Terms and Conditions for U.S.-based Services

The following Standard Terms and Conditions shall govern the services provided by WuXi AppTec, Inc. (WuXi AppTec) to Customer (hereinafter each may be referred to as “Party” or collectively as “Parties”). Any proposal, quote, work order, purchase order, or statement of work (each a “Statement of Work”) that includes by reference these Terms and Conditions shall constitute the Agreement.

 

WARRANTY AND LIMIT OF LIABILITY

WuXi AppTec makes no warranty, express or implied, except as set forth herein. WuXi AppTec agrees to perform the services in an applicable Statement of Work (the “Services”) in keeping with the standards set forth in such Statement of Work and generally prevailing industry standards.  WuXi AppTec shall use any information, materials or test articles provided by Customer (“Materials”) for purposes of performing Services in accordance with these Terms and Conditions and the applicable Statement of Work under which such Materials are provided.  WuXi AppTec shall not be liable for any claim or breach of warranty unless such claim is submitted by Customer in writing to the offices of WuXi AppTec within three (3) months following the date the Services giving rise to the claim were completed.  Under no circumstances shall WuXi AppTec be liable to Customer or any third party claiming by or through Customer for any consequential, incidental or other damages, including without limitation loss of profits, business, or damage to goodwill, regardless of the foreseeability of any of the foregoing.  WuXi AppTec's liability for breach of warranty, the Statement of Work, or these Terms and Conditions or any implied or statutory warranties or any claimed to arise by operation of law shall be limited to proven direct damages in an amount not to exceed the price of the Services under which such liability arises.  THE WARRANTIES SET FORTH HEREIN ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, WHETHER ORAL OR WRITTEN, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ALL OF WHICH ARE WAIVED BY CUSTOMER.

 

CHANGE

Customer shall have the right to request reasonable changes and/or modifications (“Changes”) to a Statement of Work under which Services are performed. Should such Changes result in an increase or decrease in the scope of the Statement of Work the prices and timelines for completion will be revised accordingly.  All such Change requests and any associated pricing and timelines will be in writing and will be signed by authorized representatives of WuXi AppTec and Customer to be considered effective.  

 

RECORDS AND STUDY REPORT

WuXi AppTec may deliver to Customer a report of findings for Services (the “Report”), as applicable.  If Customer requests a draft Report, Customer shall have fourteen (14) days from receipt of the draft Report to review the report and provide comments to WuXi AppTec.  Within twenty-one (21) days of receipt of Customer comments, WuXi AppTec will provide Customer with the final Report that will have had WuXi AppTec Quality Assurance (QA) or Technical Management (as appropriate for the Service) review and approval prior to being sent to Customer.  If no comments are received from Customer within fourteen (14) days following delivery of the draft Report, the draft Report will become the final Report, a copy of which will be delivered to Customer after WuXi AppTec QA or Technical Management (as appropriate for the Service) review and approval.  Records of Services are available for Customer review at the WuXi AppTec site where the Services were performed. WuXi AppTec will retain batch, laboratory and other technical records (“Records”) of Services for at least ten (10) years and in a manner consistent with U.S. FDA regulations and guidance relating to testing of pharmaceutical or medical device products for use in animal studies or clinical trials intended to support an application for regulatory approval.

 

DELIVERY OF PRODUCTS

Any cell bank, tissue, cell therapy, device or other product (“Product”) arising from Services will be delivered Ex Works WuXi AppTec premises which means (a) when WuXi AppTec places the Product at the disposal of Customer at WuXi AppTec’s premises not cleared for export and not loaded onto any collecting vehicle and (b) risk and title to Product pass to Customer upon delivery (“Deliver,” “Delivery,” or “Delivered,” as appropriate).  WuXi AppTec shall deliver to Customer the Certificate of Analysis or other agreed-upon documentation not later than the date of Delivery unless Product release is agreed to in advance of finalizing the Certificate of Analysis.  Transportation of Product, whether or not under any arrangements made by WuXi AppTec on behalf of Customer, shall be made at the sole risk and expense of Customer.  If within forty-five (45) days of Delivery, Customer has reasonably demonstrated that Product fails to meet specification and that such failure is solely due to the negligence of WuXi AppTec in the performance of Services and not due (in whole or in part) to acts or omissions of Customer or any third party, WuXi AppTec shall at it’s sole discretion, refund that part of the price that relates to the production of such Product by WuXi AppTec or replace such Product at its own cost and expense. 

