EX-10
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stj-sqa.htm
SUPPLIER QUALITY AGREEMENT
ST.
JUDE MEDICAL
Supplier Quality Agreement - Components
THIS
SUPPLIER QUALITY AGREEMENT (this “Agreement”)
is entered into and made effective this 10th day of February,
2016 (“Effective Date”) by and between NVE Corporation with a
mailing address of 00000 Xxxxxx Xxxx Xx., Xxxx Xxxxxxx, XX 00000 (“Supplier”)
and: (check one)
[ ]
St. Jude Medical, Cardiology Division, Inc., with a mailing address of 0000 Xxxxxx
Xxxx, Xxxxxxxx,
Xxxxxxxxx 00000 XXX (“SJM”)
[X] Pacesetter,
Inc., with a mailing address of 00000 Xxxxxx Xxxx Xxxxx, Xxxxxx, XX 00000 XXX
(“SJM”)
[ ]
Advanced Neuromodulation Systems, Inc., with a mailing address of 0000 Xxxxxxx
Xxxx, Xxxxx, Xxxxx
00000 XXX (“SJM”)
WHEREAS, various foreign and domestic laws, regulations and standards relating
to quality requirements for medical devices require SJM to have written agreements
in place with certain of its suppliers;
WHEREAS, the parties herein wish to address quality assurance matters relating
to the Components (as defined below) that SJM may purchase from Supplier from
time to time.
NOW, THEREFORE, in consideration of the mutual covenants and agreements set
forth below and for other good and valuable consideration of which receipt is
acknowledged, the parties agree as follows:
1. GENERAL
1.1 CHANGE NOTIFICATION.
Supplier shall notify SJM promptly, but in all cases within ten (10) days, of
Supplier becoming aware of a potential change to the Components (a "Proposed
Change"). Supplier shall not implement any Proposed Change without SJM's
prior written approval, which SJM shall not unreasonably withhold. If the Proposed
Change is approved by SJM, Supplier agrees to delay the implementation of the
Proposed Change as necessary to allow for SJM to obtain any regulatory clearances
and/or approvals. If the Proposed Change may affect the performance, safety or
effectiveness of the Components, Supplier shall furnish SJM a detailed, written
description of the nature, type and extent of the Proposed Change and the reason
for the Proposed Change at least one hundred eighty (180) days in advance of Supplier's
proposed implementation date for the Proposed Change.
Proposed Changes that may affect the performance,
safety or effectiveness of the Components include, but are not limited to, changes
to the following:
| | (a) | Composition or performance of the Component;
|
| | (b) | Processing or monitoring of the Component;
|
| | (c) | Quality control method(s) relating to the Component;
|
| | (d) | Location of any facility where the Component is manufactured;
|
| | (e) | ISO certification status or other regulatory status;
|
| | (f) | Significant document control system or traceability system change;
|
| | (g) | Quality system and/or organizational structure potentially impacting the manufacturing
and the quality of the Component;
|
| | (h) | Supplier's suppliers that supply components incorporated into the component;
|
| | (i) | Supply chain or manufacturing processes that significantly alter, positively
or negatively, |
| 86060 Ver. B
Supplier Quality Agreement Template
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1 of 8 |
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This confidential document is the property of
St. Jude Medical and shall not be reproduced, distributed, disclosed or used without
the express written
consent of St. Jude Medical. |
ST.
JUDE MEDICAL
Supplier Quality Agreement - Components
| | | Supplier's environmental impact. |
1.2 VENDORS AND CONTRACTORS.
Supplier maintains and exercises appropriate controls over any and all vendors
and contractors that provide services or products to Supplier that may impact
the quality of Components. All services and products provided to Supplier and
used for the Components comply in all material respects with applicable laws and
are adequate to ensure that the Components comply with their Specifications
1.3 PRODUCT CONFORMITY.
Shipments of Components to SJM will be accompanied by a Certificate of Conformance
or Certificate of Analysis. SJM will notify Supplier after receipt of the Components
if any of the Components fail to meet Specifications. Supplier may, at its option
and at its expense, re-inspect the Components at SJM's premises or perform the
re-inspection at its own facilities. In the event of reported Components damage
or failure of the Components to meet the Specifications, both parties will support
each other in conducting failure investigations. To this end, Supplier agrees
to provide documentation to SJM relevant to the manufacture of the Components.
