Amended and Restated
Agreement
by and among
Altair Nanomaterials,
Inc.,
Spectrum Pharmaceuticals,
Inc.
and
Altair Nanotechnologies,
Inc.
(only with respect to Sections
5.1,9.2, and 9.3)
Amended and Restated
Agreement
This Amended and Restated Agreement, dated as of
August 4, 2009 (the “Execution Date”), is entered into
by and between:
Altair Nanomaterials, Inc. (hereinafter
“Altair”), a Nevada corporation with principal offices
at 204 Edison Way, Reno, Nevada 89502; Spectrum Pharmaceuticals,
Inc. (hereinafter “Spectrum”), a Delaware corporation
with principal offices at 157 Technology Drive, Irvine California
92618; and (only with respect to Sections 5.1, 9.2, and 9.3) Altair
Nanotechnologies, Inc., a Canada corporation with principal offices
at 204 Edison Way, Reno, Nevada 89502.
RECITALS
WHEREAS , Altair is the owner of Patents, Know-How,
Trade Secrets and Trademarks (each, as defined below) relating to
Compounds (as defined below);
WHEREAS , Altair, Altair Nanotechnologies, Inc. and
Spectrum are parties to a License Agreement dated as of January 28,
2005 (the “License Agreement”) pursuant to which
Spectrum obtained from Altair, and Altair granted to Spectrum, the
rights set forth therein, including a license under Altair’s
Patents, Know-How, Trade Secrets and Trademarks (as defined below),
and any Improvements to develop and commercialize one or more
Compounds and/or Products (as defined below);
WHEREAS , Altair, Altair Nanotechnologies, Inc. and
Spectrum are parties to a Settlement Agreement dated as of June 6,
2006 (the “Settlement Agreement”) pursuant to which the
Parties resolved a dispute under the License Agreement;
and
WHEREAS , Altair, Altair Nanotechnology, Inc. and
Spectrum desire to amend and restate in its entirety the License
Agreement on the terms and conditions set forth herein in order for
Spectrum to obtain from Altair, and Altair to grant to Spectrum,
inter alia, an assignment of Altair’s Patents, Know-How,
Trade Secrets and Trademarks.
NOW, THEREFORE , in consideration of the premises and mutual
covenants and agreements set forth below, Altair and Spectrum
(individually referred to as “Party” and collectively
as “Parties”) hereby agree as follows:
ARTICLE 1.
DEFINITIONS
Except as otherwise expressly provided herein or
unless the context otherwise requires: (a) the use of the term
“including” shall mean “including but not limited
to”; (b) the words “herein”,
“hereof”, “hereunder” and other words of
similar import refer to this Agreement as a whole, and not to any
particular provision; (c) the use of the phrase “by
Spectrum” shall mean “by Spectrum (and/or on behalf of
Spectrum),” and the use of the phrase “by Altair”
shall mean “by Altair (and/or on behalf of Altair)”;
and (d) the following initially capitalized terms in this
Agreement, whether used in the singular or plural, shall have the
following meanings:
1.1
“Affiliate” of a Party shall mean any entity which directly
or indirectly controls, is controlled by, or is under common
control with a Party to this Agreement. For purposes of
this definition, “control” or “controlled”
means ownership, directly or through one or more Affiliates, of
more than fifty percent (50%) of the shares of stock entitled to
vote for the election of directors, in the case of a corporation,
or more than fifty percent (50%) of the equity interests in the
case of any other type of legal entity, status as a general partner
in any partnership, or any other arrangement whereby a Party
controls or has the right to control the Board of Directors or
equivalent governing body of a corporation of other
entity.
1.2
“Agreement” shall mean this Amended and Restated Agreement,
including all exhibits attached hereto, all as may be respectively
amended, modified or supplemented in writing by the Parties from
time to time in accordance with the terms of this
Agreement.
1.3
“Altair
Indemnitees” is
defined in Section 13.1.
1.4
“API”
shall mean active pharmaceutical
ingredient, and for purposes of this Agreement shall mean the
Compound included in the Product for sale in the Field in the
Territory.
1.5
“Claim”
is defined in Section
13.1.
