PURCHASE ORDER TERMS AND CONDITIONS

1. AGREEMENT: This order is Buyer's offer to Seller and becomes a binding contract, subject to the terms hereof, when accepted by acknowledgement or commencement of performance by Seller. Buyer objects to all additions, exceptions, or changes to these terms, whether contained in any printed form of Seller or elsewhere, unless approved by Buyer in writing. To the extent there are any inconsistencies between these terms and those written on the face of this order, the latter will control. Buyer is not bound by and hereby expressly rejects Seller’s general conditions of sale and any additional or different terms or provisions that may appear on any proposal, quotation, price list, acknowledgment, invoice, packing slip or the like used by Seller. Course of performance, course of dealing, and usage of trade shall not be applied to modify these Purchase Order Terms and Conditions.

 

2. PRICE: Unless otherwise specified, the prices stated on the front of this order include all charges for packing, hauling, storage, transportation to point of delivery, and taxes. Sales and use taxes not subject to exemption shall be stated separately in Seller's invoice. Seller warrants that the prices quoted in this order are no greater than those currently charged any other buyer for similar quantities of goods or services. Any price reduction extended to others by Seller prior to delivery shall also be extended to Buyer.

 

3. PAYMENT TERMS: Buyer will make undisputed payments for goods and services that meet all applicable requirements within ninety (90) days after the later of: (a) receipt of the goods or completion of performance of the services identified in this order; and (b) receipt of a complete invoice. Buyer may withhold payment of any amounts that it disputes in good faith. Payment of an invoice shall not constitute acceptance of any Products, and the invoice will be adjusted for any errors, shortages and defects. Any billing dispute will not be cause for Seller’s non-delivery of Goods or non-performance of Services. Buyer shall have the right to update its payment terms upon notice to Seller in the event Buyer makes such change at a corporate level.

 

4. REIMBURSEMENT OF EXPENSES: Any reimbursement of Seller’s expenses must be agreed upon in advance in writing by Buyer.

 

5. CHANGES: Buyer may at any time make changes in the scope or quantity of the goods or services covered by this order, in which event an equitable adjustment will be made to any price, time of performance, and other provisions of this order if appropriate. Claims for such an adjustment must be made within fifteen (15) days from the date of receipt by Seller of notice of the change. Seller agrees an understands that certain goods and/or material purchased under this Agreement may be incorporated into regulated medical devices and such medical devices are regulated under the relevant governmental authority in the market in which the medical device is sold. Accordingly, Seller agrees to notify within thirty (30) days of (a) any changes to the goods and/or materials and/or (b) any proposed changes to the processing of such goods and/or materials other than specified by the Buyer. Such notice shall be made in sufficient detail to allow Buyer to determine the impact of such change(s) upon the regulated medical devices. In addition, any changes in (x) quantities or specifications, (y) goods and/or material, or (z) processing of such goods and/or materials by Seller shall not be made without Buyer's prior written approval.

 

6. WARRANTY: Seller covenants, represents and warrants that: a) The goods or services ordered shall be merchantable; shall conform to this order, to specifications, drawings, and other descriptions referenced in this order, and to any accepted samples; shall be free from defects in materials and workmanship; shall be free from defects in design unless the design was supplied by Buyer; and shall be fit and safe for theintended purposes. Seller warrants that it has clear title to the goods and that the goods and services shall be delivered free of liens or encumbrances. b) The goods; (1) are not adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act as amended (Act), or within the meaning of any applicable state or municipal law in which the definitions of "adulteration" and "misbranding" are substantially identical with those contained in Act: (2) are not goods which may not under the provisions of Section 404, 505, 512, 515, or 516 of the Act be introduced into Interstate commerce, or which may not under substantially similar provisions of any state or municipal law be introduced into commerce;(3) are in full compliance with the Biological Products section of the Public Health Service Act, (4) are shipped on pallets free of 2,4,6-tribromoanisole (TBA) and 2,4,6-tribromophenol (TBP); and (5) otherwise comply will all applicable laws and regulations or other legal requirements concerning the manufacture, packaging and delivery of the goods. c) It will perform all services in a competent, professional and workmanlike manner and in compliance with all applicable laws, and it has the required qualifications and expertise to perform. d) It will comply with Buyer’s guidelines (and any future modifications thereto), including those related to data privacy and information security. e) Neither it, nor any of its employees, or authorized subcontractors have: a) been listed by any federal or state agency as excluded, debarred, suspended, or otherwise ineligible to participate in federal and/or state programs, including, but not limited to, exclusion, debarment, or suspension as noted by the List of Excluded Individuals/Entities (“LEIE”) issued by the Office of Inspector General of the Department of Health and Human Services Office (“OIG”), the U.S. General Services Administration (“GSA”) and/or the Food and Drug Administration (“FDA”); b) been convicted of any crime relating to any federal and/or state program; or c) been included on the Specially Designated Nationals list ("SDN List") maintained by the U.S. Department of Treasury's Office of Foreign Assets Control or any other similar list, domestic or foreign. f) No officer, director, partner, owner, principal, employee or agent of Seller is an employee of a governmental agency or instrumentality is in a position to influence the actions or decisions regarding the activities of Seller contemplated by this order. Neither Seller nor any person employed by or representing it has made, offered, promised or authorized, or shall make an offer, promise or authorize, either directly or indirectly, any official representative or employee of any governmental agency or instrumentality, any political party or officer thereof, or any candidate for public office, for the purpose of influencing a decision by any of them to take actions favorable to Buyer or Seller on any matter related directly or indirectly to the subject of this order, securing an improper advantage for Buyer, obtaining or retaining business or a business advantage, or the improper performance of a public official function or activity. g) All these warranties and other warranties as may be prescribed by law shall extend to Buyer, its successors, assigns, and customers and to users of the goods or services and shall run through any expiration date stated on the goods, or, if no expiration date is stated, then for a period of one (1) year after delivery. Claims under these warranties must be made within the applicable period prescribed by statute.