 

DISPOSAL OF ARTICLES

Test articles remaining after Services are completed or manufacturing retains (individually or collectively, “Articles”) will be maintained by WuXi AppTec in accordance with its Standard Operating Procedures or protocols, as applicable.  At the end of the applicable maintenance period, WuXi AppTec may dispose of Articles unless Customer has requested in advance that such Articles be returned.  The return of Articles to Customer shall be made at the sole risk and expense of Customer.

 

UNEXPECTED STUDY RESULT / SCIENTIFICALLY UNREASONABLE RESULT/ OUT OF SPECIFICATION RESULT

If, within fourteen (14) days of receiving a valid study result from Services, Customer notifies WuXi AppTec in writing that the result is unexpected and requests an investigation, WuXi AppTec will initiate a laboratory investigation of the result.  Customer and WuXi AppTec will agree on an appropriate course of action pending the results of the laboratory investigation.  If WuXi AppTec observes a scientifically unreasonable result from Services it will notify Customer within two (2) business days of learning of such result.  WuXi AppTec will investigate such result and the Parties will discuss and agree on an appropriate course of action.  In cases where Customer’s product specifications have been provided to WuXi AppTec, if WuXi AppTec observes an Out Of Specification (OOS) result it will notify Customer within two (2) business days of learning of such result.  Customer and WuXi AppTec will agree on the appropriate course of action to investigate the OOS result.  If the result of an investigation indicates that an unexpected, scientifically unreasonable, or OOS result is due in whole or in part to the inherent condition of the test article or the act, omission, direction, or negligence of Customer, Customer shall be liable to WuXi AppTec for the Services performed, including any retests, and materials, reagents, expenses, etc. consumed, employed, or specially obtained during the course of the laboratory investigation.  If the unexpected, scientifically unreasonable, or OOS result was caused by a combination of test article condition or the act, omission, direction, or negligence of Customer, and WuXi AppTec error, or a reasonable determination of cause cannot be ascertained, Customer shall be liable for 50% of the Services performed, including any retests, and 50% of the cost of any materials or reagents specially obtained by WuXi AppTec during the course of the laboratory investigation.  Customer is not liable to WuXi AppTec for unexpected, scientifically unreasonable, or OOS results due solely to WuXi AppTec error, and WuXi AppTec shall perform a retest, or provide a refund of any payments made by Customer for the Services giving rise to such unexpected, scientifically unreasonable, or OOS results.

 

FACILITY VISITS

Upon at least 14-day advance notice, Customer representatives may visit WuXi AppTec's facilities during normal working hours to observe Services, discuss Services with appropriate staff members of WuXi AppTec, or to inspect WuXi AppTec's facilities and Records, as they relate to Services.  While on WuXi AppTec’s premises, Customer shall adhere to any and all safety, security, and confidentiality measures required by WuXi AppTec.

 

REGULATORY AUDITS

WuXi AppTec will immediately inform Customer of any regulatory inspection that involves Services.  WuXi AppTec will permit a Customer representative to be present on site during such inspection.  WuXi AppTec will provide Customer with any observations and associated responses from a regulatory inspection directly related to Services. WuXi AppTec reserves the right to appropriately redact this documentation to preserve confidential information not related to Customer.

 

ABSENCE OF DEBARMENT

Neither WuXi AppTec nor any of WuXi AppTec personnel performing Services have been debarred, and to the best of WuXi AppTec’s knowledge, are not under consideration to be debarred, by the FDA from working in or providing services to any pharmaceutical or biotechnology company under the Generic Drug Enforcement Act of 1992.

 

TERMINATION OF SERVICES

If any Services or part thereof are delayed or terminated by Customer at Customer’s convenience either before or after commencement, Customer shall be liable to WuXi AppTec for the price of such Services initiated and any materials, reagents, and expenses consumed, employed, specially obtained, or expenses irrevocably committed for such terminated Services, and any other fees for such delay or cancellation detailed in the applicable Statement of Work.

