DISTRIBUTION AND LICENSE AGREEMENT BY AND AMONG VASOGEN INC., VASOGEN IRELAND LIMITED AND GRUPO FERRER INTERNACIONAL, S.A. APRIL 18, 2007
Exhibit
99.1
DISTRIBUTION
AND LICENSE AGREEMENT
BY
AND
AMONG
VASOGEN
IRELAND LIMITED
AND
GRUPO
▇▇▇▇▇▇ INTERNACIONAL, S.A.
APRIL
18, 2007
1
DISTRIBUTION
AND LICENSE AGREEMENT
THIS
DISTRIBUTION AND LICENSE AGREEMENT (this "Agreement") is made and entered
into
as
of this 18th day of April 2007 (the "Effective Date"),
BY
AND
AMONG:
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VASOGEN
INC., a company
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incorporated
under the laws of Canada, having its principal place of business
at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇
▇▇▇
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(hereinafter
referred to as: "Vasogen
Inc");
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Vasogen
Ireland Limited, a company duly constituted
under the laws of Ireland, having its
principal place of business at ▇▇▇▇▇▇▇, Ireland, a wholly-owned
subsidiary
of Vasogen
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(hereinafter
referred to as: "VIL");
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AND:
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GRUPO
▇▇▇▇▇▇ INTERNACIONAL, S.A., a corporation
duly constituted under the laws of
Spain, having its principal place of business
at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇
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(hereinafter
referred to as: "▇▇▇▇▇▇").
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PREAMBLE
WHEREAS
Vasogen
Inc
and
VIL
together control, through ownership or license, the rights to the
Product, Product IP Rights, the Trademarks, Vasogen Housemark(s), Intellectual
Property, the Know-how and the Patents in the Territory;
WHEREAS
VIL is a wholly owned subsidiary of Vasogen Inc
and
references to “Vasogen”,
unless otherwise specified shall mean Vasogen
Inc
and
VIL together;
2
WHEREAS
▇▇▇▇▇▇ and Vasogen desire to enter into an Agreement pursuant to which
(i)
▇▇▇▇▇▇ will undertake responsibility for the marketing, distribution and
sale
of
the Product on an exclusive basis throughout the Territory, and (ii)
▇▇▇▇▇▇
will assist Vasogen
to obtain, the Regulatory Approvals, where required and not already obtained,
to
market, distribute and sell the Product within the Territory; and
WHEREAS
▇▇▇▇▇▇, to the extent necessary to carry out the provisions of this Agreement,
needs to become a licensee of certain Product IP Rights.
3
NOW,
THEREFORE, in consideration of the mutual representations, warranties,
covenants
and agreements herein contained, the Parties hereto, intending to be
legally
bound, agree as follows:
1
DEFINITION, SCHEDULES AND INTERPRETATION
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1.1
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DEFINITIONS
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As
used
in this Agreement, the following terms shall have the
following respective
meanings:
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1.1.1
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“ACCESSORIES”
with respect to the Product has the meaning set forth in Schedule
1.1.1.
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1.1.2
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"AFFILIATE"
means, with respect to any Party, any Person that at such time
directly or
indirectly, through one or more intermediaries, controls or is
controlled
by or under common control with such Party. As used in this definition,
"control" means (i) in the case of a Person that is a corporate
entity,
direct or indirect ownership of fifty percent (50%) or more of
the stock
or shares having the right to vote (or such lesser percentage which
is the
maximum allowed to be owned by a foreign corporation in a particular
jurisdiction) for the election of directors of such Person or
Party or (ii) in the case of a Person that is an entity, but is
not a
corporate entity, the possession, directly or indirectly, of the
power to
direct, or cause the direction of, the management or policies of
such
Person
or Party, whether through the ownership of voting securities, by
contract
or otherwise.
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1.1.3
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APPLICABLE
PERCENTAGE" with respect to Disposables has the meaning set forth
in
Section 4.4.
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1.1.4
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"APPLICATION"
means an application filed with the relevant Governmental Body
seeking
Regulatory Approval to market and sell a Product in the
Territory.
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1.1.5
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"COMMERCIALLY
REASONABLE EFFORTS" mean, with respect to a Party, and its obligations
under this Agreement, the level of effort required to carry out
such
obligation in a sustainable manner consistent with the efforts
a similarly
situated biopharmaceutical or device company would devote to a
product of
similar market potential, profit potential or strategic value resulting
from its own research efforts, based on conditions then
prevailing.
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1.1.6
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"COMPETING
PRODUCT" has the meaning set forth in Section 2.3.4.
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1.1.7
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”DEVICE”
means the Celacade treatment system where the intended use for
the
VC7000A Blood Treatment System is to treat patients’ autologous fresh
blood (ex vivo) by exposure to UV light, ozone/oxygen and heat,
for
subsequent intramuscular injection.
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4
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1.1.8
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DISPOSABLE”
means the Celacade blood sample container
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1.1.9
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"EFFECTIVE
DATE" has the meaning set forth in the introduction of this
Agreement.
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1.1.10
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“ESSENTIAL
REQUIREMENTS” means all relevant pre-market legal and regulatory
requirements pertaining in the Territory with which Product must
comply in
order to be lawfully marketed in the Territory. For the avoidance
of
doubt, this shall include the national laws implementing the Medical
Devices Directive (Directive 93/42/EEC as amended or replaced from
time to
time) within the European Region.
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1.1.11
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"EUROPEAN
REGION" means the following countries: Belgium, France, Germany,
Greece,
Italy, Luxemburg, the Netherlands, Portugal, Spain and Turkey.
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1.1.12
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"European
Union” means the countries comprising the European Union and/or the
European Economic Area at the date initial notice is provided by
a Party
under Article 2.4.1.
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1.1.13
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"EXW"
has the meaning set out in the Inco terms of 2000 published by
the
International Chamber of Commerce ("ICC") as modified from time
to
time.
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1.1.14
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"FIELD
OF USE" means the use of Product as an autologous blood treatment
unit in
the treatment of heart failure or peripheral arterial disease (the
“Primary Indications”) and any other cardiovascular indications within the
scope of the Patents.
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1.1.15
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"FIRST
COMMERCIAL SALE" means with respect to any country in the Territory,
following the completion of the ICP, the first bona fide commercial
sale
of the Product to a Third Party by ▇▇▇▇▇▇ or an Affiliate or other
permitted sub-distributor of ▇▇▇▇▇▇ in such country.
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1.1.16
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"GOVERNMENTAL
BODY" means any national, supra-national (e.g., the European Commission),
regional, state or local regulatory agency, department, bureau,
commission, council or other governmental agency
or entity involved in the granting of Regulatory Approval including
but
not limited to any notified body within the meaning of the European
Union
Medical Devices legislation.
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1.1.17
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“ICP”
means the initial commercialization period of the Product, commencing
no
later than six (6) months from the Effective Date and ending no
later than
September 1, 2008, during which ▇▇▇▇▇▇ may supply the Product to
selected
clinicians in the Territory for an evaluation period, for which
the broad
outline of a marketing plan is set out in Schedule
1.1.13.
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5
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1.1.18
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"IMPROVEMENTS"
means, with respect to the Product, any new way of administration,
dosage,
configuration, design or formulation of the Product, including
any of the
foregoing that constitute a Joint Invention, but excluding any
new
indication for the Product outside the Field of Use to which Vasogen
may
obtain rights during the Term of this
Agreement.
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1.1.19
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"INTELLECTUAL
PROPERTY" means, any intellectual property rights including, without
limitation, any rights under any Patent, Trademark, Vasogen Housemark(s),
trade secret, copyright or
Know-How.
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1.1.20
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“JOINT
INVENTIONS” has the meaning set out in section 12.2.1.
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1.1.21
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"KNOW-HOW"
means information and materials which are not in the public domain
comprising the methods, processes, designs, data, formulas, manuals,
guidelines and trade secrets relating to the Product including,
without
limitation, all information necessary for obtaining the Regulatory
Approvals.
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1.1.22
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"LATIN
AMERICAN REGION" means the following countries: ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇,
▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇, ▇▇▇▇, ▇▇▇▇▇▇▇▇ and Chile.
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1.1.23
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"LIABILITIES"
means losses, damages, fines, costs, liabilities and expenses (including
the reasonable fees, costs and expenses of attorneys and other
professionals and court costs), awarded to or otherwise required
to be
paid to Third Parties in connection with any civil, criminal, statutory
or
regulatory claims of liability.
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1.1.24
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“LICENSED
RIGHTS” has the meaning set out in Section 12.1.1.
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1.1.25
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“MARKETING
PLAN”
has the meaning attributed thereto in Section
8.4.2.
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1.1.26
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"NET
SALES" means, with respect to the Disposables sold in the Territory
at
prices determined by ▇▇▇▇▇▇ in its absolute final discretion following
prior consultation with Vasogen in relation to international pricing,
the
gross amounts invoiced by ▇▇▇▇▇▇, its Affiliates and sub-distributors,
on
account of sales to Third Parties, less the
following:
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•
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trade,
quantity and cash discounts, rebates and allowances actually allowed
or
given, which are not already reflected in the amount
invoiced;
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•
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freight,
postage, shipping insurance and other transportation expenses incurred
in
transporting the Product in final form to such customers to the
extent
included in the invoice price and separately identified on the
invoice,
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•
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credits,
or refunds actually allowed for recalls of
Product;
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•
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sales,
excise and other consumption taxes, and tariffs and duties directly
related to the sale (including VAT) to the extent included in the
invoice
price and to the extent such taxes are remitted to the applicable
taxing
authority on presentation of the relevant remission confirmation
(but not
including taxes assessed against the income derived from such sale);
and
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•
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any
mandatory discounts or rebates to the competent governmental authorities
and/or social security systems pursuant to governmental regulations.
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All
consideration received by ▇▇▇▇▇▇ from Third Parties in respect the Disposables
shall be in cash and reflected in the invoiced amounts. In
the
case of discounts on “bundles” of products, ▇▇▇▇▇▇ may discount the bona fide
list price of the Disposables by the average percentage discount of all products
of ▇▇▇▇▇▇ and/or its Affiliates or sub-distributors in a particular “bundle”
(provided that such bundling is expected to yield higher aggregate Net Sales
based on increased volumes), calculated as follows:
Average
Percentage
Discounted
on a =
[1-A/B] x 100
Particular
Bundle
Where
A
equals to the total discounted price of a particular “bundle” of products, and B
equals the sum of the non-discounted bona fide list prices of each unit of
every
product in such “bundle”. ▇▇▇▇▇▇ shall provide Vasogen documentation, reasonably
acceptable to Vasogen, establishing such average discount with respect to
each
“bundle”. If ▇▇▇▇▇▇ cannot so establish the average discount of a “bundle” Net
Sales shall be based on the non-discounted list price of the Products in
the
“bundle”. If a Product is not sold separately and no bona fide list price exists
for such
Product, the Parties shall negotiate in good faith an imputed bona fide list
price for such Product,
and
Net Sales with respect thereto shall be based on such imputed list price.
▇▇▇▇▇▇
shall retain the sole right to decide whether to “bundle” any
Products,
and
nothing contained herein shall imply that ▇▇▇▇▇▇ will require the purchase
of
any Product by any non-Affiliate as a condition that the non-Affiliate be
able
to purchase another product.
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1.1.27
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"NET
SELLING PRICE" means with respect to the Disposables, the Net Sales
for
the applicable period divided by the quantity of such Disposables
invoiced
by ▇▇▇▇▇▇, its Affiliates and sub-distributors to Third Parties
during
that period, provided that the initial deemed Net Selling Price
shall be
determined by ▇▇▇▇▇▇, based on its reasonable expectations, and
the
initial price to the end user for the Disposables shall be notified
by
▇▇▇▇▇▇ to Vasogen in both cases at least 30 days prior to the First
Commercial Sale following prior consultation with
Vasogen.
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1.1.28
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"PARTY"
means Vasogen Inc and VIL or ▇▇▇▇▇▇, and "PARTIES" means Vasogen
Inc and
VIL and ▇▇▇▇▇▇.
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1.1.29
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"PATENTS"
mean the therapeutic patents and patent applications listed in
Schedule
1.1.29(a) and the Device and Disposable patents listed in Schedule
1.1. 29
(b) for the Primary Indications, to the extent that there are one
or more
claims directed to the Field of Use in such listed patents and
patent
applications, as well as all continuations, continuations-in-parts,
divisions, and renewals thereof, all patents which may be granted
thereon,
and all reissues, reexaminations, extensions, patents of additions,
and
patents of importation thereof, together with any foreign counterparts
of
any of the foregoing.
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1.1.30
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"PERSON"
means and includes any individual, corporation, partnership, firm,
joint
venture, syndicate, association, trust, Governmental Body, and
any other
form of entity or organization.
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1.1.31
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“PRIMARY
INDICATIONS” means the treatment of heart failure or peripheral arterial
disease.
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1.1.32
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“PURCHASE
ORDER” has the meaning set out in paragraph 3.2.1 of Schedule
3.1.2.
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1.1.33
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“VIGILANCE
AGREEMENT" has the meaning set forth in Section
11.1.
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1.1.34
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"PRODUCT"
means the Celacade technology consisting of the Device and the
Disposables, together with the
Accessories.