 

7. INSPECTION; TESTING: Goods purchased under this order are subject to Buyer's reasonable inspection, testing, and approval at Buyer's destination. If any of the goods or services are found to be defective in material or workmanship, non-conforming to the warranties made herein or not in conformity with the requirements of this agreement, then the Buyer shall be entitled: (i) to require the Seller to supply replacement goods or re-perform the services in accordance with this order as quickly as reasonably possible, or (ii) at the Buyer’s sole option and whether or not the Buyer has previously required the Seller to supply any replacement goods or re-perform the services, to reject and return such goods at Seller’s expense or to treat this order as terminated by Seller’s breach and require the repayment of any part of the price which had been paid. Seller shall also reimburse Buyer for all commercially reasonable, documented and actually incurred costs and expenses incurred by Buyer as a result receiving nonconforming goods, including the cost of returning the non-conforming goods to the Seller, the costs, fees and penalties payable by Buyer to a customer, costs and expenses related to or arising from Buyer's purchase of substitute goods or services, incremental training costs for substitute goods and costs to rework and redesign facilities to accommodate substitute goods or services, expedited shipping costs, recall and field correction costs, product re-testing costs and customer and regulatory authority notification costs and costs of destruction. Payment for any goods under this order shall not be deemed acceptance of the goods.

 

8. RECALL: In the event that a recall of the goods is necessitated by a defect, a failure to conform to the specifications, applicable laws, or any other reason within the Seller's control, Seller shall bear all costs and expenses of such recall, including without limitation, costs of notifying customers, customer refunds, costs of returning goods, lost profits, and other expenses incurred to meet obligations to third parties. Seller shall notify Buyer inwriting of any recalls of supplied product known by the Seller within two (2) days.

 

9. SHIPMENT OR DELIVERY SCHEDULES: Shipment or delivery of goods shall be in accordance with the schedule specified in this order. If Seller does not, or it appears that Seller will not, meet such schedule, Buyer may, in addition to any other rights or remedies provided by law or this order, require that Seller ship the goods via expedited routing to meet the schedule or to recover the time lost and Seller shall pay the difference in shipping costs. Seller shall reimburse Buyer for all commercially reasonable, documented and actually incurred costs and expenses incurred by Buyer as a result of late delivery of goods, including the costs, fees and penalties payable by Buyer to a customer. At any such time that Seller exceeds three (3) late deliveries in a thirty (30) day period, Buyer has the right to request a written action plan, normally in the form of a Supplier Corrective Action Plan (“SCAR”) from the Seller on how late deliveries are being resolved

 

10. OVERSHIPMENT: Over-shipment of goods not approved by Buyer inwriting will be returned, at Seller's expense, if such over-shipment exceeds 10% of the total order price or $500.00, whichever is smaller.

 

11. SUBSTITUTION, MODIFICATION: No substitution or modification of any goods, component parts, tooling, sources of raw materials, processes, or manufacturing sites may be made without Buyer's prior written consent.

