LICENSE AGREEMENT

Exhibit 10.7

LICENSE AGREEMENT

THIS LICENSE AGREEMENT (“ Agreement ”) is effective as of the 22nd day of December, 2003 (the “Effective Date”) by and between Devax, Inc., a Delaware corporation (“Devax”), and Occam International, B.V., a Netherlands corporation (“Occam”), a wholly owned subsidiary of Sun Biomedical, Ltd., a Bermuda corporation. Occam and Devax will be referred to collectively as the “ Parties ”.

RECITALS

A. Occam and its Affiliates are engaged in conducting research and clinical trials relating to drug-eluting stents using various proprietary drug compounds. In the course of such research and clinical trials, Occam has acquired and/or developed certain proprietary technologies and techniques, including Occam’s Drug/Polymer Composite Formulation (as set forth on Exhibit 2, attached hereto).

B. Devax possesses the rights to certain bifurcated stent systems (conical and cylindrical) used in connection with the treatment of vascular bifurcations (the “Devax Stents”).

C. Devax desires to license from Occam, and Occam desires to license to Devax, the right to use Occam’s Drug/Polymer Composite Formulation on Devax Stents, subject to the terms and conditions of this Agreement.

D. Devax desires to utilize the services of Occam or its designee for the purpose of coating Devax’s stents with Occam’s Drug/Polymer Composite Formulation, subject to the terms and conditions of this Agreement.

NOW, THEREFORE, in consideration of the mutual agreements contained in this Agreement, the Parties agree as follows:

ARTICLE I

DEFINITIONS

For purposes of this Agreement, the following terms will have the meanings set forth below (such definitions to be equally applicable to both the singular and plural forms of the terms defined). Except as otherwise indicated, all agreements or instruments defined or identified below will mean such agreements or instruments as from time to time assigned, modified, supplemented or amended in accordance with their respective terms.

1.1 “ Affiliate ” of a Person means another Person controlled by, controlling or under common control with such Person. For purposes of this definition, “control” means direct or indirect beneficial ownership of at least fifty percent (50%) of the voting interest or equity of such Person.

1.2 “ Biolimus A9 ” means the rapamycin derivative synthesized by Occam or its Affiliates which is used by Biosensors Singapore in its STEALTH I trial in Europe and further described in the patent applications in Exhibit 1 .

 

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1.3 “ CE Mark ” means the declaration of conformity according to Medical Device Directive 93/42/EEC, after receipt of all approvals necessary or required for the commercialization in the European Union of a medical device product.

1.4 “ Confidential Information ” is defined in Section 11.1.

1.5 “ Devax’s Indemnified Persons ” means Devax and its directors, officers, shareholders, employees and representatives.

1.6 “ Devax’s Non-Exclusive Licensed Field of Use ” means any applications, procedures, processes or other uses related to drug-eluting, self-expanding Stents solely for use in vascular bifurcations.

1.7 “ Enforcement Limitations ” is defined in Section 7.2.

1.8 “ Excluded Technology ” means (i) any proprietary compound of Occam or its Affiliates other than Occam’s Drug/Polymer Composite Formulation including Biolimus A9 and (ii) know-how to the extent related to any proprietary stent of Occam or its Affiliates.

1.9 “ FDA ” means the U.S. Food and Drug Administration.

1.10 “ GAAP ” means generally accepted accounting principles, consistently applied.

1.11 “ Inventions ” shall refer to any new or useful art, discovery, contribution, finding or improvement, whether or not patentable, and all related know-how. Inventions include, but are not limited to, all trade secrets, designs, discoveries, formulae, processes, manufacturing techniques, improvements and ideas.

1.12 “ Late Loss ” with respect to analysis of in-stent restenosis in humans, shall mean the average neointimal thickness inside the stent at angiographic followup, as determined by the angiographic core lab. With respect to test animals, Late Loss shall be determined by histomorphometric analysis of 3 tissue sections taken from center, distal, and proximal portions of the stent, and shall be the average of the Late Loss in the three tissue sections, where for each section, average lumen diameter is measured by averaging lumen diameter at three points around the lumen circumference, and then by subtracting the average lumen diameter result from the average inside diameter of the Stent and dividing by two.

1.13 “ Letter of Intent ” means the letter dated August 5, 2003 executed by Devax and Occam.

1.14 “ Licensed Assets ” means Licensed Patents and Licensed Know-How owned or controlled by Occam or any of its Affiliates as of the Effective Date related to Occam’s Drug/Polymer Composite Formulation that provides local delivery of Biolimus A9.

1.15 “ Licensed Know-How ” means any information, concepts, data and know-how owned or controlled by Occam or any Affiliate of Occam existing as of the Effective Date and any manufacturing methods or process improvements developed by Occam or its Affiliates for Occam’s Drug/Polymer Composite Formulation during the term of this Agreement. Licensed Know-How specifically excludes know-how to the extent related to any Excluded Technology.

