Source: https://www.exac.com/quality-agreement/
Timestamp: 2019-06-18 13:14:52
Document Index: 483317949

Matched Legal Cases: ['art 46', 'arts 160', 'art 1271', 'art 820', 'art 820', 'art 820', '§ 7']

Quality Agreement – www.exac.com
Quality Agreement Terms and Conditions Level 1-2
The following terms and conditions are hereby incorporated by reference in every purchase order issued by Exactech, Inc. and its wholly-owned subsidiaries (hereinafter “Exactech”) to the recipient of the purchase order (hereinafter “Supplier”) for the delivery of products or services listed or included therein (hereinafter “Deliverable” or “Deliverables”). These terms, conditions, and quality commitments apply to every document included with the purchase order, including but not limited, to any specification, drawing, or statement of work attached thereto (collectively the “Purchase Order” or “Agreement”).
Section I. PURCHASE ORDER; PAYMENT; CONFORMANCE; DELIVERY.
1.01 Purchase Order.
Only a properly executed Purchase Order in writing from Exactech to Supplier will be deemed an offer from Exactech and Supplier will only be paid for Deliverables that are sent pursuant to a properly executed Purchase Order.
This Purchase Order and Agreement integrates, merges, and supersedes any prior offers, negotiations, and agreements concerning the subject matter hereof and constitutes the entire agreement between the parties.
Supplier’s acknowledgment, acceptance of payment, or commencement of performance, shall constitute Supplier’s unqualified acceptance of this Purchase Order and Agreement.
Unless expressly accepted in writing by Exactech, additional or differing terms or conditions proposed by Supplier or included in Supplier’s acknowledgment are objected to by Exactech and have no effect.
1.02 Payment Terms.
Unless otherwise provided in writing, terms of payment shall be net sixty (60) days from the latest of:
Exactech’s receipt of Supplier’s invoice for this Purchase Order and Agreement; or
actual delivery pursuant to Section 1.04.
Each payment made shall be subject to reduction to the extent of amounts which are found by Exactech or Supplier not to have been properly payable, and shall also be subject to reduction for overpayments. Supplier shall promptly notify Exactech of any such overpayments and remit the amount of the overpayment except as otherwise directed by Exactech.
Exactech shall have a right to recoup or setoff, as the case may be, against payments due or at issue under an applicable Purchase Order between Exactech and Supplier.
Payment shall be deemed to have been made as of the date of electronic funds transfer or mailing Exactech’s payment with proof of delivery.
Unless otherwise specified, prices include all applicable federal, state and local taxes, duties, tariffs, and similar fees imposed by any Governmental Authority, all of which shall be listed separately on the invoice.
1.03 Conformance to Specifications and Requirements; Changes; Deviations.
Exactech shall define all specifications or requirements within the Purchase Order and Supplier shall not convey Deliverables that deviate from the requested specifications or requirements.
Supplier shall verify the current released Exactech Technical Specifications (“ETS”) revision and the associated ETS requirements from the Exactech Supplier Portal prior to conveying Deliverable(s) under this Purchase Order and Agreement.
Only a designated Exactech Procurement Representative has authority on behalf of Exactech to make changes under this Purchase Order and Agreement. All changes must be identified as such in writing and executed by the parties,
Supplier shall seek written authorization from a designated Exactech procurement representative prior to making any changes regarding to (i) Exactech products, drawings, specifications, or requirements, (ii) manufacturing processes, materials, locations, facilities, or equipment, (iii) packaging methods or material, (iv) approved raw materials, grade of raw materials, or sources of raw materials, or (v) any sub-tier suppliers that supply material for or participate in the manufacturing of Exactech product. Suppliers shall utilize Exactech change form 701-104-349 to document all proposed changes affecting Exactech product.
Design Changes. (i) For Supplier OEM/PL Devices, Supplier products are subject to design control and owned by Supplier. As such, changes to the Devices’ design are the responsibility of Supplier. (ii) For Exactech designed devices, Exactech devices are subject to design control and owned by Exactech. Changes to the design of Exactech designed products are the responsibility of Exactech. Supplier shall not make any changes to the finished devices without specific written approval from Exactech which may include revisions to Purchase Orders.
Changes to Products and Processes.
For Exactech designed devices manufactured by Supplier to Exactech specifications, if changes from approved manufacturing processes, drawing specifications, written specifications and/or purchase order specifications are desired, changes must be submitted to Exactech for written approval via Exactech form 701-104-349. This request should be directed to Exactech. Changes should be submitted prior to the completion of product to avoid loss of time and possibly scrapping of product. If the Supplier is at any time unsure as to how to proceed, immediately contact Exactech’s supply chain representative or supplier quality engineer that is assigned to the product affected, prior to proceeding.
If any change as defined above involves proprietary processes, it does not relieve the Supplier of the obligation to provide prior notification to Exactech regarding a proposed change.
Changes to specifications will be made by mutual agreement between the Supplier and Exactech. In addition to agreement of the change, Supplier and Exactech will determine the effective date of the change. When the specifications include references to brand names, Supplier and Exactech will mutually agree on the implementation of any changes made in the brand name product. Changes to the agreed upon specifications must be mutually agreed upon and communicated in writing between the parties to this Purchase Order and Agreement.
If there has been a deviation, or one is planned, from the Supplier Quality Management System and processes during the course of production, supply or service, Supplier shall immediately inform Exactech of the deviation and supply relevant data to assure Exactech will have all data and information necessary to make an informed decision regarding the deviation. Deviations should be approved by Exactech prior to the shipping of product to avoid loss of time and possible scrapping of product. If the Supplier is at any time unsure as to how to proceed, immediately contact Exactech. prior to proceeding. A copy of the approved Exactech change form 701-104-349 is to be shipped along with deliverable paperwork of the first lot produced under the deviation.
1.04 Inspection, Acceptance, and Delivery.
Unless otherwise specified on the Purchase Order, delivery shall be made FCA (Gainesville, FL) Incoterms® 2010. Exactech’s final inspection and acceptance of the Deliverable shall be at Exactech’s headquarters located at 2320 NW 66th Court, Gainesville, FL 32653—USA. Acceptance of incoming Deliverables by Exactech does not relieve the Supplier of their responsibility to furnish and warrant all work in accordance with the Specifications.