 

12. SPECIAL LAWS: In filling this order, Seller will comply with all applicable federal, state, and local laws, including the following: a) In the event this order has a value of Ten Thousand Dollars ($10,000) or more and Seller is a U.S. company or provides any of the goods or services through its U.S. operations, Seller must comply with various statutes, regulations, executive orders and legal obligations, as set forth in this Section: (1) EEO 11246 (Affirmative Action for Women and Minorities)—41 CFR 60-1.4 (A) Seller will not discriminate against any employee or applicant for employment because of race, color, religion, sex or national origin. Seller will take affirmative action to ensure that applicants are employed, and that employees are treated during employment, without regard to their race, color, religion, sex or national origin. Such action shall include, but not be limited to, the following: Employment, upgrading, demotion, transfer, recruitment or recruitment advertising, layoff or termination, rates of pay or other forms of compensation and selection for training, including apprenticeship. Seller agrees to post a notice, of such size and in such form, and containing such content as the Secretary of Labor shall prescribe, in conspicuous places in and about its plants and offices where employees covered by the National Labor Relations Act engage in activities relating to the performance of this Agreement, including all places where notices to employees are customarily posted both physically and electronically. (B) Seller will, in all solicitations or advertisement for employees placed by or on behalf of the contractor, state that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. (C) Seller will send to each labor union or representative of workers with which it has a collective bargaining agreement or other contract or understanding, a notice to be provided by the agency contracting officer, advising the labor union or workers’ representative of the contractor’s commitments under Section 202 of Executive Order 11246 and shall post copies of the notice in conspicuous place available to employees and applicants for employment. (D) Seller will comply with all provision of Executive Order 11246 of September 24, 1965, and of the rules, regulations and relevant orders of the Secretary of Labor. (E) Seller will furnish all information and reports required by Executive Order 11246 and by the rules, regulations and orders of the Secretary of Labor, or pursuant thereto, and will permit access to his books, records and accounts by the contracting agency and the Secretary or Labor for purposes of investigation to ascertain compliance with such rules, regulations and orders. (F) In the event that Seller does not comply with any of the requirements set forth in paragraphs (A) or (B) above, this Agreement may be canceled, terminated, or suspended in whole or in part, and the Seller may be declared ineligible for further Government contracts in accordance with procedures authorized in or adopted pursuant to Executive Order 11246 of September 24, 1965. Such other sanctions or remedies may be imposed as are provided in Executive Order 11246 of September 24, 1965, or by rule, regulation, or order of the Secretary of Labor, or as are otherwise provided by law. (G) Seller will include the provisions of paragraphs (A) through (D) herein in every subcontract or purchase order entered into in connection with this Agreement (unless exempted by rules, regulations, or orders of the Secretary of Labor issued pursuant to Section 204 of Executive Order 11264 of September 24, 1965), so that such provisions will be binding upon each subcontractor. Seller will take such action with respect to any such subcontract or purchase order as may be directed by the Secretary of Labor as a means of enforcing such provisions, including the imposition of sanctions for non-compliance; provided, however, if Seller becomes involved in litigation with a subcontractor, or is threatened with such involvement, as a result of such direction, Seller may request the United States to enter into such litigation to protect the interests of the United States. (2) VEVRAA (Affirmative Action for Veterans)—41 CFR 60-300.5. Seller shall abide by the requirements of 41 CFR 60-300.5(A). This regulation prohibits discrimination against qualified protected veterans and requires affirmative action by covered private contractors and subcontractors to employ and advance in employment qualified protected veterans. (3) Section 503 (Affirmative Action for Individuals with Disabilities)—41 CFR 741.5(a). Seller shall abide by the requirements of 41 CFR 741.5(a). This regulation prohibits 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. (4) Executive Order 13496 (Notice under the NLRA) --Seller shall at all times abide by the requirements of 29 CFR Part 471, Appendix A to Subpart A. This regulation requires that employees be notified of their rights under federal labor laws. Seller also represents that: b) To the extent applicable, the goods are compliant with EU RoHS (RoHS-1 and RoHS -2) Directives or country/regional equivalent and agrees to furnish evidence of compliance upon request by Buyer. c) The goods do not contain any substances regulated as a substance of very high concern (SVHC) in Annex XIV of the EU Registration, Evaluation, Authorization of Chemicals (REACH) directive, unless explicit notification is provided to Buyer in advance and subsequently as new substances are added to the REACH and Annex XIV and Candidate List periodically. d) The goods are manufactured and provided to Buyer in a manner that complies with all applicable human rights laws, including local laws and international frameworks such as but not limited to California Transparency in Supply Chain Act and provisions of the Dodd-Frank Act (conflict minerals rules). Seller further represents that the goods are conflict mineral-free, meaning any gold, tin, tantalum, or tungsten contained in the goods are sourced only from conflict – free zones, sources, and smelters. Seller agrees to cooperate and fulfill related due diligence activities with its suppliers or represents that it has already done so. e) The goods are consistent with, and can be used in compliance with, the Occupational Safety and Health Act of 1970 (OSHA),that services to be performed on Buyer's premises will be consistent with OSHA provisions, and that Seller will provide Buyer the latest material safety data sheets (MSDS) for any chemical substance determined to be hazardous: f) For any order over $10,000, Seller shall have an approved plan for small business concerns and small disadvantaged business concerns as specified under Public Law 95-507 unless Seller itself is one of these concerns.

