1. Definitions and Interpretation.
The following words and phrases shall have the following meanings when used herein:
1.1. “Conditions” means these terms and conditions of purchase set forth in this document and (unless the context otherwise requires) includes any special terms and conditions agreed in writing between Enable Injections and Vendor and set forth in the Order.
1.2.“Enable Injections” means Enable Injections, Inc., a Delaware corporation.
1.3. “Goods” means the goods described in the Order.
1.4. “Order” means a purchase order issued by Enable Injections to Vendor, and includes these Conditions which are incorporated by reference.
1.5. “Price” means the charge for the Good(s) and/or Services as set forth in the Order.
1.6. “Services” means the services described in the Order.
1.7 “Specification” includes any plans, drawings, data or other information relating to the Good(s) or Services.
1.8. “Vendor” means the entity supplying the Goods or Services as indicated on the Order.
1.9. “Vendor Personnel” includes Vendor and Vendor employees, as well as approved subcontractors, agents, and/or other representatives that render Services pursuant to the Order (collectively “Vendor Personnel”).
2. Basis of Purchase –Acceptance of Conditions
2.1. THE ORDER CONSTITUTES AN OFFER BY ENABLE INJECTIONS TO PURCHASE THE GOOD(S) AND/OR SERVICES SUBJECT TO THESE CONDITIONS.
2.2. THESE CONDITIONS SHALL APPLY TO THE ORDER TO THE EXCLUSION OF ANY OTHER TERMS WHICH: A) VENDOR QUOTATION OR PROPOSAL GIVEN TO ENABLE INJECTIONS HAS BEEN SUBJECT; OR B) VENDOR’S ACCEPTANCE OF THE ORDER IS CONDITIONED.
2.3. NO VARIATION TO THE ORDER OR THESE CONDITIONS SHALL BE BINDING UNLESS AGREED IN WRITING BETWEEN THE AUTHORIZED REPRESENTATIVES OF ENABLE INJECTIONS AND VENDOR.
2.4. ACCEPTANCE. ANY DELIVERY OF THE GOODS OR PERFORMANCE OF THE SERCIVES BY VENDOR UNDER THIS ORDER, INCLUDING ANY VENDOR ACTIONS OR COMMUNICATIONS UPON WHICH ENABLE INJECTIONS RELIES, SHALL CONSTITUTE VENDOR’S ACCEPTANCE OF THE ORDER AND THE UNCONDITIONAL ACCEPTANCE OF THESE CONDITIONS.
3.1. The quantity, quality and description of the Goods and/or Services shall be as specified in the Order and/or in any applicable Specification supplied by Enable Injections to Vendor or agreed in writing by Vendor.
3.2. Vendor and its personnel shall comply with all applicable regulations or other legal requirements concerning the performance of the Services and/or the delivery of the Goods.
3.3. Vendor Personnel will remain, at all times, in the employment or at the direction of Vendor and shall not be deemed employees of Enable Injections for any purpose. This Order does not authorize in any manner Vendor to contract in the name of or on behalf of Enable Injections, or to hire persons as employees of Enable Injections, or to otherwise act on behalf of, or hold itself out as an agent or representative of Enable Injections. No provision of this Order will be deemed to create a contractual relationship between Enable Injections and any Vendor Personnel. Vendor agrees that in the performance of this Order it shall act as independent contractor for all purposes of any kind whatsoever and all of Vendor’s Personnel shall be subject solely to the control, supervision and authority of Vendor except as may otherwise be mutually agreed upon by the parties. Vendor agrees to be responsible for and will indemnify Enable Injections for all employment, withholding or other tax liabilities of any kind or nature arising in respect of Vendor Personnel, the Services, the Goods, or amounts paid pursuant to this Order.
3.4. Vendor shall keep confidential all information, drawings, specifications, or data furnished by Enable Injections, or prepared by Vendor specifically in connection with the performance of this Order, or otherwise learned by Vendor in connection with the performance of this Order. Vendor shall not divulge or use such information, drawings, specifications or data, including the terms and conditions of this Order, to or for the benefit of any other party without the express prior written consent of Enable Injections. Vendor shall use its best efforts to ensure that the confidentiality provisions set forth herein are understood, observed and obeyed by Vendor’s employees and third parties.
