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Exhibit 10.14
CLINICAL SUPPLY AGREEMENT
This
Agreement, dated as of October 5, 2005, is made and entered into
by
and between: Light Sciences Oncology, Inc., a Washington
corporation ("LSO");
and Light Sciences Corporation, a Washington corporation
("Buyer").
RECITALS
A.
Light Sciences Corporation ("LSC") entered into agreements with
certain
third parties under which such third parties have manufactured and
supplied to
LSC talaporfin sodium (referred to as LS11) in bulk or finished
dosage form.
B.
LSC has assigned to LSO its rights under such manufacturing and
supply
agreements and has transferred to LSO approximately 3,500 vials of
LS11 in
finished dosage form, and approximately 2.5 kg of bulk LS11.
C.
Buyer has the valid right and license to use, make, have made,
sell,
offer to sell, import and otherwise dispose of LS11.
D.
Buyer wishes to acquire from LSO, and LSO wishes to supply to
Buyer,
LS11 in finished dosage form manufactured or to be manufactured
under third
party agreements for use in clinical studies under the terms and
conditions of
this Agreement.
AGREEMENT
NOW
THEREFORE, in consideration of the promises and agreements set
forth
herein, the parties agree as follows:
SECTION 1. DEFINITIONS
Whenever used in this Agreement with initial letters capitalized,
the
following terms will have the following specified meanings:
"BAXTER AGREEMENT" means the Drug Product Development and Clinical
Supply
Agreement between LSC and Baxter Pharmaceutical Solutions LLC
("Baxter"), dated
July 9, 2004, as amended from time to time.
"BULK DRUG" means talaporfin sodium manufactured and supplied by
Johnson
Matthey in bulk form under the Johnson Matthey Agreement or by
another Third
Party Manufacturer.
"CLINICAL STUDIES" means animal, preclinical or human clinical
studies of
LS11 by Buyer before marketing approval of LS11 by the regulatory
authority of
the jurisdiction where the study is conducted.
"CONFIDENTIAL INFORMATION" means any confidential or
proprietary
information of the disclosing party, whether of a scientific,
business or other
nature (including, but not limited to, trade secrets, know how and
information
relating to the products, research, studies, technology,
inventions, suppliers,
contracts, manufacturing methods, investigators, personnel,
business plans,
finances or
CLINICAL SUPPLY AGREEMENT
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scientific, regulatory, legal or other affairs of such party);
provided, that the same is marked or otherwise identified as
confidential or
proprietary information prior to, upon or promptly after receipt by
the
receiving party. However, Confidential Information does not include
any
information that: (a) was known by the receiving party prior to
communication by
the disclosing party; (b) is a matter of public knowledge at the
time of such
disclosure by the disclosing party; (c) becomes a matter of public
knowledge,
without fault on the part of the receiving party, subsequent to
disclosure by
the disclosing party to the receiving party; or (d) has been
disclosed to the
receiving party from a third party lawfully having possession of
such
Confidential Information without an obligation of confidentiality
to the
disclosing party. Subparagraph (a) will not apply to Confidential
Information
assigned or transferred to LSO by LSC on or before the date of this
Agreement.
"DRUG PRODUCT" means an investigational pharmaceutical product
containing
the Bulk Drug as the active pharmaceutical ingredient manufactured
and supplied
in finished dosage form by Baxter under the Baxter Agreement or by
another Third
Party Manufacturer.
"FIELD" has the meaning set forth in the Recitals.
"JOHNSON MATTHEY AGREEMENT" means the Research and Manufacturing
Agreement
between LSC and Johnson Matthey Pharmaceutical Materials, Inc.
d/b/a Pharm-Eco
("Johnson Matthey"), dated May 7, 2004, as amended from time to
time.
"TERM" has the meaning set forth in Section 5.1.
"THIRD PARTY MANUFACTURER" means Baxter, Johnson Matthey or any
other third
party LSO engages to supply raw material for LS11 or to manufacture
and supply
LS11 in bulk or finished dosage form, or any successor to such
entity's rights,
obligations or interests under the applicable Third Party Supply
Agreement.
"THIRD PARTY SUPPLY AGREEMENTS" means the Baxter Agreement, the
Johnson
Matthey Agreement and any other agreements under which LSO engages
a Third Party
Manufacturer to supply raw material for LS11 or to manufacture and
supply LS11
in bulk or finished dosage form.
