the consent of XXXXXX; in such cases, such assignee shall have and
may exercise all the rights, and shall assume all the obligations of the
assignor pursuant to this Agreement and any reference to the assignor in
this Agreement shall be deemed to refer to such assignee;
14.2.3 XXXXXX may assign this Agreement to an Affiliate or the purchaser
of all or substantially all its business as it relates to the Products,
without the consent of BARRIER if (i) XXXXXX remains jointly and severally
responsible of the Agreement and (ii) the Affiliate remains controlled by
XXXXXX at all time. In such cases, the assignee shall have and may
exercise all the rights, and shall assume all the obligations of the
assignor pursuant to this Agreement and any reference to the assignor in
this Agreement shall be deemed to refer to such assignee;
14.2.4 In the case of any permitted transfer the Parties hereto and the
assignee shall execute an Agreement confirming such assignment and such
assumption of obligations.
14.3 INUREMENT
This Agreement shall inure to the benefit of and be binding upon the
Parties hereto and their respective successors and permitted assigns.
14.4 FORCE MAJEURE
Neither Party shall be liable for delays in performance under this
Agreement occasioned by force majeure or any cause beyond its control,
including but not limited to war, civil disturbance, fire, flood,
earthquake, windstorm, acts of default of common carriers, strikes,
unforeseen shutdowns of sources of supply, governmental laws, acts,
regulations or orders which have not been enacted as of the Effective Date
(whether or not such later prove to be invalid) or any other occurrence,
whether or not similar in character to the foregoing.
14.5 NO AGENCY
The Parties are independent contractors. Neither is the agent or legal
representative, joint venturer, partner, employee or employer of the
other. Each Party hereto agrees not to represent itself as the agent or
legal representative of the other. This Agreement does not grant any Party
any authority to assume or create any obligation on behalf of or in the
name of the other Party.
14.6 ENTIRE AGREEMENT
The terms and conditions of this Agreement supersede the terms and
conditions of any and all prior Agreements, and any and all
representations that may have been made prior to this Agreement with
respect to the subject matter of this Agreement. The terms
30
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
and conditions herein constitute the entire Agreement between the Parties
hereto and may not be amended, changed, modified, contradicted, explained
or supplemented (including by course of dealing between the Parties, usage
of trade or otherwise) except by a written instrument signed by an
authorized officer of each of the Parties which refers specifically to
this Agreement.
14.7 FURTHER ASSURANCES
Each Party agrees to duly execute and deliver, or cause to be duly
executed and delivered, such further instruments and to do and cause to be
done such further acts and things, including, without limitation, the
filing of such additional assignments, agreements, documents and
instruments that may be necessary or as the other Party may at any time
reasonably request in connection with this Agreement or to carry out more
effectively the provisions or purposes of, or to better assure and confirm
unto such other Party its rights and remedies under, this Agreement. Each
Party agrees to cause each of its employees and agents to take all actions
and to execute, acknowledge and deliver all instruments or Agreements
reasonably requested by the other Party and necessary for the perfection,
maintenance, enforcement or defense of that Party's rights under this
Agreement.
14.8 SEVERABILITY OF CLAUSES
If any provision of this Agreement is determined to be illegal, against
public order, or otherwise unenforceable it shall not in any way defeat,
invalidate or render unenforceable any other provision of this Agreement
and each such provision shall at all times be considered separate and
severable in this Agreement.
14.9 WAIVER
No waiver by either of the Parties of any breach of any provision hereof
shall constitute a waiver of any other breach of any provision hereof.
14.10 NOTICES
Any notice required by this Agreement shall specifically reference this
Agreement, shall be in writing and may either be delivered in hand, by
facsimile during normal business hours with confirmation of receipt, by
reputable overnight courier service or be mailed with postage prepaid by
certified or registered mail, return receipt requested, to the addresses
set forth below, or such other address for itself as any of the Parties
may from time to time specify in writing to the other Party in accordance
with this article. No notice shall be deemed given until it is actually
received.
If to BARRIER: BARRIER THERAPEUTICS, INC.
000 Xxxxxxx Xxxx Xxxx
Xxxxx 0000
Xxxxxxxxx, XX 00000
Attention of: Chief Commercial Officer
Facsimile number: 000-000-0000
With a copy to: General Counsel
31
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
Facsimile number: 000-000-0000
If to XXXXXX: XXXXXX INTERNACIONAL, S.A.
Gran Xxx Xxxxxx XXX,
00-00, xxxxx.
