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EXCLUSIVE LICENSE AGREEMENT

License Agreement

EXCLUSIVE LICENSE AGREEMENT | Document Parties: ALPHATEC HOLDINGS, INC. | Alphatec Spine, Inc | Stout Medical Group LP | Stout Medical Group, Inc You are currently viewing:
This License Agreement involves

ALPHATEC HOLDINGS, INC. | Alphatec Spine, Inc | Stout Medical Group LP | Stout Medical Group, Inc

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Title: EXCLUSIVE LICENSE AGREEMENT
Governing Law: New York     Date: 11/9/2007
Industry: Medical Equipment and Supplies     Law Firm: Hawk Healthcare, LLC;Heller Ehrman LLP     Sector: Healthcare

EXCLUSIVE LICENSE AGREEMENT, Parties: alphatec holdings  inc. , alphatec spine  inc , stout medical group lp , stout medical group  inc
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Exhibit 10.2

EXCLUSIVE LICENSE AGREEMENT

This Exclusive License Agreement (this “Agreement”) is made effective as of September 11, 2007 (the “Effective Date”) by and between Alphatec Spine, Inc., a Delaware corporation with a principal place of business at 2051 Palomar Airport Road, Suite 100, Carlsbad, California 92008 (“Licensee”), and Stout Medical Group LP, a limited partnership company organized under the laws of the state of Delaware, and having a place of business at 410 East Walnut Street, Suite #8, Perkasie, Pennsylvania 18944, (“Licensor”). Licensee and Licensor are each hereafter referred to individually as a “Party” and together as the “Parties”.

WHEREAS, Licensor is the owner of or otherwise controls certain proprietary Licensed Patents and Licensed Technology (as defined below); and

WHEREAS, Licensee desires to obtain a license from Licensor under such Licensed Patents and Licensed Technology to develop and commercialize Licensed Products (as defined below); and

WHEREAS, Licensor desires to grant such license to Licensee on the terms and subject to the conditions of this Agreement.

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereby agree as follows.

1. DEFINITIONS

Whenever used in the Agreement with an initial capital letter, the terms defined in this Article 1 shall have the meanings specified.

1.1 “ Affiliate ” shall mean any company, corporation, partnership, limited liability company, trust, or other business entity that directly or indirectly controls, is controlled by, or is under common control with a designated person or entity, and for such purpose “control” shall mean the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of the entity, whether through the ownership of voting securities, by contract or otherwise.

1.2 “ Confidential Information ” shall mean with respect to a Party (the “Receiving Party”), all information which is disclosed by the other Party (the “Disclosing Party”) to the Receiving Party hereunder or to any of its employees, consultants, Affiliates, licensees or sublicensees, except to the extent that the Receiving Party can demonstrate by written record or other suitable physical evidence that such information, (a) as of the date of disclosure is demonstrably known to the Receiving Party or its Affiliates other than by virtue of a prior confidential disclosure to such Party or its Affiliates; (b) as of the date of disclosure is in, or subsequently enters, the public domain, through no fault or omission of the Receiving Party; (c) is obtained from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the Disclosing Party; or (d) is independently developed by or for the Receiving Party without reference to or reliance upon any Confidential Information of the

 


Disclosing Party. Any information in relation to the subject matter of this Agreement disclosed by a Party under that certain Mutual Confidentiality Agreement between the parties dated the 2d day of July 2007 shall, subject to the foregoing exceptions, be considered Confidential Information for purpose of this Agreement.

1.3 “ First Commercial Sale ” shall mean the date of the first transaction, transfer or disposition for value by or on behalf of Licensee or any Affiliate or Sublicensee of Licensee to a Third Party of a Licensed Product in the United States following the applicable regulatory clearance by the FDA (as defined below).

1.4 “ FDA ” shall mean the United States Food and Drug Administration and any successor agency or authority thereto.

1.5 “ Joint Inventions ” shall have the meaning given in Section 3.3.

1.6 “ Licensor Indemnitees ” and “ Licensee Indemnitees ” (each individually an “ Indemnitee ”) shall have the meaning given in Section 8.1.

1.7 “ Licensed Field ” shall mean the treatment of spinal vertebral body compression fractures.

1.8 “ Licensed Patent Rights ” shall mean any of the patent applications described in Schedule A attached hereto, and any divisional, continuation, continuation-in-part (to the extent that the continuation-in-part is entitled to the priority date of an initial patent or patent application which is the subject of this Agreement), reissue, reexamination, registration, renewal, or extension, or any patent issuing therefrom or any supplementary protection certificates related thereto, and any foreign counterparts to any of the foregoing.