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1.1.35
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"PRODUCT
IP RIGHTS" means to the extent necessary to carry out the provisions
of
this Agreement, the Intellectual Property rights used in or related
to the
Product and including, without limitation, registration dossiers
for the
Product, Regulatory Approvals, Trademarks, Vasogen Housemark(s),
Know-How
and Patents owned or controlled by Vasogen whether by license or
otherwise
and licensed to ▇▇▇▇▇▇ as of the date hereof and during the term
of this
Agreement, and shall mean all or each such Product IP Rights individually
as the case may be.
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1.1.36
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"REGION"
means any of the European Region or the Latin American Region,
as
applicable, and for purposes of paragraph 13,3,5 (ii), the following
shall
each constitute a Region:
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1.1.36.1
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Spain,
Portugal, Greece and Germany;
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1.1.36.2
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Belgium,
the Netherlands, Luxemburg, France and
Italy;
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1.1.36.3
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Argentina,
Brazil and Chile; and
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1.1.36.4
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Mexico,
Venezuela and Peru.
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1.1.37
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"REGULATORY
APPROVAL(S)" means the technical, medical and scientific licenses,
registrations, authorizations and approvals (including, without
limitation
health technology assessments, approvals of Applications, supplements,
variations and amendments, pre- and post- approvals, pricing and
Third
Party
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8
reimbursement
approvals, and labelling approvals) of a Governmental Body necessary for
the
distribution, marketing, promotion, offer for sale, supply, use, import,
exportor sale of a Product in a regulatory jurisdiction in the Territory
or
which are a prerequisite for mandatory funding of treatment involving the
Product by local health providers, commissioners or purchasers.
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1.1.38
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“SHIPPING
COSTS” has the meaning set out in Section
5.1.4.
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1.1.39
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"SPECIFICATIONS"
means, with respect to a Product, the quality assurance and quality
release specifications for the Product set forth in the Regulatory
Approval for the Product, as may be modified from time to time
in the
discretion of Vasogen.
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1.1.40
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"TERM"
means the period set forth under Section 13.1.
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1.1.41
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"TERRITORY"
means the European Region and the Latin American
Region.
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1.1.42
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"THIRD
PARTY" means any Person that is not a Party or an Affiliate of
a
Party.
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1.1.43
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"TRADEMARKS"
means any registered or unregistered trademarks, trade names or
trade
dress used and/or selected by Vasogen to designate a Product and
listed in
schedule 1.1.43.
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1.1.44
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"TRANSFER
PRICE" has the meaning set forth in Section
4.4.
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1.1.45
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"VASOGEN
HOUSEMARK(S)" mean the registered and unregistered trade/service
▇▇▇▇(s),
logo(s), trade dress, trade names or other symbols or designations
exclusively identified with Vasogen or its Product
and listed in schedule 1.1.45.
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1.2
SCHEDULES
The
Schedules which are attached to this Agreement are incorporated into this
Agreement by reference and are deemed to be part hereof.
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Schedule
1.1.1
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Accessories
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Schedule
1.1.17
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ICP
Marketing Plan
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Schedule
1.1.29
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Patents
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Schedule
1.1.43
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Trademarks
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Schedule
1.1.45
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Vasogen
Housemarks
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Schedule
3.1.2
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Forecasts
and Orders
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1.3
CURRENCY
Unless
otherwise indicated, all amounts payable under this Agreement shall be in
Euros.
1.4
CHOICE
OF LAW
This
Agreement shall be governed by and construed in accordance with the laws
of
England without regard to principles of conflicts of law.
1.5
INTERPRETATION
NOT AFFECTED BY HEADINGS OR PARTY DRAFTING
1.5.1 The
division of this Agreement into articles, sections, paragraphs, subsections
and
clauses and the insertion of headings are for convenience of reference only
and
shall not affect the construction or interpretation of this Agreement. The
terms
"this Agreement", "hereof", "herein", "hereunder" and similar expressions
refer
to this Agreement and the schedules hereto and not to any particular article,
section, paragraph, clause or other portion hereof and include any Agreement
or
instrument supplementary or ancillary hereto. Each Party acknowledges that
it
and its legal counsel have reviewed and participated in drafting the terms
of
this Agreement, and the Parties agree
that any rule of construction to the effect that any ambiguity is to be resolved
against the drafting Party shall not be applicable in the interpretation
of this
Agreement.
1.6
NUMBER
AND GENDER
In
this
Agreement, unless there is something in the subject-matter or context
inconsistent therewith, (i) words in the singular number include the plural
and
such words shall be construed as if the plural had been used, (ii) words
in the
plural include the singular and such words shall be construed as if the singular
had been used, and (iii) words importing the use of any gender shall include
all
genders where the context or Party referred to so requires, and the rest
of the
sentence shall be construed as if the necessary grammatical and terminological
changes had been made.
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1.7
REFERENCES
TO STATUTORY PROVISIONS
References
to statutory provisions shall, except where the context requires otherwise,
be
construed as references to those provisions as respectively amended or
re-enacted or as their application is modified by other provisions (whether
before or after the date of this Agreement from time to time).
1.8
REFERENCES
TO ‘INCLUDES’ AND ‘INCLUDING’
References
to the words "includes" or "including" shall be construed without limitation
to
the generality of the preceding words.
2 SUPPLY
AND DISTRIBUTION OF PRODUCT
2.1
SUPPLY
OF THE PRODUCT
Subject
to the terms and conditions of this Agreement, during the Term, Vasogen shall
sell the Device and the Disposable, ready, in each case, for sale, or in
the
case of the Device, potentially for lease or installation at no charge, as
separate finished, packaged units to ▇▇▇▇▇▇ for the Transfer
Prices set forth in Article 4.4.
2.2
DISTRIBUTION
OF THE PRODUCT
2.2.1 Subject
to the terms and conditions of this Agreement, Vasogen hereby grants to ▇▇▇▇▇▇
the exclusive right, within the Field of Use, to market, distribute and sell
the
Product for its own account in the Territory.
2.2.2 ▇▇▇▇▇▇
shall have the right to appoint its Affiliates as sub-distributors; provided,
however, that (i) ▇▇▇▇▇▇ shall
promptly notify
Vasogen thereof in writing and (ii) ▇▇▇▇▇▇ shall remain responsible to Vasogen
for the performance of its Affiliates.
2.2.3 ▇▇▇▇▇▇
may appoint as a sub-distributor any Third Party that is not an Affiliate
provided that (i) it obtains Vasogen's prior written consent, which shall
not be
unreasonably withheld, and (ii) ▇▇▇▇▇▇ shall remain responsible to Vasogen
for
the performance of such Third Party.
2.2.4 ▇▇▇▇▇▇
shall ensure that all Affiliates and other Third Party sub-distributors
appointed by ▇▇▇▇▇▇ shall abide by the terms and conditions of this
Agreement.
2.3
EXCLUSIVITY
2.3.3 The
exclusivity as referred to in this Agreement means that Vasogen,
11
provided
all terms and conditions of this Agreement are complied with by ▇▇▇▇▇▇, will
not
enter into other agreements with Third Parties for the distribution and sale
of
the Product for the Field of Use in the Territory nor sell the Product by
itself
for the Field of Use in the Territory.
2.3.4 During
the term of this Agreement, ▇▇▇▇▇▇ shall not, and shall not permit its
Affiliates, to directly or indirectly, alone or in conjunction with a Third
Party market, promote, distribute, offer for sale or sell a Competing Product.
For purposes of this Agreement, the following shall be considered a "Competing
Product": a therapeutic system delivering controlled oxidative stressors
to a
sample of autologous whole blood ex vivo for subsequent intramuscular
administration to the same patient in the Field of Use. The non-compete
provision in this section 2.3.4 shall expire 5 years from the Effective Date
and
shall thereafter only be renewed by written agreement between Vasogen and
▇▇▇▇▇▇.
2.3.5 Nothing
in this Agreement shall be construed to ▇▇▇▇▇ ▇▇▇▇▇▇ any rights or license
(i)
with respect to any Product outside of the Territory or (ii) with respect
to any
Product outside the Field of Use or (iii) with respect to any other product
of
Vasogen, or (iv) to manufacture any Product.
2.4
RIGHT
OF FIRST NEGOTIATION FOR ADDITIONAL TERRITORY
2.4.1 Commencing
on the
date
of First
Commercial Sale of the Product in the Territory and for a period of one year
thereafter, ▇▇▇▇▇▇ or Vasogen may provide written notice to the other of
its
good faith desire to contract for or in respect of rights to the Product
in all
the European Union countries outside the Territory.
During
the 60 day period following such written notice from ▇▇▇▇▇▇ or Vasogen, ▇▇▇▇▇▇
will have the right to negotiate a written agreement for such rights on
commercially reasonable terms mutually acceptable to the Parties. If the
Parties
are unable to agree
the commercial terms and enter into a definitive agreement within such 60
day
period, then Vasogen shall have no further obligation to ▇▇▇▇▇▇ outside the
Territory and will be free to negotiate an agreement with a Third Party for
such
rights. Notwithstanding the foregoing, Vasogen shall not be prohibited from
receiving expressions of interest from Third Parties during the one year
period
in respect of rights in such countries.
2.5
RESTRICTION
ON PURCHASE AND SALE OF PRODUCT
2.5.1 ▇▇▇▇▇▇
shall not actively promote the distribution or sale of the Product for delivery
at any location outside the Territory. ▇▇▇▇▇▇ shall refer to Vasogen any
order
or inquiry from outside the European Economic Area.
2.5.2 ▇▇▇▇▇▇
shall not actively promote the distribution or sale of the Product outside
of
the Field of Use or otherwise than in accordance with their Regulatory
Approvals.
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2.5.3 Unless
otherwise authorized in writing by Vasogen, ▇▇▇▇▇▇ shall not purchase any
Devices or Disposables from any person other than Vasogen.
3
FORECASTS
AND ORDERS
3.1 ESTIMATED
REQUIREMENTS; FIRM ORDERS
3.1.1 Vasogen
shall supply Devices and Disposables for use during the ICP as agreed in
the ICP
Marketing Plan. For purposes of the period following ICP, no later than April
1,
2008, ▇▇▇▇▇▇ shall provide Vasogen with a forecast showing ▇▇▇▇▇▇'▇ estimated
requirements of Devices and Disposables, within the Territory and identified
by
month for each Region, for the first twelve (12) months following the European
Society of Cardiology conference beginning August 2008. Such forecast shall
be a
binding forecast of ▇▇▇▇▇▇'▇ purchases of Devices and Disposables for the
first
three (3) months of sales within the Territory and shall be non-binding for
the
remaining nine (9) months.
3.1.2 The
process for forecasting and submitting orders for Devices and Disposables
shall
be as set out in Schedule 3.1.2.
4.
ECONOMIC
TERMS
4.1
Intentionally
left blank.
4.2
COMMERCIAL
MILESTONES FOLLOWING THE ICP
In
further consideration of the rights granted, ▇▇▇▇▇▇ shall pay Vasogen, within
sixty (60) days of the relevant First Commercial Sale, the following
non-refundable, non-creditable amounts:
|
4.2.1
First Commercial Sale in Spain:
|
xx
Euros
|
|
|
4.2.2
First Commercial Sale in France:
|
xx
Euros
|
|
|
4.2.3
First Commercial Sale in Italy:
|
xx
Euros
|
|
|
4.2.4
First Commercial Sale in Germany:
|
xx
Euros
|
|
|
4.2.5
First Commercial Sale, one time only, in any of Belgium, Netherlands
and
Luxembourg:
|
xx
Euros
|
|
|
4.2.6
First Commercial Sale in Portugal:
|
xx
Euros
|
|
|
4.2.7
First Commercial Sale in Greece:
|
xx
Euros
|
4.3
SALES
MILESTONES FOLLOWING THE ICP
In
further consideration of the rights granted, ▇▇▇▇▇▇ shall pay Vasogen, the
following non-refundable non-creditable amounts upon first reaching over
a 12
month period the following total Net Sales. For greater certainty, more than
one
Net Sales milestone may be achieved in one twelve month period. Payment
13
shall
be due within sixty (60) calendar days of the end of the financial quarter
during which the applicable Net Sales milestone is achieved.
|
Net
Sales
|
Milestone
Fee
|
|
5 Mio €
|
xx
€
|
|
10
Mio €
|
xx
€
|
|
15
Mio €
|
xx
€
|
|
20
Mio €
|
xx
€
|
|
30
Mio €
|
xx
€
|
|
40
Mio €
|
xx
€
|
|
60
Mio €
|
xx
€
|
|
80
Mio €
|
xx
€
|
|
100
Mio €
|
xx
€
|
|
120
Mio €
|
xx
€
|
|
140
Mio €
|
xx
€
|
|
160
Mio €
|
xx
€
|
4.4
TRANSFER
PRICES
4.4.1 ▇▇▇▇▇▇
shall purchase all of the Devices or Disposables for which a Purchase Order
has
been submitted to Vasogen at the Transfer Price. The Transfer Price of the
Disposables following the ICP shall be calculated as an Applicable Percentage
of
the Net Selling Price as set out below.
