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Amended and Restated Agreement

Research and Development Agreement

Amended and Restated Agreement | Document Parties: ALTAIR NANOTECHNOLOGIES INC | 93 Altair Nanotechnologies, Inc | Altair Nanomaterials, Inc | Altair, Altair Nanotechnologies, Inc | Spectrum Pharmaceuticals, Inc You are currently viewing:
This Research and Development Agreement involves

ALTAIR NANOTECHNOLOGIES INC | 93 Altair Nanotechnologies, Inc | Altair Nanomaterials, Inc | Altair, Altair Nanotechnologies, Inc | Spectrum Pharmaceuticals, Inc

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Title: Amended and Restated Agreement
Date: 8/7/2009
Industry: Chemical Manufacturing     Sector: Basic Materials

Amended and Restated Agreement, Parties: altair nanotechnologies inc , 93 altair nanotechnologies  inc , altair nanomaterials  inc , altair  altair nanotechnologies  inc , spectrum pharmaceuticals  inc
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EXHIBIT 10.3

 

 

 

 

 

Amended and Restated Agreement

 

by and among

 

Altair Nanomaterials, Inc.,

 

Spectrum Pharmaceuticals, Inc.

 

and

 

Altair Nanotechnologies, Inc.

(only with respect to Sections 5.1,9.2, and 9.3)

 

 

 

 

 

 

 


 

 

Amended and Restated Agreement

 

This Amended and Restated Agreement, dated as of August 4, 2009 (the “Execution Date”), is entered into by and between:

 

Altair Nanomaterials, Inc. (hereinafter “Altair”), a Nevada corporation with principal offices at 204 Edison Way, Reno, Nevada 89502; Spectrum Pharmaceuticals, Inc. (hereinafter “Spectrum”), a Delaware corporation with principal offices at 157 Technology Drive, Irvine California 92618; and (only with respect to Sections 5.1, 9.2, and 9.3) Altair Nanotechnologies, Inc., a Canada corporation with principal offices at 204 Edison Way, Reno, Nevada 89502.

 

RECITALS

 

WHEREAS , Altair is the owner of Patents, Know-How, Trade Secrets and Trademarks (each, as defined below) relating to Compounds (as defined below);

 

WHEREAS , Altair, Altair Nanotechnologies, Inc. and Spectrum are parties to a License Agreement dated as of January 28, 2005 (the “License Agreement”) pursuant to which Spectrum obtained from Altair, and Altair granted to Spectrum, the rights set forth therein, including a license under Altair’s Patents, Know-How, Trade Secrets and Trademarks (as defined below), and any Improvements to develop and commercialize one or more Compounds and/or Products (as defined below);

 

WHEREAS , Altair, Altair Nanotechnologies, Inc. and Spectrum are parties to a Settlement Agreement dated as of June 6, 2006 (the “Settlement Agreement”) pursuant to which the Parties resolved a dispute under the License Agreement; and

 

WHEREAS , Altair, Altair Nanotechnology, Inc. and Spectrum desire to amend and restate in its entirety the License Agreement on the terms and conditions set forth herein in order for Spectrum to obtain from Altair, and Altair to grant to Spectrum, inter alia, an assignment of Altair’s Patents, Know-How, Trade Secrets and Trademarks.

 

NOW, THEREFORE , in consideration of the premises and mutual covenants and agreements set forth below, Altair and Spectrum (individually referred to as “Party” and collectively as “Parties”) hereby agree as follows:

 

ARTICLE 1.

DEFINITIONS

 

Except as otherwise expressly provided herein or unless the context otherwise requires: (a) the use of the term “including” shall mean “including but not limited to”; (b) the words “herein”, “hereof”, “hereunder” and other words of similar import refer to this Agreement as a whole, and not to any particular provision; (c) the use of the phrase “by Spectrum” shall mean “by Spectrum (and/or on behalf of Spectrum),” and the use of the phrase “by Altair” shall mean “by Altair (and/or on behalf of Altair)”; and (d) the following initially capitalized terms in this Agreement, whether used in the singular or plural, shall have the following meanings:

 

 

 

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1.1   “Affiliate” of a Party shall mean any entity which directly or indirectly controls, is controlled by, or is under common control with a Party to this Agreement.  For purposes of this definition, “control” or “controlled” means ownership, directly or through one or more Affiliates, of more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or more than fifty percent (50%) of the equity interests in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body of a corporation of other entity.