1.9 “ Licensed Product ” shall mean any product sold by Licensee, its Affiliates or Sublicensees that embodies or uses any aspect of the Licensed Patent Rights and/or the Licensed Technology.

1.10 “ Licensed Technology ” shall mean all Technology which:

1.10.1 Licensor controls as of the Effective Date and which (i) is described in or related to any patent or patent application included in the Licensed Patent Rights and (ii) is necessary or useful for Licensee to practice the license granted to it hereunder;

1.10.2 is developed by Licensor as a part of its efforts contemplated by Section 3.2;

1.10.3 Licensor controls after the Effective Date but during the Term and which (i) it has the right to disclose and license without the payment of royalties or other consideration to any Third Party and (ii) constitutes an improvement to the subject matter of the Licensed Patent Rights or Licensed Technology as it exists on the date of determination, including Licensor’s interest in any Joint Inventions; and/or

 


1.10.4 Licensee controls after the Effective Date but during the Term and which constitutes an improvement to the subject matter of the Licensed Patent Rights or Licensed Technology as it exists on the date of determination.

1.11 “ Net Sales ” shall mean the gross amount invoiced or otherwise payable by Licensee, any of its Affiliates or any Sublicensee on account of sales or other transfers of a Licensed Product anywhere in the Territory during a designated period, less (to the extent otherwise then or previously included in amounts invoiced for such Licensed Product and in respect of which no previous deduction was taken):

1.11.1 trade, cash and quantity discounts or rebates actually allowed or taken on Licensed Products, including discounts or rebates to governmental or managed care organizations;

1.11.2 credits or allowances actually given or made for rejection of, and for uncollectible amounts (except to the extent later collected) on, or return of previously sold Licensed Products;

1.11.3 any charges for insurance, freight, and other transportation costs directly related to the delivery of Licensed Product to the extent included in the gross invoiced sales price;

1.11.4 any tax, tariff, duty or governmental charge levied on the sales, transfer, transportation or delivery of a Licensed Product (including any tax such as a value added or similar tax or government charge), other than franchise or income tax of any kind whatsoever; and

1.11.5 any import or export duties or their equivalent borne.

In addition, should Licensee be required, in order to lawfully exercise its rights as to a Licensed Product, obtain additional rights in a country to patents of any Third Parties which are not Affiliates of Licensee, which patents are (i) pending or issued on the Effective Date, and (ii) required for Licensee to practice the inventions described in the Licensed Patent Rights or Licensed Technology or exercise the license granted under this Agreement for reasons not attributable to a design selection made by Licensee for which alternative design selections not requiring such additional rights are available, then Licensee may also deduct from Net Sales with respect to a designated period the amount of the royalty Licensee is required to pay to such Third Party or Parties for such necessary rights to such patents with respect to such Licensed Product; provided that in no event (i) shall the amount of Net Sales for any designated period be reduced by more than [***] on account of royalties paid to Third Parties, and any amount so disallowed shall be lost and not carried forward and (ii) no such reduction shall be permitted with respect to additional rights obtained more than [***] after the First Commercial Sale in such country.

“Net Sales” shall not include amounts invoiced to or otherwise payable by Licensee, any of its Affiliates and/or any Sublicensees for Licensed Products sold or otherwise transferred to Licensee or any of its Affiliates and/or its Sublicensees, unless the Licensed Product is consumed by the invoiced entity.

 


1.12 “ Product Trademark ” shall mean the mark “V-Stent”, U.S. Trademark Application Serial Number 77273484.

1.13 “ Sublicensee ” shall mean any Third Party to whom Licensee grants a sublicense of some or all of the rights granted to Licensee under this Agreement.

1.14 “ Technology ” shall mean all of the following intangible legal rights, whether or not filed, perfected, registered or recorded, applicable to the Licensed Field: (i) inventions, patents, patent disclosures, patent rights, including any and all continuations, continuations-in-part, divisionals, reissues, reexaminations, utility models, industrial designs and design patents or any extensions thereof, (ii) rights associated with works of authorship, including without limitation, copyrights, copyright applications and copyright registrations and (iii) any and all proprietary ideas, inventions, discoveries, Confidential Information, data, results, formulae, designs, specifications, methods, processes, techniques, ideas, know-how, technical information (including, without limitation, structural and functional information), process information, pre-clinical information, clinical information, and any and all proprietary control and manufacturing data and materials, whether or not patentable.

