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Kindeva drug delivery purchase order terms & conditions

These Purchase Order Terms & Conditions are an integral part of the Agreement (as defined below) between KINDEVA (as defined below) and Seller (as defined below) for the supply of goods, products, materials (“Goods”) and/or services (“Services”) to KINDEVA. The contracting parties to this Agreement are (a) Kindeva Drug Delivery L.P. or its affiliate as designated on the corresponding Purchase Order (“KINDEVA”), and (b) the vendor, contractor, or service provider designated on such Purchase Order (“Seller”).

1. Agreement and acceptance

1.1. The entire agreement (the “Agreement”) between KINDEVA and Seller consists of the following documents and any inconsistencies in this Agreement shall be resolved in accordance with the following descending order of precedence:

  • (a) the purchase order referencing this document (the “Purchase Order”);
  • (b) any accompanying order form, statement of work, or similar ordering document, as negotiated and accepted by KINDEVA;
  • (c) the applicable governing contract (“Primary Agreement”);
  • (d) these Purchase Order Terms and Conditions; and
  • (e) any plans, requirements or specifications provided by KINDEVA to Seller (“Specifications”).

1.2. Nothing in the Agreement shall be interpreted to prevent KINDEVA from obtaining from any other third party, or providing to itself, any or all such Goods or Services or from ceasing to use Seller to provide such Goods or Services. The Agreement contains the entire understanding of the parties with respect to the matters contained herein and supersedes and replaces, in the entirety, any and all prior communications and contemporaneous agreements and understandings, whether oral, written, electronic or implied between the parties with respect to the subject matter hereof.

1.3. Seller shall notify KINDEVA of its acceptance of this Purchase Order or Agreement within five (5) business days of receipt from KINDEVA. If Seller does not timely notify KINDEVA of its acceptance, Seller shall be deemed to have accepted this Agreement:

  • (a) by Seller’s initiation of performance;
  • (b) by Seller’s provision of Goods or Services covered by the Purchase Order or Agreement; or
  • (c) by Seller’s acceptance of any payment made by KINDEVA pursuant to the Purchase Order or Agreement,
    in each case, whichever occurs first.

2. Delivery schedule; quantities

2.1. Seller must comply with the delivery schedule required by KINDEVA in the Agreement. The quantities of Goods shipped to KINDEVA shall not deviate from the quantities specified in the Agreement, except by execution of a written modification agreement of the parties. Goods shipped to KINDEVA prior to the delivery schedule in the Purchase Order, or in excess of the quantity ordered, may be returned to Seller at Seller’s expense and Services performed prior to the delivery schedule shall be at Seller’s risk and cost, without any obligation of payment by KINDEVA.

3. Delivery; delays in delivery

3.1. Time is of the essence and the performance of Services or delivery of Goods shall be made strictly in accordance with the schedule set out in the Purchase Order. In addition, Seller shall apply all appropriate measures to minimize any delay in such performance of Services or delivery of Goods. Any extension of time agreed to by KINDEVA regarding performance of Services or delivery of Goods shall only apply to the extended performance of Services or delivery of Goods. Any such extension shall not be deemed to be a waiver of KINDEVA’s rights to receive performance of Services or delivery of Goods that were not covered under the extension.

3.2. If, for any reason, Seller fails to substantially comply with the delivery schedule, KINDEVA, at its option, may either (i) approve a revised schedule, or (ii) may terminate the Purchase Order in accordance with clause 18. The parties agree that KINDEVA shall be entitled to liquidated damages, as a genuine pre-estimate of KINDEVA’s loss and not as a penalty, equal to one percent (1%) of the applicable Purchase Order cost for each day that delivery of Goods or performance of Services is delayed beyond ten (10) business days, up to a maximum of ten percent (10%) of the applicable Purchase Order cost. Where delay continues beyond the point at which this cap is reached, KINDEVA may pursue its other rights and remedies (including termination and damages) in respect of the continuing delay. Seller shall promptly notify KINDEVA of any actual or anticipated delays to the Purchase Order schedule.

3.3. In the event of any variation of the Purchase Order schedule without KINDEVA’s prior written authorization or failure to deliver Goods or perform Services in accordance with the Purchase Order, Seller shall be liable for all resulting losses/damages, including but not limited to, failure to meet the representations and warranties made in clause 20, excess costs of cover incurred in procuring the ordered Goods or Services from an alternative source, and production losses.

4. Price

4.1.  Supplier shall provide Customer with the lowest net price offered by Supplier for substantially similar products or services to any other customer whose aggregate annual purchase volume for such products or services is equal to or less than Customer’s aggregate annual purchase volume. If Supplier offers a lower net price to any such customer, Supplier shall immediately apply such lower price to Customer and provide a retroactive credit for all affected purchases made by Customer from the date such lower price first became effective.

 

4.2. Seller agrees that prices for Goods and Services ordered in the Purchase Order or Agreement are fixed, not subject to change, except to the extent as expressly set forth in the Agreement, and that no surcharge may be added to the price.

5. Packaging and shipping

5.1. All Goods prepared for shipment: shall be packed in appropriate containers to prevent damage or deterioration; shall comply with carrier tariffs; shall include a packing list; shall include a certificate of analysis or conformance for Goods; and shall comply with all applicable import and export regulations. For Purchase Orders involving delivery of Goods on wooden pallets, the wooden pallets used for delivery must contain the ISPM15 certification stamp or such Goods may be returned at Seller’s sole cost and risk. No charges shall be paid by KINDEVA for preparation, packing, and crating unless separately stated in the Purchase Order.

