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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: ACUSPHERE INC You are currently viewing:
This License Agreement involves

ACUSPHERE INC

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Title: LICENSE AGREEMENT
Governing Law: Delaware     Date: 10/27/2008
Industry: Biotechnology and Drugs     Law Firm: Sidley Austin;Goodwin Procter     Sector: Healthcare

LICENSE AGREEMENT, Parties: acusphere inc
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Exhibit 10.5

 

WHENEVER CONFIDENTIAL INFORMATION IS OMITTED HEREIN (SUCH OMISSIONS ARE DENOTED BY AN ASTERISK *) SUCH CONFIDENTIAL INFORMATION HAS BEEN SUBMITTED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.

 

LICENSE AGREEMENT

 

This agreement (the “Agreement”), dated the [      ] th day of [October] , 2008 (the “Effective Date”), is by and between [PURCHASER], a Delaware corporation (“Purchaser”), and [THE COMPANY], a Delaware corporation (the “Company”).

 

INTRODUCTION

 

1.                                        The Company owns the Product Intellectual Property (as such term is defined herein).

 

2.                                        The Purchaser is in the business of developing and marketing pharmaceutical products.

 

3.                                        The Company and the Purchaser are interested in establishing a licensing relationship pursuant to which the Company shall grant the Purchaser certain rights and licenses under the Product Intellectual Property.

 

NOW, THEREFORE, the Purchaser and the Company agree as follows:

 

Article I
Definitions

 

When used in this Agreement, each of the following terms shall have the meanings set forth in this Article I:

 

Section 1.1                                       Affiliate ” means, with respect to a Party, any Person that controls, is controlled by, or is under common control with such Party. For purposes of this Section 1.1, “control” shall refer to (a) in the case of a Person that is a corporate entity, direct or indirect ownership of fifty percent (50%) or more of the stock or shares having the right to vote for the election of directors of such Person and (b) in the case of a Person that is not a corporate entity, the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise.
 
Section 1.2                                       Bankruptcy Code ” means 11 U.S.C §§ 101-1330, as amended.
 
Section 1.3                                       Confidential Information ” means non-public information disclosed by the Company to the Purchaser relating to the Products, Licensed Patent Rights or Licensed Know-How, but specifically excluding Product Clinical Data disclosed in connection with the clinical development of, or regulatory approval for, a Product.

 


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Section 1.4                                       Control ” and cognates thereof means, with respect to any Licensed Know-How, Patent Rights or Confidential Information, the possession by a Party, whether directly or through Affiliates of such Party, of the ability to grant the right to access or use, or to grant a license or the right to disclose or transfer such Licensed Know-How, Patent Rights or Confidential Information, without violating the terms of any agreement or other written arrangement with, or the rights of any Third Party.
 
Section 1.5                                       Cover ” and cognates thereof means, with respect to a product, that, but for a license granted to a Party under a Valid Claim, the Development or Commercialization of such product would infringe such Valid Claim.
 
Section 1.6                                       FDA ” means the U.S. Food and Drug Administration.
 
Section 1.7                                       Governmental Authority ” means any court, tribunal, arbitrator, arbitrational panel or authority, agency, commission, official or other instrumentality of the United States or any other country, or any supra-national organization, state, county, city or other political subdivision or any self-regulatory organization.
 
Section 1.8                                       Improvements ” means any improvements, modifications, developments or inventions which a Party may make to the Product Intellectual Property after the Effective Date.
 
Section 1.9                                       Licensed Know-How ” means all inventions, methods, processes, techniques, improvements, designs, formulae, specifications, and technical, scientific and business information (including, without limitation, all biological, chemical, pharmacological, toxicological, clinical and assay information, data and analyses), whether or not patentable, which are Controlled by the Company and which relate to the Licensed Patent Rights or the Product in any way, in any field or for any purpose and in whatever form existing (including, without limitation, paper, notebooks, books, files, ledgers, records, tapes, discs, diskettes, CD-Rom and any other media on which the foregoing can be stored).
 
Section 1.10                                 Licensed Patent Rights ” means (a) the Patent Rights set forth on Exhibit A hereto, (b) counterparts of the Patent Rights set forth on Exhibit A in any country of the world and (c) all other patent rights owned or licensed by the Company and related in any way to the Product.
 