 

1.2   “Agreement” shall mean this Amended and Restated Agreement, including all exhibits attached hereto, all as may be respectively amended, modified or supplemented in writing by the Parties from time to time in accordance with the terms of this Agreement.

 

1.3   “Altair Indemnitees” is defined in Section 13.1.

 

1.4   “API” shall mean active pharmaceutical ingredient, and for purposes of this Agreement shall mean the Compound included in the Product for sale in the Field in the Territory.

 

1.5   “Claim” is defined in Section 13.1.

 

1.6   “Commercially Reasonable Efforts” shall mean the standard that a reasonable business person would use to develop, manufacture, market, sell and distribute, a product owned by it or to which it has rights, which is of similar market potential at a similar stage in its product life, taking into account, among other factors, the competitiveness of the marketplace, the proprietary position of the product and the profitability of the product.

 

1.7   “Combination Product” shall mean any Product that contains, in addition to any Compound, one or more clinically active pharmaceutical ingredients owned or controlled by a Third Party, and other than another Compound or any Improvement.

 

1.8   “Compound” shall mean, individually and collectively, the following chemical compounds: (a) lanthanum oxycarbonate 2-hydrate, including RenaZorb RZB 011, (b) lanthanum dioxycarbonate including RenaZorb RZB 012 and also known as RENALAN™, (c) the compounds known as RZB 013 and RZB 014, and (d) all intermediates, derivatives, improvements or related compounds of any of the foregoing developed by Altair prior to the Execution Date, and (e) any other compound or technology developed or under development by Altair as of the Execution Date or throughout the Term that is related to the contemplated or potential uses of the aforementioned chemical compounds.

 

1.9   “Confidential Information” shall mean any proprietary or confidential information of the Disclosing Party (except to the extent such information falls within an exception recited in Section 11.3, below) that is communicated in any way or form by the Disclosing Party to the Recipient, either prior to or after the Effective Date of this Agreement, and whether or not such information is identified as confidential.  Information that is not identified as confidential shall be deemed Confidential Information if the Recipient knows or reasonably should have known that the information communicated by the Disclosing Party is Confidential Information of the Disclosing Party. Information developed by one Party based on or derived from Confidential Information disclosed by the other Party shall be deemed Confidential Information of both Parties (and each Party shall be deemed the Disclosing Party of such Confidential Information). The terms and conditions of this Agreement shall be considered the Confidential Information of both Parties.

 

 

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1.10   “Current Market Price” shall mean the average of the reported closing sale prices on the principal securities market for Altair Nanotechnologies Inc.’s, or its successor’s, common shares for the *********** consecutive trading days immediately preceding and including the date of the milestone event.

 

1.11   “Disclosing Party” shall mean the Party making disclosure of or otherwise communicating its Confidential Information to the other Party.

 

1.12   “Dollars” or “$” shall mean the lawful currency of the United States.

 

1.13   “Effective Date”  shall mean January 28, 2005.

 

1.14   “EMEA” shall mean the European Agency for the Evaluation of Medicinal Products.

 

1.15   “FDA” shall mean the United States Food and Drug Administration, or any successor entity thereto performing similar functions.

 

1.16   “Field" shall mean all uses.

 

1.17   “First Commercial Introduction” shall mean the first date upon which a Product is shipped for sale by Spectrum (or by an Affiliate or licensee of Spectrum) in the ordinary course of business to a Third Party in any country in the Territory, after Regulatory Approval.

 

1.18   “Force Majeure” is defined in Section 15.3.

 

1.19   “Heads” is defined in Section 14.1.

 

1.20   “Human Field”  shall mean all human therapeutic and diagnostic uses.

 

1.21   “Human License Payments ” shall mean any upfront, milestone and other payments (including any premiums paid in the purchase of securities, or other consideration) received by Spectrum or its Affiliates from any licensee under a license in the Human Field to the Assigned IP assigned to Spectrum under this Agreement, except for royalty payments based on net sales of Product in the Human Field.