 

13. INDEMNIFICATION: Seller shall defend, indemnify and hold Buyer, its successors, assigns, employees, customers, and users of the goods or services harmless with respect to all claims, liability, damage, loss, and expenses, including attorney's fees, incurred relating to or caused by: a) Actual or alleged patent, copyright, or trademark infringement or violation of other proprietary right, arising out of the purchase, sale, or use of the goods or services covered by this order; b) Actual or alleged defect in the services or in the design, manufacture, or shipment of the goods; c) Actual or alleged breach of warranty; d) Failure of Seller to deliver the goods or services on a timely basis; or e) Failure of the goods or services to meet the requirements of any applicable law. In the event of a claim under this paragraph, and in addition to any and all other rights and remedies available to it, Buyer may at its option terminate this order or defer acceptance of the balance of the goods or services ordered until the claim is resolved. If Buyer is enjoined from use of the goods, Seller shall at Buyer's option, either procure for Buyer the right to continue using the goods, replace the goods with substantially equivalent goods, modify the goods so as to be usable by Buyer, or repurchase the goods at the price set forth in this order. This Paragraph 13 shall not be construed to indemnify Buyer for any loss to the extent it is attributable to Buyer's design, specification, or negligence.

 

14. INSURANCE: Seller shall obtain and keep in force for three years after the last delivery under this order commercial general liability insurance covering each occurrence of bodily injury and property damage in the amount of not less than $1 Million Dollars (or any other amount Buyer may indicate in this order) combined single limit with special endorsements providing coverage for: a) Products and Completed Operations Liability; b) Blanket Broad Form Vendor's Liability; c) Blanket Contractual Liability; d) Manufacturer’s Errors and Omissions; and e) Product Recall/Testing/Replacement Coverage. If services are performed under this order on Buyer's premises, Seller shall also obtain Premises Operations, Personal Injury, and Independent Contractors Protective Liability endorsements, and shall further obtain Workers' Compensation, Employer's Liability and Automobile Liability Insurance coverage in amounts acceptable to Buyer, and if Seller will have access to Buyer property, computer systems and/or data, Third Party Fidelity/Crime Coverage. If requested, Seller shall furnish Buyer with a certificate evidencing the required insurance.

 

15. RISK OF LOSS: Seller shall bear the risk of loss or damage to the goods covered by this order until they are delivered to and accepted by Buyer.

 

16. LIMITATION OF LIABILITY: BUYER WILL NOT BE LIABLE TO SELLER OR ANY THIRD PARTY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES (INCLUDING LOST TIME, LOST PROFITS OR LOST SALES) ARISING FROM ANY TRANSACTIONS UNDER THIS ORDER and in no event shall Buyer be liable to Seller, its successors or assigns for damages in excess of the amount due to Seller for complete performance under this Order.

 

17. AUDIT: To verify Seller’s compliance with this Order, Buyer and its representatives will have the right, at reasonable times and places and upon reasonable notice, to (a) inspect all facilities, resources and procedures employed by Seller in manufacturing or providing the goods and services; and (b) examine all books and records relating to the goods and services.

 

18. BUYER-FURNISHED MATERIAL: Seller shall not use, reproduce, or appropriate for or disclose to anyone other than Buyer, any material, tooling, dies, drawings, designs, or other property or information furnished by Buyer ("Material") without Buyer's prior written approval. Title to all Material shall remain in Buyer at all times, and where practicable the Material shall be clearly marked or tagged to indicate this ownership. Seller shall bear the risk of loss or damage to the Material until it is returned to Buyer. All Material, whether or not spoiled or used, shall be returned to Buyer at termination or completion of this order unless Buyer shall otherwise direct.