The
Transfer Prices for the periods during and following the ICP shall be as
follows:
|
Device
during
ICP
|
xx
|
|
Device
following ICP
|
Transfer
Price To be determined by the Parties through the Joint Steering
Committee, and subject to 4.4.2 below.
|
|
Disposables
during ICP
|
xx
Euros
each
|
|
Disposable
following the ICP
|
45%
of the
Net Selling Price for each year for the first five years following
the
First Commercial Sale and
|
|
42%
of such
Net Selling Price for each year
thereafter
|
For
greater certainty, (i) during the ICP, ▇▇▇▇▇▇ shall be responsible for the
costs
of shipping the Devices to the designated clinics and (ii) the Transfer Price
of
the Device following the ICP shall be determined by the Parties no later
than
April 1, 2008 and, subject to adjustment as may be required from time to
time,
shall be
14
equal
to Vasogen’s direct and indirect cost of goods for the Device, as determined in
accordance with Canadian generally acceptable accounting principles, plus
an
acceptable margin. Nothwithstanding the above but subject to the last sentence
of 4.4.2, the parties agree that Transfer Price of the Device following the
ICP
shall in no case be higher than xx Euros
4.4.2 After
the first five years following the First Commercial Sale, the Transfer Price
for
the Device and the Disposable and the Applicable Percentages shall be
subject
to
review annually and may be modified by the mutual agreement in writing of
the
Parties, provided that any modification shall maintain the relative financial
benefits to Vasogen on one hand and ▇▇▇▇▇▇ on the other and consider the
pricing
conditions in each country of the Territory. In the event that the Parties
cannot agree on a modification, the Transfer Price in respect of the Device
and
the Disposable and the Applicable Percentages shall remain as set out in
Section
4.4.1 above. Notwithstanding any of the foregoing, at no time will Vasogen
be
required to provide (i) Devices at a Transfer Price that does not cover
Vasogen’s direct and indirect cost of goods, determined in accordance with
Canadian generally accepted accounting principles, plus an acceptable margin
or
(ii) Disposables at a Transfer Price of less than xx Euros per Disposable.
4.4.3 Vasogen
shall invoice ▇▇▇▇▇▇ for Disposables upon shipment at the Forecasted Supply
Price determined in accordance with Section 4.4.5 and for Devices at the
Transfer Price in accordance with 4.4.1.
4.4.4 The
Transfer Price for the Disposables shall be reconciled each year in accordance
with the methods set forth below. The Parties shall establish a Forecasted
Supply Price in accordance with Section 4.4.5. During such year, the Transfer
Price shall be deemed to be the Forecasted Supply Price. At the end of each
year, the Transfer Price shall be calculated and reconciled with the Forecasted
Supply Price for the same time period in accordance with Section
4.4.6.
4.4.5
FORECASTED
SUPPLY PRICE
For
the
Disposable in the year in which the First Commercial Sale occurs, the Forecasted
Supply Price shall be the Applicable Percentage multiplied by the initial
deemed
Net Selling Price for the year as described in Section 1.1.27,. At least
sixty
(60) days prior to the beginning of each subsequent calendar year, the
Forecasted Supply Price for the upcoming year shall be determined for the
Disposable, based on an estimate of the Net Selling Price using data from
the
first nine months of the current calendar year. All of the foregoing shall
be
referred to as the "Forecasted Supply Price". Similarly, in the first year
in
which the First Commercial Sale occurs in an additional country within the
Territory, the Forecasted Supply Price shall take into account the projected
Net
Selling Price for that country.
15
4.4.6
ANNUAL
RECONCILIATION OF FORECASTED SUPPLY PRICE
Within
forty-five (45) days following (i) the end of each calendar year during the
Term
of this Agreement, and (ii) the expiration or earlier termination of this
Agreement, ▇▇▇▇▇▇ shall deliver to Vasogen a report and calculation of the
Net
Selling Price for the Disposable sold in the Territory during such calendar
year. Vasogen shall then calculate the reimbursement amount by multiplying
for
the Disposable (a) the Transfer Price (based on the Applicable Percentage
of the
Net Selling Price for that calendar year) less the Forecasted Supply Price
for
that calendar year by (b) the number of Disposables sold during that calendar
year. If the result of the calculation in this Section 4.4.6 is positive,
▇▇▇▇▇▇
shall pay such amount to Vasogen. If the result of the calculation in this
Section 4.4.6 is negative, ▇▇▇▇▇▇ shall be entitled to a credit for such
amount
which it may apply to future invoices.
4.5
PAYMENT
METHOD
All
payments under this Agreement shall be made by bank wire transfer in immediately
available funds to an account designated by the Party to which such payments
are
due. Any payments due under this Agreement which are not paid by the date
such
payments are due under this Agreement shall bear interest to the extent
permitted by applicable law at a rate equal to the monthly London inter-bank
offering rate U.S. dollars as quoted in The Financial Times on the first
business day of the month on which the payment was due. This Section 4.5
shall
in no way limit any other remedies available to the Parties.
4.6
EURO;
CURRENCY EXCHANGE
All
sums due under this Agreement shall be payable in Euros. With respect to
Net
Sales invoiced in a currency other than Euros, the Net Sales shall be expressed
in the domestic currency of the entity making the sale or incurring the expense,
together with the Euro equivalent, calculated using the arithmetic average
of
the spot rates on the last working day of each month of the calendar quarter
in
which the Net Sales were made. The "closing mid-point rates" published by
The
Financial Times, or any other publication as agreed to in writing by
the
Parties, shall be used as the source of spot rates to calculate the average
as
defined in the preceding sentence.
4.7 INVOICES;
TIMING OF PAYMENTS
Vasogen
shall invoice ▇▇▇▇▇▇ for all Disposables supplied hereunder at the Forecasted
Supply Price or
ICP
price (as applicable) and for all Devices at the Transfer Price on the date
of
shipment, which invoice shall include any Shipping Costs paid by Vasogen
and any
applicable taxes. Payment for the Product shall
16
be
made
by ▇▇▇▇▇▇ to Vasogen in Euros within sixty (60) calendar days of ▇▇▇▇▇▇'▇
receipt of invoice. Unless otherwise specified in this Agreement, all other
amounts due to Vasogen hereunder shall be paid by ▇▇▇▇▇▇ within sixty (60)
calendar days following the date of ▇▇▇▇▇▇'▇ receipt of invoice.
4.8
TAXES
Where
any sum due to be paid to a Party under this Article 4 is subject to any
withholding or similar tax, the Parties shall use their reasonable efforts
to do
all such acts and to sign all such documents as will enable them to take
advantage of any applicable double taxation agreement or treaty. In the event
there is no applicable double taxation agreement or treaty, or if an applicable
double taxation agreement or treaty reduces but does not eliminate such
withholding or similar tax, the Party making a payment shall pay such
withholding or similar tax to the appropriate government authority, deduct
the
amount paid from the amount due to the other Party, and secure and send to
the
other Party the best available evidence of such payment.
All
sums due under this Agreement are exclusive of sales, excise and consumption
taxes, tariffs and duties (including VAT) and any similar taxes in any
jurisdiction, which where applicable shall be paid by ▇▇▇▇▇▇ to Vasogen in
addition.
4.9
AUDIT
RIGHTS
▇▇▇▇▇▇
shall keep, and require its Affiliates and any Third Party sub-distributors
to
keep, complete and accurate books of accounts and records for the purpose
of
determining the amounts payable pursuant to this Agreement. Such books and
records shall be kept at the principal place(s) of business of ▇▇▇▇▇▇ and
its
Affiliates and Third Party sub-distributors for at least three (3) years
following the end of the calendar year to which they pertain. Such records
shall
be open for inspection during such three (3) year period by Vasogen or an
auditor chosen by Vasogen and reasonably acceptable to ▇▇▇▇▇▇ for the purpose
of
verifying the amounts payable hereunder. Such inspections may be made no
more
than once each calendar year, at reasonable times and on reasonable notice
and
once the records for a period are audited they shall not be subject to re-audit.
Inspections conducted under this Section 4.9 shall be at the expense of Vasogen,
except if a variation or error producing an underpayment in amounts payable
which exceeds five percent (5%) of the amount paid for the entire period
covered
by the inspection is established in the course of any such inspection, whereupon
all reasonable documented out-of-pocket costs relating to the inspection
for
such period shall be paid by ▇▇▇▇▇▇. In any event any unpaid amounts that
are
discovered shall be paid by ▇▇▇▇▇▇ to Vasogen, together with interest on
such
unpaid amounts at the rate set forth in Section 4.5 above.
17
5.
TERMS
OF SALE
5.1
DELIVERY
OF PRODUCT, TRANSFER OF RISKS AND PROPERTY
5.1.1 The
Product shall be sold and delivered EXW from Vasogen’s or its designee’s
warehouse or manufacturing location prior to or within twenty (20) business
days
of the date specified in the applicable Purchase Order acknowledgment. In
accordance with EXW terms, ▇▇▇▇▇▇ shall bear all risk of loss and damage
to the
Product from the time they have been placed at ▇▇▇▇▇▇'▇ disposal. Vasogen
shall
ship the Product on a carrier mutually agreed to by the Parties at ▇▇▇▇▇▇'▇
expense.
|
5.1.2
|
Delivery
of eighty percent (80%) or more of any Purchase Order shall be
considered
a complete order, provided that the remaining quantities of any
Purchase
Order are delivered within the following ninety (90) day
period.
|
5.1.3
Product
will be delivered ready for sale or lease in the Territory.
5.1.4 ▇▇▇▇▇▇
shall pay all costs, expenses, taxes (including VAT), levies, tariffs, brokerage
fees, insurance premiums and other costs and charges assessed or levied in
connection with the transportation of Product from Vasogen (the "Shipping
Costs"). If Vasogen pays any of the Shipping Costs on behalf of ▇▇▇▇▇▇, then
Vasogen shall invoice such Shipping Costs to ▇▇▇▇▇▇ and ▇▇▇▇▇▇ shall pay
such
costs in accordance with the provisions of Section 4.7 above.
5.1.5 Vasogen
shall use all Commercially Reasonable Efforts to supply ▇▇▇▇▇▇'▇ requirements
of
Devices and Disposables.
5.2
COMPLIANCE
OF PRODUCT
5.2.1 ▇▇▇▇▇▇
shall have the right to ensure that all Product complies with the Specifications
during the period of fifteen (15) working days following the date of Vasogen’s
delivery of such Product. ▇▇▇▇▇▇ shall accomplish this through consignment
checks in accordance with Vasogen procedures. In the event ▇▇▇▇▇▇ finds that
the
Product
does
not
conform to the Specifications, ▇▇▇▇▇▇ shall send a
written notice
to Vasogen within the fifteen (15) working day period following delivery.
If
Vasogen has not received any notice from ▇▇▇▇▇▇ within such fifteen (15)
working
days following delivery, ▇▇▇▇▇▇ shall be deemed to have accepted the Product
as
is. Such limitations shall not apply as per latent defects. For clarity,
▇▇▇▇▇▇
shall not have the right to return Product which conforms to the applicable
Specifications.
5.2.2 If
▇▇▇▇▇▇ receives Product from Vasogen that does not comply with the
Specifications ("non-conforming"), and sends a written notice to Vasogen
within
18
the
time period specified in section 5.2.1, Vasogen shall replace or repair,
at its
discretion, such non-conforming Product with an equal quantity of Product
that
conforms to the Specifications at no additional cost to ▇▇▇▇▇▇. If a shortage
exists with respect to a shipment of Product, ▇▇▇▇▇▇ shall so inform Vasogen,
and Vasogen shall make-up such shortage as soon as Vasogen is practicably
able
to do so at no additional cost to ▇▇▇▇▇▇ beyond the Transfer Price. The remedies
set forth in this Section 5.2.2 shall be the sole and exclusive remedies
of
▇▇▇▇▇▇ with regard to a shortage or non-conforming Product.
5.2.3 In
the
case of the Disposables, if the analysis of a sample of the Disposables
performed by or for ▇▇▇▇▇▇ indicates that a batch of Disposables does not
meet
Specifications and Vasogen's analysis of its sample from the same batch
indicates that the batch does meet Specifications, Vasogen will so advise
▇▇▇▇▇▇
and a joint investigation will be conducted to determine the cause of the
failure; and
(a) If
the
Disposables are proven to meet Specifications, then ▇▇▇▇▇▇ shall be responsible
for the cost of the joint investigation and any independent Third Party testing
of Product.
(b)
If
the
Disposables are proven not to meet Specifications, Vasogen shall be responsible
for the cost of the joint investigation and any independent Third Party testing
of Disposables, and shall replace such Disposables at its own cost.
6
REPRESENTATIONS
AND WARRANTIES
6.1
REPRESENTATIONS
AND WARRANTIES OF VASOGEN
Vasogen
represents and warrants the following:
6.1.1 it
has
full power and authority to enter into and perform its
obligations
pursuant to this Agreement and to consummate the transactions
contemplated
herein;
6.1.2 the
execution, delivery and performance of this Agreement have been duly authorized
by all necessary corporate action and constitute a legal, valid and binding
obligation of Vasogen;
6.1.3 it
shall comply with the material Specifications and the applicable Essential
Requirements within the Territory, as applicable, and shall comply, subject
to
▇▇▇▇▇▇ advising Vasogen of all relevant requirements, with local, state,
and
federal laws and regulations applicable in the Territory. Vasogen
may however make modifications to the Specifications if approved by the
applicable Governmental Body and shall thereafter inform ▇▇▇▇▇▇ of any such
modifications and provide ▇▇▇▇▇▇ with the corresponding documentation to
be
submitted to the
19
Governmental
Body, provided that such modifications shall not be implemented with regard
to
Devices or Disposables for sale in the Territory until approved by the relevant
Governmental Bodies, where such approval is necessary;
6.1.4 its
obligations under this Agreement are valid and binding and enforceable against
it in accordance with their terms, except as enforcement may be affected
by
bankruptcy, insolvency, or other similar laws and by general principles of
equity; and
6.1.5 it
has
not granted
any rights that are inconsistent with the rights and licenses granted
herein.