Notwithstanding Section 1.04(a) above, Exactech, at its cost, may inspect all products at reasonable times and places, including during manufacture and before shipment at a random test basis. Exactech shall be entitled to return suspected defect parts for Supplier evaluation and concurrence. Supplier shall provide all information, facilities, and reasonable assistance necessary for safe and convenient inspection without additional charge.
Unless otherwise specified on the Purchase Order, Supplier shall tender the Deliverable ordered by Exactech on or before the requested delivery date set forth on Purchase Order.
A complete packing list shall be enclosed with all shipments including inner containers. Supplier shall mark all containers or packages included in a shipment with necessary lifting, loading, and shipping information, including the Exactech order number (P.O. number in form), item number, Purchase Order line number, quantity, dates of shipment, the names and addresses of consignor and consignee, and any documentation required under Section 1.03. Supplier shall ship Deliverables with a Certificate of Conformance (“CoC”) and/or Certificate of Analysis (“CoA”) which contains, at a minimum (i) top level part number(s) and revision(s), (ii) subcomponent part number(s) and revision(s), (iii) subcomponent material, and if applicable, (iv) heat lot, (v) passivation, and (vi) cleaning. Applicable certifications may be submitted electronically with Exactech approval.
Section II. PRODUCT WARRANTY.
2.01 UNLESS OTHERWISE PROVIDED, SUPPLIER WARRANTS THAT ALL DELIVERABES FURNISHED PURSUANT TO THIS PURCHASE ORDER AND AGREEMENT SHALL STRICTLY CONFORM TO THE SPECIFICATIONS AND ANY OTHER REQUIREMENTS OF THIS PURCHASE ORDER AND AGREEMENT.
2.02 UNLESS OTHERWISE PROVIDED, SUPPLIER WARRANTS THAT ALL DELIVERABLES FURNISHED PURSUANT TO THIS PURCHASE ORDER AND AGREEMENT SHALL BE FREE FROM DEFECTS IN SUPPLIER MATERIAL AND WORKMANSHIP. THIS WARRANTY SHALL BEGIN UPON ACCEPTANCE OF THE PURCHASE ORDER AND EXTEND FOR A PERIOD OF ONE (1) YEAR RELATED TO THE DELIVERABLES IN THAT PURCHASE ORDER. ALL WARRANTIES SHALL RUN TO EXACTECH AND ITS CUSTOMERS.
Section III. COMPLIANCE WITH LAWS.
3.01 Supplier will at all times applicable to this Purchase Order and Agreement comply with Applicable Laws to its business or the supply of the Deliverables herein as promulgated by a cognizant Governmental Authority.
3.02 Supplier hereby represents, certifies and warrants that Supplier, its employees, officers, directors, sub-distributors, agents, or any other person associated with or acting on behalf of Supplier for the supply of the Deliverables herein, directly or indirectly, have never offered nor will offer to pay or provide, receive, or give, anything of value, and improper gratuity, or kickback to a healthcare professional, public official, or foreign political party for the purpose of gaining or retaining business or obtaining any unfair advantage, or favorable treatment in respect to the Deliverable or by or on behalf of Exactech.
3.03 If applicable, Supplier shall provide Exactech any Material Safety Data Sheet with each delivery as required by the Occupational Safety and Health Act of 1970, or any other applicable law.
3.04 If applicable, Supplier hereby represents that the products comply in all respects with the Federal Food Drug and Cosmetic Act, and specifically, that the Deliverables are not adulterated or misbranded within the meaning of that Act.
3.05 If applicable, and if the Deliverables are produced using human blood, components of human blood, of tissue or other material from a cadaveric donor, Supplier certifies that it was collected with informed consent that comports with the Common Rule, as outlined in 45 C.F.R. Part 46, as well as the Health Insurance Portability and Accountability Act, as outlined in 45 C.F.R. Parts 160, 162, and 164, 21 C.F.R. Part 1271and/or 21 C.F.R. Part 820 as applicable, the National Organ Transplant Act (42 U.S.C., Section 274e), and any applicable AATB standards.
3.06 Supplier shall comply with (i) the Employment Opportunity Clause required under Executive Order 11246 and 41 CFR 60-1.4(a), regarding nondiscrimination and affirmative action on the basis of race/ethnicity and gender, is incorporated by reference in these terms and conditions; (ii) the requirements of 41 CFR 60-741.5(a), regarding discrimination against qualified individuals on the basis of disability, and requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified individuals with disabilities; and (iii) 41 CFR 60-300.5(a), regarding discrimination against qualified protected veterans, and requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans.
Section IV. TRANSPARENCY IN SUPPLY CHAIN.
Supplier agrees to (i) not engage in any form of human trafficking or slavery, including without limitation, not using forced or involuntary labor of any type (e.g., forced, bonded, indentured, involuntary prison labor) or illegal child labor; (ii) to comply with applicable wage and hour laws and regulations, including those relating to minimum wages, overtime hours, piece rates and other elements of compensation, and provide legally mandated benefits; (iii) to treat all employees with respect and will not use corporal punishment, threats of violence or other forms of physical coercion or harassment; and (iv) to have a policy that prohibits inappropriate conduct and a process for employees to report such conduct for Supplier’s investigation and resolution. Supplier agrees to include similar requirements to those in this paragraph in contracts with its own suppliers.
Section V. QUALITY
5.01 Good Manufacturing Practices. Supplier is responsible for ensuring that all Deliverables are manufactured in material compliance with FDA’s Good Manufacturing Practices, which are now codified in the Quality System Regulation (21 C.F.R. Part 820), as well as international quality system standards, as necessary.
5.02 Quality Management System.
Supplier agrees to maintain a Quality Management System (“QMS”) that, at a minimum, conforms to the requirements of the current revisions of (i) 21 C.F.R. Part 820, (ii) ISO 13485, (iii) ISO 9001 (iv) ISO 14971 or (v) Exactech’s Supplier Quality System. Supplier shall promptly notify Exactech of any substantive changes to Supplier’s QMS or critical personnel responsible for managing its QMS.