3.5. All intellectual property rights arising from the production of Goods and/or the provision of any Services contemplated in the Order shall vest in Enable Injections exclusively free from any third party rights and Vendor agrees to execute such documentation as may be necessary to perfect the title of Enable Injections to such rights.
4. Price and Payment
4.1. The Price shall be: (A) as specified in the Order, (B) inclusive of all other duties, imposts or levied other than sales or similar non-income taxes on the value of the Services and/or Goods provided and which Vendor is obligated by law to collect and pay (“Sales Taxes”), (C) without any increase without the prior consent of Enable Injections in writing, and (D) inclusive of any other expenses which Vendor incurs in connection with providing the Services and/or delivering the Goods.
4.2. Unless otherwise specified in the Order, Enable Injections shall pay Vendor within forty-five (45) days of receipt of an accurate and complete invoice, unless Enable Injections disputes the amount charged therein. All invoices shall be addressed to and delivered in the specific manner as described in the referenced Enable Injections Order. Vendor shall remit an invoice only once; all invoices must include the following information: (i) correct Order number, (ii) geographic location where the services were provided or goods delivered; (iii) invoice number, (iv) invoice date, and (v) amount due, and (vi) remit-to address. If Enable Injections objects to any item(s) charged on any invoice, Enable Injections shall notify Vendor of its objection within thirty (30) days of receipt of the invoice, provide to Vendor the basis for Enable Injection’s objection, and pay that portion of the invoice that is not in dispute within forty-five (45) days of receipt of such invoice.
5.1. The Services shall be provided at the site, and on the date(s) or within the period specified in the Order, in either case during Enable Injection’s usual business hours or such other hours as specified in the Order.
5.2. Where the date(s) of performance of the Services is to be agreed after the placing of the Order, the parties will act reasonably in agreeing such date(s).
5.3. If the Services are to be performed, or the Goods provided, by installments, the Order will be treated as a single contract and not severable.
5.4. Unless otherwise specified, all shipments of Goods must be made F.O.B. destination, with transportation charges prepaid by Vendor and title passing to Enable Injections upon proper delivery at the destination. Enable Injections shall be entitled to reject any deliverables delivered which are not in accordance with the Order, and shall not be deemed to have accepted any deliverables until, at the earliest, Enable Injections has had a reasonable time after any latent defect in the deliverables has become apparent.
5.5. The Goods will be delivered to, and the Services will be performed at, the Delivery Address on the date or within the period stated in the Order, in each case during the Enable Injection’s normal business hours.
5.6. Enable Injections will, without penalty, be entitled to delay or reschedule the date or period of delivery stated in the Order by giving not less than seven (7) day’s notice to the Vendor, specifying the revised date or period for delivery of the Goods or performance of the Services.
Where the date of delivery of the Goods, or performance of the Services, is to be specified after the placing of the Order, the Vendor will give Enable Injections reasonable notice of the specified date.
5.7. Time is of the essence with respect to delivery of the Goods and of performance of the Services hereunder.
5.8. If the Goods are to be delivered, or the Services are to be performed by instalments, the Contract will be treated as a single contract and not severable.
5.9. Enable Injections will be entitled to reject any Goods delivered which are not in accordance with the Terms and Conditions set forth herein (together with any additional and applicable Conditions described and referenced in Section 1 herein above). Further, Enable Injections will not be deemed to have accepted any Goods until the it has had a reasonable time, in no event less than thirty (30) days, to inspect them following delivery, or in the case of a latent defect in the Goods until a reasonable time after the latent defect has become apparent.
5.10. Vendor will promptly supply Enable Injections with any instructions or other information required to allow Enable Injections to accept delivery of the Goods and performance of the Services.
5.11. Enable Injections’ rights and remedies under this Section are in addition to its rights and remedies available to it by statute and at common law.
Vendor warrants and represents that:
6.1. the Services will be performed by appropriately qualified and trained personnel and with due care and diligence and to a standard of quality as recognized in the industry and as reasonable to expect in the circumstances so as to meet any requirements as agreed by the parties;
6.2. Vendor and Vendor’s Personnel shall comply with any and all applicable laws, regulations or ordinances in respect to the Services and/or Goods under this Order;
6.3. without prejudice to any other remedy, if any Services and/or Goods are not supplied or performed in accordance with the Order, then the Enable Injections shall be entitled to reject the Goods and/or Services without payment for the same or require Vendor to promptly provide replacement Services and/or Goods.
6.4. it has full right and authority to enter into and properly perform its obligations under the Order;
6.5. it has adequate commercial general liability and any additional insurance applicable to the performance the Services and delivery of the Goods;
6.6. it will account to the relevant tax authorities for any tax, or other statutory payment in respect of the fees paid to Vendor or any of Vendor Personnel in connection with the provision of the Goods and/or Services that it is required to report and shall pay all taxes, levies, duties and assessments of every nature required by such reporting in connection with any Services and/or Goods and hereby indemnifies and holds harmless Enable Injections from and against any liability that may become due on account of any alleged nonpayment of any and all such taxes, levies, duties and assessments.
7. Indemnification and Liability
VENDOR SHALL INDEMNIFY ENABLE INJECTIONS IN FULL AGAINST ALL LIABILITY, LOSS, DAMAGES, COSTS AND EXPENSES (INCLUDING LEGAL EXPENSES) AWARDED AGAINST OR INCURRED OR PAID BY ENABLE INJECTIONS AS A RESULT OF OR IN CONNECTION WITH: (A) BREACH OF ANY WARRANTY GIVEN BY VENDOR IN RELATION TO THE GOODS AND/OR SERVICES; (B) ANY CLAIM THAT THE PROVISION OF THE GOODS AND/OR SERVICES INFRINGE, OR THEIR IMPORTATION, USE OR RESALE, INFRINGES, THE PATENT, COPYRIGHT, DESIGN RIGHT, TRADE MARK OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY OTHER PERSON, EXCEPT TO THE EXTENT THAT THE CLAIM ARISES FROM COMPLIANCE WITH ANY SPECIFICATION SUPPLIED BY ENABLE INJECTIONS; AND (C) ANY PERSONAL INJURY OR PROPERTY DAMAGE RESULTING FROM VENDOR’S PERFORMANCE OF THE SERVICES OR DELIVERY OF THE GOODS, INCLUDING ANY NEGLIGENT ACT OR OMISSION OR WILLFUL MISCONDUCT OF VENDOR OR VENDOR’S PERSONNEL, EXCEPT ANY RESULTING SOLELY FROM THE GROSS NEGLIGENCE OF ENABLE INJECTIONS.
8. Limitation of Liability
ANYTHING TO THE CONTRARY HEREIN NOTWITHSTANDING, EXCEPT FOR DAMAGES RESULTING FROM UNAUTHORIZED USE AND/OR DISCLOSURE OF THE PROPRIETARY INFORMATION, UNDER NO CIRCUMSTANCES SHALL ENABLE INJECTIONS BE LIABLE FOR AN AMOUNT OF DAMAGES IN EXCESS OF THE FEES TO BE PAID UNDER THE ORDER OR BE LIABLE FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR INDIRECT DAMAGES, LOSS OF GOOD WILL OR BUSINESS PROFITS, WORK STOPPAGE, DATA LOSS, COMPUTER FAILURE OR MALFUNCTION, ANY AND ALL OTHER COMMERCIAL DAMAGES OR LOSS, OR EXEMPLARY OR PUNITIVE DAMAGES EVEN IF ENABLE INJECTIONS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE LIMITATION OF LIABILITY SET FORTH ABOVE DOES NOT APPLY TO VENDOR’S INDEMNIFICATION OBLIGATIONS UNDER THIS AGREEMENT.
9.1. Vendor shall maintain insurance of the following types and amounts, all of which shall apply to claims for damages arising out of the Contract Documents (as defined below), and which shall be issued by insurance companies having an A.M. Best financial strength rating of A-/VIII or better:
9.1.1. Workers’ Compensation Insurance in compliance with all requirements of the laws of the State where the goods or services are provided.
Employer’s Liability Insurance providing coverage for death, bodily injury, sickness and disease, with limits of not less than $1,000,000 per occurrence.
9.1.2. General Liability Insurance providing coverage for death, bodily injury, property damage, contractual liability and products liability and completed operations, with limits of not less than $2,000,000 per occurrence.
9.1.3. Vendor shall provide Enable Injections with certificates of insurance upon request.
10.1. Enable Injections shall be entitled to cancel the Order in respect of all or part of the Services and/or Goods by giving notice to Vendor at any time prior to dispatch of the Goods or performance of the Services.
10.2. Enable Injections shall also be entitled to terminate the Order without liability by giving notice at any time if Vendor:
10.2.1. is the subject of any bankruptcy, liquidation or insolvency, including the institution of any proceeding by or against Vendor; the appointment of a receiver of any of its assets or property; or any voluntary arrangements with its creditors;
10.2.2. ceases, or threatens to cease, to carry on business; or Enable Injections reasonably believes any of the events mentioned; or
10.2.3. fails to cure a material breach immediately (or such breach is uncurable) of the Order.
10.3. Payment for Goods/Services upon Termination. In the case of any termination hereunder Vender shall be paid for all Services performed or Goods delivered through the date of termination, and, if applicable, accepted, but not yet paid for, based upon the terms, conditions and prices set forth in the Order. Enable Injections will not be liable for any costs resulting directly from termination nor any outstanding obligations of Vendor with respect to the Goods and/or Services.
11. Export and Import Compliance
11.1. Performance of the Order may involve the use of or access to products and technology of multiple origin, including the USA. The Vendor shall comply with all applicable export laws, rules and regulations. The Vendor shall comply with any and all Export Laws and Regulations, and any license(s) issued there under. The Vendor is responsible for obtaining at its cost (unless otherwise stated in the Order or Special Terms) all export authorization(s) required to provide the Goods and/or Services to Enable Injections. The Vendor shall not re-transfer any export-controlled information (e.g. technical data, technology or software) in performance of the Order to any other person or entity (including the Vendor’s dual and/or third-country national employees) without first complying with all the requirements of the applicable Export Laws and Regulations. Prior to any proposed re-transfer, the Vendor shall first obtain the written consent of Enable Injections and ensure any needed export authorizations have been obtained.
11.2. No consent granted by Enable Injections in response to any Vendor’s request shall relieve the Vendor of its obligations to comply with the provisions of Section 11.1 or the Export Laws and Regulations, nor shall any such consent constitute a waiver of the requirements of Section 11.1 hereinabove, nor constitute consent for the Vendor to violate any provision of the Export Laws and Regulations.
11.3. The Vendor shall provide the applicable export controls information for all Goods furnished and/or Services rendered by the Vendor to Enable Injections, except when the Vendor is manufacturing to Enable Injections’ Specification. If the Goods and Services are based on Enable Injections’ Specification, Enable Injections will advise the Vendor whether the technology and/or resulting Goods and Services are export controlled. If the Vendor is not the Original Equipment Manufacturer (OEM), the Vendor shall obtain the applicable export control classification information from its source of supply. The Vendor will include the export controls information on its packing slips and shipping documentation and also provide to Enable Injections at Enable Injections’ request.
11.4. The Vendor shall comply with all applicable customs laws and regulations pertaining to the importations of the Goods and/or Services. For domestic purchase orders (that is, Orders issued to entities addressed in the same country as Enable Injections), the Vendor shall assume all import responsibilities. Unless otherwise agreed in writing, Enable Injections will not assume any import responsibility or liabilities for customs duty and other taxes for Goods and/or Services procured through a domestic purchase order.
11.5. The Vendor agrees to provide prompt notification to Enable Injections in the event of changes in circumstances such as ineligibility to contract.
12. Anti-Human Trafficking
12.1. Enable Injections prohibits its employees, agents, subcontractors, suppliers and contract labor from engaging in activities that support or promote trafficking in persons, including, but not limited to, any of the following, whether directly or indirectly:
12.1.1. Trafficking in persons, including, but not limited to the following: (a) sex trafficking; or (b) the recruitment, harbouring, transportation, provision, or obtaining of a person for labour or services through the use of force, fraud, or coercion for the purpose of subjection to involuntary servitude, debt bondage, or slavery.
12.1.2. The procurement of a commercial sex act;
12.1.3. The use of forced labor in the performance of company business;
12.1.4. The use of any form of child labour;
12.1.5. The use of misleading or fraudulent recruitment activities;
12.1.6. Charging employees’ recruitment fees;
12.1.7. Failing to pay for the return transportation at the end of employment for an employee who is not a national of the country in which the work is taking place and who was brought into that country for the purpose of working;
12.1.8. Providing or arranging housing that fails to meet the host country housing and safety standards; or
12.1.9. If required, failing to provide an employment contract, recruitment agreement, or similar work document in writing, in the individual’s native language and prior to the individual departing from his or her country of origin.
12.2. The Vendor represents and warrants that it shall abide by and comply with the requirements of this Section and any relevant applicable laws or regulations. Further, the Vendor shall require its employees, agents, contract labor, subcontractors and suppliers to abide by and comply with the requirements of this Section.
12.3. Enable Injections or its authorized representatives may, at any time, audit all pertinent books, records, work sites, offices, and documentation of the Vendor in order to verify compliance with this Section. The Vendor will, in all of its lower-tier subcontracts and contracts relating to this or any other Enable Injections’ Order with the Vendor, include provisions which secure for Enable Injections all of the rights and protections provided for within this Section.
12.4. The Vendor acknowledges that if the Vendor or any of its employees, agents, or contract labor engages in any of the prohibited activities in this Section, this Order is subject to termination.
12.5. Whenever the Vendor has knowledge, whether substantiated or not, that any actual or suspected violation of this Section has occurred, the Vendor shall immediately give written notice to Enable Injections and provide all relevant information including, but not limited to, the nature of the actual or suspected violation.
12.6. The Vendor shall provide its full cooperation during any subsequent investigation of the actual or suspected violation by Enable Injections, Enable Injections’ representative, or regulatory authority. Vendor’s cooperation shall include, but not be limited to, permitting inspection of its work sites, offices, and documentation, as necessary to support any investigation.
12.7. The Vendor shall, at its own expense, defend, indemnify and hold harmless Enable Injections and its affiliates, and all of their directors, officers, agents, employees, successors and assigns, against any claims, loss, damage or expense, regardless of how arising and even if unforeseeable, including, without limitation, payment of direct, special, incidental and consequential damages and attorney’s fees, arising out of, or relating to, the Vendor’s or the Vendor’s employees, agents, subcontractors, suppliers or contract labor’s failure to comply with the requirements of this Section.
12.8. The Vendor agrees to insert the substance of this Section, including this sentence, in any lower-tier subcontract or labor contract agreements.
13. Compliance with Laws
13.1. Without limiting any other obligations under these Conditions, the Vendor shall ensure that, at all times in delivery of the Goods and Services, it complies with all applicable laws and regulations, and shall ensure that its employees, agents and representatives similarly comply.
13.2. The Vendor shall specifically ensure that it complies with all laws, in any part of the world, in relation to the registration for or payment of any taxes which might be due in connection with the performance of the Services or supply of any Goods, under this Contract.
13.4. The Vendor shall maintain environmental, health and safety management systems as appropriate to ensure compliance with applicable laws. The Vendor further agrees to continuously promote a safe and healthy workplace and a sustainable environment related to water and air quality, water and energy conservation, greenhouse gas emission reductions, solid and hazardous waste reductions. The Vendor shall convey the requirement of this Section to its suppliers.
14.1. Assignment. Vendor shall not assign or transfer or purport to assign or transfer to any other person any of its rights or subcontract any of its obligations under the Order.
14.2. Enable Property. Vendor, its employees and third parties shall not use Enable Injections proprietary marks, names and/or logos in any sales literature, news release, marketing publication or other advertisement without the express written authority of Enable Injections. Vendor shall not in any manner advertise or publish the fact that it has furnished or contracted to furnish to Enable Injections the Goods or Services herein mentioned without prior written consent of Enable Injections.
14.3. Notices. Any notice required or permitted to be given hereunder shall be deemed sufficient if made in writing and deposited in the United States mail, postage prepaid, registered or certified mail or sent via a nationally recognized overnight carrier, and addressed to the other party’s legal department at the address set forth in this Order.
14.4. Waiver. No waiver by Enable Injections of any breach of the Order by Vendor shall be considered as a waiver of any subsequent breach of the same or any other provision.
14.5. Interpretation and Construction. The headings to these Conditions are for convenience only and shall not affect their interpretation. Any reference in these Conditions to a statute or a provision of a statute shall be construed as a reference to that statute or provision as amended, re-enacted or extended at the relevant time.
14.6. Severability. If any provision of these Conditions is held by any competent authority to be invalid or unenforceable in whole or in part the validity of the other provision of these Conditions and the remainder of the provisions of these Conditions and the remainder of the provision in question shall not be affected thereby.
14.7. Governing law and Jurisdiction. The Order shall be governed by and interpreted in accordance with the laws of the State of Ohio; each party agrees to submit to the exclusive jurisdiction of the Courts the State of Ohio.
14.8. Entire Agreement. These Terms and Conditions, all applicable Orders, and any Master Services Agreement entered into between the parties and related to the goods and services, and any mutually authorized attachments hereto (collectively, the “Contract Documents”) contain the complete, exclusive and final understanding of the parties with regard to the subject matter hereof, and may be amended only by a written instrument incorporated hereto and signed by Enable Injections and Vendor.
14.9. Priority of Documents. In the event of conflicting provisions between any of the Contract Documents, the provisions shall govern in the following priority: first, any duly executed Master Services Agreement entered into between the parties related to the Goods or Services; second, the applicable Order; and third, these Terms and Conditions.
15. General Material Requirements
15.1. GENERAL REQUIREMENTS
15.1.1. The Supplier is responsible to build parts per required features and notes on drawings and any standards or specifications called out on those drawings.
15.1.2. No deviations from the drawings are allowed without written approval of Enable Injections, Inc. Any request for change in the requirement must be submitted in writing with a description of the change and, if appropriate, samples and control plan test data.
15.2. HAZARDOUS REQUIREMENTS
15.2.1 Supplier will provide certification that material is free from hazardous substances to Enable Injections.
15.3. LABELING & PACKAGING REQUIREMENTS
15.3.1. The product shall be clean, dry, and packaged in accordance with best commercial practice to protect the product against corrosion, deterioration, and physical damage during shipment.
15.3.2. Each shipping container shall contain one-part batch/lot code only.
15.3.3. Parts will be double bagged with a label on the inner bag, with the following information.
Part number and revision.
15.4. HANDLING AND STORAGE REQUIRMENTS
15.4.1. The supplier will provide components that have been stored or shipped using heat treated wood pallets or plastic pallets in accordance with ISPM15 requirements.
15.5. DOCUMENTATION REQUIREMENTS
15.5.1. The Certificate of Compliance or Conformance shall list, at a minimum:
Enable Injections part number and revision
Supplier/Manufacturer batch/lot control number
Purchase Order number
Approval Signature and date by supplier
Date of Manufacture
15.6 PARTICULATE REQUIREMENTS
15.6.1. Unless otherwise specific in the drawing, the particulate requirements are defined below. Note for item group refer to drawing note.
|Group||Classification||Embedded Particulate Requirement||Loose Particulate Requirement|
|A||Fluid Path||Particulate maximum of one particulate per unit not to exceed 0.2mm2 (≤0.2mm2).||Particulate maximum of one particulate per unit not to exceed 0.2mm2 (≤0.2mm2).|
|B||Non-Fluid Path||Particulate maximum of one particulate per unit not to exceed 0.6mm2 (≤0.6mm2).||Particulate maximum of one particulate per unit not to exceed 0.6mm2 (≤0.6mm2).|
|C||Non-OBDS component (Outside Sterile Barrier)||None||None|
15.7. CHANGE NOTIFICATION REQUIREMENTS
15.7.1. Enable Injections, Inc. is a manufacturer of medical devices and must evaluate changes to materials, components, and services for potential effect to form, fit, function and biocompatibility of finished products. Supplier is required to provide at least six (6) months (preferred 12 months) advance written notice of a temporary deviation or permanent change or, if this period is not possible, written notification within three (3) business days after learning of change.
15.7.2. Change notification is to be sent to Enable Injections Quality Management.
15.7.3. Implementation of the change is permitted only after written authorization by Enable Injections, Inc.
15.7.4. As an alternative, the supplier can provide their own customer notification of change policy, subject to Enable’s approval.