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EXCLUSIVE LICENSE AGREEMENT

License Agreement

EXCLUSIVE LICENSE AGREEMENT | Document Parties: ALPHATEC HOLDINGS, INC. | Alphatec Spine, Inc | JGMG Bengochea, LLC You are currently viewing:
This License Agreement involves

ALPHATEC HOLDINGS, INC. | Alphatec Spine, Inc | JGMG Bengochea, LLC

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Title: EXCLUSIVE LICENSE AGREEMENT
Governing Law: California     Date: 11/9/2007
Industry: Medical Equipment and Supplies     Law Firm: Rogers Towers, P.A.;Heller Ehrman, LLP     Sector: Healthcare

EXCLUSIVE LICENSE AGREEMENT, Parties: alphatec holdings  inc. , alphatec spine  inc , jgmg bengochea  llc
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Exhibit 10.1

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 an address of 2051 Palomar Airport Road, Suite 100, Carlsbad, California 92008 (“Licensee”), and JGMG Bengochea, LLC, a Florida limited liability company, with an address of 4901 VanDiveer Rd., Jacksonville FL 32210 (“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 “ Change of Control ” shall mean (a) the sale or disposition of all or substantially all the assets of the Licensee or its parent corporation; or (b) the reorganization, merger, consolidation, or similar transaction involving the Licensee or its parent corporation which results in the voting securities of such entity outstanding immediately prior to that transaction ceasing to represent at least 50% of the combined voting power of the surviving entity immediately after such transaction.

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.

 


1.3 “ Design Freeze ” shall mean, with respect to a particular Licensed Product, the date on which the Licensee has made a written decision that the design engineering with respect to such Licensed Product is complete and such Licensed Product is ready for volume production.

1.4 “ GLIF Product ” shall mean the guided lumbar interbody fusion system and the corresponding implants and instrumentation.

1.5 “ Improvements ” shall mean any enhancement, invention or discovery created or identified or controlled by Licensor during the Royalty Term, which constitutes an improvement to the subject matter of the Licensed Patent Rights or Licensed Technology.

1.6 “ IndemniteesandIndemnifying Party ” shall mean a Party, its affiliates and their respective directors, officers, employees, stockholders and agents and their respective successors, heirs and assigns.

1.7 “ Licensed Patent Rights ” shall mean (a) 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; or (b) any patent application arising from the Licensed Technology, 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.

1.8 “ Licensed Product ” shall mean any product sold by Licensee or its affiliates or Sublicensees that, absent the license provided in this Agreement, would infringe a Valid Claim of the Licensed Patent Rights, including without limitation Valid Claims of the Licensed Patent Rights covering the GLIF Product.

1.9 “ Licensed Technology ” shall mean and include all Technology, whether or not patentable, including but not limited to, techniques and materials, owned or controlled by Licensor as of the Effective Date or which becomes owned or controlled by Licensor during the Royalty Term that (a) (i) is related to any patent or patent application included in the Licensed Patent Rights, (ii) is necessary or useful for Licensee to practice the license granted to it hereunder, and (iii) which is not in the public domain; or (b) (i) is related to any of the products listed on Exhibit B attached hereto, (ii) is necessary or useful for Licensee to practice the license granted to it hereunder, and (iii) which is not in the public domain.

1.10 “ Licensee Inventions ” shall mean any enhancement, invention or discovery created or identified, owned or controlled by Licensee that does not fall within the Licensed Technology.

1.11 “ Market Launch ” shall mean, with respect to a Licensed Product, the first full-scale national commercial launch of such Licensed Product following the Licensee's building of an amount of inventory necessary to conduct such full-scale national commercial launch.

 

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1.12 “ Net Sales ” shall mean the amount received by Licensee for all Licensed Products sold by Licensee, its affiliates or Sublicensees to Third Parties throughout the Territory during each calendar quarter, less the following amounts incurred or paid by Licensee or its affiliates or Sublicensees during such calendar quarter with respect to sales of Licensed Products regardless of the calendar quarter in which such sales were made:

(a) trade, cash and quantity discounts or rebates actually allowed or taken, including discounts or rebates to governmental or managed care organizations;

(b) credits or allowances actually given or made for rejection of, and for uncollectible amounts on, or return of previously sold Licensed Products (including Medicare and similar types of rebates);

(c) 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;

(d) 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) borne by the seller thereof, other than franchise or income tax of any kind whatsoever; and

(e) any import or export duties or their equivalent borne by the seller.

“Net Sales” shall not include sales or transfers between Licensee and its affiliates or Sublicensees, unless the Licensed Product is consumed by the affiliate or Sublicensee.

