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CROSS LICENSE AGREEMENT

License Agreement

CROSS LICENSE AGREEMENT | Document Parties: Alphatec Holdings, Inc | Alphatec Spine, Inc | International Spinal Innovations, LLC You are currently viewing:
This License Agreement involves

Alphatec Holdings, Inc | Alphatec Spine, Inc | International Spinal Innovations, LLC

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Title: CROSS LICENSE AGREEMENT
Governing Law: California     Date: 8/4/2009
Industry: Medical Equipment and Supplies     Sector: Healthcare

CROSS LICENSE AGREEMENT, Parties: alphatec holdings  inc , alphatec spine  inc , international spinal innovations  llc
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Exhibit 10.1

CROSS LICENSE AGREEMENT

This License Agreement (this “Agreement”) is made effective as of June 30, 2009 (the “Effective Date”) by and among Alphatec Spine, Inc., a Delaware corporation with a principal place of business at 5818 El Camino Real, Carlsbad, California 92008 (“Alphatec”), International Spinal Innovations, LLC, a limited liability company organized under the laws of the state of Connecticut, with an address at 97 Balfour Drive, West Hartford, CT 06117 (“ISI”), and, for purposes of Sections 4.1, 4.4, 7.3, and 11.15 hereof only, Alphatec Holdings, Inc., a Delaware corporation with a principal place of business at 5818 El Camino Real, Carlsbad, California 92008 (“Holdings”). Alphatec and ISI are each hereafter referred to individually as a “Party” and together as the “Parties”.

WHEREAS, ISI is the owner of, or otherwise controls, certain proprietary Licensed ISI Patents (hereinafter defined);

WHEREAS, Alphatec is the owner of, or otherwise controls, certain proprietary Licensed Alphatec Patents (hereinafter defined);

WHEREAS, Alphatec desires to obtain a license from ISI to the Licensed ISI Patents to develop and commercialize Licensed Alphatec Products (hereinafter defined);

WHEREAS, ISI desires to obtain a license from Alphatec to the Licensed Alphatec Patents to develop and commercialize Licensed ISI Products (hereinafter defined); and

WHEREAS, ISI and Alphatec each desire to cross-license the other 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 this 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

Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately

with the Secretary of the Commission pursuant to the Registrant’s application requesting

confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as

amended.


1.2 “ Common Stock ” shall mean the common stock of Holdings, which trades on Nasdaq under the symbol ATEC and any securities into which such common stock may hereafter be reclassified, converted or exchanged.

1.3 “ 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 known to the Receiving Party or its Affiliates other than by virtue of a prior confidential disclosure to the Receiving 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.

1.4 “ Guarantee and Agreement ” shall mean the guarantee and agreement of Holdings set forth in Section 11.15 hereof.

1.5 “ Alphatec Inventions ” shall mean any enhancement, invention or discovery created or identified, owned or controlled by Alphatec that does not fall within the Licensed ISI Patents. Alphatec Inventions shall not include any invention conceived in whole or in part before or after the Effective Date by ISI or any of its agents, employees, consultants, or representatives except as provided for in Section 3.1.1 of this Agreement.

1.6 “ ISI Inventions ” shall mean any enhancement, invention or discovery created or identified, owned or controlled by ISI that does not fall within the Licensed Alphatec Patents. ISI Inventions shall not include any invention conceived in whole or in part before or after the Effective Date by Alphatec or any of its agents, employees, consultants (including when ISI acts as a consultant for Alphatec) or representatives.

1.7 “ ISI Indemnitees ” and “ Alphatec Indemnitees ” (each individually an “ Indemnitee ”) shall have the meaning given in Section 8.1.

1.8 “ Licensed Field ” shall mean [***] .

1.9 “ Licensed ISI Patents ” shall mean the patents and patent applications described in Schedule A attached hereto, and all 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 all foreign counterparts to any of the foregoing.

 

2

Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately

with the Secretary of the Commission pursuant to the Registrant’s application requesting

confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as

amended.


1.10 “ Licensed Alphatec Patents ” shall mean the patents and patent applications described in Schedule B 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.

1.11 “ Licensed Alphatec Product ” shall mean any product sold by Alphatec, its affiliates, or Sublicensees that, absent the license provided in this Agreement, would infringe a Valid Claim of the Licensed ISI Patents.

1.12 “ Licensed ISI Product ” shall mean [***] made, used, offered for sale, or sold by ISI, its affiliates, or Sublicensees that, absent the license provided in this Agreement, would infringe a Valid Claim of the Licensed Alphatec Patents.