5.2. Goods shall be delivered DAP [KINDEVA site as specified on the Purchase Order] (Incoterms 2020) unless otherwise specified in the Purchase Order. Goods shall be delivered in containers, bearing necessary labels which conform to applicable national, state and local regulations for the packaging, labeling and transport of materials, or the regulations of internationally recognized laws and standards for the packaging, labeling and transport of materials in effect at the time of shipment.

6. Payment

6.1. KINDEVA shall pay in accordance with the terms indicated on the Purchase Order only after KINDEVA’s acceptance of Goods or Services. If no payment terms are listed on the Purchase Order, payment of undisputed amounts shall be due ninety (90) days from KINDEVA’s receipt of Seller’s invoice.  Seller’s invoice shall not be sent till Kindeva has received the purchased goods or services.

6.2. If KINDEVA disputes the amount of any Seller invoice, KINDEVA may withhold amounts equal to the reasonably disputed amount from Seller’s invoices until the parties settle such dispute. Seller shall continue to perform all of its obligations under the Purchase Order during any period in which KINDEVA withholds any portion of Seller’s invoices; provided, however, the parties shall use good faith efforts to resolve any invoice disputes within thirty (30) days after identification of the disputed withheld amounts. In the event such dispute is not resolved within thirty (30) days, the arbitration provisions of clause 29 shall apply.

6.3. Without limiting any other right or remedy, KINDEVA may at any time set off any amount owing to it by Seller (whether under this Agreement, any Purchase Order, or otherwise, and whether or not the amount is presently payable) against any amount payable by KINDEVA to Seller under this Agreement or any Purchase Order.

6.4. In no event, will Supplier refuse delivery of goods as leverage to resolve disputed invoices

7. Inspection & latent defects

7.1. Payment for Goods and Services under the Purchase Order shall not constitute an acceptance thereof. All Goods and Services shall be received subject to KINDEVA’s inspection, and any KINDEVA-required test methods, to confirm that the Goods conform to the terms of the Agreement. In addition to any other available remedies, KINDEVA may pursue the following remedies for Goods or Services that do not conform to the terms of the Agreement. Upon rejection of Goods or Services, KINDEVA may at its sole discretion:

  • (a) return the Goods (if practicable) at Seller’s risk and expense for prompt refund of previous payments or prompt replacement with conforming Goods;
  • (b) halt the delivery of any additional Goods or performance of additional Services for prompt correction by Seller;
  • (c) require Seller to deliver additional quantities of Goods in the event KINDEVA receives less than the amount ordered, or to perform additional Services to correct non-conforming Services at Seller’s sole risk and expense; and/or
  • (d) accept some or all of the Goods or Services subject to an equitable adjustment in price and, if applicable, return non-conforming Goods to Seller at Seller’s risk and expense.

7.2. If KINDEVA directs Seller to repair, replace, or re-perform as appropriate to correct non-conforming Goods or Services, and Seller fails to complete the same, Seller shall refund to KINDEVA the fees paid by KINDEVA hereunder for the non-conforming Goods or Services, and shall be liable for KINDEVA’s costs of cover incurred in procuring the ordered Goods or Services from an alternative source, and production losses.

7.3. KINDEVA shall have the continuing right to reject Goods due to defects not readily discoverable from testing according to Specifications, reasonable inspection or review (“Latent Defects”), provided KINDEVA notifies Seller of the Latent Defects within sixty (60) business days after the discovery of Latent Defects, and KINDEVA may elect one or more remedies as set forth above in this Agreement. In addition, Seller shall compensate KINDEVA for any and all consequential damages incurred by KINDEVA as the result of any manufacturing failure associated with the use of Goods or Services rejected in accordance with this clause 7.

8. Changes

8.1. KINDEVA reserves the right to make changes in the Purchase Order including, without limitation, changes to the Specifications and delivery schedule (“Change Orders”). Seller agrees to perform in accordance with such Change Orders. If such Change Orders result in a decrease or increase in Seller’s cost or in the time for performance, an equitable adjustment in the price or time for performance shall be agreed to in writing between KINDEVA and Seller prior to the commencement of any additional work or incurred expenses. Any claim(s) for additional compensation hereunder must be asserted within thirty (30) days after receipt of such Change Orders. Failure of Seller to timely assert any such claim(s) shall operate as a waiver of the claim(s).

9. Returns

9.1. Subject to the following conditions, KINDEVA shall have the right to return Goods to Seller for a refund of the price paid, except to the extent such Goods were custom manufactured to Specifications unique to KINDEVA’s requirements. For custom made Goods, Seller will compensate KINDEVA for the difference between the price charged to KINDEVA for the Goods and Seller’s costs associated with selling or making the Goods. In order to exercise this right, KINDEVA must bear all costs of returning the Goods to the Seller,and the Goods must be in their original, unopened condition (except as may be required for inspection by KINDEVA).

10. Material and equipment

10.1. Unless otherwise specified, Seller must supply all material and equipment required to execute the Purchase Order. Unless otherwise agreed in writing, all Specifications, drawings, technical information, data and/or patterns, tools, equipment, or material of every description furnished to Seller by KINDEVA, or specifically paid for, either partially or totally, by KINDEVA, and any replacement thereof, or any materials affixed or attached thereto, shall be and remain the personal property of KINDEVA. While in Seller’s custody or control, the property shall be:

  • (a) held at Seller’s risk;
  • (b) insured by Seller at Seller’s expense, in an amount equal to the property’s replacement cost, with losses payable to KINDEVA; and
  • (c) subject to removal upon KINDEVA’s written request.

