EXHIBIT 10.1
Confidential treatment has been requested for portions of this Exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated by ***. A complete version of this exhibit has been
filed separately with the Securities and Exchange Commission.
LICENSE AGREEMENT
BY AND
AMONG
ALTAIR NANOMATERIALS, INC.,
SPECTRUM PHARMACEUTICALS, INC.
AND
ALTAIR NANOTECHNOLOGIES, INC.
(only with respect to Sections 6.1 and 10.2)
TABLE OF CONTENTS
ARTICLE 1. DEFINITIONS..................................... 1
1.1 "Affiliate".................................. 1
1.2 "Agreement".................................. 2
1.3 "Altair Indemnitees"......................... 2
1.4 "API"........................................ 2
1.5 "Claim"...................................... 2
1.6 "Commercially Reasonable Efforts"............ 2
1.7 "Combination Product"........................ 2
1.8 "Compound"................................... 2
1.9 "Compounds".................................. 2
1.10 "Confidential Information"................... 2
1.11 "Current Market Price"....................... 3
1.12 "Disclosing Party"........................... 3
1.13 "Dollars" or "$"............................. 3
1.14 "EMEA"....................................... 3
1.15 "FDA"........................................ 3
1.16 "Field"...................................... 3
1.17 "First Commercial Introduction".............. 3
1.18 "Force Majeure".............................. 3
1.19 "Heads"...................................... 3
1.20 "Improvement(s)"............................. 3
1.21 "Indemnified Party".......................... 3
1.22 "Indemnifying Party"......................... 3
1.23 "JDC"........................................ 3
1.24 "Know-How"................................... 4
1.25 "Launch" or "Launched"....................... 4
1.26 "Loss"....................................... 4
1.27 "Manufacturing Cost"......................... 4
1.28 "MHLW"....................................... 4
1.29 "NDA"........................................ 4
1.30 "Net Sales".................................. 4
1.31 "Patents".................................... 5
1.32 "Patent Royalty Payment(s)".................. 6
1.33 "Phase III Trial"............................ 6
1.34 "Product(s)"................................. 6
1.35 "Recipient".................................. 6
1.36 "Region"..................................... 6
1.37 "Regulatory Authority"....................... 6
1.38 "Regulatory Approval"........................ 6
1.39 "Representatives"............................ 6
1.40 "Reporting Period"........................... 6
1.41 "Rest of Territory".......................... 6
1.42 "Spectrum Indemnitees"....................... 6
1.43 "Sublicense Milestone Payments".............. 6
1.44 "Technology Royalty Payments"................ 7
1.45 "Territory".................................. 7
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1.46 "Third Party"................................ 7
1.47 "Third Party Offer".......................... 7
1.48 "Total Supply Price"......................... 7
1.49 "Trademark".................................. 7
1.50 "Trade Secrets".............................. 7
1.51 "United States" or "U.S.".................... 7
ARTICLE 2. GRANT OF RIGHTS................................. 7
2.1 Grant of License Rights to Spectrum in the
Territory.................................... 7
2.2 Sublicense of Spectrum's Rights.............. 7
2.3 Altair Reservation of Rights................. 8
ARTICLE 3. PRODUCT DEVELOPMENT AND COMMERCIALIZATION....... 8
3.1 Joint Development Committee.................. 8
3.2 Development Efforts.......................... 9
3.3 Development Plan............................. 10
3.4 Marketing.................................... 10
3.5 Spectrum's Diligence Obligations............. 10
3.6 Strategic Alliance........................... 10
ARTICLE 4. DATA AND INFORMATION; REGULATORY MATTERS........ 11
4.1 Regulatory Approval.......................... 11
4.2 Communications with Regulatory Authorities... 11
4.3 Compliance with Regulatory Standards; Adverse
Events; Post-Marketing Surveillance.......... 11
4.4 Product Complaints; Product Recall........... 12
ARTICLE 5. SUPPLY OF API................................... 12
5.1 Supply Criteria.............................. 12
5.2 Right of First Negotiation................... 12
5.3 Right to Manufacture......................... 13
5.4 Ownership of Manufacturing Data.............. 14
5.5 ***.......................................... 14
ARTICLE 6. MILESTONE AND ROYALTY PAYMENTS.................. 14
6.1 Upfront and Milestone Payments............... 14
6.2 Sublicense Milestone Payments................ 15
6.3 Intellectual Property Royalty Payments....... 16
6.4 Records and Examination...................... 17
6.5 Mode of Payment; Foreign Exchange............ 18
6.6 Taxes........................................ 18
6.7 Interest..................................... 18
ARTICLE 7. TRADEMARKS...................................... 19
7.1 Trademarks................................... 19
7.2 Cooperation; Enforcement of Trademarks....... 19
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Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
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7.3 Labeling, Advertising and Promotional
Materials.................................... 19
7.4 Quality Control.............................. 19
ARTICLE 8. IMPROVEMENTS.................................... 19
8.1 Disclosure of Improvements................... 19
8.2 Ownership of Improvements.................... 20
8.3 Grant of License to Improvements............. 20
8.4 License from a Third Party................... 20
ARTICLE 9. MAINTENANCE OF PATENT; PATENT INFRINGEMENT...... 20
9.1 Patent Prosecution and Maintenance........... 20
9.2 Patent Infringement by Third Party........... 22
9.3 Infringement Action by Third Parties......... 23
9.4 ***.......................................... 23
ARTICLE 10. REPRESENTATIONS AND WARRANTIES................. 23
10.1 Representations and Warranties............... 23
10.2 Additional Representations in Connection
with the Issuances of Common Shares.......... 24
10.3 Additional Representations of Altair......... 25
10.4 Limitations on Representations and
Warranties................................... 27
ARTICLE 11................................................. 27
COVENANTS.................................................. 27
11.1 Preservation of Title........................ 27
11.2 No Conflicts................................. 27
ARTICLE 12. CONFIDENTIALITY................................ 28
12.1 Standard of Care............................. 28
12.2 Non-Disclosure and Non-Use................... 28
12.3 Exceptions................................... 28
12.4 No Misappropriation.......................... 29
12.5 Return of Confidential Information........... 29
ARTICLE 13. TERM AND TERMINATION........................... 29
13.1 Term......................................... 29
13.2 Unilateral Termination....................... 29
13.3 Termination for Material Breach.............. 30
13.4 Termination for Insolvency or Bankruptcy..... 30
13.5 Effects of Termination....................... 30
13.6 Work-in-Progress............................. 32
ARTICLE 14. INDEMNIFICATION................................ 32
14.1 Indemnification by Spectrum................... 32
14.2 Indemnification by Altair..................... 32
14.3 Claims Procedures............................. 33
ARTICLE 15. DISPUTE RESOLUTION............................. 33
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15.1 Escalation................................... 33
15.2 Arbitration.................................. 34
15.3 Patent and Trademark Matters................. 34
ARTICLE 16. MISCELLANEOUS.................................. 35
16.1 Governing Law................................ 35
16.2 Assignment................................... 35
16.3 Force Majeure................................ 35
16.4 Publicity and Disclosure..................... 35
16.5 Notices...................................... 36
16.6 Amendment; Waiver............................ 36
16.7 Severability................................. 36
16.8 Compliance with Applicable Laws.............. 36
16.9 Survival..................................... 37
16.10 No Agency; No Implied Licenses............... 37
16.11 Construction................................. 37
16.12 Captions..................................... 37
16.13 Entire Agreement............................. 37
16.14 Counterparts; Facsimiles..................... 37
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LICENSE AGREEMENT
This License Agreement, dated as of January 28, 2005 (the "Effective
Date"), is entered into by and between:
ALTAIR NANOMATERIALS, INC. (hereinafter "Altair"), a Nevada corporation
with principal offices at 000 Xxxxxx Xxx, Xxxx, Xxxxxx 00000; SPECTRUM
PHARMACEUTICALS, INC. (hereinafter "Spectrum"), a Delaware corporation with
principal offices at 000 Xxxxxxxxxx Xxxxx, Xxxxxx Xxxxxxxxxx 00000; and (only
with respect to Sections 6.1 and 10.2) ALTAIR NANOTECHNOLOGIES, INC., a Canada
corporation with principal offices at 000 Xxxxxx Xxx, Xxxx, Xxxxxx 00000.
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, on the terms and conditions set forth herein, Spectrum desires to
obtain from Altair, and Altair desires to grant to Spectrum, the rights set
forth herein, including a license under Altair's Patents, Know-How, Trade
Secrets and Trademarks, and any Improvements to develop and commercialize one or
more Products (as defined below).
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,
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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 License Agreement, including all
schedules 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 License Agreement.
1.3 "ALTAIR INDEMNITEES" is defined in Section 14.1.
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 14.1.
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 either of the following chemical compounds:
(a) lanthanum oxycarbonate 2-hydrate or (b) lanthanum dioxycarbonate, known as
RenaZorb RZB 011 and RenaZorb RZB 012, respectively.
1.9 "COMPOUNDS" shall mean RenaZorb RZB 011 and RenaZorb RZB 012.
1.10 "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 12.3, 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.
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1.11 "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.
1.12 "DISCLOSING PARTY" shall mean the Party making disclosure of or
otherwise communicating its Confidential Information to the other Party.
1.13 "DOLLARS" OR "$" shall mean the lawful currency of the United
States.
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 human therapeutic and diagnostic uses,
excluding any non-human 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 sublicensee 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 16.3.
1.19 "HEADS" is defined in Section 15.1.
1.20 "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 sublicensees or their respective contractors after the Effective
Date, (b) made in furtherance of, and as a direct result of, either Party
performing its obligations hereunder and (c) related to a Product or to the
manufacture or use of Product by either Party, its respective Affiliates or its
respective sublicensees during the Term.
1.21 "INDEMNIFIED PARTY" is defined in Section 14.3.
1.22 "INDEMNIFYING PARTY" is defined in Section 14.3.
1.23 "JDC" shall mean the Joint Development Committee described in
Section 3.1(a).
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Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
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1.24 "KNOW-HOW" shall mean, to the extent within the scope of the license
grants made herein and necessary for the use, manufacture, sale and importation
of Products, all data, results, information (technical and scientific),
marketing reports, expertise, pre-clinical, clinical and manufacturing data
regarding the Compounds and Products.
1.25 "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 1.25, "Detailed" shall mean a sales presentation in the Territory to
medical professionals by a sales representative acting on behalf of Spectrum,
its Affiliate or sublicensee during which presentation the sales representative
promotes the Product.
1.26 "LOSS" is defined in Section 14.1.
1.27 "MANUFACTURING COST" shall mean, with respect to any pre-clinical
API or clinical API produced by a manufacturer, the sum of the following
components: (a) the costs of goods produced, including, without limitation,
direct labor, material and product testing costs of such pre-clinical API or
clinical API; (b) any Third Party royalty costs that are actually paid by such
manufacturer and are based solely and directly on the manufacture and sale to
Spectrum of such pre-clinical API or clinical API; and (c) if necessary, any
other costs borne by such manufacturer directly and solely for the transport,
customs clearance, duty and/or insurance for such pre-clinical API or clinical
API shipped to Spectrum FOB Spectrum's facilities in Irvine, California, United
States.
1.28 "MHLW" shall mean the Ministry of Health and Labour and Welfare of
Japan.
1.29 "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.
1.30 "NET SALES" shall mean the amount received by Spectrum, its
Affiliates, its sublicensees or distributors on account of sales of a Product 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
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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 sublicensees or its distributor, as the case may be, to a Third
Party which is neither an Affiliate, sublicensee or distributor of Spectrum. A
sale of Products by Spectrum, its Affiliate, its sublicensee 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 sublicensees. 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 sublicensees and on their respective payrolls, or for cost of
collections.