If Supplier is in possession of a valid QMS certificate issued by an official regulatory body and such certificate has been accepted by Exactech, either in part or in its entirety as evidence of an adequate QMS for the devices manufactured or supplied or for services rendered, Supplier shall make said certifications available to Exactech. All changes regarding the certification shall be reported to Exactech immediately upon approval of such changes by the Supplier’s regulatory body issuing the certification.
Supplier represents that all inspection, measuring, and test equipment used in the manufacturing of the Deliverable is suitable for its intended purpose and is capable of achieving valid results. Such equipment must be subject to regularly scheduled calibration, adjustment, cleaning, and maintenance to ensure the Deliverable’s specifications or requirements are met.
Supplier represents that all processes which cannot be fully verified by subsequent inspection and test, as well as all automated processes, associated with the manufacture of the Deliverable are appropriately validated. Supplier shall maintain records of all validation protocols and reports and make them available to Exactech upon request.
Supplier agrees to maintain an inventory management system that establishes positive identification and traceability of the Deliverable and optimizes inventory turns on a “first-in-first-out” basis.
5.03 Training. Supplier shall provide appropriate training to ensure that employees are competent and qualified to produce quality products. The Supplier shall review and document the required skills and competencies necessary for the production, inspection, handling, and delivery of products to Exactech. The Supplier shall provide appropriate training to ensure that employees follow applicable procedures and instructions. The Supplier shall maintain employee records of training.
5.04 Process Validations.
If the output of a Supplier’s process is not fully verified by subsequent inspection or test, the process shall be validated to ensure they will consistently meet the design requirements. The Supplier shall validate the process with a high degree of assurance and justification for validation acceptance.
The Supplier shall create a validation plan/protocol (describing the planned activities) and a validation report (documenting the outcome of the planned activities). All validated process changes shall be similarly validated prior to use. The validation shall be performed according to an approved validation plan. Exactech reserves the right to review and approve the validation plan.
Production intent materials, tooling, processes and sub-suppliers should be used to produce products for validation testing. Exactech may require product for additional validation testing.
If the Supplier uses computers, software, or other automated methods as part of the production process or for management of the QMS, the Supplier shall validate the computer software for its intended use. All software changes shall be similarly validated prior to use.
The Supplier shall keep records of these activities and make them available to Exactech upon request.
Critical cleaning processes shall be validated. Where possible, the recommendations given in Exactech specification ETS 0319 Cleaning Validation Guidance, are to be utilized to demonstrate device cleanliness. If alternate test methods are utilized the test plan must be justified and approved by Exactech.
5.05 Inspection Measuring and Test Equipment.
Supplier shall ensure that quality control is conducted in accordance with the agreed upon QMS and test methods. Supplier shall, upon request, provide Exactech with all non-proprietary (unless otherwise agreed upon) data appropriate for evaluating the contract products and/or services.
The Supplier shall ensure that all inspection, measuring and test equipment used in the manufacturing process for product is suitable for its intended purposes and is capable of producing valid results.
All Supplier documentation must be reviewed by the Supplier and contain the signature of the test/inspection personnel, or the quality control personnel performing the operation.
Supplier shall establish and maintain schedules for the calibration, adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Calibration standards used for IM&TE shall be traceable to national or international standards. Supplier shall keep records of these activities and make them available to Exactech upon request.
For Exactech designed product manufactured by Supplier to Exactech specifications, for the first time making or supplying the part or service and any revision thereafter, the Supplier shall send a first article sample and the corresponding inspection report with the first lot/serial number produced which will be indicated on the Purchase Order. The Supplier is responsible for all dimensions on the product drawing and all referenced requirements. As a courtesy, Exactech may send the Supplier a copy of the Exactech Inspection procedure(s), specifications and/or drawings indicating dimensions and requirements, however, such information does not relieve the Supplier of supplying parts or services in full compliance with all Exactech requirements. Any questions concerning this matter should be directed to Exactech Quality Assurance Department.
If the agreed upon device quality has been verified and if the production and test protocols have been properly signed, the contract device or service shall be identified by Supplier as released. Exactech shall receive a test report/ batch record/ or certificate of compliance that confirms that the devices conform to all dimensions and specifications set forth on the drawings, specifications and/or inspection procedures. Supplier is not required to send all material certifications; however, these should remain on file at the Supplier location for review. Please contact Exactech Quality Assurance for a sample Certificate of Compliance if Supplier does not have a standard form.
5.06 Identification and Traceability.
The Supplier shall properly identify product throughout the realization process and establish a system that identifies the production status, verifies product acceptance with regards to inspection and testing and properly controls product disposition.
Supplier shall complete appropriate documentation for each production batch to ensure traceability of the contract product. The production paperwork will include the following:
the name of manufacturer / Supplier
the production date and the batch designation / serial number of the base materials used
the product designation with details of the batch / serial number of the product produced
Reference of adherence to international standards or specifications, as applicable.
The Supplier shall create a traceability method for unique identification of each part or material lot, unless otherwise agreed upon by Exactech. The Supplier shall work with Exactech to develop and approve an acceptable method, location and content for marking the product.
5.07 Sub-Tier/Sub-Contracted Suppliers.
If Supplier employs a third party to perform any or part of the manufacturing, packaging, labeling, inspection, testing, release and/or handling of product that is supplied to Exactech, Supplier shall ensure that the third party has been fully qualified via the Supplier’s qualification process prior to performing such activity. Supplier shall cascade all Exactech requirements as specified by the product specification to the third party.
Supplier shall have entered into a written confidentiality agreement with any third party providing for confidentiality of all Exactech information under obligations of confidentiality similar to and requiring the same protection or greater protection of confidential information as the obligations of confidentiality between Supplier and Exactech.
Supplier shall, however, retain all obligations under this Purchase Order and Agreement whether or not a third party manufactures, packages, labels, inspects, tests, releases and/or handles product. If a third party is used by Supplier to manufacture, package, label, inspect, test, release and/or handle products, Exactech may, upon request, review the list of such third party during an on-site visit and/or audit pursuant to Section 5.12.
