Exhibit 10.7
CONFIDENTIAL TREATMENT
REQUESTED
Redacted portions are indicated by
[****]
LICENSE AGREEMENT
This LICENSE AGREEMENT (this
“ Agreement ”) is dated as of February 7,
2007 (the “ Effective Date ”) by and between
Women’s and Children’s Hospital, a facility of
Children, Youth and Women’s Health Service incorporated under
the South Australian Health Commission Act 1976, having its
principal place of business at 72 King William Road, North
Adelaide, South Australia, Australia (hereinafter referred to as
“ WCH ”), and BioMarin Pharmaceutical Inc., a
Delaware corporation, having its principal place of business at 105
Digital Drive, Novato, California 94949 (hereinafter referred to as
“ BioMarin ”).
INTRODUCTION
WHEREAS, WCH owns the WCH Licensed Product and Licensed
Technology; and
WHEREAS, BioMarin and WCH entered into that certain
License Agreement dated August 14, 1998 (the “
License Agreement ”), wherein WCH agreed to grant to
BioMarin an exclusive worldwide license to the WCH Licensed
Technology for the commercialization of the Licensed Product in
accordance with the terms and conditions set forth in the License
Agreement; and
WHEREAS , BioMarin and WCH desire to enter into this
Agreement, which shall supercede the License Agreement, to define
the terms and conditions under which WCH shall grant BioMarin an
exclusive, worldwide, perpetual, royalty -bearing license to the
Licensed Product and Licensed Technology.
NOW, THEREFORE,
in consideration of the mutual
covenants and promises contained herein and other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, WCH and BioMarin agree as follows:
Article I.
DEFINITIONS
As used in this Agreement, the
following terms, whether used in the singular or plural, shall have
the following meanings:
1.1 “ Affiliate ”
means any person, corporation, company, partnership, joint venture,
firm or other entity which controls, is controlled by or is under
common control with a Party. For purposes of this
Section 1.1 , “control” shall mean:
(a) in the case of corporate entities, direct or indirect
ownership of at least fifty percent (50%) (or such lesser
percentage that is the maximum allowed to be owned by a foreign
corporation in a particular jurisdiction) of the stock or shares
entitled to vote for the election of directors; and (b) in the
case of non-corporate entities, direct or indirect ownership of at
least fifty percent (50%) of the equity interest with the
power to direct the management and policies of such non-corporate
entities.
1.2 “ BioMarin
Improvement ” means variations, updates, modifications,
and enhancements developed, conceived or reduced to practice by
BioMarin as related to the use of rhASB, including, without
limitation, any and all developments, enhancements, modifications,
inventions or discoveries, to methods of treatment, purification
and production for rhASB to the extent such methods of treatment,
purification or production are not related to the host cell line
which expresses rhASB. For the avoidance of doubt, any improvements
or inventions related to or made in the course of developing the
Licensed Products and during the term of the License Agreement are
either BioMarin Improvements or Licensed Technology, as
applicable.
1.3 “ BioMarin Improvement
Patent Rights ” means any United States or foreign patent
or patent application which discloses or claims a BioMarin
Improvement.
1.4 “ BioMarin
Indemnitee(s) ” shall have the meaning set forth in
Section 9.4(b) .
1.5 “ Commercially
Reasonable Efforts ” means, with respect to the research,
development, manufacture, or commercialization of Licensed Product,
efforts and resources commonly used in the research-based
pharmaceutical industry for a compound or product of similar
commercial potential at a similar stage in its lifecycle, taking
into consideration its safety and efficacy, its cost of
development, the competitiveness of alternative products, its
proprietary position, the likelihood, expense and time required to
obtain regulatory and reimbursement approval, its profitability,
and other relevant factors. Commercially Reasonable Efforts shall
be determined on a market-by-market basis.
1.6 “ Confidential Information
” means trade secrets, know how and other confidential
information (including, without limitation, technical and business
information, patent information, structures, models, techniques,
formula, processes, compositions, compounds, apparatus,
specifications, samples, inventions and ideas) of either Party
which relates to the subject matter of this Agreement, including
without limitation the Licensed Product, Licensed Technology and
any BioMarin Improvements, whether or not marked as proprietary or
confidential, disclosed by the disclosing Party or obtained through
observation or examination of the disclosing Party’s
information or developments, or which, although not related to such
subject matter, is nevertheless disclosed as a result of the
Parties’ discussions but only to the extent that such
information is maintained as confidential by the disclosing Party.