 

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1.16 “ Licensed Patents ” means (i) those certain patents, patent applications and invention disclosures owned or controlled by Occam or any of its Affiliates as of the date of this Agreement related to Occam’s Drug/Polymer Composite Formulation as set forth on Exhibit 2 , (ii) all patents that are continuations-in-part, substitutions, confirmations, divisionals, reissues, registrations, re-examinations, revalidations, extensions, foreign counterparts or are otherwise based on or claim priority to the patents, patent applications and invention disclosures referred to in subsection (i) hereinabove, and (iii) all patents and patent applications relating to the Licensed Know-How, but in the case of each of (i), (ii) and (iii) above, only to the extent that claims or portions of claims cover Occam’s Drug/Polymer Composite Formulation’s use with Biolimus A9 and specifically excluding any embodiments of a patented claim that read on Excluded Technology. Occam shall promptly notify Devax of all new patents that are part of the Licensed Patents and Exhibit 1 shall be automatically amended accordingly.

1.17 “ Losses ” means all losses, damages, demands, claims, assessments, liabilities, payments and obligations, and all expenses related thereto. Losses will include any reasonable legal fees and costs incurred by an Indemnified Person in defense of or in connection with any alleged or asserted liability, payment or obligation for which indemnity is provided under Article IX whether or not such Indemnified Person is made or becomes a party to any claim or legal action.

1.18 “ Material Adverse Effect ” means any change, effect, fact, event, occurrence, state of facts or development that, individually or together with any other changes, effects, facts, events, occurrences, states of fact or developments which materially and adversely affects the ability of the applicable Party to perform its obligations under this Agreement.

1.19 “ Net Sales ” means the gross sales of Royalty Bearing Products by Devax, Devax’s Affiliates, and Sublicensees to third parties, less the amount actually allowed to such third parties for (a) allowances on account of the rejection or return of products previously sold, (b) customary trade discounts and rebates to customers to the extent actually allowed and taken, (c) actual cost of transportation, insurance, shipping and handling charges, and (d) sales, excise, turnover and similar taxes and any duties and other governmental charges imposed upon the importation, use or sale of Royalty Bearing Products. If a Royalty Bearing Product is sold as part of a larger bundle or kit that incorporates or includes other products in addition to the Royalty Bearing Product, Net Sales will be computed using an average net selling price of the Royalty Bearing Product sold separately or, if such average net selling price is unavailable, it will be computed using only that part of such sale as the Parties reasonably agree is reasonably allocated to the value of the Royalty Bearing Product as compared to the value of the larger bundle or kit sold without the Royalty Bearing Product.

1.20 “ Occam’s Drug/Polymer Composite Formulation ” means the drug/polymer composite formulation described in Exhibit 2 .

1.21 “ Occam’s Indemnified Persons ” means Occam, its Affiliates and their respective directors, officers, shareholders, employees and representatives.

 

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1.22 “ Person ” means any individual, corporation, partnership, limited liability company, joint venture, estate, trust, association, organization, labor union or other entity or governmental body, agency or authority.

1.23 “ Research ” means research and pre-clinical and clinical development and trials by Occam or any of its Affiliates relating to drug-eluting Stents.

1.24 “ Restenosis Rate ” means the in-stent, binary restenosis rate as determined by the Cardiovascular Research Foundation Qualitative Core Laboratory, or such other quantitative angiographic analysis core laboratory to which the Parties mutually agree.

1.25 “ Royalty Bearing Product ” means a drug-eluting Stent or Stent System sold by Devax, an Affiliate of Devax, or a Sublicensee of Devax (i) incorporating Occam’s Drug/Polymer Composite Formulation; or (ii) incorporating developmental, pre-clinical or clinical data related to Occam’s Drug/Polymer Composite Formulation in connection with obtaining regulatory approval of such product.

1.26 “ Specifications ” means those specifications regarding Occam’s Drug/Polymer Composite Formulation as it is applied to the Stents as the parties agree to pursuant to Section 8.11 below.

1.27 “ Stent ” means a device or graft that is implanted into a vessel to serve as scaffolding.

1.28 “ Stent System ” means a Stent mounted on a catheter. Stent System shall not include any other devices that may be supplied with the Stent other than the delivery catheter.

1.29 “ Sublicensee ” means a permitted sublicensee or assignee of the applicable Party.

ARTICLE II

GRANT OF LICENSE

2.1 Devax’s Non-Exclusive License . Subject to the terms of this Agreement, Occam hereby grants to Devax a royalty bearing, non-exclusive, worldwide license to, import, export, use, sell, and offer for sale Devax’s Stents utilizing Occam’s Drug/Polymer Composite Formulation for use in Devax’s Non-Exclusive Licensed Field of Use (“Devax’s Non-Exclusive License”). Devax shall not sublicense any of its rights acquired hereunder without the prior written consent of Occam, which consent may be withheld in Occam’s sole discretion; provided, however, that Devax may appoint distributors, sales representatives and other marketing partners.