 

1.22   “Improvement(s)” shall mean any and all inventions, discoveries, improvements, modifications, Product or pharmaceutical formulations, new indications, chemical processes, manufacturing processes, data (pre-clinical, clinical or otherwise), information, Trade Secrets and Know-How, whether or not patented or patentable, regarding Compound or Product, that are: (a) conceived or reduced to practice by either Party, its respective Affiliates or its respective licensees or their respective contractors after the Effective Date but prior to the Execution Date, and (c) related to a Compound or Product or to the manufacture or use of Compound or Product by either Party, its respective Affiliates or its respective licensees.

 

1.23   “Indemnified Party” is defined in Section 13.3.

 

 

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1.24   “Indemnifying Party” is defined in Section 13.3.

 

1.25   “Key Employees” shall mean up to five (5) of the existing employees of Altair identified by Spectrum and listed on Exhibit A hereto as of the Execution Date.

 

1.26    “Know-How” shall mean all data, results, information (technical and scientific), marketing reports, expertise, pre-clinical, clinical and manufacturing data regarding the Compounds and Products existing as of the Execution Date.

 

1.27   “Launch” or “Launched” shall mean the first date on which the Product is Detailed in a country in the Territory.  For the purposes of this Section 1.27, “Detailed” shall mean a sales presentation in the Territory to medical professionals by a sales representative acting on behalf of Spectrum, its Affiliate or licensee during which presentation the sales representative promotes the Product.

 

1.28    “Loss” is defined in Section 13.1.

 

1.29   “MHLW” shall mean the Ministry of Health and Labour and Welfare of Japan.

 

1.30   NDA ” shall mean a New Drug Application (as more fully described in 21 C.F.R. Part 314.5 et seq.), and all amendments and supplements (including NDAs) thereto, filed with the FDA in the United States, or the equivalent application filed with any equivalent Regulatory Authority in the Territory.

 

1.31   “Net Sales” shall mean the amount received by Spectrum, its Affiliates, its licensees or distributors on account of sales of a Product in the Human Field to Third Parties in the Territory, less the following deductions to the extent actually allowed or specifically allocated to the Product by the selling party using generally accepted accounting principles:

 

(i)   sales and excise taxes and duties paid or allowed by the selling party and any other governmental charges (excluding income taxes) imposed upon the production, importation, use or sale of such Product;

 

(ii)   customary trade, quantity and cash discounts allowed on Product;

 

(iii)   allowances or credits to customers on account of rejection or return of Product or on account of retroactive price reductions affecting such Product;

 

(iv)   freight and transit insurance costs, if they are included in the selling price for the Product invoiced to Third Parties, provided always that such deduction shall not be greater than the balance between the selling price actually invoiced to the Third Party and the standard selling price which would have been charged to such Third Party for such Product exclusive of freight and transit insurance in the respective country or in a comparable country.

 

For the avoidance of doubt, for each Product the Net Sales shall be calculated only once for the first sale of such Product by either Spectrum, its Affiliate, its licensees or its distributor, as the case may be, to a Third Party which is neither an Affiliate, licensees or distributor of Spectrum.  A sale of Products by Spectrum, its Affiliate, its licensees or its distributor to a wholesaler shall be regarded as the first sale of the Product for the purpose of calculating Net Sales.

 

 

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Such deductions, to be applicable, must in each case be related specifically to the Product and shall be actually allowed to or taken by Third Party purchasers and not otherwise recovered by or reimbursed from the Third Party purchasers to Spectrum, its Affiliates and/or its licensees.  No deductions shall be made for commissions paid to individuals whether they be with independent sales agencies or regularly employed by Spectrum, its Affiliates or its licensees and on their respective payrolls, or for cost of collections.

 

*******************************************************************************************************.  If Spectrum, its Affiliates or licensees receive non-monetary consideration, Altair shall be paid in cash for its share of the value of such consideration.

 

Net Sales shall not include the amount received on account of sales of a Product or of sales of a Product in a particular country for which the Term of this Agreement has expired.