5.08 Environmental Controls.
If environmental conditions could reasonably be expected to have an adverse effect on product quality, the Supplier shall establish and maintain procedures, including maintenance, adjustment, and inspection to adequately control these environmental conditions. The Supplier shall keep records of these activities and make them available to Exactech upon request.
If contact between personnel and the product could reasonably be expected to have an adverse effect on product quality, the Supplier shall establish and maintain requirements for the health, cleanliness, personal practices, and clothing of personnel to adequately control this contact.
The Supplier shall ensure that all equipment used in the manufacturing process for product is appropriately designed, constructed, placed, and installed. The Supplier shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met.
5.09 Restricted Substances.
Latex. Exactech utilizes the components and products produced by Supplier in the production of medical devices. Most of these products are used in the operating room and come into direct contact with the patient. In an effort to better serve patients that may be sensitive or allergic to latex, Exactech has adopted a Latex free policy for all products. Exactech requires that no latex be used in the manufacture, assembly, packaging, or the supply of products or services for products or components. Furthermore, Exactech requires that latex does not come into contact with products, components, or primary packaging. It is imperative that Exactech be aware if products are exposed to latex, to ensure that the most safe and effective medical products are supplied to Exactech customers.
Other. Exactech reserves the right, at a later date, to distinguish and ban any newly identified restricted substance that may or may not be used in the manufacture, storage, analysis or packaging of Exactech products.
5.10 Governmental Inspections and Inquiries.
Supplier shall promptly, and in any event within three (3) business days after the date of receipt of notice, notify Exactech in writing of, and shall provide Exactech with copies of, any correspondence and other documentation received or prepared by Supplier in connection with any of the following events to the extent necessary to meet the requirements of any Governmental or Regulatory Authority:
receipt of a regulatory letter, warning, Recall notice, notice of inspection or similar communication from any Governmental or Regulatory Authority in connection with the products or services; and
any Governmental or Regulatory Authority’s comments relating to the products or services that may require a response or action by the Company
Without limiting the generality of the foregoing, in the event that Supplier receives a letter or comments from any such Governmental or Regulatory Authority in connection with any of the Deliverables that requires a response or action by Exactech, Supplier shall promptly provide to Exactech any data or information required in preparing such response that relates to the manufacturing and supply of the Deliverables. Supplier will cooperate fully with Exactech in preparing such response.
In the event any facility that is used by Supplier or its agents to store, manufacture or otherwise supply the Deliverables is inspected by representatives of any Governmental or Regulatory Authority, Supplier shall notify Exactech promptly upon learning of such inspection, and in any event within three (3) business days after the date of learning of such inspection, and shall supply Exactech with copies of any correspondence that relates to such inspection. Exactech may, at its election, send representatives to such facility and may participate in any portion of such inspection that relates to any of the Deliverables. Supplier shall furnish to Exactech with copies of all material information supplied to, or supplied by, such Governmental or Regulatory Authority, including observations and responses within five (5) business days after the delivery of such information by the Governmental or Regulatory Authority.
Supplier shall provide Exactech with a copy of any response related to such visit or inspection for Exactech’s review and comment prior to submission of the response. Supplier shall provide Exactech with a copy of the final response promptly after it is submitted to the Governmental or Regulatory Authority.
5.11 Retention of Records.
Unless a longer period is specified in this Purchase Order and Agreement or by Applicable Laws, Supplier shall retain all records related to this Purchase Order and Agreement for thirty (30) years from the date of final payment received by Supplier. Records related to this Purchase Order and Agreement include, but are not limited to, financial, proposal, procurement, specifications, production, inspection, test, quality, shipping and export, certification records, or anything else in Supplier’s possession that is required to be maintained in the relevant Device History Record pursuant to 21 C.F.R. 820. In the event Supplier wishes to dispose of such records prior to the thirty (30) year requirement, Supplier shall contact Exactech and Exactech shall retain the right to possess such records.
At no additional cost, Supplier shall provide access to such records to Exactech within three (3) business days of the request.
5.12 Audits.
Within a reasonable time after a request is made by Exactech, Supplier shall allow Exactech, or its authorized representative, to perform audits of Supplier’s facilities, systems, documentation, and other requirements related to this Purchase Order and Agreement and Applicable Laws. The Supplier and Exactech will agree upon methods to protect intellectual property such as confidentially agreements, non-disclosure agreements, etc. Exactech shall be entitled to review compliance Supplier’s Quality Management System and processes at Supplier at all times. Supplier shall grant access to facilities to select employees of Exactech to provide them with any necessary information, or to conduct an audit/review. Audits shall be conducted at mutually agreed dates and times.
Supplier shall allow Exactech, or its authorized representative, to perform audits of its third-party supplier’s facilities, systems, documentation, and other requirements related to this Purchase Order and Agreement. Audits shall be conducted at mutually agreed dates and times. The Supplier, Exactech, and the third-party supplier will agree upon methods to protect intellectual property such as confidentially agreements, non-disclosure agreements, etc.
5.13 Insurance. Supplier warrants that it currently maintains, and will continue to maintain for a period of two (2) years after the issuance of an applicable Firm Order, commercial general liability (CGL) insurance with a minimum of $2,000,000 per occurrence limit. If requested, Supplier shall provide Exactech with a certificate of insurance evidencing Supplier’s compliance with this requirement.
Section VI. FURNISHED PROPERTY; CONFIDENTIALITY; INTELLECTUAL PROPERTY.
6.01 Furnished Property.
Exactech may provide to Supplier property owned by Exactech, including but not limited to, documents, software, drawings, raw materials, and durable or capital equipment (“Furnished Property”). Furnished Property shall be used only for the performance of this Purchase Order and Agreement and, if requested, shall be returned to Exactech immediately upon such request.
Title to Furnished Property shall remain in Exactech.
6.02 Proprietary Information and Confidentiality.
Except as hereinafter specifically provided, all information disclosed by one party to the other party and its employees pursuant to this Purchase Order and Agreement shall be in confidence. Each such receiving party and its employees, directors, agents, and representatives shall not use such information except as needed to perform its obligations under this Purchase Order and Agreement, and shall take reasonable precautions to prevent such information from being disclosed to third parties. Except as provided for elsewhere in this Purchase Order and Agreement, all materials containing such information shall be returned to the disclosing party upon expiration or Termination of this Purchase Order and Agreement. However, the previous sentence will not prevent a receiving party from retaining one copy of any documents as necessary to comply with Applicable Laws.