*** If Spectrum, its Affiliates or sublicensees 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.
1.31 "PATENTS" shall mean any and all unexpired patents and patent
applications (and any patents issued in connection with such patent
applications), as
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Securities and Exchange Commission. Confidential treatment has been requested
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specifically listed in Schedule 1.31, 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).
1.32 "PATENT ROYALTY PAYMENT(S)" is defined in Section 6.3(a).
1.33 "PHASE III TRIAL" shall mean a controlled study in humans of the
efficacy and safety of a Product that is designed to demonstrate clinically and
statistically whether the Product is safe and effective for use in a particular
indication in a manner sufficient to obtain Regulatory Approval for that Product
in a given country or territory.
1.34 "PRODUCT(S)" shall mean any human pharmaceutical product containing
a Compound as an API for use in the Field.
1.35 "RECIPIENT" shall mean the Party receiving or otherwise obtaining
Confidential Information from the Disclosing Party.
1.36 "REGION" shall mean North America, Europe, Japan or Rest of
Territory.
1.37 "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.
1.38 "REGULATORY APPROVAL" shall mean any approval(s), registrations or
authorizations of the relevant Regulatory Authority necessary for the marketing
and sale of Product in any country, territory or union in the Territory.
1.39 "REPRESENTATIVES" is defined in Section 12.2.
1.40 "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.
1.41 "REST OF TERRITORY" shall mean, collectively, all countries and
territories in the Territory except for North America, Europe and Japan.
1.42 "SPECTRUM INDEMNITEES" is defined in Section 14.2.
1.43 "SUBLICENSE MILESTONE PAYMENTS" shall mean any upfront, milestone
and other payments (including any premiums paid in the purchase of securities,
or other
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consideration) made by a sublicensee to Spectrum or its Affiliates, except for
royalty payments that are defined as a percentage of net sales of product,
pursuant to a sublicense of any rights granted by Altair pursuant to this
Agreement.
1.44 "TECHNOLOGY ROYALTY PAYMENTS" is defined in Section 6.3(b).
1.45 "TERRITORY" shall mean, subject to early termination pursuant to
Sections 3.5(a) or 13., all countries and territories in the world.
1.46 "THIRD PARTY" shall mean any person or entity other than Altair,
Spectrum or their respective Affiliates.
1.47 "THIRD PARTY OFFER" is defined in Section 5.3.
1.48 "TOTAL SUPPLY PRICE" shall mean total actual cost of supply of API
to Spectrum including all items of Manufacturing Cost, supplier's profit and any
other charges to be paid by Spectrum for supply of API.
1.49 "TRADEMARK" shall mean the trademark RenaZorb(TM).
1.50 "TRADE SECRETS" shall mean, to the extent within the scope of the
license grants made herein and necessary for the use, manufacture, sale and
importation of Products, and the manufacture of Compounds, 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.
1.51 "UNITED STATES" or "U.S." shall mean the United States of America,
its territories and possessions.
ARTICLE 2.
GRANT OF RIGHTS
2.1 GRANT OF LICENSE RIGHTS TO SPECTRUM IN THE TERRITORY. Subject to the
terms and conditions of this Agreement, including Altair's reservation of rights
set forth in Section 2.3, Altair hereby grants to Spectrum, and Spectrum hereby
accepts, an exclusive (even as to Altair), royalty-bearing license (with the
right to sublicense in accordance with Section 2.2), under the Patents,
Trademarks, Know-How and Trade Secrets to (a) use, have used, sell, have sold,
offer to sell, import and have imported, make or have made Products in the Field
in the Territory and (b) manufacture Compounds for use in the Field in the
Territory.
2.2 SUBLICENSE OF SPECTRUM'S RIGHTS. This license includes the right of
Spectrum to grant sublicenses to Affiliates and Third Parties under the licenses
and rights set forth in this Article 2, provided that: (a) the execution of a
sublicense agreement with any Affiliate or Third Party shall not in any way
diminish, reduce or eliminate any of
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Spectrum's obligations under this Agreement, and Spectrum shall remain primarily
liable for all such obligations; (b) prior to granting any sublicense, Spectrum
shall notify Altair of its proposed sublicense, including the name of the
proposed sublicensee and the rights to be sublicensed; (c) with respect to
sublicensees which are not pharmaceutical companies which sell products which
are competitive with products being sold or developed by Altair, Spectrum shall
obtain Altair's written approval prior to executing such sublicense, such
approval shall not be unreasonably withheld; and (d) Spectrum shall require and
cause each Affiliate sublicensee and Third Party sublicensee to agree in writing
in its sublicense to be bound by and comply with all of the provisions and
limitations of this Agreement applicable to Spectrum that are applicable to the
rights sublicensed. In the case that Spectrum grants sublicenses hereunder,
Spectrum always shall secure appropriate covenants, obligations and rights from
any such sublicensee so as to ensure that such sublicensee is also required to
comply with Spectrum's covenants and obligations hereunder, including, but not
limited to, its obligations related to payment of royalties and exercise of
commercially reasonable efforts to develop and market products, to the extent
that Spectrum shall not be performing such covenants and obligations. Within
twenty (20) business days after executing each such sublicense, Spectrum shall
notify Altair of the execution of such sublicense and shall, upon Altair's
written request, promptly deliver to Altair a true and complete copy of any
sublicense hereunder.
2.3 ALTAIR RESERVATION OF RIGHTS. Notwithstanding anything to the contrary
in this Agreement, Altair expressly reserves the right for itself, to use and
exploit Altair's Patents, Trademarks, Know-How and Trade Secrets for all uses,
indications and formulations outside of the Field.
ARTICLE 3.
PRODUCT DEVELOPMENT AND COMMERCIALIZATION
3.1 JOINT DEVELOPMENT COMMITTEE
(a) Representatives. Within thirty (30) days after the Effective
Date, the Parties shall form a joint development committee ("Joint Development
Committee" or "JDC") that shall consist of up to two (2) representatives each of
Altair and Spectrum, provided that the number of representatives of each of
Altair and Spectrum shall be equal at all times. A Party's representatives on
the JDC may be employees or consultants of, or other individuals that are
contractually bound to, such Party, and that agree to be bound by the terms of
confidentiality and other pertinent provisions of this Agreement. Each Party
shall retain the right to change its representatives to the JDC from time to
time, upon prior written notice to the other Party, or to appoint one or more
substitutes to serve in the place of an absent member(s).
(b) Responsibilities. The JDC shall be the forum for exchange of
information on Spectrum's Product development and commercialization activities
(including pre- and post-Launch, pre-clinical and clinical studies, regulatory
activities, and Product Registration activities). The JDC's decision-making
authority shall be limited to pre-clinical Compound and Product development
matters only. More specifically, the JDC shall (i) discuss reports made by
Spectrum pursuant to Section
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3.5(b); (ii) manage and oversee the pre-clinical development of Compounds and
Products in the Field, including, (A) overseeing and reviewing the pre-clinical
development efforts of the Parties in performing their respective activities
pursuant to this Agreement and (B) reviewing and approving the pre-clinical
development matters in the Development Plan (as defined below), and any proposed
modifications thereto; and, (iii) develop the Supply Criteria for API as set
forth in Section 5.1.
(c) Meetings. The JDC shall meet as often as necessary, but no less
than once every three to four months. Initially, it may be necessary to meet at
least once every 3 months or more often. The Parties shall meet at such times
and at such locations as shall be mutually agreed by the Parties; however,
unless otherwise agreed by the Parties, the location of such meetings shall
alternate between Altair's place of business in Reno, Nevada and Spectrum's
place of business in Irvine, California should the Parties mutually agree to
meet in person. Meetings of the JDC may be held in person, by teleconference or
by videoconference. At least one (1) representative of each Party participating
in a meeting shall constitute a quorum. All decisions of the JDC related to
pre-clinical development shall be made by unanimous vote of the Parties, with
each Party to have one vote. At the invitation of either Party, employees,
consultants and other individuals that are involved in the pre-clinical
development of Products may attend JDC meetings as non-voting participants;
provided that, such employees, consultants and other individuals shall be under
obligations of confidentiality and non-use that are at least as stringent as
those set forth in this Agreement. In the event that an urgent pre-clinical
development matter requires a decision by the JDC, the JDC members may discuss
such matter and work to reach consensus without convening a JDC meeting. Each
Party shall be responsible for bearing its own expenses, and the expenses of its
representatives, in connection with JDC meeting participation.
(d) Issue Resolution. The members of the JDC shall attempt in good
faith to reach consensus on any pre-clinical development issues presented to, or
considered by it. In the event that the JDC is unable to reach a unanimous
decision regarding an issue considered by it, then the JDC shall refer the issue
to the Chief Executive Officer of each Party, who shall meet as soon as possible
but no later than thirty (30) days after such referral, to discuss the matter in
a good faith attempt to resolve the issue in a commercially reasonable manner.
If the Parties are unable to resolve the issue, then the Chief Executive Officer
of Spectrum shall decide the matter.
3.2 DEVELOPMENT EFFORTS
(a) Responsibilities of Altair. If so requested by Spectrum, Altair
shall use Commercially Reasonable Efforts to assist Spectrum in the pre-clinical
development of Compounds and Products, including pre-clinical development
relating to chemistry, manufacturing and controls (CMC), in accordance with the
terms set forth in the Development Plan. In addition to the payments set forth
in Sections 6.1, 6.2 and 6.3 and any payments pursuant to Article 5, Spectrum
shall bear all reasonable costs and expenses in connection with Altair's
assistance pursuant to this Section 3.2(a). Such reasonable costs and expenses
shall be approved in advance by Spectrum. Notwithstanding the above, and except
for work performed under Section 3.3, Spectrum
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shall not be responsible for the cost of any work required by Altair to meet the
quality standards of API necessary to obtain and maintain Regulatory Approval
and the other criteria developed in accordance with Section 5.1 to supply the
API to Spectrum.
(b) Responsibilities of Spectrum. All activities relating to the
development and commercialization of Products shall be undertaken at Spectrum's
sole responsibility, 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 Product; (iv) all activities relating to any regulatory filings,
registrations, applications and Regulatory Approvals relating to any of the
foregoing; and (v) subject to Article 5, all activities relating to the
manufacture and supply of Compound and Products. Except for any such regulatory
items which apply to Altair's manufacture of API pursuant to Article 5, Spectrum
shall own all regulatory filings, registrations, applications and Regulatory
Approvals relating to Products.
3.3 DEVELOPMENT PLAN. Within *** after the Effective Date, Spectrum will
prepare and submit to the JDC for its review (and JDC's approval with respect to
pre-clinical development matters), a written Development Plan ("Development
Plan"). Such plan shall set forth (a) Spectrum's plans, and the timeline
therefore, for Product development activities (including pre-clinical and
clinical studies, and regulatory activities) to be conducted by Spectrum in
support of Regulatory Approval of Products throughout the Territory and (b) an
outline of the pre-clinical development assistance to be provided by Altair
pursuant to Section 3.2(a) and an estimated budget and payment schedule for such
assistance. The Development Plan shall be subject to modification from time to
time during the Term, provided that any such modification shall be submitted to
the JDC for its review (and JDC's approval with respect to pre-clinical
development matters).
3.4 MARKETING. Prior to the anticipated First Commercial Introduction of a
Product anywhere in the Territory, Spectrum shall discuss with the JDC its
marketing plan for the Product, which shall include Spectrum's plans for and
activities related to advertising, labeling, marketing, promotion, sales and
distribution of such Product throughout the Territory. The marketing plan shall
be subject to modification from time to time by Spectrum during the Term, any
such modifications to be provided by Spectrum to the JDC for its comments.