 

With respect to sales of Combination Products, Net Sales of such Combination Products shall be calculated by multiplying the Net Sales (as described above with respect to Products) of the Combination Product by the fraction A/(A+B), where A is the average sale price of the Product when sold in finished form and B is the sum of the average sale price of each other clinically active pharmaceutical ingredient included in the Combination Product, when sold separately in finished form, in each case during the applicable royalty reporting period or, if sales of both the Product and the other clinically active pharmaceutical ingredients other than the Compound did not occur in such period, then in the most recent royalty reporting period in which sales of both occurred.  In the event that such average sale prices cannot be determined for both the Product and each other clinically active pharmaceutical ingredient included in the Combination Product, Net Sales of such Combination Products shall be determined by multiplying the Net Sales (as described above with respect to Products) of the Combination Product by the fraction C/(C+D), where C is the fair market value of the Product and D is the sum of the fair market value of each other clinically active pharmaceutical ingredient included in the Combination Product, such fair market values shall be determined in good faith by the Parties.

 

1.32   “Non-Human Field” shall mean all uses other than human uses.  The Non-Human Field includes without limitation ***********.

 

1.33   “Non-Human License Payments” shall mean any upfront, milestone, royalties and other payments (including any premiums paid in the purchase of securities, or other consideration) received by Spectrum or its Affiliates from any licensee under a license in the Non-Human Field to the Assigned IP assigned to Spectrum under this Agreement.

 

1.34   Patents ” shall mean any and all unexpired patents and patent applications (and any patents issued in connection with such patent applications), including any continuations, continuations-in-part, divisions, continuing prosecution applications, requests for continued examinations, extensions, term restorations, renewals, reissues, re-examinations, and substitutions thereof, and any foreign counterparts thereof, that claim the Compound(s), the Product(s), methods of making or using the Compound(s), or methods of making or using the Product(s).  The Patents include the patents and patent applications listed on Exhibit B as of the Execution Date.

 

 

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1.35   Patent Royalty Payment(s) ” is defined in Section 5.3(a).

 

1.36   Phase III Trial ” shall mean a controlled study in humans of the efficacy and safety of a Compound or Product that is designed to demonstrate clinically and statistically whether the Compound or Product is safe and effective for use in a particular indication in a manner sufficient to obtain Regulatory Approval for that Compound or Product in a given country or territory.

 

1.37   Product” shall mean any product that contains or includes a Compound.

 

1.38   Recipient ” shall mean the Party receiving or otherwise obtaining Confidential Information from the Disclosing Party.

 

1.39   Region ” shall mean North America, Europe, Japan or Rest of Territory.

 

1.40   Regulatory Authority ” shall mean, with respect to any particular country, territory or union within the Territory, the governmental authority, body, commission, agency or other instrumentality of such country, territory or union with the primary responsibility for the evaluation or approval of medical products before such medical product can be tested, marketed, promoted, distributed or sold in such country, including such governmental bodies that have jurisdiction over the pricing of such medical product.  The term “Regulatory Authority” includes the FDA, the EMEA, the European Member State competent authorities, and the MHLW, as applicable.

 

1.41   Regulatory Approval ” shall mean any approval(s), registrations or authorizations of the relevant Regulatory Authority necessary for the marketing and sale of Compound or Product in any country, territory or union in the Territory.

 

1.42   Representatives ” is defined in Section 11.2.

 

1.43   Reporting Period ” shall begin on the first day of each calendar quarter or portion thereof and end on the last day of such calendar quarter or portion thereof.

 

1.44   Rest of Territory ” shall mean, collectively, all countries and territories in the Territory except for North America, Europe and Japan.

 

1.45   “Spectrum Common Stock”  shall mean the restricted common stock, $0.001 par value, of Spectrum.

 

1.46   Spectrum Indemnitees ” is defined in Section 13.2.

 

1.47   Technology Royalty Payments ” is defined in Section 5.3(b).

 

1.48   Territory ” shall mean all countries and territories in the world.

 

1.49   Third Party ” shall mean any person or entity other than Altair, Spectrum or their respective Affiliates.

 

 

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1.50    “Trademark” shall mean all trademarks and tradenames, listed on Exhibit B, together with any registrations or applications for registration therefor, anywhere in the world, and all other marks confusingly similar thereto, all variations of such marks, all members of any families of any of the foregoing marks, all designs and styles used by Altair in the depiction of foregoing marks and any copyrights therein, and all goodwill appurtenant to any of the foregoing that are owned or controlled by Altair as of the Execution Date.