The following information shall not be considered confidential: (i) information which was publicly known or available as of the Effective Date (b) information which hereinafter becomes publicly known or available unless as a result of a breach of any confidentiality obligation or agreement with the other party or any other person; (c) information which a disclosing party agrees is not confidential; (d) information which was in receiving party’s possession without a breach of a duty prior to being furnished to such party by or on behalf of the other party as can be evidenced by written records; (e) information which is independently developed by a receiving party without use of any Know-How, non-published patents rights or confidential information of the other party; (f) information which is disclosed to a party by a third party with no duty or obligation of confidentiality. “Know-how” in the aforementioned context shall mean technical data, formulae, standards, technical information, specifications, processes, methods, code books, raw materials, as well as all information, knowledge, assistance, trade practices and secrets related to the Deliverables.
A receiving party may disclose confidential information received hereunder if and to the extent that such disclosure is required by applicable law, provided that, the receiving party uses reasonable efforts to limit the disclosure reasonable efforts to limit the disclosure and will promptly notify disclosing party so that the disclosing party may interpose an objection to the disclosure.
Information provided by Exactech to Supplier remains the property of Exactech.
6.03 Equitable Relief. Given the nature of the confidential information and the competitive damage that would result to a party upon unauthorized disclosure, use or transfer of its confidential information to any third-party, the parties agree that monetary damages may not be a sufficient remedy for any breach of this Section VI. In addition to all other remedies provided for under Section VII, a party shall be entitled to seek specific performance and injunctive and other equitable relief as a remedy for any breach or threatened breach of this Section VI.
6.04 Intellectual Property. Supplier acknowledges that any trade secret information, any copyrightable work product, manufacturing and control documentation, any and all patent rights and any and all other intellectual property rights developed, conceived, reduced to practice, derived from or otherwise generated or contributed to by Supplier in the course of the performance of the supply hereunder shall be immediately disclosed to Exactech, and shall be owned by and belong exclusively to Exactech.
6.05 Release of Information.
Supplier shall not use “Exactech,” any other trademark or logo, in whatever shape or form, owned by Exactech, any photographs or videos of Exactech facilities or employees, any photograph, video, or computer rendering of Exactech products, or any other information regarding Exactech in any advertisement or for any promotional purpose without the prior written consent of Exactech. Exactech may immediately revoke such consent upon written notice to Supplier.
Supplier shall not, without Exactech’s prior written consent, issue or release any public announcement, press release or other statement in any form of media, including the Internet, regarding an applicable Firm Order, the provisions of this Purchase Order and Agreement, or any of the transactions contemplated hereunder, including denial or confirmation of the fact that Supplier has contracted to furnish to Exactech the materials herein ordered.
Section VII. REMEDIES.
7.01 Termination.
Supplier totally or substantially discontinues operation of its business; or
a meeting of the Supplier’s shareholders or partners is convened for the purpose of voluntarily winding-up the Supplier, or a resolution to that effect is passed; or
a final judgement is given against the Supplier which is not satisfied within 14 (FOURTEEN) days or against which an appeal or application for rescission is not noted or made within the period prescribed by law (provided that such appeal or application is properly pursued) which results in Supplier suffering a material adverse change in financial condition; or
Supplier files or has filed against it a petition in bankruptcy; or
Supplier fails to provide adequate assurance of future performance; or
Supplier becomes insolvent or suffers a material adverse change in financial condition; or
Supplier fails to comply with any of the terms of this Purchase Order and Agreement;
then, in any such event, Exactech shall be entitled, without prejudice to any other rights which it may have in terms of this Purchase Order and Agreement or in law, on account thereof, to immediately terminate this Purchase Order and Agreement and to recover from Supplier all amounts due and/or owing including all damages of whatsoever nature it may have suffered on account of the Supplier’s breach and/or the termination of this Purchase Order and Agreement.
7.02 Default.
Non-Conforming tender. If Supplier tenders Non-Conforming Deliverables, then Exactech shall have the sole discretion to:
accept all or part of the Non-Conforming Deliverables tendered at an equitable price reduction or through an equivalent credit to future Firm Orders; or
reject the Non-Conforming Deliverables; or
require Supplier, at Supplier’s cost, to make all repairs, modifications, or replacements at the direction of Exactech necessary for adequate delivery; or
Cancel this Purchase Order and Agreement in its entirety.
In any event, under this Section, transportation of replacement Deliverables, return of Non-Conforming Deliverables, and re-performance of any work shall be at Supplier’s expense. If repair or replacement is not timely, Exactech may elect to return the Non-Conforming Deliverables at Supplier’s expense. Supplier shall not re-tender a rejected Non-Conforming Deliverable without a prior disclosure of the corrective action taken.
Timely performance. Supplier’s timely performance is a critical requirement of this Purchase Order and Agreement.
Supplier fails to timely perform under this Purchase Order and Agreement; or
fails to make progress so as to endanger performance an applicable Purchase Order;
then, in any such event, Exactech shall be entitled to:
accept all or part of the tendered Deliverables at an equitable price reduction; or
cancel, by written notice, this Purchase Order and Agreement for default, in whole or in part; or
require Supplier, solely at Supplier’s own expense, to ship the Deliverables by air for next-day delivery to Exactech’s designated facility or through other expedited shipment alternative per Exactech’s instructions.
Effect of Default remedies. The remedies under this Section 7 are elective rights that shall not derogate from Exactech’s exercise of any and all rights and remedies available to it under applicable law and equity, including, without limitation, the remedies under Sections 7.01 (Termination) and 7.03 (Cover) of this Purchase Order and Agreement. Upon exercise of the remedies under this Section 7.02, Supplier shall be compensated only for Deliverables actually delivered and accepted.
7.03 Cover.
In the event of Termination or Default, Exactech shall be entitled to procure, purchase, or otherwise secure an alternative supply of Deliverables equivalent goods from a source other than Supplier (“Cover Goods”).
