MASTER TECHNOLOGY AND SERVICES AGREEMENT

EXHIBIT 10.1

 

M ASTER T ECHNOLOGY AND S ERVICES A GREEMENT

 

 

This Master Technology and Services Agreement (“Agreement,” including all attachments hereto) is entered into as of September 2, 2005 (the “Effective Date”) by and between Medidata Solutions, Inc., a Delaware corporation having its principal place of business at 79 Fifth Avenue, 8th Floor, New York, New York 10003 (“Medidata”), and NuVasive, Inc., a Delaware corporation, having its principal place of business at 4545 Towne Centre Court, San Diego, CA 92121 (“Customer”).

 

Recitals

 

W HEREAS Medidata owns or licenses certain proprietary software used for clinical trials, and offers certain hosting and other related services;

 

W HEREAS Customer desires to obtain a license from Medidata to use Medidata Applications (as defined herein) and obtain Medidata Services (as defined herein) and Medidata desires to provide to Customer a license to the Medidata Applications and provide the Medidata Services upon the terms and conditions stated herein;

 

N OW THEREFORE , for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and in consideration of mutual promises and covenants set forth hereunder, the parties agree as follows:

 

1.	Definitions.

 

1.01 “Authorized Users” means employees or agents of Customer that conduct clinical trial studies using the Medidata Applications, in each case within the Territory.

 

1.02 “Documentation” means Medidata’s online technical and/or functional user guides for Customer and the Authorized Users to operate the Medidata Applications, as modified by Medidata from time to time.

 

1.03 “Medidata Applications” shall have the meaning set forth in Schedule 1.

 

1.04 “Medidata Services” means the services provided to Customer by Medidata pursuant this Agreement (including Hosting Services, Support Services or Professional Services), and / or documented in a separate Statement of Work.

 

1.05 “Territory” shall have the meaning set forth in Schedule 1.

 

2.	Grant of License to Medidata Applications.

 

2.01 Study Use License . Subject to the terms and conditions of this Agreement (including the license restrictions set forth on Schedule 1), Medidata hereby grants to Customer a nonexclusive, nontransferable, nonsublicensable, personal and limited license during the license term set forth in Schedule 1 to access and use the Medidata Applications and Documentation for the particular clinical trial study(ies) set forth on Schedule 1 (each, a “Study Use License”). The Study Use License granted hereby shall be applicable only for the clinical trial study set forth on Schedule 1. Customer may obtain additional Study Use Licenses only upon the execution by the parties of a separate Statement of Work, setting forth the terms for the additional Study Use License(s).

 

2.02 Restrictions . Customer may access and use the Medidata Applications and Documentation solely for its own internal business purposes to conduct a clinical trial study. Only the Authorized Users may access the Medidata Applications on behalf of Customer. Customer may access and use the Medidata Applications only from locations within the Territory. Except as expressly set forth in this Agreement, Customer shall not use the Medidata Applications or Documentation to provide hosting, service bureau, time sharing, outsourcing or other services to third parties, or sell, lease, license or sublicense the Medidata Applications or Documentation to third parties or otherwise permit the use of or access to the Medidata Applications or Documentation by any third party. Customer shall not use the Medidata Applications to perform clinical trial studies for any third party or input data from any clinical trial study of any third party. Customer shall use the Medidata Applications only for lawful purposes and in accordance with this Agreement. No Study Use License may be transferred to any other clinical trial or used for any other purpose. Customer shall not have the right to self-host the Medidata Applications itself.

 

2.03 No Reverse Engineering . Customer shall not reverse engineer the Medidata Applications in any manner, including, without limitation, through decompilation or disassembly. Customer shall not create derivative works based on the Medidata Applications, it being understood that Medidata shall have all right, title or interest in and to all derivative works based on the Medidata Applications.

 

2.04 Proprietary Notices . Customer shall not remove, obscure or alter any copyright notices, trademarks or other proprietary rights notices affixed to or contained within the Medidata Applications.

 

2.05 Anti-Virus Measures . Customer shall take all reasonable precautions to prevent any virus or other malicious code from entering Customer’s systems and compromising the Medidata Applications or any services provided to Customer, including without limitation implementing routine scanning of systems using then current virus scanning software and virus profiles.

 

2.06 Source Code . Notwithstanding anything to the contrary, Customer shall have no right whatsoever, whether by the express terms of this Agreement or by any course of conduct, to use, review or access the source code for the Medidata Applications or Study Use Licenses.

 

2.07 Flow-Through Terms . The licenses granted hereby are subject to the additional terms and conditions set forth on Schedule 4.

 

3.	Medidata Services and Responsibilities.

 

3.01 Medidata Services in General . Provided that Customer has paid the applicable fees set forth herein, Medidata will provide the Medidata Services set forth in this Agreement, including the application hosting services described on Schedule 2 (the “Hosting Services”) and the support services for the Medidata Applications described on Schedule 3 (the “Support Services”). Medidata will provide the Medidata Services in a good and workmanlike manner.