1.4 PACKAGING. The
Components will be suitably packed for transit per the Specifications and in a
manner that prevents deterioration or damage during transit to SJM's facility.
Where packaging requirements are specified by SJM, packaging will be considered
part of the Component for purposes of this Agreement.
1.5 LABELING. SJM is
responsible for user information and labeling of any finished medical device,
with assistance from Supplier as requested, regarding form and content. However,
SJM shall be solely responsible for all final decisions relating to user information
and labeling of the finished medical device. All Components supplied to SJM shall
have, at a minimum, the following identification information: Supplier Name, SJM
Part Number, Lot Number and Quantity shipped. Additional required information
may be set forth in Specifications.
1.6 IDENTIFICATION.
As further specified in Article 4, Supplier will maintain identification to the
raw material lots used in the fabrication of the Components for a minimum period
of seven (7) years from date of shipment to SJM. Supplier will retain Device History
Records (as that term is defined in 21 CFR 820.3(i)) for a minimum period of twenty-five
(25) years (implantables) or fifteen (15) years (capital equipment components/devices)
or seven (7) years (disposable components/devices) from date of shipment to SJM.
Supplier will provide a copy of Device History Records and related Device Master
Records (as those terms are defined in 21 CFR 820.3(i) and (j)) upon SJM's request.
Requested copies will be provided within five (5) business days.
1.7 RAW MATERIALS.
The Components shall not contain materials derived from animal or human tissue
or other biological substances, unless otherwise disclosed in writing to SJM.
2. COMPLAINTS / PRODUCT EVALUATION / NONCONFORMANCES
SJM will file all reports it determines
are required by FDA's Medical Device Reporting (MDR), Medical Device Directive's
Vigilance Reporting regulations, and any other reports required by applicable
regulating agencies. Upon SJM's receipt of any customer complaint or other information
alleging or indicating that any Component is defective and if the allegedly defective
Component is returned to SJM, SJM may perform an initial internal product evaluation
and, if a preliminary determination is made that the possible defect is design
or manufacturing related, SJM may thereafter notify and forward the allegedly
defective Component to Supplier's product evaluation department and require Supplier
to perform an independent failure analysis of the returned Component(s).
Supplier will cooperate with and assist SJM in preparing and submitting any report
requested by SJM. If SJM returns to Supplier either allegedly defective Components
or samples of Components suspected to have problems
| 86060 Ver. B
Supplier Quality Agreement Template
| Page 2 of 8 |
|
This confidential document is the property of
St. Jude Medical and shall not be reproduced, distributed, disclosed or used without
the express written
consent of St. Jude Medical. |
ST.
JUDE MEDICAL
Supplier Quality Agreement - Components
or defects, Supplier shall, upon written request, return such Components to SJM
after Supplier has performed the necessary analysis. Supplier will promptly correct
any and all root cause(s) of any identified nonconformance and provide documentation
evidencing the completion and effectiveness of such corrections to SJM upon request.
Supplier will promptly notify SJM of any known or suspected noncompliance or nonconformance
to Specification(s), whether known from Supplier's internal quality or other activities
or information, or from third-party complaints, regulatory bodies, or other sources.
If Supplier becomes aware of any reason that will cause Components not to comply
with any Specification(s), Supplier will notify SJM promptly and in advance of
occurrence of the noncompliance.
3. SUPPLIER SITE AUDITS
Supplier will allow SJM to perform
quality assurance inspections and audits of Supplier's facility(ies) during regular
business hours and upon ten (10) business day advance written notice to Supplier
unless SJM requires, in good faith, more immediate access to Supplier's facility(ies),
in which case Supplier will not unreasonably deny SJM access to its facility(ies).