1.6
“Commercially Reasonable
Efforts” shall mean
the standard that a reasonable business person would use to
develop, manufacture, market, sell and distribute, a product owned
by it or to which it has rights, which is of similar market
potential at a similar stage in its product life, taking into
account, among other factors, the competitiveness of the
marketplace, the proprietary position of the product and the
profitability of the product.
1.7
“Combination
Product” shall mean
any Product that contains, in addition to any Compound, one or more
clinically active pharmaceutical ingredients owned or controlled by
a Third Party, and other than another Compound or any
Improvement.
1.8
“Compound”
shall mean, individually and
collectively, the following chemical compounds: (a) lanthanum
oxycarbonate 2-hydrate, including RenaZorb RZB 011, (b) lanthanum
dioxycarbonate including RenaZorb RZB 012 and also known as
RENALAN™, (c) the compounds known as RZB 013 and RZB 014, and
(d) all intermediates, derivatives, improvements or related
compounds of any of the foregoing developed by Altair prior to the
Execution Date, and (e) any other compound or technology developed
or under development by Altair as of the Execution Date or
throughout the Term that is related to the contemplated or
potential uses of the aforementioned chemical compounds.
1.9
“Confidential
Information” shall
mean any proprietary or confidential information of the Disclosing
Party (except to the extent such information falls within an
exception recited in Section 11.3, below) that is communicated in
any way or form by the Disclosing Party to the Recipient, either
prior to or after the Effective Date of this Agreement, and whether
or not such information is identified as
confidential. Information that is not identified as
confidential shall be deemed Confidential Information if the
Recipient knows or reasonably should have known that the
information communicated by the Disclosing Party is Confidential
Information of the Disclosing Party. Information developed by one
Party based on or derived from Confidential Information disclosed
by the other Party shall be deemed Confidential Information of both
Parties (and each Party shall be deemed the Disclosing Party of
such Confidential Information). The terms and conditions of this
Agreement shall be considered the Confidential Information of both
Parties.
1.10
“Current Market
Price” shall mean
the average of the reported closing sale prices on the principal
securities market for Altair Nanotechnologies Inc.’s, or its
successor’s, common shares for the *********** consecutive
trading days immediately preceding and including the date of the
milestone event.
1.11
“Disclosing
Party” shall mean
the Party making disclosure of or otherwise communicating its
Confidential Information to the other Party.
1.12
“Dollars” or
“$” shall
mean the lawful currency of the United States.
1.13
“Effective
Date” shall
mean January 28, 2005.
1.14
“EMEA”
shall mean the European Agency for
the Evaluation of Medicinal Products.
1.15
“FDA”
shall mean the United States Food
and Drug Administration, or any successor entity thereto performing
similar functions.
1.16
“Field"
shall mean all uses.
1.17
“First Commercial
Introduction” shall
mean the first date upon which a Product is shipped for sale by
Spectrum (or by an Affiliate or licensee of Spectrum) in the
ordinary course of business to a Third Party in any country in the
Territory, after Regulatory Approval.
1.18
“Force
Majeure” is defined
in Section 15.3.
1.19
“Heads”
is defined in Section
14.1.
1.20
“Human
Field” shall
mean all human therapeutic and diagnostic uses.
1.21
“Human License
Payments ” shall
mean any upfront, milestone and other payments (including any
premiums paid in the purchase of securities, or other
consideration) received by Spectrum or its Affiliates from any
licensee under a license in the Human Field to the Assigned IP
assigned to Spectrum under this Agreement, except for royalty
payments based on net sales of Product in the Human
Field.
1.22
“Improvement(s)”
shall mean any and all inventions,
discoveries, improvements, modifications, Product or pharmaceutical
formulations, new indications, chemical processes, manufacturing
processes, data (pre-clinical, clinical or otherwise), information,
Trade Secrets and Know-How, whether or not patented or patentable,
regarding Compound or Product, that are: (a) conceived or reduced
to practice by either Party, its respective Affiliates or its
respective licensees or their respective contractors after the
Effective Date but prior to the Execution Date, and (c) related to
a Compound or Product or to the manufacture or use of Compound or
Product by either Party, its respective Affiliates or its
respective licensees.