Confidential Information may be disclosed orally, visually or in
tangible form (whether by document, electronic media, or other
form).
1.7 “ Indemnify ”
shall have the meaning set forth in Section 9.4(a)
.
1.8 “ Indemnifying
Party ” shall have the meaning set forth in
Section 9.4(c) .
1.9 “ Indemnitee(s)
” shall have the meaning set forth in
Section 9.4(c) .
1.10 “ Inventions
” shall have the meaning set forth in Section 5.1
.
1.11 “ Licensed Product
” means recombinant human enzyme N-acetylgalactosamine-4-
sulfatase (rhASB) and its precursor (collectively and separately
referred to herein as rhASB) and compositions comprising same that
are developed from or utilizes any part of the Licensed
Technology.
1.12 “ Licensed
Technology ” means all developments, enhancements,
know-how, modifications, inventions, improvements, and discoveries
in the control of WCH as of August 14, 1998 related to the
Licensed Product development before August 14, 1998 and
methods of production or purification of Licensed Product developed
after August 14, 1998, but only to the extent applicable to
the host cell line which expresses rhASB or a daughter cell line
thereof, including the patent and patent applications listed in
Exhibit A , attached hereto.
1.13 “ Losses ”
shall have the meaning set forth in Section 9.4(a)
.
1.14 “ Net Sales
” means [****]
1.15 “ Party ”
means WCH or BioMarin; “Parties” means WCH and
BioMarin.
1.16 “ rhASB ”
means recombinant human enzyme N-acetylgalatosamine
4-sulfatase.
1.17 “ Term ”
shall have the meaning set forth in Section 8.1
.
1.18 “ Territory
” means the entire world.
1.19 “ Third Party
” means any entity other than WCH, BioMarin, and their
respective Affiliates.
1.20 “ WCH
Indemnitee(s) ” shall have the meaning set forth in
Section 9.4(a) .
Article II.
LICENSE
2.1 Grant to BioMarin .
Subject to the terms and conditions of this Agreement, WCH hereby
grants to BioMarin and its Affiliates an exclusive, perpetual,
nontransferable, royalty -bearing license, with the right to grant
sublicenses, under the Licensed Technology to make, have made,
develop, use, distribute, lease, promote, offer to sell, sell, have
sold, import or export Licensed Products in the
Territory.
2.2 Notice of Sublicense .
BioMarin shall provide WCH with prompt written notice of any
sublicense of the rights granted to BioMarin herein to the extent
that such sublicense could result in the sublicense generating Net
Sales, including an identification of the sublicensee and a
description of the rights sublicensed. Information regarding any
such sublicense shall be Confidential Information of
BioMarin.
2.3 Diligence . BioMarin
shall exercise Commercially Reasonable Efforts to develop and
commercialize the Licensed Product.
2.4 No Further Rights .
Except as explicitly provided in this Article II and III ,
no further license or right, express or implied, is granted by
either Party hereunder.
Article III.
DEVELOPMENT
3.1 BioMarin will be responsible for
the development and production of the Licensed Product and for
world wide supply and commercialization related to the Licensed
Product. WCH hereby grants and BioMarin accepts the right to
sublicense the Licensed Product to ensure BioMarin can enter into
partnerships or business collaborations, which involves the
manufacture, marketing, sales, and distribution of the Licensed
Products.
Article IV.
PAYMENTS
4.1 Fees to WCH . In
consideration of the license set forth in Article II above,
BioMarin shall pay to WCH nonrefundable earned royalties as set
forth below on Net Sales of Licensed Product:
4.2 Royalty Term . BioMarin
obligation to pay earned royalties to WCH under this Agreement
shall commence on the Effective Date and [****]
Article V. INTELLECTUAL
PROPERTY
5.1 Ownership of Inventions .
WCH shall have and retain sole and exclusive title to all
inventions, discoveries and know-how (“Inventions”)
which are made by either party, its employees, agents or other
parties acting under authority from either party specifically
relating to the Licensed Product.
5.2 BioMarin Improvements .
All right, title and interest to BioMarin Improvements shall remain
vested in BioMarin. WCH shall take such actions as BioMarin may
reasonably request to vest title to BioMarin Improvements with
BioMarin.
