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Title: |
Distribution and License Agreement |
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Date: |
2004 |
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Preview shows 13KB of 113KB total |
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$61 |
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#1028599 |
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DISTRIBUTION AND LICENSE AGREEMENT
BY AND AMONG
BARRIER THERAPEUTICS, INC.,
BARRIER THERAPEUTICS, N.V.
AND
GRUPO FERRER INTERNACIONAL, S.A.
NOVEMBER 4, 2004
<PAGE>
** 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 600 College Road East, Suite
3200, Princeton, New Jersey 08540
(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 Cipalstr
3, B-2440, Geel, Belgium and wholly-owned
subsidiary of BARRIER
(hereinafter referred to as: "BARRIER NV");
AND:
GRUPO FERRER INTERNACIONAL, S.A., a
corporation duly constituted under the laws
of Spain, having its principal place of
business at Gran Via Carlos III, 98, 08028,
Barcelona, Spain
(hereinafter referred to as: "FERRER").
BARRIER NV is a party to this Agreement for the sole purpose of granting to
FERRER 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 FERRER and BARRIER desire to enter into an Agreement pursuant to which
(i) FERRER will undertake responsibility for the marketing, distribution and
sale of the Products on an exclusive basis throughout the Territory, and (ii)
FERRER 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 FERRER, to the extent necessary to carry out the provisions of this
Agreement, needs to become a licensee of certain Product IP Rights.
2
<PAGE>
** 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 mark(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 FERRER 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 FERRER 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
<PAGE>
** 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 FERRER or an Affiliate or other permitted sub-distributor of
FERRER 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 Johnson and Johnson Consumer Companies, Inc., and (ii)
that certain Intellectual Property Transfer and License Agreement, dated
as of May 6, 2002, by and among BARRIER, Janssen Pharmaceutica Products,
L.P., and Ortho-McNeil 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
<PAGE>
** 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.
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