 

***

Certain confidential portions of this exhibit were omitted by means of redacting a portion of the text. This exhibit has been filed separately with the Secretary of the Securities and Exchange Commission without the redactions pursuant to the Company’s Application Requesting Confidential Treatment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

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3.02 Professional Services/Implementation and Configuration . From time to time during the term of this Agreement, Medidata and Customer may agree on implementation and configuration services, training, technical recommendation services, analysis, design services, development of and maintenance for custom software, and general consultation and professional services to be performed by Medidata (the “Professional Services”).

 

3.03 Statements of Work . For each Professional Services project, Medidata and Customer shall agree on a document setting forth the Study Use License grant (as applicable), implementation task plan, location of work, labor hours and resources allocated by task, defined deliverables by task, estimated fees and expenses and a proposed schedule for the implementation effort, as well as assumptions, boundaries and constraints in relation to the Professional Services (each, a “Statement of Work”). The parties agree that Statements of Work may not be complete statements of the Professional Services and that additional Professional Services may be required which cannot be determined as of the date of this Agreement or of the applicable Statement of Work. The time requirements and duties set forth in a Statement of Work are estimates for planning purposes only and are based on Medidata’s experience and assumptions and the quality of information furnished by Customer. Unless otherwise specified, such estimated charges are based on Medidata working during normal business hours, excluding Saturdays, Sundays and Medidata’s holidays and are exclusive of reasonable and approved travel and per diem expenses and taxes. No Statement of Work shall be construed to require Medidata to deliver the Professional Services at a fixed time or price unless otherwise mutually agreed to in writing. The initial Statement of Work for Professional Services is attached hereto as Schedule 5.

 

3.04 Duties of Customer/SOW . During the term of any Statement of Work, Customer will: (a) provide access to the office space, hardware and all other necessary devices, software, peripheral or otherwise, to permit Medidata to perform the Professional Services, if such services are to be performed at Customer’s location; (b) provide Medidata with all information, data and other materials reasonably required for successful completion of the Professional Services; and (c) timely perform all undertakings on its part to be performed, promptly review and furnish comments on any documents and other materials as requested by Medidata and provide the additional assistance and support reasonably needed for the timely completion of the Professional Services.

 

3.05 Change Orders . Prior to any material deviation from the work or fees set forth in a Statement of Work, each party must authorize a Change Order setting forth the additional work to be performed, the form of which shall be agreed to in the applicable Statement of Work.

 

3.06 Completion . Professional Services shall be deemed completed when performed or as otherwise specified by completion criteria set forth in the applicable Statement(s) of Work. In the event Customer is required pursuant to a Statement of Work to participate in verifying the completion criteria but does not timely participate, Medidata may verify the completion criteria alone based on reasonable criteria.

 

3.07 GCP and FDA Matters . Medidata will provide the Medidata Services in a professional and workman like manner and will use commercially reasonable efforts to provide the Medidata Services in conformance with (i) the protocols for any clinical trial study conducted by Customer utilizing the Medidata Applications and any reasonable additional requirements of which Customer may notify Medidata in writing, (ii) if applicable, generally accepted standards of good clinical practices (GCP), and (iii) all applicable laws, rules, and regulations relating to the conduct of any clinical study trial, particularly those of the Food and Drug Administration (FDA).

 

3.08 Customer Duties . Customer is solely responsible for and assumes all liability relating to (a) the design, structure and content of all clinical trial protocols; (b) decisions about Customer’s computer and communications systems needed to access the Medidata Applications; and (c) all purchases of any necessary hardware, software, services or licenses required by Customer to access and use the Medidata Applications as contemplated herein. Customer covenants that it will use the Medidata Applications in compliance with all applicable laws and regulations within the Territory of use and with respect to conducting clinical trials. If Medidata reasonably believes that a Medidata Service or action requested by Customer would not conform with legally permissible clinical trial criteria, Medidata may require prior to proceeding, that Customer provide a written certification of compliance with such clinical trial criteria from a senior regulatory affairs officer in form and substance reasonably satisfactory to Medidata. Customer agrees to provide notice to Medidata as soon as it becomes reasonably aware of any privacy or data protection statutes, rules or regulations which are or become applicable to its business and which could be imposed on Medidata as a result of its performance of the Medidata Services or Customer’s use of the Medidata Applications or Study Use Licenses, and any actual or potential violations thereof.

 

4.	Ownership.

 

4.01 Title to Medidata Applications . Title and full ownership of the Medidata Applications and Documentation (including in each case any derivative works thereof) are and shall remain the proprietary, confidential, copyrighted and trade secret property of Medidata and its licensors. Customer acquires only the license to use the Medidata Applications and Documentation expressly granted herein. All rights not expressly granted under this Agreement are reserved to Medidata. Except as agreed to in writing and in advance by Medidata, Customer shall not create derivative works of or from the Medidata Applications or Documentation. Customer does not acquire any right to any trademark, service mark, logo or trade name used by Medidata.