5.3 Prosecution of Patent
Rights . BioMarin shall have the right, but not the obligation,
to (in its sole discretion) file, obtain, prosecute, extend and
maintain, at its sole cost and expense, patents and patent
applications, including all divisional, continuation and
continuation-in-part applications for Inventions, BioMarin
Improvement Patent Rights and the Licensed Technology throughout
the world. BioMarin shall forward to WCH copies of any material
correspondence received from the United States or foreign patent
offices with respect to the Licensed Technology for those patents
and patent applications which, but for the license granted under
this Agreement, the manufacture, use or sale of Licensed Product,
would infringe. WCH shall have the right to comment on and to
discuss prosecution and maintenance activities with BioMarin, and,
if such comments and advice are timely offered by WCH, BioMarin
shall consider the same in good faith, but shall not be obligated
to implement any comments and advice so offered by WCH. In
addition, WCH agrees that it will not perform any act that is
deleterious to BioMarin’s efforts to prosecute the patents
for Inventions, BioMarin Improvement Patent Rights or Licensed
Technology or defend or enforce a claim within patents for the WCH
Licensed Technology; nor, initiate any procedure that could result
in the invalidation or unenforceability of any claim related to
patents for Licensed Technology.
5.4 Enforcement of Patent
Rights .
(a) Notice . Each Party shall
promptly report in writing to the other Party during the Term of
this Agreement any suspected infringement of the patent rights for
Licensed Technology or BioMarin Improvement Patent Rights of which
it becomes aware, and shall provide the other Party with all
available evidence supporting such suspected infringement or
unauthorized use.
(b) Enforcement of Patent
Rights . BioMarin shall have the right, but not the obligation,
to initiate and control patent infringement proceedings or to
otherwise enforce the rights in BioMarin Improvement Patent Rights
or Licensed Technology against any Third Party who at any time is
suspected of infringing BioMarin Improvement Patent Rights or
Licensed Technology. Further and in such case, BioMarin shall keep
WCH informed, and shall from time to time consult with WCH
regarding the status of any such suit and, upon request, shall
provide WCH, at BioMarin’s expense, with copies of all
documents filed in, and all material written communications between
the parties relating to, such suit. If necessary, upon request by
BioMarin, WCH shall join as a party to the suit. Also, upon
reasonable request by BioMarin, WCH shall reasonably cooperate with
BioMarin to execute all necessary and proper documents and take all
other appropriate action required to institute and prosecute such
action. BioMarin will promptly reimburse
WCH for any reasonable costs incurred by WCH to
join as a party or to cooperate with BioMarin in the institution
and/or prosecution of such action; provided, however, that such
costs are incurred at the request of BioMarin and appropriate
detailed supporting documentation is provided to BioMarin by
WCH.
(c) Selection of Counsel and
Payment of Expenses . BioMarin shall have the sole and
exclusive right to select BioMarin counsel for any suit referred to
in Section 5.2(b) of this Agreement and shall pay all
expenses of the suit, including attorneys’ fees and court
costs. Any damages, royalties, settlement fees or other
consideration received by BioMarin with respect to such suit shall
be retained solely by BioMarin.
5.5 Alleged Infringement of Third
Party Patent Rights .
(a) In the event that a Third Party
institutes a patent infringement suit against BioMarin, its
Affiliates, or sublicensees, as a result of BioMarin’s, its
Affiliates’, or sublicensee’s exercise of its rights
under this Agreement, BioMarin shall have the sole right to defend
such suit. BioMarin shall pay all expenses of the suit, including
attorneys’ fees and court costs. Any damages, royalties,
settlement fees or other consideration received by BioMarin with
respect to the suit shall be retained solely by BioMarin. Upon the
request of BioMarin, and at BioMarin’s expense, WCH shall use
reasonable efforts to assist and cooperate with BioMarin in
connection with the defense of such suit.
(b) In the event that a Third Party
institutes a patent infringement suit against WCH, its Affiliates,
or sublicensees, as a result of WCH’s, its Affiliates’,
or sublicensee’s exercise of its rights under this Agreement,
WCH shall have the sole right to defend such suit. WCH shall pay
all expenses of the suit, including attorneys’ fees and court
costs. Any damages, royalties, settlement fees or other
consideration received by WCH with respect to the suit shall be
retained solely by WCH. Upon the request of WCH, and at WCH’s
expense, BioMarin shall use reasonable efforts to ass