11. Taxes; duties and tariffs

11.1. Unless otherwise indicated, the Purchase Order prices shall include any and all VAT, sales, federal, state and local taxes, import duties, customs charges and tariffs applicable to the Goods or Services or to any materials incorporated therein. For the avoidance of doubt,

12. Indemnification relating to infringement of patents, trademarks, intellectual property

12.1. Seller warrants that neither the Goods or Services nor the use of the Goods or Services by KINDEVA will infringe on any existing patent, trademark or copyright. Seller shall defend, indemnify and hold harmless KINDEVA, its employees, affiliates, directors, officers, agents and customers (collectively, “Representatives”) from and against any and all losses, liabilities, costs, claims, damages and expenses (including reasonable legal costs) resulting from or arising out of any suit, claim, or demand alleging patent, trademark or copyright infringement or misappropriation of any trade secret arising out of or in connection with the Purchase Order. All royalties for patents or charges for the use of patents which may be involved in the performance of the Purchase Order shall be included in the cost of performance and shall be paid by Seller. Seller grants KINDEVA a fully paid-up, perpetual, non-exclusive, transferable, sub-licensable license to Seller’s intellectual property to the extent necessary to make, have made, use, and sell the Goods or Services. To the extent any license to a third party’s intellectual property is necessary for KINDEVA to make, have made, use, and sell the Goods or Services, Seller shall obtain such license at its sole expense for KINDEVA’s benefit.

12.2. All data, information, reports, results, documentation, databases, formulations, writings, products, compounds, discoveries, improvements, solutions, new uses, ideas, trade secrets, know-how, concepts, software programs, processes, records, research, creations, other products and all works of authorship, inventions and all other intellectual property (whether or not copyrightable, patentable or entitled to or eligible for other forms of legal protection), conceived, or reduced to practice, or otherwise prepared, developed or improved, by Seller in the course of performance of Services hereunder (“Inventions”) shall be deemed works made for hire and made in the course of Services rendered, and shall be the sole and exclusive property of KINDEVA with KINDEVA having the sole right to obtain, hold and renew, in its own name and/or for its own benefit, patents, copyrights, registrations and/or other appropriate protection. To the extent that exclusive title and/or ownership rights may not originally vest in KINDEVA as contemplated hereunder, Seller hereby irrevocably assigns, transfers, and conveys to KINDEVA all right, title and interest therein, and appoints KINDEVA as Seller’s duly authorized attorney-in-fact to execute, file, prosecute and protect the same before any government agency, court or authority. At no additional cost, Seller and its personnel shall give KINDEVA, and/or any KINDEVA designee, all reasonable assistance and execute all documents necessary to assist and/or enable KINDEVA to perfect, preserve, register and/or record its rights in any such Inventions.

12.3. Seller shall, at KINDEVA’s request, or upon the termination, cancellation, expiration, or completion of Services or this Agreement, deliver to KINDEVA all materials, data, other tangible information, or intellectual property referred to in this clause, deliverables prepared or developed as a result of this Agreement and/or any Services, and any KINDEVA documents or other materials held by or on behalf of Seller, together with all copies thereof. In no event will Seller destroy any of the foregoing documentation relating to KINDEVA projects without providing thirty (30) days’ prior written notice to KINDEVA to permit KINDEVA to obtain any such documentation.

13. Indemnification

13.1. In addition to the specific indemnification obligations outlined in clause 12 and clause 14 and to the fullest extent permitted by applicable law, Seller shall defend, indemnify and hold KINDEVA and its Representatives harmless from and against any and all claims, damages, and liabilities of every kind, including but not limited to patent infringement, trade secret misappropriation, and liability based on contributory, vicarious, or any other doctrine of secondary liability (“Losses”) arising out of or relating to any and all claims, liabilities, liens, demands, obligations, actions, proceedings, suits, causes of action (regardless of whether or not such Losses are caused in part by a party indemnified hereunder) arising out of or related to:

  • (a) Seller’s acts or omissions in connection with the Agreement;
  • (b) injury or death of any person or damage to any property resulting from or caused by Seller or its Representatives in connection with the Agreement;
  • (c) the negligence or willful misconduct of Seller or its Representatives; or
  • (d) a breach by Seller or its Representatives of any provision set forth in the Agreement.

13.2. KINDEVA or its Representatives may assume their own defense or join in the defense of any action in which they are made a party, with counsel of its own choosing, in which event the indemnities in the Agreement and the requirement to hold KINDEVA and/or its Representatives harmless shall extend to all of KINDEVA’s and/or its Representatives’ cost therein, including attorneys’ fees and litigation costs. Seller shall not have the right to settle any claim without the prior written consent of KINDEVA.

13.3. If KINDEVA is subpoenaed in a third-party litigation, Seller: (i) shall indemnify KINDEVA from and against any and all costs and expenses (including legal fees and expenses) reasonably related to such subpoena and any required internal investigations; and (ii) if Seller requests KINDEVA’s assistance in any litigation that Seller is involved in and to which KINDEVA is not a party (which assistance may include, without limitation, production of documents), Seller shall pay KINDEVA for assistance at KINDEVA’s then-current rates based on timing of the request, resource demand, and any business disruption that may be caused by such request. This clause 13 shall not be construed to limit or exclude any other claims or remedies at law or in equity that KINDEVA may assert.