1.23
“Indemnified
Party” is defined
in Section 13.3.
1.24
“Indemnifying
Party” is defined
in Section 13.3.
1.25
“Key
Employees” shall
mean up to five (5) of the existing employees of Altair identified
by Spectrum and listed on Exhibit A hereto as of the Execution
Date.
1.26
“Know-How”
shall mean all data, results,
information (technical and scientific), marketing reports,
expertise, pre-clinical, clinical and manufacturing data regarding
the Compounds and Products existing as of the Execution
Date.
1.27
“Launch” or
“Launched” shall mean the first date on which the Product
is Detailed in a country in the Territory. For the
purposes of this Section 1.27, “Detailed” shall mean a
sales presentation in the Territory to medical professionals by a
sales representative acting on behalf of Spectrum, its Affiliate or
licensee during which presentation the sales representative
promotes the Product.
1.28
“Loss” is defined in Section 13.1.
1.29
“MHLW”
shall mean the Ministry of Health
and Labour and Welfare of Japan.
1.30
“ NDA ” shall
mean a New Drug Application (as more fully described in 21 C.F.R.
Part 314.5 et seq.), and all amendments and supplements (including
NDAs) thereto, filed with the FDA in the United States, or the
equivalent application filed with any equivalent Regulatory
Authority in the Territory.
1.31
“Net
Sales” shall mean
the amount received by Spectrum, its Affiliates, its licensees or
distributors on account of sales of a Product in the Human Field to
Third Parties in the Territory, less the following deductions to
the extent actually allowed or specifically allocated to the
Product by the selling party using generally accepted accounting
principles:
(i) sales and excise
taxes and duties paid or allowed by the selling party and any other
governmental charges (excluding income taxes) imposed upon the
production, importation, use or sale of such Product;
(ii) customary trade,
quantity and cash discounts allowed on Product;
(iii) allowances or
credits to customers on account of rejection or return of Product
or on account of retroactive price reductions affecting such
Product;
(iv) freight and
transit insurance costs, if they are included in the selling price
for the Product invoiced to Third Parties, provided always that
such deduction shall not be greater than the balance between the
selling price actually invoiced to the Third Party and the standard
selling price which would have been charged to such Third Party for
such Product exclusive of freight and transit insurance in the
respective country or in a comparable country.
For the avoidance of doubt, for each Product the
Net Sales shall be calculated only once for the first sale of such
Product by either Spectrum, its Affiliate, its licensees or its
distributor, as the case may be, to a Third Party which is neither
an Affiliate, licensees or distributor of Spectrum. A
sale of Products by Spectrum, its Affiliate, its licensees or its
distributor to a wholesaler shall be regarded as the first sale of
the Product for the purpose of calculating Net Sales.
Such deductions, to be applicable, must in each
case be related specifically to the Product and shall be actually
allowed to or taken by Third Party purchasers and not otherwise
recovered by or reimbursed from the Third Party purchasers to
Spectrum, its Affiliates and/or its licensees. No
deductions shall be made for commissions paid to individuals
whether they be with independent sales agencies or regularly
employed by Spectrum, its Affiliates or its licensees and on their
respective payrolls, or for cost of collections.
*******************************************************************************************************. If
Spectrum, its Affiliates or licensees receive non-monetary
consideration, Altair shall be paid in cash for its share of the
value of such consideration.
Net Sales shall not include the amount received
on account of sales of a Product or of sales of a Product in a
particular country for which the Term of this Agreement has
expired.
With respect to sales of Combination Products,
Net Sales of such Combination Products shall be calculated by
multiplying the Net Sales (as described above with respect to
Products) of the Combination Product by the fraction A/(A+B), where
A is the average sale price of the Product when sold in finished
form and B is the sum of the average sale price of each other
clinically active pharmaceutical ingredient included in the
Combination Product, when sold separately in finished form, in each
case during the applicable royalty reporting period or, if sales of
both the Product and the other clinically active pharmaceutical
ingredients other than the Compound did not occur in such period,
then in the most recent royalty reporting period in which sales of
both occurred. In the event that such average sale
prices cannot be determined for both the Product and each other
clinically active pharmaceutical ingredient included in the
Combination Product, Net Sales of such Combination Products shall
be determined by multiplying the Net Sales (as described above with
respect to Products) of the Combination Product by the fraction
C/(C+D), where C is the fair market value of the Product and D is
the sum of the fair market value of each other clinically active
pharmaceutical ingredient included in the Combination Product, such
fair market values shall be determined in good faith by the
Parties.