1.15 “ Term ” shall have the meaning given in Section 9.1.

1.16 “ Territory ” shall mean all countries and jurisdictions of the world.

1.17 “ Third Party ” shall mean any person or entity other than Licensee, Licensor and their respective Affiliates.

2. GRANT OF RIGHTS

2.1 License to Licensee .

2.1.1 Grant of License . Licensor hereby grants to Licensee an exclusive (even as to Licensor and its Affiliates), royalty-bearing license, including the right to grant sublicenses in accordance with Subsection 2.1.2, under the Licensed Patent Rights and Licensed Technology: (i) to conduct research and development in support of the licensed uses describe in clause (ii) of this Subsection, and (ii) to make, have made, import, export, use, offer for sale or sell Licensed Products in the Licensed Field, subject to the terms and conditions of this Agreement. In addition, Licensor hereby grants to Licensee an exclusive license, including the right to grant sublicenses in accordance with Subsection 2.1.2, to use and display the Product Trademarks in connection with the exercise of its rights under the license grant in clause (ii) of this Subsection, subject to the terms and conditions of this Agreement.

2.1.2 Right to Sublicense . Licensee shall have the right to grant sublicenses, subject to the terms of this Agreement, to all or any portion of its rights under the license granted pursuant to this Section.

2.2 Right of First Discussion in Relation to Sales of Licensed Patent Rights or Licensed Technology . In the event that Licensor decides to sell any of the Licensed Patent Rights or Licensed Technology (subject, of course, to this Agreement), it shall give

 


prompt notice thereof to the Licensee. Such notice shall include a description of the Licensed Patent Rights or Licensed Technology to be sold. Thereafter, Licensee shall have [***] to notify Licensor whether Licensee is interested in commencing negotiations to obtain a fully-paid license to such Licensed Patent Rights or Licensed Technology in the Licensed Field. If Licensee does not give such notice within such [***] period, Licensor shall be entitled to sell such Licensed Patent Rights or Licensed Technology as it sees fit. If Licensee gives such written notice within such [***], the parties shall for a further [***] from the giving of such notice, or such longer time period as upon which the Parties mutually agree in writing, negotiate in good faith as to the terms of such fully-paid license in the Licensed Field, and Licensor shall not be entitled to commence negotiations with any Third Party with respect to the sale of such Licensed Patent Rights or Licensed Technology, or sell such Licensed Patent Rights or Licensed Technology, until the end of such [***] day or longer agreed-upon period, after which it shall be free to negotiate or sell such intellectual property as it sees fit.

2.3 Right of First Discussion as to New In-Field License . If, at any time during the term of the Agreement, Licensor acquires or develops intellectual property in respect of uses or applications within [***] (a “New In-Field Use”) which is not included in the Licensed Technology and which Licensor has the right to disclose and license without the payment of royalties or other consideration to any Third Party, it shall give prompt notice thereof to the Licensee. Such notice shall include a description of the intellectual property which Licensor has acquired or developed. Thereafter, Licensee shall have [***] to notify Licensor whether Licensee is interested in commencing negotiations to obtain a license to such rights (the “New In-Field License”). If Licensee does not give such notice within such [***] period, Licensor shall be entitled to license such intellectual property as it sees fit. If Licensee gives such written notice within such [***], the parties shall for a further sixty (60) days from the giving of such notice, or such longer time period as upon which the Parties mutually agree in writing, negotiate in good faith as to the terms of such New In-Field License, and Licensor shall not be entitled to commence negotiations with any Third Party in respect to a license of such intellectual property, or license such intellectual property, within the Licensed Field until the end of such [***] or longer agreed-upon period, after which it shall be free to negotiate or license such intellectual property as it sees fit. For the sake of clarity, this Section 2.2 does not apply to any intellectual property that is included in Licensed Technology and, as such, is subject to the license grant under Section 2.1.

3. DEVELOPMENT AND COMMERCIALIZATION OF LICENSED PRODUCTS.

3.1 Commercialization .

3.1.1 Responsibility . From and after the Effective Date, Licensee shall have full control and authority over the development and commercialization of Licensed Products in the Licensed Field in the Territory. Without prejudice to Section 3.3 hereof, Licensee shall own all Technology resulting solely from the efforts of its agents, Affiliates and employees as a part of such development and commercialization, but for such purposes (or any other purpose of this Agreement) Licensor shall not be considered an agent of Licensee. All activities relating to development and commercialization under this Agreement shall be undertaken at Licensee’s sole cost and expense.