 

4.02 Materials . Each party retains all rights, title and interest in and to all previously existing or newly created materials, methodologies, operating and applications software, programs, architecture data, processes, methods, creations, developments and technical information and intellectual property developed by such party. Notwithstanding the foregoing, any enhancements, or modifications to, or, derivative works or other intellectual property based on the Medidata Applications or Study Use Licenses, or components thereof, whether created solely by Customer or a third party for Customer, or jointly by Customer and Medidata or a third party, shall belong exclusively to Medidata, and Customer hereby irrevocably assigns all rights therein (including without limitation, all patent, copyright, trademark, trade secret moral rights) to Medidata. If any rights contemplated by this Section 4.02 cannot be assigned to Medidata for any reason, Customer hereby waives the enforcement of such rights, and if any such rights cannot be assigned or waived, Customer hereby grants to Medidata an exclusive, unrestricted, irrevocable, perpetual, worldwide, fully-paid, royalty-free, transferable, assignable, sub-licensable (with the right to sublicense multiple tiers) license to such rights.

 

5.	Payment Terms.

 

5.01 Payment and Fees . For the license to the Medidata Applications and the Medidata Services, Customer shall pay the fees set forth in each of the applicable Schedules in the manner set forth therein. All up-front fees specified therein must be paid in advance of Medidata granting Customer access to or use of the Medidata Applications. All prices and fees are listed in US dollars. Except as provided by Sections 8.02 and 9.01, all amounts paid to Medidata by Customer are nonrefundable. Customer shall pay all invoices properly presented per the terms of this Agreement in US dollars by check or wire within thirty (30) days after the invoice date.

 

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5.02 Invoicing Instructions . Medidata shall invoice Customer using the following contact information:

 

 

5.03 Past Due Amounts . Any amounts not paid when due hereunder shall incur a late payment charge equal to one-and-one-half percent (1.5%) per month of the amount past due (or, if less, the maximum rate permitted by law).

 

5.04 Price Changes . Medidata may increase its rates for Medidata Services from time to time, provided the aggregate increase over any one-year period does not exceed 2.5% (provided that Medidata will not increase the rates set forth in a Statement of Work or Schedule 1 unless otherwise provided therein or authorized by Customer).

 

5.05 Taxes . Customer shall be responsible for the collection and payment of any present or future services, sales, use, excise, goods, property, value added or other taxes or duties. Medidata shall be responsible only for its franchise taxes and taxes based on its net income. Upon request, Customer shall furnish to Medidata evidence of payment of any taxes payable by Customer. All payments shall be made to Medidata without deductions based on any taxes, except taxes based on Medidata’s net income or franchise taxes.

 

5.06 Cancelled Studies . Notwithstanding the foregoing, for any Study Use License under which a study has been created to be used with the Medidata Applications and is ready for configuration, yet the project is cancelled for any reason prior to the first patient data being entered, then that study will not be considered to have been started and the RAVE Environment Base License fee, if paid, will be credited towards future studies under this Agreement. In addition, if a study is cancelled after patient data is entered, the unused prorated portion of the paid RAVE Environment Base License fee, calculated based upon the Study Use License Term as specified on Schedule 1, will be credited towards future studies under this Agreement.

 

5.07 Inspection and Audit . During the term of this Agreement, at any time upon five (5) business days’ advance written notice and not more than once in each twelve (12) month period, Medidata may examine Customer’s books, records, systems and system logs related to usage of the Medidata Applications and the Study Use Licenses and the amounts due to Medidata. Medidata may conduct such examination either at Customer’s facility or through remote connection to Customer’s computer system. Such examination shall be performed at Medidata’s expense; provided, however, that if any such audit uncovers one or more underpayments in excess of five percent (5%) of the total amount determined by the audit to be payable to Medidata for the audit period, Customer shall immediately reimburse Medidata for the full costs of such audit. In addition, Customer shall immediately pay any underpayment (and applicable interest pursuant to Section 5.03), if any, uncovered during the course of the audit.

 

6.	Term and Termination

 

6.01 Term . This Agreement shall commence on the Effective Date and shall continue for two (2) years unless terminated earlier in accordance with the provisions of this Article 6 (the “Initial Term”). The Agreement shall be automatically renewed for successive renewal terms of one(1) month each (each, a “Renewal Term”; the Initial Term and any and all Renewal Terms shall be referred to as the “Term”). Either party may terminate Customer’s licenses granted hereunder upon at least ninety (90) days advance written notice to the other party prior to the end of the Initial Term or Renewal Term during which such notice is given; provided such termination shall not be effective until the end of such Initial Term or Renewal Term. For avoidance of doubt, each Study Use License shall only be valid during the Term for the applicable study . Not withstanding anything to the contrary, Medidata shall not be entitled (except with Customer’s consent) to terminate this Agreement during the Study Use License Term if Customer is in material compliance with the terms hereof.

 

6.02 Termination for Material Breach . In the event either party defaults in any material obligation in this Agreement, the non-defaulting party shall give written notice of such default. If the party in default has not cured the default within thirty (30) days of receipt of the notice, the non-defaulting party may terminate this Agreement by delivering notice thereof to the defaulting party.