14. Sanctions, trade controls, & anti-money laundering compliance

14.1. Seller represents and warrants that:

  • (a) neither Seller nor any of its officers, directors, or employees involved in the execution of this Agreement (including those participating in negotiations, meetings or acting as signatories of contractual documents) is: (a) a person or entity that appears on the Specially Designated Nationals and Blocked Persons List, the Sectoral Sanctions List or the Foreign Sanctions Evaders List maintained by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”) or any other blocked, restricted, sanctioned or denied parties list maintained by the U.S. government (including any department thereof) or any other government having jurisdiction over the transaction between Seller and KINDEVA; or (b) a person, country, or entity with whom KINDEVA is otherwise prohibited from dealing with under any applicable U.S., UK or non-U.S. economic sanctions or export control law, executive order, regulation, rule or sanction, including, but not limited to, the regulations administered by OFAC, 31 C.F.R. Parts 500-598 (the “OFAC Regulations”), the regulations administered by OFSI, the UK Sanctions and Anti-Money Laundering Act 2018, or the Export Administration Regulations, 15 C.F.R. Parts 730-774 (collectively, “Trade Control Laws”) (a “Sanctions Target”);
  • (b) Seller is not, directly or indirectly, 50% or more owned in the aggregate by one or more Sanctions Target(s), or controlled by, or under common control with, or acting for the benefit of or on behalf of, any Sanctions Target;
  • (c) Seller does not, and will not, source components, materials or Services from any sanctioned country or region as identified by the U.S. Department of the Treasury, OFSI or other relevant government authority, and will not use the Services of, or procure any material or components from, any person who is a Sanctions Target (or directly or indirectly owned or controlled by Sanctions Targets) including as a bank or financial institution, shipping company, freight forwarder, vessel, courier, insurance provider or as any other intermediary or service provider in connection with the transaction between KINDEVA and Seller;
  • (d) Seller has complied, and is in compliance, with all national and international applicable laws promulgated by any governmental authority applicable to Seller with regard to the exportation of Goods, technology or software, and has held, and currently holds, all necessary licenses with respect to the foregoing, and specifically, but without limitation of the foregoing, Seller has not exported or re-exported, and will not export or re-export any Goods, technology or software in any manner in connection with the transaction with KINDEVA that violates any applicable Trade Control Laws; and
  • (e) Seller is in compliance with all applicable U.S., UK and global anti-money laundering laws and regulations, and the financial transactions and/or financial institutions involved in the transaction with KINDEVA were, and are, at all times, in full compliance with any special designations, rules or proposed rules promulgated pursuant to Section 311 of the USA PATRIOT Act, the UK Proceeds of Crime Act 2002, the UK Money Laundering, Terrorist Financing and Transfer of Funds (Information on the Payer) Regulations 2017, and any other applicable anti-money laundering legislation.

14.2. Seller shall irrevocably and unconditionally hold KINDEVA and its Representatives fully harmless from, and keep KINDEVA and its Representatives fully indemnified against, all and any losses, damages, fines, penalties, costs and expenses whatsoever which it or they may suffer, arising or resulting from any breach or violation, caused by, or attributable to, Seller (including its employees, shareholders, affiliates, directors, officers, servants, agents, subcontractors and representatives) of any: (a) applicable Trade Control Laws; and (b) statements, representations and warranties contained hereinabove. Further, KINDEVA shall be entitled to terminate the Agreement or stop or withhold performance (including payments) hereunder, without any liability whatsoever, in the event of any breach of the statements, representations and warranties contained hereinabove or if such performance or continuation of the Agreement would, in KINDEVA’s opinion, violate any applicable Trade Control Laws or anti-money laundering laws.

15. Limitation of liability

15.1. IN NO EVENT SHALL KINDEVA BE LIABLE TO SELLER OR ITS REPRESENTATIVES FOR LOST PROFITS OR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE OR INDIRECT DAMAGES ARISING FROM OR RELATED TO THIS AGREEMENT, WHETHER OR NOT KINDEVA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

16. Assignment

16.1. Seller shall not assign the Purchase Order, this Agreement, or any compensation due or to become due hereunder, without the prior written consent of KINDEVA. Any assignment or attempted assignment made without such consent of KINDEVA shall be void.

16.2. KINDEVA may assign or novate the Purchase Order and this Agreement, in whole or in part, to any affiliate of KINDEVA or in connection with a merger, reorganization, change of control, or sale of all or substantially all of the business or assets to which this Agreement relates, without the consent of Seller.

17. Termination for convenience

17.1. KINDEVA may, at any time and upon written notice, terminate the Purchase Order, in whole or in part, regardless of whether Seller is in default under this Agreement. Such written notice shall state the extent and the effective date of termination. Upon receipt of such notice, Seller shall take all necessary steps to mitigate any losses Seller might incur on account of such termination. Upon such termination, KINDEVA’s obligation to Seller shall be limited solely to payment for:

  • (a) Goods already delivered to and accepted by KINDEVA;
  • (b) Services performed and accepted by KINDEVA; and
  • (c) with respect to Goods produced pursuant to Specifications unique to KINDEVA and not yet delivered to KINDEVA, reimbursement of the actual costs incurred by Seller in fulfillment of the Purchase Order to the extent that such costs are reasonable and are properly allocable under generally accepted accounting principles, excluding any lost or anticipated profits, as sufficiently evidenced in writing to KINDEVA.

17.2. The total payment KINDEVA is obligated to make under clause 17.1(c) shall not exceed the lesser of the actual costs incurred by Seller to fulfill the Purchase Order or fifty percent (50%) of the price which would have been paid had the Purchase Order not been terminated.

