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CONFIDENTIAL TREATMENT REQUESTED EXHIBIT 10.77
CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24(b)(2) OF THE
SECURITIES
AND EXCHANGE ACT OF 1934. CONFIDENTIAL TREATMENT REQUESTED IS
REQUESTED
AND IS NOTED WITH "[CONFIDENTIAL TREATMENT REQUESTED]." AN
UNREDACTED
VERSION OF THIS DOCUMENT HAS BEEN PREVIOUSLY FILED WITH THE
SECURITIES
AND EXCHANGE COMMISSION.
EXCLUSIVITY AGREEMENT
THIS AGREEMENT is made the day of 22nd of December 2004
BETWEEN:
(1) PFC Therapeutics, LLC, a limited liability company organized
under the
laws of Delaware, USA and having its principal place of business
at
4660 La Jolla Village Drive, Suite 825, San Diego, CA 92122
USA
(hereinafter referred to as "PFC"), and
(2) LEO Pharma A/S, a company organized under the laws of
Denmark and
having its principal place of business at Industriparken 55,
DK-2750
Ballerup, Denmark (hereinafter referred to as "LEO")
RECITALS:
(A) The parties have provisionally agreed, subject to due
diligence,
contract and the other terms and conditions specified herein, to
a
transaction in which PFC will exclusively license to LEO certain
rights
to PFC's product Oxygent(R).
(B) This Agreement sets out the framework of the exclusive
negotiations
between PFC and LEO in connection with the transaction.
NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:
1. Definitions and Interpretation
1.1. In this Agreement, the following terms shall have the
following
meanings unless the context requires otherwise:
"AFFILIATE" means any corporation, firm, partnership,
organization or
entity that directly or indirectly controls, is controlled by or
is
under common control with such entity. For the purpose of
this
definition the term "control" means direct or indirect ownership
of at
least fifty one percent (51%) of the outstanding equity voting
stock
(or such lesser percentage which is the maximum allowed to be
owned by
a foreign corporation in a particular jurisdiction) of an
entity.
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*** CONFIDENTIAL TREATMENT REQUESTED ***
"AGENCY" means any governmental authority in the Territory
responsible
for granting approvals and clearance for marketing and sale of
the
Product.
"AGREEMENT" means this Exclusivity Agreement between PFC and
LEO.
"BRIEFING PACKAGE" means the compilation of Data in relation to
the
Product and the rational for the continued development and
obtaining of
Marketing Authorizations for the Product in the European Union.
The
Briefing Package is to be filed to EMEA with the purpose of
obtaining a
scientific advice. The Briefing Package must be prepared and
filed in
relation to relevant rules and regulations as set out by EMEA
for such
procedures.
"CONTROL" or "CONTROLLED" means the possession of/or the ability
to
grant a license or sublicense of Data or other intangible rights
as
provided for herein without violating the terms of any agreement
or
other arrangement with any third party.
"DATA" means information in the possession or Control of either
Party
relating to the Product including, without limitation,
confidential
know how, technical information, technology and trade secrets
relating
to the Product, information relating to the pre-clinical and
clinical
testing of the Product, information relating to any Clinical
Trials,
information relating to any suspected adverse drug experiences
with the
Product and any toxicological, pharmacological or
pharmacokinetic
trials relating to the Product.
"EMEA" means the European Medicines Evaluation Agency.
"EXCLUSIVITY FEE" means the fee paid by LEO to PFC in exchange
of the
exclusivity period and the rights granted in Clause 2.
"CGMP" means current Good Manufacturing Practice.
"IMPROVEMENTS" means all improvements, modifications or
adaptations to
any part of the Data or the Product made or acquired by either
Party
during the term of this Agreement.
"KNOW-HOW" includes without limitations all trade mark rights,
and all
financial, scientific, technical, regulatory, marketing and
commercial
know-how and Data concerning the Product.
"MARKETING AUTHORIZATIONS" means any approvals, product
and/or
establishment licenses, marketing authorizations or
registrations of
any federal, state or local Agency necessary for the
commercial
manufacture, use, storage, import, export, transport, marketing
or sale
of the Product in any country or regulatory jurisdiction of
the
Territory.
