Medical product design contract services agreement

17. Regulation
CUSTOMER shall be responsible for submission to and acceptance by FDA of any premarket notification (“510(k)”) submission or premarket approval application (“PMA”) required to commercially distribute the Products in the United States and for approval by their foreign equivalents (e.g., IVDD registration) for the Products. CUSTOMER also shall be responsible for submission to and acceptance by FDA of any investigational device exemption (“IDE”) application required to conduct clinical studies of the Products in the United States and the foreign equivalent of an IDE application to conduct clinical studies of the Products in other countries. CUSTOMER shall, at its expense, prepare, hold and maintain all necessary applications to analytically and clinically test and obtain government regulatory approvals to market, distribute and sell Products. As appropriate, CUSTOMER will supply CONTRACT MANUFACTURER a certification that assures accuracy and completeness of documentation submitted for each Product prior to submission to regulatory authorities such as the FDA and certification of FDA’s permission to market or clinically study the Products. Additionally, if CUSTOMER is required to notify the FDA of a change in location where the Products will be designed or manufactured, CUSTOMER agrees to submit and obtain any required FDA approval or clearance for such change. Additionally, the term “Manufacturer” as referred to in Chapter 21 of the CFR (or its foreign equivalents), and all requirements thereof, shall mean “CUSTOMER.” In all FDA or equivalent regulatory respects, CUSTOMER shall be solely responsible for the design of the Product.

18. Quality Specifications
In providing design support, CONTRACT MANUFACTURER shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from CONTRACT MANUFACTURER upon request.

19. Inspection of Facility

Upon reasonable advance written notice, CUSTOMER may inspect the documents related to the design support services provided under this Agreement at CONTRACT MANUFACTURER’s facilities during CONTRACT MANUFACTURER’s regular business hours, provided that such inspection does not unduly affect CONTRACT MANUFACTURER’S operations. CUSTOMER and its representatives shall observe all security and handling measures of CONTRACT MANUFACTURER while on CONTRACT MANUFACTURER’s premises. CUSTOMER and its representatives acknowledge that their presence on CONTRACT MANUFACTURER’s property is at their sole risk. If CUSTOMER inspects CONTRACT MANUFACTURER’s facilities under this Section, CUSTOMER shall provide CONTRACT MANUFACTURER with a copy of CUSTOMER’s inspection report within thirty (30) days after completing the inspection.

20. Notification of Inspection of CUSTOMER by Governmental Authority
CUSTOMER shall immediately notify CONTRACT MANUFACTURER of any inspection of CUSTOMER’s facilities or request for information by FDA or any other governmental authority that is reasonably related to Products for which CONTRACT MANUFACTURER provides design support services under this Agreement and shall provide CONTRACT MANUFACTURER with a copy of any notice of observations issued by the governmental authority and any written or electronic request for information. CUSTOMER also shall provide CONTRACT MANUFACTURER with a copy of the CUSTOMER’s response to the notice of observations and any written or electronic request for information.

21. MDR & Vigilance Reporting

The CUSTOMER shall be responsible for all MDR and Vigilance reporting. The customer shall notify CONTRACT MANUFACTURER of all required reporting and provide CONTRACT MANUFACTURER with copies of any MDR or Vigilance reports filed that are related to Product for which CONTRACT MANUFACTURER has provided design support services. CONTRACT MANUFACTURER shall, on request, provide CUSTOMER with assistance with any product failure investigation.

22. Notification of Enforcement Action

CUSTOMER shall provide CONTRACT MANUFACTURER with a copy of any written or electronic communication that it receives from FDA or any other governmental authority, including a FDA Warning Letter, in which FDA or any other governmental authority seeks or threatens to seek enforcement action, including, but not limited to, a voluntary or mandatory recall, detention, seizure, injunction, prosecution, or civil fines that is reasonably related to the design services covered by this Agreement.

23. Correction or Removal Notification

For the purpose of this Section, “correction or removal” means an action taken to repair, modify, adjust, relabel, destroy, or inspect the Products covered by this Agreement with or without their physical removal from their point of use to some other location, including, but not limited to, a recall, market withdrawal, stock recovery, of safety alert. In the event CUSTOMER reasonably believes that it may be required to initiate a recall or other correction or removal with respect to Products covered by this Agreement, CUSTOMER shall immediately notify CONTRACT MANUFACTURER. Unless otherwise agreed by the parties in writing, CUSTOMER shall undertake any correction or removal at the CUSTOMER’s expense.

24. Entire Agreement

This Agreement constitutes the entire agreement between CONTRACT MANUFACTURER and CUSTOMER relating to the subject matter hereof and supersedes all prior or contemporaneous oral or written communications, proposals and representations with respect to its subject matter. No modification to this Agreement will be binding unless in writing and signed by a duly authorized representative of each party.

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first written above.

VentureOutsource.com, 2006


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