2.2 Diligence. Devax hereby agrees to use its commercially reasonable efforts to develop and commercialize Devax’s Stents utilizing Occam’s Drug/Polymer Composite Formulation, to conduct such tests and trials and obtain such approvals as may be necessary for the sale of the Devax Stents incorporating Occam’s Drug/Polymer Composite Formulation in the United States and other major countries, and to generate royalties therefrom. During the term of this Agreement, or any

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

renewals thereof, Devax shall not make, use, sell, or offer to sell any drug eluting stent using rapamycin, or any of its derivatives other than Biolimus A9.

2.3 Right to Terminate . If Devax fails to obtain CE Mark approval for a Royalty Bearing Product within [ *** ] after the Effective Date or fails to commence commercial sales of Devax’s Stents utilizing Occam’s Drug/Polymer Composite Formulation outside the United States by [ *** ] or within the United States by [ *** ], Occam shall have the right to terminate this Agreement upon ninety (90) days’ written notice to Devax given within sixty (60) days of the applicable failure.

ARTICLE III

COATING SERVICES

3.1 Purchase of Coating Services . Devax shall retain the services of Occam or its designee on a contract basis to apply Occam’s Drug/Polymer Composite Formulation to Devax’s stents (the “Coating Services”). So long as this Agreement remains in force and effect, and subject to Section 3.8 below, Devax shall only use Occam or its designee to perform the Coating Services on Devax’s Stents. Any third party that Occam intends to use to perform the Coating Services, other than Occam’s Affiliates, shall be subject to Devax’s approval, which will not be unreasonably withheld. In the event of any shortage of capacity or material relating to Occam’s Drug/Polymer Composite Formulation, Occam shall allocate such resources to fill Devax’s orders in the same proportion as Devax’s orders relate to orders from all customers of Occam.

3.2 Forecasts and Purchase Orders . Commencing within sixty (60) days after the Effective Date, at the beginning of each calendar month, Devax shall provide a forecast of the number of Stents to be coated during the following twelve (12) month period (the “Forecasts”), by month. The first three (3) months of each Forecast shall be binding and the balance shall be for planning purposes. In addition, Devax shall provide Occam with purchase orders for the Coating Services (the “Purchase Orders”) corresponding with at least the binding portion of each Forecast. The Purchase Orders shall specify the number of Stents which Devax desires to be coated by Occam and Devax’s desired date of completion, which in any case shall not be less than thirty (30) days after the date on which the Purchase Order is delivered to Occam. Each such Purchase Order shall be subject to acceptance by Occam, except that Occam shall accept all Purchase Orders corresponding to the number of Stents in the binding portion of the Forecast for such months. To the extent any such Purchase Orders for any month exceed 100% of the Forecast issued ninety (90) days prior to such month, Occam shall use its commercially reasonable efforts to coat such excess number of Stents. Each Purchase Order and any acknowledgment thereof shall be governed by the terms of this Agreement, rather than any inconsistent terms which may be set forth in the purchase order or acknowledgment, except for those terms specifying quantity, delivery dates, shipping or delivery instructions and other general information.

3.3 Delivery of Stents . Stents shall be shipped by Devax bulk non-sterile to Occam or its permitted designee in accordance with each applicable Purchase Order. Occam or its permitted designee shall apply Occam’s Drug/Polymer Composite Formulation to the Stents and ship coated

 

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Stents to Devax bulk non-sterile, for further processing by Devax. Unless otherwise agreed, the coated Stents shall be returned to Devax within ninety (90) days of the delivery of the uncoated Stents to Occam by Devax. Title to Stents and to coated Stents shall remain with Devax, provided Occam shall be liable for any loss or damages to Stents while such Stents are in the possession of or under the control of Occam or its agents.

3.4 Compliance with Laws and Regulations . The Coating Services shall be performed by Occam or its permitted designee in accordance with all applicable laws and regulations including, where applicable, the FDA rules and regulations and Good Manufacturing Practices as promulgated by the FDA in effect at the time the coating services are performed. Occam or its permitted designee shall maintain such quality control systems and procedures as shall be appropriate to allow compliance with the requirements of International Standards Organization 9000 Series standards as applicable to Occam or its permitted designee. Occam shall promptly notify Devax prior to making any material change in the coating process or components. Occam shall not implement such change without the written consent of Devax, unless such change is required to ensure the safety or efficacy of the product. Occam shall keep complete and accurate records pertaining to the Coating Services for at least three (3) years or for such longer period if and as required by applicable law or regulation. Occam shall make available such records to Devax for such lawful purpose as Devax may reasonably request in writing.

3.5 Conformity with Specifications . The coated Stents shall be subjected to quality control inspection by Occam in accordance with Occam’s quality control standards and systems. Occam shall certify that the coated Stents, when shipped to Devax hereunder, shall comply with the Specifications. Each shipment of Stents shall be accompanied by a certificate of compliance stating the results of Occam’s release testing and compliance with the Specifications, the costs of which shall be included in Occam’s cost of manufacturing.