 

1.51   “Trade Secrets” shall mean all Confidential Information, inventions (including, without limitation, unpatented or unpatentable inventions, but excluding Patents), techniques, methods, processes, assays, developments, materials, compositions of matter of any type or kind, standard operating procedures, formulas, specifications, technology, tooling, and stability data existing as of the Execution Date and related to the use, development, manufacture, sale and importation of Compounds and/or Products.

 

1.52   United States ” or “ U.S .” shall mean the United States of America, its territories and possessions.

 

ARTICLE 2.

GRANT OF RIGHTS

 

2.1   Assignment of Rights to Spectrum in the Territory .  Subject to the terms and conditions of this Agreement, Altair agrees to assign and hereby assigns to Spectrum, and Spectrum hereby accepts, all right, title and interest in and to the Patents, Know-How, Trademarks and Trade Secrets (including Improvements) (all together the “Assigned IP”).  As owner of all such right, title and interest, Spectrum shall have the right to use the Assigned IP for all purposes, including to use, have used, sell, have sold, offer to sell, import and have imported, make or have made Compounds and/or Products in the Field in the Territory, and Spectrum shall be free to grant licenses to its Affiliates and Third Parties under the Assigned IP.  Commencing with the Execution Date and throughout the Term, Altair shall not, directly or indirectly, (i) research, develop or commercialize any Compound or Product in the Field and in the Territory or (ii) except and to the extent where such is required by any law, regulation or order of any governmental authority, take any action or inaction that would materially negatively or adversely affect the development, regulatory filings, sublicensing and/or commercialization of any Compound or Product..

 

The assignment by Altair to Spectrum of the Assigned IP pursuant to this Section 2.1 shall be in all respects free and clear of any and all liens, hypothecations, mortgages, charges, security interests, pledges and other encumbrances and claims of any nature.

 

Altair hereby covenants and agrees that it will, at the reasonable request of Spectrum, and without further consideration, promptly execute and deliver, and cause its employees and/or contractors to execute and deliver, all documents reasonably necessary to effectuate the assignment of the Assigned IP to Spectrum and take all actions reasonably necessary to assist Spectrum to perfect and maintain title to the Assigned IP in Spectrum. Aside from the initial IP transfer efforts limited to three days of meetings and/or equivalent Altair employee time, Spectrum shall be responsible for any reasonable costs (in accordance with the rates set forth in Exhibit A) incurred by Altair in complying with the requirements of this paragraph.

 

 

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2.2   Disclosure by Altair.  Promptly after the Execution Date, Altair will provide Spectrum with all data, Know-How and other information (including manufacturing information) that it has, regarding the Compounds and Product, including any such information concerning its efforts to improve the Compounds and all data, Know-How, information, results and records related to the manufacture of API, Compounds and finished Products, that has not previously been disclosed to Spectrum, which shall be subject to nondisclosure restrictions by any other agreement (unless such disclosure is required by applicable law, regulation, government authority or the rules of any stock exchange on or through which Spectrum or its Affiliates’ securities trade).  Promptly after the Execution Date, Altair shall provide Spectrum with all quantities of Compounds and Products in the possession of Altair.

 

ARTICLE 3.

PRODUCT DEVELOPMENT AND COMMERCIALIZATION

 

3.1   Development, Manufacturing and Commercialization Activities.   Commencing with the Execution Date, all activities relating to the development, manufacture and commercialization of Compounds and Products shall be undertaken at Spectrum’s sole responsibility, and in its sole discretion and at its sole cost and expense, including: (i) all pre-clinical development activities; (ii) all activities related to clinical trials; (iii) all marketing, promotion, sales, distribution, import and export activities relating to any Compound or Product; (iv) all activities relating to any regulatory filings, registrations, applications and Regulatory Approvals relating to any of the foregoing; and (v) all activities relating to the manufacture and supply of Compound and Products by itself or through its Affiliates or any Third Party.  Spectrum shall own all regulatory filings, registrations, applications and Regulatory Approvals relating to Compounds and Products and all data, results and other information relating to the Compounds and Products (irrespective of whether the regulatory filings, registrations, applications and Regulatory Approvals occurred, were conceived, or derived or resulted from activities that occurred before or after the Execution Date), including data, results and information derived and/or resulting from the manufacturing of the Compounds or Products .  For the avoidance of doubt, any costs and expenses that accrued or were incurred by Altair relating to the development, manufacture or commercialization of Compounds or Products prior to the Execution Date remain Altair’s sole responsibility.