 

6.03 Termination for Insolvency . In the event that either party becomes insolvent (i.e., becomes unable to pay its debts in the ordinary course of business as they come due) or makes assignment of this Agreement for the benefit of creditors, the other party may terminate this Agreement immediately upon written notice.

 

6.04 Effect of Termination . Termination or expiration of this Agreement shall automatically terminate all services provided, and licenses granted, by Medidata hereunder, and Customer shall cease all use of the Medidata Applications on the effective date of termination or expiration. Within thirty (30) days after the termination or expiration of this Agreement, each party shall return to the other, or at such party’s direction destroy, and certify to such party in writing that the original and all copies, in whole or in part, of the other party’s Confidential Information (including, without limitation, the Medidata Applications, Documentation and Medidata Marks) have been returned or destroyed. To the extent that Medidata Services or Medidata Applications have been delivered to Customer, the due dates of all payments owed by Customer to Medidata per this Agreement shall be automatically accelerated so they become due and payable via immediate wire transfer on the effective date of termination or expiration.

 

7.	Confidentiality.

 

7.01 Confidential Information . The parties may receive or have access to information that is confidential to one or the other party (the “Confidential Information”). Confidential Information shall mean competitively sensitive materials and information, in whatever form, written, oral or otherwise, that include, but shall not be limited to (i) all versions of the Medidata Applications and Documentation, (ii) the distinctive methods or procedures which Medidata uses in the design, development, licensing, support, or maintenance of the Medidata Applications, (iii) the terms and pricing under this Agreement, (iv) each party’s business processes and strategies, and (v) all information clearly identified by either party as confidential. Notwithstanding the foregoing, a party’s Confidential information shall not include information that, as evidenced by documentary evidence: (a) is or becomes generally available to the public through no act or omission of the other party; (b) was in the other party’s lawful possession prior to the disclosure and had not been obtained by the other party either directly or indirectly from the disclosing party or from a third party whom the receiving party knows or should know is under an obligation of confidentiality with the owner of the Confidential Information; (c) is lawfully disclosed to the other party by a third party without restriction on disclosure; (d) is independently developed by the other party; or (e) is obligated to be disclosed by court order or government requirement.

 

7.02 Nondisclosure . Each party agrees to hold each other party’s Confidential Information in confidence during the term of this Agreement and for a period of five (5) years after termination or expiration of this Agreement, or, with respect to Confidential Information protected by trade secret, such longer period as required to maintain such trade secret protection in such Confidential Information. Each party agrees not to make the other party’s

 

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Confidential Information available in any form to any third party (provided that a party may make the terms and pricing of this Agreement available to auditors and legal counsel who are bound by confidentiality obligations with respect thereto) or to use the other party’s Confidential Information for any purpose other than the implementation of this Agreement. Each party agrees to take all reasonable steps to ensure that Confidential Information is not disclosed or distributed by any person or entity in violation of the terms of this Agreement. Within thirty (30) days after any request made from time to time by a party hereto, the other party shall return to the requesting party, or at the requesting party’s direction destroy, and certify to the requesting party in writing that the original and all copies, in whole or in part, of the Confidential Information (other than the Medidata Applications or Documentation) have been returned to the requesting party or destroyed. If the receiving party is compelled to disclose any of the disclosing party’s Confidential Information by court order or government regulation, it will disclose only that portion thereof which it is compelled to disclose and shall reasonably cooperate with the disclosing party’s efforts to obtain an order or other reliable assurance that confidential treatment will be accorded to the Confidential Information so disclosed.

 

8.	Limited Warranties and Exclusions.

 

8.01 Medidata Warranties . Medidata warrants to Customer that it has the right and authority to grant the Study Use License hereunder and that for ninety (90) days from Delivery of the Medidata Applications as defined in Schedule 1, the Medidata Applications will substantially perform in all material respects the functions described in the then-current version of the Documentation when used and/or accessed in accordance with all terms and conditions of this Agreement and of the then-current version of the Documentation. Medidata warrants to Customer that during the Term of this Agreement, the Medidata Applications (as modified from time to time) and the Medidata Services (as amended from time to time) are and will continue to be compliant with FDA 21 CFR Part 11, GCP (Good Clinical Practice) and relevant FDA regulations.

 

8.02 Procedure . Customer must provide Medidata prompt notice of any claim under the warranties set forth in Section 8.01, must provide such notice within the applicable warranty period and must provide to Medidata documentation of the error or deficiency and the necessary software and data required to reproduce the error or deficiency of the Medidata Applications, and all other reasonable support and assistance in discovering the cause or a cure for the reported error or deficiency of the Medidata Applications. Customer’s exclusive remedies in the case of any nonconformity or defect in the Medidata Applications for which Medidata is responsible shall be limited to the following, at Medidata’s sole option: (a) providing modifications or fixes with respect to any such error or defect in a timely manner; (b) replacing the applicable Medidata Applications; or (c) refunding amounts paid by Customer to Medidata for the nonconforming Medidata Applications, as depreciated on a five-year straight line schedule beginning on the date the Medidata Applications was made available to Customer, and terminate Customer’s license therefor.