1.32
“Non-Human Field” shall
mean all uses other than human uses. The Non-Human Field
includes without limitation ***********.
1.33
“Non-Human License
Payments” shall mean any upfront, milestone, royalties and
other payments (including any premiums paid in the purchase of
securities, or other consideration) received by Spectrum or its
Affiliates from any licensee under a license in the Non-Human Field
to the Assigned IP assigned to Spectrum under this
Agreement.
1.34
“ Patents ” shall
mean any and all unexpired patents and patent applications (and any
patents issued in connection with such patent applications),
including any continuations, continuations-in-part, divisions,
continuing prosecution applications, requests for continued
examinations, extensions, term restorations, renewals, reissues,
re-examinations, and substitutions thereof, and any foreign
counterparts thereof, that claim the Compound(s), the Product(s),
methods of making or using the Compound(s), or methods of making or
using the Product(s). The Patents include the patents
and patent applications listed on Exhibit B as of the Execution
Date.
1.35
Patent Royalty
Payment(s) ” is
defined in Section 5.3(a).
1.36
“ Phase III Trial
” shall mean a controlled study in humans of the efficacy and
safety of a Compound or Product that is designed to demonstrate
clinically and statistically whether the Compound or Product is
safe and effective for use in a particular indication in a manner
sufficient to obtain Regulatory Approval for that Compound or
Product in a given country or territory.
1.37
“ Product” shall
mean any product that contains or includes a Compound.
1.38
“ Recipient ”
shall mean the Party receiving or otherwise obtaining Confidential
Information from the Disclosing Party.
1.39
“ Region ” shall
mean North America, Europe, Japan or Rest of Territory.
1.40
“ Regulatory Authority
” shall mean, with respect to any particular country,
territory or union within the Territory, the governmental
authority, body, commission, agency or other instrumentality of
such country, territory or union with the primary responsibility
for the evaluation or approval of medical products before such
medical product can be tested, marketed, promoted, distributed or
sold in such country, including such governmental bodies that have
jurisdiction over the pricing of such medical
product. The term “Regulatory Authority”
includes the FDA, the EMEA, the European Member State competent
authorities, and the MHLW, as applicable.
1.41
“ Regulatory Approval
” shall mean any approval(s), registrations or authorizations
of the relevant Regulatory Authority necessary for the marketing
and sale of Compound or Product in any country, territory or union
in the Territory.
1.42
“ Representatives
” is defined in Section 11.2.
1.43
“ Reporting Period
” shall begin on the first day of each calendar quarter or
portion thereof and end on the last day of such calendar quarter or
portion thereof.
1.44
“ Rest of Territory
” shall mean, collectively, all countries and territories in
the Territory except for North America, Europe and
Japan.
1.45
“Spectrum Common
Stock” shall
mean the restricted common stock, $0.001 par value, of
Spectrum.
1.46
“ Spectrum Indemnitees
” is defined in Section 13.2.
1.47
“ Technology Royalty
Payments ” is defined in Section 5.3(b).
1.48
“ Territory ”
shall mean all countries and territories in the world.
1.49
“ Third Party ”
shall mean any person or entity other than Altair, Spectrum or
their respective Affiliates.
1.50
“Trademark”
shall mean all trademarks and
tradenames, listed on Exhibit B, together with any registrations or
applications for registration therefor, anywhere in the world, and
all other marks confusingly similar thereto, all variations of such
marks, all members of any families of any of the foregoing marks,
all designs and styles used by Altair in the depiction of foregoing
marks and any copyrights therein, and all goodwill appurtenant to
any of the foregoing that are owned or controlled by Altair as of
the Execution Date.
