EXHIBIT 10.40
CLINICAL SUPPLY
AGREEMENT
THIS CLINICAL SUPPLY
AGREEMENT (the
“Agreement”) is entered into as of the 1
st day of June, 2006 (the “Effective
Date”) by and between SCHERING AKTIENGESELLSCHAFT , a
German corporation having a principal place of business at
Müllerstraße 178, D-13342 Berlin, Germany
(“Schering”) and SONUS PHARMACEUTICALS, INC. , a
Delaware corporation having a principal place of business at 22026
20th Avenue SE, Bothell, Washington 98021
(“Sonus”). Schering and Sonus are referred to
individually as a “Party” and collectively as
“Parties.”
WHEREAS , Schering and Sonus have entered into a
Collaboration and License Agreement having an effective date of
October 17, 2005 (the “License Agreement”) for the
development and commercialization of the Product in the Territory
(each as defined below);
WHEREAS , pursuant to the License Agreement, Sonus has
granted to Schering exclusive rights to develop and commercialize
the Product in the Territory, which rights include, among other
rights, the right to elect to make the Product and have the Product
made on its behalf;
WHEREAS
, Schering gave written notice of its election to assume
responsibility for manufacture and supply of Product on March 2,
2006, but has not yet established internal or external
manufacturing capabilities for the Product, and the Parties desire
that Sonus supply Schering with clinical supplies of the
Product pursuant to the MSA (as defined below) until Schering
establishes such manufacturing capabilities; and
WHEREAS , pursuant to Section 7.02 of the License
Agreement, the Parties wish to provide for each Party’s
rights and responsibilities in connection with the clinical supply
of the Product to Schering by Sonus as set forth in the terms and
conditions of this Agreement.
NOW, THEREFORE
, in consideration of the premises
and the mutual covenants and agreements contained herein, the
Parties agree as follows:
1.
Definitions.
Capitalized terms used in this
Agreement (other than the headings of the Articles and Sections),
whether used in the singular or plural, shall have the meaning set
forth below, or, if not listed below, the meaning as designated in
the text of this Agreement.
“ Affiliate ”
means, with respect to any Person, any other Person that directly
or indirectly controls, is controlled by or is under common control
with such Person. For the purposes of this definition, a
Person shall be deemed to control another Person if such Person
possesses the power to direct or cause the direction of the
management, business and policies of such Person, whether through
ownership of fifty percent (50%) or more of the voting securities
of such Person, by contract or otherwise.
“
API ” or “
Active Pharmaceutical
Ingredient ” means any component
of the Product that is intended to furnish pharmacological activity
or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease, or to affect the structure or
any function of the
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body of man or animals, but does not
include intermediates used in the synthesis of such
ingredients.
“ Certificate of
Analysis ” means a certificate that accompanies each
shipment of Product certifying that the Product meets the
Specifications.
“ Certificate of
Compliance ” means a certificate that accompanies each
shipment of Product certifying that the Product has been
manufactured according to cGMP.
“ cGMP ” means
current Good Manufacturing Practices regulations promulgated by
FDA, as they may be amended from time to time. cGMP also includes
published standards of FDA (or other standards of FDA that are
generally recognized within the United States pharmaceutical
industry) that relate to the testing, manufacturing, processing,
packaging, holding or distribution of drug substances and finished
drugs. cGMP also includes similar standards, guidelines and
regulations promulgated or otherwise required by the European
Commission, and published standards of the European Commission (and
other standards of the European Commission that are generally
recognized within the European pharmaceutical industry), including
the Guide to Good Manufacturing Practices for Medicinal Products as
promulgated under European Directive 91/356/EEC, as amended from
time to time, that relate to the testing, manufacturing,
processing, packaging, holding or distribution of drug substances
and finished drugs..