Xxxxxxxxx, Xxxxx
Attention of: Licensing Department
Facsimile number: x00 00 000 00 00
With a copy to: XXXXXX INTERNACIONAL, S.A.
LEGAL DEPARTMENT
Gran Xxx Xxxxxx XXX,
00-00, xxxxx.
Xxxxxxxxx, Xxxxx
Attention of: Legal Department
Facsimile number: + 34 93 490 89 33
14.11 SUCCESSORS AND ASSIGNS
This Agreement shall ensure to the benefit of and be binding upon the
Parties hereto and their respective successors and permitted assigns.
14.12 EXECUTION IN COUNTERPARTS
This Agreement may be executed in counterparts, each of which, when so
executed and delivered, shall be deemed to be an original, and all of
which counterparts, taken together, shall constitute one and the same
instrument.
14.13 UNITED NATIONS CONVENTION
The United Nations Convention on Contracts for the International Sale of
Goods will not apply in any way to this Agreement or to the transactions
contemplated by this Agreement or otherwise to create any rights or to
impose any duties or obligations on any Party to this Agreement. Any
rights which have arisen or which might in the future arise under the
United Nations Convention on Contracts for the International Sale of Goods
are waived and released by all Parties to this Agreement.
LANGUAGE
The Parties hereto confirm that it is their wish that this Agreement be
drawn up in English only.
14.14 PUBLICITY
Neither Party will issue a press release or make any public announcement
in connection with the execution of this Agreement or the terms hereof,
unless mutually agreed to by the Parties or required by law. XXXXXX shall
not make any public announcement regarding any of the Products without
BARRIER's prior written consent. BARRIER shall be entitled to describe
this Agreement in any document which it files with the Securities
32
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
and Exchange Commission ("SEC") after providing XXXXXX at least five (5)
business days to review and comment on such description, or the maximum
such lesser time as may be possible in an emergency. After issuing any
mutually approved press release, public announcement or making any such
SEC filing, each Party may make public disclosures in a manner consistent
with the description contained in any such press release, public
announcement or filed document. Prior to filing this Agreement with the
SEC, BARRIER shall notify XXXXXX and, if requested in writing by XXXXXX
within five (5) business days after such notification, request that the
SEC grant confidential treatment to the provisions for which the
non-filing Party has requested.
The remainder of this page was intentionally left blank.
Signatures on the following page
33
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
SIGNATURES
IN WITNESS WHEREOF each of the Parties has caused this Agreement to be executed
on its behalf by a duly authorized officer on the date and place shown below.
BARRIER THERAPEUTICS, INC.
(BARRIER)
Per: /s/ Xx Xxxxxxxx
----------------------------------------
Print Name: Xx Xxxxxxxx
Print Title: Chief Commercial Officer
Date: November 4, 0000
Xxxx/Xxxxxxx: Xxxxxxxxx, XX, XXX
BARRIER THERAPEUTICS, N.V.
(BARRIER NV)
Per: /s/ Geert Cauwenbaugh
----------------------------------------
Print Name: Geert Cauwenbaugh, Ph.D.
Print Title: Executive Officer
Date: November 4, 0000
Xxxx/Xxxxxxx: Xxxxxxxxx, XX, XXX
GRUPO XXXXXX INTERNACIONAL, S.A.
(XXXXXX)
Per: /s/ Xxxxx Xxxxxxxx
----------------------------------------
Print Name: Xxxxx Xxxxxxxx
Print Title: Director General
Date: 4th November 2004
City/Country: Barcelona
Per: /s/ Xxxx Xxxxx
----------------------------------------
Print Name: Xxxx Xxxxx
Print Title: Finance Director
Date: 4th November 2004
City/Country: Barcelona
SIGNATURE PAGE TO DISTRIBUTION AND LICENSE AGREEMENT
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
SCHEDULE 1.1.29
PATENTS
THE ZIMYCAN PRODUCT
[**]
THE KETANSERIN PRODUCT
[**]
THE SEBAZOLE PRODUCT
[**]
THE LIAROZOLE PRODUCT
[**]
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
SCHEDULE 8.1.3
MINIMUM PURCHASE QUOTAS FOR ZIMYCAN AND SEBAZOLE PRODUCTS
SEE ATTACHED
ALL FIGURES DENOMINATED IN UNITS
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
[**]
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
[**]
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
SCHEDULE 8.1.4
MINIMUM PURCHASE QUOTAS FOR KETANSERIN AND LIAROZOLE PRODUCTS
SEE ATTACHED
ALL FIGURES DENOMINATED IN UNITS
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
[**]
** Certain information in this exhibit has been omitted and will be filed
separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
[**]