Spectrum shall consider in good faith any comments made by the JDC in response
to such modifications to the marketing plan.
3.5 SPECTRUM'S DILIGENCE OBLIGATIONS
(a) Spectrum shall use Commercially Reasonable Efforts to develop
and commercialize one or more Products and to introduce one or more Products in
the Field and in the Territory. In the event that Spectrum fails to meet its
diligence obligations herein with respect to a certain country, in accordance
with the provisions and requirements of Section 13.3, for a material breach of
this provision, Altair shall have the
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right, but not the obligation, to terminate this Agreement with respect to that
country, and such country shall be automatically removed from the Territory.
(b) Spectrum shall obtain Regulatory Approvals throughout the
Territory, and shall regularly report (no less than once every ***) to the JDC
with respect to Spectrum's Product formulation development (including all
ingredients used or planned to be used in the Product) and regarding efforts and
activities in connection with the the Development Plan and the marketing of the
Product.
(c) In the event that Spectrum fails to: (i) *** within *** of the
Effective Date; and (ii) *** within *** of the Effective Date, then Altair shall
have the right, but not the obligation, to terminate this Agreement in whole;
provided that, the JDC shall regularly review these milestones and shall have
the authority to change them should scientific and/or regulatory circumstances
warrant such changes. Any modifications of these milestones by the JDC shall be
subject to the procedures set forth in Section 3.1, including Section 3.1(d) for
issue resolution.
3.6 STRATEGIC ALLIANCE. The Parties shall negotiate in good faith to
establish a joint development program for the development of TiNano Spheres(TM)
for delivery of certain Spectrum compounds in certain human pharmaceutical
applications.
ARTICLE 4.
DATA AND INFORMATION; REGULATORY MATTERS
4.1 REGULATORY APPROVAL. Spectrum shall be responsible, at its expense,
for (i) preparing and filing all Investigational New Drug Applications (INDs)
and NDAs pertaining to the Product in the Field throughout the Territory (ii)
all activities necessary or appropriate to perform prior to filing such INDs and
NDAs, (iii) all activities related to obtaining approval(s) of such 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.
4.2 COMMUNICATIONS WITH REGULATORY AUTHORITIES. Spectrum shall keep Altair
and the JDC advised as to all material regulatory actions, issues and affairs in
the Territory, and shall provide Altair with copies of material official
regulatory actions and decisions.
4.3 COMPLIANCE WITH REGULATORY STANDARDS; ADVERSE EVENTS; POST-MARKETING
SURVEILLANCE. 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 Products throughout the Territory.
Spectrum shall consult with Altair with respect to all investigations and
reports of adverse drug reactions and responses to Regulatory Authorities. Each
Party shall promptly deliver to the other all correspondence that it receives
from Regulatory Authorities relating to the safety of Product, except for
procedural, non-substantive communications.
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4.4 PRODUCT COMPLAINTS; PRODUCT RECALL
(a) Product Complaints. Spectrum shall have sole control over the
response to all material complaints regarding Product in the Territory. Altair
shall promptly refer any Product complaints in the Territory of which it becomes
aware to Spectrum for Spectrum's response. The Parties shall promptly provide to
each other copies of all relevant documentation and information regarding any
such Product complaints.
(b) Product Recall. If either Spectrum or Altair discovers or
becomes aware of any fact, condition, circumstance or event (whether actual or
potential) concerning or related to Product that may reasonably require recall
or market withdrawal of Product or a "Dear Doctor" letter relating to Product,
such Party shall communicate such fact, condition, circumstance or event
promptly to the other Party. In the event (but only in the event) (i) any
governmental agency or Regulatory Authority issues a request, directive or order
that Product be recalled, (ii) a court of competent jurisdiction orders that
Product be recalled or (iii) Spectrum reasonably determines that Product should
be recalled or withdrawn from the market or that a "Dear Doctor" letter should
be sent relating to use of 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, except where such remedial action
arose out of the failure of any API supplied by Altair to Spectrum under this
Agreement and any related supply agreement between Altair and Spectrum to meet
the API specifications set forth in such agreement, in which case the
responsibility for costs shall be determined on a case by case basis depending
on the comparative negligence of the Parties.
ARTICLE 5.
SUPPLY OF API
5.1 SUPPLY CRITERIA. Within *** of the Effective Date, the JDC shall meet
to develop criteria for the supply of API necessary to support the
commercialization of Products (hereinafter "Supply Criteria"). Such Supply
Criteria shall include quantities of API (including time needed for the
manufacture of such API) necessary to support projected development, performance
and quality standards for such API (including, adherence to specifications and
full compliance to applicable Regulatory Authorities' regulations and guidelines
and quality standards for production processes such as cGMP), timelines to begin
manufacture of commercial quantities of API and manufacturing capacity. Such
Supply Criteria shall be determined by the JDC in accordance with the provisions
of Section 3.1 and shall serve as the basis for developing supply agreements as
set forth below.
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5.2 RIGHT OF FIRST NEGOTIATION. At any time during the Term, if Spectrum
seeks to manufacture API, by itself, or through its Affiliates or any Third
Party, Altair shall have the right to negotiate an agreement with Spectrum to be
the exclusive supplier, on a Region-by-Region basis, of Spectrum's requirements
for API; provided that Altair is able to meet the quality standards of API
necessary to obtain and maintain Regulatory Approval in such Region and the
other Supply Criteria developed in accordance with Section 5.1. In addition, for
those Regions in which Altair proposes to supply API, it shall in good faith use
Commercially Reasonable Efforts to manufacture cGMP compliant API. In such
event, Spectrum shall first notify Altair in writing of its intention to seek a
supply of API. For a period of ninety (90) days from Altair's receipt of
Spectrum's written notice, Spectrum and Altair shall negotiate in good faith the
terms and conditions of a supply agreement. If, after such 90-day period, the
Parties are unable to agree to the terms of such supply agreement:
(a) Within thirty (30) days, Altair shall provide to Spectrum its
final offer with respect to such supply agreement, terms of which shall
demonstrate compliance with the Supply Criteria and shall include: the Region(s)
to which its offer applies and the Total Supply Price for API, subject to
Section 5.5 below; and
(b) Spectrum shall be free (subject to Section 5.3) to negotiate in
good faith a supply agreement with any Third Party, the terms of which shall
address the same terms as those in Altair's final offer (i.e., the Supply
Criteria, the applicable Region(s) and Total Supply Price).
In the event that Altair declines to supply API for certain Region(s) or
any Regions in the Territory, Spectrum shall be free to negotiate a supply
agreement on any terms with any Third Party for the supply of API for such
Region(s) declined by Altair or for the whole Territory if Altair declines to
supply API in any Region, without regard to Section 5.3.
5.3 RIGHT TO MANUFACTURE.
(a) In the event that Altair demonstrates to the satisfaction of the
JDC, subject to the issue resolution requirements of Section 3.1(d), that it has
met or can meet, the Supply Criteria developed in accordance with Section 5.1
with respect to the Territory or the proposed Regions within the Territory, then
Altair shall have the right to manufacture API in the proposed Territory or
Regions on the terms proposed in its final offer unless: (a) within thirty (30)
days of Altair's final offer, Spectrum receives a bona fide Third Party offer to
manufacture API for any such Region(s) covered by Altair's final offer pursuant
to Section 5.2(a) ("Third Party Offer"); and (b) such Third Party Offer meets
the Supply Criteria; and (c) such Third Party Offer's Total Supply Price is less
than the Total Supply Price in Altair's final offer pursuant to Section 5.2(a).
***
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(b) In the event that the JDC determines, subject to the issue
resolution requirements of Section 3.1(d), that Altair is unable to meet the
Supply Criteria in any Region or the Territory, then Spectrum shall be free to
enter into a supply agreement with any Third Party for supply of Compound in any
such Region or the Territory. For the avoidance of doubt, this Section 5.3 shall
not apply to a Third Party offer to manufacture API for the Region(s) or the
Territory for which Altair declines to supply API.
5.4 OWNERSHIP OF MANUFACTURING DATA. In the event that Altair is the
exclusive supplier of API to Spectrum for the Territory, Altair shall solely own
all data, results and other information relating to the manufacture of API.
However, Altair shall share copies of all such data, results and other
information with Spectrum.
5.5 ***
ARTICLE 6.
MILESTONE AND ROYALTY PAYMENTS
6.1 UPFRONT AND MILESTONE PAYMENTS. As consideration for the license
rights granted to Spectrum under Article 2, Spectrum shall pay to Altair the
following amounts, (each of which shall be payable only once per Product, unless
expressed otherwise below) each within thirty (30) days of the applicable events
set forth below, in accordance with the terms and conditions of this Article 6
(except as set forth in Section 6.2, under no circumstances shall such amounts,
once paid, be refundable or creditable against any other payments):
(a) Upfront payment on the Effective Date: (i) Two hundred thousand
dollars ($200,000) to purchase common shares of Altair Nanotechnologies, Inc. or
its successor, subject to Section 10.2, at a 100% premium to the Current Market
Price as of the Effective Date; and (ii) One hundred thousand (100,000) shares
of common stock of Spectrum, subject to Section 10.2;
(b) Upon demonstration of satisfactory ***. One hundred thousand
(100,000) shares of common stock of Spectrum, having the same restrictions as
those shares paid by Spectrum pursuant to Section 6.1(a), as of the date of the
report, deemed necessary by the Parties for purposes of FDA registration, of
animal testing demonstrating ***. The demonstration study for this milestone
shall be designed by Altair in consultation with Spectrum and shall be conducted
at Spectrum's expense by an independent laboratory selected by Altair. In the
event that the Parties can not agree, taking into account the experimental
margin of error, whether this milestone has been met as to the similarity of the
results, or if the Parties agree that ***. Within a reasonable time after such
consultations, Spectrum shall notify Altair whether it wishes to continue with
development of Product under this Agreement despite ***. Upon such notice that
it intends to continue developing Product, the milestone will be deemed met, and
the
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payment shall become due and payable. If Spectrum does not intend to continue
such development, this Agreement shall be deemed terminated pursuant to Section
13.2.
(c) Upon *** in a Phase III Trial of a Product: (i) *** to purchase
common shares of Altair Nanotechnologies, Inc., or its successor, subject to
Section 10.2, at a 100% premium to the Current Market Price as of the date of
*** in a Phase III Trial of a Product or (ii) *** in the event that Altair
Nanotechnologies, Inc.'s, or its successor's, common shares is not publicly
traded on the date of such milestone event;
(d) Upon the acceptance of an NDA for a Product by the FDA: (i) ***
to purchase common shares of Altair Nanotechnologies, Inc., or its successor,
subject to Section 10.2, at a 50% premium to the Current Market Price of Altair
Nanotechnologies, Inc.'s common shares as of the date of the acceptance of an
NDA for a Product in the United States or (ii) *** in the event that Altair
Nanotechnologies, Inc.'s, or its successor's, common shares is not publicly
traded on the date of such milestone event;
(e) Upon Obtaining NDA Approval by the FDA: ***
(f) Upon Obtaining NDA approval by the EMEA ***
(g) Upon Obtaining NDA approval by the MHLW: ***
(h) Milestones based on annual, Territory-wide Net Sales: Except as
set forth in Section 6.2, for the avoidance of doubt, the following milestone
payments shall not be creditable against any other milestone payments
hereunder:
(i) Upon *** of annual Net Sales: ***
(ii) Upon *** of annual Net Sales: ***
(iii) Upon *** of annual Net Sales: ***
(iv) Upon *** of annual Net Sales: ***
(v) Upon *** of annual Net Sales: ***
Spectrum shall notify Altair of the achievement of each of the milestone
events set forth in subsections (b) through (g) of this Section 6.1 within the
payment timeline corresponding to the milestone event set forth above.