1.13 “ Net Sales ” shall mean the gross amount invoiced or otherwise payable to Alphatec, its Affiliates, or Sublicensees on account of sales or other transfers of a Licensed Alphatec 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):

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

1.13.2 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 Alphatec Products;

1.13.3 sales commissions paid to a Third-Party;

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

1.13.5 any tax, tariff, duty or governmental charge levied on the sales, transfer, transportation or delivery of a Licensed Alphatec 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

1.13.6 any import or export duties or their equivalent borne.

In addition, should Alphatec be required, in order to lawfully exercise its rights as to a Licensed Alphatec Product, to obtain additional rights in a country to patents of any Third Parties which are not Affiliates of Alphatec, which patents are (i) pending or

 

3

Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately

with the Secretary of the Commission pursuant to the Registrant’s application requesting

confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as

amended.


issued on the Effective Date, and (ii) required for Alphatec to practice the inventions described in the Licensed ISI Patents, then Alphatec may also deduct from Net Sales with respect to a designated period the amount of the royalty Alphatec is required to pay to such Third Party or Parties for such necessary rights to such patents with respect to such Licensed Alphatec Product.

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

1.14 “ Shares ” shall have the meaning set forth in Paragraph 4.1.1(a) hereof.

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

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

1.17 “ 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, re-examinations, 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.

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

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

1.20 “ Third Party ” shall mean any person or entity other than Alphatec, ISI and their respective Affiliates.

1.21 “ Valid Claim ” shall mean a claim indicated as allowable in an issued, unexpired patent or in a pending patent application within the Licensed ISI Patents and Licensed Alphatec Patents 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 interference proceedings.

 

4

Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately

with the Secretary of the Commission pursuant to the Registrant’s application requesting

confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as

amended.


1.22 “ First Commercial Sale ” shall mean the date of the first transaction, transfer or disposition for value by or on behalf of Alphatec or any Affiliate or Sublicensee of Alphatec to a Third Party of a Licensed Alphatec Product.

2. GRANT OF RIGHTS

2.1 License Grant to Alphatec .

2.1.1 ISI Grant of License to Alphatec . ISI hereby grants to Alphatec an exclusive (even as to ISI, but subject to the limitations set forth in Subsection 2.1.2) royalty-bearing license, including the right to grant sublicenses, to the Licensed ISI Patents to make, have made, import, export, use, offer for sale or sell Licensed Alphatec Products in the Territory, and to conduct research and development in support of the aforementioned licensed uses, in all cases, subject to the terms and conditions of this Agreement. The license granted in this subsection shall entitle Alphatec to sell and market Licensed Alphatec Products through Third-Party distributors.

2.1.2 Limitation of ISI’s License Grant to Alphatec . With respect to any laterally delivered multi-shaft interbody implant, ISI’s license grant to Alphatec in Subsection 2.1.1 is non-exclusive, and shall only be sublicensable in accordance with Subsection 6.2.

2.2 License Grant to ISI . Alphatec hereby grants to ISI a non-exclusive, fully-paid, royalty-free license including the right to grant sublicenses, provided that such sublicense shall only be granted in accordance with Subsection 6.2, to the Licensed Alphatec Patents to make, have made, import, export, use, offer for sale or sell a Licensed ISI Product in the Territory, and to conduct research and development in support of the aforementioned licensed uses, in all cases, subject to the terms and conditions of this Agreement. The license granted in this subsection shall entitle ISI to sell and market ISI Products through Third-Party distributors.

3. DEVELOPMENT AND COMMERCIALIZATION OF LICENSED ALPHATEC PRODUCTS.

3.1 Commercialization .

3.1.1 Responsibility . From and after the Effective Date, Alphatec shall have full control and authority over the development and commercialization of Licensed Alphatec Products in the Licensed Field in the Territory. Alphatec shall own all Alphatec Inventions. Alphatec shall own all Technology resulting from (i) the joint efforts of the agents, Affiliates and employees of ISI and Alphatec during the term of this Agreement, or (ii) any efforts performed by ISI pursuant to Section 3.2.

 

5

Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately

with the Secretary of the Commission pursuant to the Registrant’s application requesting

confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as

amended.


3.1.2 Diligence . After the Effective Date, Alphatec will exercise commercially reasonable efforts to develop a Licensed Alphatec Product, such commercially reasonable efforts to take into account the competitiveness of the marketplace, the proprietary position of the Licensed Alphatec Product, the relative potential safety and efficacy of the Licensed Alphatec Product, the cost of goods and availability of capacity to manufacture and supply the Licensed Alphatec Product at commercial scale, the profitability of the applicable Licensed Alphatec Product, and other relevant factors including, without limitation, technical, legal, scientific or medical factors.

