Purchase Order Terms

These terms (“Terms”) are incorporated in any purchase order (“Order”) for goods and other deliverables (referred to as “Goods”) and services (“Services”) issued by Kindeva Drug Delivery L.P., or any affiliate, including Kindeva Drug Delivery Limited (collectively “Kindeva”) to the supplier providing the Goods and/or Services identified in that Order (“Seller”), except to the extent any Terms conflict with a written agreement, executed by both Kindeva and Seller (the “Parties”), or other written terms Kindeva has provided to Seller, that specifically cover that transaction.

1. SCOPE. Seller has accepted an Order (including these Terms) if Seller gives a verbal, written or electronic acknowledgment of, or initiates performance under, that Order. By accepting an Order, Seller’s acceptance is limited to the Order’s terms (which include these Terms). No additional or conflicting term in any Seller acknowledgment, invoice, bid, proposal, or other documentation is binding on Kindeva, unless Kindeva specifically agreed to it in writing. All Goods and Services will be delivered to Kindeva in strict conformance with any packaging, product and/or service standards, specifications, agreed sample(s), and other requirements provided by Kindeva or approved in writing by Kindeva (the “Requirements”).
2. DELIVERY. Unless otherwise stated in the Order, all Goods will be shipped freight collect or freight prepaid; provided that Goods shipped internationally are sold FCA (Incoterms 2020) destination, unless otherwise indicated in an Order. If Seller is responsible for shipping Goods, Seller will ship Goods via the most economical route and in a single shipment. Seller will deliver all Goods and Services within the time period stated in the Order, unless Kindeva specifies a longer, or the Parties agree to a shorter, time period. Seller will make no charge for any packing, crating, storage, insurance, shipping, or delivery expense, unless authorized in the Order. Seller will pay any excess costs due to failure to follow Kindeva’s shipping instructions. If Seller delivers any Goods amount other than that stated in the Order without Kindeva’s prior written consent, Kindeva may return any part or all of that delivery, at Seller’s expense. Kindeva’s determination of the Goods’ count and weight is conclusive, unless Seller encloses a packing slip stating a different amount. The Parties shall make all reasonable efforts to resolve amicably any material discrepancy between Kindeva’s determination of the Goods’ count and weight, and that included in a packing slip provided to Kindeva by Seller.  TIME IS OF THE ESSENCE FOR ALL ORDERS.
3. PRICES AND PAYMENT. Goods and Services will be delivered to Kindeva for the price stated in the Order. Unless the Order states different payment terms, payments are net ninety (90) days to be paid in United States dollars. Kindeva’s payments may be adjusted in its sole discretion for Seller’s errors, defects or non-compliance with the Order (including these Terms). Each invoice must relate to only one Order, and be issued and dated no earlier than the Goods’ and/or Services’ delivery date. Each Seller invoice and all related documents (such as packaging lists, bills of lading, freight bills and correspondence) must include: (a) Order number; (b) applicable Order line item number(s) and unit of measure; and (c) Kindeva’s identification number (if provided by Kindeva). Seller warrants that the prices being paid by Kindeva and the Goods and/or Services provided to Kindeva by Seller are not affected in any manner or to any extent by collusion or any other anti-competitive activity. Kindeva may, at its option and on notice to Seller, convert any of its ordering, purchasing, and payment methods to be electronically enabled and Seller will, at its expense: (y) provide any necessary electronic data interface for the technology’s implementation; and (z) use the applicable electronic method designated by Kindeva.
4. ORDER CHANGE, SUSPENSION OR CANCELLATION.
   1. Kindeva may change an Order by giving electronic notice to Seller prior to shipment of the applicable Goods or performance of the Services. If any Order change causes an adjustment in price or delivery date, the Parties will negotiate in good faith to make an equitable adjustment and modify an Order accordingly, provided that Seller gives Kindeva notice of that adjustment claim within three (3) business days after receipt of Kindeva’s Order change notice. Kindeva may require Seller to suspend all or part of Seller’s performance under an Order for up to twelve (12) consecutive calendar months. Seller will suspend performance and resume performance, as directed by Kindeva. If any Order suspension causes an adjustment in price, the Parties will make an equitable adjustment and modify an Order accordingly, provided that Seller gives Kindeva notice of that adjustment claim within three business days after receipt of Kindeva’s Order suspension notice.
   2. Kindeva may cancel an Order, without cause, at any time by electronic or written notice to Seller, but if Kindeva’s notice of cancellation is issued less than five (5) days prior to a scheduled Goods delivery date or Services performance date, then Seller will be entitled to reimbursement for: (a) if Goods, any unique raw materials that cannot be returned to Seller’s supplier or sold to other Seller customer(s) and are necessary to provide those Goods due on that delivery date; or (b) if Services, the fees for those Services completed prior to the cancellation by Kindeva and Seller’s actual, out-of-pocket expenses paid to third parties that are not refundable and were reasonably necessary to provide those Services. If Seller fails to comply with all of an Order’s Terms or admits its inability to meet its financial obligations, or it otherwise becomes apparent that Seller will not be able to fulfill its obligations under an Order due to Unavoidable Delay or other cause, then Kindeva may cancel an Order at any time by electronic or written notice to Seller without any liability of any kind to Seller, in addition to any other legal or equitable remedies Kindeva may have.
   3. Kindeva may change an Order by giving electronic notice to Seller prior to shipment of the applicable Goods or performance of the Services. If any Order change causes an adjustment in price or delivery date, the Parties will negotiate in good faith to make an equitable adjustment and modify an Order accordingly, provided that Seller gives Kindeva notice of that adjustment claim within three (3) business days after receipt of Kindeva’s Order change notice. Kindeva may require Seller to suspend all or part of Seller’s performance under an Order for up to twelve (12) consecutive calendar months. Seller will suspend performance and resume performance, as directed by Kindeva. If any Order suspension causes an adjustment in price, the Parties will make an equitable adjustment and modify an Order accordingly, provided that Seller gives Kindeva notice of that adjustment claim within three business days after receipt of Kindeva’s Order suspension notice.
   4. Kindeva may cancel an Order, without cause, at any time by electronic or written notice to Seller, but if Kindeva’s notice of cancellation is issued less than five (5) days prior to a scheduled Goods delivery date or Services performance date, then Seller will be entitled to reimbursement for: (a) if Goods, any unique raw materials that cannot be returned to Seller’s supplier or sold to other Seller customer(s) and are necessary to provide those Goods due on that delivery date; or (b) if Services, the fees for those Services completed prior to the cancellation by Kindeva and Seller’s actual, out-of-pocket expenses paid to third parties that are not refundable and were reasonably necessary to provide those Services. If Seller fails to comply with all of an Order’s Terms or admits its inability to meet its financial obligations, or it otherwise becomes apparent that Seller will not be able to fulfill its obligations under an Order due to Unavoidable Delay or other cause, then Kindeva may cancel an Order at any time by electronic or written notice to Seller without any liability of any kind to Seller, in addition to any other legal or equitable remedies Kindeva may have.
   5. Kindeva may change an Order by giving electronic notice to Seller prior to shipment of the applicable Goods or performance of the Services. If any Order change causes an adjustment in price or delivery date, the Parties will negotiate in good faith to make an equitable adjustment and modify an Order accordingly, provided that Seller gives Kindeva notice of that adjustment claim within three (3) business days after receipt of Kindeva’s Order change notice. Kindeva may require Seller to suspend all or part of Seller’s performance under an Order for up to twelve (12) consecutive calendar months. Seller will suspend performance and resume performance, as directed by Kindeva. If any Order suspension causes an adjustment in price, the Parties will make an equitable adjustment and modify an Order accordingly, provided that Seller gives Kindeva notice of that adjustment claim within three business days after receipt of Kindeva’s Order suspension notice.
   6. Kindeva may cancel an Order, without cause, at any time by electronic or written notice to Seller, but if Kindeva’s notice of cancellation is issued less than five (5) days prior to a scheduled Goods delivery date or Services performance date, then Seller will be entitled to reimbursement for: (a) if Goods, any unique raw materials that cannot be returned to Seller’s supplier or sold to other Seller customer(s) and are necessary to provide those Goods due on that delivery date; or (b) if Services, the fees for those Services completed prior to the cancellation by Kindeva and Seller’s actual, out-of-pocket expenses paid to third parties that are not refundable and were reasonably necessary to provide those Services. If Seller fails to comply with all of an Order’s Terms or admits its inability to meet its financial obligations, or it otherwise becomes apparent that Seller will not be able to fulfill its obligations under an Order due to Unavoidable Delay or other cause, then Kindeva may cancel an Order at any time by electronic or written notice to Seller without any liability of any kind to Seller, in addition to any other legal or equitable remedies Kindeva may have.
5. TRADEMARKS AND INTELLECTUAL PROPERTY. Seller will use a Kindeva trademark, tradename, or corporate logo (“Kindeva Mark”) only if required by the Requirements. Seller will, at Kindeva’s direction and at any time specified by Kindeva, return to Kindeva or destroy all materials containing a Kindeva Mark. While Seller is providing Goods and/or Services for Kindeva and at any time thereafter, Seller will not use Kindeva’s name or Kindeva Mark in any manner, including promotional or advertising materials, or otherwise assert affiliation with Kindeva or a Kindeva affiliate, except with Kindeva’s prior written consent in each instance.  In the event of arising intellectual property related to provision of Goods and/or Services by Seller to Kindeva under an Order, the Parties agree that ownership of such arising intellectual property shall be owned by Kindeva if related to the Kindeva business or products, or otherwise follow inventorship according to U.S. law.  Nothing in these Terms shall affect either Party’s rights to its intellectual property existing prior to the effective date of these Terms or developed independently from the activities under these Terms (“Background Intellectual Property”) or imply the grant of any license to its Background Intellectual Property unless expressly set forth herein.
6. KINDEVA MATERIAL & KINDEVA EQUIPMENT. Kindeva owns any materials Kindeva provides to Seller or that are produced or reimbursed at Kindeva’s expense in connection with an Order, including, without limitation, raw materials, databases, digital content, data, or documents (“Kindeva Material”) and any tooling or other equipment that Kindeva provides to Seller or that is produced or reimbursed at Kindeva’s expense in connection with an Order (“Kindeva Equipment”). Seller authorizes Kindeva to file UCC financing statements and other documentation without Seller’s signature to acknowledge Kindeva’s ownership of these items. Seller will not sell, pledge, transfer or remove from Seller’s facility any Kindeva Material or Kindeva Equipment. Seller will use all Kindeva Material and Kindeva Equipment solely to perform its obligations under Orders and for no other purpose. Seller will not alter, or take any steps seeking to alter, any Kindeva Equipment. Seller will use its best efforts to maintain the security and confidentiality of all Kindeva Material and Kindeva Equipment. Seller has all risk of loss or damage to Kindeva Equipment and Kindeva Material, and will, at Kindeva’s request, immediately restore or replace any damaged or lost Kindeva Equipment or Kindeva Material with equivalent item(s), equipment, or material(s). Promptly on Kindeva’s request, Seller will return to Kindeva all Kindeva Equipment and unused Kindeva Material in their original condition, except for reasonable wear, with Kindeva liable only for crating and shipping costs. Seller will maintain all Kindeva Equipment in a safe and proper condition using industry standards and indemnify Kindeva for, and defend it against, all claims arising out of Seller’s use of Kindeva Equipment. All intellectual property rights in Kindeva Material or Kindeva Equipment shall belong to Kindeva and Seller will assign such intellectual property rights including copyright and/or design rights to Kindeva upon request on terms provided by Kindeva. If the Parties establish Kindeva Material loss allowances, Seller will reimburse Kindeva for any excess losses, at Kindeva’s delivered cost to Seller. Seller will inspect Kindeva Material that will be incorporated into Goods and promptly inform Kindeva of any non-compliance with the Requirements.
7. WARRANTIES & REMEDIES.
   1. In addition to all implied and express warranties available and applicable under the Uniform Commercial Code (“UCC”), UK Sale of Goods Act 1979 and UK Sale of Good and Services Act 1982 as may be amended, other local laws, and/or these Terms, Seller warrants that: (a) all Goods and Services will be free from any encumbrance and conform to all Requirements and the applicable Order; (b) all Goods will be without any defect in design (except to the extent designed by Kindeva), manufacture, processing, materials and workmanship and conform in all respects to the Requirements; (c) all Goods will be made or processed, and all Services will be performed, in compliance with all laws applicable to Seller and its business in accordance with Section 8. Seller also warrants that: (x) Seller has the expertise, experience, skill, and resources to perform its obligations under any Order (including these Terms); (y) no Good or Service infringes on any third party’s intellectual property rights; and (z) Seller has no third-party obligations that conflict in any way with Seller’s obligations under these Terms.
   2. In addition to all available remedies, Kindeva may reject any Goods or Services not meeting Seller’s warranties, and: (a) obtain substitutes and offset, or require Seller to reimburse Kindeva for, all additional costs associated with the substitutes; or (b) require Seller, at Kindeva’s option, to either replace the affected Goods or re-perform the affected Services without charge, or to reimburse Kindeva that Good’s price, plus any Kindeva Material’s delivered cost, or that Service’s price. Kindeva may, but is not obligated to, inspect or test Goods and Services at Kindeva’s premises, Seller’s premises or those of any Seller subcontractor performing under an Order. Kindeva’s acceptance of delivery, inspection, or payment for any Good or Service does not waive any of Seller’s warranties or other obligations. Seller will use its best efforts to assist Kindeva in investigation of, and corrective action for, Kindeva customer complaints related to the Goods and/or Services.
   3. In addition to all implied and express warranties available and applicable under the Uniform Commercial Code (“UCC”), UK Sale of Goods Act 1979 and UK Sale of Good and Services Act 1982 as may be amended, other local laws, and/or these Terms, Seller warrants that: (a) all Goods and Services will be free from any encumbrance and conform to all Requirements and the applicable Order; (b) all Goods will be without any defect in design (except to the extent designed by Kindeva), manufacture, processing, materials and workmanship and conform in all respects to the Requirements; (c) all Goods will be made or processed, and all Services will be performed, in compliance with all laws applicable to Seller and its business in accordance with Section 8. Seller also warrants that: (x) Seller has the expertise, experience, skill, and resources to perform its obligations under any Order (including these Terms); (y) no Good or Service infringes on any third party’s intellectual property rights; and (z) Seller has no third-party obligations that conflict in any way with Seller’s obligations under these Terms.
   4. In addition to all available remedies, Kindeva may reject any Goods or Services not meeting Seller’s warranties, and: (a) obtain substitutes and offset, or require Seller to reimburse Kindeva for, all additional costs associated with the substitutes; or (b) require Seller, at Kindeva’s option, to either replace the affected Goods or re-perform the affected Services without charge, or to reimburse Kindeva that Good’s price, plus any Kindeva Material’s delivered cost, or that Service’s price. Kindeva may, but is not obligated to, inspect or test Goods and Services at Kindeva’s premises, Seller’s premises or those of any Seller subcontractor performing under an Order. Kindeva’s acceptance of delivery, inspection, or payment for any Good or Service does not waive any of Seller’s warranties or other obligations. Seller will use its best efforts to assist Kindeva in investigation of, and corrective action for, Kindeva customer complaints related to the Goods and/or Services.
8. COMPLIANCE WITH LAWS & SELLER RESPONSIBILITY.
   1. Seller will comply with all applicable laws and regulatory requirements in performance of its obligations to fulfill an Order, including environmental, health and safety requirements valid at the time, even if not expressly referred to in any specification. In addition, Seller will comply with (a) any Kindeva regulatory requirements; and (b) any Kindeva supplier responsibilities as may be published and updated from time to time and are incorporated by reference as in existence as of the date of this Order.  Seller warrants that the Goods will not contain any of the substances prohibited by applicable laws, and that any restricted substances contained in the Goods will not exceed the relevant concentration values permitted by applicable laws in force at the time the Goods are supplied. Upon request by Kindeva, Seller will promptly provide Kindeva with satisfactory documentation that Goods do not exceed restricted values or contain prohibited substances, the concentration of each substance subject to restricted values, and any other reports of the occurrence of substances in the Goods that may require disclosure to governmental bodies, customers, or other third-parties.
   2. Supply of the Goods or Services or any part thereof may not be subcontracted or assigned by Seller to any third party without Kindeva’s prior written consent. Where consent to subcontracting or assignment is given, Seller shall be fully responsible for any acts and omissions of Seller’s subcontractors or assignees in all respects.
   3. Seller warrants that all Seller employees, agents, and subcontractors (“Seller Personnel”) performing any of Seller’s obligations under an Order will have employment authorization that complies with all applicable laws and without use of labor resulting from mental or physical coercion, physical punishment, slavery, human trafficking, or other oppressive labor conditions. On Kindeva’s request, Seller will provide Kindeva with all documentation and information Kindeva requires to conduct an export control license assessment relating to Seller Personnel. If Kindeva determines that an export license is needed for certain Seller Personnel, Kindeva may, in its discretion, pursue that export license or instruct Seller not to use that Seller Personnel to perform Seller’s obligations under an Order.
   4. Seller will comply with applicable national and international anti-bribery rules, including, without limitation, the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act and applicable EU, OECD and Council of Europe anti-bribery rules. Seller will not offer, make, promise to make, or authorize the making of any gift or payment of money or anything of value either directly or indirectly for purposes of (a) influencing any act or decision of any government official or political party (or candidate thereof) (collectively, “Officials”); (b) inducing an Official to do or omit to do any act in violation of the lawful duty of that Official; or (c) inducing an Official to use influence with a non-U.S. government or instrumentality to facilitate Seller’s performance of its obligations under any Order. Seller and its affiliates must at all times keep complete and accurate books and records. All records and information that Seller provides to Kindeva pertaining to the performance of each Order must be complete and accurate.
   5. On request, and no more often than annually, Seller will provide Kindeva with a Long Term Supplier’s Declaration in respect of all eligible supplies per EC Regulations 1207/2001 and 1617/2006.
   6. Seller will comply with all applicable laws and regulatory requirements in performance of its obligations to fulfill an Order, including environmental, health and safety requirements valid at the time, even if not expressly referred to in any specification. In addition, Seller will comply with (a) any Kindeva regulatory requirements; and (b) any Kindeva supplier responsibilities as may be published and updated from time to time and are incorporated by reference as in existence as of the date of this Order.  Seller warrants that the Goods will not contain any of the substances prohibited by applicable laws, and that any restricted substances contained in the Goods will not exceed the relevant concentration values permitted by applicable laws in force at the time the Goods are supplied. Upon request by Kindeva, Seller will promptly provide Kindeva with satisfactory documentation that Goods do not exceed restricted values or contain prohibited substances, the concentration of each substance subject to restricted values, and any other reports of the occurrence of substances in the Goods that may require disclosure to governmental bodies, customers, or other third-parties.
   7. Supply of the Goods or Services or any part thereof may not be subcontracted or assigned by Seller to any third party without Kindeva’s prior written consent. Where consent to subcontracting or assignment is given, Seller shall be fully responsible for any acts and omissions of Seller’s subcontractors or assignees in all respects.
   8. Seller warrants that all Seller employees, agents, and subcontractors (“Seller Personnel”) performing any of Seller’s obligations under an Order will have employment authorization that complies with all applicable laws and without use of labor resulting from mental or physical coercion, physical punishment, slavery, human trafficking, or other oppressive labor conditions. On Kindeva’s request, Seller will provide Kindeva with all documentation and information Kindeva requires to conduct an export control license assessment relating to Seller Personnel. If Kindeva determines that an export license is needed for certain Seller Personnel, Kindeva may, in its discretion, pursue that export license or instruct Seller not to use that Seller Personnel to perform Seller’s obligations under an Order.
   9. Seller will comply with applicable national and international anti-bribery rules, including, without limitation, the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act and applicable EU, OECD and Council of Europe anti-bribery rules. Seller will not offer, make, promise to make, or authorize the making of any gift or payment of money or anything of value either directly or indirectly for purposes of (a) influencing any act or decision of any government official or political party (or candidate thereof) (collectively, “Officials”); (b) inducing an Official to do or omit to do any act in violation of the lawful duty of that Official; or (c) inducing an Official to use influence with a non-U.S. government or instrumentality to facilitate Seller’s performance of its obligations under any Order. Seller and its affiliates must at all times keep complete and accurate books and records. All records and information that Seller provides to Kindeva pertaining to the performance of each Order must be complete and accurate.
   10. On request, and no more often than annually, Seller will provide Kindeva with a Long Term Supplier’s Declaration in respect of all eligible supplies per EC Regulations 1207/2001 and 1617/2006.
9. CONFIDENTIAL INFORMATION.
   1. The term: (a) “products” as used only in this Section 9 means all products manufactured or sold by or for Kindeva or services performed for Kindeva, including the Goods and Services; and (b) “Kindeva Confidential Information” means information or tangible materials, whether or not designated by Kindeva as confidential, pertaining to: (i) product development, design, formulations, composition, research and development, or specifications; (ii) product manufacturing techniques, rates or quantities; (iii) equipment used to make products; (iv) any other aspects of Kindeva’s business relating to products and services, including without limitation marketing, sales, customers and non-public financial data; (v) all Orders placed by Kindeva; and (vi) the Parties’ relationship.
   2. Seller will: (a) keep all Kindeva Confidential Information confidential; (b) use Kindeva Confidential Information only as necessary to perform Seller’s obligations under the Order; and (c) ensure that its employees, agents, and Kindeva-approved subcontractors abide by these confidentiality obligations. If Seller receives any tangible materials constituting Kindeva Confidential Information, then Seller will return those to Kindeva, on Kindeva’s request or at the end of the applicable Order. Kindeva Confidential Information does not include information that is: (x) available to the public in any publication; (y) known to Seller prior to its receipt from Kindeva as evidenced by Seller’s written records; or (z) available to Seller from another source without breach of any agreement or violation of law. If required by judicial or administrative process to disclose Kindeva Confidential Information, Seller agrees to promptly give Kindeva notice, allow Kindeva reasonable time to oppose such process, and seek to have the third party treat the information confidentially to the extent legally permissible.
   3. The term: (a) “products” as used only in this Section 9 means all products manufactured or sold by or for Kindeva or services performed for Kindeva, including the Goods and Services; and (b) “Kindeva Confidential Information” means information or tangible materials, whether or not designated by Kindeva as confidential, pertaining to: (i) product development, design, formulations, composition, research and development, or specifications; (ii) product manufacturing techniques, rates or quantities; (iii) equipment used to make products; (iv) any other aspects of Kindeva’s business relating to products and services, including without limitation marketing, sales, customers and non-public financial data; (v) all Orders placed by Kindeva; and (vi) the Parties’ relationship.
   4. Seller will: (a) keep all Kindeva Confidential Information confidential; (b) use Kindeva Confidential Information only as necessary to perform Seller’s obligations under the Order; and (c) ensure that its employees, agents, and Kindeva-approved subcontractors abide by these confidentiality obligations. If Seller receives any tangible materials constituting Kindeva Confidential Information, then Seller will return those to Kindeva, on Kindeva’s request or at the end of the applicable Order. Kindeva Confidential Information does not include information that is: (x) available to the public in any publication; (y) known to Seller prior to its receipt from Kindeva as evidenced by Seller’s written records; or (z) available to Seller from another source without breach of any agreement or violation of law. If required by judicial or administrative process to disclose Kindeva Confidential Information, Seller agrees to promptly give Kindeva notice, allow Kindeva reasonable time to oppose such process, and seek to have the third party treat the information confidentially to the extent legally permissible.
10. PERSONAL INFORMATION. “Personal Information” means information about a particular individual that, on its own or in combination with other information, identifies an individual, in any form and any media. Seller may access, collect, or process Personal Information during its performance under an Order. Seller will keep all that Personal Information confidential, use it only as necessary to perform Seller’s obligations under an Order, and promptly notify Kindeva of any judicial process that might require its disclosure. Seller will, at Kindeva’s option, either return or destroy all that Personal Information on Kindeva’s request. In addition, Seller will: (a) create, obtain, process and use Personal Information only in compliance with all applicable laws; (b) restrict access to Personal Information to only those Seller employees as is necessary to perform Seller’s obligations under an Order; (c) ensure that all Seller employees with such access have obligations as strict as Seller’s obligations under this Section and have been informed of those obligations; (d) use security measures to protect all Personal Information from unauthorized access, use, disclosure, alteration or destruction; (e) maintain any records that include Personal Information in accurate and current form; (f) on Kindeva’s request, provide reasonable assistance with updating, correcting, verifying, and providing individuals with access to their Personal Information related to an Order; and (g) promptly notify Kindeva if any unauthorized person accesses, uses, or discloses any Personal Information related to an Order, or if any individual requests access to, correction of, or revokes consent for, Personal Information related to an Order.
11. PRODUCTION DISCONTINUATION. Prior to Seller’s discontinuing the manufacture or sale of any Good identified in any Order issued by Kindeva during the preceding twelve (12) months: (a) Seller will fill all current Orders for that Good; (b) Seller will give Kindeva at least six months’ prior written notice of that discontinuation; and (c) Kindeva will have the right to issue a last-time buy Order for, and Seller will deliver, that discontinued Good at its then-current price in an amount up to Kindeva’s largest twelve-month purchase volume (based on Orders issued).
12. INDEMNIFICATION & INSURANCE. Seller will indemnify, defend, and hold harmless Kindeva, its affiliates, and their successors, assigns, officers, directors, employees, and agents for, from and against any claim, liability, loss, damage, lien, judgment, duty, fine, civil penalty and cost, including attorneys’ fees and litigation expenses, arising out of: (a) Seller’s failure to comply with any of its obligations under an Order (including these Terms), which may include, without limitation, those relating to a resulting Good recall or other reasonable action Kindeva takes regarding any such failure; (b) violation of third-party intellectual property rights; and (c) claims arising out of handling, packaging, labeling, storage, treatment, removal, transportation, and disposal of Goods or any waste material at any Seller site or related to the Goods under any laws, including, without limitation, the Comprehensive Environmental Response, Compensation and Liability Act (42 U.S.C. Sections 9601 et seq. as amended, known as “CERCLA”), the Hazardous Materials Transportation Act (49 U.S.C. Sections 5101 et seq.), the Resource Conservation and Recovery Act (42 U.S.C. Sections 6901 et seq., known as “RCRA”), European Regulation 1907/2006 REACH, UK REACH, Directive  2002/95/EC, known as “RoHS” and Directive 94/62/EC, Packaging Directive, and/or any local laws that transpose RoHS and the Packaging Directive, or any other current or future law of similar effect. These indemnities do not affect any other Kindeva remedies. Seller will maintain liability, property damage, and other insurance to protect Kindeva from all the foregoing risks, and will, on request, supply certificates evidencing this coverage.
13. U.S. GOVERNMENT SUBCONTRACT TERMS AND CONDITIONS. Be advised that Seller’s Goods and/or Services may be included in products and/ or services Kindeva sells directly or indirectly to the U.S. Government. Due to such sales, certain, limited number of Federal Acquisition Regulation (FAR) and Defense FAR Supplement (DFARS) contract clauses required for the purchase of commercial items by the U.S. Government, will be “flowed down” in all Orders. The applicable FAR and DFARS clauses, including any explanatory notes following the clause citations, and other terms and conditions that apply to Orders for commercial items (“Flow-Downs”) will be provided to Seller for applicable transactions. The Flow-Downs will be incorporated into this Order by reference to the extent required by applicable Federal laws and/or regulations, or as necessary to protect the rights and obligations of Kindeva as such clauses are included in U.S. Government prime contracts or higher-tier subcontracts awarded to Kindeva. These Flow-Downs will have the same force and effect as if they were included in full text in this Order.
14. ENGINEERING CHANGE. An Engineering Change is a mechanical, electrical, material, process, formulation, or location change that could affect the Good’s safety, performance, cost, reliability, appearance, materials (including source of supply), or composition. Unless the Parties have otherwise agreed to a more stringent communication process, either Party may request an Engineering Change, but it will occur only if the Parties agree in writing as to the implementation date, any resulting impact to the Requirements, cost savings, or other outcomes.
15. UNAVOIDABLE DELAY. If a Party cannot perform its obligations, in whole or in part, under an Order as a result of civil or military authority, war, flood, fire, epidemic, or other condition or cause beyond its reasonable control and not related to its fault or negligence (an “Unavoidable Delay”), that Party will be excused from that performance during the Unavoidable Delay to the extent that performance is prevented or delayed. If Seller has an Unavoidable Delay, Kindeva may modify or terminate any Orders on notice to Seller without liability to Seller. During a Seller Unavoidable Delay, Seller will allocate any available Goods as is fair and reasonable. Unavoidable Delay will not include: (a) any labor dispute; (b) non-performance by Seller’s supplier; or (c) any delay preventable by Seller through moving the affected Goods to an alternate Kindeva-approved Seller facility.
16. SELLER WAIVER OF DAMAGES. KINDEVA WILL NOT, UNDER ANY CIRCUMSTANCES, BE LIABLE TO SELLER FOR SPECIAL, INDIRECT, OR CONSEQUENTIAL DAMAGES (INCLUDING BUT NOT LIMITED TO, LOSS OF PROFITS) IN ANY WAY RELATED TO GOODS, SERVICES, AN ORDER, OR ITS TERMINATION, REGARDLESS OF THE LEGAL OR EQUITABLE THEORY ON WHICH THE DAMAGES ARE SOUGHT.
17. DISPUTE RESOLUTION. Any claim or dispute arising from, or relating to, a Good, Service, or an Order (including these Terms) for an Order issued by Kindeva Drug Delivery L.P.: (a) will be governed by the laws of the State of Minnesota, United States of America, without regard to its conflicts of law provisions; and (b) must only be litigated in a federal or state court of competent jurisdiction in the State of Minnesota, USA.  Any claim or dispute arising from, or relating to, a Good, Service, or an Order (including these Terms) for an Order issued by Kindeva Drug Delivery Limited: (a) will be governed by the laws of England, without regard to its conflicts of law provisions; and (b) must only be litigated in English courts.  Each Party consents to the above-referenced and applicable courts’ personal jurisdiction. Each Party will bear its own costs in dispute resolution, except that if a Party commences litigation, the losing Party in that litigation will pay all the prevailing Party’s attorneys’ fees, court costs, and other expenses related to that litigation. The 1980 United Nations Convention on Contracts for the International Sale of Goods will not govern an Order. All negotiations will be conducted in English, and all documents, including all Orders, will be written in English.
18. NOTICES. Unless otherwise stated in these Terms, any permitted or required notice must be in writing and personally delivered, including via any internationally recognized overnight service: (a) for Orders issued by Kindeva Drug Delivery L.P., to Kindeva at: Kindeva Drug Delivery L..P., 11200 Hudson Road, Minnesota, USA 55129, Attention: Chief Executive Officer, with copy to Kindeva General Counsel at the same address, and for Orders issued by Kindeva Drug Delivery Limited, to Kindeva at: Kindeva Drug Delivery Limited, Derby Road, Loughborough, Leicestershire, LE11 5SF, United Kingdom; and (b) to Seller at the address to which the applicable Order was sent. Notice of a Party’s address change will be given as stated above.
19. GENERAL TERMS. Reference in these Terms to laws includes all federal, state, provincial, regional, territorial and local laws, statutes, regulations, rules ordinances and directives of any government. Each Order (including these Terms) is the Parties’ final and complete agreement, and it terminates all their prior written or oral agreements and understandings as to that Order’s subject matter except no Order is intended to terminate or supersede any existing confidentiality or intellectual property agreement by the Parties, including, without limitation, a General Supplier & Patent Agreement or Supplier Agreement or any written agreement between the Parties that specifically covers the Order or other written terms Kindeva has provided to Seller, that specifically covers that Order. All these Terms including, without limitation, those relating to safety, regulatory compliance, warranty, insurance, indemnification, and confidentiality will survive an Order’s end and be fully enforceable thereafter to the full extent necessary to protect the Party in whose favor they run. A Party’s failure(s) to insist on strict performance, or to exercise its rights, under an Order, does not waive subsequent compliance with that Order. All Kindeva rights and remedies under an Order are cumulative, and in addition to any other rights and remedies provided in law or equity. Seller may not assign an Order or any of its rights or obligations under an Order, including, without limitation, any subcontracting (“Assignment”), without Kindeva’s prior written consent. No purported Assignment by Seller is binding on Kindeva without its prior written consent. No Kindeva consent to a Seller Assignment relieves Seller of any obligations under an Order, and Seller will ensure that any full assignee assumes all of Seller’s obligations under these Terms and that any subcontractor is bound by terms as stringent as these Terms. Except as otherwise provided in these Terms, an Order may only be modified by a written document signed by the Parties’ authorized representatives.