3.6 Other Services . At the request of Devax and subject to the further approval of Occam or its designee, Occam may make available to Devax (i) additional laboratory analysis services, including, characterization of the drug release characteristics of the coated Devax Stent, drug elution, biocompatibility, design verification and process validation; and (ii) required animal studies and other scientific studies which may be required by regulatory authorities to obtain regulatory approvals (collectively “Laboratory Services”). Notwithstanding the foregoing, Occam’s refusal or inability to provide Laboratory Services on a timely basis to Devax shall in no way diminish or excuse Devax’s performance obligations under this Agreement. If Devax requests Laboratory Services from Occam, Occam or its designee shall provide a price quotation and proposed delivery schedule for the performance of such services, taking into account Occam’s own testing schedule for in-house products and other commitments to third parties. Devax shall have the right to obtain Laboratory Services from other vendors so long as a copy of the test results and procedures used are supplied to Occam promptly after they are completed (such information being subject to the confidentiality provisions contained in this Agreement) and any such third party vendor agrees in writing to be bound by the confidentiality provisions contained in this Agreement.

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

3.7 Payment for Coating Services .

(a) In consideration of the Coating Services to be performed by Occam or its designee hereunder, Devax shall pay for each coated Stent meeting the Specifications delivered to Devax, [ *** ].

(b) For purposes of this Section 3.7, “standard cost” shall mean the cost of Occam and its Affiliates (expressed on a per unit coated basis) of coating the Stents, including raw materials and direct labor and benefits (i.e., that portion of basic wages, labor and related payroll taxes and employee benefits spent in actual production and testing (including the release testing described in Section 3.5 above) which can be identified with or charged to such coated Stents), determined in accordance with GAAP. Standard cost shall include the proportionate cost of any overhead, including without limitation, indirect labor, related payroll taxes, employee benefits, depreciation, taxes, insurance, rent, repairs and maintenance, supplies, utilities, factory administrative expenses, applications engineering specific to coating the Devax Stent, and start-up costs, but shall exclude any costs related to under-utilized capacity. Occam shall use commercially reasonable efforts to reduce the standard costs of coated Stents. Occam may adjust the standard cost not more often than once per year, unless there is a greater than five percent (5%) change in process yield, labor or material costs (other than a change arising from Occam failing to meet the target yield to be set forth in the Specifications) in which case Occam shall have the right to adjust the standard cost with thirty (30) days notice to Devax. In no event shall the standard cost increase more than the amount of increase in the Producer Price Index for pharmaceutical preparations (PCU 2834) as published by the Bureau of Labor Statistics of the U.S. Department of Labor (web address: http://www.bls.gov/data/home.htm) for the corresponding period.

(c) Devax shall have the right to audit the records of Occam pertaining to the determination of its standard cost. Occam will provide Devax and its representatives with access to the records during reasonable business hours, to check, at Devax’s expense, the standard costs under this Agreement. Devax will give Occam written notice of its election to audit the records related to the standard cost due not less than ten (10) business days prior to the proposed date of review of Occam’s records by Devax’s representatives. Any such audit shall be conducted by a licensed certified public accountant who shall be required to execute a non-disclosure agreement prior to reviewing any of Occam’s records. Occam will maintain sufficient records to permit the audit for three (3) years. Upon completion of any audit, the auditors will report to Devax the amount of the discrepancy in standard costs, if any, and Devax will promptly provide a copy of the results to Occam. If an audit reveals an underpayment or overpayment by Devax, Devax will pay, or Occam will refund, as applicable, the amount due; provided, however, that no payment shall be due from Occam if the standard cost was properly determined, within five percent (5%) either way, under principles of GAAP based on the average of the previous year’s data. Each party shall be responsible for their own expenses in connection with the audit. Any disagreement as to the results of the audit shall be decided by neutral, binding arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association, upon the written request of one party after service of that request on the other party. The parties shall attempt to agree on one arbitrator. If they cannot agree

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

on one arbitrator, each party shall select one arbitrator and those two arbitrators shall agree upon a third arbitrator who alone shall hear and determine the dispute. The cost of the arbitration shall be borne equally by the parties. All arbitrators designated by the parties shall be retired judges who previously presided in courts in the State of California. The arbitration shall be conducted in accordance with Part III, Title 9 of the California Code of Civil Procedure and the parties shall have the right to discovery in accordance with California Code of Civil Procedure Section 1283.05.

(d) Occam shall tender invoices to Devax for all services performed, which invoices shall be due and payable no later than thirty (30) days after the later of the date of invoice or date of shipment of the coated Stents covered by such invoice.

(e) The parties acknowledge that due to variations in yield not all of the Stents provided to Occam will be coated in accordance with the Specifications, and Devax agrees to provide Occam with enough Stents to yield the quantity ordered pursuant to Section 3.2 above.

3.8 Devax’s Right to Manufacture in Certain Events .

(a) Contingent Manufacturing Right . If Devax has met all of its obligations and is not in default under this Agreement, Occam shall grant to Devax the right to manufacture Occam’s Drug/Polymer Composite Formulation and to apply it to Devax’s Stents in the following instances, each of which shall be referred to as a “Supply Failure”:

(i) in the event the Occam fails to fill [ *** ] of Devax’s orders with coated Stents conforming to the Specifications (forecasted and ordered in accordance with Section 3.2) for any [ *** ]; or

(ii) upon the cessation of operations of Occam relating to Occam’s Drug/Polymer Composite Formulation, the dissolution or winding up of Occam, or the commencement of voluntary or involuntary bankruptcy or insolvency proceedings, which proceedings are not dismissed within sixty (60) days, unless this Agreement has been terminated. Notwithstanding the foregoing, in all cases, Devax shall be required to pay to Occam or its successor in interest, all payments required under this Agreement.