 

3.2   Altair Product Support.   Altair shall use commercially reasonable efforts to reasonably assist Spectrum in understanding the development and manufacture processes of Compounds transferred hereunder.  Notwithstanding, Altair shall use commercially reasonable best efforts to provide Spectrum with reasonable access to the Key Employees for a period of up to six (6) months after the Execution Date.  If a Key Employee is no longer employed by Altair, Altair will promptly notify Spectrum of such change in employment status and shall not prevent Spectrum in any way, mean, shape or form from contacting and employing the Key Employee, and shall provide Spectrum with any known contact information of the Key Employee subject to any restrictions which may exist under any applicable laws. Aside from the initial technology transfer efforts noted in Section 2.1 and in order to provide the above Altair Product Support, Spectrum shall have no more than a total of five (5) days of meetings and/or equivalent of Altair total employee time with the Key Employees. Beyond the foregoing five (5) days Spectrum shall be responsible for any reasonable costs (in accordance with the rates set forth in Exhibit A) incurred by Altair in complying with the requirements of this paragraph.

 

3.3   Spectrum Diligence Obligations. Spectrum shall use commercially reasonable efforts to timely develop and commercialize one or more Products and to introduce one or more Products in the Field and countries within in the Territory.

 

 

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ARTICLE 4.

 DATA AND INFORMATION; REGULATORY MATTERS

 

4.1   Regulatory Approval .  Commencing with the Execution Date, Spectrum shall be responsible, in its sole discretion and at its expense, for (i) preparing and filing all regulatory submissions including Investigational New Drug Applications (INDs) and NDAs pertaining to the Compounds or Products in the Field throughout the Territory, (ii) all activities necessary or appropriate to perform prior to filing such regulatory submissions, including INDs and NDAs, (iii) all activities related to obtaining approval(s) of such regulatory submissions, including INDs and NDAs and (iv) upon obtaining such approval(s), all activities and responsibilities related to maintaining each Regulatory Approval in good standing in compliance with all applicable laws and regulations.  Spectrum shall be the owner of all resulting Regulatory Approvals in the Territory.

 

For the avoidance of doubt, any costs and expenses that accrued or were incurred by Altair relating to the regulatory matters for Compounds or Products prior to the Execution Date remain Altair’s sole responsibility.  Any regulatory materials prepared or filed by Altair for any Compound or Product in the Field prior to the Execution Date shall be transferred to Spectrum.

 

4.2   Compliance with Regulatory Standards and Regulatory Correspondence .  Spectrum shall adhere to and comply with all applicable ethical, legal and regulatory standards and requirements in connection with the Regulatory Approval and commercialization of Compounds and Products throughout the Territory. Altair shall promptly deliver to Spectrum all correspondence that it receives from Regulatory Authorities relating to any Compound or Product.

 

4.3   Product Complaints; Product Recall

 

(a)   Product Complaints.  Spectrum shall have sole control over the response to all material complaints regarding Compound or Product in the Territory.  Altair shall promptly refer any Compound or Product complaints in the Territory of which it becomes aware to Spectrum for Spectrum’s response.  Altair shall promptly provide to Spectrum copies of all relevant documentation and information regarding any such Compound or Product complaints.

