Validation Service Purchase Agreement

VALIDATION SERVICE PURCHASE AGREEMENT

This Validation Service Purchase Agreement (the Agreement) is entered into as of Effective Date: by and between Provider Name: with principal place of business at Address: , and Client Name: with principal place of business at Address: .

RECITALS

WHEREAS, Provider is engaged in the business of providing validation services, including validation planning, execution, reporting and remediation support in accordance with applicable industry standards; and

WHEREAS, Client requires validation services for the systems, products or processes identified in Exhibit A (the Services) and desires to engage Provider to perform such Services under the terms and conditions set forth herein; and

WHEREAS, Provider represents that it has the personnel, expertise and resources necessary to perform the Services in accordance with the performance standards agreed by the parties.

NOW, THEREFORE, in consideration of the mutual promises and covenants contained herein, the parties agree as follows:

1. SERVICES

1.1 Scope. Provider shall perform the Services described in the Service Description below and in any statement of work issued under this Agreement. Provider shall provide qualified personnel and shall perform the Services in a professional and workmanlike manner in accordance with industry standards.

1.2 Deliverables. Provider shall deliver validation plans, test protocols, reports and other documentation as set forth in the Service Description. All deliverables shall identify the date of issuance and shall be delivered in electronic format unless otherwise agreed in writing.

2. FEES AND PAYMENT

2.1 Fees. In consideration for the Services, Client shall pay Provider the fees set forth below. Fees are exclusive of taxes and out-of-pocket expenses unless otherwise specified.

2.2 Invoicing. Provider shall invoice Client for fees and approved expenses in accordance with the Payment Terms. Client shall pay all undisputed invoices within days of the invoice date.

3. ACCEPTANCE

3.1 Acceptance Criteria. Acceptance of deliverables shall be in accordance with the Acceptance Criteria set forth below. Client shall have a period of days from receipt to review and either accept or provide written rejection describing deficiencies.

4. TERM AND TERMINATION

4.1 Term. The term of this Agreement shall commence on the Effective Date and shall continue until completion of the Services unless earlier terminated in accordance with this Section.

4.2 Termination for Convenience. Either party may terminate this Agreement for convenience upon providing written notice no less than days to the other party.

4.3 Termination for Cause. Either party may terminate immediately upon written notice if the other party materially breaches this Agreement and fails to cure within days after written notice of such breach.

5. CONFIDENTIALITY

5.1 Confidential Information. "Confidential Information" means nonpublic information disclosed by either party that is marked confidential or that reasonably should be understood to be confidential given the nature of the information and the circumstances of disclosure. Confidential Information includes validation data, protocols, test results and business information.

5.2 Obligations. Each party shall (a) protect the other's Confidential Information with the same degree of care it uses to protect its own confidential information, but not less than reasonable care; (b) use Confidential Information only to perform its obligations under this Agreement; and (c) restrict disclosure to employees and agents who have a need to know and are bound by confidentiality obligations no less protective than those in this Agreement.

6. INTELLECTUAL PROPERTY

6.1 Ownership. Except for Client Materials, Client shall own all right, title and interest in the validation results and deliverables upon payment in full. Provider shall retain ownership of its pre-existing materials, tools and methodologies.

6.2 License. Provider hereby grants Client a non-exclusive, non-transferable license to use Provider's deliverables solely for Client's internal purposes and solely to the extent necessary to use the deliverables for the validated systems or processes.

7. WARRANTIES; DISCLAIMER

7.1 Mutual Warranties. Each party warrants that it has all requisite corporate power and authority to enter into this Agreement and perform its obligations hereunder.

7.2 Provider Warranty. Provider warrants that the Services will be performed in a professional manner consistent with industry standards and the agreed Service Description for a period of days following acceptance. Provider's sole obligation for breach of this warranty shall be to re-perform the deficient Services at no additional charge.

7.3 Disclaimer. EXCEPT FOR THE WARRANTIES EXPRESSLY SET FORTH IN THIS SECTION, PROVIDER DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY OR ARISING BY COURSE OF DEALING, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

8. LIMITATION OF LIABILITY

8.1 Limitation. EXCEPT FOR LIABILITY ARISING FROM A PARTY'S GROSS NEGLIGENCE, WILLFUL MISCONDUCT, OR A BREACH OF CONFIDENTIALITY OR INDEMNIFICATION OBLIGATIONS, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGES, INCLUDING LOST PROFITS.

8.2 Liability Cap. PROVIDER'S AGGREGATE LIABILITY UNDER THIS AGREEMENT SHALL NOT EXCEED THE TOTAL FEES PAID BY CLIENT TO PROVIDER FOR THE SPECIFIC SERVICES GIVING RISE TO THE CLAIM DURING THE TWELVE MONTHS PRECEDING THE CLAIM.

9. INDEMNIFICATION

9.1 Provider Indemnity. Provider shall indemnify, defend and hold harmless Client and its officers, directors and employees from and against any third-party claims arising out of Provider's breach of its representations, warranties or the negligence or willful misconduct of Provider in performing the Services.

9.2 Client Indemnity. Client shall indemnify, defend and hold harmless Provider from and against any third-party claims arising from Client's misuse of the deliverables, Client Materials, or breach of this Agreement.

10. INSURANCE

Provider shall maintain, at Provider's expense, commercial general liability insurance and professional liability/errors and omissions insurance customary for the industry and sufficient to cover Provider's obligations under this Agreement. Upon request, Provider shall furnish certificates evidencing such insurance.

11. NOTICES

All notices required or permitted under this Agreement shall be in writing and delivered to the addresses set forth below or to such other address as a party may designate by notice in accordance with this Section. Notices shall be deemed given upon receipt when delivered in person, by certified mail or by nationally recognized overnight courier.

12. AMENDMENT; WAIVER

No amendment or waiver of any provision of this Agreement shall be effective unless in writing and signed by authorized representatives of both parties. The failure of either party to enforce any right shall not constitute a waiver of that right.

13. COUNTERPARTS

This Agreement may be executed in counterparts, each of which shall be deemed an original and all of which together shall constitute one instrument. Signatures transmitted by electronic means shall be deemed original signatures for all purposes.

14. GOVERNING LAW; SEVERABILITY; ENTIRE AGREEMENT

14.1 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the state of without regard to conflict of laws principles.

14.2 Severability. If any provision of this Agreement is held to be invalid or unenforceable, the remainder of this Agreement shall remain in full force and effect and the invalid or unenforceable provision shall be replaced by a valid and enforceable provision that most closely reflects the parties' intent.

14.3 Entire Agreement. This Agreement, including any exhibits or statements of work referenced herein, constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, understandings and communications, whether written or oral.

15. MISCELLANEOUS

15.1 Relationship of the Parties. Provider is an independent contractor and nothing in this Agreement creates an employment, partnership or agency relationship between the parties.

15.2 Assignability. Neither party may assign this Agreement without the prior written consent of the other party, except that either party may assign to an affiliate or in connection with a merger or sale of substantially all assets.

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