 

CONFIDENTIALITY

During performance of Services and for five (5) years thereafter, each Party will treat as proprietary and confidential all information provided by the other Party in connection with this Agreement that (i) is identified in writing at the time of disclosure as confidential, (ii) if orally disclosed, is identified in writing as confidential no later than thirty (30) days after such oral disclosure, or (iii) should reasonably be understood to be confidential by the receiving Party in light of the nature of the information and the circumstances under which is it is disclosed (the “Confidential Information”).  Each Party will use reasonable care to avoid disclosing and will not knowingly disclose the same to any person or entity other than the disclosing Party or its designated representatives, and will use such Confidential Information solely for performance hereunder.  Without limiting the generality of the foregoing, the raw data, and Report derived or developed from the Services is the Confidential Information of Customer.  Excluded from obligations of confidentiality is any information that the receiving Party can demonstrate is (i) already known to the receiving Party as evidenced by competent proof; (ii) independently developed or discovered by the receiving Party without the use of the disclosing Party’s Confidential Information, as evidenced by competent proof; (iii) in the public domain, other than through breach of this Agreement or any of the receiving Party’s confidentiality obligations to the disclosing party; or (iv) disclosed to the receiving Party by a third party not in breach of a duty of confidentiality owed to the disclosing Party.  A receiving Party may disclose Confidential Information of the disclosing Party to the extent required to be disclosed by law; provided that to the extent permitted by applicable law the receiving Party gives prompt prior written notice to the disclosing Party and provides reasonable cooperation with the disclosing Party’s efforts to seek confidential treatment for the Confidential Information.  Upon the expiration or termination of this Agreement, or at any time at the disclosing Party’s request, the receiving Party shall return or, if consented to in advance by the disclosing Party, destroy, all manifestations of the disclosing Party’s Confidential Information except to the extent the receiving Party is required by law to retain copies of such Confidential Information.

 

OWNERSHIP AND INVENTIONS

All Materials owned or Controlled by Customer and furnished to WuXi AppTec for the purpose of performing Services or other similar obligation and all associated intellectual property rights will remain the exclusive property of Customer.  "Controlled" means with respect to Materials and associated intellectual property rights, the ability to grant access and/or a license without violating the terms of any agreement or arrangement with any third party. Upon full payment to WuXi AppTec of the fees due for Services, WuXi AppTec hereby assigns to Customer all right, title, and interest in all inventions, improvements, designs, formulas, methods, processes and writings, whether or not copyrightable or patentable that embodies Materials provided hereunder and discovered solely as a result of using such Materials (collectively, the "Inventions"). WuXi AppTec agrees, upon Customer’s request and at Customer’s expense, to do all things reasonably necessary to obtain patents or copyrights on any Inventions discovered exclusively as a result of performing Services and to execute any documents necessary to formalize the afore-mentioned assignments.  Notwithstanding the foregoing, Customer acknowledges that WuXi AppTec possesses certain inventions, processes, know-how, trade secrets, other intellectual property and assets, including but not limited to, methods, procedures, expertise, controls, computer technical expertise and software which have been developed by WuXi AppTec (collectively, the “WuXi AppTec Property”).  Customer and WuXi AppTec agree that any WuXi AppTec Property or improvements thereto which are used, improved, modified or developed by WuXi AppTec under or during the term of this Agreement, are the product of WuXi AppTec’s technical expertise possessed and developed by WuXi AppTec prior to or during the performance of this Agreement and are the sole and exclusive property of WuXi AppTec regardless if such WuXi AppTec Property or improvements thereto are incorporated or embedded in any Inventions or deliverable generated or due hereunder.  For the avoidance of doubt, protocols, methods, controls, SOPs, specifications, or documents (other than Reports) that are produced by WuXi AppTec for Services (collectively, “Service Instruments”) are furnished solely with respect to Services, and WuXi AppTec will retain all common law, statutory, ownership, and other reserved rights in such Service Instruments.

 

INDEMNIFICATION

Except to the extent caused by the reckless or willful misconduct of WuXi AppTec, Customer shall indemnify and hold harmless WuXi AppTec, its officers, directors, agents and employees from and against any and all losses, costs, damages and/or expenses (including, without limitation, reasonable costs of counsel), incurred by any such indemnitee as a result of or in connection with any claim by any third party 1) for injury (physical, emotional, psychological or other) or death of any person or physical damage to any property arising out of the testing, development, manufacture, sale or other use or distribution of any material or product which is the subject of Services, or 2) alleging WuXi AppTec’s use of Customer’s Materials, or Customer patent rights that are supplied to Wuxi AppTec by Customer infringes any rights (including, without limitation, any intellectual or industrial property rights) vested in any third party (whether or not the Customer knows or ought to have known about the same).  WuXi AppTec will promptly notify Customer of any claim of which it becomes aware and will cooperate with Customer’s reasonable requests in connection with defense of such claim, at Customer’s expense.