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"NET SALES" means the adjusted gross invoice price, the adjusted
gross
invoice price being the aggregate sales of LEO and its
Affiliates of
the Product to unaffiliated third parties in the Territory (but
not
including sales between LEO and its Affiliates) less sales
returns and
allowances, including trade, quantity and cash discounts and any
other
adjustments, including those granted on account of price
adjustments,
billing errors, rejected goods, damaged goods, recalls,
returns,
rebates, chargeback rebates, fees, reimbursements or similar
payments
granted or given to wholesalers or other distributors
(including
retailers), buying groups, health care insurance carriers or
other
institutions, freight and insurance charges billed to the
customers,
customs or excise duties, sales tax and other taxes (except
income
taxes) or duties relating to sales, and any payment in respect
of sales
to any governmental or regulatory authority in respect of any
federal
or state Medicaid, Medicare or similar program, all as
determined in
accordance with generally accepted accounting principles on a
basis
consistent with Company LEO's audited financial statements.
"NEW PRESENTATION" means any pharmaceutical product
incorporating
perflubron and/or perflubrodec. whether alone or in combination
with
other active or inactive ingredients, and any salts or
derivatives of
such Product. "Product" shall include Combination Products.
"PARTIES" means PFC and LEO and "Party" means either of them as
the
context indicates.
"PATENTS" means patents covering inventions that may be
developed by
either Party during the term of the License Agreement and that
relate
specifically to the Product, any Improvements or any New
Presentations
and any continuations, continuations-in-part, divisional,
provisionals
or any substitute applications, any patent issued with respect
to any
such patent applications, any reissue, reexamination, renewal
or
extension (including any supplementary patent certificate) of
any such
patent, and any confirmation patent or patent of addition based
on any
such patent, and all foreign counterparts of any of the
foregoing.
"PERIOD OF EXCLUSIVITY" The period which will commence on
signature of
this Agreement by both Parties and which shall expire no later
than
sixty (60) days after receipt of EMEA's written scientific
opinion to
the Briefing Package filed.
"PRODUCT" means Oxygent(R) a 60% w/v perflubron emulsion to be
used for
the treatment or alleviation of diseases in humans and as
further
described in Patents or any Improvements thereof.
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*** CONFIDENTIAL TREATMENT REQUESTED ***
"TERRITORY" means Europe (countries to be defined but will
include EU
countries, EU membership applicants, EU associated countries
including
NO and CH) and Canada (Other territories outside USA should
be
discussed e.g. Middle East, South America where LEO is quite
strong).
"TRADE MARKS" means the trade marks, including Oxygent(R), owned
by
PFC, including registrations and applications for registration
thereof
(and all renewals, modifications and extensions thereof) and
used in
connection with the Product in the Territory.
2. Period of Exclusivity and Option
In consideration of the Exclusivity Fee paid by LEO to PFC
the
following shall apply:
2.1. Neither PFC nor any of its Affiliates, nor any third
parties acting on
behalf of PFC and its Affiliates, will in the Territory during
the
Period of Exclusivity:
2.1.1 Discuss the Product with any party other than LEO and
its
Affiliates with a view to selling, licensing or otherwise
granting rights to the Product to any other person;
2.1.2 Approach or seek buyers or licensees for the Product
other
than LEO and its Affiliates;
2.1.3 Provide a draft contract or confidential information
concerning the Product to anyone other than LEO and its
Affiliates;
2.1.4 Negotiate or agree with anyone other than LEO or its
Affiliates any terms for the purchase or licensing of the
Product; or
2.1.5 Offer or grant rights to the Product or create any liens
or
encumbrances over the Product, other than in favour of LEO
and
its Affiliates.
2.2. In the Period of Exclusivity PFC will provide to LEO an
exclusive
option (even to PFC) (the "Option") to enter into an agreement
(the
"License Agreement") with the below main conditions to be
included. The
License Agreement must be negotiated and signed by the Parties
before
the Briefing Package is filed at EMEA (ref. Clause 4.1). The
License
Agreement shall come into force as provided below.
2.2.1 TYPE OF AGREEMENT: LEO will be appointed exclusive
licensee
(even to PFC) of the Product in the Territory. The license
will include the exclusive right of LEO to import and/or
manufacture, develop, obtain marketing authorization, store,
distribute, market and sell the Product for the term of the
License Agreement.
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2.2.2 FIELD OF USE: The field of use of the Product is in
the
treatment or alleviation of diseases in humans.
2.2.3 DURATION AND TERMINATION OF THE LICENSE AGREEMENT: The
License
Agreement shall come into force when and if LEO decides
within
the Period of Exclusivity to exercise the Option and,
subject
to the Parties' rights of termination to be specified in
the License Agreement, the License Agre
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