6.2 SUBLICENSE MILESTONE PAYMENTS. Spectrum or its Affiliates, as
applicable, shall pay to Altair a non-refundable, non-creditable payment of ***
of all Sublicense Milestone Payments; provided that, in the event that any
Sublicense Milestone Payments are due and owing on account of the attainment of
a sublicense milestone event that is the same as any of those set forth in
Section 6.1, then the amount of such Sublicense Milestone Payment to Altair
hereunder shall be *** of the difference between the milestone amount under
Section 6.1 and the Sublicense Milestone Payment for the same
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event under the provisions of the sublicense.
6.3 INTELLECTUAL PROPERTY ROYALTY PAYMENTS
(a) Patent Royalty Rate; Reports. On a quarterly basis, and in
addition to any milestone payments payable to Altair pursuant to Section 6.1,
sublicense payments payable to Altair pursuant to Section 6.2, payments for
Altair's pre-clinical development assistance pursuant to Section 3.2(a), and any
payments for API payable to Altair pursuant to Article 5, 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 6:
(i) *** percent (***%) of Net Sales for Annual
Territory-wide Net Sales of up to ***
(ii) *** percent (***%) of Net Sales for Annual
Territory-wide Net Sales between ***
(iii) *** percent (***%) of Net Sales for Annual
Territory-wide Net Sales exceeding ***
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
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
sublicensees 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 rights and licenses
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 within the country in question ("Technology
Royalty Payment") and continuing until there is generic competition 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
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Royalty Payment is not an extension of Altair's patent rights beyond their term,
but rather is a period determined for the convenience of the Parties in
appropriately compensating Altair for the rights and licenses granted herein
including those rights and licenses under Altair's Know-How, Trade Secrets and
Trademarks.
Technology Royalty Payments shall be made on a quarterly basis and paid
within ninety (90) days after the end of each reporting period. Each Technology
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 Technology 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 Technology Royalty
Payments and reports related to Net Sales by Spectrum's Affiliates and its
sublicensees shall be made to Altair by Spectrum with (or as a part of)
Spectrum's own payments and reports.
(c) Reduction for Third Party Royalty Obligations. If it is
necessary for Spectrum to acquire and pay for one or more royalty-bearing
licenses from one or more Third Party(ies) in order to fully exercise the
license rights granted by Altair hereunder such that it is necessary for
Spectrum to pay royalties to such Third Party(ies), the royalties owed to Altair
under Section 6.3 shall be reduced by *** of the amount of such Third Party
royalties actually paid by Spectrum; ***
6.4 RECORDS AND EXAMINATION
(a) Records. Spectrum and its Affiliates shall keep full, true and
accurate books of account and supporting data and records, and shall cause its
sublicensees to do the same, containing all particulars that may be necessary
for the purpose of calculating and verifying Product sales, Net Sales, and
royalty obligations under this Agreement, on a Product-by-Product and
country-by-country basis for at least three (3) Spectrum fiscal years following
the end of the Spectrum fiscal year to which they pertain, for examination in
accordance with the provisions of Section 6.5(b).
(b) Examination. If Altair disagrees with the reports provided by
Spectrum, pursuant to Section 6.3, with reasonable justification for such
disagreement, then upon reasonable written notice to Spectrum, a certified
public accountant designated by Altair and reasonably acceptable to Spectrum
shall have the right to audit such records of Spectrum and its Affiliates and to
review the terms of any sublicenses granted by Spectrum, in order to confirm the
accuracy and completeness of all such reports and all such payments. Altair
shall bear all costs and expenses incurred in connection with any such audit.
Such examination shall be made during regular business hours and upon at least
thirty (30) days prior written notice. After review of the accountant's
examination report, Spectrum shall promptly pay any uncontested, understated
amounts. Any overpayment shall be promptly refunded or shall be fully creditable
against amounts
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payable in subsequent payment periods, at Spectrum's election. Spectrum shall
pay contested, understated amounts, if any, that are due promptly after the
dispute is resolved. If Altair's accountant reasonably determines that Royalty
Payments under this Agreement have been, for any four (4) consecutive Reporting
Periods in total, understated by more than ***, Spectrum shall pay the
out-of-pocket costs of the examination. The Parties agree that all Spectrum and
its Affiliates information subject to examination under this Section 6.4(b) may
only be used by Altair for purposes germane to this Section 6.4(b). Altair shall
retain and cause its accountant to retain all such information in confidence.
6.5 MODE OF PAYMENT; FOREIGN EXCHANGE. All upfront and milestone payments,
Royalty Payments, Minimum Annual Royalties and payments for the purchase of API
that are payable by Spectrum under this Agreement shall be paid in Dollars to
Altair via wire transfer of immediately available funds, or by check if
requested by Altair, and shall be made where directed by Altair from time to
time. For the purpose of computing Net Sales in a currency other than Dollars,
such currency shall be converted into Dollars using the average conversion rate
for the relevant period as reported by The Wall Street Journal on the last
Business Day of the applicable Reporting Period.
6.6 TAXES. Each Party shall: comply with applicable tax authority
guidelines regarding filing and reporting for income tax purposes, discuss with
each other applicable tax provisions to this Agreement and reasonably cooperate
with each other in obtaining certain desired tax treatments. Neither Party shall
treat its relationship with the other Party under this Agreement as a
partnership or as a pass through entity for tax purposes. The Parties agree that
any taxes that Spectrum is required by law to withhold from amounts payable to
Altair under this Agreement (whether under this Article 6 or otherwise) shall be
deducted by Spectrum from the amounts paid to Altair hereunder at the rate(s)
required by applicable law, and shall be promptly paid to the appropriate
governmental authority on behalf of Altair. Spectrum shall promptly provide to
Altair receipts from the government or taxing authority evidencing payment of
such taxes, if available, or other written proof of payment if official receipts
are not available, and shall provide reasonable assistance to Altair to obtain
tax credits therefore.
6.7 INTEREST. All payments not made by Spectrum when due shall bear
interest, calculated from the date such payment was due, at a rate per annum
equal to the lesser of: (a) two percent (2%) over the prime rate of interest as
published in the weekly Federal Reserve H.15 Bulletin, or any successor bulletin
thereto or (b) the highest rate permitted by applicable law.
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ARTICLE 7.
TRADEMARKS
7.1 TRADEMARKS. Other than RenaZorb(TM), all trademarks used in connection
with each Product shall be owned by Spectrum. The development, creation,
registration, maintenance and defense of any trademark(s) other than
RenaZorb(TM) shall be at Spectrum's expense.
7.2 COOPERATION; ENFORCEMENT OF TRADEMARKS. Altair shall, upon Spectrum's
request, cooperate with Spectrum in any action necessary or desirable to protect
the trademark(s) used or proposed to be used in connection with a Product.
Spectrum shall promptly notify Altair of any apparent infringement by a Third
Party of the Trademark. Spectrum shall also have the right, but not the
obligation, to enforce the Trademark, after notification to Altair and at
Spectrum's risk and expense (including, without limitation, in actions brought
under the Xxxxxx Act in the U.S. and in actions based on comparative
advertising, commercial libel or similar claims in other countries of the
Territory). In any such case, Spectrum shall solicit the participation and views
of Altair during each stage of the action and keep Altair fully informed with an
opportunity to participate in the decision-making process. Spectrum may not
settle or compromise such case without the prior written consent of Altair. In
any such case, Altair shall be entitled, at its own expense, to join as a party
in pursuing enforcement if legally permissible. Should Altair's direct
participation in the legal proceedings be indispensable, Spectrum shall be
entitled to request Altair, at Spectrum's expense, to pursue remedies (which
request Altair shall not unreasonably refuse). On an ongoing basis, upon
Altair's reasonable request, Spectrum shall provide Altair with copies of all
relevant papers, pleadings, correspondence and other documentation in Spectrum's
possession or control relating to the registration, maintenance or enforcement
of the Trademark.
7.3 LABELING, ADVERTISING AND PROMOTIONAL MATERIALS. All necessary
trademark notations, such as "(R)" or "(TM)" shall be used as appropriate with
the Trademark.
7.4 QUALITY CONTROL. Spectrum agrees to use the Trademark only in
connection with the Products. When requested in writing, Spectrum agrees to send
to Altair samples of Product, Product labels, packaging, advertising copy and
promotional materials bearing the Trademark and any other documents which may
permit Altair to determine whether the Trademark uses meet the standards,
specifications and directions approved by Altair.
ARTICLE 8.
IMPROVEMENTS
8.1 DISCLOSURE OF IMPROVEMENTS. Each Party shall promptly and fully
disclose to the other Party any and all Improvements. Such disclosure shall
provide sufficient details regarding the Improvement to enable the Parties to
properly evaluate the inventorship of such Improvement under the U.S. patent
laws.
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8.2 OWNERSHIP OF IMPROVEMENTS
(a) Any Improvement that primarily pertains to the chemistry, morphology,
physical characteristics, etc. of the Compounds (including any modifications
thereto) shall be solely owned by Altair, regardless of which Party conceived,
developed or reduced to practice such Improvement. Any Improvement that
primarily pertains to Product manufacture, Product formulation or Product
delivery shall be solely owned by Spectrum, regardless of which Party conceived,
developed or reduced to practice such Improvement.
(b) Subject to Section 9.1(c), any patent applications with respect to
Improvements which are solely owned by one Party as determined in subsection
8.2(a) and which are considered necessary in the reasonable legal and business
judgment of the owning Party will be prepared and filed by, and at the sole
expense of, such owning Party. Each Party hereby agrees to provide the other
with reasonable assistance in assigning (if applicable), preparing, filing,
prosecuting and maintaining such patent applications related to such
Improvements. Each Party shall own and maintain, at its sole expense, any
trademarks associated with the Improvements owned by such Party.
8.3 GRANT OF LICENSE TO IMPROVEMENTS. Altair hereby grants to Spectrum a
non-exclusive, perpetual, worldwide, royalty-free license to use the
Improvements owned by Altair pursuant to subsection 8.2(a) in the Field.
Spectrum hereby grants to Altair a non-exclusive, perpetual, worldwide,
royalty-free license to use the Improvements owned by Spectrum pursuant to
subsection 8.2(a) outside of the Field. During the Term of this Agreement, both
Parties shall notify the other if it intends to grant a license to any such
Improvements to a Third Party. If, after receiving such notice, the other Party
notifies the Party intending to grant the license that such grant would be
competitive to its Products or products, then such third party license shall not
be granted during the Term of this Agreement.
8.4 LICENSE FROM A THIRD PARTY. In the event that commercialization of a
Product, including a Product incorporating any Improvement, requires a license
from a Third Party, Spectrum shall consult with Altair regarding any such Third
Party license and the terms thereof. Altair may elect, where possible, to be a
licensee outside of the Field. Spectrum shall use its good faith effort to
assist Altair in obtaining such rights for Altair outside of the Field.
ARTICLE 9.
MAINTENANCE OF PATENT; PATENT INFRINGEMENT
9.1 PATENT PROSECUTION AND MAINTENANCE. *** Altair shall maintain, in its
responsibility and at its expense, those Patents which include claims outside
the Field and Spectrum shall maintain, in its responsibility and at its expense,
those Patents which solely relate to the Field.
(a) Outside the Field. For Patents which include claims related to
uses outside the Field, Altair shall direct and control the preparation, filing,
prosecution and
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with respect to the omitted portions.