 


3.1.2 Diligence . After the Effective Date, Licensee will exercise commercially reasonable efforts to develop a Licensed Product, such commercially reasonable efforts to take into account the competitiveness of the marketplace, the proprietary position of the Licensed Product, the relative potential safety and efficacy of the Licensed Product, the cost of goods and availability of capacity to manufacture and supply the Licensed Product at commercial scale, the profitability of the applicable Licensed Product, and other relevant factors including, without limitation, technical, legal, scientific or medical factors. Following the First Commercial Sale of a Licensed Product, the Licensee shall use commercially reasonable efforts to engage no less than [***] clinicians reasonably acceptable to Licensor to serve as “product champions” for such Licensed Product.

3.2 Licensor Assistance . Prior to the First Commercial Sale of a Licensed Product, Licensor agrees that it shall provide commercially reasonable assistance to the Licensee in connection with the development and commercialization of a Licensed Product as described in Schedule B hereto in exchange for the compensation also described in Schedule B . Licensor shall own all Technology resulting solely from the efforts of the agents, Affiliates and employees of Licensor as a part of such development and commercialization, (but for such purposes (or any other purpose of this Agreement) Licensee shall not be considered an agent of Licensor), but such Technology shall be deemed included in the Licensed Technology.

3.3 Joint Inventions . Technology conceived, developed or reduced to practice jointly by employees or consultants of Licensor and Licensee during the term hereof shall be jointly owned by them (“Joint Inventions”). For purposes of this Section 3.3 Technology that is the subject of a patent application shall be deemed to have been developed jointly by employees or consultants of Licensee and Licensor, and thus be a Joint Invention, if at least one employee or consultant of each of Licensee and Licensor is required to be named as an inventor in such application in order for such patent to be valid, and a comparable concept shall apply to Technology not the subject of a patent application. Subject to its right of abandonment or other forfeiture, Licensee shall be responsible, at its costs, for preparing, filing and, prosecuting patent applications which are available with respect to Joint Inventions in the [***] (and elsewhere as it may elect), using patent counsel reasonably chosen by Licensee, and for maintaining any patents obtained thereon. Licensee shall keep Licensor reasonably appraised as to the prosecution of each such patent application. Licensee agrees to send Licensor copies of all file histories and prosecution documents for each of the patent applications of the Licensed Patent Rights, within thirty (30) days of receipt by Licensor. Licensee shall have the right in its discretion to abandon or otherwise cause or allow to be forfeited, any patents or applications therefore as to Joint Inventions. Licensee shall give Licensor at least sixty (60) days written notice prior to abandonment or other forfeiture so as to permit, but not obligate, Licensor, to file, in the name of Licensor, for protection as to such patent or application, at its cost and expense, and Licensee shall have no interest in such patent or applications or underlying Joint Inventions (which shall thereupon cease to be Joint Inventions by shall rather be Confidential Information of Licensor). In any event each Party will, and will cause its employees and consultants to, provide any assistance and executed agreements and instruments as are reasonably requested by a Party which is seeking to obtain in accordance herewith patents or other protection with respect to any Joint Inventions.

 


3.4 Licensee License Grant . Licensee hereby grants to Licensor:

3.4.1 Non-exclusive License . a non-exclusive, fully-paid and royalty-free, perpetual license, including the right to grant sublicenses, under all Technology owned by Licensee as a result of the activities set forth in Section 3.1: (i) to conduct research and development in support of the licensed uses describe in clause (ii) of this Subsection, and (ii) to make, have made, import, export, use, offer for sale or sell any component or product for indications outside of the treatment of spinal disorders, subject to the terms and conditions of this Agreement; and

3.4.2 Exclusive License . an exclusive, fully-paid and royalty-free, perpetual license, including the right to grant sublicenses, under its interest in all Joint Inventions: (i) to conduct research and development in support of the licensed uses describe in clause (ii) of this Subsection, (ii) to make, have made, import, export, use, offer for sale or sell any component or product for indications outside of the treatment of spinal disorders, subject to the terms and conditions of this Agreement, and (iii) to prosecute at Licensor’s sole cost and for its sole benefit infringements of Joint Inventions within the scope of the licenses granted in clauses (i) and (ii) of this Subsection 3.4.2.

