EX-10.49 41 filename41.htm

 

Exhibit 10.49

 

 Quality-843
Rev 001
Page 1 of 7
Title: Abbreviated Quality Agreement Template (level2)

 

This QUALITY AGREEMENT (“Agreement”) between SynCardia Systems, LLC, with principal offices at 1992 E. Silverlake Road, Tucson AZ, 85713-3865 and Carclo Technical Plastics, SynCardia Level 2 (crucial) Supplier (“Supplier”), with principal offices at 22 Manchester Road, Unit 10, Derry, NH 03038, describes the commitment both parties agree to make to ensure that their respective products and services (“Product”) satisfy the quality requirements called out in this agreement.

 

1. DEFINITIONS

 

a. Design History File (DHF): A compilation of documentation that describes the design history of a product

 

b. Device Master Record (DMR): A compilation of records containing the procedures and specifications for a finished device. Supplier generated DHF records may be requested as part of the DMR.

 

c. Industry Standards: As a medical device company, SynCardia requires Suppliers to reference the following standards as applicable to SynCardia devices:

 

i.   21 CFR Part 820 Quality System Regulation

 

ii.   GHTF/SG3/N17:2008 Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

 

iii.   Guidance for Industry Contract Manufacturing Arrangements for Drugs: Quality Agreements, May 2013

 

iv.   ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes

 

d. PRODUCT: Product covers Parts and Services. Parts such as components, sub-assemblies, manufacturing materials, in-process devices, finished devices, returned devices, or services such as software development, consulting, calibration, or design that are being provided by the Supplier, are all considered as Product.

 

Table 1: Product Covered by this Quality Agreement

 

#

PRODUCT/SERVICE NAME

 SUPPLIER
PART NUMBER		 SYNCARDIA
PART NUMBER		 PRODUCT/SERVICE
DESCRIPTION
1 Blank, Left Base 100672-001 100672-001 Manufacturing
2 Blank, Right Base 100673-001 100673-001 Manufacturing
3 Base Blank, Right, 50cc 170401-001 170401-001 Manufacturing
4 Base Blank, Left, 50cc 170403-001 170403-001 Manufacturing
5 20mm OP Inner Sleeve 170450-002 170450-002 Manufacturing
6 20mm OP Outer Sleeve 170451-002 170451-002 Manufacturing
7 22mm OP Inner Sleeve 170452-002 170452-002 Manufacturing

 

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Title: Abbreviated Quality Agreement Template (level2)

 

8 22mm OP Outer Sleeve 170453-002 170453-002 Manufacturing
9 18 mm OP Inner Sleeve, 50cc 170500-001 170500-001 Manufacturing
10 18 mm OP Inner Sleeve, 50cc 170501-001 170501-001 Manufacturing
11 20mm OP Inner Sleeve, 50cc 170502-001 170502-001 Manufacturing
12 20mm OP Outer Sleeve, 50cc 170503-001 170503-001 Manufacturing
13 23mm SynHall Inner Sleeve, 50cc 170504-001 170504-001 Manufacturing
14 23mm SynHall Outer Sleeve, 50cc 170505-001 170505-001 Manufacturing
15 25mm SynHall Inner Sleeve, 50cc 170506-001 170506-001 Manufacturing
16 23mm SynHall Outer Sleeve, 50cc 170507-001 170507-001 Manufacturing
17 Quick Connect Molded Blank 190001-001 190001-001 Manufacturing
18 Holding Ring, Snap, 25mm 734093-001 734093-001 Manufacturing
19 Gasket, Holding Ring, 25mm 734093-002 734093-002 Manufacturing
20 Holding Ring, Snap, 27mm 734093-003 734093-003 Manufacturing
21 Gasket, Holding Ring, 27mm 734093-004 734093-004 Manufacturing
22 Holding Ring, Snap, 23mm 734093-005 734093-005 Manufacturing
23 Gasket, Holding Ring, 23mm 734093-006 734093-006 Manufacturing
24 Arbor Press, Center Post Adjusting 734112-001 734112-001 Manufacturing
25 Arbor Press Stand, Valve 734113 002 734113-002 Manufacturing
26 Screw Plate for 27mm Dummy Ring 850006 850006 Manufacturing
27 Inflow Dummy Ring For 27mm Valves 850007 850007 Manufacturing
28 Screw Plate for 25mm Dummy Ring 850048 850048 Manufacturing
29 Outflow Dummy Ring For 25mm Valves 850050 850050 Manufacturing
30 Mold: 70cc Outflow Connector 850067 850067 Manufacturing
31 Mold: C-70 Mesh Preformed, Right 850138 850138 Manufacturing
32 Mold: C-70 Mesh Preformed, Left 850139 850139 Manufacturing
33 Mold, Blood Diaphragm, 50cc 870001-001 870001-001 Manufacturing