“ Confidential
Information ” means all information and materials
regarded by the disclosing Party as confidential (including,
without limitation, information relating to the Sonus Technology,
as defined in the License Agreement) furnished by one Party to the
other pursuant to this Agreement and all information created or
developed during the course of the Parties’ collaboration
hereunder, whether in oral, written, graphic or electronic
form. Confidential Information shall not include any
information which the receiving party can prove by competent
evidence:
(a)
is now or hereafter becomes, through no fault or failure to act on
the part of the receiving Party, generally known or
available,
(b)
is known by the receiving Party, without obligations of
confidentiality, at the time of receiving such information, as
demonstrated by written evidence,
(c)
is hereafter furnished to the receiving Party by a third party, as
a matter of right and without restriction on
disclosure,
(d)
is independently developed by the receiving Party without the aid,
application or use of the disclosing party’s Confidential
Information, as demonstrated by written evidence, or
(e)
is the subject of written permission to disclose provided by the
disclosing Party.
“ Contract Manufacturing
Agreement ” means an agreement between Sonus and a Third
Party contract manufacturer regarding the manufacture of all or
part of the clinical supply of the
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Product. For the avoidance of
doubt, the MSA and the Quality Agreement shall be considered
Contract Manufacturing Agreements.
“ EU ” means the
countries of the European Union as constituted from time to
time.
“FDA”
means the United States Food and
Drug Administration or successor agency thereto.
“ FD&C Act ”
means the United States Federal Food, Drug and Cosmetic Act, as
amended.
“Field”
means all uses of the Product for
the diagnosis, prevention, treatment, cure or mitigation of all
disease states, conditions, disorders and indications in humans or
in animals
“ Investigator Sponsored
Study ” or “ ISS ” means any clinical
study with respect to the Product in the Field where the sponsor of
the study is a physician or group of physicians acting as
sponsor-investigator(s) and neither of the Parties nor any of their
Affiliates or sublicensees accept the role of sponsor or co-sponsor
of such a study.
“ MSA ” means the
Manufacturing and Supply Agreement between Sonus and Gensia Sicor
Pharmaceutical Sales, Inc. (now known as Sicor Pharmaceuticals,
Inc.), effective as of June 26, 2002.
“ NDA ” means New
Drug Application, as described in FDA regulations, 21 C.F.R. 50,
including all amendments and supplements to the
application.
“ NDA Support Trial
” means any clinical study with respect to the Product in the
Field that will be part of the initial NDA (as defined in the
License Agreement) submission, excluding the Pivotal Trial (as
defined in the License Agreement).
“ Product ” means
the product known as TOCOSOL® Paclitaxel, as more particularly
described in the License Agreement.
“ Quality Agreement
” means the Quality Agreement for the Manufacturing and
Supply of Tocosol® Paclitaxel Injectable Emulsion between
Sonus and Sicor Pharmaceuticals, Inc., effective as of February 1,
2005. A complete copy of the Quality Agreement is attached
hereto as Exhibit A.
“ ROW ” means all
countries, territories and geographical areas of the world,
excluding the United States of America and its territories,
commonwealths and possessions.
“ ROW Registrational
Trial ” means any clinical study with respect to the
Product in the Field that will be part of an application for
approval by any regulatory authority in the ROW.
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“ Schering Sponsored
Study ” or “ CSS ” means any
non-registrational clinical study with respect to the Product in
the Field where the sponsor of the study is Schering or its
Affiliates.
“ Specifications
” means the regulatory, manufacturing, quality control and
quality assurance procedures, processes, practices, standards,
instructions and any other attributes that the Parties agree upon,
or that are otherwise required, in connection with the manufacture
of the Product, as may be amended by the Parties from time to
time. A complete copy of the Specifications, as agreed by the
Parties, is attached hereto as Exhibit B.
“ Term ” has the
meaning specified in Section 6.1 of this Agreement.
“ Territory ”
means the entire world.
“ Third Party ”
means any entity other than Schering, Sonus or any of their
Affiliates.
2.
Supply of Product
2.1
Clinical Supply. Pursuant to the terms
hereof, Sonus shall, during the term
of this Agreement, manufacture, either by itself of through a Third
Party, and supply to Schering clinical supply of the Product
necessary to support ISS, CSS, NDA Support Trials, ROW
Registrational Trials, and any other investigational study
sponsored or conducted by Schering.
2.2
Quality of Product. All Product