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maintenance of all such Patents in the Territory. Altair shall, in its sole
discretion and expense, select outside patent counsel to carry out such
activities. To the extent the patents or applications relate to any uses within
the Field, Altair shall consult with Spectrum and with the JDC with regard to
the preparation, filing, prosecution and/or maintenance of the Patents and the
scope of claims contained therein. Notwithstanding the preceding sentence,
however, Altair shall in all events have final decision-making authority with
respect to the preparation, filing, prosecution and/or maintenance of such
Patents and the scope of claims contained therein. Spectrum shall cooperate
fully with Altair, at Altair's request, in all matters relating to the
preparation, filing, prosecution and/or maintenance of the Patents, including
without limitation, signing any necessary or appropriate documents, providing
written and testimonial evidence, and doing such other acts as Altair may
reasonably require. In the event Altair elects to discontinue or abandon the
prosecution and/or maintenance of any such Patents, Altair shall give Spectrum
at least sixty (60) days' prior written notice of its election to discontinue or
abandon any such Patent during which time Spectrum may elect, in its sole
discretion, to continue and maintain such Patent at its sole cost and expense by
delivery of written notice to Altair. If Spectrum does not notify Altair in
writing during such sixty (60) day period that it is exercising such rights, the
Patent shall be deemed abandoned and neither Altair nor Spectrum shall have any
further responsibility for any such abandoned Patent.
(b) Solely in the Field. Spectrum shall direct and control the
preparation, filing, prosecution and maintenance of all Patents in the Territory
which do not include claims related to uses outside of the Field. Spectrum
shall, in its sole discretion and expense, select outside patent counsel to
carry out such activities. Notwithstanding the foregoing, Spectrum shall consult
with Altair and with the JDC with regard to the preparation, filing, prosecution
and/or maintenance of the Patents and the scope of claims contained therein.
Notwithstanding the preceding sentence, however, Spectrum shall in all events
have final decision-making authority with respect to the preparation, filing,
prosecution and/or maintenance of such Patents and the scope of claims contained
therein. Altair shall cooperate fully with Spectrum, at Spectrum's request, in
all matters relating to the preparation, filing, prosecution and/or maintenance
of the Patents, including without limitation, signing any necessary or
appropriate documents, providing written and testimonial evidence, and doing
such other acts as Spectrum may reasonably require. In the event Spectrum elects
to discontinue or abandon the prosecution and/or maintenance of any such
Patents, such Patent shall at that time be excluded from the definition of
Patents and from the scope of the licenses granted under this Agreement.
Spectrum shall give Altair at least sixty (60) days' prior written notice of its
election to discontinue or abandon any such Patent during which time Altair may
elect, in its sole discretion, to continue and maintain such Patent at its sole
cost and expense by delivery of written notice to Spectrum. If Altair does not
notify Spectrum in writing during such sixty (60) day period that it is
exercising such rights, the Patent shall be deemed abandoned and neither Altair
nor Spectrum shall have any further responsibility for any such abandoned
Patent. If Altair does not exercise its rights to maintain such Patent, and
Spectrum later elects to continue and maintain such Patent, then the Patent
shall remain within the definition of Patents and licenses hereunder.
(c) Joint Inventions. For purposes of this Agreement all inventions
relating to API, the Compounds or Products are Improvements unless otherwise
mutually
21
agreed to by the Parties. If the Parties mutually agree that an invention is not
an Improvement which ownership is governed by Section 8.2, all other inventions
jointly created, generated, conceived, made, developed, or reduced to practice
jointly by the Parties as of the result of the work performed under this
Agreement shall be the joint property of Spectrum and Altair. Spectrum shall
file, prosecute and maintain patents to any joint inventions, as determined by
the U.S. patent laws. The costs and expenses of such joint inventions shall be
borne by Spectrum. If Spectrum no longer desires to retain responsibility for
such joint invention or for such joint invention in a particular country,
Spectrum will provide at least sixty (60) days written notice to Altair, and
Altair shall have the right, but not the obligation, to assume such
responsibility at its sole cost and expense.
9.2 PATENT INFRINGEMENT BY THIRD PARTY
(a) Notice of Infringement. If, during the Term, either Party
becomes aware of any infringement, threatened infringement or suspected
infringement by any Third Party of any Patent in the Field in the Territory,
such Party shall promptly give written notice to the other Party thereof, with
all available details in its possession.
(b) Spectrum's Right to Pursue Remedies Against Infringement.
Spectrum shall have the first right, but not the obligation, to file suit or
take other action to prevent such infringements of any Patents. To the extent
Spectrum takes such action, Spectrum shall control any such action and may enter
into settlements, stipulated judgments or other arrangements respecting such
infringement, at its own expense; provided, however, that such proposed
settlements, judgments or arrangements shall be subject to Altair's consent, not
to be unreasonably withheld. In the event that Spectrum takes such action,
Spectrum shall indemnify, defend and hold Altair harmless from any costs,
expenses and liabilities respecting the action for such claimed infringement.
Altair shall permit an action to be brought by Spectrum in Altair's name if
required by law. Altair agrees to provide all assistance that Spectrum may
reasonably require in any litigation, including providing written evidence,
deposition and trial testimony, for which Spectrum shall pay to Altair a
reasonable hourly rate of compensation. Any damages or other recovery from an
infringement action undertaken by Spectrum pursuant to this Section 9.2(b) shall
be used (1) first to reimburse Spectrum's legal costs and expenses incurred in
such action, and (2) thereafter apportioned between the Parties as necessary to
return the Parties as nearly as possible to the same relative position they
would have had without the infringement. Spectrum shall promptly notify Altair
in writing of its intention with regard to any such infringement. In the event
that Spectrum elects not to take action against an actual or threatened
infringement, Altair shall have the right to take action against such
infringement, in which case Altair shall (i) pay any and all costs and expenses
incurred in such action, (ii) indemnify, defend and hold Spectrum harmless from
any costs, expenses or liability respecting all such action, and (iii) retain
any and all recovery from such action. Spectrum agrees to provide all assistance
that Altair may reasonably require in any litigation, including providing
written evidence, deposition and trial testimony, for which Altair shall pay to
Spectrum a reasonable hourly rate of compensation.
22
9.3 INFRINGEMENT ACTION BY THIRD PARTIES. If a Third Party makes or
threatens against Spectrum, its Affiliates or sublicensees any claim of
infringement of a right based upon the use of, or arising as a result of the
exercise of the rights and licenses granted hereunder (each an "Alleged
Infringement"), Spectrum shall have the right and obligation to respond to and
defend any and all such Alleged Infringements. Spectrum shall promptly notify
Altair in writing and provide a copy of (i) any claim of Alleged Infringement
filed with a court or governmental authority or (ii) any written notice of an
Alleged Infringement from an attorney or law firm. Altair shall have the right
to jointly manage any such litigation, including the selection of counsel, and
agrees to provide any necessary assistance that Spectrum may reasonably require
in any such defense action. In the event of disagreement between Spectrum and
Altair regarding litigation strategy or other matters pertaining to the
litigation, including the selection of counsel, Spectrum shall have the final
decision after consideration of Altair's position. If the Parties are successful
in defending against the Alleged Infringement, reasonable costs of defense shall
be equally shared between the Parties. Should claims be made directly against
Altair, Altair shall also have the right, at its own expense, to retain counsel
of its choice for its own defense in which case each Party will be responsible
for its own costs and attorney fees. ***
9.4 ***
ARTICLE 10.
REPRESENTATIONS AND WARRANTIES
10.1 REPRESENTATIONS AND WARRANTIES. Each Party hereby represents and
warrants to the other Party as of the Effective Date that:
(a) such Party (i) is duly organized, validly existing and in good
standing under the laws of the jurisdiction where it is organized; (ii) has the
requisite power and authority and the legal right to enter into this Agreement
and to perform its obligations hereunder; and (iii) has taken all necessary
action on its part to authorize the execution and delivery of this Agreement and
the performance of its obligations hereunder;
(b) this Agreement has been duly executed and delivered on behalf of
such Party, and constitutes a legal, valid and binding obligation, enforceable
against such Party in accordance with its terms, except as enforceability may be
limited by bankruptcy, fraudulent conveyance, insolvency, reorganization,
moratorium and other laws relating to or affecting creditors' rights generally
and by general equitable principles;
(c) all necessary consents, approvals and authorizations of all
governmental authorities and other persons required to be obtained by such Party
in connection with this Agreement have been obtained; and
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Securities and Exchange Commission. Confidential treatment has been requested
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(d) the execution and delivery of this Agreement and the performance
of such Party's obligations hereunder, to the present knowledge of the Party,
(i) do not conflict with or violate any requirement of any material law or
regulation of any court, governmental body or administrative or other agency
having authority over it, and (ii) do not conflict with, or constitute default
under, any contractual obligation of such Party.
10.2 ADDITIONAL REPRESENTATIONS IN CONNECTION WITH THE ISSUANCES OF COMMON
SHARES. Notwithstanding the other provisions in this Agreement, and for purposes
of this Section 10.2 only, Altair Nanotechnologies, Inc. shall be considered a
"Party" to the following representations and warranties:
(a) Each Party represents, warrants and covenants that (i) all
common shares, or shares of common stock, as the case may be, that may be issued
to the other Party under Section 6.1 of this Agreement will, upon issuance, be
duly authorized, validly issued, fully paid and nonassessable, will be issued in
compliance with all applicable laws (subject to Section 10.2(i)), and will be
issued without charge to the other Party for any transaction-related tax or
other expenses in connection with such issuance and (ii) Altair
Nanotechnologies, Inc. will at all times have authorized and reserved for
issuance hereunder a sufficient number of common shares to provide for the
issuances contemplated by Section 6.1 of this Agreement.
(b) Each Party confirms that it has been given sufficient access to
information regarding the other and in connection with its decision to purchase
or receive the common shares, or shares of common stock, as the case may be, of
the other Party, including the opportunity to ask questions of, and receive
answers from, persons acting on behalf of the other Party and concerning their
respective financial affairs, prospects and condition.
(c) Spectrum represents and warrants that it is resident in or
otherwise subject to the securities legislation of the United States, and the
purchase by and sale to Spectrum of any common shares of Altair
Nanotechnologies, Inc. has occurred only in the United States.
(d) Altair represents and warrants that (i) it is resident in or
otherwise subject to the securities legislation of the United States, and the
purchase by and sale to Altair of any common stock of Spectrum has occurred only
in the United States; (ii) Altair, by reason of its business or financial
expertise, has the capacity to protect its own interests in connection with its
acquisition of shares of the common stock of Spectrum and (iii) Altair is an
"accredited investor" as defined in Rule 501 of Regulation D of the Securities
Act of 1933, as amended (the "Securities Act").
(e) Each Party represents, warrants and covenants that it shall
acquire the common shares, or shares of common stock, as the case may be, of the
other Party for its own account and not for the account or on behalf of others,
and it is doing so with the intent of retaining the common shares, or shares of
common stock, as the case may be, as an investment and without the current
intent to redistribute the common shares, or shares of common stock, as the case
may be.
24
(f) Spectrum acknowledges that: (i) no securities commission or
similar authority has reviewed or passed on the merits of the Altair
Nanotechnologies, Inc. common shares issuable under this Agreement; (ii) without
limiting the generality of the foregoing, any common shares of Altair
Nanotechnologies, Inc. issued to Spectrum pursuant to Section 6.1 hereof may not
be sold, transferred, hypothecated or otherwise traded in Canada or to or for
the benefit of a Canadian resident until the date which is four months and one
day following the issuance thereof and the certificate evidencing such common
shares may bear a legend to that effect; (iii) there is no government or other
insurance covering such common shares of Altair Nanotechnologies, Inc.; (iv)
there are risks associated with the acquisition of the common shares of Altair
Nanotechnologies, Inc.; and (v) there will be restrictions under Canadian and
provincial securities laws on Spectrum's ability to resell the common shares of
Altair Nanotechnologies, Inc.