 

8.03 Network Connection . Customer may access the Medidata Applications by various means, including a public Internet network or common carrier connection or other TCP/IP-enabled network connection (“Network Connection”) provided by an Internet Service Provider, online service provider or other network provider. Customer understands and accepts that the reduced performance or non-availability of this Network Connection may result in reduced performance, interruption or temporary termination of the Medidata Applications. Customer further understands and accepts that Medidata bears no responsibility for the performance or availability of the Network Connection. Medidata shall have no liability to Customer, its Customers or any third person for any loss or expense relating to reduced performance, interruption or termination of the Medidata Applications due to the reduced performance or unavailability of a Network Connection.

 

8.04 Exclusions . Medidata is not liable for: (a) misuse of the Medidata Applications; (b) use of the Medidata Applications with data or software of third parties or with hardware which is incompatible with the Medidata Applications and not recommended by Medidata; or (c) errors in the Medidata Applications resulting from Customer’s configuration or manipulation of the Medidata Applications, in each case not specifically recommended by Medidata.

 

8.05 Mutual Warranties . Each party represents and warrants to the other party that: (i) such party has the power and authority to execute and deliver this Agreement and has taken all necessary corporate action to authorize the execution and delivery of this Agreement; (ii) this Agreement is and shall be the legal, valid, and binding obligation of such party and shall be enforceable in accordance with its terms; and (iii) such party will comply with all applicable privacy or data protection statutes, rules or regulations governing the respective activities of that party.

 

8.06 Disclaimer . It shall be Customer’s responsibility for determining the suitability of the Medidata Applications for Customer’s use. EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 8 OR ELSEWHERE IN THIS AGREEMENT, AND TO MAXIMUM THE EXTENT PERMITTED UNDER APPLICABLE LAW, MEDIDATA MAKES NO, AND HEREBY DISCLAIMS ANY, REPRESENTATION, WARRANTY OR GUARANTY, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE MEDIDATA APPLICATIONS, STUDY USE LICENSES AND ANY MEDIDATA SERVICES PROVIDED UNDER THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, ANY IMPLIED WARRANTY: (1) OF MERCHANTABILITY OR SATISFACTORY QUALITY; (2) OF FITNESS FOR A PARTICULAR PURPOSE; OR (3) ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING, OR USAGE OF TRADE. MEDIDATA MAKES NO WARRANTY THAT OPERATION OF THE MEDIDATA APPLICATIONS OR THE STUDY USE LICENSES WILL BE UNINTERRUPTED OR ERROR FREE OR THAT ALL DEFECTS WILL BE CORRECTED.

 

9.	Disclaimers of Damage and Limitations of Liability.

 

9.01 Limitation of Remedies . For all claims by either party relating to the other party’s performance or nonperformance under this Agreement, for all claims regarding the Medidata Applications or the Medidata Application’s failure to comply with any warranties in this Agreement, and for all claims related to other services provided by Medidata hereunder, whether such claims are made in contract, tort, strict liability, or otherwise, the injured party’s sole remedy and the other party’s exclusive liability (and Customer’s subcontractors’ exclusive liability to Medidata; and Medidata’s suppliers’, licensors’, service providers’ and subcontractors’ exclusive liability to Customer) shall be (i) the exclusive remedy specified in this Agreement for such claim, or (ii) if no exclusive remedy is specified, or if after commercially reasonable efforts the responsible party is unable to provide the exclusive remedy as specified, the recovery of the injured party’s actual, direct damages up to, in the aggregate: (a) for claims related to Medidata Applications for which a one-time or up-front license fee was paid by Customer to Medidata, the unamortized value of such one-time or up-front license fee actually paid by Customer to Medidata for the specific Medidata Applications giving rise to the claim(s); and (b) for all other Medidata Applications and Medidata Services, the actual amount paid by Customer to Medidata during the twelve (12) months prior to such claim(s) for the specific Medidata Applications or Medidata Service(s) giving rise to such claim(s). Customer’s liability shall not exceed the greater of the amount of the fees (a) due and owing to Medidata under this agreement, or (b) received by Medidata from Customer pursuant to this agreement for the twelve (12) month period immediately prior to the date on which claim is made therefor.

 

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9.02 Disclaimer of Certain Damages .

 

(1)

IN NO EVENT SHALL MEDIDATA AND ITS SUPPLIERS, LICENSORS, SERVICE PROVIDERS AND SUBCONTRACTORS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING BUT NOT LIMITED TO, LOSS OF PROFIT, LOST DATA, RERUN TIME, INACCURATE INPUT, WORK DELAYS, LOSS OF USE, BUSINESS INTERRUPTION, LOSS OF BUSINESS REPUTATION OR GOODWILL, COSTS OF SUBSTITUTE SERVICES OR DOWNTIME COSTS) SUFFERED BY CUSTOMER OR ANY THIRD-PARTY, HOWEVER CAUSED, REGARDLESS OF THE THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, PRODUCT LIABILITY OR OTHERWISE, EVEN IF MEDIDATA HAS BEEN PREVIOUSLY ADVISED OF THE POSSIBILITY, OR HAS CONSTRUCTIVE KNOWLEDGE, OF SUCH DAMAGES, AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE. THIS AGREEMENT SHALL NOT CONVEY UPON ANY THIRD PARTY ANY RIGHTS HEREUNDER, AND NO THIRD PARTY SHALL BE DEEMED A THIRD PARTY BENEFICIARY HEREOF.