 

(b)   Product Recall.  If Altair discovers or becomes aware of any fact, condition, circumstance or event (whether actual or potential) concerning or related to a Compound or Product that may reasonably require recall or market withdrawal of Compound or Product or a “Dear Doctor” letter relating to Compound or Product, Altair shall communicate such fact, condition, circumstance or event promptly to Spectrum.  In the event (but only in the event) (i) any governmental agency or Regulatory Authority issues a request, directive or order that Compound or Product be recalled, (ii) a court of competent jurisdiction orders that Compound or Product be recalled or (iii) Spectrum reasonably determines that Compound or Product should be recalled or withdrawn from the market or that a “Dear Doctor” letter should be sent relating to use of Compound or Product, Spectrum shall take all appropriate remedial actions with respect thereto.  To the extent that it is necessary or appropriate to communicate with any person or entity in the Territory, including any Regulatory Authority or governmental agency, the media or any customer, concerning any such fact, condition, circumstance or event, Spectrum shall be the primary contact concerning remedial action.  Any costs associated with any remedial action shall be borne by Spectrum.

 

 

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ARTICLE 5.

MILESTONE AND ROYALTY PAYMENTS

 

5.1   Upfront and Milestone Payments .  As consideration for the assignment granted to Spectrum under Article 2, Spectrum shall pay to Altair the following amounts, (each of which shall be payable only once) each within thirty (30) days of the applicable events set forth below, in accordance with the terms and conditions of this Article 5 (except as set forth in Section 5.2, under no circumstances shall such amounts, once paid, be refundable or creditable against any other payments):

 

(a)   Upfront payment having occurred prior to Execution Date:  The Parties acknowledge previous payment by Spectrum prior to the Execution Date of: (i) Two hundred thousand dollars ($200,000) to purchase 38,314 common shares of Altair Nanotechnologies, Inc. at the then current market value of $3.88 per share of Altair Nanotechnologies, Inc. common shares; and (ii) One hundred thousand (100,000) shares of Spectrum Common Stock.

 

(b)   Milestone and settlement payment having occurred prior to the Execution Date.  The Parties acknowledge previous payment by Spectrum prior to the Execution Date of one hundred forty thousand (140,000) shares of Spectrum Common Stock (which includes 100,000 shares delivered in respect of a milestone related to satisfactory lanthanum serum levels and 40,000 shares delivered in consideration of the transfer of technology related to formulation improvements to certain Products developed by Altair).

 

(c)   Upon Execution Date.  Within ten (10) business days of the Execution Date, Spectrum shall pay $750,000, in shares of Spectrum Common Stock, subject to Section 9.2.  The number of shares of Spectrum registered Common Stock to be issued to Altair upon the Execution Date shall be calculated by dividing the applicable payment amount by the closing price, as reported by NASDAQ, per share of the Spectrum registered Common Stock on July 1, 2009 The Parties agree that to the best of their knowledge no other consideration or payments are currently due and payable to Altair from Spectrum as of the Execution Date

 

(d)   Upon enrollment of 50 patients in a Phase III Trial of a Product in the Human Field:  (i) ********************************** to purchase common shares of Altair Nanotechnologies, Inc., or its successor, subject to Section 9.2, at a 100% premium to the Current Market Price as of the date of ****************************in a Phase III Trial of a Product in the Human Field or (ii) ********************************** in the event that Altair Nanotechnologies, Inc.’s, or its successor’s, common shares are not publicly traded on the date of such milestone event ; (with “publicly traded”, for purposes of this Section 5.1, meaning registered under section 12(b) of the Securities Exchange Act of 1934, as amended, and listed on a national securities exchange in the United States registered under such Act).

 

 

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(e)   *************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************;

 

(f)   Upon Obtaining NDA Approval by the FDA: ******************** *****************************************************************************************************************************;

 

(g)   *************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************************;

 

(h)   Upon Obtaining NDA approval by the MHLW:  Two Million Dollars ($2,000,000) as of the date of NDA approval by the MHLW of a Product in the Human Field; and

 

(i)   Milestones based on annual, Territory-wide Net Sales:  Except as set forth in Section 5.2, for the avoidance of doubt, the following one-time milestone payments shall not be creditable against any other milestone payments hereunder. Each subsequent payment below is in addition to the prior payment:

 

(i)   Upon ********************** of annual Net Sales of Products in the Human Field:  ***********************;

 

(ii)   Upon ********************************** of annual Net Sales of Products in the Human Field:  ***********************;

 

(iii)   Upon ********************************************* of annual Net Sales of Products in the Human Field:  *****************************;

 

(iv)   Upon *************************** of annual Net Sales of Products in the Human Field:  ************************************; and

 

(v)   Upon ************************* of annual Net Sales of Products in the Human Field:  ***************************.