(b) Licensed Assets . In the event of a Supply Failure, Occam shall grant a non-exclusive license to Devax for the for the balance of the term of this Agreement of the Licensed Assets (comprised of Licensed Patents and Licensed Know-How) to enable Devax to make Occam’s Drug/Polymer Composite Formulation and perform the Coating Services on the Devax Stents on its own and in its own facility. If the non-exclusive license is granted hereunder, Devax shall have the right to sublicense its rights thereunder to contract manufacturers; provided, however (i) that such contract manufacturers execute confidentiality agreements containing the confidentiality obligations set forth in Article X hereof; and (ii) Devax obtains Occam’s prior written consent, which consent shall not be unreasonably withheld.

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [ * * * ], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 506 OF THE SECURITIES ACT OF 1933, AS AMENDED

ARTICLE IV

PAYMENTS

4.1 Payments . In consideration of the Non-Exclusive License granted by Occam under this Agreement, Devax will pay to Occam the following:

(a) [ * * * ] upon completion of Devax’s due diligence investigation with regard to the Licensed Patents and pre-clinical data regarding Occam’s Drug/Polymer Composite Formulation, which investigation shall be completed sixty (60) days after the receipt by Devax of such information from Occam, and Devax’s reasonable satisfaction with the results of such investigation. If Devax requests additional documents from Occam, it will not extend the length of the due diligence period so long as Occam acts diligently in getting the requested documents to Devax. Subject to the execution of a confidentiality agreement by Devax’s counsel, Occam shall provide Devax’s counsel (but not Devax) with a copy of the patent applications for the Licensed Patents, the molecular structure of Biolimus A9, and a written evaluation of prior art with respect to Occam’s Drug/Polymer Composite Formulation. Occam disclaims any and all warranties, express and implied, with respect to any such written evaluation of prior art provided to Devax’s counsel. Devax’s counsel shall not provide any copies, or discuss the contents, of any such patent applications or prior art, with Devax . In the event that Devax is not reasonably satisfied with such investigation, prior to the expiration of such 60-day period, Devax may terminate this Agreement on notice to Occam without financial liability. Upon such termination, Devax shall return all information obtained from Occam or any of its Affiliates in the course of its due diligence investigation. All confidentiality obligations of Devax hereunder and shall survive such termination and the return of information in accordance with Article X.

(b) [ * * * ] upon the successful completion of (i) a 28-day animal study resulting in greater than fifty percent (50%) reduction in Late Loss in straight stent segments in those animals when compared to similar segments in the applicable bare metal control group, which study shall be commenced by Devax within six (6) months after the Effective Date and diligently prosecuted to completion, including production of a histomorphology report, a copy of which shall promptly be sent via courier parcel to Occam upon completion; and (ii) thirty (30) human implants resulting in an average of less than 0.35mm Late Loss in straight stent segments at the 6-month angiographic follow-up, in each case utilizing the Devax Stents with Occam’s Drug/Polymer Composite Formulation; provided, however, that if the 6-month angiographic follow-up in the above-referenced trial is not completed on or before that date which is twenty-four (24) months following the Effective Date, but the animal study has been completed with a 50% or greater reduction in Late Loss in straight stent segments, then the payment provided for in this Section 4.1(b) shall become due and payable based on the results generated from the above-referenced animal study. In the event Devax fails to commence the animal study within six (6) months from the Effective Date, Occam shall have the right to immediately terminate this Agreement without further notice to Devax. Each of the time periods specified in this Section 4.1(b) shall be extended in the event of any delay caused by the failure of Occam to provide coated Stents as ordered by Devax for the applicable study, such extension to be equal to the length of the delay actually caused by Occam’s failure to provide Devax

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

with the coated Stents for the applicable study. In the event that the results of the animal or human study does not meet the specified criteria (i) or (ii) as described in this paragraph, Devax may terminate this Agreement on written notice to Occam given within thirty (30) days after such results have been determined. In the event that this Agreement remains in full force and effect after completion of the animal and human study, but the animal and/or human study does not satisfy the specified criteria (i) and/or (ii), and during the continuing term of this agreement Devax completes additional animal studies and/or human studies, then at such time as at least one of each of the animal and human studies, including the results of the initial animal and human study, satisfy the specified criteria (i) and (ii), the payment specified in this paragraph shall become due and payable.

(c) The payment to be made to Occam pursuant to Section 4.1(b) shall be made by Devax so that it is received by Occam within sixty (60) days after it becomes due and payable pursuant to Section 4.1(b) above and shall be non-refundable and non-creditable.

4.2 Royalties .

(a) Royalty Rate . Commencing with the calendar year 2005, Devax will pay to Occam a royalty equal to [***].