(g) Altair acknowledges that: (i) no securities commission or
similar authority has reviewed or passed on the merits of the shares of Spectrum
common stock issuable under this Agreement; (ii) there is no government or other
insurance covering such common shares of Altair Nanotechnologies, Inc.; and
(iii) there are risks associated with the acquisition of shares of the common
stock of Spectrum, including without limitation those described in Spectrum's
filings with the Securities and Exchange Commission.
(h) Each Party acknowledges that (i) it must and shall bear the
economic risk of holding the common shares, or shares of common stock, as the
case may be, of the other Party for an indefinite period of time because at the
time such shares are issued they will not have been registered under the
Securities Act or any other securities law and, therefore, cannot be sold unless
they are subsequently registered under applicable national, federal, provincial
and state securities laws or an exemption from such registration is available;
(ii) the shares may not be resold or transferred on the official stock transfer
records of the other Party without furnishing to such Party an opinion of
counsel reasonably acceptable to the other Party that such sale or transfer of
the shares will not violate the registration provisions of applicable national,
federal, provincial and state securities laws; and (iii) certificates
representing the shares shall have endorsed on them a restrictive legend to this
effect.
(i) Each Party acknowledges that the other Party is relying on the
representations, warranties, covenants and acknowledgments in this Section 10.2
to ensure that any common shares, or shares of common stock, as the case may be,
issued under the terms of this Agreement can be issued in reliance on exemptions
from applicable registration and prospectus requirements under Canadian
securities laws and exemptions from registration requirements under United
States federal and state securities laws.
10.3 ADDITIONAL REPRESENTATIONS OF ALTAIR
(a) Altair hereby represents and warrants that as of the Effective
Date: (i) it has not previously granted any right, license or interest in or to
the Patents, Trade
25
Secrets, or Know-How, or any portion thereof, inconsistent with the rights
granted to Spectrum herein; and (ii) to the best of its present knowledge, there
are no material adverse proceedings, claims or actions pending or threatened
relating to the Patents which would materially interfere with Altair's
performance of its obligations or power to make the grants and covenants
hereunder, or Spectrum's use of the Patents.
(b) To Altair's present knowledge, as of the Effective Date, all
patent or patent applications within the Patents are in compliance with all
legal requirements in the Territory regarding the filing, examination, and
maintenance fees. The above shall not apply to a requirement that, if not
satisfied, would not result in a revocation or lapse or otherwise adversely
affect the enforceability of the patents in question. To Altair's present
knowledge, Altair has not taken any action or, failed to take any action
(including a failure to disclose material prior art in connection with the
prosecution of any patent), or used or enforced or, failed to use or enforce any
of the patent or patent applications within the Patents in a manner that would
result in the abandonment or unenforceability of any of the patent or patent
applications within the Patents.
(c) As of the Effective Date, to Altair's present knowledge, no
patent or patent applications within the Patents have been or are now involved
in any interference, reissue, reexamination or opposing proceeding in any
jurisdiction within the Territory. To Altair's present knowledge, no such action
has been threatened. To Altair's present knowledge, there is no patent of any
person that claims the same subject matter as is claimed in the patent or patent
applications within the Patents, and Altair is not aware of any prior art that
invalidates any claim in any of the patent or patent applications within the
Patents.
(d) To Altair's present knowledge, Altair owns, or possesses
adequate licenses or other rights to use, all of the Patents, Trade Secrets, and
Know How.
(e) To Altair's present knowledge, the use of the Patents, Trade
Secrets, or Know-How to develop, make, have made, use, sell, offer for sale,
have sold, import and export and commercialize Products in the Field in the
Territory, would not infringe upon, violate or constitute the unauthorized use
of any rights owned or controlled by any Third Party, including any patent of
any Third Party. No litigation is now pending and no notice or other claim has
been received by Altair, (A) alleging that Altair has engaged in any activity or
conduct that infringes upon, violates or constitutes the unauthorized use of the
patents of any Third Party, or (B) challenging the ownership, use, validity or
enforceability of any of the patent or patent applications within the Patents.
(f) To Altair's present knowledge, no Third Party is
misappropriating, infringing, diluting or violating any of the Patents, Trade
Secrets, or Know-How, and no claims for any of the foregoing have been brought
against any Third Party by Altair. Altair has taken reasonable steps in
accordance with normal industry practice to protect all of the Patents, Trade
Secrets, or Know-How.
(g) Altair is the owner of all right, title and interest in and to
all of the Patents. The Patents are free and clear of any and all encumbrances,
covenants,
26
conditions and restrictions or, other adverse claims or interests of any kind or
nature, and Altair has not received any written notice or claim or, any oral
notice or claim, challenging Altair's complete and exclusive ownership of the
Patents or suggesting that any other person has any claim of legal or beneficial
ownership with respect thereto, and there is no agreement, decree, arbitral
award or other provision or contingency which obligates Altair to grant licenses
in the Patents.
10.4 LIMITATIONS ON REPRESENTATIONS AND WARRANTIES. THE LIMITED WARRANTIES
CONTAINED IN SECTIONS 10.1, 10.2 AND 10.3 ARE THE SOLE WARRANTIES GIVEN BY THE
PARTIES HEREUNDER. NEITHER PARTY MAKES ANY IMPLIED WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE, NOR, EXCEPT AS SET FORTH IN THIS ARTICLE
10, ANY WARRANTIES AS TO THE VALIDITY OR ENFORCEABILITY OF ANY PATENTS LICENSED
HEREUNDER, THE NON-INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS OF A THIRD
PARTY, OR THE SAFETY OR EFFICACY OF ANY PRODUCT MADE HEREUNDER NOR ANY
WARRANTIES ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES OR
OTHERWISE, AND ALL OTHER EXPRESS OR IMPLIED REPRESENTATIONS AND WARRANTIES
PROVIDED BY COMMON LAW, STATUTE OR OTHERWISE ARE HEREBY DISCLAIMED BY BOTH
PARTIES. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR
INDIRECT, PUNITIVE, SPECIAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES OF ANY KIND,
INCLUDING LOSS OF PROFITS AND LOSS OR INTERRUPTION OF BUSINESS; PROVIDED THAT
THE FOREGOING PROVISION SHALL NOT BE CONSTRUED TO LIMIT (a) A PARTY'S
INDEMNIFICATION OBLIGATION UNDER THIS AGREEMENT FOR THIRD PARTY CLAIMS WHICH MAY
INCLUDE INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY AND OTHER TYPES OF
DAMAGES; OR (b) DAMAGES ARISING FROM BREACH OF A PARTY'S CONFIDENTIALITY
OBLIGATIONS.
ARTICLE 11.
COVENANTS
11.1 PRESERVATION OF TITLE. Altair shall retain ownership and title to all
Patents licensed hereunder and shall use diligent efforts at least equivalent to
those Altair uses for its other technology of like kind to preserve and maintain
such ownership and title, subject to Spectrum fully performing all of its
obligations under this Agreement.
11.2 NO CONFLICTS. Neither Party shall grant any right, license or
interest in or to the Patents, or any portion thereof, inconsistent with the
rights granted to Spectrum herein. Without the other Party's prior written
consent, neither Party shall enter into any agreement that creates additional
obligations upon the other Party or limits the exercise of the other Party's
rights hereunder or diminishes the other Party's rights hereunder.
27
ARTICLE 12.
CONFIDENTIALITY
The terms of that certain Nondisclosure/nonuse Agreement by and between
Altair Nanotechnologies, Inc. and Spectrum, dated November 3, 2004 (to the
extent such Nondisclosure/nonuse Agreement is not inconsistent to this
Agreement) shall be in addition to the provisions of this Article 12.
12.1 STANDARD OF CARE. Each Party shall keep all Confidential Information
of the other Party in strict confidence and shall not use such Confidential
Information for any purpose other than the purposes of, or as permitted by, this
Agreement. This provision will survive any termination or expiration of the
Agreement. In consideration of disclosure by either Party to the other Party of
Confidential Information in written, oral, graphic, demonstrative or electronic
form pursuant to the terms of this Agreement, the Recipient undertakes, unless
otherwise stipulated herein, (a) to protect and maintain the Disclosing Party's
Confidential Information using the same degree of care as it uses to maintain
the secrecy of its own information of like kind, but in no event less than a
reasonable standard of care; and (b) to use the Disclosing Party's Confidential
Information only to accomplish the purposes of this Agreement.
12.2 NON-DISCLOSURE AND NON-USE. Recipient shall not disclose the
Disclosing Party's Confidential Information, except only to its and its
Affiliates' officers, directors, employees, agents or consultants, to authorized
licensees and sublicensees, to authorized contractors or subcontractors, or to
Regulatory Authorities, in each case only when such person(s) have a need to
know such Confidential Information in furtherance of the objectives of this
Agreement (collectively, the "Representatives"), to the extent necessary to
enable such Representatives to perform a Party's obligations under this
Agreement; provided that prior to such disclosure, such Representatives shall be
bound to Recipient by obligations of non-use and non-disclosure that are similar
to or more stringent than those imposed on Recipient pursuant to this Agreement
and that cover the Confidential Information to be disclosed to such
Representatives. Each Party further agrees to refrain, and to cause its
Representatives to refrain, from directly or indirectly taking any action that
would constitute or facilitate the unauthorized use or disclosure of the
Disclosing Party's Confidential Information.
12.3 EXCEPTIONS. The obligations of confidence, non-use and non-disclosure
set out in this Article 12 shall not apply to information to the extent that:
(a) Such information is, or later becomes, publicly available
through no fault of Recipient or any of Recipient's Representatives; provided
that Confidential Information shall not be deemed to be generally available to
the public merely because some part of such information is embodied in general
disclosures or because individual features, components or combinations thereof
are now or become known to the public; or
(b) Recipient can demonstrate and document that such information was
in its rightful possession, without a restriction on use or disclosure, prior to
receipt of the information from the Disclosing Party (or from an entity acting
on behalf of the Disclosing Party); or
(c) Recipient can demonstrate such information was rightfully
received from a Third Party without any restriction on use or disclosure of such
information; or
28
(d) Recipient can demonstrate by written evidence that such
information was independently developed by Recipient without access to or use,
directly or indirectly, of Confidential Information of the Disclosing Party; or
(e) Such information is required to be disclosed in response to a
valid order from a judicial or administrative authority or in order to file or
prosecute patent applications; provided, however, that Recipient shall: (i)
promptly notify the Disclosing Party of such disclosure requirement, (ii) use
Commercially Reasonable Efforts to limit disclosure to only such authority and
only to the extent required by such order and (iii) make Commercially Reasonable
Efforts to obtain confidential treatment or a protective order for the
disclosure so ordered.
Notwithstanding the foregoing, this Section 12.3 shall not apply to patent
applications or other patent filings prior to final issuance of a corresponding
patent.
12.4 NO MISAPPROPRIATION. Each Party represents that the transfer of
Confidential Information, of intellectual property rights and know-how, and of
rights in Product-related documentation by one Party to the other Party pursuant
to this Agreement shall not, to the actual knowledge of the transferring Party,
misappropriate the proprietary or trade secret information of a Third Party.
12.5 RETURN OF CONFIDENTIAL INFORMATION. Upon the termination or
expiration of this Agreement and the written request of the Disclosing Party,
Recipient shall immediately return to the Disclosing Party or destroy (in
Recipient's sole discretion) all Confidential Information of the Disclosing
Party in whatever form and all copies thereof. Within thirty (30) days after the
date of expiration or termination of this Agreement, the Receiving Party shall
furnish the Disclosing Party with a certificate, duly executed by an officer of
the Receiving Party, confirming that the Receiving Party has complied with its
obligations under this Section 12.5.