34

 Mold, Long Skirt, Intermediate Diaphragm, 50cc

870002-001

870002-001

Manufacturing
35 Mold, Air Diaphragm, 50cc 870003-001 870003-001 Manufacturing
36 Mold, Housing, Left, 50cc 870004-001 870004-001 Manufacturing
37 Mold, Housing, Right, 50cc 870005-001 870005-001 Manufacturing
38 Mold Housing Lower Body, 50cc 870006-001 870006-001 Manufacturing

 

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Title: Abbreviated Quality Agreement Template (level2)

 

39 Outflow Dummy Ring, 50cc 870007-001 870007-001 Manufacturing
40 Inflow Dummy Ring, 50cc 870008-001 870008-001 Manufacturing
41 Dummy Ring Screw Plate, 50cc 870009-001 870009-001 Manufacturing
42 Mold, Inflow Connector, 50cc 870010-001 870010-001 Manufacturing
43 Mold, Outflow Connector, 50cc 870011-001 870011-001 Manufacturing
44 Mold, Mesh, 50cc, Left 870012-001 870012-001 Manufacturing
45 Mold, Mesh, Right, 50cc 870013-001 870013-001 Manufacturing

 

e. Request for Supplier Corrective Action (RSCA): A request for corrective action issued to the Supplier to correct a non-conformance found affecting the quality of a product or service provided.

 

2. RESPONSIBILITIES

 

a. The Supplier shall assign a Quality Representative for the duration of this contract. This individual shall be responsible for overseeing Supplier activities that impact Syncardia products.

 

b. Supplier agrees to provide Product in accordance with all applicable SynCardia specification documents, drawings, and industry standards or procedures. This includes the manufacture, supply, testing, packaging, labeling, storage and shipment of Product to SynCardia.

 

c. SynCardia will maintain a Design History File (DHF) during product development. If Supplier participates during product development, Supplier will provide SynCardia with all documentation necessary to support the product (DHF).

 

d. All controlled documentation, including that which is Supplier-generated, required for the manufacture and testing of the SynCardia Finished Device will be maintained by SynCardia in the Device Master Record (DMR).

 

3. DOCUMENTED QUALITY SYSTEM

 

a. Supplier shall maintain a documented system for ensuring consistent Product quality and compliance. A formal Quality Management System (QMS) is recommended but not required.

 

b. If the Supplier operates an ISO certified QMS, Supplier shall provide a copy of their current certificate to SynCardia. Changes in the certification status of Supplier’s QMS shall be promptly reported to SynCardia.

 

4. NOTIFICATION OF REGULATORY AGENCIES

 

a. SynCardia shall be responsible for all communication with regulatory authorities including notification of process and product changes and the submission of Annual Reports.

 

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Title: Abbreviated Quality Agreement Template (level2)

 

b. SynCardia shall be responsible for all recall activities related to Finished Device and for reporting to regulatory authorities according to SynCardia’s written procedures.

 

c. Supplier shall provide necessary information to assist with any investigations required by SynCardia as a result of a potential recall or field action.

 

d. In the event of a Supplier-generated Product recall, the Supplier shall notify SynCardia within two business days.

 

5. LABELING

 

a. Supplier shall control all operations to prevent Product mix-ups, and to maintain traceability and product identification.

 

b. Supplier shall keep records of these activities and make them available to SynCardia upon request.

 

c. Supplier shall clearly identify each Product container and the respective Product within, in accordance with SynCardia specifications, for the purpose of Product identification and traceability.

 

6. NONCONFORMING PRODUCT

 

a. Supplier is responsible for notifying SynCardia of any nonconforming Product that has already been shipped to SynCardia within two (2) business days of discovery.

 

b. Supplier and SynCardia shall cooperate in conducting investigations or implementing corrective actions with respect to nonconforming Product.

 

c. If investigations conducted by SynCardia reveal that Supplier workmanship has contributed to a Product nonconformance, a Request for Supplier Corrective Action (RSCA) may be issued to Supplier.

 

7. AUDITS and CORRECTIVE ACTION

 

a. Supplier shall allow SynCardia, or its authorized representative or notified body, to perform audits of the Supplier’s facilities, systems, documentation, and other requirements related to this agreement and to the Product.

 

b. The scope of the audit shall be limited to Products supplied for SynCardia and related processes, and will be conducted at mutually agreed dates and times.