6.2
REPRESENTATION
AND WARRANTIES OF ▇▇▇▇▇▇
▇▇▇▇▇▇
represents and warrants the following:
6.2.1 it
has
full power and authority to enter into and perform its obligations pursuant
to
this Agreement and to consummate the transactions contemplated
herein;
6.2.2 the
execution, delivery and performance of this Agreement have been duly authorized
by all necessary corporate action and constitute a legal, valid and binding
obligation of ▇▇▇▇▇▇;
6.2.3 its
obligations under this Agreement are valid and binding and enforceable against
it in accordance with their terms, except as enforcement may be affected
by
bankruptcy, insolvency, or other similar laws and by general principles of
equity;
6.2.4 it
shall perform its obligations hereunder in compliance with all applicable
laws
and regulations whether they be local or otherwise;
6.2.5 it
has
the commercial capacity to distribute and sell the Product in the Territory;
and
6.2.6 there
are no agreements or commitments to which it or any of its Affiliates is
a party
that conflicts with its obligations hereunder.
7.
OBLIGATIONS
OF VASOGEN
7.1
FORM
AND PROMOTION
7.1.1 During
the Term of this Agreement, Vasogen shall, upon request from ▇▇▇▇▇▇, assist
▇▇▇▇▇▇ in the preparation of sales promotional material in order to
facilitate sales and marketing of the Product, together with such information
as
20
Vasogen
deems appropriate in connection with any warranties relating to the Product,
provided that any out-of-pocket costs incurred by Vasogen shall be for the
account of ▇▇▇▇▇▇, subject to prior approval of ▇▇▇▇▇▇.
7.1.2 Prior
to using any promotional materials for the Product for the first time and
on
subsequent amendments, ▇▇▇▇▇▇ shall submit a sample of such materials to
Vasogen
for approval. Vasogen shall use Commercially Reasonable Efforts to approve
such
materials within ten (10) business days for materials in English and twenty
(20)
days for materials in a language other than English. Should ▇▇▇▇▇▇ receive
no
resonse from Vasogen within that period, the materials shall be deemed
approved.
7.1.3 ▇▇▇▇▇▇
shall provide Vasogen with samples of all promotional materials that ▇▇▇▇▇▇
uses
for the Product for use by Vasogen and Vasogen's other partners outside of
the
Territory, at Vasogen's cost and expense for reproduction of the materials
and
Vasogen shall reimburse ▇▇▇▇▇▇ for out of pocket costs attributable
proportionately to copyright fees payable on promotional materials used by
Vasogen.
|
7.2
|
OPERATIONS
SUPPORT AND OTHER
|
7.2.1 Vasogen
shall provide ▇▇▇▇▇▇ with the technical, preclinical and clinical data related
to the Product in its possession or to which Vasogen may have access and
the
right to use that is required to enable ▇▇▇▇▇▇ to execute the activities
for
which it is responsible.
8
REGULATORY
OBLIGATIONS
8.1
REGISTRATION
OF PRODUCT
The
Product has been CE Marked in Europe by Vasogen. However, Vasogen shall be
entitled to modify indications approved under the CE ▇▇▇▇ (i) to reflect
results
of the SIMPADICO and ACCLAIM trials in accordance with the Essential
Requirements or (ii) as mutually agreed with ▇▇▇▇▇▇. Subject to the foregoing,
▇▇▇▇▇▇, based on the information provided by Vasogen, will at its own expense
use Commercially Reasonable Efforts to assist Vasogen to obtain the necessary
permits, licenses, authorizations, registrations or approvals that may be
required in accordance with each Region's laws and regulations, or under
any
other Governmental Body, as may be required for the sale, distribution and
promotion of the Product in the Territory.
8.2
REGULATORY
APPROVALS
8.2.1 VIL
will act as Vasogen’s European
Authorised Representative in the Territory and use Commercially Reasonable
Efforts, in conjunction with ▇▇▇▇▇▇, to obtain such Regulatory Approvals
as may
be required, in accordance with local
21
Regulations,
provided that Vasogen shall be entitled to modify the indications approved
under
the CE ▇▇▇▇ (i) to reflect results of the SIMPADICO and ACCLAIM clinical
trials
in accordance with the Essential Requirements or (ii) as mutually agreed
with
▇▇▇▇▇▇. Within 3 business days of receipt of any Regulatory Approval, VIL
shall
provide Vasogen and ▇▇▇▇▇▇ with an electronic copy of such Regulatory Approval.
The
initial regulatory plan shall be developed jointly by VIL and ▇▇▇▇▇▇ and
submitted for consideration by the Joint Steering Committee as part of the
ICP
Marketing Plan. An updated regulatory plan shall be developed annually by
VIL
and ▇▇▇▇▇▇ and reviewed annually by the Joint Committee, at least 30 days
prior
to the end of each calendar year. In the case of Regulatory Approvals for
the
Latin American Region, ▇▇▇▇▇▇ shall be responsible for the expenses incurred
by
▇▇▇▇▇▇ in obtaining such Regulatory Approvals. ▇▇▇▇▇▇ shall allow Vasogen
to
conduct audits of the processes affecting Product quality, as may be required
pursuant to the Regulatory Approvals.
8.3
LABELLING
8.3.1 ▇▇▇▇▇▇
shall assist Vasogen in translating labels for the Product and shall assist
Vasogen in the preparation of the appropriate labels in compliance with
Regulatory Approvals. The inventory shall be either shipped with appropriate
labelling or ready for labeling, as agreed between the Parties, and as
approved by the Governmental Body in accordance with all standards, laws
and
regulations applicable to each country of the Territory, as notified by ▇▇▇▇▇▇
to Vasogen from time to time.
8.3.2 Consistent
and in accordance with Section 12.3.3, Vasogen shall be identified on the
appropriate labels of the Product and on all promotional
and educational materials as the manufacturer and holder of
the
Product IP
Rights thereof, including any notifications deemed necessary by Vasogen,
unless
prohibited by applicable law or otherwise instructed by Vasogen. ▇▇▇▇▇▇ shall
represent itself as the distributor of the Product.
8.4
OTHER
OBLIGATIONS
▇▇▇▇▇▇
shall:
8.4.1 use
Commercially Reasonable Efforts, at its expenxe, to promote, distribute,
market
and sell the Product in the Territory in accordance with Regulatory Approvals
and, in particular, shall in good faith carry out the marketing plan for
the
ICP, the broad outline of which is set out in Schedule 1.1.13; No later than
90
days from the Effective Date, ▇▇▇▇▇▇ shall provide the detailed marketing
plan
for the ICP to Vasogen for acceptance.
8.4.2 No
later than April 1, 2008, ▇▇▇▇▇▇ shall present to Vasogen a detailed marketing
plan for the Product after the ICP, including budget and timeline for
22
launching,
promoting, marketing, distributing and selling the Product for the Field
of Use
in the Territory, quality metrics, a reimbursement plan, the results of a
pricing study for the Product conducted by ▇▇▇▇▇▇, the terms and conditions
of
sale of the Device and Disposable and annual sales objectives, which marketing
plan shall be subject to approval by Vasogen particularly for consistency
with
the international commercial strategy for the Product (the “Marketing
Plan”).
8.4.3 properly
execute the approved Marketing
Plan and carry out its obligations under this Agreement;
8.4.4 honor
any warranty offered by Vasogen on the Device or Disposables, in accordance
with
the terms and conditions of sale of the Device and Disposable respectively,
as
set out in the Marketing Plan;
8.4.5 manage
any consumers' and/or health professionals’ and/or customers’ complaints in a
diligent and expeditious manner, as it would for its own product for purposes
of
regulatory compliance, andinform VIL and Vasogen without delay of any
significant increase in the number of complaints in association with Product,
all pursuant to the Vigilance Agreement; and
8.4.6 be
responsible for complying with all local laws and regulations in the Territory
including, without limitation, laws and regulations relating to the importation
and sale of the Product.
8.4.7 assume
all costs related to Product installation or de-installation, service and
training of its representatives and end users in the Territory. All
installation, service and training of end users shall at all times be undertaken
in accordance with Vasogen’s policy and Standard Operating Procedures, including
in relation to the provision of training to clinicians and the access of
representatives to clinical treatment zones where patients are present. Should
▇▇▇▇▇▇ request Vasogen to undertake such activities, ▇▇▇▇▇▇ and Vasogen shall
agree on a fee for services. In addition, ▇▇▇▇▇▇ shall be responsible for
the
costs to ship Devices to designated clinical sites during the ICP and to
return
Devices to Vasogen at no charge on the later of (i) the end of the ICP and
(ii)
the availability of the next generation of Devices.
8.4.8 facilitate
access to the clinical sites for Vasogen personnel or their designees as
necessary for the purposes of providing additional technical support or
troubleshooting.
8.4.9 track
and report to Vasogen monthly, as of the last day of each month and, except
for
inventory, on a cumulative year to date basis (i) the number of Devices
installed and in use, (ii) the relevant sales prices or lease or other
arrangements entered into in connection with such Devices, (iii) the number
of
Disposables sold or provided at no cost to the end user, (iv) the Net Selling
Price for the Disposables (v) Net Sales and (vi) the number of Devices and
Disposables on hand in inventory. Such report shall be due within 10 business
days of the end of each month.
23
8.4.10
track and report to Vasogen monthly, all relevant data related to the use,
technical performance and servicing of the Devices. In addition, at regular
intervals to be mutually agreed, ▇▇▇▇▇▇ will provide to Vasogen copies of
the
electronic Device data logs. ▇▇▇▇▇▇ will undertake to maintain adequate back-up
and archiving of all Device related data to be made available to Vasogen
on
request as necessary.
8.4.11
Provide to Vasogen details of all customer feedback and complaints including
but
not limited to those classified as per 11.1
9.
MUTUAL
UNDERTAKINGS
9.1
JOINT
COMMERCIALIZATION COMMITTEE
As
soon
as
practicable following the Effective Date,
the
Parties will establish a Joint Commercialization Committee (JCC) to monitor
the
implementation and execution of the Marketing Plan, including reimbursement
strategy, operations and logistics and the regulatory and vigilance plan,
including for purposes of the ICP. Vasogen and ▇▇▇▇▇▇ shall each designate
at
least two (2) members to serve on the JCC, one of whom must be the person
within
▇▇▇▇▇▇ designated as Product Manager. The JCC shall meet at least twice
annually
and at such other times as agreed to by the committee members.
9.2 JOINT
STEERING COMMITTEE
As
soon
as practicable following the Effective Date, the Parties shall form a Joint
Steering Committee. Vasogen and ▇▇▇▇▇▇ shall each designate two (2) members
to
serve on the Joint Steering Committee and such members shall be senior
executives of the designating Party. Each member shall serve until removed
by
the Party appointing the member. The initial members of the Joint Steering
Committee shall be named by Vasogen and ▇▇▇▇▇▇ within 30 days of the Effective
Date. The mandate of the Joint Steering Committee shall be (i) to review
the
work and recommendations of the Joint Commercialization Committee, (iii)
to
resolve disputes of the Joint Commercialization Committee, (iv) to consult
on
and review annually the Forecasted Supply Price, (vi) to review the ICP
marketing plan and, annually, at least 30 days prior to the end of the calendar
year, to review an updated Marketing Plan and Regulatory and Reimbursement
Plan
as well as the vigilance plan for the upcoming calendar year, (vii) to consider
the potential sharing of the costs and benefits of future product development
and cost reduction programs and (viii) to perform such other duties to
facilitate the collaboration as the Parties deem necessary. Each
24
Party
shall have one vote and both Parties must agree on all decisions of the
Joint
Steering Committee.
10.
INDEMNIFICATION
|
10.1
|
INDEMNIFICATION
BY VASOGEN
|
Vasogen
shall indemnify, protect and hold ▇▇▇▇▇▇ and ▇▇▇▇▇▇’▇ directors, officers, and
employees (the “▇▇▇▇▇▇ Indemnified Parties”) harmless from and against any and
all Liabilities, asserted at any time arising out of (i) any breach or
misstatement by Vasogen of its representations and warranties made in this
Agreement, or (ii) the Product itself (characteristics inherent to the Product),
the manufacture, use of the Product produced by or for Vasogen or its designees
(whether under defective Product liability or otherwise) or (iii) any negligent
act or omission or gross negligence, recklessness or willful misconduct of
Vasogen or any of its Affiliates; or (iv) any other breach by Vasogen of
its
obligations under this Agreement except in each case, to the extent caused
by
any negligent act or omission or gross negligence, recklessness or willful
misconduct of any of the ▇▇▇▇▇▇ Indemnified Parties.
10.2 INDEMNIFICATION
BY ▇▇▇▇▇▇
▇▇▇▇▇▇
shall indemnify, protect and hold Vasogen and Vasogen’s directors, officers,
employees and agents (“Vasogen Indemnified Parties”) harmless from and against
any and all Liabilities, asserted at any
time
arising out of or involving (i) any breach or misstatement by ▇▇▇▇▇▇ of its
representations and warranties made in this Agreement or (ii) the promotion,
storage, handling, sale and distribution of the Product by ▇▇▇▇▇▇ or its
designees, or (iii) any negligent act or omission or gross negligence,
recklessness or willful misconduct of ▇▇▇▇▇▇ or any of its Affiliates; or
(iv)
any other breach by ▇▇▇▇▇▇ of its obligations under this Agreement except
in
each case, to the extent caused by any negligent act or omission or gross
negligence, recklessness or willful misconduct of any of the Vasogen Indemnified
Parties.