The purchase of Cover Goods under this section shall not derogate from Exactech’s exercise of any and all rights and remedies available to it under applicable law and equity, including, without limitation, the remedies of Termination and Default.
7.04 Probation. In addition to the Remedies above, Exactech may place a Supplier on probationary or disqualified status at any time for reasons such as, but not limited to: Issuance of corrective actions, poor audit and/or quality performance, and lack of Supplier response.
Section VIII. EFFECT OF TERMINATION.
8.01 Termination of Rights and Return of Supplies. Upon the expiration or Termination of this Purchase Order and Agreement:
All rights granted to Supplier hereunder shall immediately terminate and shall forthwith revert to Exactech.
At Exactech’s request, Supplier shall immediately deliver to Exactech any supplies, materials, and drawings that Supplier has received from Exactech or has specifically produced for the performance of this Purchase Order and Agreement.
8.02 Return of Confidential Information. Within thirty (30) days following the termination of this Purchase Order and Agreement, each party shall deliver to the other party any and all Confidential Information of such party then in its possession, except for one (1) copy which may be kept in such party’s counsel’s office for archival purposes and to evidence of compliance with this Purchase Order and Agreement.
8.03 Surviving Obligations. In the event this Purchase Order and Agreement expires, is completed, or is terminated, the obligations contained in the following clauses shall survive: Section II; Section 5.10, 5.11, 5.12 and this Section VIII.
Section IX. INDEMNIFICATION; COSTS.
9.01 Supplier shall indemnify and hold harmless Exactech, its Affiliates and the directors, officers and employees of such entities, and the successors and assigns of any of the foregoing (the “Exactech Indemnitees”), from and against any and all losses, liabilities, damages, penalties, fines, costs and expenses (including reasonable attorneys’ fees and other expenses of litigation) (“Losses”) incurred by any Exactech Indemnitee resulting from any claims by third-parties arising from, or occurring as a result of: (a) negligence or willful misconduct in connection with Supplier’s performance of its obligations or exercise of its rights under this Purchase Order and Agreement; or (b) any material breach of any representations, warranties or covenants by Supplier under this Purchase Order and Agreement for which the following sections are expressly included: Section II; Section III; Section IV; Section V; Section VI.
9.02 Supplier shall further bear all costs associated with any Recall, whether voluntary or otherwise, that is due to the delivery of non-conforming Deliverables. Exactech shall notify Supplier of any such claims in a timely manner so that Supplier may mitigate any such claims, damages, losses, costs, or expenses.
Section X. CHOICE OF LAW; JURISDICTION.
10.01 This Purchase Order and Agreement and all questions regarding its existence, validity, interpretation, breach or performance, and any dispute or claim arising out of or in connection with it (whether contractual or non-contractual in nature such as claims in tort, from breach of statute or regulation or otherwise), shall be governed by, and construed and enforced in accordance with, the laws of the State of Florida, United States.
10.02 The United Nations Conventions on Contracts for the International Sale of Goods shall not be applicable to this Purchase Order and Agreement.
10.03 If the parties are unable to resolve the dispute through informal dispute resolution, the federal or state courts of competent jurisdiction in Alachua County, Florida shall be the sole and exclusive venue for resolution of all disputes directly or indirectly arising under or relating to this Purchase Order and Agreement. Each party hereby irrevocably waives, to the fullest extent permitted by Applicable Laws, any right it may have to a trial by jury with respect to any litigation directly or indirectly arising under or relating to this Purchase Order and Agreement. However, nothing in this Section 10.03 shall prevent Exactech from seeking injunctive relief through any court of competent jurisdiction as necessary to protect its confidential information a and intellectual property rights as provided for in Section 6.03.
Section XI. FORCE MAJEURE.
Neither party shall be held liable to the other party nor be deemed to have defaulted under or breached this Purchase Order and Agreement for failure or delay in performing any obligation under this Purchase Order and Agreement (other than failure to make payment when due) when such failure or delay is caused by or results from causes beyond the reasonable control of the affected party including embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, fire, floods, or other acts of God. The affected party shall notify the other party of such force majeure circumstances as soon as reasonably practicable, and shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances. Such excuse from liability shall be effective only to the extent and duration of the event(s) causing the failure or delay in performance and provided that the party has not caused such event(s) to occur.
Section XII. MISCELANENOUS PROVISIONS.
12.01 Entire Agreement; Amendments. This Purchase Order and Agreement, together with the Schedules thereto, contain the entire understanding of the parties with respect to the subject matter hereof and thereof and supersede and cancel all previous express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, in respect to the subject matter hereof and thereof. This Purchase Order and Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both parties hereto.
12.02 Headings. The captions to the several Sections hereof are not a part of this Purchase Order and Agreement, but are merely for convenience to assist in locating and reading the several Sections hereof.
12.03 Supplier Assignment; No Third-Party Beneficiaries. Any assignment of Supplier’s rights or delegation of Supplier’s duties under this Purchase Order and Agreement shall be void, unless prior written consent is given by Exactech. This Purchase Order and Agreement is not intended to confer upon any person other than the parties (Supplier / Exactech) any rights or remedies.
12.04 Independent Contractors. It is expressly agreed that the parties shall be independent contractors and that the relationship between the two parties shall not constitute a partnership, joint venture or agency. Neither party shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other party, without the prior written consent of the other party.
12.05 No Waiver. Failure by either party to enforce any of the provisions of this Purchase Order and Agreement or applicable law shall not constitute a waiver of the requirements of such provisions or law, or as a waiver of the right of a party thereafter to enforce such provision or law.
12.06 Severability. If any one or more of the provisions contained in this Purchase Order and Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the parties. The parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Purchase Order and Agreement.
12.07 Definitions. For purposes of this Purchase Order and Agreement:
Means all agencies, commissions, officials, courts and other governmental and regulatory authorities and instrumentalities, whether federal, state, provincial, regional, or local, of the United States and any other countries in which the Deliverables are manufactured, marketed, sold, tested, investigated or regulated, and all states or other political subdivisions thereof and supranational bodies applicable thereto.