17.3. Seller shall comply with KINDEVA’s instructions concerning Goods that Seller has already furnished or partly furnished to KINDEVA. Notwithstanding contrary provisions in this Agreement, in the event of termination for convenience of a Purchase Order prior to delivery, KINDEVA shall have no responsibility to pay for:

  • (a) finished Goods in production or Goods fabricated or procured by Seller for producing such Goods when such Goods were fabricated or procured by Seller unnecessarily in advance or in excess of KINDEVA’s delivery schedule;
  • (b) items normally carried in inventory by Seller, as distinguished from Goods that are specially made to KINDEVA’s Specifications; or
  • (c) Services that have not been performed.

17.4. Termination by KINDEVA under this clause shall be without prejudice to any claims KINDEVA may have against Seller. The payment provided under this provision shall constitute KINDEVA’s only liability in the event the Purchase Order is terminated as provided in this clause 17. The foregoing shall not apply to any termination by KINDEVA on account of Seller’s default under clause 18.

18. Termination for default

18.1. Each of the following events shall constitute a default by Seller for purposes of this Agreement:

  • (a) the insolvency of Seller;
  • (b) any assignment for the benefit of creditors of Seller;
  • (c) the voluntary or involuntary filing of a petition, order or other decree in bankruptcy by or against Seller;
  • (d) the commencement of any proceeding, under court supervision or otherwise, for liquidation of, reorganization of, or the composition, extension, arrangement or readjustment of the obligations of Seller;
  • (e) failure by Seller to comply with KINDEVA’s reasonable instructions and Change Orders;
  • (f) failure by Seller to comply with any of the provisions of the Purchase Order;
  • (g) failure of the Goods to conform to Seller’s warranties contained in the Agreement or otherwise made by Seller;
  • (h) failure of Seller to make deliveries as scheduled;
  • (i) Seller’s breach of any representations or warranties in the Agreement; and
  • (j) any actual or alleged violation of KINDEVA’s Supplier Guidelines posted at KINDEVA’s website https://www.kindevadd.com/supplier-code-of-conduct/ [

18.2. In the event of any such default, KINDEVA, in addition to other rights it may have under applicable law or other terms of this Agreement, shall have the right:

  • (a) to refuse to accept further delivery of Goods or performance of Services;
  • (b) to return to Seller, at Seller’s expense, any Goods already delivered and to recover all payments made and for expenses incurred;
  • (c) to recover any advance payments to Seller for undelivered or returned deliverables and/or for Services that have not been performed; and
  • (d) to procure the ordered Goods and Services from an alternative source.

19. Waiver

19.1. No delay or omission in exercising any right or remedy shall operate as a waiver thereof or of any other right or remedy, and no single or partial exercise thereof shall preclude any other or further exercise thereof or the exercise of any other right or remedy. The rights, powers, elections and remedies of the parties hereunder are cumulative and in addition to those which the parties have at law or in equity. KINDEVA’s failure to object to any provision contained in any communication from Seller shall not be deemed to be an acceptance of such provision or a waiver of any provision of this Agreement.

20. Warranties & representations; compliance with laws and policies

20.1. Seller represents and warrants that all Goods:

  • (a) shall be merchantable and fit for the intended purpose(s);
  • (b) shall conform with any Specifications and with applicable drawings, samples, or other descriptions given to Seller by KINDEVA;
  • (c) shall be free from defects in materials and workmanship; and
  • (d) shall be free from defects in design except if the defect is inherent in Specifications provided by KINDEVA.

20.2. Seller represents and warrants that all Services:

  • (a) shall be performed in a timely, workmanlike and professional manner, using materials that are free from defects;
  • (b) shall be performed and completed in accordance with the Specifications and any delivery dates provided by KINDEVA; and
  • (c) shall not conflict with, or be prohibited in any way by, any contract or statutory obligation to which Seller is bound.

20.3. Seller expressly warrants and certifies that (i) Seller is not debarred under Section 306 of the United States Food, Drug and Cosmetic Act (the “Act”) (21 U.S.C. §§ 335a(a) or (b)) and (ii) Seller did not and will not use in any capacity the Services of any person debarred under the Act or who has engaged in activities that could lead to being debarred. Should Seller become debarred under such Act or become aware of using in any capacity the Services of any person debarred, Seller shall promptly notify KINDEVA and shall amend the certification provided herein accordingly.

20.4. Seller warrants and represents that it has (i) full ownership, clear title free of any liens, or (ii) the right to perform Services or deliver Goods to KINDEVA under the Purchase Order or Agreement. The foregoing warranties do not constitute a waiver of any other rights of KINDEVA, express or implied. These warranties shall run to KINDEVA, its successors and assigns, its customers and the users of its products, and shall survive acceptance, inspection and payment.

20.5. The warranties in this clause shall survive delivery, inspection, acceptance and payment, and shall remain in effect for the longer of (i) twenty-four (24) months following delivery and acceptance of the Goods or completion of the Services, or (ii) any applicable shelf-life, expiry, or warranty period specified in the Specifications. If any Goods or Services fail to conform to these warranties during the warranty period, Seller shall, at KINDEVA’s election and at Seller’s cost (including all shipping, handling, and re-testing costs), promptly repair, replace, or re-perform the non-conforming Goods or Services, or refund the amounts paid, in each case without prejudice to KINDEVA’s other rights and remedies.