 

c. SynCardia may issue a Request for Supplier Corrective Action (RSCA) to Supplier to address Product non-conformances, SynCardia complaints and/or critical findings from on-site audits.

 

8. CHANGE CONTROL

 

a. Supplier shall notify SynCardia of all changes that require approval as described and summarized below:

 

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TYPE OF CHANGE

SYNCARDIA
APPROVAL

REQUIRED

 SYNCARDIA
NOTIFICATION
REQUIRED

DOCUMENTATION REQUIRED

Facility Move

  

X

 Advanced notification and validation of the new facility. SynCardia regulatory required.
Change in Manufacturing Equipment or Process

X

   Validation or Equivalency Report. SynCardia regulatory required.
Like-for-like Equipment Part Replacement outside of Preventive Maintenance  

X

Advanced notification and Part Equivalency Report or evidence of verification

Equipment Part Replacement not on approved parts list or Part Change – i.e., breakdown or not Like-for-Like repair

X

  

Supplier provided change requests, risk assessment and supporting documentation validation or Part Equivalency Report. SynCardia regulatory required.
Equipment move within a Facility  

X

 Advanced notification and validation protocol & report. SynCardia regulatory required.

Product Material Change

X

  

Material Analysis, risk assessment, product validation/verification (impact assessment). SynCardia regulatory required.

Process Material Change

X

  

Risk assessment and validation protocol & report (impact assessment). SynCardia regulatory required.
Manufacturing Improvements (no potential for Product/Process Impact)

X

  

Supplier provided change request and supporting documentation demonstrating no Product/Process Impact.
Product/Process Parameters/Specs

X

   Design Control Requirements. SynCardia regulatory required.

Product Software Change

X

  

Design Control Requirements and verification & validation protocol and report. SynCardia regulatory required.

Subcontractor Change

X

   Advanced Notification. Subcontractor qualification. SynCardia regulatory required.

Reduced inspectional requirements (finished QC inspection only)

X

  

Justification for change including supporting data. SynCardia regulatory required.
Reduced in process visual inspection requirements (workmanship standards)

X

   Statistical assessment to support process change. SynCardia regulatory required.

 

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Title: Abbreviated Quality Agreement Template (level2)

 

TYPE OF CHANGE

SYNCARDIA
APPROVAL

REQUIRED

 SYNCARDIA
NOTIFICATION
REQUIRED

DOCUMENTATION REQUIRED

Deviations from product specification affecting fit, form or function with impact to SynCardia Product.

X

  

Non-conformance or Scrap Report and evidence of quarantine pending disposition.

Product Configuration

X

  

Justification for change redlines to drawings for packaging/configuration. SynCardia regulatory required.

Storage Conditions

X

Note 1

   Demonstration that specification and product labeling requirements are met.
Manufacturing Environmental Controls  

X

 Validation and verification protocol & report. SynCardia regulatory required.

Test Methods

X

   Justification and method/equipment validation. SynCardia regulatory required.

Labels and Labeling

X

   Label/Labeling proof. SynCardia regulatory required.

Crucial Supplier change

X

  

Advanced notification and validation, risk assessment and verification protocol and report. SynCardia regulatory required.

Significant changes to Management, Quality System or Ownership

  

X

Organization chart, IRS forms and SynCardia regulatory required.

 

Note 1: Supplier shall manufacture the products in a controlled environment and ensure that the products are always handled and stored in a manner that will prevent damage, degradation and mix-ups.

 

9. DISPUTES

 

a. Both parties will use their commercially reasonable efforts to resolve any claim, controversy or dispute concerning any matter related to this agreement.

 

b. If legal action is commenced, Supplier shall continue to perform its obligations under this agreement pending final resolution of the dispute.

 

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Rev 001
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Title: Abbreviated Quality Agreement Template (level2)

 

This Agreement is effective as of the approval date on the signature page of this agreement and will continue through the completion of the contract services provided by Supplier to SynCardia, until it is superseded by a new version, or until the business relationship between Supplier and SynCardia is terminated.

 

In Witness Whereof, the parties have, by duly authorized persons, executed this Agreement.

 

SynCardia Systems, LLC   Carclo Technical Plastics
     
Signature:  /s/ Blagoberto Herrera   Signature:  /s/ Jeff Mackenzie
Name: Blagoberto Herrera   Name: Jeff Mackenzie
Title: Vice President of Quality   Title: COO
Date: 4 April 2019   Date: 3/15/19
     
Address:   Address:
     
1992 E. Silverlake Road
Tucson, Arizona 85713		  

22 Manchester Road, Unit 10,

Derry, NH 03038

     
Phone Number: 520.545.1234   Phone Number: 724.539.1833

 

Quality-806 Rev 001