10.3 PROCEDURE
10.3.1 If
any claim or action is asserted against a Party, or the Affiliate of a Party,
to
this Agreement that would entitle such Party to indemnification pursuant
to
either of the foregoing Sections 10.1 or 10.2 (a “Third Party Claim”), such
Party who seeks indemnification (the “Indemnitee”) will give written notice
thereof to the Party to this Agreement from whom indemnification is sought
(the
“Indemnitor”) promptly, provided, however, that failure to give such
notification will not affect the indemnification provided hereunder except
to
the extent the Indemnitor shall have been actually prejudiced as a result
of
such failure.
25
10.3.2 If
a Third Party Claim is made against an Indemnitee and the Indemnitor
acknowledges in writing its obligation to indemnify the Indemnitee therefore,
the Indemnitor will be entitled, within one hundred twenty (120) days after
receipt of written notice from the Indemnitee of the commencement or assertion
of any such Third Party Claim to assume the defense thereof (at the expense
of
the Indemnitor) with counsel selected by the Indemnitor and reasonably
satisfactory to the Indemnitee, for so long as the Indemnitor is conducting
a
good faith and diligent defense. Should the Indemnitor so elect to assume
the
defense of a Third Party Claim, the Indemnitor will not be liable to the
Indemnitee for any legal or other expenses subsequently incurred by the
Indemnitee in connection with the defense thereof. If the Indemnitor assumes
the
defense of any Third Party Claim, the Indemnitee shall have the right to
participate in the defense thereof and to employ counsel, at its own expense,
separate from the counsel employed by the Indemnitor. If the Indemnitor assumes
the defense of any Third Party Claim, the Indemnitor will promptly supply
to the
Indemnitee copies of all correspondence and documents relating to or in
connection with such Third Party Claim and keep the Indemnitee informed of
developments relating to or in connection with such Third Party Claim, as
may be
reasonably requested by the Indemnitee (including, without limitation, providing
to the Indemnitee on reasonable request updates and summaries as to the status
thereof). If the Indemnitor chooses to defend a Third Party Claim, all
Indemnitees shall reasonably cooperate with the Indemnitor in the defense
thereof (such cooperation to be at the expense, including reasonable legal
fees
and expenses, of the Indemnitor). If the Indemnitor does not elect to assume
control of the defense of any Third Party Claim within the 120-day period
set
forth above, or if such good faith and diligent defense is not being or ceases
to be conducted by the Indemnitor, the Indemnitee shall have the right, at
the
expense of the Indemnitor, after three (3) Business Days notice to the
Indemnitor of its intent to do so, to undertake the defense of the Third
Party
Claim for the account of the Indemnitor (with counsel selected by the
Indemnitee), but shall not compromise or settle such Third Party Claim, without
the consent of the Indemnitor which consent shall not be unreasonably withheld.
10.3.3 If
the Indemnitor acknowledges in writing its obligation to indemnify the
Indemnitee for a Third Party Claim, the Indemnitee will agree to any settlement,
compromise or discharge of such Third Party Claim that the Indemnitor may
recommend that by its terms obligates the Indemnitor to pay the full amount
of
losses (whether through settlement or otherwise) in connection with such
Third
Party Claim and unconditionally and irrevocably releases the Indemnitee
completely from all liability in connection with such Third Party Claim;
provided, however, that, without the Indemnitee’s prior written consent, which
consent shall not be unreasonably withheld, the Indemnitor shall not consent
to
any settlement, compromise or discharge (including the consent to entry of
any
judgment), and the Indemnitee may refuse to agree to any such settlement,
compromise or discharge, that provides for injunctive or other nonmonetary
relief affecting the
26
Indemnitee.
If
the Indemnitor acknowledges in writing its obligation to indemnify the
Indemnitee for a Third Party Claim, the Indemnitee shall not (unless required
by
law) admit any liability with respect to, or settle, compromise or discharge,
such Third Party Claim without the Indemnitor’s prior written consent (which
consent shall not be unreasonably withheld).
|
10.4
|
CONSEQUENTIAL DAMAGES
|
Other
than amounts payable with respect to a Third Party Claim pursuant to an
indemnification obligation, neither Party hereto will be liable for lost
profits
arising from or relating to any breach of this Agreement (whether direct
or
indirect) or special, incidental or consequential damages arising out of
this
agreement or the exercise of a Party’s rights hereunder, regardless of any
notice of such damages.
10.5 INSURANCE
The
Parties shall maintain, during the Term, commercial general liability insurance,
(including Product liability, contractual liability, bodily injury, property
damage and personal injury) adequate enough to cover its indemnification
obligations under this Article 10. During the Term, the Parties shall not
permit
such insurance to expire or be canceled without reasonable prior written
notice
to the other Party and without providing for comparable replacement insurance
prior to such expiry or cancellation. A
Party’s liability to the other is in no way limited to the extent of the
insurance coverage.
11.
REGULATORY
MATTERS
11.1 ADVERSE
REACTIONS, INCIDENTS AND NEAR INCIDENTS
Promptly
following the Effective Date, but in no event later than 30 days prior to
the
anticipated use of the Product during the ICP, the Parties shall negotiate
in
good faith and execute a vigilance agreement providing that VIL shall be
responsible for vigilance in the Territory and containing terms customary
for
similar agreements, including a joint recall procedure and the timely provision
of information to Vasogen and ▇▇▇▇▇▇ (the "Vigilance Agreement").
11.2 COMMUNICATIONS
WITH GOVERNMENTAL BODIES; INQUIRIES
11.2.1 VIL
will be responsible for
obtaining and maintaining Regulatory Approvals and communicating with
Governmental Bodies on regulatory matters. ▇▇▇▇▇▇ will assist VIL, at VIL’s
request, in obtaining such Regulatory Approvals. Notwithstanding
the foregoing, Vasogen shall be entitled to modify the indications approved
under the CE ▇▇▇▇ (i) to reflect results of the SIMPADICO and ACCLAIM trials
in
accordance with the Essential Requirements or (ii) as mutually agreed with
▇▇▇▇▇▇.
27
11.2.2 Upon
being contacted by any Governmental Body in the Territory in connection
with a Product or any other matter which might reasonably be
expected to affect the rights or obligations of the other Party under
his
Agreement, the Party so contacted shall immediately notify the other
Party. Each Party, as appropriate, shall respond to all inquiries regarding
the Product, from Governmental Bodies throughout the Territory
and the Parties shall provide one another with reasonable assistance
in this regard.
11.3 RECALLS
In
the
event that either Party determines that an “event”, “incident”, or “near
incident” (as those terms are defined in the Vigilance Agreement) or
circumstance has occurred which may result in the need for a recall or other
removal of the Product from the market, such Party shall advise and consult
with
the other Party with respect thereto as to the appropriate measures to be
taken,
as set out in the Vigilance Agreement, provided that Vasogen shall have final
decision making authority in respect of a recall as provided by applicable
health regulatory requirements.
11.4 RECALL
PROCEDURE
The
manner in which the recall is to be carried out shall be set out in the
Vigilance Agreement.
11.5 COST
OF
RECALLS
Except
as expressly
otherwise provided in the Vigilance Agreement, the Parties shall share
equally all costs of a recall, market withdrawal or other corrective action
with
respect to any Product in the Territory. Notwithstanding the foregoing,
a Party
shall bear any and all costs of a recall, market withdrawal or other corrective
action with respect to a Product in the Territory to the extent such recall,
market withdrawal or other corrective action is attributable predominantly
to
the fault of such Party and results from:
(A)
in
the case of Vasogen: (i) a grossly negligent or reckless act or omission
or
intentional misconduct on the part of Vasogen or its Affiliates, and in
no part
from a grossly negligent or reckless act or omission or intentional misconduct
on the part of ▇▇▇▇▇▇ or its Affiliates or sub-distributors, (ii)
characteristics inherent to the Product, (iii) the failure of Product to
be
manufactured by Vasogen in compliance in all material respects with all
applicable laws, rules and regulations, and in accordance with the
Specifications,
following notice of non-compliance from ▇▇▇▇▇▇;
or
(iv) material breach by Vasogen of applicable laws, rules or regulations,
or the
provisions of this Agreement; and
28
(B)
in
the case of ▇▇▇▇▇▇: (i) a grossly negligent or reckless act or omission
or
intentional misconduct on the part of ▇▇▇▇▇▇ or its Affiliates or
sub-distributors, and not from a grossly negligent or reckless act or omission
or intentional misconduct on the part of Vasogen or its Affiliates; (ii)
any
failure to
handle, store, promote or distribute Product in compliance with Vasogen
specifications, and all
applicable laws, rules and regulations from and after delivery of Product
to
▇▇▇▇▇▇; or (iii) material breach by ▇▇▇▇▇▇ of applicable laws, rules or
regulations or the provisions of this Agreement.
Notwithstanding
the foregoing, neither Party shall have any obligation to reimburse or otherwise
compensate the other Party or its Affiliates for any lost profits or income
that
may arise in connection with any recall, market withdrawal or corrective
action
with respect to a Product.
12.
INTELLECTUAL
PROPERTY
12.1 LIMITED
KNOW-HOW AND PATENTS LICENSE
12.1.1 Subject
to the terms and conditions of this Agreement, and only to the extent required
to perform its obligations and undertakings pursuant to this Agreement, Vasogen
hereby grants to ▇▇▇▇▇▇ an exclusive, non-transferable license throughout
the
Territory to use the Product IP Rights, Know-How, Patents, and Improvements
owned by Vasogen for the sole purpose of: the sale, marketing and distribution
of the Product in the Territory in the Field of Use in accordance with
Regulatory Approvals, as provided herein (collectively the “Licensed Rights”).
However, Vasogen shall be permitted to use the Licensed Rights in the Territory
and in the Field of Use to obtain Regulatory Approvals and for research and
development purposes, and to use the Licensed Rights in the Territory for
any
purpose outside the Field of Use, provided that such activities do not prejudice
▇▇▇▇▇▇’▇ rights under the Agreement. Both Parties acknowledge that the conduct
of a further clinical trial in the Terrritory would not prejudice ▇▇▇▇▇▇’▇
rights. Vasogen shall keep ▇▇▇▇▇▇ informed of any such activities.
▇▇▇▇▇▇
shall not, at any time during the continuance of this Agreement or thereafter,
directly or indirectly, by itself or through its employees, agents or related
companies, contest or assist any other company or person in contesting the
validity of any of the Patents or Licensed Rights or the right, title and
interest of Vasogen to the Patents or Licensed Rights.
12.1.2
Vasogen also grants to ▇▇▇▇▇▇ for the purpose provided for pursuant to the
provisions of sub-section 12.1.1, (i) an exclusive, non-transferable right
and
license throughout the Territory in the Field of Use to use such Know-How
and
Patents of which Vasogen is entitled to sub-licence such rights.
29
12.1.3
Vasogen shall be responsible for the defense of the Patents (including
proceedings related to infringement of the Patents by a third party) and/or
Licensed Rights including any legal proceedings in respect of infringement
of
third party rights in respect of use of the Licensed Rights as it may determine
necessary, acting in good faith, to allow ▇▇▇▇▇▇ to exploit the Licensed
Rights
in accordance with the spirit and intent of Agreement, and, in cases where
it is
determined necessary to do so, Vasogen shall bring any actions or defenses
in
connection therewith. ▇▇▇▇▇▇ shall cooperate with Vasogen and render Vasogen
its
reasonable assistance in the defense of the Patents and/or Licensed Rights
(including proceedings relating to infringement of the Patents by a third
party)
or defense against third party allegations of infringement of third party
rights
in respect of use of the Licensed Rights at Vasogen's expense. Any damages
and
costs recovered shall be for Vasogen's sole benefit and Vasogen shall be
entitled to enter into any settlement agreement or consent to judgment as
it
considers reasonable, provided that ▇▇▇▇▇▇ is allowed to exploit the Licensed
Rights in accordance with the spirit and intent of the Agreement.
12.1.4 ▇▇▇▇▇▇
will notify Vasogen promptly in writing when it becomes aware of possible
infringement of the Licensed Rights by a third party or if ▇▇▇▇▇▇ becomes
aware
that a third party is alleging infringement of third party rights in respect
of
use of the Licensed Rights.
12.1.5
Vasogen shall be responsible for prosecution and maintenance of Patents and
pending patent applications as is applicable. Vasogen shall be responsible
for
all costs relating to the filing, prosecution, and maintenance of Patents.
Vasogen may, during the term of this Agreement, discontinue prosecution of
pending patent applications, decide not to file additional patent applications,
or discontinue payment of maintenance fees for patents listed in Schedules
1.1.23(a) and (b), provided that it has determined, acting in good faith,
that
▇▇▇▇▇▇ will still be allowed to exploit the Licensed Rights in accordance
with
the spirit and intent of the Agreement. In such event, Vasogen will give
▇▇▇▇▇▇
reasonable prior notice of such decisions or actions to allow ▇▇▇▇▇▇ to decide
whether to continue, on Vasogen’s behalf, prosecution of such patent
applications, file patent applications, or continue payment of maintenance
fees
for such patents.