(b) Annual Minimum Royalty. Commencing with the calendar year 2005 and for each calendar year thereafter so long as this Agreement remains in force and effect, Devax shall pay a minimum annual royalty to Occam in the sum of [ *** ] (the “Minimum Annual Royalty”). In the event that in any calendar year the [ *** ] royalties payable for such year are [ *** ], then the shortfall for that year shall be payable to Occam on or before the due date for the royalties for the last quarter of such calendar year.

(c) Royalty Obligation. The obligation to pay royalties hereunder will arise upon the sale by Devax, its Affiliates or its Sublicensees, if any, to third parties, except that the Minimum Annual Royalty shall be due even if there are no Net Sales of Royalty Bearing Products. Sublicense Royalties due will be deemed to accrue when Royalty Bearing Products are sold to such un-Affiliated third party. The obligation to pay royalties to Occam will be imposed only once with respect to the same unit of Royalty Bearing Product.

(d) Payment of Royalties . All royalty amounts payable to Occam pursuant to this Section will be paid quarterly within sixty (60) days following the completion of the applicable calendar quarter, will be made in United States Dollars and will be calculated in the currency of the sale and then converted into United States Dollars at the conversion rate existing in the United States (referencing the “U.S. dollar noon buying rates” or its equivalent) published in the Wall Street Journal on the last working day of each period during which royalties are calculated, net of applicable exchange related charges. Each royalty payment will be accompanied by a statement from Devax showing total Net Sales, the applicable royalty rate and the total royalty payment owing.

(e) Occam shall have the right to audit the records of Devax pertaining to the sale of Royalty Bearing Products. Devax will provide Occam and its representatives with access to the

 

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records during reasonable business hours, to check, at Occam’s expense, the royalties due under this Agreement. Occam will give Devax written notice of its election to audit the records related to the royalties due not less than ten (10) business days prior to the proposed date of review of Devax’s records by Occam’s representatives. Any such audit shall be conducted by a licensed certified public accountant who shall be required to execute a non-disclosure agreement prior to reviewing any of Devax’s records. Devax will maintain sufficient records to permit the audit for three (3) years after the completion of each respective reporting period. Devax will prepare its records and reports according to GAAP. Upon completion of any audit, the auditors will report to Occam the amount of the discrepancy in payment, if any, and Occam will promptly provide a copy of the results to Devax. If an audit reveals an underpayment or overpayment by Devax, Devax will pay, or Occam will refund, as applicable, the amount due. If an audit reveals an underpayment of more than five percent (5%), Devax will pay interest on the underpayment, computed from the date of such underpayment at an annual rate equal to the U.S. prime rate as published in The Wall Street Journal as of the date of such underpayment plus five percent (5%). Each party shall be responsible for their own expenses in connection with the audit. Any disagreement as to the results of the audit shall be decided by neutral, binding arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association, upon the written request of one party after service of that request on the other party. The parties shall attempt to agree on one arbitrator. If they cannot agree on one arbitrator, each party shall select one arbitrator and those two arbitrators shall agree upon a third arbitrator who alone shall hear and determine the dispute. The cost of the arbitration shall be borne equally by the parties. All arbitrators designated by the parties shall be retired judges who previously presided in courts in the State of California. The arbitration shall be conducted in accordance with Part III, Title 9 of the California Code of Civil Procedure and the parties shall have the right to discovery in accordance with California Code of Civil Procedure Section 1283.05.

4.3 Payment Procedures; Withholdings . Each amount required to be paid under this Agreement to Occam will be paid via wire transfer to an account designated in writing by Occam. Devax shall pay, and shall indemnify and hold Occam harmless from, all taxes, duties and levies directly imposed by all foreign, federal, state, local or other taxing authorities (including, without limitation, export, sales, use, excise, and value-added taxes) based on transactions or payments under this Agreement, other than taxes imposed on Occam’s net income. All amounts payable hereunder by Devax shall be paid without deduction or withholding for or on account of Occam; provided, however, that if Devax is required by law to deduct or withhold any taxes, levies, or charges in respect of any amounts payable to Occam hereunder, Devax shall pay the relevant taxation authority the minimum amounts necessary to comply with applicable law in a timely manner prior to the date on which interest or penalties will attach thereto. Notwithstanding the foregoing, provided that Occam provides Devax with appropriate documentation providing that the royalty payments made to Occam by Devax under this Agreement are exempt from deduction or withholding of tax imposed by a particular taxation authority, all payments made by Devax to Occam under this Agreement with respect to royalties subject to such requirement to withhold shall be made free and clear of, and without deduction or withholding for or on account of, any present or future income, stamp or other taxes, levies, imposts, duties, charges, fees, deductions or withholdings, now or hereafter imposed, levied, collected, withheld or assessed by such taxation authority.