 

(2)

IN NO EVENT SHALL CUSTOMER AND ITS SUBCONTRACTORS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING BUT NOT LIMITED TO, LOSS OF PROFIT, LOST DATA, RERUN TIME, INACCURATE INPUT, WORK DELAYS, LOSS OF USE, BUSINESS INTERRUPTION, LOSS OF BUSINESS REPUTATION OR GOODWILL, COSTS OF SUBSTITUTE SERVICES OR DOWNTIME COSTS) SUFFERED BY MEDIDATA, OR ANY THIRD-PARTY. HOWEVER CAUSED, REGARDLESS OF THE THEORY OF LIABILITY, WHETHER IN CONTRACT, TORT, PRODUCT LIABILITY OR OTHERWISE, EVEN IF CUSTOMER HAS BEEN PREVIOUSLY ADVISED OF THE POSSIBILITY, OR HAS CONSTRUCTIVE KNOWLEDGE, OF SUCH DAMAGES, AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE.

 

9.03 Exclusions . The limitations and disclaimers in Section 9.01 and Section 9.02 shall not apply with respect to: (a) either party’s liability for infringement of the other party’s or a third party’s proprietary rights (including, without limitation, the indemnification obligations of this Agreement related thereto); (b) either party’s liability for damage to or destruction of tangible personal property or real property; (c) either party’s liability under Article 7; or (d) Customer’s liability under Sections 2.03 or 2.06 or Article 5.

 

9.04 Commercial Nature . The Medidata Applications, Study Use Licenses and Medidata Services are business products and services, the application of which is commercial rather than consumer-oriented in nature. In executing this Agreement, the parties recognize, to the maximum extent permitted by applicable law, that the consumer protection laws in the Territory do not apply.

 

10.	Indemnification.

 

10.01 Infringement Indemnify . Subject to Section 10.02, Medidata shall, at its own expense, indemnify and defend Customer against any claim by a third party that the Medidata Applications as used in compliance with this Agreement infringes a valid U.S. patent issued prior to the Effective Date, Berne Convention copyright or U.S. trade secret (a “Claim”), provided that Customer: (i) provides Medidata with prompt written notice of the Claim; and (ii) permits Medidata to exclusively defend, compromise, settle or appeal such Claim. Customer shall provide Medidata with full information, assistance and cooperation, at Medidata’s expense, to enable Medidata to defend, compromise, settle and/or appeal such Claim and shall not settle or compromise any Claim without Medidata’s prior written consent. The provisions set forth in this Section10.01 shall not prohibit the participation of Customer with Medidata in the defense or appeal of any Claim should Customer choose to participate, at its own expense (such expense not being indemnified by Medidata) and with attorneys of its own choice, provided that Medidata shall have sole control and authority with respect to any such defense, compromise, settlement, appeal or similar action related to the Claim. Medidata shall pay any final award of damages assessed against Customer resulting from a Claim defended by Medidata pursuant to this Section 10.01, including any awarded costs or attorneys’ fees, or any settlement amount agreed to by Medidata.

 

10.02 Exclusions . Medidata shall have no obligation to Customer under Section 10.01 if the alleged infringement or violation is based upon:

 

(i) Use of the Medidata Applications other than as set forth herein and in the then-current version of the Documentation;

 

(ii) Any modification or alteration to or of the Medidata Applications performed (without the written approval of Medidata) by anyone (including Customer) other than Medidata or its subcontractors, agents or assignees;

 

(iii) Medidata’s compliance with Customer’s designs, specifications or instructions if Medidata is unable to follow such designs, specifications or instructions without infringement or violation;

 

(iv) Combination, operation or use with software, hardware, information, data, or other materials, not approved or supplied by Medidata, if infringement (including, without limitation, contributory infringement) would have been avoided by use without such software, hardware, information, data, or other materials;

 

(v) Use of a superseded or altered release of the Medidata Applications if the infringement would have been avoided by use of the current unaltered release of the Medidata Applications; or

 

(vi) Use of the Medidata Applications after Medidata’s notice to cease use of the Medidata Applications due to a claim of infringement.