12.2
INVENTIONS
AND NEW INDICATIONS
12.2.1 Vasogen
shall retain sole ownership of and exclusive title in the Product IP Rights.
Any
and all inventions relating to the Product resulting from the activities
conducted by ▇▇▇▇▇▇'▇ directors, employees or agents under this Agreement
during
the course of the collaboration shall be promptly disclosed in writing to
Vasogen and vice versa with respect to Vasogen inventions resulting from
the
collaboration with ▇▇▇▇▇▇ (each, a "Joint Invention") and such Joint
30
Invention
shall be jointly owned by Vasogen and ▇▇▇▇▇▇.
▇▇▇▇▇▇
shall be entitled to use the Joint Invention solely for purposes of
commercializing the Product in the Territory during the Term and all rights
to
the Joint Invention shall revert to Vasogen upon termination or expiry of
the
Agreement.
12.2.2 In
the event that Vasogen shall obtain Regulatory Approval for an indication
for
the Product outside the Field of Use, Vasogen shall so notify ▇▇▇▇▇▇ in writing.
▇▇▇▇▇▇ shall have thirty (30) calendar days from the receipt of such written
notification to notify Vasogen in writing of its desire to negotiate for
a
license to such indication on the terms and conditions of this Agreement
mutatis
mutandis, including Transfer Price, but excluding milestones on First Commercial
Sale and milestones on annual total Net Sales. Should ▇▇▇▇▇▇ make such a
written
notification, then within a period of thirty (30) calendar days there from,
the
parties shall enter into an amendment to this Agreement Should the parties
not
consummate an amendment to this Agreement in this period of thirty (30) calendar
days, the offer to ▇▇▇▇▇▇ shall be deemed formally withdrawn and Vasogen
shall
have the right to negotiate and consummate a license with a Third Party;
provided, however, that Vasogen shall not consummate such a license with
such
Third Party unless the terms of such license offered to such Third Party
are no
more favorable than the terms previously offered to ▇▇▇▇▇▇. If such terms,
in
the aggregate, are more favorable than the terms previously offered to ▇▇▇▇▇▇,
then Vasogen, by written notice, shall offer such terms to ▇▇▇▇▇▇ and ▇▇▇▇▇▇
shall have fifteen (15) calendar days from Vasogen’s notice in which to accept
such offer and consummate an amendment to this Agreement.
12.3 LICENSE
GRANT OF TRADEMARKS
12.3.1 Selection
of Trademarks and Vasogen Housemark(s) for the Product shall be at Vasogen's
sole discretion and Vasogen shall own all right, title and interest in and
to
any and all such Trademarks and Vasogen Housemark(s).
12.3.2 Vasogen
shall be responsible for maintaining and registering any Trademarks and Vasogen
Housemark(s). Vasogen shall be responsible for all costs relating to the
filing
and renewal of trademark
applications
for the Trademarks and Vasogen Housemark(s).
12.3.3 All
packaging materials, package inserts, labels and promotional materials relating
to a Product distributed in the Territory shall display the Trademarks and
such
Vasogen Housemark(s) as may be determined by Vasogen, in a form and style
to be
determined by Vasogen and in accordance with local laws and regulations.
▇▇▇▇▇▇ shall not use any other trademark in connection with the Product without
obtaining Vasogen's prior consent in writing; provided, however, this provision
shall not be construed to prohibit the continued use of ▇▇▇▇▇▇'▇ company
name
and logo in connection with its activities under this Agreement. ▇▇▇▇▇▇ shall
submit a sample of such materials displaying the
31
Trademarks
and Housemark(s) to Vasogen for approval. Vasogen shall use Commercially
Reasonable Efforts to approve such materials within twenty (20) days for
materials in English and thirty (30) days for materials in a language other
than
English. In the absence of a written response from Vasogen within the period
provided above, such materials shall be deemed approved by Vasogen. ▇▇▇▇▇▇
will
also include in such materials, any notifications deemed necessary by Vasogen,
including but not limited to ownership of the Trademarks and Housemark(s)
by
Vasogen and licensed use notifications.
12.3.5 ▇▇▇▇▇▇
agrees to notify Vasogen promptly in writing if it becomes aware of any
conflicting use of or application for registration of the Trademarks and/or
Vasogen Housemark(s), or of any trademark confusingly similar thereto, or
of any
known or alleged infringements, or allegations of infringement of trademark
rights by a third party as a result of use of the Trademarks and/or Vasogen
Housemark(s), as well as of
any unfair
competition involving the Trademarks and/or Vasogen Housemark(s) which shall
come to its attention.
12.3.6 Vasogen
shall be responsible for the defense of the Trademarks and/or Vasogen
Housemark(s) and shall determine in its sole discretion as to whether it
will
bring any actions in connection therewith. If Vasogen decides to do so, ▇▇▇▇▇▇
shall cooperate with Vasogen and render Vasogen its reasonable assistance
in the
defense of the Trademarks and/or Vasogen Housemark(s) at Vasogen's expense.
Any
damages and costs recovered shall be for Vasogen's sole benefit.
12.3.7
Other than as provided herein, ▇▇▇▇▇▇ shall not use or register at any time,
whether during the continuance of this Agreement or thereafter, any business
or
tradename, company name, trademark, labeling or packaging design that
incorporates, is substantially identical with or is deceptively or confusingly
similar to any of the Trademarks or Vasogen Housemark(s).
12.3.8
Vasogen, during the term of this Agreement, may discontinue pending trademark
applications in respect of the Trademarks and/or Vasogen Housemark(s) or
discontinue payment of maintenance
for
trademark
registrations listed in Schedules 1.1.34 and 1.1.37, provided that it has
determined, acting in good faith, that ▇▇▇▇▇▇ will still be allowed to exploit
the Licensed Rights in accordance with the spirit and intent of the Agreement.
In such event, Vasogen will give ▇▇▇▇▇▇ reasonable prior notice of such
decisions or actions to allow ▇▇▇▇▇▇ to decide whether to continue prosecution
of such trademark applications or continue, on Vasogen’s behalf, maintenance of
such trademark registrations.
32
12.4 OTHER
RIGHTS
During
the term of this Agreement, Vasogen retains all rights not expressly
granted
or licensed hereunder including without limitation, the right to use the
Product
IP Rights in connection with the manufacturing, labeling, marketing, sale
and
distribution of the Product and the right to commercially exploit the Product
IP
Rights and expand its activities in any way and in any country of the world
outside the Territory.
12.5 CONFIDENTIAL
INFORMATION
Each
Party shall not, at any time or under any circumstances, without the prior
written consent of the other Party, directly or indirectly communicate or
disclose to any Person any confidential knowledge or information of the other
Party howsoever acquired including without limitation information received
by a
Party relating to or concerning the customers, Product, technology, Know-how,
Patents, Intellectual Property, trade secrets, systems, operations or other
confidential information regarding the other Party's business or that of
any of
its Affiliates ("Confidential Information"), nor shall it utilize or make
available any such knowledge directly or indirectly in connection with any
business or activity in which it is or proposes to be involved, or in connection
with the solicitation or acceptance of employment with any Person. For the
purposes of this Article, the obligations of non-disclosure hereunder shall
not
apply for Confidential Information which:
12.5.1 is
a part of the public domain through no act or omission of the receiving Party
or
its officers, employees, agents, sub-distributors, advisors or other
representatives;
12.5.2
was
lawfully within the receiving Party’s possession prior to its receipt thereof
from the other Party;
12.5.3 was
received in good faith by the receiving Party from a Third Party, who was
lawfully in possession of, and had the right to disclose,
the
same; or
33
12.5.4 is
information which the receiving Party is required by law to disclose, provided
that the receiving Party first notifies the other Party that it believes
it is
required to disclose such information and it allows that Party a reasonable
period of time to contest the disclosure of such information.
13.
TERM
AND TERMINATION
13.1 TERM
Subject
to
termination as hereinafter provided, the term of this Agreement shall commence
on the Effective Date and shall expire on a country by country basis (i)
in
countries where Devices and Disposables were delivered for purposes of the
ICP,
12 years from the date of the first delivery of the Device and Disposable
to
▇▇▇▇▇▇ in the relevant country for purposes of the ICP and (ii) in countries
where no Devices and Disposables were delivered for purposes of the ICP,
12
years from the date of the first delivery of the Device and Disposable for
purposes of the ICP in any country.
13.2 RENEWAL
Provided
▇▇▇▇▇▇ is in compliance with its obligations and unless ▇▇▇▇▇▇ gives Vasogen
notice three months prior to the initial expiry of the Agreement that it
does
not intend to renew the Agreement , this Agreement shall be automatically
renewed at the end of the Term for consecutive periods of two (2) years each
upon
the same terms and conditions, unless the Parties mutually agree to modify
such
terms and conditions..
13.3 EARLIER
TERMINATION
This
Agreement may be terminated, prior to the expiration of the term hereof upon
any
of the following:
13.3.1 TERMINATION
UPON BUSINESS FAILURE. To the extent permitted by applicable law, either
Party
shall have the option to terminate this Agreement immediately upon notice
to the
other Party in the event that (i) the other Party becomes insolvent, or subject
to proceedings for its adjudication as a bankrupt, (ii) a receiver, trustee,
or
custodian is appointed for the other Party, or (iii) the other Party makes
an
assignment for the benefit of creditors, or is liquidated or dissolved, and
(iv)
in the event of the occurrence of any action or event which is, the equivalent
in law of one or more of the events described in this subsection
13.3.1;
13.3.2
EITHER
PARTY FOR CAUSE OR FORCE MAJEURE. This Agreement may be terminated by either
Party (i) on a country by country basis in the event that the other Party
is in
default of any of the material terms and conditions herein with respect
to
such country and fails to remedy (including
34
payment
of any alleged damages) such default within sixty (60) days of a notice thereof
from the other Party
or (ii) due to force majeure which remains unresolved for more than sixty
(60)
days;
13.3.3
DEFAULT
OF PAYMENT. This Agreement may be terminated in the event that ▇▇▇▇▇▇ is
in
default of payment and ▇▇▇▇▇▇ fails to remedy such default within thirty
(30)
days of a notice thereof from Vasogen;
13.3.5
TERMINATION
BY ▇▇▇▇▇▇. ▇▇▇▇▇▇ shall have the right to terminate this Agreement on a country
by country basis if:
(i)
a
Regulatory Approval required in a specific country to
market the Product is not obtained from a Governmental Body through no
fault of
▇▇▇▇▇▇ after at least a year of Commercially Reasonable Efforts, or
(ii)
for
any
other reason beyond the reasonable control of ▇▇▇▇▇▇, ▇▇▇▇▇▇ reasonably
determines in good faith that commercialization of a given Product is not
feasible or is economically unreasonable in a given country or countries
of the
Territory. Notwithstanding the above, before ▇▇▇▇▇▇ exercises such right,
both
Parties shall meet and discuss in good faith in order to try to find an
alternative solution. In addition, if ▇▇▇▇▇▇ and Vasogen are unable to arrive
at
an alternative solution with respect to a country and ▇▇▇▇▇▇ has previously
exercised its right to terminate this Agreement with respect to another country
in the same Region, then Vasogen shall have the option, in its sole discretion,
to terminate this Agreement as to such Product for the entire Region, or
(iii)
a
Product is withdrawn from the market due to safety reasons by Vasogen,
where Vasogen has not resolved the safety issue to allow re- introduction
within six (6) months.
13.3.6
TERMINATION
BY VASOGEN. Vasogen may terminate this Agreement on a country by country
basis
if:
|
(i)
|
▇▇▇▇▇▇
fails to use Commercially Reasonable Efforts to assist Vasogen
in the
registration of the Product,
|
|
(ii)
|
the
ICP Marketing Plan referred to in Section 8.4.1 is not accepted
by
Vasogen, provided that before such right is exercised by Vasogen,
both
Parties shall meet and discuss in good faith how the ICP Marketing
Plan
can be adjusted to accommodate the needs of both
Parties.
|
|
(iii)
|
the
Marketing Plan referred to in Section 8.4.2 is not agreed by
Vasogen
|
|
(iv)
|
After
the ICP ▇▇▇▇▇▇ fails to launch and actively sell and promote the
Product
in a given country of the Territory within xx after the required
Regulatory Approvals have been obtained,
|
35
|
(v)
|
After
the ICP, ▇▇▇▇▇▇ ceases
to sell the Product in a given country of the Territory for a period
of
six months, except in circumstances where the Product has been
withdrawn
for safety reasons or Vasogen has failed to supply the Device or
Disposables,
|
|
(vi)
|
During
the Term of this Agreement, ▇▇▇▇▇▇ experiences a Change of Control,
or
enters into any Agreement with respect to any such Change of Control
transaction, and as of the date of the closing of the Change of
Control
transaction the surviving entity would be promoting, distributing,
marketing or selling a Competing Product in any country in the
Territory.