Additionally, if SJM determines an audit of Supplier's subcontractor is necessary,
Supplier agrees it shall use commercially reasonable efforts to obtain subcontractor
approval for SJM to conduct such audits. Supplier will cooperate with SJM's inspector
and will provide SJM access to non-proprietary information and/or records that
are associated with supplied Components in order to properly perform any such
inspection or audit. In cases where SJM has a reasonable need to review proprietary
information and/or records to determine the quality of the Components supplied,
Supplier will cooperate in good faith with respect to the manner in which such
records will be reviewed. The audit may include, without limitation, records relating
to manufacturing compliance with the applicable specifications, quality control
inspection reports and procedures, design history requirements, and compliance
to applicable United States Food and Drug Administration ("FDA") and
international quality system regulatory requirements. If SJM requires any corrective
action from Supplier in connection with such audits for non-conformances, Supplier
will take said corrective action or will promptly inform SJM in writing of the
reasons why Supplier believes such corrective action is not required or cannot
be completed within the time period set forth by SJM. Following completion of
corrective action by Supplier, SJM may conduct a follow-up audit to verify completeness
and effectiveness of any agreed upon and documented corrective action. Further
actions may result if, in SJM's judgment, the corrective actions cannot be verified
and/or are believed to be ineffective in preventing further occurrences, up to
and including termination of the parties' commercial relationship.
4. REGULATORY
SJM must comply with specific
quality system requirements, including current revisions of US FDA 21 CFR 820,
EN/ISO 13485 and 14971, and Japan's Ministry of Health, Labour and Welfare (MHLW)
Ministerial Ordinance No. 169. Supplier warrants that its manufacturing processes
and systems and the Components comply with all applicable specifications, laws
and regulations including but not limited to 21 CFR Part 820, at all times during
this Agreement.
Supplier will notify SJM within
five (5) business days of receiving any advance notice of a planned inspection
of any Supplier facility(ies) involved with manufacturing, assembly, or packaging
of Components by any international, national or local regulatory or legal compliance
agency or organization, e.g., US FDA, EU Notified Body, EU Competent Authority,
and CE xxxx certification organizations. If any regulatory or legal agency or
organization commences an inspection of any such Supplier facility(ies) without
providing advance notice to Supplier, Supplier will notify SJM within one (1)
business day of the commencement of such inspection.
| 86060 Ver. B
Supplier Quality Agreement Template
| Page 3 of 8 |
|
This confidential document is the property of
St. Jude Medical and shall not be reproduced, distributed, disclosed or used without
the express written
consent of St. Jude Medical. |
ST.
JUDE MEDICAL
Supplier Quality Agreement - Components
If Supplier is issued inspectional observations
or citations (e.g., US FDA Form FDA-483 or similar document) or any other correspondence
or notification from a regulatory or legal organization asserting any noncompliance(s)
affecting Components or any facility(ies) used to manufacture, hold, or process
Components (including but not limited to a US FDA Warning Letter or untitled letter),
Supplier will notify and provide a copy of the observations, citations, or other
notification or correspondence to SJM within one (1) business day of its issuance
to Supplier. Supplier will respond to any such communication in writing within
any requested or applicable time frame (e.g., 15 days for US FDA Form-483 or Warning
Letter) and will provide a copy of its response to SJM at the time submitted to
the relevant regulatory or legal organization. Prior to submitting its response,
Supplier will allow SJM reasonable time to review the planned response insofar
as the response relates to the Components or their manufacture, packaging, or
processing.
Supplier agrees that entities with regulatory oversight of SJM's products (e.g.,
EU Notified Body, EU Competent Authority, or US FDA) may examine all records and
information, including technical documentation, associated with the Components
to the extent authorized by law or regulation, and may audit Supplier's and its
subcontractor's manufacturing facilities to the extent and in any manner authorized
by law or regulation.
Table 1 identifies Supplier's record retention responsibilities. Supplier must
notify SJM prior to destroying any records listed in Table 1 that are associated
with Components, and agrees to send the records to SJM upon request, in lieu of
destroying the records.
Checkmark below indicates which type of SJM devices
supplied Components are utilized in relation to requirements surrounding record
retention periods.
Serviceable devices [ ]
Disposable devices [ ]
Implantable devices [X]
| 86060 Ver. B
Supplier Quality Agreement Template
| Page 4 of 8 |
|
This confidential document is the property of
St. Jude Medical and shall not be reproduced, distributed, disclosed or used without
the express written
consent of St. Jude Medical. |
ST.