SECTION 2. CLINICAL SUPPLY OF DRUG PRODUCT
2.1
OBLIGATION OF LSO TO
SUPPLY
LSO
will use commercially reasonable efforts to supply to Buyer
such
quantities of Drug Product as Buyer may order from LSO during the
Term; provided
such quantities do not exceed the quantities set forth in Buyer's
most recent
forecast under Section 3.2 and can be supplied from LSO's then
available
inventory of Drug Product or by a Third Party Manufacturer under a
Third Party
Supply Agreement. Buyer acknowledges that LSO will supply itself
and third
parties with Drug Product from its existing inventory, and that LSO
is not
obligated to maintain its existing inventory of Bulk Drug or Drug
Product, or
reserve inventory for Buyer, or enter into additional manufacturing
and supply
agreements. In the event of a shortage of available Drug Product,
LSO will
allocate the available Drug Product. Upon reasonable request, LSO
will furnish
to Buyer a current inventory of Drug Product being manufactured for
LSO and in
LSO's possession or control.
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2.2
SUBMISSION OF ORDERS
TO THIRD PARTY MANUFACTURERS
If
the quantity of Drug Product ordered by Buyer under Section 2.1
exceeds
LSO's then available inventory, LSO will notify Buyer, and, upon
Buyer's
request, LSO will submit a firm order for Drug Product with a Third
Party
Manufacturer, and, if necessary, will also submit firm orders with
other Third
Party Manufacturers for quantities of raw material and Bulk Drug
needed to
manufacture the requested Drug Product. Any orders submitted to a
Third Party
Manufacturer are subject to acceptance by the Third Party
Manufacturer and the
terms and conditions of the applicable Third Party Supply
Agreement, including,
without limitation, minimum quantities. Further, if the Third Party
Manufacturer
requires an advance payment before accepting the order or milestone
or other
progress payments, Buyer will pay to LSO the full amount of the
advance payment
before LSO submits the order to the Third Party Manufacturer and
any milestone
or other progress payments as they become due to the applicable
Third Party
Manufacturer. If the Third Party Manufacturers capable of supplying
the
requested raw material, Bulk Drug or Drug Product, as the case may
be, reject
LSO's order or are not able to supply the requested materials on
terms
acceptable to LSO and Buyer, then LSO will have no further
obligations with
respect to the supply of Drug Product that exceeds LSO's then
available
inventory.
2.3
USE OF DRUG PRODUCT
FOR CLINICAL STUDIES
Buyer will purchase, and LSO will supply to Buyer, Drug Product
under this
Agreement solely for use in Clinical Studies in the Field. Buyer
will not use
Drug Product acquired under this Agreement other than to conduct
Clinical
Studies in the Field, and Buyer will comply with all restrictions
on use and
other requirements set forth in the applicable Third Party
Manufacturer
Agreements.
2.4
ALTERNATE SOURCE OF
SUPPLY
Promptly after the date of this Agreement, or three (3) years
before the
projected date of Buyer's first commercial sale of LS11 drug
product, whichever
occurs last, Buyer will undertake commercially reasonable efforts
to identify,
qualify and enter into agreements with one or more third parties
for the
manufacture and supply of LS11 drug product. LSO will reasonably
cooperate with
Buyer to establish such alternate sources of supply and transition
supply of
drug product from LSO to such third parties, including, without
limitation,
furnishing available technical assistance and documentation. Buyer
will pay LSO
its then current FTE rates for such assistance and reimburse LSO
all reasonable
travel and other out-of-pocket expenses incurred in connection
therewith.
2.5
PROCESS
IMPROVEMENTS
Subject to LSO's obligations to third parties and provided LSO
has
sufficient rights, LSO will grant to Buyer a non-transferable,
non-exclusive
license to use any improvements to the Drug Product manufacturing
process
developed or made by or for LSO during the Term for the sole
purpose of
manufacturing talaporfin sodium drug product. The license granted
under this
Section 2.5 includes the right to sublicense under a written
sublicense
agreement reasonably acceptable to LSO for the sole purpose of
having talaporfin
sodium manufactured by a third party for Buyer.
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SECTION 3. TERMS AND CONDITIONS OF SALE
3.1
ORDERS
Buyer will complete, sign and submit to LSO a written order
specifying the
quantity of Drug Product that Buyer wishes to purchase, the desired
dose per
vial, desired delivery date and any specific requested shipping
instructions.
Buyer will order Drug Product in the minimum quantities specified
in EXHIBIT A.
All orders will be subject to acceptance by LSO and consistent with
the terms of
this Agreement and the applicable Third Party Supply
Agreements.
3.2
FORECASTS
Promptly after signing this Agreement and thereafter on the first
business
day of each calendar quarter during the Term, Buyer will provide
LSO with a
three (3) month rolling forecast of Buyer's reasonable estimate of
the
quantities of Drug Product that Buyer will need and order in each
quarter
covered by the forecast. Such estimates are estimates only and not
binding on
Buyer or LSO.
3.3
FIRM ORDERS
The
quantities set forth in