 

10.03 Infringement Remedies . Notwithstanding anything to the contrary in the foregoing, should Customer’s right to continue to use the Medidata Applications pursuant hereto be subject to a claim that it infringes or misappropriates a valid patent or copyright or other intellectual property right, or if Medidata reasonably believes such a claim may arise, Medidata may fulfill its obligations under this Article 10 by, in Medidata’s sole discretion and at no cost to Customer:

 

(i) Procuring for Customer the right or license to continue to use the Medidata Applications;

 

(ii) Modifying the Medidata Applications to render it non-infringing but substantially functionally equivalent to the Medidata Applications prior to such modification; or

 

(iii) If the alternatives described in clauses (i) and (ii) of this Section 10.03 are not commercially practicable, Medidata may terminate the license to the Medidata Applications, in which case Medidata shall refund to Customer all fees paid by Customer to Medidata for unused use of or support for the allegedly infringing Medidata Applications. For the purposes of this Section 10.03(iii), the fees with respect to allegedly infringing Medidata Applications licensed for a one-time or up-front license fee shall be the unamortized value of such one-time or up-front license fee actually paid by Customer to Medidata for such allegedly infringing Medidata Applications, as depreciated on a five-year straight line schedule beginning on delivery of such allegedly infringing Medidata Applications to Customer. Upon such refund, Customer shall return such allegedly infringing Medidata Applications and Customer’s right to use such Medidata Applications shall cease.

 

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10.04 Effect . THIS ARTICLE 10 STATES MEDIDATA’S ENTIRE LIABILITY AND CUSTOMER’S EXCLUSIVE REMEDY FOR INFRINGEMENT AND/OR MISAPPROPRIATION, WHETHER SUCH ACTION, CLAIM OR PROCEEDING IS BASED ON BREACH OF WARRANTY OR ANY OTHER CAUSE OF ACTION. EXCEPT AS STATED ABOVE, MEDIDATA DISCLAIMS ALL INDEMNITIES, EXPRESS, IMPLIED OR STATUTORY FOR INTELLECTUAL PROPERTY INFRINGEMENT AND/OR MISAPPROPRIATION.

 

10.05 Other Indemnities . Medidata and Customer shall each indemnify, defend and hold harmless the other party against any and all costs (including reasonable attorneys’ fees) arising out of the indemnifying party’s breach of any of its obligations under this Agreement. Customer shall indemnify, defend and hold Medidata harmless from any claims and liability to third parties against any and all costs (including reasonable attorneys’ fees) arising out of: (i) any claim related to Customer’s or any third party’s use of the Medidata Applications, except claims arising pursuant to Medidata’s indemnity obligations under Section 10.01; or (ii) any claim that any materials, software, or other items provided to Medidata by Customer infringes a third party’s intellectual property rights.

 

11.	Miscellaneous

 

11.01 Assignment . This Agreement may not be transferred or assigned directly or indirectly by Customer without the prior written consent of Medidata, which consent may be withheld in Medidata’s sole discretion; provided that either party may transfer or assign this Agreement in connection with a sale of all or substantially all of its assets that relate to this Agreement or in connection with a change of control of Medidata.

 

11.02 Waiver . The failure of either party to enforce any of the provisions of this Agreement shall not constitute a waiver of the provisions or of the right of the party to enforce each and every provision contained in this Agreement.

 

11.03 Severability . If any provision of this Agreement for any reason shall be declared void, illegal, invalid or unenforceable in whole or in part, such provision shall be severable from all other provisions herein and shall not affect or impair the validity or enforceability of any other provisions of this Agreement.

 

11.04 Survival . The following provisions shall survive expiration or termination of this Agreement for any reason: Sections 5.01, 5.02, 5.03, 5.05, 5.07, 6.04, 11.04, 11.07, 11.08, 11.09, 11.12, and Articles 1, 4, 7, 8, 9 and 10.

 

11.05 Headings . The headings listed throughout this Agreement are only for convenience or reference only, are not a part of this Agreement and are not to affect the construction of, or be taken into consideration in interpreting, any provision of this Agreement.

 

11.06 Force majeure . Neither party shall be liable for any delay or failure to perform its obligations under this Agreement if prevented from doing so by a cause or causes beyond its reasonable control. Without limiting the generality of the foregoing, such causes include acts of God, the public enemy, fires, floods, storms, earthquakes, riots, terrorism, strikes, blackouts, wars or war operations, restraints of government, utility failures, computer hackers, denial of service attacks, software viruses, or causes which could not with reasonable diligence be controlled or prevented by the party.

 

11.07 Governing Law; Arbitration . Customer acknowledges that Medidata is based in the State of New York, USA, and requires uniformity and consistency in the laws under which it deals with all of its domestic and international customers. Accordingly, this Agreement shall be governed and construed, and all arbitrations hereunder shall be determined, in accordance with the laws of the State of New York, without regard to its conflicts of laws rules. The United Nations Convention on Contracts for International Sale of Goods shall not apply to this Agreement. The original of this Agreement has been written in English and English is the governing language of this Agreement. Customer waives any right it may have under the law of its territory to have this Agreement interpreted by or written in the language of the territory. In any action or proceeding to enforce rights under this Agreement, the prevailing party will be entitled to recover reasonable costs and attorneys’ fees. Any disputes arising out of this Agreement or the breach thereof shall be resolved by binding arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association, and judgment on the award rendered by the arbitrator(s) may be entered in any court having jurisdiction thereof. Notwithstanding the foregoing either party may apply to a court of competent jurisdiction for injunctive or equitable relief or to enforce or defend its intellectual property rights.