ARTICLE 13.
TERM AND TERMINATION
13.1 TERM. The term of this Agreement shall commence on the Effective Date
and shall continue, on a Product-by-Product and country-by-country basis, until
the later to occur of (a) expiration or final rejection without right of appeal
of the last-to-expire Patent that covers such Product in such country; or (b)
*** ("Term"), unless terminated earlier pursuant to Article 13 of this
Agreement.
13.2 UNILATERAL TERMINATION. Spectrum shall have the unilateral right to
terminate this Agreement, in its entirety or on a Product-by-Product or
country-by-country basis, at any time for any reason upon prior written notice
to Altair given at least sixty (60) days prior to the desired date of
termination.
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29
13.3 TERMINATION FOR MATERIAL BREACH. If either Party materially breaches
this Agreement at any time, and fails to cure such breach within one hundred
twenty (120) days of written notice thereof from the non-breaching Party, (which
notice shall describe the breach and shall state the non-breaching Party's
intention to terminate this Agreement if such breach is not cured), the
non-breaching Party shall have the right after such 120-day period, in its
discretion, to terminate this Agreement. Such termination shall be effective
immediately upon the breaching Party's receipt of a notice of termination from
the non-breaching Party, unless the breaching Party can establish that it cured
the breach prior to its receipt of such notice of termination. For purposes of
this Agreement, it is not a "material breach" of this Agreement by Spectrum if
the development of a Product is delayed due to the following: (i) scientific,
medical or technical reasons beyond Spectrum's reasonable control despite its
exercise of Commercially Reasonable Efforts; (ii) an event of Force Majeure; or
(iii) the fault of Altair.
13.4 TERMINATION FOR INSOLVENCY OR BANKRUPTCY. Each Party, in addition to
any other remedies available to it at law or in equity, may, to the extent
permissible under applicable law, terminate this Agreement by written notice to
the other Party in the event the other Party shall:
(a) become insolvent or bankrupt, or become unable financially to
conduct business and perform as contemplated by this Agreement;
(b) make an assignment for the benefit of its creditors pursuant to
a statutory requirement;
(c) appoint a trustee or receiver for itself for all or a
substantial part of its property;
(d) have any case or proceeding commenced or other action taken by
or against itself in bankruptcy that is not dismissed within sixty (60) days of
filing;
(e) seek reorganization, liquidation, dissolution, a winding-up
arrangement, composition or readjustment of its debts or other relief under any
bankruptcy, insolvency, reorganization or other similar act or law of any
jurisdiction, now or hereafter in effect; or
(f) have issued against itself a warrant of attachment, execution,
distraint or similar process against any substantial part of its property, the
issuance of which causes a material adverse effect.
13.5 EFFECTS OF TERMINATION
(a) Rights Upon Expiration. Following the expiration of the Term,
excluding any termination prior to expiration of this Agreement, Spectrum shall
have and retain a perpetual, fully paid-up, non-exclusive license under the
Patents, Know-How, Trade Secrets, and Altair's Improvements, and Altair shall
retain a perpetual, fully paid-up, non-exclusive license to Spectrum's
Improvements. Subject to Altair's rights and
30
licenses to Spectrum's Improvements, Spectrum shall retain all rights and
interest in all materials, inventions, discoveries and know-how (whether or not
patentable or patented) solely generated by Spectrum in the course of performing
research and development activities under the licenses granted in this
Agreement. Other than rights intended to survive expiration, or as otherwise
provided under Section 13.5(e), neither Party shall have any further rights or
obligations upon the expiration of this Agreement.
(b) Rights Upon Termination by Altair Under Sections ***, 13.3 or
13.4 or by Spectrum under Section 13.2. Upon any termination of this Agreement
by Altair under Section ***, 13.3 or 13.4 or by Spectrum under Section 13.2
occurring prior to the normal expiration date of this Agreement, (i) all rights
and licenses granted by Altair to Spectrum shall terminate and revert to Altair;
(ii) Altair shall retain a perpetual, fully paid-up, non-exclusive license to
Spectrum's Improvements; (iii) Spectrum shall return to Altair or destroy at
Altair's option all Know-How and Trade Secrets in Spectrum's possession; and
(iv) Spectrum shall promptly (i.e., within three months of such termination or
expiration) transfer and, to the extent possible, assign to Altair or to an
Altair Affiliate or a Third Party designated by Altair, as Altair may direct,
all pre-clinical, clinical and technical data, information, files and other
materials in the possession or under the control of Spectrum relating to
Compound and Product and the development, Regulatory Approval and
commercialization thereof, and, in the case where Altair is not the manufacturer
of API, Spectrum shall also promptly (i.e., within three months of such
termination or expiration) transfer and, to the extent possible, assign to
Altair or to an Altair Affiliate or a Third Party designated by Altair, as
Altair may direct, any technology Spectrum may have which is necessary or useful
to make the Compound or Product. The foregoing provisions shall also apply to
the partial termination of this Agreement by Spectrum on a Product-by-Product or
country-by-country basis in accordance with Section 13.2, provided, however,
that in such event: (1) only those rights specified in (i) and (iv) above that
solely pertain to the Product and/or country being terminated would revert back
to Altair; (2) only that Know-How and Trade Secrets which solely pertain to the
Product and/or country being terminated would be returned to Altair or destroyed
by Spectrum.
(c) Rights Upon Termination by Spectrum Under Section 13.3. Upon any
termination of this Agreement by Spectrum under Section 13.3 occurring prior to
the normal expiration date of this Agreement, Spectrum shall retain the licenses
granted by Altair to Spectrum hereunder (including the licenses to Altair's
Improvements) for the Term otherwise intended by this Agreement; ***
(d) Rights Upon Termination by Spectrum Under Section 13.4. Upon any
termination of this Agreement by Spectrum under Section 13.4 occurring prior to
the regularly scheduled expiration date of this Agreement, the licenses granted
by Altair to Spectrum up to such date of termination shall convert to a fully
paid-up, exclusive license and Spectrum's obligations under this Agreement shall
terminate; ***
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(e) Payments. Not later than ninety (90) days after the expiration
or termination date of this Agreement, each Party shall pay to the other Party
any amounts that are then due and payable.
13.6 WORK-IN-PROGRESS. Notwithstanding anything in this Agreement to the
contrary, upon any such early termination of the license granted hereunder in
accordance with this Agreement, Spectrum shall be entitled to finish any
work-in-progress and to sell any completed inventory of a Product which remain
on hand as of the date of the termination, so long as Spectrum pays to Altair
the royalties applicable to said subsequent sales in accordance with the terms
and conditions as set forth in this Agreement, provided that no such sales shall
be permitted after the expiration of six (6) months after the date of
termination.
ARTICLE 14.
INDEMNIFICATION
14.1 INDEMNIFICATION BY SPECTRUM. Spectrum shall defend, indemnify and
hold harmless Altair, its Affiliates, its sublicensees and their respective
employees, officers, directors, agents and representatives (the "Altair
Indemnitees") against any and all damages (including for bodily injury, death
and property damage), actions, suits, claims, demands, investigations,
liabilities, penalties and expenses (including reasonable fees and disbursements
of attorneys and consultants) (collectively, a "Loss") arising from or occurring
as a result of a Third-Party's claim, action, suit, judgment or settlement
("Claim") against an Altair Indemnitee to the extent such Loss is based on or
arises out of the (a) clinical testing of Product by Spectrum or its Affiliates;
(b) the manufacture, use, handling labeling, packaging, sale, distribution,
other disposition, importation or exportation of Product, by or on behalf of
Spectrum, its Affiliates, sublicensees or distributors; (c) the administration
of Product to or the use of Product by any individual (including associated
Product liability, including any defect inherent in the Product or the API); (d)
any breach by Spectrum of this Agreement or any of its covenants, agreements,
representations or warranties set forth in this Agreement; or (e) the negligence
or willful misconduct of Spectrum or any Spectrum Indemnitee (as defined in
Section 14.2 below); provided, however, that the foregoing indemnification and
other obligations shall not apply to any Loss to the extent such Loss is caused
by: (i) the failure (undiscoverable by Spectrum in the exercise of ordinary care
applicable to the industry) of any API supplied by Altair to Spectrum pursuant
to this Agreement and any related supply agreement between Altair and Spectrum
to meet the API specifications set forth in such agreement (for the avoidance of
doubt, any Loss resulting from API supplied by Altair in accordance with the API
specifications agreed between Altair and Spectrum shall be subject to Spectrum's
indemnification obligations under this Section 14.1); (ii) a breach by Altair of
this Agreement or any of its covenants, agreements, representations or
warranties set forth in this Agreement; or (iii) the negligence or willful
misconduct of Altair or an Altair Indemnitee.
14.2 INDEMNIFICATION BY ALTAIR. Altair shall defend, indemnify and hold
harmless Spectrum, its Affiliates, its sublicensees and their respective
employees, officers, directors, agents and representatives (the "Spectrum
Indemnitees") against any
32
Loss occurring as a result of a Claim against an Spectrum Indemnitee to the
extent such Loss is based on or arises out of (a) the failure (undiscoverable by
Spectrum in the exercise of ordinary care applicable to the industry) of any API
supplied by Altair to Spectrum under this Agreement and any related supply
agreement between Altair and Spectrum to meet the API specifications set forth
in such agreement; (b) a breach by Altair of this Agreement, any of its
covenants, agreements, representations or warranties set forth in this
Agreement; or (c) the negligence or willful misconduct of Altair or any Altair
Indemnitee; provided, however, that the foregoing indemnification and other
obligations shall not apply to any Loss to the extent such Loss is subject to or
within the scope of Spectrum's indemnification and other obligations under
Section 14.1, above.
14.3 CLAIMS PROCEDURES. A person or entity entitled to be indemnified by
the other Party (an "Indemnified Party") pursuant to Section 14.1 or 14.2 hereof
shall give written notice to the other Party (the "Indemnifying Party") promptly
after such Indemnified Party has actual knowledge of any threatened or asserted
claim as to which indemnity may be sought, and shall permit the Indemnifying
Party to assume the defense of any such claim or any litigation resulting
therefrom; provided that:
(a) the failure of any Indemnified Party to give notice as provided
herein shall not relieve the Indemnifying Party of its obligations under this
Agreement to the extent that such failure to give notice did not result in
prejudice to the Indemnifying Party or the Indemnifying Party's insurer;
(b) the Indemnifying Party, in the defense of any such Claim, shall
not, except with the approval of the Indemnified Party (which approval shall not
be unreasonably withheld), consent to entry of any judgment or enter into any
settlement which (i) would result in injunctive or other relief being imposed
against the Indemnified Party; or (ii) does not include as an unconditional term
thereof the giving by the claimant or plaintiff to such Indemnified Party of a
release from all liability in respect to such claim or litigation; and
(c) the Indemnified Party shall furnish such information regarding
itself or the claim in question as the Indemnifying Party may reasonably request
in writing, and shall be reasonably required in connection with the defense of
such claim or litigation resulting therefrom.
ARTICLE 15.
DISPUTE RESOLUTION
15.1 ESCALATION. Prior to taking action as provided in Section 15.2 of
this Agreement, the Parties shall first submit such dispute to Spectrum's Chief
Executive Officer and to Altair's Chief Executive Officer (the "Heads") for
resolution. The Heads to whom any dispute is submitted shall attempt to resolve
the dispute through good faith negotiations over a reasonable period, not to
exceed forty-five (45) days following one Party's receipt of a notice of dispute
from the other Party, unless otherwise agreed by the Heads. Such forty-five (45)
day period shall be deemed to commence on the date the dispute was submitted to
the Heads. All negotiations pursuant to this Section 15.1 shall
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be confidential, and shall be treated as compromise and settlement negotiations
for purposes of applicable rules of evidence.