1.51
“Trade
Secrets” shall mean
all Confidential Information, inventions (including, without
limitation, unpatented or unpatentable inventions, but excluding
Patents), techniques, methods, processes, assays, developments,
materials, compositions of matter of any type or kind, standard
operating procedures, formulas, specifications, technology,
tooling, and stability data existing as of the Execution Date and
related to the use, development, manufacture, sale and importation
of Compounds and/or Products.
1.52
“ United States ”
or “ U.S .” shall mean the United States of
America, its territories and possessions.
ARTICLE 2.
GRANT OF RIGHTS
2.1
Assignment of Rights to Spectrum
in the Territory . Subject to the terms and conditions
of this Agreement, Altair agrees to assign and hereby assigns to
Spectrum, and Spectrum hereby accepts, all right, title and
interest in and to the Patents, Know-How, Trademarks and Trade
Secrets (including Improvements) (all together the “Assigned
IP”). As owner of all such right, title and
interest, Spectrum shall have the right to use the Assigned IP for
all purposes, including to use, have used, sell, have sold, offer
to sell, import and have imported, make or have made Compounds
and/or Products in the Field in the Territory, and Spectrum shall
be free to grant licenses to its Affiliates and Third Parties under
the Assigned IP. Commencing with the Execution Date and
throughout the Term, Altair shall not, directly or indirectly, (i)
research, develop or commercialize any Compound or Product in the
Field and in the Territory or (ii) except and to the extent where
such is required by any law, regulation or order of any
governmental authority, take any action or inaction that would
materially negatively or adversely affect the development,
regulatory filings, sublicensing and/or commercialization of any
Compound or Product..
The assignment by Altair to Spectrum of the
Assigned IP pursuant to this Section 2.1 shall be in all respects
free and clear of any and all liens, hypothecations, mortgages,
charges, security interests, pledges and other encumbrances and
claims of any nature.
Altair hereby covenants and agrees that it will,
at the reasonable request of Spectrum, and without further
consideration, promptly execute and deliver, and cause its
employees and/or contractors to execute and deliver, all documents
reasonably necessary to effectuate the assignment of the Assigned
IP to Spectrum and take all actions reasonably necessary to assist
Spectrum to perfect and maintain title to the Assigned IP in
Spectrum. Aside from the initial IP transfer efforts limited to
three days of meetings and/or equivalent Altair employee time,
Spectrum shall be responsible for any reasonable costs (in
accordance with the rates set forth in Exhibit A) incurred by
Altair in complying with the requirements of this
paragraph.
2.2
Disclosure by
Altair. Promptly after the Execution Date, Altair will
provide Spectrum with all data, Know-How and other information
(including manufacturing information) that it has, regarding the
Compounds and Product, including any such information concerning
its efforts to improve the Compounds and all data, Know-How,
information, results and records related to the manufacture of API,
Compounds and finished Products, that has not previously been
disclosed to Spectrum, which shall be subject to nondisclosure
restrictions by any other agreement (unless such disclosure is
required by applicable law, regulation, government authority or the
rules of any stock exchange on or through which Spectrum or its
Affiliates’ securities trade). Promptly after the
Execution Date, Altair shall provide Spectrum with all quantities
of Compounds and Products in the possession of Altair.
ARTICLE 3.
PRODUCT DEVELOPMENT AND
COMMERCIALIZATION
3.1
Development, Manufacturing and
Commercialization Activities. Commencing with the Execution Date, all
activities relating to the development, manufacture and
commercialization of Compounds and Products shall be undertaken at
Spectrum’s sole responsibility, and in its sole discretion
and at its sole cost and expense, including: (i) all pre-clinical
development activities; (ii) all activities related to clinical
trials; (iii) all marketing, promotion, sales, distribution, import
and export activities relating to any Compound or Product; (iv) all
activities relating to any regulatory filings, registrations,
applications and Regulatory Approvals relating to any of the
foregoing; and (v) all activities relating to the manufacture and
supply of Compound and Products by itself or through its Affiliates
or any Third Party. Spectrum shall own all regulatory
filings, registrations, applications and Regulatory Approvals
relating to Compounds and Products and all data, results and other
information relating to the Compounds and Products (irrespective of
whether the regulatory filings, registrations, applications and
Regulatory Approvals occurred, were conceived, or derived or
resulted from activities that occurred before or after the
Execution Date), including data, results and information derived
and/or resulting from the manufacturing of the Compounds or
Products . For the avoidance of doubt, any costs and
expenses that accrued or were incurred by Altair relating to the
development, manufacture or commercialization of Compounds or
Products prior to the Execution Date remain Altair’s sole
responsibility.
