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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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*** CONFIDENTIAL TREATMENT REQUESTED ***
"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
spec
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