 

FORCE MAJEURE

WuXi AppTec and Customer shall not be held responsible for failure or delay in performance of their obligations under or in connection with the Agreement due to, but not limited to, the following: acts of God, government actions, labor disputes, civil disturbances, power outages, fire, natural disasters, material shortages, or failure of suppliers or subcontractors because of any of the above conditions.  If such delay persists for a period longer than sixty (60) days, Customer may terminate the Services and shall pay WuXi AppTec for Services performed in compliance with the Agreement prior to receipt of the notice of termination.

 

INVOICING

Unless otherwise specified in the Statement of Work, the price for custom Services will be invoiced 50% upon initiation and 50% upon issuance of CoA or Report, as applicable and the price for any standard (non-custom) Service will be invoiced 100% upon issuance of a Report. In the event that Customer requests a draft Report, Customer will be invoiced at the time the draft Report is issued.  Payment terms are net 30 days.  Invoices are billed and payable in U.S. dollars only.  In the event of Customer’s default of payment WuXi AppTec may at its discretion and without prejudice to any other of its accrued rights be entitled to suspend the provision of the Services or associated Reports, or to treat the Agreement as repudiated on not less than ten (10) days prior notice in writing to Customer.

 

PUBLICATION

Neither Party may use the other Party’s name or logo in any form of advertising, promotion or publicity, including press releases and technical reports, without the prior written consent of the other Party.  This term does not restrict a Party’s ability to use the other Party’s name in filings with the Securities and Exchange Commission, FDA, or other governmental agencies, when required to do so.

 

INDEPENDENT PARTIES

Nothing in these Terms and Conditions or Statement of Work will be construed as to create any relationship between WuXi AppTec and Customer other than that of independent contracting parties.  Neither Party shall have any right, power, or authority to assume create or incur any expense, liability, or obligation, express or implied, on behalf of the other Party.

 

WAIVER

Either Party’s failure to enforce at any time any of the provisions of the Agreement, to exercise any election or option provided herein, or to require at any time performance of any of the provisions hereof, shall in no way be construed to be a waiver of such provisions, nor in any way to affect the validity of the Agreement or any part thereof, or the right of either Party thereafter to enforce each and every such provision.

 

SEVERABILITY

The illegality or invalidity of any provision (or any part thereof) of any applicable Statement of Work, or these Standard Terms and Conditions shall not affect the legality, validity or enforceability of the remainder of its provisions or the other parts of such provision as the case may be.

 

DISPUTE RESOLUTION

In the event of any dispute arising under the Agreement, senior executives of WuXi AppTec and Customer with decision-making authority will enter into good faith negotiations to resolve the dispute.  The Parties agree to submit any unresolved dispute to a sole mediator selected by the Parties as soon as reasonable, but no later than sixty (60) days after notice.  If not thus resolved, the matter shall be submitted to an arbitration proceeding in Minneapolis, MN and the parties shall share equally the filing fees, arbitration fess, or other costs of such proceedings, except that each Party shall be responsible for it own attorney’s fees and other out-of-pocket arbitration expenses unless the arbitrators decide otherwise.  The proceeding shall be conducted under the then prevailing rules for commercial arbitration of the American Arbitration Association by a panel of three (3) arbitrators to be chosen according to such rules, one of whom must have substantial experience in the field of contract testing services.  The arbitrators shall have the authority to permit limited discovery to the extent reasonably required by a Party in order to establish its case.  The decision of the arbitrators shall be final and binding and may be entered and enforced in any court of competent jurisdiction.  Any monetary award shall be payable in U.S. dollars, free of any tax, offset or other deduction.  Any determination of the arbitration shall be confidential to the parties hereto and binding solely on the parties hereto. 

 

ENTIRE AGREEMENT

This Agreement embodies the entire understanding of WuXi AppTec and Customer and there are no promises, terms, conditions or obligations, oral or written, expressed or implied, other than those contained in the Agreement.  The Agreement supersede all previous agreements (if any) which may exist or have existed between WuXi AppTec and Customer relating to the Services.  Notwithstanding the foregoing, any previously executed Confidentiality Agreement still in effect between the Parties shall remain in full force and effect. These Terms and Conditions may only be modified by a written agreement signed by duly authorized representatives of WuXi AppTec and Customer.