 

11.08 Non-Solicitation . During the term of this Agreement, and for a period of twelve (12) months after the expiration or termination of this Agreement, neither party will solicit, offer work to, employ, or contract with (whether as a partner, employee or independent contractor, directly or indirectly) one or more of the other party’s employees, except where expressly authorized in writing in advance by such other party. In the event a party breaches the foregoing sentence, as the non-breaching party’s sole remedy and the breaching party’s sole obligation, the breaching party will pay to the non-breaching party compensation equal to 150% of the annualized compensation paid or offered, under a written offer of employment, to such employee or employees by the breaching party. The parties acknowledge that: (a) each party has a valid interest in maintaining a stable work force; (b) this provision is reasonably tailored to that purpose; and (c) the liquidated damages amount is a reasonable approximation of the costs and damages that the non-breaching party would incur as a result of such action by the breaching party. Notwithstanding the foregoing provisions, the restrictions contained in this Section 11.08 shall not apply to, and no liability shall attach to either party with respect to, solicitations or advertisements for employment made to the general public.

 

11.09 Injunctive Relief . The parties acknowledge that violations of Article 4 and Article 7 of this Agreement may result in irreparable harm to the non-violating party for which remedies other than injunctive relief may be inadequate, and that the non-violating party shall be entitled to receive from a court of competent jurisdiction injunctive or other equitable relief to restrain such unauthorized acts in addition to other appropriate remedies. In the event of any claimed breach of any provisions of this Agreement, and in the event a party requests any injunctive relief or other relief in equity to stop or enjoin any act or acts by the other party, the parties agree that should such relief be granted by any court, that the requesting party shall not be required to post any bond or other surety as a pre-condition to such relief being granted and enacted.

 

11.10 Export . The United States and certain foreign countries may regulate the export and re-export of technology originating in the United States. Exporting and re-exporting may include the electronic transfer or dissemination of content and software to foreign countries, to certain foreign nationals, and to certain specially designated nationals. Customer agrees to abide by these laws and their regulations, including but not limited to the Export Administration Act and the Arms Export Control Act. Customer shall comply with all applicable provisions of export and import statutes and regulations. Customer shall not export, re-export, transfer, divert, or disclose, directly or indirectly, including via remote access, the Medidata Applications, the Study Use Licenses, the Medidata Services or any confidential information contained or embodied in any of the foregoing, or any direct product thereof, except as authorized under United States law and the law of the applicable country.

 

11.11 Notices . All notices and demands under this Agreement shall be in writing and shall be sufficient if sent by fax, registered mail or courier service in English, in each instance with confirmation of receipt, to the other party at its address given below, or at another

 

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address designated by such party in writing at a later time. A notice shall be deemed given on the date it was received.

 

11.12 Independent Contractors . Medidata and Customer will be and shall act as independent contractors, and neither party is authorized to act as an agent or partner of, or joint venture with, the other party for any purpose. Neither party by virtue of this Agreement shall have any right, power, or authority to act or create any obligation, express or implied, on behalf of the other party.

 

11.13 Entire Agreement . This Agreement constitutes the complete and exclusive statement of the terms and conditions between the parties, and supersedes all prior negotiations, agreements and representations. There are no other agreements or representations not set forth herein. The Agreement shall not be modified except by written consent of both parties.

 

I N W ITNESS W HEREOF , the parties do hereby execute this instrument, with each signatory warranting its authority to enter into this Agreement on behalf of the party it represents.

 

		A CCEPTED : 9/6/05
N U V ASIVE , I NC .						M EDIDATA S OLUTIONS , I NC .
BY:		/s/ Kevin O’Boyle				BY:		/s/ Peter B. Harker
		Authorized signature						Authorized signature
		Kevin O’Boyle						Peter B. Harker
		Name						Name
		EVP & CFO						Chief Financial Officer
		Title						Title

 

 

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Schedule 1: Medidata Applications

 

This Schedule 1 is incorporated by reference into and made a part of the Technology and Services Agreement (the “Agreement”) made between Medidata Solutions, Inc. (“Medidata”) and NuVasive, Inc. (“Customer”). Any capitalized terms not defined in this Schedule shall have the meaning set forth in the Agreement. Should a conflict arise between this Schedule and the Agreement, the provisions of this Schedule shall control.

 

The following restrictions apply to Customer’s use of the Medidata Applications (including related Documentation).

 

Medidata Applications (including Documentation) :

 

Medidata’s RAVE Environment

 

Medidata Vision Developer

 

Territory : North America

 

Study Use License Term :

 

This Study Use License pertains to “A Pivotal, Multi-center, Randomized, Controlled Trial Evaluating the Safety and Effectiveness of the NuVasive Anterior Cervical Total Disc Replacement (CTDR) Versus *** *** in Subjects with Single-Level Cervical Disc Disease”, protocol NUVA-CTDR-0501. The terms of the Study Use License will terminate upon the earlier of (i) completion of the study and (ii) *** months after Medidata makes the Medidata Applications available to Customer.

 

Delivery : Delivery and acceptance (“Delivery”) of the Medidata Applications will be deemed to have occurred on the Effective Date.

 

Fees for the Medidata Applications shall be follows:, and shall apply only during the Study Use License Term: