Insulet and Supplier agree that Supplier will sell to Insulet product from time to time ordered pursuant to Insulet’s purchase order, or otherwise, (“Order”) and that EACH ORDER THAT IS PLACED OR PURCHASE MADE SHALL BE SUBJECT TO AND GOVERNED BY THESE TERMS AND CONDITIONS OF PURCHASE (“AGREEMENT”). Documents designated by Insulet in the body of the Order, including supplemental terms and conditions, if any, are incorporated by reference the same as if set out in full therein and will form a part of the Order and this Agreement. Supplier’s affirmative acceptance of the Order, commencement of work on the merchandise subject to the Order, or shipment of such product, whichever occurs first, shall be deemed acceptance of the Order and this Agreement. Any actual or deemed acceptance of the Order is limited to acceptance of the express terms contained on the Order and in this Agreement. Any Supplier proposal for additional or different terms, and any attempt by Supplier to vary in any degree any of the terms of the Order or this Agreement in Supplier’s acceptance is hereby objected to and rejected. Notwithstanding Insulet’s objection to and rejection of such proposals, such proposals shall not operate as a rejection of the Order or this Agreement unless such variances are in the terms of the description, quantity, price or delivery schedule of the product, but such proposals shall be deemed a material alteration of the Order or this Agreement, or both, as applicable, and the Order and this Agreement shall be deemed accepted by Supplier without said or additional or different terms. In no event is this Agreement to be construed as a contract which establishes an exclusive supplier contract relationship between Supplier and Insulet, or to otherwise impose any minimum or guaranteed purchases or amounts upon Insulet. It is Supplier’s responsibility to comply with the Order, this Agreement, and all referenced documents, and to clarify with Insulet any inconsistencies or conflicts among them. Should Supplier fail to contact Insulet to resolve conflicts or inconsistencies, Supplier will be solely responsible for errors resulting from such conflicts or inconsistencies. Where documents other than this Agreement are referenced in the Order, the version(s) of such document(s) in effect at the time of Order effective date shall apply.
Specifications, patterns, requirements, drawings, designs, notes, instructions, engineering information, technical data, and any other identifying information which is unique or categorical to the product (collectively, “Specifications”) furnished by either Party to the other, or referred to in the Order shall be incorporated into the Order by their reference. Supplier shall be fully and solely responsible for obtaining data adequate to design, manufacture, fabricate, construct, and deliver any product in compliance with all requirements of the Order. Any product delivered to Insulet under an Order will be supplied according to Insulet’s instructions regarding the above information and in accordance with the FDA Quality System Regulation (21 CFR Part 820) and all applicable international product and business standards. No changes are to be made to the Specifications or the product without written approval from Insulet. Supplier shall obtain from Insulet written approval of all Specification deviations; otherwise, any un-approved deviations shall be deemed incompliant with the Order. This shall include deviations for all product produced from Insulet tooling which are not in compliance with Insulet’s Specifications. Insulet shall retain title to all such Specifications and/or related documents which it provides or causes to be given to Supplier. Supplier shall not use any of such Specifications, other Insulet documents or the information contained therein for any purpose other than in performance of the Order. Supplier shall not disclose such documents or information to any party other than Insulet or a party duly authorized, in writing, by Insulet. Upon Insulet’s request, Supplier shall promptly return to Insulet all such documents and copies.
Insulet shall have the right at any time to make changes in drawings, designs, specifications, materials, packaging, time and place of delivery, and method of transportation associated with the Order. If any such changes cause an increase or decrease in the cost, or the time required for performance, an equitable adjustment shall be made, subject to Insulet’s approval, and the Order shall be modified in writing, by Insulet, accordingly. Supplier agrees to accept any such changes subject to this paragraph. Where Insulet requests in an Order that specific materials or accessories be used in the Supplier’s performance thereof, Supplier may not substitute such materials or accessories with any other materials or accessories without written permission from Insulet.
Unless otherwise agreed by Insulet and Supplier in writing, payment shall be made by Insulet separately for each Order. Insulet shall pay all undisputed invoice amounts for each Order in U.S. dollars sixty (60) days from Insulet’s receipt of Supplier’s invoice for that Order, less deposits paid to Supplier, if any, unless otherwise agreed to by Insulet and Supplier.
All claims for money due or to become due from Insulet shall be subject to deduction or setoff by Insulet by reason of any counterclaim arising out of this or any other transaction with Supplier.
Supplier hereby agrees to make on-time delivery based on the timeline set forth in the Order. If the Order does not specify a delivery date or timeline, Supplier shall assume that the delivery is to be made as soon as reasonably possible. Any delivery made after the date specified in the Order shall be deemed late. If any part of the product delivered by Supplier is delivered late, or otherwise does not comply with the terms and conditions hereof or in the Order as to quality or otherwise, Insulet may either (a) reject and return all or any part of the product ordered thereunder for full credit, including freight or (b) at Insulet’s option, utilize all or any part of said product, holding Supplier liable for all damages resulting from Supplier’s failure to deliver the product by the date specified in the Order. Deliveries shall not be made earlier than five (5) days prior to the requested delivery date unless approved by Insulet. Insulet reserves the right to accept or reject partial shipments.
All shipments shall be routed per routing instructions, if applicable, in the Order or at the request of Insulet. If specific routing is indicated and not complied with, all extra cartage will be charged against Supplier. In the event Supplier does not follow Insulet’s routing instructions resulting in product arriving at incorrect locations, Supplier will reship the products at its own expense. In the event of an embargo, Supplier shall contact Insulet immediately for instructions.
All product shipped F.O.B. delivered or F.O.B. destination shall be at Supplier’s risk until actual receipt by Insulet, and Insulet assumes no liability for loss or damage to products occurring prior to Insulet’s receipt thereof.
If in order to comply with Insulet’s required delivery date it becomes necessary for Supplier to ship products in a manner which is more expensive than the manner specified in the Order, any increased transportation costs resulting therefrom shall be paid for by Supplier, unless Insulet agrees in advance to such rerouting or expedited handling fees. No custom shipping charges of any kind, including charges for boxing or cartage, freight or special handling, will be allowed unless specifically agreed to by Insulet in writing. Pricing by weight, where applicable, covers net weight of products, unless otherwise agreed in writing. Any costs incurred by Insulet because of Supplier’s non-compliance with the terms and conditions in an Order shall be charged back to Supplier.
Insulet shall be under no duty to inspect product purchased hereunder before its use in manufacture and/or resale, and the processing, manufacture or resale shall not constitute an acceptance of the product or a waiver of any claim. Complaints or notice of defects in product will be considered timely if made within thirty (30) days after discovery by Insulet of such defects. Insulet reserves the absolute right to reject and refuse acceptance of product which is not in accordance with Insulet’s instructions, specifications, drawings and data or not in accordance with Supplier’s warranty (express or implied) and to return same to Supplier at Supplier’s expense. Payment for any product purchased by, and delivered to, Insulet hereunder shall not be deemed an acceptance thereof.
Insulet reserves the right to terminate any Order or any part thereof at any time for any reason. In the event of such termination of an Order, Supplier shall immediately stop all work or preparation therefor, and shall immediately cause any of its own suppliers or subcontractors to cease such work. In the event of Insulet’s cancellation of an Order before Supplier’s delivery in accordance with such Order Supplier bears actual reasonable direct, non-cancellable, non-recoverable costs already incurred as a direct result of and in furtherance of performing on such Order prior to the notice of termination, it shall provide Insulet with proof thereof in the course of any effort to recover such costs from Insulet, which costs Insulet shall not reimburse without due review and approval. In no event shall Supplier be paid for any work done on an Order after receipt of a notice of termination thereof, nor for any costs incurred by Supplier’s suppliers or subcontractors which Supplier could reasonably have avoided or mitigated or with respect to materials that can be returned, redirected or resold to other customers.
Insulet may also terminate an Order or any part thereof for cause in the event of any default by the Supplier, or if the Supplier fails to comply with any of the terms and conditions of the Order or this Agreement. For purposes of the foregoing sentence “cause” includes late delivery or late performance, a delivery of defective or nonconforming goods or workmanship, failure to provide Insulet, upon request, of reasonable assurances of future performance, a breach of any of Supplier’s warranties, any other material default or failure of compliance by Supplier with the terms and conditions hereof, the commencement or continuance of any bankruptcy or insolvency proceeding by or against Supplier, or any legal process or order directing or requiring Insulet to undertake or refrain from undertaking any business or certain types of business with the result that the goods and/or services ordered hereunder shall be unnecessary, or lawfully or contractually forbidden, to Insulet.
Product furnished to satisfy Insulet’s Specifications shall not be furnished or quoted to any third party or used by Supplier for any purpose other than fulfilling Orders for Insulet. Such Specifications along with any other non-public information or materials provided by Insulet to Supplier shall be confidential, shall remain Insulet’s property, and shall be returned to Insulet immediately upon request. Unless otherwise agreed to in writing, no commercial or technical information disclosed in any manner or at any time to Insulet by Supplier shall be deemed secret or confidential and Supplier shall have no rights against Insulet with respect thereto except such rights as any exist under any applicable patent law.
In the event Supplier engages in work or preparation pursuant to an Order that creates any ideas, inventions, or other intellectual property rights capable of protection, such ideas and inventions shall be deemed works for hire and are the sole and exclusive property of Insulet without requirement of any further payment by Insulet hereunder. In the event it is determined by statute, regulation, court other legal tribunal, or other qualified governmental body or decree that Insulet is not the owner of such intellectual property, Insulet and Supplier hereby grants to Insulet a word-wide, fully-paid, royalty-free, transferable sublicense to make, have made, use, sell or offer for sale or import products possessing such intellectual property.
Supplier shall neither make nor permit any of its respective directors, officers, employees, agents, representatives, advisors, affiliates, or other third parties under its direction or control to make any press release, public announcement or other public disclosure with respect to the existence of an Order or this Agreement or the terms hereof without the prior written consent of a duly authorized agent of Insulet.
Supplier expressly warrants that all product furnished under the Order shall conform to all Specifications and appropriate standards, shall be new and not refurbished or reconditioned, unless expressly agreed to in writing by Insulet, and will be free from defects in material or workmanship. Supplier warrants that all such product will conform to any statements made on the containers, labels, and advertisements for such product, and that all product will be adequately contained, packaged, marked and labeled and, at the time Insulet takes title to the products, the products shall not be adulterated, misbranded, or otherwise in violation of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A., Section 301 et seq., as amended from time to time. Supplier warrants to Insulet that at the time of sale Supplier has good title to the products, free and clear of all security interests, liens or encumbrances, and that such products shall be in material compliance with all applicable federal laws, rules, and regulations. In the event that Insulet has previously purchased conforming product of the same description from Supplier, Supplier agrees that the product to be delivered under the current Order shall be identical in all respects to the product previously ordered. Supplier warrants that all product furnished under the Order will be merchantable and will be safe and appropriate for the purpose for which product of that kind is normally used. If Supplier knows or has reason to know the particular purpose for which Insulet intends to use the product, Supplier warrants that such product will be fit for such particular purpose. Supplier warrants that product furnished will conform in all respects to samples. Inspection, test, acceptance or use of the product furnished under the Order shall not affect the Supplier’s obligation under this warranty, and such warranties shall survive inspection, test, acceptance and use. Supplier’s warranty shall run to Insulet, its successors, assigns and customers, and users of products sold by Insulet. Supplier agrees to replace, or correct defects of, any product not conforming to the foregoing warranty promptly without expense to Insulet, when notified of such non-conformity by Insulet, provided Insulet elects to provide Supplier with the opportunity to do so. In the event of failure of Supplier to correct defects in or replace nonconforming product promptly, Insulet, after reasonable notice to Supplier, may make such corrections or replace such product and charge Supplier for the cost incurred by Insulet in doing so.
Supplier warrants that prices shown on the Order shall be complete, and no additional charges of any type shall be added without Insulet’s express written consent. Such additional charges include, but are not limited to drayage, shipping, packaging, labeling, customs duties, taxes, storage, insurance, boxing and crating. Payment terms date from receipt of material purchased or date of receipt of invoice, whichever is later.
Supplier shall defend, indemnify and hold harmless Insulet against all claims or liabilities and expenses (including attorney’s fees) arising out of, or resulting from, the infringement of any intellectual property or other proprietary rights of any person including, without limitation, the infringement of any trademarks, trade names, trade dress, trade secrets, patents or the violation of any copyright laws or any other applicable federal, state, or local laws, rules or regulations. In the event that any claim is made against Insulet with respect to the foregoing, or in the event the product is misbranded or bears illegal descriptive matter, Insulet shall have the right, in addition to all other rights under contract or otherwise given by law, to cancel the Order for that product, and any other Order with Supplier, and to return product already delivered for full credit.
If the accomplishment of the Order requires or contemplates the performance of services or labor by Supplier’s employees, or persons under contract to Supplier, on Insulet’s property, or property of Insulet’s customers, Supplier agrees that the persons doing such work shall not be considered employees of Insulet. Supplier shall maintain all necessary insurance coverages, including general liability and Workers’ Compensation insurance covering Supplier’s associates or persons under contract to Supplier with limits which are reasonable in light of the Supplier’s business. Upon Insulet’s request, Supplier shall furnish Insulet with a certificate of insurance that identifies Insulet as an additional insured with respect to all forms of coverage available to Supplier pursuant to its policy or policies of general liability insurance, and such other forms of insurance as Insulet may request, and with the limits of liability reasonably requested by Insulet. All such policies of insurance shall contain a waiver of subrogation rights against Insulet. Supplier shall furnish to Insulet a certificate of insurance evidencing such coverage, certifying that the policy or policies of insurance described therein will not be altered, modified or canceled without giving Insulet thirty (30) days advance written notice. Supplier shall defend, indemnify and hold harmless Insulet from any and all claims or liabilities arising out of the work covered by this paragraph including all claims or liabilities arising out of the use of Insulet’s tools, equipment or other facilities.
Supplier shall defend, indemnify and hold harmless Insulet and its distributors and customers against all damages, claims or liabilities and expenses (including attorney’s fees) arising out of, or resulting in any way from, any (a) defect in the product purchased from Supplier under an Order, (b) any bodily injury or property damage caused by the use or possession of the products; (c) the label, labeling, promotional literature, or other information concerning products provided by Supplier; (d) the negligent act or omission or other wrongful conduct of Supplier; (e) the breach of any representation or warranty of Supplier, including those contained in this Agreement or created by operation of law; (f) any recall of the products; (g) Supplier’s failure or alleged failure to warn, advise Insulet of the need to warn, or adequately test the products; and (h) the failure of the products to meet Insulet’s specifications, if any. This indemnification shall be in addition to the warranty obligations of Supplier and shall not be conditioned upon the waiver of any claims Insulet may have against Supplier.
The Order, any documents incorporated therein by reference therein, and this Agreement constitute the entire agreement between Insulet and Supplier with respect to the subject matter hereof.
In the event of delay or temporary discontinuance of Insulet’s business in whole or in part by reason of fire, flood, tempest, earthquake, war, act of God, terrorist act, embargo, or other cause beyond Insulet’s control, may at its option, cancel any undelivered Order in whole or in part or delay delivery or acceptance occasioned by said causes. Supplier shall hold such goods or refrain from furnishing such services at the direction of Insulet, and Supplier shall deliver the product when the cause effecting the delay is eliminated. Insulet shall be responsible only for Supplier’s direct additional costs in holding the product or delaying performance of the Order at Insulet’s request. Whenever any actual or potential labor dispute delays or threatens to delay the timely performance of an Order, Supplier shall immediately give notice thereof to Insulet.
Supplier shall not assign the Order at any time, and any right thereunder is not assignable, without the written consent of Insulet nor shall Insulet be under any obligation to recognize any assignment of monies payable thereunder, nor of any rights in the product ordered therein, nor of any other rights arising thereunder, or to pay any monies or deliver or return any product ordered thereunder to any assignee without like consent. Notwithstanding the foregoing, Insulet may assign an Order or any right thereunder without the written consent of Supplier.
Insulet’s failure to insist on performance of any of the terms or conditions herein or in the Order on any one occasion, or to exercise any right or privilege, or Insulet’s waiver of any breach hereunder shall not thereafter waive any other terms, conditions, or privileges, whether of the same or similar type, on any other occasion.
Supplier shall comply will all Insulet policies which Insulet may from time to time supply to Supplier.
All articles, materials and workmanship, as well as facilities where they are produced, will be subject to inspection and tests by Insulet, the FDA, or Insulet’s ISO Notified Body during manufacture and at all times and places to the extent practicable. Supplier shall provide and shall require all of Supplier’s subcontractors to provide full opportunity for such inspections in a manner acceptable to the inspectors. If an inspection or test is made on Supplier’s premises, Supplier shall provide all reasonable facilities and assistance for the safety and convenience of the inspectors in the performance of their duties. In the event this Order is in excess of $2,500, the duly authorized representatives of Insulet and the government of the United States shall, until three years after final payment under this Order or until such further time as may be designated in the applicable government regulations, have access to and the right to examine any pertinent books, papers, documents and records of Supplier involving manufacturing and quality assurance transactions related to this Order other than financial records. The Supplier agrees to retain in proper order for efficient retrieval, all such records for a period of fifteen (15) years. Supplier agrees to include in each subcontract Supplier might make hereunder appropriate provisions to the same effect. Insulet shall have the right for itself and on behalf of its customers to audit Supplier and its suppliers with a minimum thirty (30) days notice.
The Supplier, in performing the work required by the Order, represents and warrants that it shall comply with (a) the nondiscrimination provisions of Executive Orders 11246, 11141, 11625, 12138, 11758, and 11701, and any subsequent amendments thereof and to comply with the Rules and Regulations issued thereunder and agrees not to discriminate against any associate or applicant for employment because of race, religion, color, sex, age, national origin, handicap or veteran status; and (b) all applicable federal, state and municipal laws, regulations, codes, ordinances and orders, and any permit conditions as to which Insulet has or should have knowledge, as the same may be in effect as of the time of the performance under the Order, including but not limited to full compliance with export and import laws, the U.S. Foreign Corrupt Practices Act, applicable provisions of The Health Insurance Portability and Accountability Act, Good Clinical Practice regulations (ICH-E6 Consolidated Guidance, April 1996), the Code of Federal Regulations (CFR), Title 21, Part 50, and any applicable data protection or privacy laws, rules, regulations and directives, including without limitation the requirements of Massachusetts General Laws c. 93H (Security Breaches) and the regulations promulgated thereunder including without limitation, 201 CMR 17.03 and 201 CMR 17.04 (Standards for the Protection of Personal Information of Residents of the Commonwealth) and the U.S. Department of Commerce Privacy Principles with respect to the EU Law, General Data Protection Regulation (GDPR) of 14 April 2016 on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data, in each case as to the extent applicable to the particular Order.
The weights, measures, sizes, legends or words stamped, painted, branded or otherwise appearing on the product or container, must comply in every respect with the laws, regulations, codes, ordinances and other requirements of the United States, and applicable local and state laws and regulations. Supplier also represents that by acceptance of the Order it has, and will continue, during the performance of the Order, to comply with the provisions of all other Federal, State and local laws, and regulations from which liability may accrue to Insulet from any violation thereof by Supplier.
This Agreement, and any claim or controversy relating hereto, shall be governed by and interpreted exclusively in accordance with the laws of the Commonwealth of Massachusetts without giving effect to the conflict of laws principles thereof. Insulet and Supplier hereto irrevocably submit to the jurisdiction of the state and federal courts situated within the Commonwealth of Massachusetts, city of Boston, with respect to any disputes arising hereunder.
IN NO EVENT SHALL INSULET BE LIABLE FOR ANTICIPATED PROFITS OR FOR INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND. INSULET’S LIABILITY ON ANY CLAIM OF ANY KIND FOR ANY LOSS OR DAMAGE ARISING OUT OF OR IN CONNECTION WITH OR RESULTING FROM THE ORDER, THIS AGREEMENT OR FROM THE PERFORMANCE OR BREACH THEREOF SHALL IN NO CASE EXCEED THE PRICE ALLOCABLE TO THE PRODUCT OR A UNIT THEREOF WHICH GIVES RISE TO THE CLAIM. INSULET SHALL NOT BE LIABLE FOR PUNITIVE OR TREBLE DAMAGES, OR OTHER PENALTIES OF ANY DESCRIPTION. ANY ACTION RESULTING FROM ANY BREACH ON THE PART OF INSULET AS TO THE PRODUCT DELIVERED HEREUNDER MUST BE COMMENCED WITHIN ONE YEAR AFTER THE ACTUAL DATE OF SUCH BREACH-GIVING RISE TO THE ALLEGED CAUSE OF ACTION.