4.4 Warrant . As additional consideration for the rights granted by, and the obligations of, Occam hereunder Devax shall issue to Occam a warrant to purchase 658,335 shares of Devax common stock at an exercise price of $2.96 per share (the “Warrant”). The Warrant shall not be exercisable until the successful completion of (i) a 28-day animal study resulting in greater than

 

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fifty percent (50%) reduction in Late Loss in straight stent segments in those animals when compared to similar segments in the applicable bare metal control group, and (ii) thirty (30) human implants resulting in an average of less than 0.35mm Late Loss in straight stent segments at the 6-month angiographic follow-up, in each case utilizing the Devax Stents with Occam’s Drug/Polymer Composite Formulation. The form of the Warrant is attached as Exhibit 3 .

4.5 Right to Participate in Subsequent Sale or Issuance . Devax hereby grants Occam a right to participate with respect to any sale or issuance by Devax after the date hereof of any shares of, or other securities or rights convertible into or exercisable for, or entitling the holder thereof to receive directly or indirectly, additional shares of Devax’s common stock or securities convertible into or exercisable or exchangeable for common stock. Such right shall be governed by the terms of Devax’ Investor Rights Agreement, as amended to include Occam.

ARTICLE V

TESTING AND CLINICAL TRIALS

5.1 Additional Testing . The Parties acknowledge that there will be a substantial amount of testing to be performed on the Devax Stent coated with Occam’s Drug/Polymer Composite Formulation, including, without limitation, in-vitro feasibility testing for the combination of the Stent, the coating and the drug such as drug elution, biocompatibility, design verification and process validation; and required animal studies, human clinical studies, including a CE Mark clinical study, U.S. FDA pilot study and U.S. IDE clinical study. In addition there will be various submissions to regulatory agencies both within and outside of the United States to receive approval for the marketing of the Devax Stent coated with Occam’s Drug/Polymer Composite Formulation. Devax shall be responsible for conducting all necessary testing, performing proper clinical studies and trials and preparing and filing all required submissions to the appropriate regulatory agencies. All of such work shall be conducted and performed in a professional manner consistent with Good Laboratory Practices (“GLP”) and as further defined by FDA and/or EN (European Norm) standards for the conduct of trials.

5.2 Clinical Data . Subject to such information becoming available, Occam will provide Devax with access to its clinical data from its own testing activities to support Devax’s regulatory filings.

5.3 Payment for Testing, Trials and Submissions . Devax shall be solely responsible for all costs and expenses in connection with the conduct of all necessary studies, testing and trials in connection with the coated Devax Stent and the preparation and filing of submissions to the necessary regulatory bodies.

ARTICLE VI

REPRESENTATIONS AND WARRANTIES OF OCCAM

Occam represents and warrants to Devax as follows:

6.1 Organization of Occam . Occam is a corporation duly organized, validly existing and in good standing under the laws of the Netherlands. Occam has full power and authority to own,

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

lease and operate its properties and to conduct its business in the manner and in the places where such properties are owned or leased or its business is conducted.

6.2 Authorization of Transaction . Occam has full corporate power and authority to execute, deliver and perform this Agreement and to carry out the transactions contemplated herein. All necessary actions, corporate or otherwise, have been taken by Occam to authorize and approve the execution, delivery and performance of this Agreement and the transactions contemplated herein, and this Agreement is the legal, valid and binding obligation of Occam, enforceable against Occam in accordance with its terms, except to the extent enforceability may be limited by applicable bankruptcy, reorganization, insolvency, moratorium or other similar laws from time to time in effect affecting creditors’ rights generally or by principles governing the availability of equitable remedies (collectively, “ Enforcement Limitations ”).

6.3 No Conflict With Obligations and Laws . Neither the execution, delivery and performance of this Agreement, nor the performance of the transactions contemplated by this Agreement, will: (a) constitute a breach or violation of any provision of Occam’s charter documents or by-laws; (b) to the knowledge of Occam, require any authorization, approval, consent or waiver of any governmental authority or third party; (c) constitute (with or without the passage of time or giving of notice) a default under or breach of any contract, agreement, instrument, commitment or obligation to which Occam is a party or by which Occam is bound or give any Person the right to declare a breach, accelerate, terminate, modify or cancel any right or obligation thereunder, which in any such case would reasonably be expected to have a Material Adverse Effect; or (d) to the knowledge of Occam, result in a violation of any law, rule, regulation, administrative order or judicial order, decree or judgment, which in any such case would reasonably be expected to have a Material Adverse Effect.

6.4 Licensed Patents . [ *** ] Exhibit 1 sets forth a complete and correct list of all patent applications and invention disclosures currently owned by Occam or licensed by Occam from one or more of its Affiliates related to Biolimus A9 and/or Occam’s Drug/Polymer Composite Formulation.

6.5 Finder’s Fees . Occam has not incurred nor become liable for any broker’s commission or finder’s fees relating to or in connection with the transactions contemplated by this Agreement.

6.6 Litigation . Occam has received no notice of any, and Occam has no knowledge of any, pending or threatened claim, action, suit, arbitration or other proceeding pending or, to the knowledge of Occam, threatened against Occam that will or would prevent or hinder the consummation of the transactions contemplated by this Agreement and there is no outstanding court order, court decree or court stipulation applicable to Occam that relates to this Agreement or affects the transactions contemplated by this Agreement.