20.6. Seller shall, in the performance of the Purchase Order, comply with all applicable laws, statutes, rules, regulations and orders of governmental, public and quasi-public authorities, including with respect to Goods required to be manufactured according to Good Manufacturing Practices, the rules, regulations, directives and guidance documents of the U.S. Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency, the U.S. Drug Enforcement Administration (in respect of controlled substances), and the International Council for Harmonization. Seller shall comply in all respects with KINDEVA’s Supplier Guidelines posted here: https://www.kindevadd.com/supplier-code-of-conduct/.. At KINDEVA’s request, upon reasonable notice, Seller shall make its records and facilities available for audit by KINDEVA (or its designated representative) to enable KINDEVA to assess Seller’s compliance with and performance under this Agreement.

21. Recall and quality cooperation

21.1. If any Goods are or may be subject to a recall, field alert, market withdrawal, or regulatory action (whether initiated by KINDEVA, Seller, or any regulatory authority), Seller shall promptly notify KINDEVA and provide all reasonable cooperation and assistance. Where the recall or action arises from Seller’s breach of this Agreement, defective Goods, or non-conforming Services, Seller shall bear all reasonable costs of the recall or corrective action, including the costs of notification, retrieval, testing, replacement, and destruction, without prejudice to KINDEVA’s other rights and remedies. Seller shall retain records relating to the Goods (including batch, lot, and certificate-of-analysis records) for the period required by applicable law and Good Manufacturing Practice and shall make them available to KINDEVA and relevant regulatory authorities on request. This clause is without prejudice to any separate quality or technical agreement between the parties, which shall govern in the event of conflict on quality matters.

22. Bribery and corrupt practices

22.1. KINDEVA requires Seller to comply with all applicable anti-corruption laws, regulations and policies worldwide that prohibit the making, offering or promise of any payment or anything of value, directly or indirectly, to a government official or a government agency (“Officials”), when the payment is intended to influence an act or decision or the retention of business. Accordingly, Seller represents, agrees and warrants that it shall comply with all applicable anti-corruption laws, rules and regulations, including but not limited to the United States Foreign Corrupt Practices Act and the UK Bribery Act, and that it shall not make any payment of money, gifts, services or anything of value either directly or indirectly, to an Official, when the payment is intended to influence an act or decision or the retention of business.

23. Confidential information

23.1. Definition: As used in this Agreement, the term “Confidential Information” means any confidential or proprietary scientific, technical, intellectual property, trade, business and/or financial information, including pricing information contained in any Purchase Order, of a party (the “Disclosing Party”) provided to the other party (the “Receiving Party”) or to which the Receiving Party has access under this Agreement, whether such information is in oral, written or electronic form and whether or not it is identified as confidential. Notwithstanding the other provisions of this Agreement, a party’s Confidential Information does not include information which the Receiving Party can establish by competent proof:

  • (a) is otherwise readily available to the public through no fault of the Receiving Party;
  • (b) has been rightfully received by the Receiving Party from a third party without restrictions on disclosure and other than in breach of any obligation to the Disclosing Party;
  • (c) has been independently developed by or for the Receiving Party without use of the Disclosing Party’s Confidential Information; or
  • (d) was known to the Receiving Party prior to its first receipt from the Disclosing Party.

23.2. Confidentiality Obligation: The Receiving Party agrees to hold the Confidential Information of the Disclosing Party in trust and confidence and not to disclose such Confidential Information except to those of its employees (including employees of its affiliates) who have a need to know such information for purposes of performing such party’s obligations under this Purchase Order and who are under an obligation of confidentiality that would apply to such information; or as otherwise approved by the Disclosing Party in writing. Notwithstanding the foregoing limitations on disclosure, the Receiving Party may disclose such Confidential Information of the Disclosing Party as is required by any law, rule, regulation, order, decision, decree, subpoena or other legal process to be disclosed. If such disclosure is required by any of the foregoing, the Receiving Party shall, if legally permitted, notify the Disclosing Party of such request promptly prior to any disclosure so as to permit the Disclosing Party to oppose or limit such disclosure by appropriate legal action.

23.3. Restrictions on Use: The Receiving Party agrees that it shall not use the Disclosing Party’s Confidential Information except for the purposes of fulfilling its obligations under this Agreement or as otherwise expressly contemplated by this Agreement.

Reverse Engineering Prohibition: The Receiving Party shall not, and shall procure that its personnel shall not, reverse engineer, decompile, disassemble, scrape or otherwise attempt to derive the Disclosing Party’s formulations, processes or know-how from any Goods, materials or data supplied under or in connection with this Agreement.

23.4. Protective Measures: In protecting the secrecy of and avoiding disclosure and unauthorized use of the Disclosing Party’s Confidential Information, the Receiving Party shall take at least those measures that it uses to protect its own confidential information; however, in no event shall less than a reasonable standard of care be used. The Receiving Party shall immediately notify the Disclosing Party in the event of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information of which the Receiving Party is or becomes aware, provided that in no event shall such notification be deemed an admission for evidentiary purposes.

23.5. Return of Confidential Information: Upon the written request of the Disclosing Party, the Receiving Party shall promptly return to the Disclosing Party or destroy all tangible Confidential Information of the Disclosing Party in its possession or control, except that one (1) copy may be retained by the Receiving Party solely for record-keeping purposes and except that neither party shall have any obligation to return or destroy computer files that are created during automatic system back-up.