Means, with respect to any country or jurisdiction, any Governmental Authority involved in granting approval of or regulating of the investigation, manufacture, distribution, marketing, sale, pricing or reimbursement of the Deliverables in that country or jurisdiction, including the FDA in the United States.
Means the current released Exactech Technical Specifications.
“Supplier Quality Management System”
Means the Quality Management System maintained by Supplier per Section 5.02.
Means all applicable common law, statutes, ordinances, rules, regulations, codes, requirements, laws or orders of any Governmental Authority.
“Non-Conforming Deliverables”
Means any tendered Deliverable which is not in compliance with Section 1.03; Section II; Section III; Section IV; and Section V.
Means the removal or correction (including repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a marketed product that a Regulatory Authority would likely consider to be in violation of the laws it administers and against which the Regulatory Authority could initiate legal action. “Recall” does not include a market withdrawal or stock recovery, as those terms are defined in 21 C.F.R. § 7.3.
Supplier Purchase Order Terms and Conditions Level 3-4
The following terms and conditions are hereby incorporated by reference in every purchase order issued by Exactech, Inc. and its wholly-owned subsidiaries (hereinafter “EXACTECH”) to the recipient of the purchase order (hereinafter “SUPPLIER”) for the delivery of products or services listed or included therein (hereinafter “Deliverable”). These terms and conditions apply to every document included with the purchase order, including but not limited, to any specification, drawing, or statement of work attached thereto (collectively the “Purchase Order”).
This Purchase Order integrates, merges, and supersedes any prior offers, negotiations, and agreements concerning the subject matter hereof and constitutes the entire agreement between the parties.
SUPPLIER’s acknowledgment, acceptance of payment, or commencement of performance, shall constitute SUPPLIER’s unqualified acceptance of this Purchase Order. (d) Unless expressly accepted in writing by EXACTECH, additional or differing terms or conditions proposed by SUPPLIER or included in SUPPLIER’s acknowledgment are objected to by EXACTECH and have no effect.
Any assignment of SUPPLIER’s rights or delegation of SUPPLIER’s duties under this Purchase Order shall be void, unless prior written consent is given by EXACTECH.
CONFORMANCE TO SPECIFICATIONS AND REQUIREMENTS
SUPPLIER agrees to defend, indemnify, and hold harmless EXACTECH and its customers from and against any claims, damages, losses, costs, and expenses, including reasonable attorney’s fees, which are based upon a claim that the Deliverable conveyed under this Purchase Order does not conform to the specifications or requirements. SUPPLIER shall further bear all costs associated with any recall, whether voluntary or otherwise, that is due to the delivery of non-conforming Deliverables. EXACTECH shall notify SUPPLIER of any such claims in a timely manner so that SUPPLIER may mitigate any such claims, damages, losses, costs, or expenses.
If requested by EXACTECH, SUPPLIER shall ship Deliverables with a Certificate of Conformance (CoC) and/or Certificate of Analysis (CoA) which contains, at a minimum (i) top level part number(s) and revision(s), (ii) subcomponent part number(s) and revision(s), (iii) subcomponent material, and if applicable, (iv) heat lot, (v) passivation, and (vi) cleaning. (d) SUPPLIER’s timely performance is a critical requirement of this Purchase Order. In the event SUPPLIER fails to timely perform under the Purchase Order, EXACTECH may, in its sole discretion, require SUPPLIER to expedite shipment at SUPPLIER’s sole expense or cancel the Purchase Order per Section 7.
SUPPLIER represents that all inspection, measuring, and test equipment used in any manufacturing of the Deliverable is suitable for its intended purpose and is capable of achieving valid results. Such equipment must be subject to regularly scheduled calibration, adjustment, cleaning, and maintenance to ensure the Deliverable’s specifications or requirements are met.
Only a designated EXACTECH Procurement Representative has authority on behalf of EXACTECH to make changes under this Purchase Order. All changes must be identified as such in writing and executed by the parties.
SUPPLIER shall seek written authorization from a designated EXACTECH Procurement Representative prior to making any material changes related to (i) EXACTECH products, drawings, specifications, or requirements, (ii) manufacturing processes, locations, facilities, or equipment, (iii) packaging methods or material, (iv) approved raw materials, grade of raw materials, or sources of raw materials, or (v) any sub-tier suppliers responsible for any of these functions.
If SUPPLIER delivers non-conforming Deliverables, EXACTECH may in its sole discretion, in addition to any other remedies available at law or at equity, (i) accept all or part of the Deliverables at an equitable price reduction, or (ii) reject such Deliverables, or (iii) require SUPPLIER, at SUPPLIER’s cost, to make all repairs, modifications, or replacements at the direction of EXACTECH necessary to enable such Deliverables to comply in all respects with Purchase Order requirements.
SUPPLIER shall not re-tender rejected Deliverable without disclosing the corrective action taken.
EXACTECH, by written notice, may terminate this Purchase Order for default, in whole or in part, if SUPPLIER (i) fails to comply with any of the terms of this Purchase Order; (ii) fails to make progress so as to endanger performance of this Purchase Order; (iii) fails to provide adequate assurance of future performance; (iv) files or has filed against it a petition in bankruptcy; or (v) becomes insolvent or suffers a material adverse change in financial condition.
Following a termination for default under this Purchase Order, SUPPLIER shall be compensated only for Deliverables actually delivered and accepted. EXACTECH may require SUPPLIER to deliver to EXACTECH any supplies, materials, and drawings that SUPPLIER has specifically produced or acquired for the terminated portion of this Purchase Order.
Upon the occurrence and during the continuation of a default, EXACTECH may exercise any and all rights and remedies available to it under applicable law and equity, including without limitation, cancellation of this Purchase Order.
Information provided by EXACTECH to SUPPLIER remains the property of EXACTECH. SUPPLIER agrees to comply with the terms of any Non-Disclosure Agreement with EXACTECH and to comply with all proprietary information markings and restrictive legends applied by EXACTECH to anything provided hereunder to SUPPLIER. SUPPLIER agrees not to use any EXACTECH provided information for any purpose except to perform this Purchase Order and agrees not to disclose such information to third parties without the prior written consent of EXACTECH.
