Exhibit 10.1
07 May 2009
WARNER CHILCOTT COMPANY,
LLC
P.O.Box 1005
Fajardo
Puerto Rico
00738
Terms for exchanging the LEO
80185 Body Indication with a New LEO Product
Reference is made to the Master
Agreement dated as of April 1, 2003 between Galen (Chemicals)
Limited and LEO Pharma A/S (“LEO”) (the “Master
Agreement”) as amended by Addendum I dated as of
September 14, 2005 between Warner Chilcott Company, LLC
(formerly Warner Chilcott Company, Inc.) (“WCCI”) and
LEO (the “Addendum”) and to the License, Supply and
Development Agreement dated as of September 14, 2005 between
LEO and WCCI, as amended (the “DC Agreement”). In
consideration of the covenants and agreements contained herein and
notwithstanding anything to the contrary set forth in the Master
Agreement, the Addendum and the DC Agreement, LEO and WCCI hereby
agree as follows:
Whereas WCCI has expressed its
interest in marketing a new LEO product described in Exhibit A
hereto (the “New Product”) in the the Territory (as
defined in the DC Agreement) instead of LEO 80185 (trunk
indication) for the topical treatment of psoriasis vulgaris in
adults described in Appendix IV to the DC Agreement (the
“80185 Product”); and
Whereas LEO has agreed to attempt to
develop such New Product.
Now therefore WCCI and LEO have
agreed to enter into this Letter Agreement.
LEO and WCCI agree that:
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1.
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LEO shall cease
development of the 80185 Product for the Territory until such time
as it delivers the 80185 Development Resumption Notice (as defined
below) to WCCI in accordance with the terms hereof.
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2.
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LEO will
develop the New Product for the Territory on the following
conditions:
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a.
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Between
January 1, 2010 and December 1, 2010 LEO shall deliver
written notice to WCCI providing that (i) LEO will continue
the development of the New Product for the Territory (such notice,
the “New Product Development Notice”) or (ii) LEO
will resume the development of the 80185 Product for the Territory
and will terminate its development hereunder with respect to the
New Product (such notice, the “80185 Development Resumption
Notice”), it being understood that such election of whether
to continue the New Product development or resume the 80185 Product
development shall be determined in LEO’s sole
discretion.
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b.
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If LEO delivers
a New Product Development Notice in accordance with
Section 2(a) hereof the parties shall execute an amendment to
Appendix IV of the DC Agreement on or prior to January 15,
2011 deleting the 80185 Product and including the New Product as an
Appendix IV Product (as defined in the DC Agreement) and WCCI shall
pay the following milestones to LEO:
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i.
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USD 25,000,000
(United States Dollars twenty five million) no later than
January 15, 2011;
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ii.
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USD 10,000,000
(United States Dollars ten million) 15 (fifteen) days after the
acceptance for filing of an NDA or an sNDA for the approval of the
New Product with the United States Food and Drug Administration
(the “FDA”); and
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iii.
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USD 15,000,000
(United States Dollars fifteen million) 15 (fifteen) days after the
approval by the FDA of the New Product for the
Territory.
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For the av