23.6. Term of Obligation: The parties’ obligations under this clause 23 shall continue in effect during the term and for a period of five (5) years following termination or expiration of the Agreement; provided, however, that any Confidential Information that constitutes a trade secret under applicable law shall remain protected for so long as such information qualifies as a trade secret under applicable law.

24. Data protection, cybersecurity requirements & network access

24.1. This Agreement incorporates all Seller and any subcontractor information security representations governed by the Kindeva Security Addendum posted at KINDEVA’s website https://www.kindevadd.com/supplier-code-of-conduct/ Each party shall comply with all applicable data protection and privacy laws in force from time to time.

24.2. To the extent Seller processes personal data on behalf of KINDEVA in connection with this Agreement, the parties shall enter into a written data processing agreement incorporating the terms required by Article 28 of the UK GDPR and/or EU GDPR (as applicable) before any such processing begins. Seller shall not engage any sub-processor to process such personal data without KINDEVA’s prior written authorization and shall impose on any authorized sub-processor data-protection obligations no less protective than those in the data processing agreement.

24.3. Whether providing authorized remote services to KINDEVA through its network or performing onsite services at KINDEVA’s premises, Seller and any subcontractor:

  • (a) shall not use non-KINDEVA-owned information technology hardware, hardware components, or software (“assets”) to connect to any group of KINDEVA-owned devices, computers, or other electronic means that communicate and are interconnected (“network”);
  • (b) shall not remove KINDEVA’s assets from KINDEVA’s premises without KINDEVA’s written authorization;
  • (c) shall use KINDEVA’s assets only as authorized in writing by KINDEVA for purposes of this Agreement; and
  • (d) shall only connect with, interact with, or use computer networks and equipment, and communications resources including, but not limited to, serial ports, parallel ports, fax machines, and modems, programs, tools or routines as KINDEVA agrees, at Seller’s risk and expense, and then only in compliance with the Kindeva Security Addendum or with any applicable KINDEVA policies.

24.4. KINDEVA may monitor, in accordance with applicable laws, any communications made over or data stored in KINDEVA’s computer networks and equipment or communications resources.

24.5. Supplier shall implement and maintain appropriate administrative, technical, physical, and organizational safeguards, consistent with Good Industry Practice, to protect Supplier’s systems, networks, and data, including any Kindeva data, from unauthorized access, use, disclosure, modification, destruction, loss, corruption, theft, ransomware, malware, or other security incidents. Supplier shall maintain a written information security program and, throughout the Term, adhere to the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework, ISO/IEC 27001, or another industry-recognized framework providing substantially equivalent safeguards. Such safeguards shall include, at a minimum, access controls, multi-factor authentication, encryption of Kindeva data in transit and at rest, vulnerability management, and security awareness training. Supplier shall notify Kindeva in writing within twenty-four (24) hours of becoming aware of any actual or suspected security incident affecting Kindeva data, systems, or services and shall cooperate fully with Kindeva’s investigation and remediation efforts. Supplier shall ensure that any subcontractor with access to Kinsdeva data is subject to cybersecurity obligations no less protective than those set forth herein.

24.6. For purposes of this Section, “Good Industry Practice” means the degree of skill, care, diligence, prudence, and foresight that would reasonably be expected from a competent and experienced supplier performing similar services under similar circumstances.

 

25. Equal opportunity and non-discrimination

25.1. To the extent Seller is a federal contractor or subcontractor subject to the following regulations, Seller represents and warrants that it shall comply with all applicable equal opportunity and non-discrimination requirements, including as applicable: (a) the equal opportunity clause for protected veterans at 41 CFR 60-300.5(a) (VEVRAA); (b) the equal opportunity clause for individuals with disabilities at 41 CFR 60-741.5(a) (Section 503 of the Rehabilitation Act); (c) 29 CFR Part 471, Appendix A (notification of employee rights); and (d) FAR 52.222-90 (Addressing DEI Discrimination by Federal Contractors), where applicable to KINDEVA’s contracts, and Seller shall provide any certification reasonably required by KINDEVA to comply with Executive Order 14398 and its implementing Federal Acquisition Regulation provisions.

26. Insurance

26.1. Seller shall maintain adequate and appropriate insurance with respect to its obligations under this Agreement including, without limitation, comprehensive general liability insurance, statutory workers’ compensation insurance, disability benefits insurance, employer’s liability insurance, errors and omissions insurance and product liability insurance. At a minimum, Seller shall maintain: (a) commercial general liability insurance (including product liability and completed operations) of not less than USD 5,000,000 per occurrence and in the aggregate; (b) where Services are provided, professional liability / errors and omissions insurance of not less than USD 2,000,000; (c) employer’s liability insurance of not less than USD 1,000,000; and (d) statutory workers’ compensation insurance. All such liability policies shall (i) name KINDEVA and its Representatives as additional insureds, (ii) be primary and non-contributory to any insurance maintained by KINDEVA, (iii) contain a waiver of subrogation in favour of KINDEVA, and (iv) provide for at least thirty (30) days’ prior written notice to KINDEVA of cancellation, non-renewal, or material reduction in coverage. Upon request, Seller shall provide certificates of insurance evidencing the requisite coverage to KINDEVA.

27. Force majeure

27.1. Neither party shall be liable in damages for any delay or default in such party’s performance hereunder if, to the extent and for so long as such default or delay is due to events that are beyond such party’s reasonable control and not to its acts or omissions, including acts of God, regulation or law or other action or failure to act of any government or agency thereof, war or insurrection, civil commotion, earthquake, flood or severe storm, labor disturbances, or epidemic; provided, however, that the party seeking relief hereunder shall immediately notify the other party of such cause(s) beyond such party’s reasonable control. The party that may invoke this clause shall use all commercially reasonable endeavors to preserve its ongoing obligations to the other.