The provisions set forth above are in addition to and do not alter, change or supersede any obligations contained in a Non-Disclosure Agreement between the parties.
SUPPLIER shall not provide any proprietary information to EXACTECH without prior execution of a NonDisclosure Agreement by the parties.
SUPPLIER warrants that any SUPPLIER designed Deliverables procured under this Purchase Order will not infringe or otherwise violate the intellectual property rights of any third party in the United States or any foreign country. SUPPLIER agrees to defend, indemnify, and hold harmless EXACTECH and its customers from and against any claims, damages, losses, costs, and expenses, including reasonable attorney’s fees, arising out of any action by 3 a third party that is based upon a claim that any SUPPLIER designed Deliverables procured under this Purchase Order infringes or otherwise violates the intellectual property rights of any person or entity.
SUPPLIER acknowledges that any trade secret information, any copyrightable work product, any and all patent rights and any and all other intellectual property rights developed, conceived, reduced to practice, derived from or otherwise generated or contributed to by SUPPLIER in performing the services hereunder shall be immediately disclosed to EXACTECH, and shall be owned by and belong exclusively to EXACTECH.
SUPPLIER will notify EXACTECH of any Deliverables subject to export controls and certify that SUPPLIER has complied with any applicable export control laws prior to transfer of Deliverables.
Unless otherwise specified, all Deliverables must be packed in accordance with good commercial practice.
A complete packing list shall be enclosed with all shipments. SUPPLIER shall mark containers or packages with necessary lifting, loading, and shipping information, including the EXACTECH Purchase Order number, item number, dates of shipment, and the names and addresses of consignor and consignee. Bills of lading shall include this Purchase Order number.
Unless otherwise specified, delivery shall be FOB Place of Shipment.
SUPPLIER shall arrange for the Deliverables to arrive at EXACTECH’s designated facility by the delivery date set forth on the accepted Purchase Order. In the event that the Deliverables have not arrived at EXACTECH’s designated facility by the delivery date set forth on the Purchase Order, Supplier shall, solely at its own expense, ship the Deliverables by air for next-day delivery to EXACTECH’s designated facility.
PAYMENTS, TAXES, AND DUTIES
Unless otherwise provided, terms of payment shall be net sixty (60) days from the latest of EXACTECH’s receipt of SUPPLIER’s proper invoice or actual delivery.
EXACTECH shall have a right to recoup or setoff, as the case may be, against payments due or at issue under this Purchase Order or any other purchase order between the parties.
Payment shall be deemed to have been made as of the date of mailing EXACTECH’s payment or electronic funds transfer. (e) Unless otherwise specified, prices include all applicable federal, state and local taxes, duties, tariffs, and similar fees imposed by any government, all of which shall be listed separately on the invoice.
SUPPLIER shall provide EXACTECH with a last time buy notice at least (6) months prior to the discontinuance of a Deliverable under this Purchase Order.
SUPPLIER shall not, without EXACTECH’S prior written consent, issue or release any public announcement, press release or other statement in any form of media, including the Internet, regarding the Purchase Order, the provisions hereof, or any of the transactions contemplated hereunder, including denial or confirmation of the fact that SUPPLIER has contracted to furnish to EXACTECH the materials herein ordered.
Unless otherwise provided, SUPPLIER warrants that all SUPPLIER designed Deliverables furnished pursuant to this Purchase Order shall strictly conform to applicable specifications, drawings, samples, descriptions, and other requirements of this Purchase Order.
Unless otherwise provided, SUPPLIER warrants that all Deliverables furnished pursuant to this Purchase Order shall be free from defects in SUPPLIER material and workmanship. This warranty shall begin upon final acceptance and extend for a period of one (1) year.
Unless otherwise provided, if any nonconforming Deliverable is identified within the warranty period, SUPPLIER, at EXACTECH’s option, shall promptly repair or replace the Deliverable. Transportation of replacement Deliverable, return of nonconforming Deliverable, and re-performance of any work shall be at SUPPLIER’s expense. If repair or replacement is not timely, EXACTECH may elect to return the non-conforming Deliverable at SUPPLIER’s expense. All warranties shall run to EXACTECH and its customers.
CHOICE OF LAW, DISPUTE RESOLUTION, AND VENUE
This Purchase Order and any matter arising out of or related to this Purchase Order shall be governed by the laws of the State of Florida without regard to its conflicts of laws provisions.
If the parties are unable to resolve the dispute through informal dispute resolution, federal or state courts of competent jurisdiction in Alachua County, Florida shall be the sole and exclusive venue for resolution of all disputes directly or indirectly arising under or relating to this Purchase Order. Each party hereby irrevocably waives, to the fullest extent permitted by applicable law, any right it may have to a trial by jury with respect to any litigation directly or indirectly arising under or relating to this Purchase Order.
SUPPLIER agrees to comply with all applicable local, state, and federal laws, rules, and regulations. SUPPLIER shall procure all licenses and permits and shall pay all required taxes or fees applicable to SUPPLIER’s duties under this Purchase Order.
If applicable, SUPPLIER shall provide EXACTECH any Material Safety Data Sheet with each delivery as required by the Occupational Safety and Health Act of 1970, or any other applicable law.
SUPPLIER shall not offer, receive, or give any improper gratuity or kickback for the purpose of obtaining or retaining business or receiving favorable treatment as an EXACTECH supplier.
If applicable, SUPPLIER hereby represents that the Deliverable complies in all respects with the Federal Food Drug and Cosmetic Act, and specifically, that the Deliverable is not adulterated or misbranded within the meaning of that Act.
Each clause, paragraph and subparagraph of this Purchase Order is severable, and if one or more of them are declared invalid, the remaining provisions of this Purchase Order will remain in full force and effect.
In the event this Purchase Order expires, is completed, or is terminated, SUPPLIER shall not be relieved of those obligations contained in the following clauses:
Failure by either party to enforce any of the provisions of this Purchase Order or applicable law shall not constitute a waiver of the requirements of such provisions or law, or as a waiver of the right of a party thereafter to enforce such provision or law.
The rights and remedies of either party in this Purchase Order are cumulative and in addition to any other rights and remedies provided by law or in equity.