3.2 ISI Assistance . ISI shall transfer to Alphatec all drawings, prototypes and other related materials in its possession or control as of the Effective Date that relate to a single-shaft Licensed Alphatec Product (the “Prototype Transfer”). As consideration for the Prototype Transfer, within ten (10) business days of the receipt of an invoice from ISI, Alphatec shall reimburse ISI for all expenses incurred as of the Effective Date in connection with the creation of the materials that are the subject of the Prototype Transfer; provided that such payment shall not exceed [***] . In addition, upon Alphatec’s reasonable request, ISI will provide commercially reasonable assistance to develop Alphatec’s first Licensed Alphatec Product. Alphatec will pay ISI for such assistance [***] plus reasonable travel and out-of-pocket expenses.

4. PAYMENTS AND ROYALTIES

4.1 Initial Payment; Milestone Payments; Royalty Payments; Royalty Rates; and Minimum Quarterly Royalty .

4.1.1 Initial Payment Upon the terms and subject to the conditions contained herein, Alphatec shall issue and transfer with full title guaranteed, two hundred sixty thousand (260,000) shares (the “Shares”) of Common Stock (the “Share Payment”). ISI’s license grant to Alphatec constitutes full consideration for the Share Payment. The Share Payment shall be due and payable within twenty (20) business days of the Effective Date. The payment described in this Subsection 4.1.1 shall not be credited against or otherwise reduce any other amounts payable hereunder.

4.1.2 Milestone Payments . Alphatec shall pay milestone payments to ISI (each such payment a “Milestone Payment”) as specified below no more 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

[ *** ]

 

[ *** ]

[ *** ]

 

[ *** ]

[ *** ]

 

[ *** ]

 

6

Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately

with the Secretary of the Commission pursuant to the Registrant’s application requesting

confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as

amended.


4.1.3 Royalty Payments . During the Term of this Agreement, Alphatec shall pay to ISI within thirty (30) days of the end of each calendar quarter royalties of [***] of Net Sales of Licensed Alphatec Products. Only one royalty shall be payable to ISI pursuant to this Section 4.1.3 for each sale of a Licensed Alphatec Product, notwithstanding that more than one patent or patent claim reads upon such Licensed Alphatec Product.

4.1.4 Minimum Royalty Payment . In accordance with the chart set forth in this Subsection 4.1.4, Alphatec shall pay ISI a minimum annual royalty 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 year, in the event that the sum of the earned royalties on Net Sales paid pursuant to Subsection 4.1.3 above with respect to such calendar is less than the minimum annual royalty for such year designated below, the obligation to pay the difference to ISI shall accrue on the last day of such year and be payable by Alphatec no later than forty-five (45) days following the end of such year:

 

Twelve (12) Months Ending

 

Minimum Annual Royalty

[ *** ]

 

[ *** ]

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.

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 Alphatec to ISI accruing under this Agreement, by national, state or local governments, will be assumed and paid by Alphatec, except taxes levied thereon as income to ISI and if such taxes are required by applicable law to be withheld by Alphatec they will be deducted from payments due to ISI and will be timely paid by Alphatec to the proper taxing authority for the account of ISI, a receipt or other proof of payment therefore secured and sent to ISI as soon as practicable. Alphatec shall remit all payments to ISI hereunder from within the United States.

 

7

Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately

with the Secretary of the Commission pursuant to the Registrant’s application requesting

confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as

amended.


4.3 Records Retention; Review .

4.3.1 Record Retention . Alphatec shall keep accurate books and accounts of the computation of the number of Licensed Alphatec Products sold and the Net Sales of Alphatec, its Affiliates and Sublicensees of Licensed Alphatec Products, and shall cause such Affiliates and Sublicensees to keep such records of their respective sales of Licensed Alphatec Products and Net Sales of Licensed Alphatec Products, in sufficient detail to permit accurate determination of all figures necessary for verification of payments required to be paid hereunder, which books and accounts shall be maintained for at least three (3) years from the end of the calendar year to which they pertain.