Section 1.11                                 Net Sales ” means the aggregate amount invoiced on account of sales of a Product by the Purchaser or any of its Affiliates or sublicensees to a third party in the Territory (but not including sales between the Purchaser and its Affiliates where the Product is intended for resale) less the following reductions relating to such sales:
 
(i) trade, quantity and cash discounts or rebates, which are not already reflected in the amount invoiced;
 
(ii) any adjustments or allowances on account of price adjustments, billing errors, rejected goods, damaged goods, returns and withdrawal, recall or relabeling of Product;

 


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(iii) credits, volume rebates, charge-back and prime vendor rebates, reimbursements or similar payments granted or given to, or related administrative, processing or other fees charged to, wholesalers and other distributors, buying groups, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations or other institutions or health care organizations, which are not already reflected in the amount invoiced;
 
(iv)  any tax, tariff, customs duty, excise or other duty or other governmental charge including, without limitation, value added taxes(other than a tax on income) levied on the manufacture, sale, transportation or delivery of the Product and remitted to the applicable taxing authority;
 
(v) payments or rebates paid in connection with sales of the Product to any governmental or regulatory authority in respect of any state or federal Medicare, Medicaid or similar programs, or other managed care programs, which are not already reflected in the amount invoiced;
 
(vi) freight, postage, handling, shipping, insurance or other transportation costs charged to the customer whether invoiced separately or included within the selling price; and
 
(vii) amounts allocated for bad debt determined by generally accepted accounting principles consistently applied.
 
For purposes of this definition, the Product shall be considered “sold” and “reductions” allowed when so recorded in the Purchaser or its Affiliates or sublicensees (as the case may be) consolidated and consolidating financial statements prepared in accordance with generally accepted accounting principles. The first sale to a third party in an arms-length transaction shall be regarded as the first sale for the purpose of calculating Net Sales.
 
Section 1.12                                 NDA ” means a New Drug Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 314 et seq., for FDA approval of a new drug product.
 
Section 1.13                                 Order ” means any writ, judgment, decree, injunction, award or similar order of any Governmental Authority, including any award in an arbitration proceeding (in each case, whether preliminary or final).
 
Section 1.14                                 Parties ” means the Purchaser and the Company.
 
Section 1.15                                 Party ” means the Purchaser or the Company, as the context may require.
 
Section 1.16                                 Patent Rights ” means United States and foreign patents and patent applications and all substitutions, divisions, continuations, continuations-in-part, requests for continued examinations, reissues, reexaminations and extensions thereof.
 
Section 1.17                                 Person ” means any natural person or any corporation, company, partnership, joint venture, firm or other entity, including without limitation a Party.
 
Section 1.18                                 Product ” and cognates thereof mean celecoxib in all delivery methods, formulations and dosages.

 


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Section 1.19                                 Product Clinical Data ” means all pre-clinical and clinical data, databases and intellectual property relating to the Product and the Licensed Patent Rights, including without limitation, raw case report files, final study reports, toxicology reports, regulatory information including all investigational new drug applications and such other information and data as may have been generated during or in connection with any pre-clinical and phase I clinical studies or other studies conducted on the Product or with respect to any Licensed Patent Rights.
 
Section 1.20                                 Product Intellectual Property ” means all Product Clinical Data, Licensed Patent Rights and Licensed Know-How, and any Improvements to any such Product Intellectual Property to the extent performed by the Company or by a third party at the Company’s direction in accordance with the terms of this Agreement.
 
Section 1.21                                 Product Payments ” means the Upfront License Payment and the Regulatory Milestone Payment.
 
Section 1.22                                 Regulatory Milestone Payment ” has the meaning ascribed to such term in Section 2.11.
 
Section 1.23                                 Requirements of Law ” means any law, statute, code, treaty, Order, ordinance, rule, regulation or other requirement promulgated or enacted by any Governmental Authority.
 
Section 1.24                                 Royalty ” has the meaning ascribed to such term in Section 2.11.
 
Section 1.25                                 Tax ” and cognates thereof mean all of the following: (i) any sales, use ad valorem, transfer, franchise, license, excise, stamp, production, withholding, value added, environmental, or other tax, custom or duty or governmental fee or other like assessment or charge to the extent directly related to the sale of Products (thereby explicitly excluding any income, employment or profits tax or any sort) that may be imposed by any Governmental Authority for such sale of Products and (ii) any liability for the payment of amounts described in (i) above as a result of being a member of an affiliated, consolidated, combined or unitary group for any taxable period.
 
Section 1.26                                 Territory ” means all locations and jurisdictions worldwide.
 
Section 1.27                                 Third Party ”  means any person or entity other than a Party or any of its Affiliates.
 
Section 1.28                                 Upfront License Payment ” has the meaning ascribed to such term in Section 2.9.
 
