Exhibit 10.32
ADDENDUM I
to MASTER AGREEMENT (the
“ Master Agreement ”) dated 1 April 2003
between GALEN (CHEMICALS) LIMITED , 4 Adelaide Street, Dun
Laoghaire, Co. Dublin, Ireland (“ GALEN ”) and
LEO Pharma A/S , Industriparken 55, DK-2750 Ballerup,
Denmark (“ LEO ”) (this
“Addendum”).
WHEREAS , the rights and obligations of GALEN under the
Master Agreement have, with the consent of LEO, been assigned to
WARNER CHILCOTT COMPANY, INC. (“WCCI”), an
Affiliate of GALEN;
WHEREAS , WCCI and LEO have on the date hereof entered
into a series of inter-related agreements and addenda with respect
to the agreements described in Article 2 ; and
WHEREAS , WCCI and LEO desire to amend the Master
Agreement by entering into this Addendum.
NOW THEREFORE,
the Parties hereby agree as
follows:
Article 1
Definitions
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1.1
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Capitalized
terms not otherwise defined herein shall have the meanings set
forth in the Master Agreement.
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1.2
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“
Party ” means WCCI or LEO, as the case may be, and
“ Parties ” means WCCI and LEO.
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1.3
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“
Products ” means (i) any pharmaceutical
formulation containing calcipotriol (calcipotriene) as the only
active pharmaceutical ingredient (including Dovonex® ointment,
cream and scalp solution) and any other such formulations in any
form including, but not limited to, a gel, foam, spray, mousse or
liquid, whether such formulation has been developed, is being
developed or may be developed in the future and (ii) any
pharmaceutical formulation containing calcipotriol (calcipotriene)
and steroid, including Dovobet® ointment, LEO 80185, LEO
80190, and any other such formulations in any form including, but
not limited to, an ointment, cream, gel, solution, foam, spray,
mousse or liquid, whether such formulation has been developed, is
being developed or may be developed in the future.
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Article 2
Operative
Agreements
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2.1
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Simultaneously
with the signing of this Addendum the Parties have signed the
following agreements and addendum with respect to the Operative
Agreements:
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(a)
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License, Supply
and Development Agreement, attached to this Addendum as Appendix
A (the “ DC Agreement ”). All references to
the Dovobet® Agreement contained in the Master Agreement,
shall be deemed to refer to the DC Agreement, as may be amended
from time to time.
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(b)
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Amended and
Restated Dovonex® Agreement, attached to this Addendum as
Appendix B (the “ Amended and Restated Dovonex
Agreement ”). All references to the Dovonex®
Agreement in the Master Agreement, shall be deemed to refer to the
Amended and Restated Dovonex® Agreement, as may be amended
from time to time.
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(c)
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Addendum I to
the Development Agreement, attached to this Addendum as Appendix
C (the “ Development Agreement Addendum I
”). All references to the Development Agreement in the Master
Agreement, shall be deemed to refer to the Development Agreement as
amended by the Development Agreement Addendum I, and as may be
further amended from time to time.
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2.2
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In addition to
the agreements and addendum set forth in Article 2.1 the
Parties have entered into the following agreements:
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(a)
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Right of First
Refusal Agreement, attached to this Addendum as Appendix D
(the “ Right of First Refusal Agreement
”).
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(b)
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Amended and
Restated Cooperation Agreement, attached to this Addendum as
Appendix E (the “ Amended and Restated Cooperation
Agreement ”).
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(c)
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Confidentiality
Agreement attached to this Addendum as Appendix F (the
“ Confidentiality Agreement ”).
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(d)
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Letter
Agreement attached to this Addendum as Appendix G (the
“ Letter Agreement ”).
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Article 3
Studies
This Article 3 is intended to
encompass the clinical development of all line extensions of
Products, except (i) studies for the initial registration of
Products, (ii) studies required for the development of the
Appendix IV Products as set forth in Article 3.1 of the DC
Agreement and (iii) the studies described in the Amended and
Restated Cooperation Agreement (see Article 3.7(b) of this
Addendum). As used herein, “ Appendix IV Products
” has the meaning ascribed to it in the DC Agreement. This
Article 3 is not intended to encompass product development, which
is addressed separately in the DC Agreement.
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MASTER AGREEMENT
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ADDENDUM I
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2/8
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3.1
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WCCI shall not
perform a pre-clinical or clinical study, seeding trial,
observational study or any other pre or post marketing study
relating to the Products, without the prior written consent of LEO
and the prior written approval of the protocols by LEO, such
consent and approval not to be unreasonably withheld. Products to
be used in any such studies or trials shall be delivered by LEO to
WCCI at a price equivalent to 75% of the purchase price agreed by
the Parties for such product.
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3.2
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In the event a
Party (the “ Proposing Party ”) desires to
conduct a pre-clinical or clinical study, seeding trial,
observational study or any other pre or post marketing study
relating to the Products (individually, a “ Study
” and collectively, the “ Studies ”), such
Party shall promptly deliver a study outline to the other Party
(the “ Receiving Party ”). In addition, the
Proposing Party shall indicate whether such Study (i) is
intended for use in obtaining a Registration (such as for a new
indication or other labelling change for a Product in the
Territory) (a “ Registration Study ”) or
(ii) is not intended for use in obtaining a Registration (such
as an early experience trial or observational study) (a “
Non-Registration Study ”).
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3.3
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Except as
expressly set forth in this Article 3 or in a separate study
agreement, each Party shall be responsible for funding all Studies
conducted by or on behalf of such Party.
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3.4
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Subject to
applicable Law, including applicable privacy laws, data (including
results) from each Study conducted by or on behalf of either Party
shall be made available to the other Party (and may be made
available by LEO to any of its licensee(s) having rights to the
Product which is the subject of such Study, each, a “
Product Licensee ”) for the purpose of safety
reporting or compliance with compulsory regulatory reporting
requirements regardless of which Party has conducted and/or funded
the study in question.
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If data becomes publicly available
through the publication of results of a Registration Study, such
data and results that have been made public may be used by either
Party (and may be made available by LEO to any Product Licensee(s))
for medical marketing purposes and all other lawful purposes
regardless of which Party has conducted and/or funded such Study.
Data from Non-Registration Studies conducted by or on be
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