4.3.2 Review . At the request of ISI, which shall not be made more frequently than once per calendar year during the Term, on a business day designated by ISI upon at least thirty (30) days’ prior written notice to Alphatec, Alphatec shall permit, under confidentiality obligations with terms substantially the same as those hereunder, an independent certified public accountant reasonably selected by ISI and reasonably acceptable to Alphatec to inspect (during regular business hours) the relevant records required to be maintained by Alphatec under Subsection 4.3.1. In the event such inspection reveals an underpayment, such underpayment shall be due and payable by Alphatec within thirty (30) days of the date of such inspection, together with interest thereon from the date the amount due but unpaid was first due until the date paid, at the lower of [***] per annum or the maximum rate permitted by applicable law. Such inspection shall be at the expense of ISI unless there is an underpayment that differs by greater than [***] from the amount that was otherwise due, in which event Alphatec shall pay the reasonable costs of the inspection. The foregoing is without prejudice to the right of Alphatec to dispute the conclusion of the accountant, but such dispute shall not relieve Alphatec of its obligation to pay interest and, under the circumstances described, costs of inspection as to amount actually due.

4.4 Matters Related to the Issuance of Common Stock .

4.4.1 Representations, Warranties and Certain Covenants of Alphatec and of Holdings . Alphatec and Holdings, each separately and jointly represent, warrant, and covenant that:

(a) Assuming the covenant of ISI contained in Subsection 4.4.2 of this Agreement is complied with, the issuance to ISI of each Share will be in compliance with all applicable federal and state securities laws in connection with the offer, issuance and sale of the securities.

(b) The execution, delivery and performance of this Agreement by Holdings, the issuance and sale of the Shares and the consummation by Holdings of the other transactions by it contemplated hereby do not and will not on the date of the

 

8

Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately

with the Secretary of the Commission pursuant to the Registrant’s application requesting

confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as

amended.


issuance and sale of the Shares (i) conflict with or violate any provision of Holdings’ or any of its subsidiaries certificates or articles of incorporation, bylaws or other organizational or charter documents, or (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any lien or encumbrance upon any of the properties or assets of Holdings or any of its subsidiaries, or give to others any rights of termination, amendment, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other instrument or other understanding to which Holdings or any of its subsidiaries is a party or by which any property or asset of Holdings or any such subsidiary is bound or affected, in each case with respect to this Subsection (ii), to a degree that would have a material adverse effect on the assets or results of operations of Holdings or its subsidiaries when considered as a whole (a “Material Adverse Effect”), or (iii) conflict with or result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which Holdings or any such subsidiary is subject (including federal and state securities laws and regulations), or by which any property or asset of Holdings or any such subsidiary is bound or affected, in each case with respect to this Subsection (iii), to a degree that would have a Material Adverse Effect.

(c) Prior to the issuance of the Shares, Holdings shall obtain all consents, approvals, orders, authorizations or registrations, qualifications, designations, declarations, and make all filings or registrations with any court or other federal, state, local or other governmental authority or other person that is required in order to issue the Shares.

(d) The Shares, when issued in accordance herewith, will be (i) duly authorized, (ii) duly and validly issued, (iii) fully paid and nonassessable, and (iv) free and clear of all liens or encumbrances imposed by Holdings, other than restrictions on transfer provided for herein.

(e) At all times prior to the second anniversary of the last issuance of the Shares during which there are Shares outstanding which have not been previously (i) sold or transferred to or through a broker or dealer or underwriter in a public distribution, or (ii) sold or transferred in a transaction exempt from the registration and prospectus delivery requirements of the Securities Act of 1933, as amended (the “Securities Act”), in the case of either Subsection (i) or Subsection (ii) in such a manner that, upon the consummation of such sale or transfer, all transfer restrictions and restrictive legends with respect to such Shares upon the consummation of such sale or transfer and Holdings shall use its commercially reasonable efforts to: (1) comply with the requirements of Rule 144(c) under the Securities Act with respect to current public information about Holdings, and (2) furnish to ISI such non-publicly available reports and documents of Holdings as ISI may reasonably request to avail itself of Rule 144 of the Securities Act, or any similar rule or regulation of the United States Securities Exchange Commission allowing ISI to sell the Shares without registration.

4.4.2 Representations and Warranties of ISI . ISI represents and warrants that (i) it is an “accredited investor” as that term is defined in Rule 501(a) of Regulation D of the Securities Act; (ii) it is acquiring the Shares for investment for ISI’s own

 

9

Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately

with the Secretary of the Commission pursuant to the Registrant’s application requesting

confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as

amended.


account and not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, without prejudice, however, to ISI’s right to at all times to sell or otherwise dispose of any or all of the Shares so issued in compliance with applicable federal and state securities laws and (iii) it does not have any contract, undertaking, agreement or arrangement with any person to sell, transfer or grant participation to such person or to any third pers


 
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