3.2
Altair Product
Support. Altair shall use commercially reasonable efforts
to reasonably assist Spectrum in understanding the development and
manufacture processes of Compounds transferred
hereunder. Notwithstanding, Altair shall use
commercially reasonable best efforts to provide Spectrum with
reasonable access to the Key Employees for a period of up to six
(6) months after the Execution Date. If a Key Employee
is no longer employed by Altair, Altair will promptly notify
Spectrum of such change in employment status and shall not prevent
Spectrum in any way, mean, shape or form from contacting and
employing the Key Employee, and shall provide Spectrum with any
known contact information of the Key Employee subject to any
restrictions which may exist under any applicable laws. Aside from
the initial technology transfer efforts noted in Section 2.1 and in
order to provide the above Altair Product Support, Spectrum shall
have no more than a total of five (5) days of meetings and/or
equivalent of Altair total employee time with the Key Employees.
Beyond the foregoing five (5) days Spectrum shall be responsible
for any reasonable costs (in accordance with the rates set forth in
Exhibit A) incurred by Altair in complying with the requirements of
this paragraph.
3.3
Spectrum Diligence
Obligations. Spectrum
shall use commercially reasonable efforts to timely develop and
commercialize one or more Products and to introduce one or more
Products in the Field and countries within in the
Territory.
ARTICLE 4.
DATA AND INFORMATION;
REGULATORY MATTERS
4.1
Regulatory Approval
. Commencing with the
Execution Date, Spectrum shall be responsible, in its sole
discretion and at its expense, for (i) preparing and filing all
regulatory submissions including Investigational New Drug
Applications (INDs) and NDAs pertaining to the Compounds or
Products in the Field throughout the Territory, (ii) all activities
necessary or appropriate to perform prior to filing such regulatory
submissions, including INDs and NDAs, (iii) all activities related
to obtaining approval(s) of such regulatory submissions, including
INDs and NDAs and (iv) upon obtaining such approval(s), all
activities and responsibilities related to maintaining each
Regulatory Approval in good standing in compliance with all
applicable laws and regulations. Spectrum shall be the
owner of all resulting Regulatory Approvals in the
Territory.
For the avoidance of doubt, any costs and
expenses that accrued or were incurred by Altair relating to the
regulatory matters for Compounds or Products prior to the Execution
Date remain Altair’s sole responsibility. Any
regulatory materials prepared or filed by Altair for any Compound
or Product in the Field prior to the Execution Date shall be
transferred to Spectrum.
4.2
Compliance with Regulatory
Standards and Regulatory Correspondence . Spectrum shall adhere to and comply
with all applicable ethical, legal and regulatory standards and
requirements in connection with the Regulatory Approval and
commercialization of Compounds and Products throughout the
Territory. Altair shall promptly deliver to Spectrum all
correspondence that it receives from Regulatory Authorities
relating to any Compound or Product.
4.3
Product Complaints; Product
Recall
(a) Product
Complaints. Spectrum shall have sole control over the
response to all material complaints regarding Compound or Product
in the Territory. Altair shall promptly refer any
Compound or Product complaints in the Territory of which it becomes
aware to Spectrum for Spectrum’s response. Altair
shall promptly provide to Spectrum copies of all relevant
documentation and information regarding any such Compound or
Product complaints.