However, before Vasogen exercises its right of Termination under
this
clause 13.3.6 (vi), Vasogen shall allow ▇▇▇▇▇▇ and/or the surviving
entity
a period of six months to either divest or discontinue selling
such
Competing Product. For purposes of this Agreement "Change of Control"
shall mean with respect to a Party (a) the merger or consolidation
of such
Party and any Third Party which results
in the voting securities of such Party outstanding immediately
prior
thereto ceasing to represent more than fifty percent (50%) of the
combined
voting power of the surviving entity immediately after such merger
or
consolidation, or (b) any Third Party, together with its affiliates,
becoming the beneficial owner of fifty percent (50%) or more of
the
combined voting power of the outstanding securities of the Party,
or (c)
the sale or other transfer to a Third Party of all or substantially
all of
such Party's assets, or
|
|
(vii)
|
▇▇▇▇▇▇
contests the validity or property rights of Vasogen of/in the Licensed
Rights or executes or causes to be executed at any time any act
capable of
infringing the rights of Vasogen and/or the Licensed
Rights
|
13.4 RESULTS
OF EXPIRY
Upon
the scheduled expiration of the Term:
|
(i)
|
▇▇▇▇▇▇
shall cease to be entitled to use the Licensed Rights
|
|
(ii)
|
▇▇▇▇▇▇
shall transfer to Vasogen any marketing authorizations or other
Regulatory
Approvals for Product held in ▇▇▇▇▇▇'▇ name;
|
|
(iii)
|
▇▇▇▇▇▇
shall return to Vasogen all information or materials given to ▇▇▇▇▇▇
by
Vasogen in whatever form or medium, including any Confidential
Information
provided to ▇▇▇▇▇▇ by Vasogen (including, but not limited to, any
documents, in any form or medium, created by or on behalf of ▇▇▇▇▇▇
which
includes Vasogen’s Confidential Information);
and
|
|
(iv)
|
Vasogen's
obligation to supply the Device and Disposable shall
terminate
|
36
▇▇▇▇▇▇
shall immediately cease
(i) to
be
entitled to use the Licensed Rights;
(ii) all
use, sale, distribution and marketing of the Product; and
(iii) representing
itself as the authorized distributor of Vasogen;.
13.5 RESULTS
OF TERMINATION
13.5.1 Upon
termination of this Agreement on a country by country basis as applicable,
by
Vasogen pursuant to clauses 13.3.1, 13.3.2, 13.3.3, 13.3.4 or 13.3.6 or by
▇▇▇▇▇▇ all the rights, titles, interests and privileges resulting from this
Agreement shall automatically revert to Vasogen, and subsequently:
13.5.1.1
▇▇▇▇▇▇
shall immediately cease
(i) to
be
entitled to use the Licensed Rights;
(ii) all
use, sale, distribution and marketing of the Product; and
(iii) representing
itself as the authorized distributor of Vasogen;
13.5.1.2
▇▇▇▇▇▇
shall return to Vasogen all information or materials given to ▇▇▇▇▇▇ by Vasogen
in whatever form or medium, including any Confidential Information provided
to
▇▇▇▇▇▇ by Vasogen (including, but not limited to, any documents, in any form
or
medium, created by or on behalf of ▇▇▇▇▇▇ which includes Vasogen’s Confidential
Information);
13.5.1.3
if
requested by Vasogen, ▇▇▇▇▇▇ shall sell to Vasogen, at the original net Transfer
Price paid by ▇▇▇▇▇▇ plus actual freight charges for delivery to Vasogen,
all of the Product sold by Vasogen to ▇▇▇▇▇▇ and on hand in ▇▇▇▇▇▇'▇ place
of
business or in the possession or the control of ▇▇▇▇▇▇ at the time of
termination of this Agreement and deliver same to Vasogen forthwith upon
request;
13.5.1.4
in
case
Vasogen decides not to buy back all of the Product sold by Vasogen to ▇▇▇▇▇▇
and
on hand in ▇▇▇▇▇▇'▇ place of business or in the possession or the control
of
▇▇▇▇▇▇ at the time of termination of this Agreement, then ▇▇▇▇▇▇ shall be
entitled to sell it during a period of six (6) months following
termination;
13.5.1.5
▇▇▇▇▇▇
shall transfer back to Vasogen any Regulatory Approvals required to be in
its
name.
13.5.2 In
the event that Vasogen commits a material
breach of this Agreement, ▇▇▇▇▇▇ shall give written notice to Vasogen and
Vasogen shall have sixty (60) days to cure each breach. If such breach cannot
reasonably be cured within such sixty (60) day period following written
notification from ▇▇▇▇▇▇, then
37
the
Parties agree to negotiate in good faith and/or follow the provisions provided
under clause 14.1, provided that, until a final decision is taken, this
Agreement shall continue in full force and effect allowing ▇▇▇▇▇▇ to continue
its commercial activities with the Product.
14.
GENERAL
14.1 DISPUTE
RESOLUTION; ARBITRATION
The
Parties recognize that disputes may from time to time arise which relate
to
either Party's rights and obligations hereunder. It is the objective of the
Parties to comply with the procedures set forth in this Agreement to use
all
reasonable efforts to facilitate the resolution of such disputes in an expedient
manner by mutual agreement. The Parties agree that, in the first instance,
all
disputes should be submitted to the Joint Steering Committee for resolution.
In
the event the Joint Steering Committee is unable to resolve any such dispute
within thirty (30) days after the matter is first submitted to the Joint
Steering Committee, either Party may submit the matter to arbitration pursuant
to this Section14.1.
Any
dispute, controversy or claim between Vasogen and ▇▇▇▇▇▇ relating to the
breach,
termination, construction, interpretation, application of (or at the occasion
of) this Agreement, which cannot be settled by the Joint Steering Committee
shall be settled, when permitted by law, by binding arbitration under the
following terms and conditions:
14.1.1 either
Vasogen or ▇▇▇▇▇▇ may demand that a dispute, controversy, or claim be submitted
to arbitration. Such demand shall be made in writing to the other Party at
the
notification address set forth in this Agreement;
14.1.2 all
matters submitted by Vasogen and ▇▇▇▇▇▇ for settlement by binding arbitration
shall be decided by a single arbitrator agreeable to both Vasogen and ▇▇▇▇▇▇.
If
Vasogen and ▇▇▇▇▇▇ are unable to agree upon a single arbitrator within a
period
of fifteen (15) business days following the transmission by either Party
of the
notice referred to in section 14.1.1, an arbitrator shall be appointed in
accordance with the then existing Rules of Conciliation and Arbitration of
the
International Chamber of
Commerce (the "Rules"), if for any reason an arbitrator cannot be appointed
in
this manner, this section 14.1.2 shall cease to apply to the dispute,
controversy or claim in question and any Party may apply to a court of competent
jurisdiction for the settlement thereof;
14.1.3 all
arbitration authorized by this Agreement shall be conducted in accordance
with
the Rules, to the extent such Rules are not inconsistent with the terms of
this
Agreement;
38
14.1.4 decisions
and awards rendered by arbitration authorized by this Agreement may be entered
and enforced by either Vasogen or ▇▇▇▇▇▇ in any court having jurisdiction.
Vasogen and ▇▇▇▇▇▇ hereby irrevocably consent and submit to the jurisdiction
of
such court for purposes of such enforcement;
14.1.5
in the event either Vasogen or ▇▇▇▇▇▇ does not reasonably comply with a final
decision or award made by the arbitrator, such non-complying Party shall
bear
all costs and expenses, including attorney's fees, incurred by the other
Party
in obtaining enforcement of the decision or award;
14.1.6 during
any period of arbitration concerning this Agreement or any part thereof,
this
Agreement shall remain in full force and effect and all terms shall be complied
with by both Vasogen and ▇▇▇▇▇▇;
14.1.7 the
arbitrator shall not add to, subtract from, or modify any of the terms or
conditions of the Agreement;
14.1.8 the
arbitrator shall use its best efforts (i) to complete the process of arbitration
including the arbitration hearing within one hundred and twenty (120) days
of
his nomination and (ii) to render a decision or an award within thirty (30)
days
after the close of arbitration hearings;
14.1.9 the
arbitrator, in his discretion, shall allocate all costs of the arbitration
between Vasogen and ▇▇▇▇▇▇. However, neither Vasogen nor ▇▇▇▇▇▇ shall be
required to pay the costs of the other Party;
14.1.10 all
arbitration proceedings authorized by this Agreement shall be held in London,
England and shall be conducted in the English language and all documents
referred to shall be in English;
14.1.11 this
section 14.1 shall not apply in cases where a Party is seeking, as a remedy
to a
dispute, controversy or claim, the issue of an interlocutory injunction or
another similar remedy and except for the purpose of filing the award or
obtaining an order of enforcement, as the case may be, for the purpose of
rendering the award executory. In cases where section 14.1 shall not apply
under
this section, the Parties hereby submit to the exclusive jurisdiction of
the
English Courts.
14.1.12
EACH PARTY WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY;
14.1.13 EACH
PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE OR, EXEMPLARY
DAMAGES
FROM THE OTHER; AND
14.1.14 EACH
PARTY HERETO WAIVES ANY CLAIM OF CONSEQUENTIAL DAMAGES
FROM THE OTHER.
39
14.2.1 Except
as expressly provided herein, neither this Agreement nor any interest or
rights
hereunder shall be assignable by a Party without the prior written consent
of
the other;
14.2.2 Vasogen
may assign this Agreement to an Affiliate or the purchaser of all or
substantially all its business as it relates to the Product, without the
consent
of ▇▇▇▇▇▇; in such cases, such assignee shall have and may exercise all the
rights, and shall assume all the obligations of the assignor pursuant to
this
Agreement and any reference to the assignor in this Agreement shall be deemed
to
refer to such assignee;
14.2.3 ▇▇▇▇▇▇
may assign this Agreement to an Affiliate or the purchaser of all or
substantially all its business as it relates to the Product, without the
consent
of Vasogen if (i) ▇▇▇▇▇▇ remains jointly and severally responsible for the
Agreement and (ii) in the case of assignment to an Affiliate, the Affiliate
remains controlled by ▇▇▇▇▇▇ at all time. In such cases, the assignee shall
have
and may exercise all the rights, and shall assume all the obligations of
the
assignor pursuant to this Agreement and any reference to the assignor in
this
Agreement shall be deemed to refer to such assignee in addition to the assignor;
14.2.4
In
the case of any permitted transfer the Parties hereto and the assignee shall
execute an Agreement confirming such assignment and such assumption of
obligations.
14.3 INUREMENT
This
Agreement shall inure to the benefit of and be binding upon the Parties hereto
and their respective successors and permitted assigns.
14.4 FORCE
MAJEURE
Neither
Party shall be liable for delays in performance under this Agreement occasioned
by force majeure or any cause beyond its control, including but not limited
to
war, civil disturbance, fire, flood, earthquake, windstorm, acts of default
of
common carriers, strikes, excluding Party employee strikes, unforeseen shutdowns
of sources of supply, governmental laws, acts, regulations or orders which
have
not been enacted as of the Effective Date (whether or not such later prove
to be
invalid) or any other occurrence, whether or not similar in character to
the
foregoing.
40
14.5 NO
AGENCY
The
Parties are independent contractors. Neither is the agent or legal
representative, joint venturer, partner, employee or employer of the other.
Each
Party hereto agrees not to represent itself as the agent or legal representative
of the other. This Agreement does not grant any Party any authority to assume
or
create any obligation on behalf of or in the name of the other
Party.
14.6 ENTIRE
AGREEMENT
The
terms and conditions of this Agreement supersede the terms and conditions
of any
and all prior Agreements and, subject to Article 14.16, any and all
representations that may have been made prior to this Agreement with respect
to
the subject matter of this Agreement. The terms and conditions herein constitute
the entire Agreement between the Parties hereto and may not be amended, changed,
modified, contradicted, explained or supplemented (including by course of
dealing between the Parties, usage of trade or otherwise) except by a written
instrument signed by an authorized officer of each of the Parties which refers
specifically to this Agreement.
14.7 FURTHER
ASSURANCES
Each
Party agrees to duly execute and deliver, or cause to be duly executed and
delivered, such further instruments and to do and cause to be done such further
acts and things, including, without limitation, the filing of such additional
assignments, agreements, documents and instruments that may be necessary
or as
the other Party may at any time reasonably request in connection with this
Agreement or to carry out more effectively the provisions or purposes of,
or to
better assure and confirm unto such other Party its rights and remedies under,
this Agreement. Each Party agrees to cause each of its employees and agents
to
take all actions and to execute, acknowledge and deliver all instruments
or
Agreements reasonably requested by the other Party and necessary for the
perfection, maintenance, enforcement or defense of that Party's rights under
this Agreement.
14.8 SEVERABILITY
OF CLAUSES
If
any
provision of this Agreement is determined to be illegal, against public
order,
or otherwise unenforceable it shall not in any way defeat, invalidate or
render
unenforceable any other provision of this Agreement and each such provision
shall at all times be considered separate and severable in this Agreement.
14.9 WAIVER
No
waiver by either of the Parties of any breach of any provision hereof shall
constitute
a waiver of any other breach of any provision hereof.