Section 1.29                                 Valid Claim ” means a claim of any issued, unexpired United States or foreign patent, which shall not have been donated to the public, disclaimed, nor held invalid or unenforceable by a court of competent jurisdiction in an unappealed or unappealable decision.

 


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Article II
Grant of License; Disclosure of Know-How; Clinical Data

 

Section 2.1                                       License Grant . Subject to the terms and conditions of this Agreement, the Company hereby grants to the Purchaser the exclusive, worldwide, irrevocable right and license under the Licensed Patent Rights and the Licensed Know-How for any and all applications, uses and purposes and in any field with respect to the Product, including without limitation, to develop, make, have made, use, offer for sale, sell and import pharmaceutical formulations and products. The term of such license shall be determined on a country-by-country basis, with such license to continue with respect to a specific country until the expiration in such country of any Patent Rights owned by Company providing market exclusivity to the Purchaser under the Product in the applicable country, including any Licensed Patent Rights.

 

Section 2.2                                       Commercialization . The Purchaser agrees to use commercially reasonable efforts to develop and commercialize the Product in the United States on a timely basis and thereafter to sell the Product in the United States.

 

Section 2.3                                       Disclosure of Licensed Know-How . During the term of this Agreement, the Purchaser shall have access, as reasonably requested by the Purchaser, to personnel of the Company and its Affiliates at reasonable times during normal business hours and upon prior notice for discussions relating to regulatory, scientific, medical and other technology contained in or relating to the Licensed Know-How. In addition, to the extent required by the Purchaser, the Purchaser shall have access to all documents of the Company and its Affiliates related in any way to any such discussions.

 

Section 2.4                                       Transfer of Pre-Clinical and Clinical Data . During the term of this Agreement, the Purchaser shall have access, as reasonably requested by the Purchaser, to personnel of the Company and its Affiliates at reasonable times during normal business hours and upon prior notice for discussions relating to regulatory, scientific, medical and other matters relating to preclinical and clinical data related in any way to the Product or the Product Intellectual Property. In addition, to the extent required by the Purchaser, the Company shall provide access to its, and its Affiliates, facilities, personnel and records in connection with any regulatory filings or submissions that the Purchaser may make with respect to the Product. After the transfer of such preclinical and clinical data related in any way to the Product Intellectual Property, the Company shall have no right, title or interest in such data.

 

Section 2.5                                       Sublicensees . The Purchaser shall be entitled to grant one or more sublicenses under the licenses granted pursuant to this Agreement, provided, however, that the Purchaser shall not be permitted to sublicense rights broader than those granted hereunder. Notwithstanding the foregoing, no such sublicense by Purchaser shall alter Purchaser’s obligation to pay the Royalty to the Company in accordance with Section 2.11.

 

Section 2.6                                       Section 365(n) of the Bankruptcy Code . All rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be, deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. The Parties shall retain and may fully exercise all of their respective rights and elections under the Bankruptcy Code.

 


*CONFIDENTIAL TREATMENT REQUESTED

 

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Section 2.7                                       Improvements . Each Party shall own all right, title and interest in and to any Improvements it creates or develops. To the extent that the Company creates or develops Improvements, such Improvements shall become part of the Product Intellectual Property and shall be licensed to the Purchaser pursuant hereto, and the Company shall notify the Purchaser of such Improvements and deliver such Improvements and all records, data, information and know-how related thereto to the Purchaser, in each such case promptly after the creation or development of such Improvements and no later than thirty (30) days after the creation or development of such Improvements.

 

Section 2.8                                       Additional Assignments . On the Effective Date, the Parties shall execute the Assignment Agreement attached hereto as Exhibit D .

 

Section 2.9                                       Upfront License Payment . Upon the Effective Date, the Purchaser shall pay to the Company a one-time upfront license payment of Five Million U.S. Dollars ($5,000,000) (the “Upfront License Payment”).

 

Section 2.10                                 Regulatory Milestone License Payment . In addition to the Upfront License Payment, upon the Purchaser’s receipt from the FDA of final approval of the first NDA prepared by the Purchaser with respect to the Product for any indication, the Purchaser shall pay within thirty (30) days of such final approval to the Company an additional one-time payment of Fifteen Million U.S. Dollars ($15,000,000) (the “Regulatory Milestone Payment”).