 

 

 

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Spectrum shall notify Altair of the achievement of each of the milestone events set forth in subsections (b) through (i) of this Section 5.1 within the payment timeline corresponding to the milestone event set forth above.  Additionally, for any payment made in shares of Spectrum stock, outside of any requirements of any applicable law or regulation, including those that pertain to Rule 144 stock, Spectrum shall not take any action or inaction that would prevent Altair from selling or otherwise trading such shares and shall timely maintain all SEC reporting requirements that are applicable to this provision.

 

5.2   License Payments.

 

(a)   Human Field.  Spectrum or its Affiliates, as applicable, shall pay to Altair a non-refundable, non-creditable payment of ***************of all Human License Milestone Payments for licenses in the Human Field; provided that, in the event that any Human License Milestone Payments are due and owing on account of the attainment of a Human license milestone event that is the same as any of those set forth in Section 5.1, then the amount of such Human License Milestone Payment to Altair hereunder shall be ************** of the difference between the milestone amount under Section 5.1 and the Human License Milestone Payment for the same event under the provisions of the license.

 

(b)   Non-Human Field.  Spectrum or its Affiliates, as applicable, shall pay to Altair a non-refundable, non-creditable payment of ************** of all Non-Human License Payments for licenses in the Non-Human Field.

 

5.3   Intellectual Property Royalty Payments

 

(a)   Human Field Patent Royalty Rate; Reports.  On a quarterly basis, and in addition to any milestone payments payable to Altair pursuant to Section 5.1 and license payments payable to Altair pursuant to Section 5.2, Spectrum shall pay to Altair, within ninety (90) days after the end of each Reporting Period, the following intellectual property royalty payments (“Patent Royalty Payments”) in accordance with the terms and conditions of this Article 5:

 

(i)   ******************* on the portion of annual Net Sales of each Product in the Human Field in any calendar year in the Territory less than ****************************;

 

(ii)   **************** on the portion of annual Net Sales of each Product in the Human Field in any calendar year in the Territory greater than or equal to **************************************** and less than ******************************; and

 

(iii)   ****************** on the portion of annual Net Sales of each Product in the Human Field in any calendar year in the Territory greater than or equal to *************************************.

 

 

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The obligation of Spectrum to make the above Patent Royalty Payments shall commence upon the first Launch in each country in the Territory, and shall apply on a Product-by-Product and country-by-country basis for each given Product in the Human Field in each given country with an applicable Patent until the expiration of the last-to-expire Patent that covers the Product within the country in question.  Each Patent Royalty Payment shall be accompanied by a written report (to be prepared in a mutually agreeable format), setting forth (without limitations) information necessary for the calculation of such Patent Royalty Payment (including, on a country-by-country basis, the gross sales of each Product sold); the calculation of Net Sales from such gross sales; the royalties payable in Dollars; and any withholding taxes required by law to be deducted.  Unless otherwise requested or consented to in writing by Altair, all Patent Royalty Payments and reports related to Net Sales by Spectrum’s Affiliates and its licensees shall be made to Altair by Spectrum with (or as a part of) Spectrum’s own payments and reports.

 

(b)   Technology Royalty.  In consideration of the assignment granted under Altair’s Know-How, Trade Secrets and Trademarks to Spectrum, Spectrum shall pay to Altair, on a country-by-country and Product-by-Product basis, a royalty of ******************** **************** commencing on the expiration of the last-to-expire Patent that covers such Product in the Human Field within the country in question (“Technology Royalty Payment”) and continuing until there is generic competition, i.e. , first sale of any third party product containing or including any Compound or Product, within the country in question.  In addition, this Technology Royalty Payment shall also be applicable in those countries for which there is no Patent covering such Product(s), until there is generic competition within the country in question.  The Parties expressly agree that the payment period of this Technology Royalty Payment is not an extension of Altair’s patent rights beyond their term, but


 
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