 

19. REFERENCES TO BUYER: Seller shall not present nor publish, nor submit for publication, any work specifically resulting in relation to goods or services supplied solely for Buyer or that identifies or may identify Buyer without Buyer’s prior written approval. Seller shall not use Buyer’s name in any advertising, articles, press release, social media, promotional materials or website advertising, or disclose to any third party the terms of this order or the fact that Seller is supplying goods or services to Buyer, without Buyer’s prior written consent (which is in its sole discretion to grant or withhold).

 

20. USE OF SELLER'S INFORMATION: All information disclosed to Buyer in connection with this order is furnished as part of the consideration for Buyer's placement of this order. This information is not to be treated as confidential or proprietary, and no claim will be asserted against Buyer, its assigns, or customers, for its disclosure or use.

 

21. TERMINATION: a) Buyer may terminate this order, in whole or in part, without liability: If Buyer anticipated Seller's breach of this order and Seller does not provide adequate assurance of its performance within ten (10) days of Buyer's request; if deliveries are not made at the time or in the quantities specified; or in the event of a breach or failure by Seller to meet other terms of this order. This right shall be in addition to any other remedies provided Buyer by law. b) Buyer may terminate this order, in whole or in part, at any time for its convenience by notice to Seller in writing. Seller's sole compensation for such termination shall be payment by Buyer of the percentage of the total order price corresponding to the proportion of work completed in filling the order prior to such notice, plus any reasonable expenses incurred by Seller in terminating orders and work in progress. Such termination claim must be submitted to Buyer within sixty (60) days of the date of termination and shall be subject to audit by Buyer. c) Upon any termination under this paragraph, title to all equipment materials, work-in-progress, finished products, plans, drawings, specifications, information, special tooling, and any other items for which Seller may submit a claim shall vest in Buyer, and Seller shall promptly deliver these items to Buyer and take all necessary action to protect such property prior to such delivery.

 

22. SETOFF: Any counterclaim against Seller or any of its related entities by Buyer or any of its related entities which arise out of this or any other transaction may be set off against any money due seller under this order.

 

23. ASSIGNMENT; SUBCONTRACTING: Seller shall not assign this order without Buyer’s prior written consent, which Buyer may withhold in its sole discretion, and any attempted assignment without Buyer’s consent will be void. Any permitted assignee shall assume in writing all obligations of Seller under this order; provided, however, that Seller shall remain primarily liable for such obligations. Buyer may assign the order without the consent of Seller. The order will be binding upon and inure to the benefit of the permitted assigns of each party.

 

24. WAIVER; SEVERABILITY: No waiver by Buyer of any breach of this order by Seller shall be considered as a waiver of any subsequent breach of the same or any other provision. No claim or right arising out of a breach of the terms and conditions of this order can be discharged in whole or in part by a waiver or renunciation of the claim or right unless such waiver or renunciation is supported by consideration and is in writing signed by the aggrieved party. If at any time any one or more of the provisions contained this order is or should become invalid, illegal or unenforceable in any respect under any law, rule, regulation or ruling, the validity, legality, and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby.

 

25. CONTROLLING LAW; VENUE: This order and the performance under it shall be controlled and governed by the law of the Commonwealth of Massachusetts, and Seller hereby submits to the jurisdiction of the courts of the Commonwealth of Massachusetts for purposes of resolving any dispute.

 

26. INJUNCTIVE RELIEF: Buyer may seek injunctive relief by a court of competent jurisdiction in accordance with the Venue section above.

 

27. REMEDIES NOT EXCLUSIVE: The rights and remedies of Buyer provided under these Terms and Conditions are cumulative and not exclusive and are in addition to any other rights and remedies provided at Law or in equity.

 

28. INDEPENDENT CONTRACTOR: The relationship of the parties is that of independent contractors. The parties will not be deemed partners or joint ventures, nor will one party be deemed an agent or employee of the other party. Neither party has any express or implied right to assume or create any obligation on behalf of, or in the name of, the other party or to bind the other party to any contract, agreement or undertaking with any third party, and no conduct of a party shall be deemed to imply such right.

 

29. NOTICES: Any notices required or permitted under this order will be in writing, will refer specifically to the order, and will be sent by recognized national or international overnight courier or registered or certified mail, postage prepaid, return receipt requested, or delivered by hand to the address set forth in this order. Notices under the order will be deemed to be duly given: (a) when delivered by hand; (b) two days after deposit with a recognized national or international courier; or (c) on the delivery date indicated in the return receipt for registered or certified mail. A party may change its contact information immediately upon written notice to the other party in accordance with this section.

 

30. AMENDMENT: Any modification to this order must be in writing and signed by an authorized representative of each party