1.13 “ Royalty Term ” shall mean, with respect to each Licensed Product, the period commencing on the Effective Date and continuing on a country-by-country, and product-by-product basis until the longer of (a) the last to expire of the Licensed Patent Rights covering the Licensed Product, or (b) [***] years from the Effective Date.

1.14 “ 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.

1.15 “ Technology ” shall mean and include any and all unpatented, proprietary ideas, inventions, discoveries, Confidential Information, data, results, formulae, designs, images, specifications, instruction manuals, SOPs, methods, processes, techniques, ideas, know-how, technical information (including, without limitation, structural and functional information), notebooks, process information, pre-clinical information, clinical information, and any and all proprietary control and manufacturing data and materials.

1.16 “ Term ” shall mean the period commencing on the Effective Date and continuing until the end of the last Royalty Term, unless this Agreement is terminated or expires sooner in accordance with the terms of this Agreement.

 

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

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

1.19 “ Valid Claim ” shall mean a claim indicated as allowable in an issued, unexpired patent or in a pending patent application within the Licensed Patent Rights that (a) has not been finally cancelled, withdrawn, abandoned or rejected by any administrative agency or other body of competent jurisdiction, (b) has not been revoked, held invalid, or declared unpatentable or unenforceable in a decision of a court or other body of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, (c) has not been rendered unenforceable through disclaimer or otherwise, and (d) is not lost through an interference proceeding.

2. GRANT OF RIGHTS

2.1 License to Licensee .

2.1.1 Grant of License . Licensor hereby grants to Licensee an exclusive, royalty-bearing license, including the right to grant sublicenses in accordance with Section 2.1.2, under the Licensed Patent Rights and Licensed Technology and Licensor’s interest in any Improvements, to develop, have developed, make, have made, use, have used, sell, offer for sale, have sold, import, have imported, export and have exported, Licensed Products and to practice the Licensed Technology in the Territory, for any and all uses, subject to the terms and conditions of this Agreement.

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

2.1.3 Retained Rights . Subject to the other terms of this Agreement, Licensor retains no right to use the Licensed Technology or practice the Licensed Patent Rights or to use Licensor’s interest in Improvements.

3. RESPONSIBILITY FOR LICENSED PRODUCTS.

3.1 Responsibility and Assistance .

3.1.1 Responsibility . From and after the Effective Date, Licensee shall have full control and authority over the development, commercialization and regulatory approval of Licensed Products in the Territory. Licensee shall own all Licensee Inventions and data, results and all other information arising from any such activities under this Agreement. All activities relating to development and commercialization under this Agreement shall be undertaken at Licensee’s sole cost and expense, except as otherwise expressly provided in this Agreement.

 

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3.1.2 Licensor Assistance . Licensor agrees that it shall provide commercially reasonable assistance to the Licensee, to the extent that such assistance does not interfere with [***] practice of medicine, in connection with the development, commercialization and regulatory approval of (i) the GLIF Product, and (ii) Licensed Product's that relate to the Licensed Technology set forth on Exhibit B attached hereto. The Parties agree that the Licensor shall not be required to provide more than [***] per calendar quarter providing such assistance. In addition, the Parties agree that if the Licensee requests that such assistance be performed outside of the [***] that the Licensor shall be compensated at a rate of [***] per hour. Licensor shall promptly disclose to the Licensee all Licensed Patent Rights and all Licensed Technology which are created, become owned or controlled by the Licensor during the [***] following the Effective Date. Licensee shall reimburse Licensor for any reasonable out-of-pocket expenses in connection therewith.

4. PAYMENTS AND ROYALTIES

4.1 Common Stock Issuance; Milestone Payments and Royalty Payments .

4.1.1 Common Stock Issuance . Within thirty (30) days of the Effective Date Licensee shall issue to Licensor seven hundred fifty thousand (750,000) shares of Alphatec Holdings, Inc. Common Stock (the “Common Stock”). [***] shares of the Common Stock shall be subject to a lockup (the “Lockup”) pursuant to which the Licensor shall agree to not directly or indirectly, offer, sell, contract to sell, grant any option to purchase, hypothecate, pledge, or otherwise dispose of or transfer title to any of the Common Stock for a period of [***] years after the date that the stock is granted. Notwithstanding the previous sentence (a) in the event of a Change of Control, [***], (b) upon the Design Freeze of the GLIF Product [***], and (c) upon the Market Launch of the GLIF Product [***].

4.1.2 Milestone Payments . Licensee shall pay Licensor a milestone payment (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. All Milestone Payments described in this Section 4.1.2 shall not be credited against earned royalties.