JUDE MEDICAL
Supplier Quality Agreement - Components
Table 1: Primary Supplier Record Retention Requirements
| Record Description | Supplier Retention Period for Components Used in Serviceable Devices
| Supplier Retention Period for Components Used in Disposable Devices
| Supplier Retention for Components used in Implantable Devices |
| Calibration Records | 15 years
| 7 years | 25 years |
| Customer Shipment Records | 15 years
| 7 years | 25 years |
| Design Specifications | 15 years
| 7 years | 25 years |
| Device History Files | 15 years after last device has been manufactured
| 7 years after last device has been manufactured | 25 years after last device has been manufactured
|
| Device History Records | Non-Disposable Devices - 15 years after last device has been manufactured
| 7 years after manufacturing date | 25 years after manufacturing date |
| EU Technical File/Design Dossier | Permanent
| Permanent | Permanent |
| Facility Records, including, but not limited to: Water System,
HEPA and Maintenance | 15 years
| 7 years | 25 years |
| In-Process and Final Product Test Records | 15 years after last device has been manufactured
| 7 years after last device has been manufactured | 25 years after last device has been manufactured
|
| Lot History Records | 15 years
| 7 years | 25 years |
| Manufacturing Processes and Instructions | 15 years
| 7 years | 25 years |
| Raw Material / Component Traceability Records | 15 years
| 7 years | 25 years |
| 86060 Ver. B
Supplier Quality Agreement Template
| Page 5 of 8 |
|
This confidential document is the property of
St. Jude Medical and shall not be reproduced, distributed, disclosed or used without
the express written
consent of St. Jude Medical. |
ST.
JUDE MEDICAL
Supplier Quality Agreement - Components
| Record Description | Supplier Retention Period for Components Used in Serviceable Devices
| Supplier Retention Period for Components Used in Disposable Devices
| Supplier Retention for Components used in Implantable Devices |
| Process Qualification (including tooling and fixtures) and Process Validation
Documentation | 15 years after last device has been manufactured
| 7 years after last device has been manufactured | 25 years after last device has been manufactured
|
| Process Risk Assessment documentation (i.e. FMEA)
| 15 years
| 7 years | 25 years |
| Product and Label Specifications | 15 years
| 7 years | 25 years |
| Sterilization Process and Test Records | 15 years after last device has been manufactured
| 7 years after last device has been manufactured | 25 years after last device has been manufactured
|
| Identity of Subcontractors of Supplier used in the manufacture, processing,
testing, or inspection of SJM product. | 15 years
| 7 years | 25 years |
| Technical Records | Permanent
| Permanent | Permanent |
5. FIELD ACTION
If either Supplier or SJM determines
or is required or requested by any regulatory agency or other legal authority
to undertake a field action relating to any of the finished devices incorporating
Components, the non-acting party will cooperate and assist in locating and retrieving
the finished medical devices or Components and provide applicable documentation
to the party conducting the field action as reasonably necessary. Further actions
may result in the event such field action is due to Supplier's failure to meet
its quality system requirements or if Components do not conform to Specifications.
If Supplier undertakes a field
action (whether on its own initiative or at the request of a third-party other
than SJM) or is required or requested by any regulatory agency or other legal
authority to undertake a field action, and such field action relates to any Components
or finished products that incorporate Components, Supplier shall notify SJM as
promptly as possible and no later than two (2) business days after the decision,
request, or requirement to undertake the field action, as applicable.
6. CERTAIN DEFINITIONS
For purposes of this Agreement:
(a) "Component" means all constituent parts, elements, ingredients,
assemblies, sub-assemblies, raw materials, or similar items incorporated into
an SJM medical device, which Supplier is qualified to supply to SJM and which
SJM may purchase from time to time from Supplier; and (b) "Specification"
means the detailed description of the requirements for a Component as set forth
in the technical drawings or other documentation associated with such Component.
Unless otherwise provided, all terms used in this Agreement that are defined in
the QSR or other FDA regulations have the meanings set forth in those regulations.
| 86060 Ver. B
Supplier Quality Agreement Template
| Page 6 of 8 |
|
This confidential document is the property of
St. Jude Medical and shall not be reproduced, distributed, disclosed or used without
the express written
consent of St. Jude Medical. |
ST.