(b) Product
Recall. If Altair discovers or becomes aware of any
fact, condition, circumstance or event (whether actual or
potential) concerning or related to a Compound or Product that may
reasonably require recall or market withdrawal of Compound or
Product or a “Dear Doctor” letter relating to Compound
or Product, Altair shall communicate such fact, condition,
circumstance or event promptly to Spectrum. In the event
(but only in the event) (i) any governmental agency or Regulatory
Authority issues a request, directive or order that Compound or
Product be recalled, (ii) a court of competent jurisdiction orders
that Compound or Product be recalled or (iii) Spectrum reasonably
determines that Compound or Product should be recalled or withdrawn
from the market or that a “Dear Doctor” letter should
be sent relating to use of Compound or Product, Spectrum shall take
all appropriate remedial actions with respect
thereto. To the extent that it is necessary or
appropriate to communicate with any person or entity in the
Territory, including any Regulatory Authority or governmental
agency, the media or any customer, concerning any such fact,
condition, circumstance or event, Spectrum shall be the primary
contact concerning remedial action. Any costs associated
with any remedial action shall be borne by Spectrum.
ARTICLE 5.
MILESTONE AND ROYALTY
PAYMENTS
5.1
Upfront and Milestone
Payments . As
consideration for the assignment granted to Spectrum under Article
2, Spectrum shall pay to Altair the following amounts, (each of
which shall be payable only once) each within thirty (30) days of
the applicable events set forth below, in accordance with the terms
and conditions of this Article 5 (except as set forth in Section
5.2, under no circumstances shall such amounts, once paid, be
refundable or creditable against any other payments):
(a) Upfront payment
having occurred prior to Execution Date: The Parties
acknowledge previous payment by Spectrum prior to the Execution
Date of: (i) Two hundred thousand dollars ($200,000) to purchase
38,314 common shares of Altair Nanotechnologies, Inc. at the then
current market value of $3.88 per share of Altair Nanotechnologies,
Inc. common shares; and (ii) One hundred thousand (100,000) shares
of Spectrum Common Stock.
(b) Milestone and
settlement payment having occurred prior to the Execution
Date. The Parties acknowledge previous payment by
Spectrum prior to the Execution Date of one hundred forty thousand
(140,000) shares of Spectrum Common Stock (which includes 100,000
shares delivered in respect of a milestone related to satisfactory
lanthanum serum levels and 40,000 shares delivered in consideration
of the transfer of technology related to formulation improvements
to certain Products developed by Altair).
(c) Upon Execution
Date. Within ten (10) business days of the Execution
Date, Spectrum shall pay $750,000, in shares of Spectrum Common
Stock, subject to Section 9.2. The number of shares of
Spectrum registered Common Stock to be issued to Altair upon the
Execution Date shall be calculated by dividing the applicable
payment amount by the closing price, as reported by NASDAQ, per
share of the Spectrum registered Common Stock on July 1, 2009 The
Parties agree that to the best of their knowledge no other
consideration or payments are currently due and payable to Altair
from Spectrum as of the Execution Date
(d) Upon enrollment of
50 patients in a Phase III Trial of a Product in the Human
Field: (i) ********************************** to
purchase common shares of Altair Nanotechnologies, Inc., or its
successor, subject to Section 9.2, at a 100% premium to the Current
Market Price as of the date of ****************************in a
Phase III Trial of a Product in the Human Field or (ii)
********************************** in the event that Altair
Nanotechnologies, Inc.’s, or its successor’s, common
shares are not publicly traded on the date of such milestone event
; (with “publicly traded”, for purposes of this
Section 5.1, meaning registered under section 12(b) of the
Securities Exchange Act of 1934, as amended, and listed on a
national securities exchange in the United States registered under
such Act).
(e)
*************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************;
(f) Upon Obtaining NDA
Approval by the FDA: ********************
*****************************************************************************************************************************;
(g)
*************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************;
(h) Upon Obtaining NDA
approval by the MHLW: Two Million Dollars ($2,000,000)
as of the date of NDA approval by the MHLW of a Product in the
Human Field; and
(i) Milestones based
on annual, Territory-wide Net Sales: Except as set forth
in Section 5.2, for the avoidance of doubt, the following one-time
milestone payments shall not be creditable against any other
milestone payments hereunder. Each subsequent payment below is in
addition to the prior payment:
(i) Upon
********************** of annual Net Sales of Products in the Human
Field: ***********************;
(ii) Upon
********************************** of annual Net Sales of Products
in the Human Field: ***********************;
(iii) Upon
********************************************* of annual Net Sales
of Products in the Human
Field: *****************************;
(iv) Upon
*************************** of annual Net Sales of Products in the
Human Field: ************************************;
and
(v) Upon
************************* of annual Net Sales of Products in the
Human Field: ***************************.