 

Event

  

Milestone Payment

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

 

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4.1.3 Market Launch Milestone. In the event that the Market Launch of the GLIF Product has not occurred within [***] of the Effective Date (the “GLIF Projected Market Launch Date”), the Licensor shall be entitled to terminate the license granted pursuant to this Agreement with respect to the Licensed Patent Rights and the Licensed Technology, unless the primary reason that such launch date has not been met is due to the Licensor's failure to meet the obligations set forth in Section 3.1.2; provided that the Licensor shall not be entitled to terminate under this section the license granted pursuant to this Agreement with respect to the Licensed Patent Rights and Licensed Technology if the Licensee pays the Licensor [***] within [***] after the GLIF Projected Market Launch Date, such payment to be in addition to and not credited against future royalties due to Licensor.

4.1.4 Royalty Payments for GLIF Product . During the Royalty Term, Licensee shall pay to Licensor earned royalties at the rate of [***] of all Net Sales of the GLIF Product sold by Licensee.

4.1.5 Royalty Payments for Non-GLIF Licensed Products . During the Royalty Term, Licensee shall pay to Licensor earned royalties at the rate of [***] of all Net Sales of Licensed Products (excluding the GLIF Product) sold by Licensee.

4.1.6 Minimum Royalties . Licensee shall pay Licensor the following minimum amounts each calendar year listed next to such amount. No minimum annual royalty described in this Subsection 4.1.6 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 paid in accordance with Subsections 4.1.4, 4.1.5 and 4.1.7 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 (the “Royalty Shortfall Payment”) shall be payable by Licensee no later than [***] following the end of such calendar year:

 

Calendar Year Ending

  

Minimum Annual Royalty

[***]

   [***]

[***]

   [***]

In the event that the Licensee fails to pay the Royalty Shortfall Payment within the applicable time period, the Licensor shall be entitled to terminate this Agreement, provided that the Licensor gives notice of the requirement to pay the Royalty Shortfall Amount to the Licensee and gives the Licensee [***] to pay such amount.

 

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4.1.7 Payment of Royalties . For purposes of determining when a sale of any Licensed Product occurs under this Agreement, the sale shall be deemed to occur on the date the Licensed Product is invoiced and paid for in full by the purchaser. Each royalty payment shall be accompanied by a report specifying: the Net Sales (including an accounting of deductions taken in the calculation of Net Sales); the applicable exchange rate to convert from any foreign country’s currency to United States Dollars (which calculation shall be determined in accordance with Section 4.2.1); and the royalties payable in United States Dollars. Unless otherwise expressly provided, Licensee shall make any royalty payments owed to Licensor hereunder in arrears, within thirty (30) days from the end of each quarter in which such payment accrues.

4.1.8 Third Party Royalty Offset . In the event that Licensee, in order to exploit the license granted to it under Section 2.1 of this Agreement, makes payments to one or more Third Parties (“Third Party Payments”) as consideration for a license to intellectual property, in the absence of which the Licensed Product could not legally be used or sold in such country, then Licensee shall have the right to reduce the royalties otherwise due to Licensor in Sections 4.1.3 and 4.1.4 for such Licensed Product by [***] of such Third Party Payments. Payments to any Third Party by Licensee shall be cumulative and any excess payments uncredited to a particular royalty payment period shall be credited to future royalty payments owed by Licensee or until fully credited. The Parties agree that the Third Party Payments referred to in this Section 4.1.8 shall not apply to any royalty obligations to which the Licensee is a party as of the Effective Date.

4.1.9 One Royalty . Only one royalty, shall be payable to Licensor hereunder for each sale of a Licensed Product.

4.2 Accounting and Withholding .

4.2.1 Accounting . All payments hereunder shall be made in the United States in United States dollars. 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.

4.2.2 Tax Withholding; Restrictions on Payment . Licensee shall make, out of amounts due Licensor, any applicable withholding or other required tax or duty payments it is required by law to make on behalf of Licensor and shall provide Licensor upon request with such written documentation regarding any such payment as available to Licensee relating to an application by Licensor for a foreign tax credit for such payment with the United States Internal Revenue Service.

 

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4.3 Royalty Payments; Review .

4.3.1 Royalties . Commencing as of the date of first commercial sale of the first Licensed Product hereunder, Licensee and its affiliates and Sublicensees shall keep for at least two (2) years from the end of the calendar year to which they pertain, complete and accurate records of sales by Licensee or its affiliates and Sublicensees, as the case may be, of each Licensed Product, in sufficient detail to allow the accuracy of the payments hereunder to be confirmed.

4.3.2 Review . At the request of Licensor, which shall not be made more frequently than once per calendar year during the Term, upon at least thirty (30) days’ prior written notice from Licensor, and at the expense of Licensor; Licensee shall permit, u


 
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