 

Section 2.11                                 Royalties . In addition to the Product Payments, the Purchaser shall pay to the Company a royalty of * percent (*%) of Net Sales of the Products in the Territory (the “Royalty”). The Purchaser shall pay such royalty on a country-by-country basis for the Net Sales of the Products in the applicable country during each calendar quarter, within forty-five (45) days after the end of the applicable calendar quarter. The Purchaser shall pay the Royalty applicable to each country in US dollars. At the time of such payment, the Purchaser shall also provide to the Company a written statement of Net Sales showing in reasonably specific detail, on a country-by-country basis, (a) the calculation of Net Sales; (b) royalties payable in US dollars, which shall have accrued hereunder based upon Net Sales; (c) withholding taxes, if any, required by law to be deducted with respect to such sales; (d) the dates of the first commercial sales of the Product in any jurisdiction during the reporting period; and (e) the exchange rates used to determine the amount of US dollars (collectively, the “Royalty Statement”). If any currency conversion shall be required in connection with the calculation of payments hereunder, such conversion shall be made using the average exchange rates published by OANDA.com or a comparable service for the applicable period in which Purchaser records the sale giving rise to the payment obligation set forth herein. Purchaser shall be entitled to deduct Purchaser’s actual currency conversion costs from the Royalties payable hereunder.

 

Section 2.12                                 Consideration . The Product Payments, the Royalty payments and the mutual promises provided herein shall constitute consideration for the licenses and other rights granted hereunder.

 

Section 2.13                                 Records and Audit . During the term of this Agreement, for a period of three (3) years after the conclusion of the applicable calendar year, the Purchaser shall keep complete and accurate records of Net Sales in sufficient detail to permit the Company to confirm

 


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the completeness and accuracy of: (i) the information presented in each Royalty Statement and (ii) the calculation of Net Sales. The Purchaser shall permit a recognized independent auditing firm reasonably acceptable to the Purchaser to audit and/or inspect records of the Purchaser solely to the extent required to verify: (A) the completeness and accuracy of the Royalty Statements; (B) the calculation of Net Sales and (C) the amount of Royalty payments for the Product for the previous year. Such inspection shall be conducted during the Purchaser’s normal business hours, no more than once in any twelve (12) month period and upon at least thirty (30) days prior written notice by the Company to the Purchaser. If such firm establishes that such payments were underpaid for the preceding year, the Purchaser shall have the right to engage a recognized independent auditing firm to verify the findings of the audit. If the firm engaged by Purchaser verifies the findings of the firm engaged by the Company, the Purchaser shall pay the Company the amount of any such underpayments for the preceding year, plus interest at a rate equal to the Prime Rate of interest as reported in the Wall Street Journal on the date payment is due, within thirty (30) days after the date the Purchaser delivers to the Company the report of the firm engaged by the Purchaser, which report so establishes that such payments were underpaid for the preceding year. Notwithstanding the foregoing, the firm engaged by the Purchaser shall deliver its findings in a prompt manner after being engaged by the Purchaser. If the firm engaged by the Company establishes that such payments were overpaid for the preceding year, the Company shall pay the Purchaser the amount of any such overpayment for the preceding year, within thirty (30) days after the date the Company delivers to the Purchaser such firm’s report so establishing that such payments were overpaid for the preceding year. The Company shall bear the full cost of the firm it engages unless such audit discloses an underpayment by more than five percent (5%) of the amount due for the preceding year and such underpayment of more than five percent (5%) is verified by the firm engaged by the Purchaser if it chooses to engage a firm for audit verification purposes. The Purchaser shall bear the full cost of the firm it engages to verify the audit findings.

 

Section 2.14                                 Payments . The Product Payments and the Royalty payments shall be made electronically in US Dollars and to such place and account as may be designated from time to time for that purpose by the Company to Purchaser in writing.

 

Section 2.15                                 Withholding Taxes . All sums payable by either Party under this Agreement (including without limitation the Product Payments and the Royalty payments) shall be paid in full and without any set-off, counterclaim, taxes, duties, levies, fees, charges, deduction or withholding on any ground whatsoever, except as may be required by law. The Parties shall consider together to what extent, if at all, it may lawfully be possible to mitigate the amount of such deduction or withholding or of the amount required to be paid as aforesaid, including the use of best efforts to make timely and procedurally correct application for relief from withholding tax in respect of any such payment. For any taxes, duties, levies, fees, charges, deduction or withholding on any ground whatsoever withheld or to be withheld, each Party agrees to timely deliver all certificates and forms as may be necessary and appropriate to establish an exemption from Tax or file Tax returns as would be necessary with respect to such Taxes.

 


*CONFIDENTIAL TREATMENT REQUESTED

 

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