4. PAYMENTS AND ROYALTIES

4.1 Initial Payment; Milestone Payments, Payment of Royalties; Royalty Rates; Minimum Royalties; Milestone Payments .

4.1.1 Initial Payment . Licensee shall pay Licensor a lump-sum, fully-earned and non-refundable payment of [***] within three (3) business days of delivery by Licensor to Licensee of a preliminary specification for an initial Licensed Product as defined in Schedule C , which sum shall not be credited against or otherwise reduce any other amounts payable hereunder. Such delivery shall occur not later than [***].

4.1.2 Milestone Payments . Licensee shall pay Licensor milestone payments (each a “Milestone Payment”) in the amount specified below no later than thirty (30) days after the occurrence of the corresponding event designated below, unless this Agreement has been terminated prior to such due date. No Milestone Payments described in this Subsection 4.1.2 shall be credited against or otherwise reduce any other amounts payable hereunder.

 

Event

  

Milestone Payment

[***]    [***]
[***]    [***]
[***]    [***]
[***]    [***]
[***]    [***]

 


4.1.3 Royalty Payments . During the Term, Licensee shall pay to Licensor within thirty (30) days of the end of each calendar quarter earned royalties of [***] of Net Sales during such calendar quarter. Each royalty payment shall (i) be accompanied by a report specifying: the Net Sales (including an accounting of deductions taken in the calculation of Net Sales) and (ii) state the applicable exchange rate used in conversion from any foreign country’s currency to United States Dollars (which conversion shall be determined in accordance with Subsection 4.2.2). Earned royalties described in this Subsection 4.1.3 shall only be credited against minimum royalties which would otherwise be due as contemplated by Subsection 4.1.4 and shall not be credited against or otherwise reduce any other amounts payable hereunder.

4.1.4 Minimum Royalties . Licensee shall pay Licensor the following minimum annual royalty amounts in each calendar year listed next to such amount. No minimum annual royalty described in this Subsection 4.1.4 shall be credited against or otherwise reduce any other amounts payable hereunder. For a particular calendar year, in the event that the sum of the earned royalties on Net Sales timely paid in accordance with Subsection 4.1.3 above with respect to the four calendar quarters of such calendar year are less than the minimum annual royalty for such year designated below, the obligation to pay the difference to Licensor shall accrue on the last day of such calendar year and be payable by Licensee no later than [***] following the end of such calendar year:

 

Calendar Year Ending

  

Minimum Annual Royalty

[***]    [***]
[***]    [***]
[***]    [***]
[***]    [***]

4.1.5 One Royalty . Only one royalty shall be payable to Licensor hereunder for each sale of a Licensed Product, notwithstanding that more than one patent or patent claim reads upon such Licensed Product and/or such Licensed Product embodies or was made using one or more aspects of Licensed Technology.

4.2 Payment, Conversion and Withholding .

4.2.1 Payment . All payments hereunder shall originate in the United States and be made in United States dollars. Licensor hereby directs that all payments, save payments for services and expense reimbursement as contemplated by Section 3.2, be divided as follows and paid by wire transfer or other means reasonably selected by the payee to the following persons or as they shall direct from time to time:

 

[***]

  

[***]

[***]

   [***]

[***]

   [***]

 


4.2.2 Conversion . Conversion of foreign currency to United States dollars shall be made at the conversion rate existing in the United States (as reported in The Wall Street Journal ) on the last business day of the quarter immediately preceding the applicable calendar quarter. If The Wall Street Journal ceases to be published, then the rate of exchange to be used shall be that reported in such other business publication of national circulation in the United States as the Parties reasonably agree.

4.2.3 Tax Withholding; Restrictions on Payment . All taxes, assessments and fees of any nature levied or incurred on account of any payments from Licensee to Licensor accruing under this Agreement, by national, state or local governments, will be assumed and paid by Licensee, except taxes levied thereon as income to Licensor and if such taxes are required by applicable law to be withheld by Licensee they will be deducted from payments due to Licensor and will be timely paid by Licensee to the proper taxing authority for the account of Licensor, a receipt or other proof of payment therefore secured and sent to Licensor as soon as practicable. Licensee shall remit all payments to Licensor hereunder from within the United States.

4.3 Records Retention; Review .

4.3.1 Royalties . Licensee shall keep accurate books and accounts of the computation of the number of Licensed Products sold and the Net Sales of Licensee, its Affiliates and Sublicensees of Licensed Products, and shall cause such Affiliates and Sublicensees to keep such records of their respective sales of Licensed Products and Net Sales of Licensed Products, in sufficient detail to permit accurate determination of all figures ne


 
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