15.2 ARBITRATION. Any dispute (except for (a) patent and trademark
disputes described in Section 15.3 and (b) disputes within the decision making
authority of the JDC as set forth in this Agreement) between the Parties that is
not resolved by negotiation and/or escalation pursuant to Sections 15.1 shall,
upon the submission of a written request by either Party to the other Party, be
resolved exclusively by binding arbitration in California, U.S., before one (1)
neutral arbitrator, unless either Party promptly requests a three (3)-person
panel of arbitrators, in which event the three arbitrators shall be used. Any
arbitration proceedings shall be conducted in accordance with the Rules of the
American Arbitration Association, except to the extent that such rules are
inconsistent with this Agreement, and shall be conducted in the English
language. In the event of arbitration by three arbitrators, each Party shall
select a neutral arbitrator, and shall notify the other Party of its selection
of such arbitrator within thirty (30) days after receipt by one Party of the
other Party's written request for binding arbitration. The two arbitrators shall
then mutually select a third neutral arbitrator in accordance with the Rules of
the American Arbitration Association. Each arbitrator shall be free of any
subject matter conflict and conflict with a Party. The arbitrator(s) shall
resolve the dispute in accordance with this Agreement and the substantive laws
(without regard to conflict-of-law and choice-of-law principles thereof, and
excluding the rules of procedure) of the State of California, U.S. The decision
of the arbitrator(s) shall be final and shall be fully and irrevocably accepted
by the Parties. The arbitrator(s) are empowered to award interim and final
injunction and equitable relief but, except as expressly set forth in this
Agreement, the arbitrator(s) are not empowered to award treble, punitive,
exemplary or any other damages in excess of compensatory damages, and each Party
irrevocably waives any claim to recover such damages. The final award of the
arbitrator(s) shall be the sole and exclusive remedy of the Parties, and shall
be enforceable in any court of competent jurisdiction. The Parties agree that
they shall share equally the cost of the arbitration filing and hearing fees,
and the cost of the arbitrator(s). Each Party shall bear its own attorneys' fees
and expert fees and all associated costs and expenses, provided that the
arbitrator(s) may award attorneys' fees to the Party deemed by the arbitrator(s)
to be the Party substantially prevailing in the proceeding.
15.3 PATENT AND TRADEMARK MATTERS. Notwithstanding the other provisions of
this Article 15, any dispute that requires resolution of the validity,
infringement or claim interpretation of any Patent or Trademark (a) that is
issued in the United States, shall be subject to actions before the U.S. Patent
and Trademark Office and/or submitted exclusively to the federal court located
in the jurisdiction of the district where any of the defendants resides; and (b)
that is issued in any other country, shall be brought before an appropriate
regulatory or administrative body or court in that country, and the Parties
hereby consent to the jurisdiction and venue of such courts and bodies. For the
avoidance of doubt, such Patent and Trademark disputes shall not be subject to
the provisions of Section 15.2.
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ARTICLE 16.
MISCELLANEOUS
16.1 GOVERNING LAW. This Agreement, and any arbitration hereunder, shall
be governed, interpreted and construed in accordance with the substantive laws
of the State of California, U.S., without regard to conflict-of-laws and
choice-of-law principles thereof.
16.2 ASSIGNMENT. Neither Party may assign this Agreement, in whole or in
part, without the prior written consent of the non-assigning Party, such consent
not to be unreasonably withheld, except, to a successor in interest pursuant to
a merger, acquisition or sale of all or substantially all of the assignor's
assets. Subject to the limitations on assignment herein, this Agreement shall be
binding upon and inure to the benefit of any successors in interest and
permitted assigns of Altair and Spectrum. Any such successor or permitted
assignee of Spectrum's interest shall expressly assume in writing the
performance of all terms and conditions of this Agreement to be performed by
Spectrum.
16.3 FORCE MAJEURE. Neither Party shall be held liable or responsible to
the other Party, nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of this
Agreement, when and to the extent such failure or delay is caused by or results
from acts beyond the affected Party's reasonable control, including, without
limitation, fire, floods, earthquakes, embargoes, war, acts of war (whether war
be declared or not), acts of terrorism, insurrections, riots, civil commotions,
strikes, lockouts, acts of God, government acts, or any other cause beyond the
reasonable control of the affected Party (hereinafter a "Force Majeure").
Notwithstanding the foregoing, Altair shall not lose any rights of payment under
Section 3.2(a) and Article 6 which have accrued prior to the Force Majeure.
16.4 PUBLICITY AND DISCLOSURE. Except as required by law or the rules of
the principal stock exchange on which the Party's stock is traded, no Party
shall originate any public statement, news release or other public announcement
(oral or written), whether in the public press, stockholders' reports, at
investors meetings or meetings with individual investors, or otherwise, relating
to this Agreement or to any sublicense hereunder, or to the performance
hereunder or any such agreements, or use a Party's name for any purpose,
including, without limitation, in connection with the advertising or sale of
Products, without the prior written approval of the other Party, such consent
not to be unreasonably withheld. The Parties each agree to respond to each such
request within five (5) business days of receipt of a request (unless a shorter
period of time is necessary to comply with law). In the case of unintentional
public disclosure concerning this Agreement, any Product or any other subject
matter hereof, the disclosing Party shall promptly inform the other Party of
such disclosure and the other Party shall be entitled to make a public
announcement regarding the subject matter of the disclosure. The other Party
shall notify the disclosing Party of their intention to make such an
announcement. Following a Party's consent to or approval of the public
disclosure of any information pursuant to this Section 16.4, both Parties shall
be entitled to make subsequent public announcements of such information without
renewed compliance with this Section 16.4, unless the scope and/or duration of
such consent or approval is expressly limited. Upon
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conclusion of this Agreement, the Parties will publish a press release on their
future cooperation.
16.5 NOTICES. Any communications or notices required or permitted to be
given by either Party under this Agreement shall be in writing, and shall be
either personally delivered or sent by internationally recognized courier (e.g.,
FedEx, DHL), to the addresses set forth below, or to such other addresses as
designated by one Party to the other Party by notice pursuant hereto.
IF TO SPECTRUM PHARMACEUTICALS, INC.:
000 Xxxxxxxxxx Xxxxx
Xxxxxx, Xxxxxxxxxx 00000
Attn: Xxxxxx X. Xxxxxxxxx, MD
Telephone: 000.000.0000
AND
IF TO ALTAIR NANOMATERIALS, INC.:
000 Xxxxxx Xxx
Xxxx, Xxxxxx 00000
Attn: Secretary of the Company
Telephone: 0-000-000-0000
WITH A COPY TO:
Xxxxxx Xxxxxx White & XxXxxxxxx LLP
000 Xxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Xxx Xxxxxx, Esq.
16.6 AMENDMENT; WAIVER. No waiver of any term or condition of this
Agreement shall be effective unless made in writing and executed by an
authorized representative of each Party. No failure to act by either Party shall
be deemed to be a waiver of any of such Party's rights herein. Except as
otherwise expressly provided herein, no alteration of or modification to this
Agreement shall be effective unless made in writing and executed by an
authorized representative of each Party.
16.7 SEVERABILITY. In the event that any provision of this Agreement, or
any part hereof, is held to be void, invalid or unenforceable, then the Parties
shall promptly discuss such issue and replace such void, invalid or
unenforceable provision with a valid and enforceable provision that shall
achieve as far as possible the intentions of the Parties.
16.8 COMPLIANCE WITH APPLICABLE LAWS. Each Party, its Affiliates and its
sublicensees shall comply in all material respects with all applicable laws,
rules, regulations and governmental orders in connection with their respective
activities and obligations related to this Agreement. Without limiting the
foregoing, each Party, its
36
Affiliates and its sublicensees shall comply in all material respects with all
applicable United States and foreign laws with respect to the transfer of items
and related technical data to foreign countries, including the Export
Administration Regulations and their foreign equivalents.
16.9 SURVIVAL. Termination or expiration of this Agreement for any reason
shall be without prejudice to any rights which shall have accrued to the benefit
of either Party prior to such termination or expiration, and shall not relieve
either Party from its obligations which are expressly indicated to survive
expiration or termination of this Agreement. The following Articles and Sections
shall survive termination or expiration of this License Agreement, with such
limitations as are noted: Article 1, to the extent definitions are embodied in
the following listed Articles and Sections of this Agreement; Articles 12
through 16 and, to the extent rights have accrued prior to such termination,
Article 6, Sections 8.2, 8.3, 10.1, 10.2, 10.3 and 10.4 and any other provisions
of this Agreement which, by their context, are intended to survive the
termination or expiration of this Agreement.
16.10 NO AGENCY; NO IMPLIED LICENSES. Nothing herein shall be deemed to
create an agency, joint venture, amalgamation, partnership, employment,
franchise, fiduciary or similar relationship between Spectrum and Altair.
Spectrum and Altair are not Affiliates of one another. Notwithstanding any of
the provisions of this Agreement, neither Party shall at any time enter into,
incur, or hold itself out to Third Parties as having authority to enter into or
incur, on behalf of the other Party, any commitment, expense, or liability
whatsoever. Nothing in this Agreement shall be construed as granting either
Party, by implication, estoppel or otherwise, any license or other rights which
are not expressly set forth herein.
16.11 CONSTRUCTION. The Parties mutually acknowledge that they and their
respective attorneys have participated in the negotiation and preparation of
this Agreement. Ambiguities, if any, in this Agreement shall not be construed
against any Party, irrespective of which Party may be deemed to have drafted
this Agreement or authorized the ambiguous provision.
16.12 CAPTIONS. Titles, headings and other captions are for convenience
only, and are not to be used for interpreting this Agreement. Such titles,
headings and other captions shall not be deemed to affect in any way the
language of the provisions to which they refer.
16.13 ENTIRE AGREEMENT. This Agreement, including all Schedules attached
hereto, which are hereby incorporated by reference, and that certain
Nondisclosure/nonuse Agreement by and between Altair Nanotechnologies, Inc. and
Spectrum, dated November 3, 2004 (to the extent such Nondisclosure/nonuse
Agreement is not inconsistent to this Agreement) contains the entire
understanding between the Parties hereto with respect to the subject matter
hereof.
16.14 COUNTERPARTS; FACSIMILES. This Agreement may be executed by original
or facsimile signature in several counterparts, all of which shall be deemed to
be
37
originals, and all of which, taken together, shall constitute one and the same
Agreement. Notwithstanding the foregoing, the Parties shall deliver original
execution copies of this Agreement to one another as soon as practicable
following execution thereof.
[SIGNATURE PAGE FOLLOWS]
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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed by their duly authorized representatives, effective as of the day and
year first above written.
SPECTRUM PHARMACEUTICALS, INC. ALTAIR NANOMATERIALS, INC.
____________________________________________ ______________________________
Signature Signature
By: Xxxxxx Xxxxxxxxx, M.D. By: Xxxx Xxxxxxx, Ph.D.
Title: Chief Executive Officer and President Title: Chief Executive Officer
ALTAIR NANOTECHNOLOGIES, INC.
(only with respect to Sections
6.1, 10.2, and 10.3)
______________________________
Signature
By: Xxxx Xxxxxxx, Ph.D.
Title: Chief Executive Officer
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SCHEDULE 1.31
PATENTS AND TRADEMARKS
***
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with respect to the omitted portions.