Spectrum shall notify Altair of the achievement
of each of the milestone events set forth in subsections (b)
through (i) of this Section 5.1 within the payment timeline
corresponding to the milestone event set forth
above. Additionally, for any payment made in shares of
Spectrum stock, outside of any requirements of any applicable law
or regulation, including those that pertain to Rule 144 stock,
Spectrum shall not take any action or inaction that would prevent
Altair from selling or otherwise trading such shares and shall
timely maintain all SEC reporting requirements that are applicable
to this provision.
(a) Human
Field. Spectrum or its Affiliates, as applicable, shall
pay to Altair a non-refundable, non-creditable payment of
***************of all Human License Milestone Payments for licenses
in the Human Field; provided that, in the event that any Human
License Milestone Payments are due and owing on account of the
attainment of a Human license milestone event that is the same as
any of those set forth in Section 5.1, then the amount of such
Human License Milestone Payment to Altair hereunder shall be
************** of the difference between the milestone amount under
Section 5.1 and the Human License Milestone Payment for the same
event under the provisions of the license.
(b) Non-Human
Field. Spectrum or its Affiliates, as applicable, shall
pay to Altair a non-refundable, non-creditable payment of
************** of all Non-Human License Payments for licenses in
the Non-Human Field.
5.3
Intellectual Property Royalty
Payments
(a) Human Field Patent
Royalty Rate; Reports. On a quarterly basis, and in
addition to any milestone payments payable to Altair pursuant to
Section 5.1 and license payments payable to Altair pursuant to
Section 5.2, Spectrum shall pay to Altair, within ninety (90) days
after the end of each Reporting Period, the following intellectual
property royalty payments (“Patent Royalty Payments”)
in accordance with the terms and conditions of this Article
5:
(i)
******************* on the portion of annual Net Sales of each
Product in the Human Field in any calendar year in the Territory
less than ****************************;
(ii) ****************
on the portion of annual Net Sales of each Product in the Human
Field in any calendar year in the Territory greater than or equal
to **************************************** and less than
******************************; and
(iii) ******************
on the portion of annual Net Sales of each Product in the Human
Field in any calendar year in the Territory greater than or equal
to *************************************.
The obligation of Spectrum to make the above
Patent Royalty Payments shall commence upon the first Launch in
each country in the Territory, and shall apply on a
Product-by-Product and country-by-country basis for each given
Product in the Human Field in each given country with an applicable
Patent until the expiration of the last-to-expire Patent that
covers the Product within the country in question. Each
Patent Royalty Payment shall be accompanied by a written report (to
be prepared in a mutually agreeable format), setting forth (without
limitations) information necessary for the calculation of such
Patent Royalty Payment (including, on a country-by-country basis,
the gross sales of each Product sold); the calculation of Net Sales
from such gross sales; the royalties payable in Dollars; and any
withholding taxes required by law to be deducted. Unless
otherwise requested or consented to in writing by Altair, all
Patent Royalty Payments and reports related to Net Sales by
Spectrum’s Affiliates and its licensees shall be made to
Altair by Spectrum with (or as a part of) Spectrum’s own
payments and reports.
(b) Technology
Royalty. In consideration of the assignment granted
under Altair’s Know-How, Trade Secrets and Trademarks to
Spectrum, Spectrum shall pay to Altair, on a country-by-country and
Product-by-Product basis, a royalty of ********************
**************** commencing on the expiration of the last-to-expire
Patent that covers such Product in the Human Field within the
country in question (“Technology Royalty Payment”) and
continuing until there is generic competition, i.e. , first
sale of any third party product containing or including any
Compound or Product, within the country in question. In
addition, this Technology Royalty Payment shall also be applicable
in those countries for which there is no Patent covering such
Product(s), until there is generic competition within the country
in question. The Parties expressly agree that the
payment period of this Technology Royalty Payment is not an
extension of Altair’s patent rights beyond their term,
but