JUDE MEDICAL
Supplier Quality Agreement - Components
7. SJM AFFILIATES
This Agreement shall apply to
all Components supplied to any SJM Affiliate and any such Affiliate shall be deemed
a third party beneficiary of this Agreement. For purposes hereof, "Affiliate"
means any entity that, from time to time, directly or indirectly controls, is
controlled by, or is under common control with SJM, or that is a successor (including,
without limitation, by change of name, dissolution, merger, consolidation, reorganization,
sale or other disposition) to SJM or its business and assets. Other than as expressly
set forth in this Section, this Agreement does not and is not intended to confer
any rights or remedies upon any person other than the parties.
8. NOTICES TO SJM
Any notices to be given by Supplier
to SJM pursuant to this Agreement shall be sent via email to the SJM Supplier
Quality Manager at each affected ship-to site. In addition to email notification,
any notices concerning matters set forth in Section 1 (General), Section 2 (Complaints/Product
Evaluation/Nonconformances), Section 3 (Supplier Site Audits), Section 4 (Regulatory)
or Section 5 (Field Action) shall also be sent to the SJM Supplier Quality Manager
at each affected ship-to site by certified or registered mail, return receipt
requested, postage prepaid by FedEx or comparable overnight or express mail service
with delivery confirmation.
9. CHOICE OF LAW/FORUM/VENUE
Any provisions relating to choice
of law, forum or venue set forth in a supply agreement, purchase order or similar
commercial agreement between SJM and Supplier relating to the purchase and sale
of Components shall likewise apply to this Agreement with respect to matters arising
hereunder relating to such Components.
10. TERM
This Agreement is effective as
of the Effective Date and shall remain in effect for so long as any Components
furnished by Supplier to SJM may be in use.
11. ASSIGNMENT
Neither party may transfer or
assign this Agreement or any of its respective rights or obligations hereunder
to any third party, either directly or by operation of law, without the prior
written consent of the other party, which consent will not be unreasonably withheld,
except that no consent or notice will be required if SJM assigns this Agreement
or any of its respective rights or obligations hereunder to an Affiliate..
12. COMPLETE AGREEMENT/MODIFICATIONS/WAIVERS/SEVERABILITY
This Agreement contains the complete
agreement between the parties relating to the subject matter hereof and there
are no other promises, representations, inducements, terms or conditions, except
as herein provided. This Agreement supersedes and terminates all prior agreements,
whether oral or written, relating to the subject matter hereof, and any actual
or alleged promises, representations, inducements, terms, conditions or agreements
relating to the subject matter hereof which are not expressly made a part of this
Agreement are invalid, void and unenforceable. This Agreement may be modified
only by written agreement signed by duly authorized officers of each party. Waiver
by a party of a breach or violation of any provision of this Agreement shall not
operate as, or be construed to be, a waiver of any prior, concurrent or subsequent
breach. None of the provisions of this Agreement are considered waived by a party
except when such waiver is given in writing.
| 86060 Ver. B
Supplier Quality Agreement Template
| Page 7 of 8 |
|
This confidential document is the property of
St. Jude Medical and shall not be reproduced, distributed, disclosed or used without
the express written
consent of St. Jude Medical. |
ST.
JUDE MEDICAL
Supplier Quality Agreement - Components
In the event any provision in
this Agreement is held to be invalid or unenforceable, all other provisions of
this Agreement are deemed severable and will remain enforceable to the full extent
permitted by law.
13. COUNTERPARTS/FACSIMILE SIGNATURES
This Agreement may be executed
in counterparts, each of which are deemed an original, but which together constitute
one and the same instrument. Copies of signatures sent by facsimile transmission
or by PDF scan/email transmission are deemed to be originals for purposes of execution
and proof of this Agreement.
IN WITNESS WHEREOF, the authorized representatives of the parties have executed
this Agreement as of the Effective Date.
| NVE Corporation | SJM |
| |
| By: /s/ Xxxxxx X. Xxxxx | By: /s/ XXXXX XXXXXXXX |
| (Signature) | (Signature) |
| | |
| Name: Xxxxxx X. Xxxxx | Name: XXXXX XXXXXXXX |
| (Printed Name) | (Printed Name) |
| | |
| Title: President and CEO | Title: SR. DIRECTOR, SUPPLIER ASSURANCE |
| (Position in company) | (Position in company) |
| 86060 Ver. B
Supplier Quality Agreement Template
| Page
8 of 8 |
|
This confidential document is the property of St. Jude Medical and shall not
be reproduced, distributed, disclosed or used without the express written
consent of St. Jude Medical. |