41
14.10 NOTICES
14.10.1
Any notice required by this Agreement shall specifically reference this
Agreement,
shall be in writing and may either be delivered in hand, by facsimile
during
normal business hours with confirmation of receipt, by reputable overnight
courier
service or be mailed with postage prepaid by certified or registered mail,
return
receipt requested, to the addresses set forth below, or such other address
for
itself as any of the Parties may from time to time specify in writing to
the
other Party
in accordance with this article.
|
If
to Vasogen:
|
||
|
▇▇▇▇
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇,
|
||
|
▇▇▇▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇
|
||
|
▇▇▇▇▇▇
|
||
|
▇▇▇
▇▇▇
|
||
|
Attention
of: Chief Executive Officer
|
||
|
Facsimile
number: ▇▇▇ ▇▇▇ ▇▇▇▇
|
With
a
copy to: Vice-President, Corporate & Legal Affairs
|
Facsimile
number:
|
||
|
If
to VIL
|
Vasogen
Ireland Limited
|
|
|
▇▇▇▇▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇
|
||
|
▇▇▇▇▇▇▇,
▇▇. ▇▇▇▇▇
|
||
|
▇▇▇▇▇▇▇
|
||
|
Attention
of: Director
|
||
|
Facsimile
number: 011 35 3 61472 060
|
||
|
If
to ▇▇▇▇▇▇:
|
GRUPO
▇▇▇▇▇▇ INTERNACIONAL, S.A.
|
|
|
▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇
|
||
|
▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇
|
||
|
Attention
of: Licensing Department
|
||
|
Facsimile
number: ▇▇▇ ▇▇ ▇▇▇ ▇▇ ▇▇
|
||
|
With
a copy to:
|
GRUPO
▇▇▇▇▇▇ INTERNACIONAL, S.A.
|
|
|
LEGAL
DEPARTMENT
|
||
|
▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇
▇▇▇▇▇
|
||
|
▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇
|
||
|
Attention
of: Legal Department
|
||
|
Facsimile
number: + 34 93 490 89 33
|
42
|
14.10.2
|
Any
notice given pursuant to this clause shall be deemed
to
|
have
been received:
(a) if
delivered by hand, at the time of delivery; or
(b)
if
delivered by prepaid certified or registered mail, on the fifth business
day
in
the country of the recipient following the day of posting; or
(c) if
delivered by facsimile, on acknowledgement by the recipient facsimile
receiving
equipment if the acknowledgement occurs before 1700 hours local
time on a business day in the county of the recipient, and in any other
case on the following business day; or
(d)
if
delivered by overnight courier, on the day after posting
14.11
EXECUTION
IN
COUNTERPARTS
This
Agreement may be executed in counterparts, each of which, when so executed
and
delivered, shall be deemed to be an original, and all of which counterparts,
taken together, shall constitute one and the same instrument.
14.12 UNITED
NATIONS CONVENTION
The
United Nations Convention on Contracts for the International Sale of Goods
will
not apply in any way to this Agreement or to the transactions contemplated
by
this Agreement or otherwise to create any rights or to impose any duties
or
obligations on any Party to this Agreement. Any rights which have arisen
or
which might in the future arise under the United Nations Convention on Contracts
for the International Sale of Goods are waived and released by all Parties
to
this Agreement.
14.13
LANGUAGE
The
Parties hereto confirm that it is their wish that this Agreement be drawn
up in
English only.
14.14
PUBLICITY
Neither
Party will issue a press release or make any public announcement in connection
with the execution of this Agreement or the terms hereof, unless mutually
agreed
to by the Parties or required by law. ▇▇▇▇▇▇ shall not make any
43
public
announcement regarding any of the Product without Vasogen's prior written
consent. Vasogen shall be entitled to describe this Agreement in any document
which it files with the Securities
and
Exchange Commission ("SEC") and the Ontario Securities Commission after
providing ▇▇▇▇▇▇ at least five (5) business days to review and comment on
such
description, or the maximum such lesser time as may be possible in an emergency.
After issuing any mutually approved press release, public announcement or
making
any such SEC filing, each Party may make public disclosures in a manner
consistent with the description contained in any such press release, public
announcement or filed document. Prior to filing this Agreement with the SEC,
Vasogen shall notify ▇▇▇▇▇▇ and, if requested in writing by ▇▇▇▇▇▇ within
five
(5) business days after such notification, request that the SEC grant
confidential treatment to the provisions for which the non-filing Party has
requested.
14.15 THIRD
PARTY RIGHTS
No
third party shall have the right to enforce any provision of this Agreement
by
virtue of the Contracts (Rights of Third Parties) ▇▇▇ ▇▇▇▇.
14.16
FRADULAENT
MISREPRESENTATION
Nothing
in this Agreement removes or overrides any right of action by any Party in
respect of any fraudulent misrepresentation.
The
remainder of this page was intentionally left blank.
Signatures
on the following page
44
IN
WITNESS WHEREOF each of the Parties has caused this Agreement to be
executed
on its
behalf by a duly authorized officer on the date and place shown
below.
|
Per:
/s/
▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇
|
|
|
Print
Name: ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇
|
|
|
Print
Title: Chief Executive Officer
|
|
|
Date
April 18, 2007 City/Country:
Barcelona, Spain
|
|
|
Vasogen
Ireland Limited
|
|
|
Per:
/s/
▇▇▇▇ ▇▇▇▇
|
|
|
Print
Name: ▇▇▇▇ ▇▇▇▇
|
|
|
Print
Title: Director
|
|
|
Date:
11th
April ‘07 City/Country:
Dublin, Ireland
|
|
|
GRUPO
▇▇▇▇▇▇ INTERNACIONAL, S.A.
|
|
|
(▇▇▇▇▇▇)
|
|
|
Per:
/s/
▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇
|
|
|
Print
Name: ▇▇. ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇
|
|
|
Print
Title: VP, International Business Development
|
|
|
Date:
April 18, 2007
|
|
|
City/Country:
Barcelona, Spain
|
|
|
Per:/s/
▇▇▇▇ ▇. Fumanal
|
|
|
Print
Name: ▇▇▇▇ ▇. Fumanal
|
|
|
Print
Title: VP Domestic Business Pharma
Division
|
45
Schedule
1.1.17
Initial
Commercialization Period Marketing Plan
Timeline
for roll-out
Number
of Devices required for installation
Location
of install sites and identity of participating clinicians
Number
of
Disposables required
Term
of
ICP, including start date
Training
(technicians and end-users)
Service
and maintenance
Installation
Assets
allocation (e.g. headcount and financial resource requirements)
Retail
Price at which Device or Disposable may be sold to end user
Product
label, including but not limited to the following: therapeutic usage and
indication (i.e., target population) , primary efficacy label claims, user
manual, instructions for use (IFU)
Reimbursement
strategy (specific to ICP)
Regulatory
strategy (specific to ICP)
Quality
agreement/strategy
Product
positioning/message strategy
Promotional/sales
strategies/tactics as appropriate (specific to ICP)
Quality
Metrics
47
SCHEDULE
1.1.29
PATENTS
48
Schedule
1.1.29(a)
|
Country
|
Patent/Application
No.
|
Title
|
|
Belgium
|
680346
|
Method
of increasing the nitric oxide concentration in blood
|
|
96911890.0
|
Endothelial
lining effects and treatment of vasospastic disorders
|
|
|
1128837
|
Medicament
for preventing and reversing atherosclerosis in mammals
|
|
|
1267897
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
|
|
Germany
|
69332087.7
|
Method
of increasing the nitric oxide concentration in blood
|
|
69620436.2-08
|
Endothelial
lining effects and treatment of vasospastic disorders
|
|
|
69905602.0
|
Medicament
for preventing and reversing atherosclerosis in mammals
|
|
|
60107065.8-08
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
|
|
Spain
|
2179828
|
Method
of increasing the nitric oxide concentration in blood
|
|
0768886
|
Endothelial
lining effects and treatment of vasospastic disorders
|
|
|
1128837
|
Medicament
for preventing and reversing atherosclerosis in mammals
|
|
|
1267897
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
|
|
France
|
680346
|
Method
of increasing the nitric oxide concentration in blood
|
|
96911890.0
|
Endothelial
lining effects and treatment of vasospastic disorders
|
|
|
1128837
|
Medicament
for preventing and reversing atherosclerosis in mammals
|
|
|
1267897
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
49
|
Greece
|
680346
|
Method
of increasing the nitric oxide concentration in blood
|
|
0768886
|
Endothelial
lining effects and treatment of vasospastic disorders
|
|
|
1267897
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
|
|
Italy
|
29258/BE/2002
|
Method
of increasing the nitric oxide concentration in blood
|
|
0768886
|
Endothelial
lining effects and treatment of vasospastic disorders
|
|
|
1128837
|
Medicament
for preventing and reversing atherosclerosis in mammals
|
|
|
1267897
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
|
|
Luxembourg
|
680346
|
Method
of increasing the nitric oxide concentration in blood
|
|
0768886
|
Endothelial
lining effects and treatment of vasospastic disorders
|
|
|
1128837
|
Medicament
for preventing and reversing atherosclerosis in mammals
|
|
|
1267897
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
|
|
The
Netherlands
|
EP0680346
|
Method
of increasing the nitric oxide concentration in blood
|
|
0768886
|
Endothelial
lining effects and treatment of vasospastic disorders
|
|
|
1128837
|
Medicament
for preventing and reversing atherosclerosis in mammals
|
|
|
1267897
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
50
|
Portugal
|
EP0680346
|
Method
of increasing the nitric oxide concentration in blood
|
|
0768886
|
Endothelial
lining effects and treatment of vasospastic disorders
|
|
|
1128837
|
Medicament
for preventing and reversing atherosclerosis in mammals
|
|
|
1267897
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
|
|
Brazil
|
PI9915270.3
|
Medicament
for preventing and reversing atherosclerosis in mammals
|
|
01/07705-8
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
|
|
Mexico
|
228687
|
Medicament
for preventing and reversing atherosclerosis in mammals
|
|
230976
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
|
|
Ireland
|
S2006/0475
|
Treatment
of congestive chronic heart failure
|
|
▇▇▇▇▇▇
|
▇▇
▇▇▇▇ ▇▇▇▇▇ B
|
Treatment
of congestive heart failure by pretreated autologous
blood
|
|
U.S.
|
60/791037
(PCT
Application filed
April
5, 2007)
|
Treatment
of elevated C-reactive protein levels
|
|
60/815938
(PCT
Application filed
April
5, 2007)
|
Treatment
of elevated C-reactive protein levels
|
|
|
Canada
|
2556233
|
Treatment
of mild chronic heart failure in human patients
|
|
2558181
|
Treatment
of mild chronic heart failure in human patients
|
|
|
2559600
|
Treatment
of mild chronic heart failure in human patients
|
|
|
Europe
|
1243278
(will
be validated in Belgium, France, Germany, Greece, Italy, Luxembourg,
the
Netherlands, Portugal, and Spain)
|
Method
of increasing the nitric oxide concentration in
blood
|
51
Schedule
1.1.29(b)
|
Country
|
Patent/Application
No.
|
Title
|
|
Belgium
|
1214037
|
Apparatus
for conditioning mammalian blood
|
|
Germany
|
600
09 724.2
|
Apparatus
for conditioning mammalian blood
|
|
Spain
|
1214037
|
Apparatus
for conditioning mammalian blood
|
|
France
|
1214037
|
Apparatus
for conditioning mammalian blood
|
|
Greece
|
20040402076
|
Apparatus
for conditioning mammalian blood
|
|
Italy
|
1214037
|
Apparatus
for conditioning mammalian blood
|
|
The
Netherlands
|
1214037
|
Apparatus
for conditioning mammalian blood
|
|
Portugal
|
1214037
|
Apparatus
for conditioning mammalian blood
|
|
Europe
|
2708073.8
|
Apparatus
and process for conditioning and de-bubbling organic fluid
|
|
0270872.0
|
Needle
assembly and heat sealer for patient injection apparatus and
process
|
52
Schedule
1.1.43
|
1
|
Trademark
Application/Registration No.
|
Trademark
|
|
Europe
|
003642436
|
CELACADE
|
|
003829827
|
CIRCLE
Design
|
|
|
Brazil
|
826252460,
826252478, 826252486, and 826252494
|
▇▇▇▇▇▇▇▇
|
|
▇▇▇▇▇▇
|
▇▇▇▇▇▇,
828892, 840588, and ▇▇▇▇▇▇
|
▇▇▇▇▇▇▇▇
|
|
▇▇▇▇▇▇
|
2004
002567
|
CELACADE
|
53
Schedule
1.1.45
|
Trademark
Application/Registration No.
|
Trademark
|
|
|
Europe
|
004106662
|
VASOGEN
|
54
Forecasts
and Orders
3.1.2 Taking
into account initially the three month binding forecast provided by ▇▇▇▇▇▇
under
3.1.1 of the Agreement, on the first day of every calendar month during the
Term
commencing October 1, 2008, ▇▇▇▇▇▇ shall provide Vasogen with a good faith,
forecast update of its estimated requirements by month and for each Region,
of
Devices and Disposables for the twelve (12) month period commencing on the
first
day of the immediately following calendar month (each a "Forecast Update").
3.1.3 ▇▇▇▇▇▇'▇
specified requirements for Devices and Disposables for the next three (3)
calendar months of each Forecast Update on a rolling weekly basis shall
constitute a binding order for the purchase of Devices and Disposables (each,
a
"Firm Order"). The remainder of any Forecast Update shall be non-binding.
3.2 PURCHASE
ORDERS
3.2.1 For
each Product, ▇▇▇▇▇▇ shall specify, on a Purchase Order or similar alternate
document the requested quantity of Devices and Disposables, requested delivery
dates and destination.All such orders shall be in full lot quantities in
respect
of Disposables. Each Purchase Order shall be in a form and contain terms
previously agreed to by the Parties. Vasogen will acknowledge receipt of
each
order and the anticipated shipment date. The shipment of Devices and/or
Disposables shall be made within a maximum of twenty (20) business days from
the
projected shipment date specified on our order acknowledgement.
3.2.2 In
the
event of any conflict between the terms and conditions of this Agreement
and the
terms and conditions of any Purchase Order or any other document, the terms
and
conditions of this Agreement shall prevail.
55