27.2. For the avoidance of doubt, none of the following shall constitute an event of force majeure or excuse or delay a party’s performance: (a) changes in law, tariffs, duties, taxes, or customs charges; (b) increases in the cost of raw materials, components, labour, energy, or transport, or other changes in market or economic conditions; (c) a party’s inability to pay or lack of funds; or (d) any act, omission, or default of Seller’s subcontractors or suppliers that is within Seller’s reasonable control. An event of force majeure shall not relieve either party of any payment obligation that accrued before the event.

27.3. In the event that Seller’s ability to supply Goods subject to any Purchase Order is affected by an event described in this clause: (i) Seller’s obligation under any such Purchase Order to supply ordered quantities of Goods to KINDEVA shall have priority over any obligations of Seller to deliver Goods to any other customer; and (ii) KINDEVA shall have a right of first refusal to buy all or any available Goods in Seller’s stock as of the time that such event arose. Upon the conclusion of the event and restored availability of the subject Goods, any such affected KINDEVA Purchase Order shall be fulfilled by Seller as a priority over other customer orders for the Goods. If the cause(s) continues unabated for one hundred eighty (180) days, KINDEVA shall be entitled to terminate this Agreement upon written notice to Seller.

28. Independent contractor

28.1. Seller and KINDEVA intend that an independent contractor relationship shall be created by this Agreement and nothing herein shall be construed as creating an employer/employee relationship, partnership, joint venture, or other business group or concerted action. Seller and its employees and agents shall not be entitled to participate in, or receive, any benefit or right as an employee of KINDEVA. Seller shall not at any time represent its relationship to KINDEVA as anything other than that of an independent contractor.

29. Governing law; arbitration

29.1. This Agreement, and all actions, causes of action, or claims of any kind that may be based upon, arise out of, or relate to this Agreement, or the negotiation, execution, or performance of this Agreement, shall be governed by, interpreted under, and construed in accordance with the laws of the State of New York, United States, if the Goods are delivered to a US address, and the law of England and Wales, if the Goods are delivered to a UK address, in each case without regard to the principles of conflicts of law.

29.2. All disputes arising from or related to this Agreement shall be submitted to arbitration before a single arbitrator administered by, and under the rules then prevailing of, the arbitral institution and at the seat designated below, which rules are determined to be incorporated by reference into this Agreement, and judgment on the award may be entered in any court of competent jurisdiction. Where the governing law of this Agreement is the law of England and Wales, the seat of arbitration shall be London, United Kingdom, administered by the London Court of International Arbitration (LCIA). Where the governing law of this Agreement is the laws of New York, the seat of arbitration shall be New York City, NY, administered by the American Arbitration Association (AAA) under its Commercial Arbitration Rules. KINDEVA may in its sole discretion consent to an alternative location for the arbitration. The parties acknowledge and agree that all proceedings shall be conducted in English and that the United Nations Convention on Contracts for the International Sale of Goods is specifically excluded from application to this Agreement.

29.3. The arbitrator shall have exclusive authority to resolve any dispute relating to the interpretation, applicability, enforceability, or formation of the agreement to arbitrate, including but not limited to any claim that all or part of the agreement to arbitrate is void or voidable for any reason. Unless the parties agree otherwise, the parties and the arbitrator shall treat the proceedings, any related discovery, and the decisions as confidential, except in connection with judicial proceedings ancillary to the arbitration, such as a judicial challenge to, or enforcement of, an award, and unless otherwise required by law or to protect a legal right of a party. The arbitrator is empowered to impose reasonable limits on discovery, if any, and the time and manner for presenting evidence, with the goal of an efficient and economical arbitration process. The arbitrator must follow the rule of law in entering any award or relief in the arbitration.

30. Notices

30.1. All notices under this Agreement shall be in writing and sent to the addresses stated on the Purchase Order (or as later notified in writing), delivered by hand, by recorded or registered post, or by email with confirmation of receipt. A notice shall be deemed received: if delivered by hand, on delivery; if sent by post, on the second business day after posting (or the seventh business day after posting for international mail); and if sent by email, on the next business day after sending, provided no automated delivery-failure notice is received. This clause does not apply to the service of legal proceedings.

31. Severability

31.1. If any provision of this Agreement is held to be invalid, illegal, or unenforceable, that provision shall be deemed modified to the minimum extent necessary to make it valid and enforceable, or, if it cannot be so modified, it shall be severed, and the remaining provisions of this Agreement shall continue in full force and effect.

32. Survival

32.1. Any provision of this Agreement that by its nature is intended to survive termination or expiry — including the provisions on Inspection & Latent Defects (clause 7), indemnification (clauses 12 and 13), intellectual property and Inventions (clause 12), Confidential Information (clause 23), data protection (clause 24), warranties (clause 20), limitation of liability (clause 15), and Governing Law; Arbitration (clause 29) — shall survive termination or expiry of this Agreement.

33. Third party rights

33.1. Except that KINDEVA’s Representatives may enforce the indemnities, releases, and hold-harmless obligations expressed to be given in their favour, a person who is not a party to this Agreement has no right under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Agreement. The parties may vary, rescind, or terminate this Agreement without the consent of any such third party.

Kindeva Drug Delivery L.P. | 11200 Hudson Road, Woodbury, MN 55129, USA | KINDEVA v1.0, 2026