6.7 Warranty Disclaimers . The parties acknowledge that Occam’s Drug/Polymer Composite Formulation on Devax’s Stents is being developed according to Devax’s specifications and requirements. Except as expressly provided in this Article VI, Occam makes

 

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no representations or warranties of any kind, express or implied, with respect to the License granted hereunder. EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE VI, OCCAM HEREBY EXPRESSLY DISCLAIMS ANY IMPLIED OR EXPRESS WARRANTIES, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT, WITH RESPECT TO ANY RIGHTS LICENSED HEREUNDER. UNDER NO CIRCUMSTANCES WILL OCCAM BE LIABLE TO DEVAX OR ANY OF DEVAX’S INDEMNIFIED PERSONS FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGES, INCLUDING, WITHOUT LIMITATION, LOSS OF REVENUE OR ANTICIPATED PROFITS OR LOST BUSINESS ARISING FROM ANY USE BY DEVAX OR DEVAX’S INDEMNIFIED PERSONS OF THE LICENSED ASSETS EVEN IF A REPRESENTATIVE OF OCCAM HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OCCURRING.

ARTICLE VII

REPRESENTATIONS AND WARRANTIES OF DEVAX

Devax hereby represents and warrants to Occam as follows:

7.1 Organization of Devax . Devax is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware with full power and authority to own, lease and operate its properties and to conduct its business in the manner and in the places where such properties are owned or leased or such business is conducted.

7.2 Authorization of Transaction . Devax has full corporate power and authority to execute, deliver and perform this Agreement and to carry out the transactions contemplated herein. All necessary actions, corporate or otherwise, have been taken by Devax to authorize and approve the execution, delivery and performance of this Agreement, the issuance of the Warrant and the transactions contemplated herein, and this Agreement is the legal, valid and binding obligation of Devax enforceable in accordance with its terms, except to the extent enforceability may be limited by Enforcement Limitations. The execution and delivery of this Agreement, the issuance of the Warrant, and the performance by Devax of its obligations hereunder and thereunder have been duly and validly authorized by all necessary action by the Board of Directors of Devax.

7.3 No Conflict of Transaction with Obligations and Laws . Neither the execution, delivery and performance of this Agreement, the issuance of the Warrant, nor the performance of the transactions contemplated by this Agreement, will: (a) constitute a breach or violation of Devax’s Articles of Incorporation or by-laws; (b) require any authorization, approval, consent or waiver of any governmental authority or third party; (c) constitute (with or without the passage of time or the giving of notice) a default under or breach of any contract, agreement, instrument, commitment or obligation to which Devax is a party or by which Devax is bound, which in any such case would reasonably be expected to have a Material Adverse Effect; or (d) result in a violation of any law, rule, regulation, administrative order, judicial order, decree or judgment applicable to Devax, which in any such case would reasonably be expected to have a Material Adverse Effect.

7.4 Finder’s Fee . Devax has not incurred nor become liable for any broker’s commission or finder’s fees relating to or in connection with the transactions contemplated by this Agreement.

 

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7.5 Litigation . Devax has received no notice of any, and Devax has no knowledge of any, pending or threatened claim, action, suit, arbitration or other proceeding pending or, to the knowledge of Devax, threatened against Devax that will or would prevent or hinder the consummation of the transactions contemplated by this Agreement and there is no outstanding court order, court decree or court stipulation applicable to Devax that relates to this Agreement or affects the transactions contemplated by this Agreement.

7.6 Devax’s Rights to the Devax Stent . Devax owns and holds all rights to the Devax Stent and Stent System, neither of which (currently or would after commercialization) infringe or otherwise conflict with, any proprietary or other rights of any third party.

7.7 Rights Limited to Field of Use . Devax will not practice any of the rights in, to or under the Licensed Assets outside of Devax’s Non-Exclusive Field of Use.

7.8 Warranty Disclaimers . Except as expressly provided in this Article VII, Devax makes no representations or warranties of any kind, express or implied, with respect to the subject matter of this Agreement. UNDER NO CIRCUMSTANCES WILL DEVAX BE LIABLE TO OCCAM OR ANY OF OCCAM’S INDEMNIFIED PERSONS FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGES, INCLUDING, WITHOUT LIMITATION, LOSS OF REVENUE OR ANTICIPATED PROFITS OR LOST BUSINESS ARISING FROM ANY USE BY DEVAX OR DEVAX’S INDEMNIFIED PERSONS OF THE LICENSED ASSETS OR ANY BREACH OR ALLEGED BREACH OF THIS AGREEMENT EVEN IF A REPRESENTATIVE OF OCCAM HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OCCURRING, PROVIDED HOWEVER THAT THE FOREGOING LIMITATION ON DAMAGES SHALL NOT APPLY TO ANY UNAUTHORIZED USE OR DISCLOSURE BY DEVAX OF CONFIDENTIAL INFORMATION OF OCCAM.

7.9 Capitalization of Devax . Immediately prior to the Effective Date, there are (a) one million eight hundred forty-nine thousand five hundred (1,849,500) shares of common stock of Devax issued and outstanding, (b) nine hundred three thousand nine hundred sixty (903,960)&nb